v>EPA
Unted Slates
Environmental Protection
Healthcare Environmental Assistance Resources
Pollution Prevention and Compliance Assistance
for Healthcare Facilities
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Exhibit XI-23
RCRA Policy Excerpts
EPA Region 2 267
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UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
WASHINGTON, D.C. 20460
June 14, 1990
MEMORANDUM
SUBJECT: RCRA Waste Classification of Laboratory Standards
FROM: David Bussard, Director
Characterization and Assessment Division (OS-330)
TO: Howard Wilson, Manager
Environmental Compliance Program
Environmental Health and Safety Division (PM-273)
This.is in response to your memorandum of March 1, 1990, in which you requestec
that we provide clarification for the classification of wastes generated in
laboratories. Specifically, you presented examples relevant to the preparation of
laboratory standards using substances-regulated under 40 CFR 261.33(e) and (f)
(the Pand U lists).
1) QUESTION: In the preparation of performance evaluation (PE) samples
containing P or U-listed chemicals, an aliquot of the sample is taken and diluted 10
- 1000 fold to a final volume of one liter of water or solvent before analysis. The
first question related to this scenario is whether the PE sample is a commercial
chemical product (CCP) or is eligible for exclusion as a sample. Second, if the PE
sample is indeed considered a commercial chemical product, you inquired whether
the dilution of the PE sample before analysis is considered "use."
For example, organic semi-volatile PE samples to be analyzed for SDWA and NPDE:
certification will contain toxaphene (P123). Would the disposal of excess analytical
solution be considered P123, D015 (if over 0.5 mg/L),D002 (if pH < 2), or a
combination of the above?
ANSWER: Such samples are regulated as commercial chemical products provided
that they have only one active ingredient. In the example you provided, the
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formulation consists of water plus the CCP as the sole active ingredient and,
therefore, the excess analytical solution is correctly classified as EPA Hazardous
Waste No. P123.
(2) QUESTION: In the preparation of laboratory standards, P and U-listed che :al;
are mixed with water, acids, bases, or solvents. The resulting standard solution an
disposed of when there is an excess, when they have exceeded their shelf life, or
when they have been contaminated (not through use). The disposal of these waste
standard solutions bring about several waste classification questions.
2A) QUESTION: Are these waste standard solutions P or U-Iisted wastes in cases in
which the P/U listed solute is dissolved in water, acidic/basic solutions, organic
solvents, or homogeneously mixed in an inert medium such as soil?
ANSWER: The answer in all these situations is "yes," Dissolving or diluting these
chemical products to make laboratory standards (in lieu of buying such solutions)
does not constitute use of these chemicals. TheFederal Register notice which
describes the sole active ingredient rule (§261.33 (d)> refers to the fact that many
of the compounds listed under§261.33 (e) and (f) are frequently dissolved in
solvents, preservatives, and the like, but this fact does not detract from the
material's meeting the listing description (see 45FR 78529, November 25, 1980).
Assuming that there is a sole active ingredient (or, in this case, analyte), the
mixtures you describe in your question meet the listing description in 40 GFR
261.33 even if the solvent (s) used are also listed in§261.33..
2B) QUESTION: If in the preparation of standards an acid or base is used as tb->
solvent for a P or U-listed chemical and the final solution is corrosive, is the
solution, upon disposal, D002 or D004 -D017 if it exceeds the EP Toxicity crit 3,
or a P/U-listed waste? For example, the atomic absorption analysis of arsenic
requires the preparation of a standard with arsenic trioxide. Specifically, i.32 g of
As2O3 (P012)analytical reagent grade) is dissolved in one liter of distilled water,
and several milliliters of concentrated nitric acid are added for preservation. Would
the correct waste classification be P012, D004, or D002 (if pH < 2) or a
combination thereof?
ANSWER: This situation is similar to the previous question. The solution
you describe definitely meets the listing description for P012. Even if the
waste is classified as a listed waste, waste generators should furnish
information regarding whether the waste also exhibits any hazardous
waste characteristics. There are several reasons for this: 1) safety of
personnel at these facilities; 2) There are restrictions in§5264 and 265
regarding various characteristic wastes (e.gT reactivity and ignitability) in
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landfills or surface impoundments; and 3) The Land Disposal Restrictions
program requires such knowledge to comply with Part 268 standards. (Se
55 FR 22520 - 22720, June 1, 1990.) Although Federal law does not
require that all applicable waste codes be placed on the hazardous waste
manifests, Land Disposal Restrictions regulations will require that all wast
codes be reported for the purposes of meeting LDR provisions. (See 40
CFR 268.7.) In addition, many state agencies may have more stringent
rules concerning proper manifesting of wastes in which listing and
characteristic waste codes apply.
2C) QUESTION: In the preparation of quality control solutions, commercial chemic
products (either in liquid or solid form) are dissolved in an organic solvent. Becaus
the organic solvent is used for Fts solvent properties (i.e, to solubilize mobilize, or
dissolve other chemical substances), any excess or expired solutions should be
disposed of with the spent solvent hazardous waste identification number. Is this
correct? • "
For example, if a solution of 0.01 g aldrin (P004) and 0.01 g dieldrin (P037)
dissolved in 100 mL of methanol is to be disposed ofwould the waste be classified
as F003 and P037 and P004? The methanol, in this case, is used to solubilize the
pesticide constituents, and the waste, therefore, meets the spent solvent listing.
'»
ANSWER: The above statements are not correct. The answer to these
questions is just like the answer to question 2A. Assuming that there is
only one active ingredient (i.e., analyte or solute), the excess or expired
solutions should be given the applicable commercial chemical product
hazardous waste identification number under§261.33 no matter how
many solvents are used (even if the solvents themselves are listed in
§261.33). In the above example, more than one active ingredient exists,
therefore the solutidn does not meet any listing description at this time.
Additionally, when a solvent is used to formulate a compound or product
(such a CCP), neither the solvent nor the formulated product meets the
listing description for spent solvents. (See 50FR 53315, December 31,
1985.) The disposed solution would have to be tested for hazardous wast
characteristics, and would probably fail the ignitability (D001)
characteristic.
3) QUESTION: Laboratories prepare many reagents with P and U-listed chemicals.
During the analysis of polychlorinated dibenzo-p-dioxins and dibenzofurans, a
reagent containing methylene chloride/methanol/benzene (75:20:5) is used. Upor
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disposal of excess reagent, would the mixture be identified as U080 (methylene
chloride/CCP), U154 (methanol/CCP), U019 (benzene/CCP), F002 (methyiene,
chloride/solvent), F003 (methanol/solvent), or F005 (benzene/solvent)?
A .
ANSWER: None of the above; If anyone P or U-listed chemical is disso,\/ed
in this reagent for the purpose of analysis, the discarded unused reagent
would carry the waste code of that particular solute. (See answers to 2A
and 2C.) From the description of the reagent you provided above, the
unused reagent would be hazardous only if it exhibits a hazardous
characteristic. This particular reagent would probably exhibit the
characteristic of ignitability (D001). Please note that this waste also would
be EP toxic for benzene when the newly promulgated organic Toxicity
Characteristic becomes effective in September, 1990.
\ ' '•'..-
Thank you for your inquiry. If you have any further questions, please contact Ron
Josephsori of my staff at 475-6715.
cc: Waste Management Division Directors, Regions I -X
Susan Bromm, OWPE (OS-520)
FaxBack # 11523
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FAXBACK 12438
9441.1985(03)
July 31, 1985
LABORATORY WASTE EXCLUSION
Mr. Vincent J. Tersegno
2749 Delk Road, S.E.
Marietta, Georgia 30067
Dear Mr. Tersegno:
Mr. Mitch Dubensky of the Office of Water Regulations
and Standards forwarded your letter dated December 7, 1984, to
the Office of Solid Waste since the exclusion you discussed in
40 CFR §261.4(d) applied to hazardous waste regulated by the
Resource Conservation and Recovery Act.
As you know, the laboratory waste exclusion insures that
waste samples are not subject to all the hazardous waste regula-
tions while the waste is being handles by the sample collector,
transporter and laboratory for the purposes of waste character-
ization. The amendment specifically avoided using the word
"generator" since the exclusion intended to designate any
person collecting a potentially regulated sample.
The enclosed copy of the September 25, 1981, Federal
Register notice provides further explanatory material in
the preamble. On page 47426, the first full paragraph of the
middle column explains that samples are sent for testing to
determine whether or not the was"te is hazardous. Furthermore,
testing to identify the composition or characteristics of a
sample is not treatment as defined in §260.10(a) as stated in
Section C on page 47428. The first sentence at the top of the
right column on page 47428 says any laboratory that treats or
stores hazardous wastes prior to disposal must comply with
applicable RCRA regulations since these activities are not
covered by the exclusion.
The waste is excluded from RCRA regulations as long as it
meets the §261.4(d) terms. At the site where a waste is produced,
the storage and transportation prior to shipment to a testing
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laboratory is not regulated. The term "generator" is defined
in §260.10(a) as the person at a given site whose act or process
produces RCRA hazardous waste or whose act first causes a
hazardous waste to become subject to regulation. Therefore,
in many cases, waste covered by the laboratory exclusion has
had no generator as long as the waste is covered by the
laboratory exclusion. If the waste is sent back to the site
it came from, the waste would be subject to regulation then,
and the generator would be at the original site. If the waste
was kept by the laboratory for disposal, the laboratory is the
generator. If the waste was sent back to a [third party who
collected the waste for analysis, that collector is generator.
(Of course, some of these parties may be small quantity generators
subject to §261.5.) The second sentence in the second paragraph
of Section II on page 47426 of the preamble says the samples
are shipped from the generator or sample collector, but the
regulation only refers to sample collectors. The regulation
is worded appropriately because the sample collector may not
be the person who is ultimately considered to be the generator
of the waste.
Enclosed is a copy of the October 30, 1980, Federal Register
which specifies that several people may qualify as the generator
of waste. Although the specific examples in Section III
on page 72026-7 do not apply directly to your inquiry, the
multiple definition idea means that the term sample collector
could be the person who owns the waste or the person who actually
removes the waste aliquot for analysis. No doubt your laboratory
has made contractual agreements with your customers regarding
the disposition of samples that specifies returning waste to
the site it came from, in which case sample collector refers
to the company that paid you to take aliquots of waste for them.
As you can see, the preambles and Agency explanations
sometimes clarify the intent and coverage of the regulations.
The Office of Solid Waste and Emergency Response sponsors the
RCRA/Superfund Hotline which can answer many of these kinds of
questions toll free on a routine basis at 800-424-9346. Of
course, many States have authorized hazardous waste programs
which have taken the place of the RCRA program. States may have
more stringent requirements, so you should confer with them
regarding specific State requirements. The Hotline can provide
you with a list of the State Agency contacts.
If you have any other questions about this issue, please
do not hesitate to contact me at (202) 382-4804.
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Sincerely yours,
Irene S. Horner
Environmental Protection Specialist
Studies and Methods Branch (WH-562B)
Enclosures
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FAXBACK 13291
TEST SAMPLES, EXCLUSION FROM HAZARDOUS WASTE
9431.1989(03)
June 5, 1989
MEMORANDUM
SUBJECT: Management of Test Samples as Hazardous Waste
\
FROM: Howard Wilson, Manager
Environmental Compliance Programs
TO: Environmental Compliance Managers
This memo is intended to clarify a letter from the EPA's
Office of Solid Waste on the management of laboratory samples
under the Resource Conservation Recovery Act (40 CFR Part 261).
According to 40 CFR Part 261.4 (d) (1), samples collected
solely for the purposes of testing are exempted from the
regulations for hazardous waste management. I would like to
emphasize that this is a qualified exemption. The samples are
exempt from regulation as long as they meet any of the following
conditions contained in 261.4 (d) (1) (i..vi):
(i) Being transported from the collector to the
laboratory
(ii) Being transported from the laboratory back to the
collector for following testing
(iii) Being stored at the collector waiting to go to the
laboratory
(iv) Being stored at the laboratory before being tested
(v) Being stored at the laboratory after being tested
but before being returned to the collector
(vi) Being stored at the laboratory for a specific
' purpose after being tested (i.e. for a court case
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in which the sample is evidence, etc.)
Regulation 261.4 (d) (3) states that the exemption does not apply
if the laboratory determines the waste is hazardous and the
conditions listed above are no longer being met.
According to 40 CFR Part 261.5 (a), facilities that generate
less than 100 kg/mo of hazardous waste or 1 kg/mo of acute
hazardous waste are exempt from hazardous waste regulations.
This exemption is also conditional, based on a generator's
compliance with the following:
-2-
o Determining if their waste is hazardous; this is
required by 261.5 (b), which references 261.5 (g),
which cites 262.11.
o Disposing of their waste at a facility authorized to
accept it; this is required by 261.5 (f) (3) and 261.5
(9) (3).
Generators of less than 100 kg/mo of hazardous waste would also
be subject to RCRA requirements under regulation 262.34 if they
accumulate, for the purpose of disposal, greater than 1000 kg of
hazardous waste.
In summary, samples held for testing need not be
managed as hazardous waste while they are being tested. Once
they are determined to be wdste, a determination of whether the
waste is hazardous must be made if it hasn't been already. If
the waste is determined to be a hazardous waste, it must be
managed in full compliance with all applicable regulations,
including 40 CFR Parts 261.5 and 262.11.
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Faxback 12894
9441.1987(32)
RCRA/Superfund/OUST Hotline Monthly Report Question
April 1987
3. Multiple Generator Location and Consolidation
A company owns several small factories in different
counties. Each factory generates less than 100 kilograms
of hazardous waste per month, and is subject to reduced
regulation under D261.5. Options for disposal of waste
from conditionally exempt generators are provided in
D261.5(f)(3). (a) May the conditionally exempt generators
transport waste to one of the company's facilities for
consolidation and subsequent shipment to a RCRA disposal
facility? (b) Does the facility of the generator who is
consolidating the waste qualify as a "transfer facility"?
(c) Does the generator who consolidates the waste become
a full quantity generator if he ships more than 1000 kg
of hazardous waste from his site per month? (or a
100-1000 kg/mo generator if he ships between 100 and 1000
kg of waste per month?)
(a) Under D261.5(f)(3) in order to remain exempt from certain
regulations, a conditionally exempt small quantity generator may
ensure delivery of his hazardous waste to a storage, treatment, or
disposal facility that is one the following types of facilities:
(i.) permitted under Part 270 of 40 CFR; or
(ii.) in interim status under Parts 265 and 270 of 40
CFR; or
(iii.) authorized to manage hazardous waste by a state
with a hazardous waste management program approved under
Part 271 of 40 CFR; or
(iv.) licensed, registered or permitted by the state to
manage municipal or industrial solid waste; or
(v.) beneficially uses, reuses or reclaims the waste.
In order for one of the generators to serve as a central collection
point for the other generators, he would have to qualify as one of
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the above mentioned facilities. Realistically, the easiest approach
would be for the generator to receive State approval to manage the
consolidated waste shipments.
(b) If the generator does not receive authorization from his
State, he may still receive and store the waste for a
period of time if he qualifies as a transfer facility.
Under D263.12, waste may be stored at a transfer facility
for ten days or less without requiring interim status or
a permit. The December 31, 1980 Federal Register (45 FR
86966) defines the term transfer facility to refer to
transportation terminals (including vehicle parking
areas, loading docks and other similar areas), break-bulk
facilities or any other facility commonly used by
transporters to temporarily hold shipments of hazardous
waste during transportation. It is possible that this
generator facility may qualify as a transfer facility, as
long as the waste is not stored on-site for more than 10
days.
(c) If the waste is not sent to a facility specified under
D261.5(9)(3)(1)-(V), it is no longer conditionally exempt
waste, and each generator must comply with applicable
regulations. Thus, if the generator cannot receive state
approval nor qualify as a transfer facility, he must
obtain a permit for storage of hazardous waste.
n
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MEMORANDUM
SUBJECT: Hazardous Waste Generated in Laboratories
FROM: Elizabeth Cotsworth, Director Office of Solid Waste
TO: RCRA Senior Policy Advisors, EPA Regions I-X
i
The purpose of this memo is to reiterate and clarify the Environmental Protection Agency= s (EPA)
policies under the Resource Conservation and Recovery Act (RCRA) hazardous waste management
program regarding: 1) who may make a hazardous waste identification, and 2) the regulatory status of o
site treatment of hazardous waste. This memo is aimed primarily toward academic institutions that
generate hazardous waste in laboratories.
Background Academic institutions across the country vary in size and complexity. Many are large
quantity generators (LQGs) of hazardous waste, generating$ 1000 kg/month; or >1 kg of acute
hazardous waste/month. LQGs must comply with the regulations in 40 CFR 262.34(a) for the
accumulation of waste on-site. Hazardous wastes produced by LQGs may be accumulated on-site withou
interim status or a permit for 90 days or less. Many other academic institutions are small quantity
generators (SQGs), generating >100 kg/month but <1000 kg/month of hazardous waste. SQGs must
comply with 40 CFR 262.34(d) for accumulation of waste on-site. Hazardous wastes produced by SQGs
may be accumulated on-site without interim status or a permit for 180 days or less.
Many of the hazardous wastes managed at academic institutions are produced and initially accumulated i
research laboratories. The satellite accumulation provisions of 40 CFR 262.34(c) allow for reduced
requirements for hazardous waste accumulated in containers at or near any point of generation. Both
LQGs and SQGs may take advantage of the reduced requirements while hazardous waste is in satellite
accumulation areas, such as laboratories, provided the waste is managed in accordance with the
provisions of 40 CFR 262.34(c) (e.g., properly labeled).
Who may determine whether a waste is hazardous?40 CFR Section 262.11 states, A A person who
generates a solid waste...must determine if that waste is a hazardous waste...@ A A person @ is defined
as A an individual, trust, firm, joint stock company, Federal Agency, corporation (including a governme
corporation), partnership, association, State, municipality, commission, political subdivision of a State, c
any interstate body@ (40 CFR Part 262.10). A A person @ is not limited to a specific individual.
Therefore, any individual who is part of the A person @ (as defined) may make a hazardous waste
determination. The hazardous waste determination is not limited to theindividual who actually produces
a solid waste. For example, Environmental, Health & Safety (EH&S) personnel may make a hazardous
waste determination for a waste produced by an individual researcher, as long as the EH&S personnel ar
the researcher are part of the same A person @ (e.g., academic institution).
Of course, EPA= s objective is to ensure accurate hazardous waste identification. Proper waste
identification is important in order to allow the generator to comply with applicable requirements such a;
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those for labeling and marking pursuant to 40 CFR 262.34. In short, it is theA person = s @
responsibility to ensure that the individuals within the organization who are making the hazardous waste
determination obtain all the necessary information from whichever individuals within the organization
have that information. In practice, a hazardous waste determination in a laboratory setting would .alh
be a collaborative effort between the individual researcher who produces the waste and EH&S p nne
who may make the hazardous waste determination. That is, EH&S personnel making a hazardous waste
determination should receive sufficiently accurate and detailed information about each waste from the
individual researcher to ensure accurate waste identification.
We realize that having addressed the question ofwho may make a hazardous waste determination may
also raise the question ofwhere a hazardous waste determination is made. The issue is whether a
hazardous waste determination must be made in the laboratory (typically a satellite accumulation area) c
at a central accumulation area. EPA is not addressing this question in this memo, but intends to address
this question in a future guidance or rulemaking.
What is the regulatory status of on-site treatment of hazardous waste?EPA has consistently
interpreted its regulations to allow generators to treat hazardous waste in their accumulation tanks and
containers, without obtaining a permit or having interim status. This is true for both LQGs and SQGs. O
course, all generators are allowed to treat only the hazardous waste that is generated on-site. A permit
would be required to store and/or treat hazardous waste that is consolidated from offsite locations.
Examples of treatment that may be conducted in accumulation tanks and containers include precipitating
heavy metals from solutions, and oxidation/reduction reactions.
There are three reasons for this interpretation. First, we discussed the relationship between storage,
treatment and disposal in the preamble of the January 12, 1981, Federal Register (46 FR 28062808). In
that preamble, we noted that treatment can occur at a permitted disposal or storage facility without
affecting that facility = s regulatory status. We believe that treatment activities should similarly not
change the regulatory status of generators. Since the regulations do not impose additional standard for
treatment when it occurs at a storage facility that requires a permit, there is no basis for regulatin,
treatment more strictly at a storage facility which does nctfrequire a permit, such as a generator = 5
accumulation area.
Second, the provisions of 40 CFR 262.34(a) for LQGs and 40 CFR 262.34(d) for SQGs require
generators to comply with most of the technical standards for containers (Part 265 Subpart I) and tanks
(Part 265 Subpart J) with which an interim status storage facility would have to comply. Of the provisioi
for treatment, storage and disposal facilities only the financial responsibility, closure/postclosure and
corrective action regulations would not apply to gen erators that treat hazardous waste.
Third, treatment often renders waste less hazardous, or more amenable for further treatment, recycling,
shipment off site, etc. A requirement for generators to obtain a permit for any onsite treatment would
very likely discourage such practices.
Finally, with regard to who may treat a hazardous waste, a generator is defined asA any person, by site,
whose act or process produces hazardous waste... @ (40 CFR. 2601.10). Therefore, again, any individua
who is part of the A person, @ as defined, including EH&S personnel, is allowed to conduct treatment,
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provided that the individual complies with the training requirements of 40 CFR 262.34(a)(4) for LQGs
or 40 CFR 262.34(d)(5) for SQGs. Additionally, nothing in 40 CFR 262.34 precludes generators from
transferring waste between tanks or containers to facilitate storage or treatment.
It should be noted, however, that some forms of treatment by generators are not allowed without a pern
For example, incineration is regulated by specific standards for incinerators (Part 264/265 Subpart O),
and burning waste in boilers and industrial furnaces is regulated under the specific standards for those
units (Part 266 Subpart H).
If the waste is being treated on-site and the treatment residue is destined to be land disposed, the
generator still has responsibilities under the lancj disposal restrictions (LDR) program. The LDRs requir
that hazardous waste must be treated by a specified method or to a specified constituent concentration
level before it (or its residue) may be placed in the land. The generator must know the treatment standar
applicable to his/her waste and either treat to meet the treatment standard or send it to a treater to do so.
Generators who treat waste on-site to remove a hazardous characteristic must prepare a waste analysis
plan if treatment occurs in units that do not require a RCRA permit (see 40 CFR 262.34(a)(4) for LQGs
and 40 CFR 262.34(d)(4) for SQGs). In addition, there are some generator paperwork requirements
associated with the LDRs (40 CFR 268.7(a)). More information about the LDR program may be found :
A Land Disposal Restrictions: Summary of Requirements @at
http://www.epa.gov/epaoswer/hazwaste/ldr/new.htmSome treatment units have been and continue to be
specifically excluded from permitting. For example, owners and operators of elementary neutralization
units are not required to obtain a RCRA permit (40 CFR 270.1(c)(2)(v)). Similarly, many forms of onsit;
recycling of hazardous waste can be performed without a permit, since EPA generally does not regulate
the recycling process itself. However, any accumulation of hazardous waste prior to placement in an
exempt unit or prior to recycling would be regulated under 40 CFR 262.34, as discussed above.
On a related matter, for those LQGs that accumulate hazardous waste for longer than 90 days, or SQGs
that accumulate hazardous waste for longer than 180 days, and therefore require a permit, the Agency
recently proposed a rule that would streamline the permitting requirements for facilities that store and/or
treat their hazardous waste on-site in tanks and containers (October 12, 2001; 66 FR.52192). The Agency
anticipates finalizing the rule in early 2003.
Please note that this letter discusses only the federal hazardous waste regulations. States that are
authorized to implement the RCRA program may have regulations that are different than the federal
regulations provided they are not less stringent than the federal program. If you have any questions,
please contact Kristin Fitzgerald at (703) 308-8286 or fitzgerald.kristin@epa.gov
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EPA 530-R-97-005b
NTIS SUB-9224-97-002
Frequently Asked Questions on Mixed Waste
What is mixed waste?
Mixed waste is waste that contains a hazardous waste component and a
radioactive material component. A hazardous waste is either listed under 40 CF?
Part 261, Subpart D, and/or exhibits a characteristic described in 40 CFR Part
261, Subpart C. Radioactive material must be classified as source, special
nuclear, or byproduct material subject to the Atomic Energy Act of 1954 (AEA)
(42 U.S.C. n201 et seq.).
How is mixed waste regulated?
Mixed waste is jointly regulated under both RCRA and the AEA. RCRA regulates
the hazardous waste portion of the waste as any other hazardous waste, while
the AEA regulates the RCRA-exempt radioactive portion (52 FR 15939; May 1,
1987).
— Who regulates mixed waste?
Mixed waste is regulated by EPA, the Nuclear Regulatory Commission (NRC), and
the Department of Energy (DOE). EPA regulates the hazardous waste portion,
while the NRC or DOE regulate the radioactive portion. The NRC typically
regulates mixed wastes from commercial and non-DOE federal facilities, while
DOE regulates materials from DOE facilities.
Who generates mixed waste?
Mixed waste is typically generated by certain federal facilities, nuclear power
plants, industrial sites, research laboratories, and medical institutions
(Mixed Waste Incineration: (I) Background, EPA402-F-95-004).
Do the land disposal restrictions apply to mixed waste?
Mixed waste, regardless of its type of radioactive element, is hazardous waste
and consequently subject to RCRA hazardous waste regulations, including the
land disposal restrictions. Treatment standards for hazardous wastes are found
in n268.40 of the RCRA regulations. In some cases special treatment standards
are listed for mixed wastes, such as for radioactive lead solids (D008) and
elemental mercury contaminated with radioactive materials (D009). When no
special standards are listed, the normal treatment standards for the particular
waste code apply (55 FR 22644; June 1, 1990).
How are any inconsistencies that may arise between RCRA and AEA regulation
resolved?
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Section 1006 of the RCRA statute provides that if application of both RCRA and
AEA regulations creates a conflict, the AEA regulation would take precedence tc
the extent of the inconsistency between the regulations (OSWER Directive
9541.00-6; also 52 FR 15940; May 1, 1987). ;
Fax-on-Demand 14079
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FAXBACK12549
ANTI-NEOPLASTIC AGENTS IN HOSPITAL WASTES, DISPOSAL OF
9442.1986(02)
JAN 30 1986
MEMORANDUM
SUBJECT: Disposal of Anti-Neoplastic Agents in Hospital Wastes
FROM: Jeff Denit, Deputy Director
Office of Solid Waste (WH-562)
TO: Kenneth D. Feigner, Chief
EPA, Region X
Waste Management Branch
The issue regarding possible hazards posed by anti-neoplastic
drugs has been brought to our attention within the last couple of
years. With large increases in both the numbers of anti-neoplasties
available for use in chemotherapy and the number of patients being
treated with these drugs, hospital personnel have express con-
cern with handling and disposal of these chemicals (and materials
contaminated with these chemicals).
Anti-neoplasties, as a class of chemicals, are not regulated
under RCRA. However, the following are listed as hazardous waste
under 40 CFR. 261.33(f):
U035 Chlorambucil
U058 Cyclophosphamide
U059 Daunomycin ,
U150 Melphalan
U010 Mitomycin C
U206 Streptozotocin
U237 Uracil mustard
However, since these wastes are identified only as "toxic"
wastes, under D261.22(f) they are subject to the standard
small quantity generator exclusion. As a practical matter, this
means that unless large volumes of the chemicals are discarded
(i.e., 100 kg/mo or more) which in most cases is unlikely, or
the facility is a large quantity generator, the majority of
these wastes will remain unregulated.
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The Agency is aware that manufacturers and health care
facilities recommend incineration of anti-neoplasties and materials
contaminated with these chemicals. Although there is no concensus
among health care professionals as to the appropriate temperature
necessary for destruction, many facilities arejncinerating
these wastes at temperatures between 1800~- 2200~F. Since
the Agency has not investigated the efficiencies of incinerating
these wastes, we have not provided guidance or taken a position
with respect to this issue.
At this time, we have no plans to commit resources to the
study of anti-neoplasties or to initiate any further rulemaking
action. We recommend that State officials (in Seattle) contact
the manufacturers of these drugs to gather information on recom-
mended handling and disposal practices.
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Page 1 of 2
February 4, 1986
Mr. Thomas J. Dufficy
Senior Counsel
National Association of
Photographic Manufactures, Inc.
600 Mamaroneck Avenue
Harrison, New York 10528
Dear Mr. Dufficy:
This in response to your letter dated January 16, 1986, concerning the regulatory
status of photographic films and papers under Subtitle C of RCRA. As you state in
your letter, representative samples of high volume sensitized products— '
unprocessed and processed Industrial Radiographic and Kodacolor VR 400 films-
were tested using the extraction procedure (EP) toxicity test; these films did not
exhibit EP toxicity. The Radiographic films, you state, have the highest silver
coverage (i.e., approximately 49 troy ounces per 1000 ft2) and, thus, represents
the worst case. The Kodacolor VR 400 film is representative, you believe, of the
amateur films processed by photo finishers and also has the highest silver coverag
of the amateur films (i.e., approximately 34 troy ounces per 1000 ft2). Based on
this test data, you believe that used photographic films and papers are not subject
to the hazardous waste rules.
• , As you are aware, solid wastes are defined as hazardous under RCRA if they are
listed or exhibit one or more of the hazardous waste characteristics (i.e.,
ignitability, corrosivity, reactivity, or EP toxicity). Since photographic films and
papers are not specifically listed, they would only be defined as hazardous if they
exhibit any of the hazardous waste characteristics. The test data provided in your
letter appears to demonstrate that used photographic films or papers are not EP
toxic. I assume you have reached a similar determination that photographic films
and paper also are not ignitable, corrosive, or reactive. Based on these conclusions
photographic films and paper, in and of themselves, do not appear to be hazardou:
under RCRA and therefore, are not subject to the EPA hazardous waste
management regulations
Under 40 C.F.R. §261 (e.g, photographic films and papers being shipped for
, recovery of silver are not subject to regulation)^!/ You should be aware, however,
that although this data appears to support your claim that photographic films and
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' Page 2 of j
paper are not hazardous, each generator is still responsible for making this
determination. Moreover, wastes not hazardous under EPA regulations may be
hazardous under authorized State programs. Requirements of authorized pronram;
that are more stringent that EPA requirements are federally enforceable^
Faxback 1112:
Please feel free to give me a call if I can be of any further assistance; my telephon
number is (202) 475-8551.
Sincerely yours,
Matthew A. Straus, Chief
Waste Identification Branch (WH-562B)
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Page 3 of:
I/ In your letter, you indicate that photographic films and papers would not b,e
considered a spent material since they are not contaminated through use. I do not
agree with this interpretation of the rules (jLe, used photographic films and paper
would be defined as a spent material); however, since these materials are not
hazardous under RCRA, this point is moot. .
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Faxback 13622
9444.1993(05)
HOTLINE QUESTIONS AND ANSWERS
September 1993
RCRA |
1. Nitroglycerin Pills as Commercial Chemical Products
A pharmaceutical company manufactures pills that contain a low
percentage of nitroglycerine, with inert ingredients making up the
remainder of the content. The manufacturer must throw away a batch
of pills that has exceeded its shelf life. When discarded, are the
pills a hazardous waste? If so, what waste code would apply?
The pills discarded by the manufacturer are a hazardous waste
with the waste code P081. Several hundred commercial chemical
products are listed in 40 CRF DD261.33(e) and (f). Nitroglycerine
is listed in D261.33(f) with the waste code PO81. The Comment in
D261.33(d) defines the term "commercial chemical product" as unused
chemicals that are either (1) pure or technical grades, or (2)
formulations that contain the listed chemical as the only active
ingredient. The P- and U- listings apply to such unused
formulations of commercial chemical products regardless of the
concentration of the sole active ingredient; except for the
listings for warfarin and salts (P001 and U248) and zinc phosphide
(P122 and U249), there is no critical percentage or cut-off
concentration of the sole active ingredient that will cause a waste
to fall within, or be excluded from, the listing. In this example,
the pills constitute a formulation containing nitroglycerine as the
sole active ingredient. Since the pills have not been used for
their intended purpose (simply incorporating the nitroglycerine
into the formulation does not constitute use), and nitroglycerine
is the only component serving the function of the product (i.e., as
medicine), the discarded pills are appropriately classified as
hazardous waste PO81.
D
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Faxback 13718
9444.1994(10)
December 1994
HOTLINE QUESTIONS AND ANSWERS
3. Epinephrine Residue In A Syringe Is Not P042
A hospital administers the drug epinephrine to patients by
injection with a syringe. After the proper dose is injected, excess
epinephrine and epinephrine residue remain in the syringe.
Epinephrine appears on the P-list of hazardous wastes at 40 CFR
261.33(e) as P042. Is the epinephrine remaining in the syringe a
P-listed hazardous waste when the syringe is discarded?
The epinephrine in the discarded syringe would not be classified as
a listed hazardous waste. The P-Iist of hazardous wastes applies to
unused discarded commercial chemical products. Commercial chemical
products arc defined as commercially pure grades and technical
grades of the listed chemicals or chemical formulations in which
the listed chemical is the sole active ingredient, which have not
been used for their intended purpose (54 FR 31335, 31336; July 28,
1989). Drug residues often remain in a dispensing instrument after
the instrument is used to administer medication. EPA considers
such residues remaining in a dispensing instrument to have been
used for their intended purpose. The epinephrine remaining in the
syringe, therefore, is not a commercial chemical product and not a
P042 hazardous waste. The epinephrine could be a RCRA hazardous
waste, however, if it exhibits a characteristic of hazardous waste.
D
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Faxback 11156
9441.1986(42)
MAY 20 1986
Mr. Paul B. Guptill
Missouri Hospital Association
P.O. Box 60
4713 Highway 50 West
Jefferson City, Missouri 65102
Dear Mr. Guptill:
This is in response to your letter dated April 14,
1986, regarding the regulatory status of used x-ray film
being sent to refiners for silver reclamation. In order
to answer this question, one must first determine whether
the used x-ray film is considered a solid waste. Under
the hazardous waste rules, all spent materials, and listed
sludges and listed by-products that are sent for reclamation
are defined as solid wastes, (see 40 CFR 261.2(c), used
x-ray film would be defined as a spent material.I/ Therefore,
used x-ray film would be defined as a solid and hazardous
waste if it is listed or exhibits one or more of the hazardous
waste characteristics (i.e., ignitability, corrosivity,
reactivity, or extraction procedure (EP) toxicity).2/
Since these films are not specifically listed, they would
only be defined as hazardous if they exhibit any of the
hazardous waste characteristics. Based on test data provided
by the National Association of Photographic Manfacturers (NAPM),
I/ A spent material is any material that has been used and
as a result of such use can no longer serve the purpose
for which it was produced without processing.
2/ In your letter, you argue that used x-ray film going
to a refiner would not be considered hazardous,
regardless of their hazardous levels. However, the
Agency has always defined the hazardousness of the
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Page 2 of
waste based upon the characteristics of the waste
and not how it is managed.
-2-
these films, in and of themselves, do not appear to be
hazardous under RCRA. Therefore, used x-ray films are
probably not subject to the Federal hazardous waste management
regulations (see enclosure).
You should be aware, however, that although the data
provide by NAPM appears to suggest that these films are
non-hazardous, each generator is still responsible for
making this determination. If the generator determines
that their used x-ray films are hazardous, they would be
subject to the hazardous waste rules. However, the only
requirements under the Federal regulations that would be
imposed upon the generator would be to get an identification
number and to comply with the uniform hazardous waste
manifest. I, therefore, question the cost figures estimated
by the Missouri Department of Natural Resources (DNR) for
hospitals to comply with the hazardous waste rules.
Please feel free to give me a call if I can be of any
further assistance my telephone number is (202) 4758551.
Sincerely,
Matthew A. Straus
Chief
Waste Identification Branch
Enclosures
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FAXBACK 12946
9441.1987(45)
CONTAINERS USED TO HOLD LISTED CHEMOTHERAPY DRUGS
JUN 16 1987
Mr. Fred Kamienny
Vice President
PRN Service, Inc.
1210 Morse
Royal Oak, Michigan 48067
Dear Mr Kamienny:
This responds to your letter of April 13, 1987, regarding
the regulatory status of chemotherapy drugs and related supplies.
In particular, you questioned whether the weight of the "empty"
vial should be included in determining the amount of drug residues
to be disposed.
As you pointed out, several chemotherapy drugs are listed in
40 CFR 261.33(f) (commonly known as the U-list). As such, these
wastes are regulated under the EPA hazardous wastes regulations
(unless subject to the small quantity generator exclusion). Included
in the listing are the following discarded commercial chemical
products, off-specification species, container residues, and spill
residues:
1) chlorambucil (U035)
2) cyclophosphamide (U058)
3) daunomycin (U059)
4) melphalan (U150)
5) mitomycin C (U010)
6) streptozotocin (U206)
7) uracil mustard (U237)
Under EPA regulations governing the management of hazardous
wastes, any container used to hold these chemicals (such as vials)
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Page 2 of:
are considered hazardous wastes unless these containers meet the
criteria of an "empty container." Under the empty container
provisions such vials are excluded from regulation if the material
has been removed by pouring, pumping, and aspirating, and no more
than 1 inch of residue remains in the bottom of the vial or no
more than 3 percent by weight of the total capacity of the container
remains in the container. (See 40 CFR 261.7)
-2-
The Agency is aware, however, that prudent practice dictates
that materials contaminated with these chemicals (such as syringes,
vials, gloves, gowns, aprons, etc.) not be handled after use.
Therefore, to minimize exposure to these toxic chemicals, the
Agency recommends that the entire volume of waste be weighed and
that there be no attempt to remove any residue from the vial
before disposal.
Chemotherapy drugs that are not listed hazardous wastes are
not regulated by EPA. However you should contact your State or
local government regarding the management of these chemicals.
Also, the National Institutes of Health (NIH) provides guidance
on handling and management of antineoplastics. Contact Harvey
Rogers, at NIH for further information. Mr. Rogers may be reached
at (301) 496-7775.
If you should have any further questions regarding regulatory
requirements for specific wastes, you may call RCRA Hotline at
(800) 424-9346, or contact Mitch Kidwell, of my staff, at (202)
382-4805.
i
Sincerely,
Jacqueline W. Sales, Chief
Regulation Development Section
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UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
APRIL 25, 1988
U3H3
Michael Geary
Bio-Ecological Services, Inc. :
6525 Morrison Blvd. I
P.O. Box 2048
Charlotte, NC 28226
Dear Mr. Geary:
This letter is in response to your March 24, 1988, request for clarification of the
status of certain antineoplastic drug wastes. Your request was for an interpretation
of 40 CFR 261.33, with respect to excess antineoplastic drug formulations which
are not needed and thus are discarded.
If an antineoplastic drug is mixed with diluents, such as water or saline solution,
the excess diluted or undiluted amount to be discarded is unused commercial
chemical product. If the discarded unused commercial chemical product is listed in
40 CFR 261.33, the material is a listed hazardous waste regardless of dilution with
water or saline because the product still would be the sole active ingredient.
However, it is not considered a "spent material." Section 261.1 (c) (1) defines &
spent material as any material that has been used and as a result of contaminatiof
can no longer serve the purpose for which it was produced without processing. The
portion antineoplastic drug, if diluted, has not yet been used for its intended
function, nor is it contaminated.
If an antineoplastic drug is mixed with diluents and with other Pharmaceuticals for
use, the unused mixed excess portion that is discarded is a solid waste. If the
antineoplastic drug is listed in 40 CFR 261.33, the unmixed excess portion is a
listed hazardous waste provided the antineoplastic drug is the sole active ingredier
in the mixed formulation. If it is not the sole active ingredient, the mixture would
not be the listed hazardous wastes; he????? the formulation may still be hazardous
if it exhibits any of the hazardous waste characteristics.
In all of the situations you described, the material (if it met the listing in 40 CFR
261.33) would have to be sent to a permitted or interim status hazardous waste
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Page2!of
management facility, if the facility generates more than 1 kg per month of acutely
hazardous waste, or more than 100 kg/month of non-acutely hazardous waste, Se
40 CFR 261.5(f) and (g) for the hazardous waste management options for
conditionally exempt small quantity generators of hazardous waste.
In addition, any State in which you generate, transport, treat, store, or dispose of
these formulations may have regulations that are more stringent than the Federal
hazardous waste rules. You therefore should check with the State agencies to
determine what regulations, if any, apply to handling these materials.
If you have further questions regarding the status of wastes containing PHsted or
U-listed commercial chemical products, please contact Wanda LeBleu-Biswas at
(202) 382-7392.
Sincerely
Devereaux Barnes, Directo
Characterization anc
Assessment Divisior
B.E.S.
BIO-ECOLOGICAL SERVICES, INC.
6525 Morrison Blvd. P.O. Box 2048 Charlotte, North Carolina 28226
Telephone (704) 364-1039
800-533-7994
March 24, 1988
U.S. E.P.A.
Office of Solid Waste
Sylvania Lawrence, Acting Director
WH-562A
401 M Street Southwest
Washington, D.C. 20460
Dear Ms. Lawrence:
I am in need of clarification involving the delisting of U-listed antineoplastic drugs
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1 Page 3 of
used in cancer treatment wards at hospitals and clinics. Specifically, if a Ulisted
antineoplastic is mixed for treatment purposes and the remaining material is sent
for disposal, is the material still U-listed?
Please address specifically:
1) Antineoplastics nixed with diluents like water or saline.
a) Is unused portion "spent" or still U-listed?
2) Antineoplastics mixed with diluents and other Pharmaceuticals.
a) Is the antineoplastic in the remaining portion still the "sole active
component", thus still maintaining the U-listing?
b) Is the unusual portion "spent" or still U-listed?
I do understand that virgin product, spill material, and off-spec product are listed.
Are the antineoplastics mixed for treatment still listed?
If no U-listing remains, then do these materials have to be sent to a hazardous
waste incinerator or treated as hazardous waste?
My concern is due to the fact that there are no published Threshold Limit values or
LD50 values materials. Also that there is no clear definition to determine whether
these materials are "spent".
Please clarify these questions in the agencies opinion. The response will be Used tc
determine our corporate position on matters concerning antineoplastic disposal.
If you have any questions, please contact me at (704) 3641039.
Sincerely,
BIO-ECOLOGICAL SERVICES INC.
Michael J. Geary
Manager of Environmental and Compliance
MJG/cbr
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FaxBack # 11343
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Page 1 of 2
Nov. 18, 1980
Randal M. Reynolds
Environmental Process Engineer
Gold Kist, Inc.
P.O. Box 2210
Atlanta, Georgia 30301
Dear Mr. Reynolds:
This is in response to your letter of October 30, 1980, requesting clarification of oui
hazardous waste management regulations and a related question and answer sheet
concerning the rinsate from the triple rinsing of containers which have held
chemical products listed in 261.33(e). You content that such rinsate should not be
considered a hazardous waste—as we indicated in our question and answer book—
unless it exhibits one or more of the characteristics of hazardous waste identified ir
Subpart C of Part 261 or is listed as a hazardous waste in§261.31 or §261.32.
We contend that such rinsate is a hazardous waste because of the "mixture rule" ol
§261.3 (a) (2) (ii) which states that a solid waste is a hazardous waste if "it is a
mixture of solid waste and one or more of the hazardous waste listed in Subpart D
. .." (see 45 Federal Register 33119). A chemical product listed in§261.33;which is
being rinsed from a container (and, therefore, being discarded) is a "hazardous
waste listed in Subpart D." The rinsing solution is a "solid waste" because it is beini
discarded. The rinsate is a "mixture of solid waste and a hazardous waste listed in
Subpart D." Therefore, the rinsate is a hazardous waste. I might point out that the
rinsate, in some cases, may be a hazardous waste for additional reasons-those
you point out—but the citation I have given is the bases for the interpretation in
our question and answer book.
i ' - - •..••'
I trust that this clarifies this matter for you. I apologize for the tardiness of this
response but we have been overwhelmed with requests for clarification of our
regulations.
Sincerely yours,
Gary N. Dietrid-
Associate Deputy Assistant Administrate
for Solid Waste
bcc: Filomena Chau w/incoming
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Faxback 11559
9432.1990(03)
OFFICE OF SOLID WASTE AND EMERGENCY RESPONSE
SEP 13 1990
Charles Winwood
Assistant Commissioner
Office of Inspection and Control
U.S. Customs Service
1301 Constitution Avenue, NW
Washington, D.C. 20229
Dear Mr Winwood:
Thank you for your letter of July 12, 1990 concerning the
current and future regulatory status of "empty" containers under
40 CFR 261.7.
Your statement is correct that this section allows, in some
cases, up to one inch of residue to remain in a container that
held certain hazardous wastes and be considered empty for
purposes of the Resource Conservation and Recovery Act (RCRA)
regulations. However, the "one-inch" rule is only part of the
definition of an "empty container" in 261.7(b). This definition
has three parts and is dependent on the type of waste the
container held. In other words, how one determines whether a
container is empty depends on the material previously contained.
Enclosed with this letter for your review, and for the use of
your staff, is a discussion of the Agency's interpretation and
rationale for this important provision. The current rule was our
way of defining when a container no longer poses a serious
hazard, but we did not have definitive data to support the
conclusion.
I have asked Mike Petruska, Chief of the Waste
Characterization Branch, to contact your staff. His Branch is
responsible for generator and transporter issues, and I think it
appropriate for them to meet as this would allow us to understand
more fully your concerns and to discuss alternative regulatory
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Page
definitions to rectify this situation.
My understanding of your concern is that border inspections
of containers may unknowingly expose your agents to hazardous
waste through this regulatory definition. This is a legitimate
concern, and you should note that this situation may be rectified
through our work on the administration's Export Bill pursuant to
the Basel Agreement. When it is finalized, it is anticipated
that it will subject hazardous waste that is currently exempt
from Subtitle C requirements e.g., "empty" containers) to the
provisions governing the import and export of hazardous waste.
My staff will continue working with your staff to ensure that
situations such as this are covered in the final bill.
In the interim, EPA will continue working with Customs on
training efforts such as the recently completed U.S. Customs/NEIC
training of 500 customs inspectors on the Mexican border.
Currently, we are discussing the feasibility of expanding this
effort to include joint training of U.S. and Canadian customs
officials with Environment Canada. Adequate training for
inspection procedures for hazardous waste shipments is probably
the best method of ensuring the continued safety of Customs
employees.
Thank you for your interest in this issue, I look forward to
continuing to work with the Customs Service on hazardous waste
issues. If I or my staff can be of any further assistance,
please do not hesitate to contact me.
Sincerely,
i
Original Document signed
Sylvia K. Lowrance
Director
Office of Solid Waste
Enclosure
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Page 3 cr
ENCLOSURE
The definition of "empty" containers in 40 CFR 261.7 has
three parts and is dependent on the type of waste the container
held. In other words, how one determines whether a container is
empty depends on the material previously contained.
The first part of the definition applies to containers which
held hazardous wastes other than compressed gases or acute
hazardous wastes. For such containers, the regulations provide
that an empty container is one from which all wastes have been
removed that can be removed using practices commonly employed to
remove materials from that type of container, (e.g., pouring,
pumping, aspirating), and that no more than 2.5centimeters (one
inch) of residue remain on the bottom of the container or inner
liner (40 CFR 261.7 (b)(l)(l)(i) and (ii)). Additionally, in the
August 18, 1982 Federal Register, the Environmental Protection
Agency (EPA) provides a weight alternative to this "one-inch"
rule. Specifically, the Agency allows 3 percent by weight of the
total capacity of the container to remain in containers that are
less than or equal to 110 gallons in size. For containers
greater than 110 gallons, an empty container is one from which
all residues have been removed by normal means, and no more than
0.3 percent by weight of the total capacity of the container
remains in the container (40 CFR 261.7 (b)(l)(iii)).
In the preamble to the August 18, 1982 Federal Register, EPA
discusses the incorrect substitution, by members of the regulated
community, of the word "or" for the word "and" at the end of
paragraph 261.7 (b)(l)(i). This substitution would lead an
individual to believe that the practice of leaving one inch of
residue in a container qualifies the container as being "empty",
whether or not all of the waste has been removed to the extent
possible using methods commonly employed. The Agency
emphatically states that this is not the case. When the two
paragraphs are correctly read together, it is clear that one inch
of residue is an overriding constraint, to be utilized only if
all wastes cannot be removed by normal practices.
The second part of the definition covers containers which
have held hazardous wastes which are compressed gases. For these
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Paae 4-c*
containers to be considered empty under RCRA, the pressure inside
the container must approach atmospheric pressure.
The third part of the definition covers containers that have
held acute hazardous listed in 261.31, 261.32 or 261.33(e). For
such a container to meet the definition of "empty" under
261.7(b), the container must be triple rinsed with an appropriate
solvent, or in the case of a container with an inner liner, the
inner liner must be removed.
i
The EPA discusses the rational for the1 definition of "empty
container" in the preamble of the November 25, 1980 Federal
Register (45 FR 78525). "EPA believes that, except where the
hazardous waste is an acutely hazardous material listed in
261.33(e), the small amount of hazardous waste residue that
remains in individual empty, unrinsed containers does not pose a
substantial hazard to human health or the environment." However,
EPA was still (and remains) somewhat concerned with unregulated
container residues.
This concern was illustrated later in the November preamble,
when the Agency set forth three options for regulation of the
residues in "empty" containers and solicited comments on these
options, as well as any data indicating that unregulated residues
may pose a substantial hazard to human health and the
environment. The three options were 1) to require triple rinsing
for all containers; 2) to regulate the residue when it is removed
from a container; and 3) to impose a limit on the amount of
unregulated residue. Of the three options presented, EPA
considered triple rinsing for all containers to offer the
greatest protection to human health and the environment. This
approach would ensure that the only container residues left
unregulated would be trace amounts remaining after triple rinsing
or an equivalent cleaning operation. Thus, if all containers
were required to be triple rinsed before they were considered
"empty" under RCRA, the potential for environmental and health
problems associated with these containers could be substantially
reduced.
The Agency addressed the comments received in response to
the November 25, 1980 solicitation in the August 18, 1982 Federal
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Page 5 or
Register. Most commenters found the triple rinsing option
undesirable and the Agency had no data to support the proposal of
the triple rinse option based on the comments received.
Accordingly, the Agency has continued to implement the "oneinch"
rule (or the 3 percent/0.3 percent alternative) under Federal
regulations.
It is also important to note that the shipment of empty
containers which have held hazardous wastes may be registered
under more stringent or additional State, local, or Federal
regulations. For example, under the Department of Transportation
(DOT) regulations, a container which has held a hazardous
material must be cleaned and purged of its contents before the
hazardous material label can be removed (49 CFR 173.29).
D
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Page 1 of
FAXBACK 12307
PPC 9441.1984(26)
CONTAINERS THAT HELD COMMERCIAL CHEMICAL PRODUCTS, DEFINITION OF EMPTY
SEP 11 1984
Mr. William M. Parker III
Akzo Chemie America
300 S Wacker Drive
Chicago, IL 60606
Dear Mr. Parker:
I am responding to your request for a written confirmation
of the interpretation that the RCRA/Superfund Hotline gave you.
According to 40 CFR D261.7(b) (1), containers that held commercial
chemical products from 40 CFR D261.33(f) are empty when they
have been emptied using the practice commonly used to remove
materials and no more than one inch of residue remains on the
bottom of the container, or no more than 3 percent of the weight
of the container's capacity remains if the container is 110
gallons or less in size.
Thus, pouring out the contents from a bag, then shaking
and tapping the outside of bags containing solid maleic anhydride
(U147) or solid phthalic anhydride (U190) is a common emptying
practice. This practice would likely result in empty containers
meeting the definition cited above. These "empty containers" are
not subject to Federal RCRA regulation.
Of course, the 44 states and territories that have instituted
hazardous waste programs that operate in lieu of RCRA may have
slightly different viewpoints on this issue. You should be
familiar with regulatory standards of any States you deal with.
The RCRA/Superfund Hotline (800/424-9346) can send you a
list of the State hazardous waste agency addresses and phone
numbers if you need it.
I am glad to be able to confirm the Hotline's assessment
of your emptying practices. Let me know if I can be of any
future assistance.
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' Page 2 of
Sincerely yours,
Alan S. Corson
Chief
Studies and Methods Branch
D
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Page 1 of
Faxback 12342
9441.1985(04)
RCRA/SUPERFUND HOTLINE MONTHLY SUMMARY
DECEMBER 84
3.
A treatment, storage, or disposal facility (TSDF) has agreed to accept "empty
containers" per D261.7. Upon receiving the containers (55 gallon drums), the
TSDF found that although the containers held less than one inch, the containers
could be and were emptied further by inverting the container and pouring out
additional hazardous waste. According to D261.7(b)(l)(i), a container that
has held hazardous waste is empty if all wastes have been removed that can be
removed using the practices commonly employed to remove materials from that
type of container, e.g., pouring, pumping, and aspirating. If the TSDF further
empties the container by pouring, was the container "empty" when received even
though it held under one inch of material?
No; the container was not empty. Preamble language to the August 18, 1982
Federal Register (47 FR 36093) states that "it should be clear that one
inch of waste material is an overriding constraint and may remain in an
empty container only if it cannot be removed by normal means." this
indicates that a container must be emptied by pouring, pumping and
aspirating. Then, if the container holds less than one inch, the container
is empty per D261.7.
Source: Alan Corson (202) 382-4776
Research: Bill Rusin
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Page 1 of
Faxback 11452
9453.1989(08)
OFFICE OF SOLID WASTE AND EMERGENCY RESPONSE
AUG 21989
T.R. Kirk, Environmental Scientist
Fehr-Graham & Associates
660 W. Stephenson St.
Freeport, Illinois 61032
Dear Mr. Kirk:
This is in response to your letter of July 6, 1989,
requesting a clarification of 40 CFR Section 262.34(c), the
"satellite accumulation" provision. Section 262.34(c)(l) states
that, provided certain requirements are met, "a generator may
accumulate as much as 55 gallons of hazardous waste or one quart
of acutely hazardous waste listed in Section 261.33(e) in
containers at or near any point of generation where wastes
initially accumulate, which is under the control of the operator
of the process generating the waste ..." Your question concerns
whether the 55 gallon limit on hazardous waste applies to the
total quantity of hazardous waste accumulated at the sateljite
location, or it is applies to each waste stream accumulated at
the satellite location.
The 55 gallon limit applies to the total of all the non-
acutely hazardous waste accumulated at a satellite accumulation
area. In the enclosed Federal Register notice of December 20,
1984 (49 FR 49568) EPA explicitly states that the 55 gallon limit
on non-acutely hazardous waste applies to each satellite
accumulation area.
Although the total amount of hazardous waste.that may be
accumulated at any one satellite area is limited to 55 gallons,
EPA intentionally did not limit the total number of satellite
areas at a generator's facility nor specify the size of the
containers to be used for accumulation. A case-by-case analysis
is necessary to determine whether a generator is accumulating
more than 55 gallons of waste at one satellite area, or whether a
generator has more than one satellite area. An example of a
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situation that would not be in compliance with the regulations is
-2-
given in the enclosed Federal Register notice on page 49569,
column 3. The appropriate State or EPA Regional office would
make these case-by-case determinations.
If you have any further questions regarding this letter, you
may contact Emily Roth of my staff at (202J) 382-4777.
Sincerely,
Original Document signed
Syliva K. Lowrance
Director
Office of Solid Waste
Enclosure .
D
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FAXBACK 12859
9453.1987(01)
SATELLITE ACCUMULATION AREA AND REGULATIONS
February 11, 1987
i
Brent C. Bradford
Executive Secretary
Utah Solid and Hazardous Waste Committee
288 North 1460 West
P.O. Box 16690
Salt Lake City, Utah 84116-0690
Dear Mr. Bradford:
Robert Duprey, Director of the Waste Management Division in
Region VIII, forwarded your letter of January 8, 1987 to this
Office. This letter contains our response to the questions you
raised regarding issues relating to the Federal regulations for
satellite accumulation under 40 CFR 262.34(c).
1. What is the intent of the Federal regulation with respect to
the total amount (volume) of hazardous waste at each satellite
accumulation area?
A generator may accumulate as much as 55 gallons of
hazardous waste, or one quart of acutely hazardous waste, in
containers at or near any point of generation where the waste
initially accumulates and which is under the control of the
operator of the process. EPA believes that only one waste would
normally be accumulated at each satellite are, and that the
exempted accumulation should be limited to 55 gallons. Although
the total amount of hazardous waste that may be accumulated at
any one satellite area is limited to 55 gallons, EPA
intentionally did not limit the total number of satellite areas
at a generator's facility nor specify the size of the containers
to be used for accumulation (though we believe many facilities
will use 55-gaIlon drums).
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2. Does the Federal regulation limit the number of containers
that can be placed at a satellite accumulation area?
The Federal regulations do not limit the number of
containers that can be placed at a satellite accumulation area,
rather, the regulations limit the total gallons accumulated to
-2-
55.
3. As described in the Utah proposed interpretation, will Utah
be equivalent to the Federal regulations if the State allows more
than 55 gallons of hazardous waste to be accumulated in more than
one drum..., but require personnel training, preparedness and
prevention and contingency plans?
No, a "satellite accumulation area" is limited to a total
accumulation of 55 gallons, not 165 gallons as proposed.
4. Is Utah's interpretation of "three days" to mean three
"working" days equivalent to EPA's intent?
Yes.
5. Will Utah be equivalent to EPA if we require that the date be
placed on the full drum?
Yes, if a facility uses 55-gallon drums, then the date
excess accumulation began must be clearly marked on the drum.
I trust that the above discussion answers your questions and
concerns relating to the Federal satellite accumulation
requirements. If not, Chet Oszman of my staff (202-3824499) is
willing to provide clarification as needed.
Sincerely,
Susan E. Bromm
Acting Director
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Permits and State Programs Division
cc: Kent Gray, State of Utah
Robert Duprey, Region VIII
Patricia Brechlin, Region VIII
Chester Oszman, PSPD
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EPA530-R-01-0041
PB2001-103 672
RCRA, SUPERFUND & EPCRA CALL CENTER MONTHLY REPORT
December 2001
1. Cabinets as Satellite Accumulation Areas
A large quantity generator may accumulate hazardous waste without obtaining a RCRA permit in
containers at or near the point of generation provided he or she complies with the satellite accumulatioi
standards in 40 CFR Section 262.34(c). These standards require that the containers be marked-with the
words "Hazardous Waste" or with other words that identify the contents of the container (§>62.34(c)(l)
(ii)). If the generator has a satellite accumulation area that is located inside a cabinet, does a hazardous
waste label placed on the outside of the cabinet fulfill the marking requirement, or must each individual
container within the cabinet be labeled?
Placing a label with the words "Hazardous Waste" on the outside of the cabinet may satisfy the satellite
accumulation area marking requirements provided the cabinet meets the definition of container. A
container is a portable device in which material is stored, transported, treated, disposed of, or otherwise
handled (§260.10). As a satellite accumulation area, the cabinet would have to be located at or near the
point of generation and be under control of the operator of the process where the wastes are initially
generated. In addition, the generator would have to maintain the cabinet in accordance with the container
standards. These standards require that the cabinet be in good condition, be made of materials compatiblt
with the waste that would be stored in it, and must always be closed during storage except when waste is
being added or removed (§262.34(c)(l)(i)). If the cabinet does not meet the definition of container and
cannot be managed according to the applicable container standards, each individual container within the
cabinet would need to be labeled and managed in accordance with all other satellite accumulation area
requirements.
FB 14587
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UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
WASHINGTON, D.C. 20460
OFFICE C
SOLID WASTE AND EMERGENCY RESPONS
SEPTEMBER 2, 1987
Mr. Fred Hutchison
Radiation and Lab Safety Officer
Safety Office
University of Idaho
Moscow, Idaho 83843
Dear Mr. Hutchison:
Thank you for your July 29, 1987, letter concerning the accumulation time for acu
hazardous waste and hazardous waste. Your understanding of accumulation time
for acute hazardous waste and hazardous waste is correct. The Resource
Conservation and Recovery Act/Superfund Hotline staff have given the correct
answer to your question.
Acute hazardous wastes are counted and managed separately from hazardous
wastes (§261.5 (e)). In the example given, the generator would have 90 days to
send the acute hazardous waste off-site, but would have 180 days for the non-
acute hazardous waste.
If I can be of any further assistance, please let me know.
'Sincerely
Marcia E. William
Dj recto
Office of Solid Wast
FaxBack* 1128;
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Faxback 11424
9453.1989(05)
OFFICE OF SOLID-WASTE AND EMERGENCY RESPONSE
APR 21 1989
Mr. Stephen J. Axtell
Smith & Schnacke
2000 Courthouse Plaza NE
Post Office Box 1817
Dayton, Ohio 45401-1817
Dear Mr. Axtell:
This letter is in response to your letter of February 23, 1989,
requesting clarification of the generator accumulation time
requirements of 40 CFR 262.34. You ask when the accumulation time
begins for an unknown waste that, upon analysis, is found to meet
the definition of hazardous waste. Initially, the container was
improperly labelled or not labelled at all. A sample of the
contents was sent off site for analysis, and was found to be
hazardous. .
In your letter you relate that Chris Bryant of the RCRA Hotline
indicated that the accumulation time for an unknown waste begins
when the analytical results indicating that the waste is hazardous
are received. Unfortunately, this information was incorrect. The
correct reading of Section 262.34 in this instance follows:
Section 262.34(a) provides a limited exemption from the
requirement that those who store hazardous waste must obtain
permits. To obtain the exemption, a generator must comply with
all the requirements of Section 262.34. If the date on which the
accumulation began was not marked on the drum (Section 262.34(a)
(2)) or the drum was not marked "Hazardous Waste" (Section 262.34
(a)(3)), then the generator has not met the pre-conditions for the
exemption from permitting requirements and is an operator of a
storage facility subject to the requirements of 40 CFR Parts 264 and
265 and the permit requirements of 40 CFR Part 270.
Where a generator does meet the conditions of Section 262.34,
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the accumulation time begins when a waste is generated or when
it is first taken from a "satellite" accumulation area operated
pursuant to 40 CFR 262.34(c). Waste is generated either when it
is produced or when it is first caused to be subject to regulation
(40 CFR 260.10), not when a generator first analyzes the waste.
If the waste in the drum was a listed or characteristic hazardous
waste when it was produced, then the one-time 90-day accumulation
time could begin only at the time the waste was produced or removed
from the satellite accumulation area.
-2-
If the waste was not subject to regulation when it was first
stores, e.g., the material had not yet been listed as a
regulated hazardous waste, then the 90-day period would have
begun when the waste became subject to regulation—upon the
effective date of the new listing. A generator's failure to
properly analyze, label, and accumulate waste does not exempt
the waste from regulation.
If we can be of any further assistance, please contact
Emily Roth at (202) 382-4777.
Sincerely,
Original Document signed
Sylvia K. Lowrance, Director
Office of Solid Waste
D
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Faxback 13410
9453.1990(03)
RCRA/SUPERFUND HOTLINE MONTHLY SUMMARY
OCTOBER 1990
1. Clarification of Section 262.34(a) Accumulation Time for Excess of
55-Gallon Limit in Satellite Accumulation Areas
i
The owner/operator of a manufacturing company maintains a generator
satellite accumulation area pursuant to Section 262.34(c). The operator
has exceeded the 55-gallon accumulation limit and according to Section
262.34(c)(2), has three days to remove this waste from the satellite
area and manage it either in a 90-day storage area as a large quantity
generator in compliance with Section 262.34(a), manage the waste at an
on-site permitted unit, or ship the waste off-site. Does the 90-day
accumulation time for large quantity generators in Section 262.34(a)
begin at the time the 55-gallon limit is exceeded or after the
three-day transition period in Section 262.34(c)?
1. Clarification of Section 262.34(a) Accumulation Time for Excess of
55-Gallon Limit in Satellite Accumulation Areas (Cont'd)
The owner/operator has up to a 93-day accumulation time for the excess
waste generated at the satellite accumulation area (90-day clock in
Section 262.34(a), plus up to three days for waste transfer). The March
24, 1986 Federal Register, which clarifies small quantity generator
provisions, states "...as soon as the 55-gallon limit has been exceeded
in any satellite area, any excess waste is subject to all applicable
RCRA requirements within three days. This means that the 180/270 day
on site accumulation provision for 100-1000 kg/mo, generators applies
to any excess waste three days after the 55-gallon limit has been
exceeded." (51 FR 10162). If the generator chose to remove the waste
from the satellite area before the three-day transfer provision
expired, he would subject the waste to the 90-day clock provisions.
For example, if the above operator chose to move his excess waste from
the satellite area after just one day, the 90-day accumulation time in
Section 262.34 would begin as the waste entered the 90-day accumulation
area, not after three days. The generator has chosen not to utilize
the other two days that were available for transfer.
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Source: Emily Roth, OSW (202) 382-4627
Research: Mic LeBel, GRC
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Faxback 11812
9451.1994(01)
United States Environmental Protection Agency
Washington, D.C. 20460
Office of Solid Waste and Emergency Response
February 10, 1994 |
Mr. Thomas J. Dolce
GZA-AET
140 Broadway
Providence, Rhode Island 20903
Dear Mr. Dolce:
Thank you for your letter of December 17, 1993, regarding
counting waste in satellite accumulation areas. You specifically
asked if a small quantity generator who collects hazardous wastes
at satellite accumulation areas must count this waste for the
purpose of determining generator status.
The regulations at 40 CFR 261.5(c) state what is, and is not
included when making quantity determinations.
Hazardous waste that is not subject to regulation or that is-
subject only to D262.ll, D262.12, D262.40(c) and D262.41 is not
included in the quantity determinations of this part and parts 262
through 266, 268, and 270 and is not subject to any of the
requirements of those parts. Hazardous waste that is subject to the
requirements of D261.6(b) and (c) and subparts C,D, and F of part
266 is included in the quantity determination of this part and is
subject to the requirements of parts 262 through 266 and 270.
To determine generator status, generators must count all
hazardous waste generated at their facility in a calendar month.
Wastes not included in the monthly determination are either not
subject to regulation or subject to only the notification and
reporting requirements in 40 CFR section 262.22, 262.12, 262.40(c)
and section 262.41 as cited above.
Wastes stored in satellite accumulation areas are subject to
certain container standards (e.g., sections 265.171, 265.172, and
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265.173(a)). The container standards are not among those listed in
section 261.5(c) as "not included in the quantity determination."
Therefore, wastes in the satellite accumulation areas must be
included in the generators's monthly waste quantity determination
as well as other on-site quantity determinations.
For further discussion of this and other generator
requirements please see 51 FR 10151, March 24, 1986. We have
enclosed a copy of this Federal Register notice for your
convenience. If you have questions about this letter, please
contact Ann Codrington of my staff at (202) 260-4777.
Thank you for your interest in the safe management of
hazardous waste.
Sincerely,
Michael Shapiro
Director, Office of Solid Waste
D
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Faxback 11728
9453.1993(01)
United States Environmental Protection Agency
Washington, D.C. 20460
Office of Solid Waste and Emergency Response
February 23, 1993
Mr. D.B. Redington
Director, Regulatory Management
Monsanto Company
800 N. Lindbergh Boulevard
St. Louis, Missouri 63167
Dear Mr. Redington,
Thank you for your letter dated December 15, 1992, concerning
the hazardous waste storage regulations under the Resource
Conservation and Recovery Act (RCRA). In your letter, you requested
a clarification of the satellite accumulation provisions for
hazardous waste generators (40 CFR 262.34(c)(l)), particularly for
the types of wastes you described as being "generated from diverse
sources throughout a facility."
We have a policy of allowing EPA Regions, and states
authorized to implement the RCRA hazardous waste program, to answer
site-specific inquiries about the hazardous waste regulations.
However, the types of wastes you described in your letter (e.g.,
post-consumer items such as used nickel-cadmium batteries that
exhibit a characteristic of hazardous waste), are the same types of
wastes that are under consideration in an ongoing rulemaking effort
within the Office of Solid Waste (OSW). Therefore, we feel it would
be appropriate for us to provide you with some clarification
regarding these "universal wastes" and the satellite accumulation
provision under the existing generator requirements.
Based on your description of how and where these waste types
are generated, it is evident that the phrase "at or near the point
of generation where wastes initially accumulate" (see footnote I),
requires clarification. We agree that there may be circumstances
where certain hazardous wastes, which by their mode of use are
generated in small amounts throughout a facility or part of a
facility, could be accumulated under the reduced requirements
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Page 2 Of
described at D262.34(c)(l), provided that the conditions of this
regulation are met. For like wastes generated from many individual
locations (e.g., nickel-cadmium batteries), we would interpret the
"at or near the point of generation..." language to include a
specific satellite area designated by the generator that
facilitates the accumulation of this material prior to moving it to
a designated hazardous waste storage area. A generator should be
able to define the locations of waste generation being served by a
satellite accumulation area (within a generator facility or part of
a facility). This is to ensure that a determination can be made as
to when the 55-gallon limit has been reached for a particular
satellite area.
The condition that wastes accumulated under the satellite
provision "be under the control of the operator of the process
generating the waste" is still applicable. However, we would view
this condition as being satisfied for certain "universal wastes"
provided the generator demonstrates that the personnel responsible
for generating and/or accumulating the waste have adequate control
over the temporary storage of these wastes. The EPA recognizes that
for many of these "universal wastes," the person who first takes an
item out of service (e.g., an employee who replaces a dead battery
used in a calculator) may not be the same person responsible for
the accumulation of all of these wastes; rather, another worker may
have the responsibility of overseeing the temporary storage of
maintenance-related wastes. Alternatively, a maintenance worker who
replaces mercury thermostats throughout a factory might also be
assigned responsibility for the location at which the accumulated
used thermostats are temporarily stored.
I would like to emphasize that the satellite accumulation
provision was intended to accommodate situations where relatively
small amounts of hazardous waste are unavoidably accumulated
throughout.a facility prior to placing them in designated hazardous
waste storage areas; the goal is that this temporary accumulation
is performed responsibly and safely, with adequate oversight and
control. I would also note that we have not defined the term
"universal waste" in this letter (see footnote 2), but have instead
used some examples of these wastes to clarify the satellite
accumulation provision. The applicability of the satellite
accumulation provision will always depend upon a generator's
particular set of circumstances, which are site-specific;
therefore, any questions regarding specific wastes at specific
facilities are best answered by the agency implementing the RCRA
program for that particular facility.
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Lastly, as was mentioned above, EPA is developing standards to
streamline the regulatory requirements for some of these types of
"universal wastes," to facilitate the separation of these materials
from the municipal waste stream, and to encourage proper treatment
and/or recycling. This rule was recently published, and we have
enclosed a copy of it for your convenience. We would encourage you
to read it and submit to us any comments you may have. If you have
any questions on this rulemaking effort, or on any other issue
discussed in this letter, please call Charlotte Mooney or Ross
Elliott of my staff at (202) 260-8551. Thank you for your interest
in the responsible management of hazardous waste.
Sincerely,
Sylvia K. Lowrance, Director
Office of Solid Waste
cc: EPA Regional Waste Management
Division Directors, I-X
1 Defines the satellite accumulation "area."
2 The term is at this point, as you described, an "emerging
term."
Enclosure
D
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Faxback 11442
9453.1989(07)
UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
JUL 13 1989
MEMORANDUM
SUBJECT: "Satellite" Accumulation
FROM: Sylvia K. Lowrance, Director
Office of Solid Waste
TO: David A. Ullrich, Associate Division Director
Office of RCRA
Waste Management Division (5HR-13)
In response to your memorandum of June 13, 1989, we have
addressed the questions posed by Ohio EPA regarding our
requirements of 40 CFR Section 262.34(c) concerning satellite
accumulation.
Specifically, in the attachment to your memorandum, Ohio EPA
asks if roll-off boxes meet the definition of containers and may
be used at satellite accumulation areas. It is our view that if
the roll-off boxes meet the definition of container found in
Section 260.10 and are managed in accordance with the applicable
container requirements of Sections 265.171, 265.172, and
265.173(a), they may be utilized in satellite accumulation.
Section 260.10 defines "container" as "any portable device
in which a material is stored, transported, treated, disposed of
or otherwise handled." A roll-off box is a portable device. The
container requirements include: (1) that the container be in
good condition (i.e., not leaking), (2) that the container be of
a material, or lined with a material, which is compatible with
the waste, and, (3) that the container be closed during storage,
except to add or remove waste.
The ??? other requirement under Section 262.34(c)(l) states
that the container be marked with the words "Hazardous Waste" or
other words that identify the contents. This is the extent of
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the physical requirements for satellite accumulation containers.
Therefore, as long as the quantity limits and time limits for
excess quantities are met, the roll-off box may be classified as
a satellite accumulation container.
-2-
However, for containers used in off-site shipment of
hazardous waste, the Department of Transportation (DOT) packaging
specifications for the hazard class must be met. DOT regulations
governing the transportation of hazardous ijnaterials are found in
49 CFR Parts 171 through 177. '
Ohio EPA has also raised a concern about the ability of a
generator to determine when the 55 gallon quantity, limit for
satellite accumulation of hazardous waste (or one quart of acute
hazardous waste), is exceeded if roll-off boxes are used. The
dimensions, or capacity, of the roll-off boxes are not mentioned
in the Ohio EPA attachment. Under our regulations any type of
container may be used as a satellite accumulation device provided
it meets the Section 260.10 definition for container, and is used
in accordance with the above-mentioned container provisions of
Part 265. We ask that Ohio EPA inform us if they find that the
use of roll-off boxes of various volumes and capacities
contributes to a generator's inability to quantify his waste.
In addition to answering these questions, we offer the
following observation. It appears that the Ohio EPA has a
thorough understanding of the Section 262.34 requirements and
provides an accurate interpretation of the regulations. However,
you should note that, upon removal from an accumulation storage
area, hazardous waste may also be managed in an on-site permitted
unit (45 FR 76624, November 19, 1980).
If you have any questions regarding this memorandum, please
do not hesitate to contact me or have your staff contact Emily
Roth at (202) 382-4777.
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EPA530-R-99-005b
SUB-9224-99-002
RCRA/SUPERFUND HOTLINE MONTHLY REPORT
February 1999
1, Movement of Waste Between Satellite Accumulation Areas
Pursuant to 40 CFR Section 262.34(c), large quantity generators (LQGs) and smal
quantity generators (SQGs) are allowed to accumulate hazardous waste in satellite
accumulation areas without complying with all of the generator accumulation
provisions, or obtaining a RCRA permit or interim status. The satellite accumulatio
provisions allow LQGs and SQGs to accumulate hazardous waste in containers at c
near any point of generation where wastes initially accumulate and which is under
the control of the operator of the process generating the waste. If a facility has
multiple satellite accumulation areas, can an LQG or SQG move wastes from one
satellite area to another satellite area?
An LQG or SQG cannot move wastes between satellite accumulation areas. Once a
waste leaves a satellite accumulation area, the waste should be destined for an
accumulation area which is fully regulated under Sections 262.34(a) or (d), or Part
264 or 265. The regulatory requirements for satellite accumulation areas are
designed to provide the generator with a safe and efficient manner to accumulate
limited amounts of hazardous waste at or near the point of generation, prior to
moving the waste to a fully regulated storage area. This eliminates the need to
frequently move smaller quantities of hazardous waste within the generator's.
facility (49 FR 49569; December 20, 1984). It was not EPA's intent to allow
hazardous wastes to be moved from one satellite accumulation area to another.
Furthermore, if waste is moved between satellite accumulation areas, this calls intc
question whether the waste is being stored in a satellite accumulation area "at or
near the point of generation where wastes initially accumulate."
Faxback 14337
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EPA530-R-99-012I
SUB-9224-99-012
RCRA, SUPERFUND & EPCRA HOTLINE MONTHLY REPORT
December 1999
1. Inspection of Satellite Accumulation Containers
A large quantity generator (LQG) that is accumulating hazardous waste on-site fc
90 days or less in containers must cornply with 40 CFR Part 265, Subpart I
(§262.34(a)(l)(i)). Section 265.174 of Subpart I requires owners and operators t
inspect containers weekly for leaks and deterioration caused by corrosion or other
factors. Are LQGs required to inspect hazardous waste containers in satellite.
accumulation areas at or near the waste's point of generation in accordance with
§262.34(c)?
Hazardous waste containers used to accumulate hazardous waste at or near any
point of generation ("satellite accumulation") and in compliance with§262.34(c)
are not required to be inspected weekly. A generator accumulating hazardous
waste in satellite accumulation areas must comply with §265.171, 265.172, and
265.173(a) (§262.34(c)(l)(i)). These requirements include that a LQG ensure thai
the containers are in good condition, that the waste is compatible with the
containers, and that the containers are kept closed except when necessary to add
or remove waste. In addition, if the container begins to leak the generator must
transfer the waste to a container that is in good condition. Section 265.174,
regarding weekly inspection, is not a requirement for containers of hazardous was
in a satellite accumulation area. Therefore, LQGs are not required to conduct a
weekly inspection of containers in satellite accumulation areas so long as they
comply with the provisions of §262.34(c). Authorized states may require weekly
inspection of containers in satellite accumulation areas, as states may have more
stringent requirements than the federal regulations.
Faxback 14418
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FAXBACK 14029
PPC 9451.1996(04)
UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
WASHINGTON, D.C. 20460
May 1, 1996
Brenda J. Boykin
Shaw, Pittman, Potts, & Trowbridge ,
2300 N Street, N.W.
Washington, D.C. 20037
Dear Ms. Boykin:
Thank you for your letter of August 15, 1995 requesting an
interpretation of the regulations that apply to generators who
accumulate waste in containers at or near the point of generation
where wastes .initially accumulate. Specifically, you ask whether
the regulation at 40 CFR 262.34 would allow the generator to
accumulate more than 55 gallons of non-acutely hazardous waste at
one time at a satellite location.
As you may know, the regulations at 40 CFR 262.34(c)(l)
state that "a generator may accumulate as much as 55 gallons of
non-acute hazardous waste or one quart of acutely hazardous
waste...in containers at or near any point of generation where
wastes initially accumulate, which is under the control of the
operator of the process generating the waste..." Such accumulation
may take place provided that the waste is placed in containers
that are in good condition, the waste is compatible with their
containers, the containers are marked with the words "Hazardous
Wastes" or other words that identify the contents, and the
containers are covered when the generator is not adding or
removing waste. See 49 FR 49568 - 49572, Dec. 20, 1984. Should
the 55 gallon limit be exceeded, Section 262.34(c) requires the
generator to mark the container holding the excess accumulation of
hazardous waste with the date the excess amount began
accumulating, and after three days, manage that excess waste in
accordance with Section 262.34(a).
Your question relates to the interpretation of 40 CFR
262.34(c)(2) which states that:
A generator who accumulates either hazardous waste or acutely
hazardous waste listed in D261.33(e) in excess of the amounts
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Page 2 of
listed in paragraph (c)(l) of this section at or near any point of
generation must, with respect to that amount of excess waste,
comply within three days with paragraph (a) of this section or
other applicable provisions of this chapter. During the three-day
period the generator must continue to comply with paragraphs
(c)(l)(I) through (ii) of this section. The generator must mark
the container holding the excess accumulation of hazardous waste
with the date the excess amount began accumulating.
According to these provisions, the generate^ has 3 days
after the 55 gallon limit has been exceeded to transfer the excess
waste from the satellite area. In order to answer your question
of whether waste above the 55 gallon limit may be accumulated in
the 3 day interim period and remain subject to the accumulation
area provisions, it is necessary to refer to the preamble language
of December 20, 1984, which considers the potential hazards of
accumulating hazardous waste in these sites. In the December 20,
1984 Federal Register notice, the Agency states that "...the
accumulation at satellite areas of up to 55 gallons of non-acutely
hazardous waste is reasonable and safe and does not pose a threat
to human health and the environment" (49 FR 49569, Dec. 20, 1984).
However, in the discussion which followed, the Agency questioned
the safety of the accumulation of non-acutely hazardous waste in
amounts above the 55 gallon limit. "Because the weight of
evidence suggests limited use by the regulated community of
containers larger than 55 gallons and because spills of 110
gallons of non-acutely hazardous waste would pose a higher
environmental threat, EPA does not believe that the satellite
accumulation level should be higher than 55 gallons." Id.
The preamble language above illustrates the Agency's view
that waste accumulation in satellite accumulation areas should not
be excessive. Although it is clear that the Agency did not intend
for amounts as large as 110 gallons to be accumulated on a routine
basis, it is not specific about whether small amounts of
non-acutely hazardous waste exceeding the 55 gallon limit may be
accumulated routinely. The Agency understands that due to the
nature of the production process, there may be special cases in
which small quantities of wastes above the 55 gallon limit may
need to be accumulated for brief periods in one accumulation area.
Thus, we interpret that the satellite accumulation provisions of
40 CFR 262.34(c)(l) permit the generator to continue to accumulate
nominal quantities of a non acutely hazardous waste in excess of
the 55 gallon limit as long as the additional wastes accumulated
during the 3-days are managed in accordance with section
262.34(c)(l). Any excess waste must be managed (including
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transferring that excess waste to the generator's 90-day
accumulation area) in accordance with section 262.34(a) within
three days.
The Agency does not expect that any accumulation over the 55
gallon limit will be excessive and believes that most facilities
should be aware of the process waste generation rate and should be
able to arrange for the removal of any excess accumulation within
the 3-day time frame, thereby avoiding excessive accumulation of
waste over the 55 gallon limit. The Agency also understands that
there may be one-time circumstances during which quantities in
excess of 110 gallons are generated. In such cases, the Agency
recommends that you contact your state waste management office for
further guidance on how such occurrences should be handled.
Also, because states may have regulations and
interpretations that are more stringent than the federal
regulations, the Agency strongly recommends that you check with
your state waste management office (or Regional office in
unauthorized states) for questions specific to the amount of waste
allowed above the 55 gallon limit in the particular states where
your clients operate. This interpretation is not binding on
authorized states.
I hope this response is of assistance. If you have
additional questions, please contact Ann Codrington of my office
at(202)260-8551.
Sincerely yours,
Michael Shapiro, Director
Office of Solid Waste
cc: Bill Hamele
i
Attachment
SHAW, PITTMAN, POTTS & TROWBRIDGE
2300 N Street, N.W.
Washington, D.C. 20037
(202)663-8000
Facsimile(202) 663-8007
August 15, 1995
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Page 4» of
Ms. Sylvia K. Lowrance
Director, Office of Solid Waste
Office of Solid Waste and Emergency Response
U.S. Environmental Protection Agency
401 M Street, S.W.
Washington, D.C. 20460
Re: Satellite Accumulation Rule; Request for Interpretation
Dear Ms. Lowrance:
I am writing to request an interpretation of the rule that
applies to generators who accumulate hazardous waste in satellite
accumulation containers. 40 C.F.R. D 262.34(c) states that "[a]
generator may accumulate as much as 55 gallons of hazardous waste
... in containers at or near any point of generation" provided
that the generator complies with certain requirements. The rule
states that if the generator accumulates more than 55 gallons of
waste, he must "with respect to that amount of excess waste" move
the waste to the facility's long-term (e.g., 90-day) storage area
within three days.
My question is whether the generator can temporarily have
more than 55 gallons of hazardous waste at a single satellite
location. This could occur, for example, if the generator has
filled one 55-gallon container with hazardous waste and intends to
move that container to the long-term storage area within three
days. If the generator then starts filling a new 55-gallon
container in the three-day period before he or she removes the old
one, this would mean that the total quantity of hazardous waste at
the satellite accumulation location could exceed 55 gallons
temporarily (because it would include the filled 55-gallon
container as well as the amount that accumulates during the
three-day period). I am uncertain1 whether the rule would allow
the generator to have more than 55 gallons at one time at a
satellite location, even under these circumstances, and I would
appreciate your clarification.
Please contact me if you require any additional information
in order to respond to this inquiry. Thank you for your
assistance.
Sincerely,
Brenda J. Boy kin
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Exhibit XI-24
Federal Regulations
EPA Region 2 266
-------
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Environmental Protection Agency
§266.23
AUTHORITY: 42 U.S.C. 1006, 2002(a), 3001-3009,
3014, 6905, 6906, 6912, 6921, 6922, 6924-6927, 6934,
and 6937.
SOURCE: 50 FR 666, Jan. 4, 1985, unless oth-
erwise noted.
Subparts A-B [Reserved]
Subpart C—Recyclable Materials
Used in a Manner Constituting
Disposal
§266.20 Applicability.
(a) The regulations of this subpart
apply to recyclable materials that are
applied to or placed on the land:
(1) Without mixing with any other
substance (s); or
(2) After mixing or combination with
any other substance (s). These mate-
rials will be referred to throughout this
subpart as "materials used in a manner
that constitutes disposal."
(b) Products produced for the general
public's use that are used in a manner
that constitutes disposal and that con-
tain recyclable materials are not pres-
ently subject to regulation if the recy-
clable materials have undergone a
chemical reaction in the course of pro-
ducing the products so as to become in-
separable by physical means and if
such products meet the applicable
treatment standards in subpart D of
part 268 (or applicable prohibition lev-
els in §268.32 or RCRA section 3004 (d),
where no treatment standards have
been established) for each recyclable
material (i.e., hazardous waste) that
they contain.
(c) Anti-skid/deicing uses of slags,
which are generated from high tem-
perature metals recovery (HTMR) proc-
essing of hazardous waste K061, K062,
and F006, in a manner constituting dis-
posal are not covered by the exemption
in paragraph (b) of this section and re-
main subject to regulation.
(d) Fertilizers that contain recycla-
ble materials are not subject to regula-
tion provided that:
(1) They are zinc fertilizers excluded
from the definition of solid waste ac-
cording to §261.4(a)(21) of this chapter;
or
(2) They meet the applicable treat-
ment standards in subpart D of Part 268
of this chapter for each hazardous
waste that they contain.
[50 FR 666, Jan. 4, 1985, as amended at 52 FR
21307, June 5, 1987; 54 FR 36970, Sept. 6, 1989;
59 FR 43500, Aug. 24, 1994; 67 FR 48414, July
24, 2002]
§266.21 Standards applicable to gen-
erators and transporters of mate-
rials used in a manner that con-
stitutes disposal.
Generators and transporters of mate-
rials that are used in a manner that
constitutes disposal are subject to the
applicable requirements of parts 262
and 263 of this chapter, and the notifi-
cation requirement under section 3010
of RCRA.
§266.22 Standards applicable to stor-
ers of materials that are to be used
in a manner that constitutes dis-
posal who are not the ultimate
users.
Owners or operators of facilities that
store recyclable materials that are to
be used in a manner that constitutes
disposal, but who are not the ultimate
users of the materials, are regulated
under all applicable provisions of sub-
parts A through L of parts 264 and 265
and parts 270 and 124 of this chapter
and the notification requirement under
section 3010 of RCRA.
§266.23 Standards applicable to users
of materials that are used in a man-
ner that constitutes disposal.
(a) Owners or operators of facilities
that use recyclable materials in a man-
ner that constitutes disposal are regu-
lated under all applicable provisions of
subparts A through N of parts 124, 264,
265, 268, and 270 of this chapter and the
notification requirement under section
3010 of RCRA. (These requirements do
not apply to products which contain
these recyclable materials under the
provisions of §266.20(b) of this chapter.)
(b) The use of waste or used oil or
other material, which is contaminated
with dioxin or any other hazardous
waste (other than a waste identified
solely on the basis of ignitability), for
dust suppression or road treatment is
prohibited.
[50 FR 666, Jan. 4, 1985, as amended at 50 FR
28750, July 15, 1985; 59 FR 48042, Sept. 19, 1994]
-------
§266.70
40 CFR Ch. 1 (7-1-03 Edition)
Subpart D-E [Reserved]
Subpart F—Recyclable Materials
Utilized for Precious Metal Re-
covery
§266.70 Applicability and require-
ments.
(a) The regulations of this subpart
apply to recyclable materials that are
reclaimed to recover economically sig-
nificant amounts of gold, silver, plat-
inum, paladium, irridium, osmium,
rhodium, ruthenium, or any combina-
tion of these.
(b) Persons who generate, transport,
or store recyclable materials that are
regulated under this subpart are sub-
ject to the following requirements:
(1) Notification requirements under
section 3010 of RCRA;
(2) Subpart B of part 262 (for genera-
tors), §§263.20 and 263.21 (for trans-
porters), and §§265.71 and 265.72 (for per-
sons who store) of this chapter; and
(3) For precious metals exported to or
imported from designated OECD mem-
ber countries for recovery, subpart H of
part 262 and §265.12(a)(2) of this chap-
ter. For precious metals exported to or
imported from non-OECD countries for
recovery, subparts E and F of 40 CFR
part 262.
(c) Persons who store recycled mate-
rials that are regulated under this sub-
part must keep the following records to
document that they are not accumu-
lating these materials speculatively (as
defined in §261.1(c) of this chapter);
(1) Records showing the volume of
these materials stored at the beginning
of the calendar year;
(2) The amount of these materials
generated or received during the cal-
endar year; and
(3) The amount of materials remain-
ing at the end of the calendar year.
(d) Recyclable materials that are reg-
ulated under this subpart that are ac-
cumulated speculatively (as defined in
§261.1(c) of this chapter) are subject to
all applicable provisions of parts 262
through 265, 270 and 124 of this chapter.
[50 FR 666, Jan. 4, 1985, as amended at 61 FR
16315, Apr. 12, 1996]
Subpart G—Spent Lead-Acid
Batteries Being Reclaimed
§266.80 Applicability and require-
ments.
(a) Are spent lead-acid batteries ex-
empt from hazardous waste manage-
ment requirements? If you generate,
collect, transport, store, or regenerate
lead-acid batteries for reclamation pur-
poses, you may be exempt from certain
hazardous waste management require-
ments. Use the following table to de-
termine which requirements apply to
you. Alternatively, you may choose to
manage your spent lead-acid batteries
under the "Universal Waste" rule in 40
CFR part 273.
If your batteries * * *
(1) Will be reclaimed
through regeneration
(such as by electrolyte
replacement).
(2) Will be reclaimed
other than through re-
generation.
(3) Will be reclaimed
other than through re-
generation.
(4) Will be reclaimed
other than through re-
generation.
(5) Will be reclaimed
other than through re-
generation.
And if you * * *
generate, collect, and/or
transport these bat-
teries.
store these .batteries
but you aren't the re-
claimer.
store these batteries
before you reclaim
them.
don't store these bat-
teries before you re-
claim them.
Then you * * •
are exempt from 40 CFR parts 262 (except
for §262.11) 263, 264, 265, 266, 268, 270,
1 24 of this chapter, and the notification re-
quirements at section 3010 of RCRA.
are exempt from 40 CFR parts 262 (except
for §262.11) 263, 264, 265, 266, 270, 124
of this chapter, and the notification require-
ments at section 3010 of RCRA.
are exempt from 40 CFR parts 262 (except
for §262.11) 263, 264, 265, 266, 270, 124
of this chapter, and the notification require-
ments at section 3010 of RCRA.
must comply with 40 CFR 266.80(b) and as
appropriate other regulatory provisions de-
scribed in 266.80(b).
are exempt from 40 CFR parts 262 (except
for §262.11) 263, 264, 265, 266, 270, 124
of this chapter, and the notification require-
ments at section 3010 of RCRA.
And you * * *
are subject to 40 CFR
parts 261 and §262.11
of this chapter.
are subject to 40 CFR
parts 261 and §262.11,
and applicable provi-
sions under part 268.
are subject to 40 CFR
parts 261, §262.1 1,and
applicable provisions
under part 268.
are subject to 40 CFR
parts 261, §262.11, and
applicable provisions
under part 268.
are subject to 40 CFR
parts 261, §262.11, and
applicable provisions
under part 268.
-------
§260.20
40 CFR Ch. I (7-1-03 Edition)
(12) "Screening Procedures for Estimating
the Air Quality Impact of Stationary
Sources, Revised", October 1992, EPA Publi-
cation No. EPA-450/R-92-019, Environmental
Protection Agency, Research Triangle Park,
NC.
(13) "ASTM Standard Test Methods for
Preparing Refuse-Derived Fuel (RDF) Sam-
ples for Analyses of Metals," ASTM Stand-
ard E926-88, Test Method C—Bomb, Acid Di-
gestion Method, available from American
Society for Testing Materials, 1916 Race
Street, Philadelphia, PA 19103.
(14) "API Publication 2517, Third Edition",
February 1989, "Evaporative Loss from Ex-
ternal Floating-Roof Tanks," available from
the American Petroleum Institute, 1220 L
Street, Northwest, Washington, DC 20005.
(15) "ASTM Standard Test Method for
Vapor Pressure—Temperature Relationship
and Initial Decomposition Temperature of
Liquids by Isoteniscope," ASTM Standard D
2879-92, available from American Society for
Testing and Materials (ASTM), 1916 Race
Street, Philadelphia, PA 19103.
(16) Method 1664, Revision A, n-Hexane Ex-
tractable Material (HEM; Oil and Grease)
and Silica Gel Treated n-Hexane Extractable
Material (SGT-HEM; Non-polar Material) by
Extraction and Gravimetry. Available at
NTIS, PB99-121949, U.S. Department of Com-
merce, 5285 Port Royal, Springfield, Virginia
22161.
(b) The references listed in paragraph
(a) of this section are also available for
inspection at the Office of the Federal
Register, 800 North Capitol Street,
NW., Suite 700, Washington, DC. These
incorporations by reference were ap-
proved by the Director of the Federal
Register. These materials are incor-
porated as they exist on the date of ap-
proval and a notice of any change in
these materials will be published in the
FEDERAL REGISTER.
[46 FR 35247, July 7, 1981, as amended at 50
FR 18374, Apr. 30, 1985; 52 FR 8073, Mar. 16,
1987; 52 FR 41295, Oct. 27, 1987; 54 FR 40266,
Sept. 29, 1989; 55 FR 8949, Mar. 9, 1990; 55 FR
25493, June 21, 1990; 56 FR 7206, Feb. 21, 1991;
58 FR 38883, July 20, 1993; 58 FR 46049, Aug.
31. 1993; 59 FR 468, Jan. 4, 1994; 59 FR 28484,
June 2, 1994; 59 FR 62926, Dec. 6, 1994: 60 FR
17004, Apr. 4, 1995; 62 FR 32462, June 13, 1997;
64 FR 26327, May 11, 1999; 66 FR 34376, June
28, 2001]
Subpart C—Rulemaking Petitions
§ 260.20 General.
(a) Any person may petition the Ad-
ministrator to modify or revoke any
provision in parts 260 through 266, 268
and 273 of this chapter. This section
sets forth general requirements which
apply to all such petitions. Section
260.21 sets forth additional require-
ments for petitions to add a testing or
analytical method to part 261, 264 or 265
of this chapter. Section 260.22 sets
forth additional requirements for peti-
tions to exclude a waste or waste-de-
rived material at a particular facility
from §261.3 of this chapter or the lists
of hazardous wastes in subpart D of
part 261 of this chapter. Section 260.23
sets forth additional requirements for
petitions to amend part 273 of this
chapter to include additional haz-
ardous wastes or categories of haz-
ardous waste as universal waste.
(b) Each petition must be submitted
to the Administrator by certified mail
and must include;
(1) The petitioner's name and ad-
dress;
(2) A statement of the petitioner's in-
terest in the proposed action;
(3) A description of the proposed ac-
tion, including (where appropriate)
suggested regulatory language; and
(4) A statement of the need and jus-
tification for the proposed action, in-
cluding any supporting tests, studies,
or other information.
(c) The Administrator will make a
tentative decision to grant or deny a
petition and will publish notice of such
tentative decision, either in the form
of an advanced notice of proposed rule-
making, a proposed rule, or a tentative
determination to deny the petition, in
the FEDERAL REGISTER for written pub-
lic comment.
(d) Upon the written request of any
interested person, the Administrator
may, at his discretion, hold an infor-
mal public hearing to consider oral
comments on the tentative decision. A
person requesting a hearing must state
the issues to be raised and explain why
written comments would not suffice to
communicate the person's views. The
Administrator may in any case decide
on his own motion to hold an informal
public hearing.
(e) After evaluating all public com-
ments the Administrator will make a
18
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Environmental Protection Agency
§260.22
final decision by publishing in the FED-
ERAL REGISTER a regulatory amend-
ment or a denial of the petition.
[45 FR 33073, May 19, 1980, as amended at 51
FR 40636, Nov. 7, 1986; 57 FR 38564, Aug. 25,
1992; 60 FR 25540, May 11, 1995]
§260.21 Petitions for equivalent test-
ing or analytical methods.
(a) Any person seeking to add a test-
ing or analytical method to part 261,
264, or 265 of this chapter may petition
for a regulatory amendment under this
section and §260.20. To be successful,
the person must demonstrate to the
satisfaction of the Administrator that
the proposed method is equal to or su-
perior to the corresponding method
prescribed in part 261, 264, or 265 of this
chapter, in terms of its sensitivity, ac-
curacy, and precision (i.e., reproduc-
ibility).
(b) Each petition must include, in ad-
dition to the information required by
§260.20(b):
(1) A full description of the proposed
method, including all procedural steps
and equipment used in the method;
(2) A description of the types of
wastes or waste matrices for which the
proposed method may be used;
(3) Comparative results obtained
from using the proposed method with
those obtained from using the relevant
or corresponding methods prescribed in
part 261, 264, or 265 of this chapter;
(4) An assessment of any factors
which may interfere with, or limit the
use of, the proposed method; and
(5) A description of the quality con-
trol procedures necessary to ensure the
sensitivity, accuracy and precision of
the proposed method.
(c) After receiving a petition for an
equivalent method, the Administrator
may request any additional informa-
tion on the proposed method which he
may reasonably require to evaluate the
method.
(d) If the Administrator amends the
regulations to permit use of a new test-
ing method, the method will be incor-
porated in "Test Methods for the Eval-
uation of Solid Waste: Physical/Chem-
ical Methods," SW-846, U.S. Environ-
mental Protection Agency, Office of
Solid Waste, Washington, DC 20460.
[45 FR 33073, May 19, 1980, as amended at 49
FR 47391, Dec. 4, 1984]
§ 260.22 Petitions to amend part 261 to
exclude a waste produced at a par-
ticular facility.
(a) Any person seeking to exclude a
waste at a particular generating facil-
ity from the lists in subpart D of part
261 may petition for a regulatory
amendment under this section and
§260.20. To be successful:
(1) The petitioner must demonstrate
to the satisfaction of the Adminis-
trator that the waste produced by a
particular generating facility does not
meet any of the criteria under which
the waste was listed as a hazardous or
an actutely hazardous waste; and
(2) Based on a complete application,
the Administrator must determine,
where he has a reasonable basis to be-
lieve that factors (including additional
constituents) other than those for
which the waste was listed could cause
the waste to be a hazardous waste, that
such factors do not warrant retaining
the waste as a hazardous waste. A
waste which is so excluded, however,
still may be a hazardous waste by oper-
ation of subpart C of part 261.
(b) The procedures in this Section
and §260.20 may also be used to petition
the Administrator for a regulatory
amendment to exclude from
§261.3(a)(2)(ii) or (c), a waste which is
described in these Sections and is ei-
ther a waste listed in subpart D, or is
derived from a waste listed in subpart
D. This exclusion may only be issued
for a particular generating, storage,
treatment, or disposal facility. The pe-
titioner must make the same dem-
onstration as required by paragraph (a)
of this section. Where the waste is a
mixture of solid waste and one or more
listed hazardous wastes or is derived
from one or more hazardous wastes, his
demonstration must be made with re-
spect to the waste mixture as a whole;
analyses must be conducted for not
only those constituents for which the
listed waste contained in the mixture
was listed as hazardous, but also for
factors (including additional constitu-
ents) that could cause the waste mix-
ture to be a hazardous waste. A waste
which is so excluded may still be a haz-
ardous waste by operation of subpart C
of part 261.
(c) If the waste is listed with codes
"I", "C", "R", or "E", in subpart D,
19
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§260.22
40 CFR Ch. I (7-1-03 Edition)
(1) The petitioner must show that the
waste does not exhibit the relevant
characteristic for which the waste was
listed as defined in §261.21, §261.22,
§261.23, or §261.24 using any applicable
methods prescribed therein. The peti-
tioner also must show that the waste
does not exhibit any of the other char-
acteristics defined in §261.21, §261.22,
§261.23, or §261.24 using any applicable
methods prescribed therein;
(2) Based on a complete application,
the Administrator must determine,
where he has a reasonable basis to be-
lieve that factors (including additional
constituents) other than those for
which the waste was listed could cause
the waste to be hazardous waste, that
such factors do not warrant retaining
the waste as a hazardous waste. A
waste which is so excluded, however,
still may be a hazardous waste by oper-
ation of subpart C of part 261.
(d) If the waste is listed with code
"T" in subpart D,
(1) The petitioner must demonstrate
that the waste:
(i) Does not contain the constituent
or constituents (as defined in Appendix
VII of part 261 of this chapter) that
caused the Administrator to list the
waste, using the appropriate test meth-
ods prescribed in "Test Methods for
Evaluating Solid Waste, Physical/
Chemical Methods," EPA Publication
SW-846, as incorporated by reference in
§260.11; or
(ii) Although containing one or more
of the hazrdous constituents (as de-
fined in appendix VII of part 261) that
caused the Administrator to list the
waste, does not meet the criterion of
§261.11 (a) (3) when considering the fac-
tors used by the Administrator in
§261.11 (a) (3) (i) through (xi) under
which the waste was listed as haz-
ardous; and
(2) Based on a complete application,
the Administrator must determine,
where he has a reasonable basis to be-
lieve that factors (including additional
constituents) other than those for
which the waste was listed could cause
the waste to be a hazardous waste, that
such factors do not warrant retaining
the waste as a hazardous waste; and
(3) The petitioner must demonstrate
that the waste does not exhibit any of
the characteristics defined in §261.21,
§261.22, §261.23, and §261.24 using any
applicable methods prescribed therein;
(4) A waste which is so excluded,
however, still may be a hazardous
waste by operation of subpart C of part
261.
(e) If the waste is listed with the code
"H" in subpart D,
(1) The petitioner must demonstrate
that the waste does not meet the cri-
terion of §261.11(a)(2); and
(2) Based on a complete application,
the Administrator must determine,
where he has a reasonable basis to be-
lieve that additional factors (including
additional constituents) other than
those for which the waste was listed
could cause the waste to be a haz-
ardous waste, that such factors do not
warrant retaining the waste as a haz-
ardous waste; and
(3) The petitioner must demonstrate
that the waste does not exhibit any of
the characteristics defined in §261.21,
§261.22, §261.23, and §261.24 using any
applicable methods prescribed therein;
(4) A waste which is so excluded,
however, still may be a hazardous
waste by operation of subpart C of part
261.
(f) [Reserved for listing radioactive
wastes.]
(g) [Reserved for listing infectious
wastes.]
(h) Demonstration samples must con-
sist of enough representative samples,
but in no case less than four samples,
taken over a period of time sufficient
to represent the variability or the uni-
formity of the waste.
(i) Each petition must include, in ad-
dition to the information required by
§260.20(b):
(1) The name and address of the lab-
oratory facility performing the sam-
pling or tests of the waste;
(2) The names and qualifications of
the persons sampling and testing the
waste;
(3) The dates of sampling and testing;
(4) The location of the generating fa-
cility;
(5) A description of the manufac-
turing processes or other operations
and feed materials producing the waste
and an assessment of whether such
processes, operations, or feed materials
can or might produce a waste that is
not covered by the demonstration;
20
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Environmental Protection Agency
§260.30
(6) A description of the waste and an
estimate of the average and maximum
monthly and annual quantities of
waste covered by the demonstration;
(7) Pertinent data on and discussion
of the factors delineated in the respec-
tive criterion for listing a hazardous
waste, where the demonstration is
based on the factors in §261.11 (a) (3);
(8) A description of the methodolo-
gies and equipment used to obtain the
representative samples;
(9) A description of the sample han-
dling and preparation techniques, in-
cluding techniques used for extraction,
containerization and preservation of
the samples;
(10) A description of the tests per-
formed (including results);
(11) The names and model numbers of
the instruments used in performing the
tests; and
(12) The following statement signed
by the generator of the waste or his au-
thorized representative:
I certify under penalty of law that I have
personally examined and am familiar with
the information submitted in this dem-
onstration and all attached documents, and
that, based on my inquiry of those individ-
uals immediately responsible for obtaining
the information, I believe that the submitted
information is true, accurate, and complete.
I am aware that there are significant pen-
alties for submitting false information, in-
cluding the possibility of fine and imprison-
ment.
(ii) [Reserved]
(j) After receiving a petition for an
exclusion, the Administrator may re-
quest any additional information
which he may reasonably require to
evaluate the petition.
(k) An exclusion will only apply to
the waste generated at the individual
facility covered by the demonstration
and will not apply to waste from any
other facility.
(1) The Administrator may exclude
only part of the waste for which the
demonstration is submitted where he
has reason to believe that variability
of the waste justifies a partial exclu-
sion.
[45 FR 33073, May 19, 1980, as amended at 50
FR 28742, July 15, 1985; 54 FR 27116, June 27,
1989; 58 FR 46049, Aug. 31, 1994]
EDITORIAL NOTE: For information on the
availability of a guidance manual for peti-
tions to delist hazardous wastes, see 50 FR
21607, May 28, 1985.
§260.23 Petitions to amend 40 CFR
part 273 to include additional haz-
ardous wastes.
(a) Any person seeking to add a haz-
ardous waste or a category of haz-
ardous waste to the universal waste
regulations of part 273 of this chapter
may petition for a regulatory amend-
ment under this section, 40 CFR 260.20,
and subpart G of 40 CFR part 273.
(b) To be successful, the petitioner
must demonstrate to the satisfaction
of the Administrator that regulation
under the universal waste regulations
of 40 CFR part 273: Is appropriate for
the waste or category of waste; will im-
prove management practices for the
waste or category of waste; and will
improve implementation of the haz-
ardous waste program. The petition
must include the information required
by 40 CFR 260.20(b). The petition should
also address as many of the factors
listed in 40 CFR 273.81 as are appro-
priate for the waste or category of
waste addressed in the petition.
(c) The Administrator will grant or
deny a petition using the factors listed
in 40 CFR 273.81. The decision will be
based on the weight of evidence show-
ing that regulation under 40 CFR part
273 is appropriate for the waste or cat-
egory of waste, will improve manage-
ment practices for the waste or cat-
egory of waste, and will improve imple-
mentation of the hazardous waste pro-
gram.
(d) The Administrator may request
additional information needed to
evaluate the merits of the petition.
[60 FR 25540, May 11, 1995]
§260.30 Variances from classification
as a solid waste.
In accordance with the standards and
criteria in §260.31 and the procedures in
§260.33, the Administrator may deter-
mine on a case-by-case basis that the
following recycled materials are not
solid wastes:
(a) Materials that are accumulated
speculatively without sufficient
amounts being recycled (as defined in
§261.1(c)(8) of this chapter);
21
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§260.31
40 CFR Ch. I (7-1-03 Edition)
(b) Materials that are reclaimed and
then reused within the original produc-
tion process in which they were gen-
erated; and
(c) Materials that have been re-
claimed but must be reclaimed further
before the materials are completely re-
covered.
[50 FR 661, Jan. 4, 1985; 50 FR 14219, Apr. 11,
1985, as amended at 59 FR 48041, Sept. 19,
1994]
§260.31 Standards and criteria for
variances from classification as a
solid waste.
(a) The Administrator may grant re-
quests for a variance from classifying
as a solid waste those materials that
are accumulated speculatively without
sufficient amounts being recycled if
the applicant demonstrates that suffi-
cient amounts of the material will be
recycled or transferred for recycling in
the following year. If a variance is
granted, it is valid only for the fol-
lowing year, but can be renewed, on an
annual basis, by filing a new applica-
tion. The Administrator's decision will
be based on the following criteria:
(1) The manner in which the material
is expected to be recycled, when the
material is expected to be recycled,
and whether this expected disposition
is likely to occur (for example, because
of past practice, market factors, the
nature of the material, or contractual
arrangements for recycling);
(2) The reason that the applicant has
accumulated the material for one or
more years without recycling 75 per-
cent of the volume accumulated at the
beginning of the year;
(3) The quantity of material already
accumulated and the quantity expected
to be generated and accumulated be-
fore the material is recycled;
(4) The extent to which the material
is handled to minimize loss;
(5) Other relevant factors.
(b) The Administrator may grant re-
quests for a variance from classifying
as a solid waste those materials that
are reclaimed and then reused as feed-
stock within the original production
process in which the materials were
generated if the reclamation operation
is an essential part of the production
process. This determination will be
based on the following criteria:
(1) How economically viable the pro-
duction process would be if it were to
use virgin materials, rather than re-
claimed materials;
(2) The prevalence of the practice on
an industry-wide basis;
(3) The extent to which the material
is handled before reclamation to mini-
mize loss;
(4) The time periods between gener-
ating the material and its reclamation,
and between reclamation and return to
the original primary production proc-
ess;
(5) The location of the reclamation
operation in relation to the production
process;
(6) Whether the reclaimed material is
used for the purpose for which it was
originally produced when it is returned
to the original process, and whether it
is returned to the process in substan-
tially its original form;
(7) Whether the person who generates
the material also reclaims it;
(8) Other relevant factors.
(c) The Regional Administrator may
grant requests for a variance from
classifying as a solid waste those mate-
rials that have been reclaimed but
must be reclaimed further before re-
covery is completed if, after initial rec-
lamation, the resulting material is
commodity-like (even though it is not
yet a commercial product, and has to
be reclaimed further). This determina-
tion will be based on the following fac-
tors:
(1) The degree of processing the ma-
terial has undergone and the degree of
further processing that is required;
(2) The value of the material after it
has been reclaimed;
(3) The degree to which the reclaimed
material is like an analogous raw ma-
terial;
(4) The extent to which an end mar-
ket for the reclaimed material is guar-
anteed;
(5) The extent to which the reclaimed
material is handled to minimize loss;
(6) Other relevant factors.
[50 FR 662, Jan. 4, 1985, as amended at 59 FR
48041, Sept. 19, 1994]
22
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§261.1
40 CFR Ch. I (7-1-03 Edition)
261.9 Requirements for Universal Waste.
Subpart B—Criteria for Identifying the
Characteristics of Hazardous Waste
and for Listing Hazardous Waste
261.10 Criteria for identifying the character-
istics of hazardous waste.
261.11 Criteria for listing hazardous waste.
Subparf C—Characteristics of Hazardous
Waste
261.20 General.
261.21 Characteristic of ignitability.
261.22 Characteristic of corrosivity.
261.23 Characteristic of reactivity.
261.24 Toxicity characteristic.
Subparf D—Lists of Hazardous Wastes
261.30 General.
261.31 Hazardous wastes from non-specific
sources.
261.32 Hazardous wastes from specific
sources.
261.33 Discarded commercial chemical prod- '
ucts, off-specification species, container
residues, and spill residues thereof.
261.35 Deletion of certain hazardous waste
codes following equipment cleaning and
replacement.
261.38 Comparable/Syngas Fuel Exclusion.
APPENDIX I TO PART 261—REPRESENTATIVE
SAMPLING METHODS
APPENDIX II TO PART 261—METHOD 1311 TOX-
ICITY CHARACTERISTIC LEACHING PROCE-
DURE (TCLP)
APPENDIX III TO PART 261—CHEMICAL ANAL-
YSIS TEST METHODS
APPENDIX iv TO PART 261—[RESERVED FOR
RADIOACTIVE WASTE TEST METHODS!
APPENDIX V TO PART 261—[RESERVED FOR IN-
FECTIOUS WASTE TREATMENT SPECIFICA-
TIONS]
APPENDIX VI TO PART 261—[RESERVED FOR
ETIOLOCIC AGENTS!
APPENDIX VII TO PART 261—BASIS FOR LIST-
ING HAZARDOUS WASTE
APPENDIX vin TO PART 261—HAZARDOUS CON-
STITUENTS
APPENDIX IX TO PART 261—WASTES EXCLUDED
UNDER §§260.20 AND 260.22
AUTHORITY: 42 U.S.C. 6905, 6912(a), 6921,
6922. 6924{y) and 6938.
SOURCE: 45 FR 33119, May 19, 1980, unless
otherwise noted.
Subpart A—General
S 261.1 Purpose and scope.
(a) This part identifies those solid
wastes which are subject to regulation
as hazardous wastes under parts 262
through 265, 268, and parts 270, 271, and
124 of this chapter and which are sub-
ject to the notification requirements of
section 3010 of RCRA. In this part:
(1) Subpart A defines the terms
"solid waste" and "hazardous waste".
identifies those wastes which are ex-
cluded from regulation under parts 262
through 266, 268 and 270 and establishes
special management requirements for
hazardous waste produced by condi-
tionally exempt small quantity genera-
tors and hazardous waste which is re-
cycled.
(2) Subpart B sets forth the criteria
used by EPA to identify characteristics
of hazardous waste and to list par-
ticular hazardous wastes.
(3) Subpart C identifies characteris-
tics of hazardous waste.
(4) Subpart D lists particular haz-
ardous wastes.
(b)(l) The definition of solid waste
contained in this part applies only to
wastes that also are hazardous for pur-
poses of the regulations implementing
subtitle C of RCRA. For example, it
does not apply to materials (such as
non-hazardous scrap, paper, textiles, or
rubber) that are not otherwise haz-
ardous wastes and that are recycled.
(2) This part identifies only some of
the materials which are solid wastes
and hazardous wastes under sections
3007, 3013, and 7003 of RCRA. A material
which is not defined as a solid waste in
this part, or is not a hazardous waste
identified or listed in this part, is still
a solid waste and a hazardous waste for
purposes of these sections if:
(i) In the case of sections 3007 and
3013, EPA has reason to believe that
the material may be a solid waste
within the meaning of section 1004(27)
of RCRA and a hazardous waste within
the meaning of section 1004(5) of RCRA;
or
(ii) In the case of section 7003, the
statutory elements are established.
(c) For the purposes of §§261.2 and
261.6:
(1) A "spent material" is any mate-
rial that has been used and as a result
of contamination can no longer serve
the purpose for which it was produced
without processing;
(2) "Sludge" has the same meaning
used in §260.10 of this chapter;
(3) A "by-product" is a material that
is not one of the primary products of a
30
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Environmental Protection Agency
§261.2
production process and is not solely or
separately produced by the production
process. Examples are process residues
such as slags or distillation column
bottoms. The term does not include a
co-product that is produced for the
general public's use and is ordinarily
used in the form it is produced by the
process.
(4) A material is "reclaimed" if it is
processed to recover a usable product,
or if it is regenerated. Examples are re-
covery of lead values from spent bat-
teries and regeneration of spent sol-
vents.
(5) A material is "used or reused" if
it is either:
(i) Employed as an ingredient (in-
cluding use as an intermediate) in an
industrial process to make a product
(for example, distillation bottoms from
one process used as feedstock in an-
other process). However, a material
will not satisfy this condition if dis-
tinct components of the material are
recovered as separate end products (as
when metals are recovered from metal-
containing secondary materials); or
(ii) Employed in a particular func-
tion or application as an effective sub-
stitute for a commercial product (for
example, spent pickle liquor used as
phosphorous precipitant and sludge
conditioner in wastewater treatment).
(6) "Scrap metal" is bits and pieces
of metal parts (e.g.,) bars, turnings,
rods, sheets, wire) or metal pieces that
may be combined together with bolts
or soldering (e.g., radiators, scrap auto-
mobiles, railroad box cars), which when
worn or superfluous can be recycled.
(7) A material is "recycled" if it is
used, reused, or reclaimed.
(8) A material is "accumulated spec-
ulatively" if it is accumulated before
being recycled. A material is not accu-
mulated speculatively, however, if the
person accumulating it can show that
the material is potentially recyclable
and has a feasible means of being recy-
cled; and that—during the calendar
year (commencing on January 1)—the
amount of material that is recycled, or
transferred to a different site for recy-
cling, equals at least 75 percent by
weight or volume of the amount of that
material accumulated at the beginning
of the period. In calculating the per-
centage of turnover, the 75 percent re-
quirement is to be applied to each ma-
terial of the same type (e.g.. slags from
a single smelting process) that is recy-
cled in the same way (i.e., from which
the same material is recovered or that
is used in the same way). Materials ac-
cumulating in units that would be ex-
empt from regulation under §261.4(c)
are not to be included in making the
calculation. (Materials that are al-
ready defined as solid wastes also are
not to be included in making the cal-
culation.) Materials are no longer in
this category once they are removed
from accumulation for recycling, how-
ever.
(9) "Excluded scrap metal" is proc-
essed scrap metal, unprocessed home
scrap metal, and unprocessed prompt
scrap metal.
(10) "Processed scrap metal" is scrap
.metal which has been manually or
physically altered to either separate it
into distinct materials to enhance eco-
nomic value or to improve the handling
of materials. Processed scrap metal in-
cludes, but is not limited to scrap
metal which has been baled, shredded.
sheared, chopped, crushed, flattened.
cut, melted, or separated by metal type
(i.e., sorted), and, fines, drosses and re-
lated materials which have been ag-
glomerated. (Note: shredded circuit
boards being sent for recycling are not
considered processed scrap metal. They
are covered under the exclusion from
the definition of solid waste for shred-
ded circuit boards being recycled
(§261.4(a)(13)).
(11) "Home scrap metal" is scrap
metal as generated by steel mills,
foundries, and refineries such as
turnings, cuttings, punchings. and bor-
ings.
(12) "Prompt scrap metal" is scrap
metal as generated by the metal work-
ing/fabrication industries and includes
such scrap metal as turnings, cuttings,
punchings. and borings. Prompt scrap
is also known as industrial or new
scrap metal.
[45 FR 33119, May 19, 1980, as amended at 48
FR 14293, Apr. 1, 1983; 50 FR 663. Jan. 4, 1985;
51 FR 10174, Mar. 24, 1986; 51 FR 40636. Nov. 7.
1986; 62 FR 26018. May 12, 19971
§ 261.2 Definition of solid waste.
(a)(l) A solid waste is any discarded
material that is not excluded by
31
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§261.2
40 CFR Ch. I (7-1-03 Edition)
§261.4 (a) or that is not excluded by
variance granted under §§260.30 and
260.31.
(2) A discarded material is any mate-
rial which is:
(i) Abandoned, as explained in para-
graph (b) of this section; or
(ii) Recycled, as explained in para-
graph (c) of this section; or
(iii) Considered inherently waste-like,
as explained in paragraph (d) of this
section; or
(iv) A military munition identified as a
solid waste in 40 CFR 266.202.
(b) Materials are solid waste if they
are abandoned by being:
(1) Disposed of; or
(2) Burned or incinerated; or
(3) Accumulated, stored, or treated
(but not recycled) before or in lieu of
being abandoned by being disposed of,
burned, or incinerated. •
(c) Materials are solid wastes if they
are recycled—or accumulated, stored, or
treated before recycling—as specified
in paragraphs (c)(l) through (4) of this
section.
(1) Used in a manner constituting dis-
posal, (i) Materials noted with a "*" in
Column 1 of Table I are solid wastes
when they are:
(A) Applied to or placed on the land
in a manner that constitutes disposal;
or
(B) Used to produce products that are
applied to or placed on the land or are
otherwise contained in products that
are applied to or placed on the land (in
which cases the product itself remains
a solid waste).
(ii) However, commercial chemical
products listed in §261.33 are not solid
wastes if they are applied to the land
and that is their ordinary manner of
use.
(2) Burning for energy recovery, (i) Ma-
terials noted with a "*" in column 2 of
Table 1 are solid wastes when they are:
(A) Burned to recover energy;
(B) Used to produce a fuel or are oth-
erwise contained in fuels (in which
cases the fuel itself remains a solid
waste).
(ii) However, commercial chemical
products listed in §261.33 are not solid
wastes if they are themselves fuels.
(3) Reclaimed. Materials noted with a
"*" in column 3 of Table 1 are solid
wastes when reclaimed (except as pro-
vided under §261.4(a)(17)). Materials
noted with a "—"in column 3 of Table
1 are not solid wastes when reclaimed.
(4) Accumulated speculatively. Mate-
rials noted with a "*" in column 4 of
Table 1 are solid wastes when accumu-
lated speculatively.
TABLE 1
Sludges (listed in 40 CFR Part 261 .31 or 261 .32
Sludges exhibiting a characteristic of hazardous waste
By-products (listed in 40 CFR 261 31 or 261 32)
By-products exhibiting a characteristic of hazardous waste
Commercial chemical products listed in 40 CFR 261.33
Scrap metal other than excluded scrap metal (see 261.1(c)(9))
luting dis-
posal
(§261.2(c)(1))
1
c)
C)
C)
(")
(*)
0
Energy
recovery/ fuel
(§261.2(c)(2)>
2
C)
C)
(')
(")
C)
Reclamation
(§261.2(c}{3))
(except as
provided in
261.4(a)(17)
for mineral
secondary
materials)
3
{*)
C)
I ~~ — '
Speculative
accumulation
(§261.2(0(4))
4
(")
(")
(*)
1 '
C)
Note: The terms "spent materials," "sludges," "by-products," and "scrap metal" and "processed scrap metal" are defined'in
§261.1.
(d) Inherently waste-like materials. The
following materials are solid wastes
when they are recycled in any manner:
(1) Hazardous Waste Nos. F020, F021
(unless used as an ingredient to make a
product at the site of generation), F022,
F023, F026, and F028.
(2) Secondary materials fed to a halo-
gen acid furnace that exhibit a char-
acteristic of a hazardous waste or are
32
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Environmental Protection Agency
§261.3
listed as a hazardous waste as defined
in subparts C or D of this part, except
for brominated material that meets the
following criteria:
(i) The material must contain a bro-
mine concentration of at least 45%; and
(ii) The material must contain less
than a total of 1% of toxic organic
compounds listed in appendix VIII; and
(iii) The material is processed contin-
ually on-site in the halogen acid fur-
nace via direct conveyance (hard pip-
ing).
(3) The Administrator will use the
following criteria to add wastes to that
list:
(i)(A) The materials are ordinarily
disposed of, burned, or incinerated; or
(B) The materials contain toxic con-
stituents listed in appendix VIII of part
261 and these constituents are not ordi-
narily found in raw materials or prod-
ucts for which the materials substitute
(or are found in raw materials or prod-
ucts in smaller concentrations) and are
not used or reused during the recycling
process; and
(ii) The material may pose a substan-
tial hazard to human health and the
environment when recycled.
(e) Materials that are not solid waste
when recycled. (1) Materials are not
solid wastes when they can be shown to
be recycled by being:
(i) Used or reused as ingredients in an
industrial process to make a product,
provided the materials are not being
reclaimed; or
(ii) Used or reused as effective sub-
stitutes for commercial products; or
(iii) Returned to the original process
from which they are generated, with-
out first being reclaimed or land dis-
posed. The material must be returned
as a substitute for feedstock materials.
In cases where the original process to
which the material is returned is a sec-
ondary process, the materials must be
managed such that there is no place-
ment on the land. In cases where the
materials are generated and reclaimed
within the primary mineral processing
industry, the conditions of the exclu-
sion found at §261.4(a)(17) apply rather
than this paragraph.
(2) The following materials are solid
wastes, even if the recycling involves
use, reuse, or return to the original
process (described in paragraphs (e)(l)
(i) through (iii) of this section):
(i) Materials used in a manner consti-
tuting disposal, or used to produce
products that are applied to the land;
or
(ii) Materials burned for energy re-
covery, used to produce a fuel, or con-
tained in fuels; or
(iii) Materials accumulated specula-
tively; or
(iv) Materials listed in paragraphs
(d)(l) and (d)(2) of this section.
(f) Documentation of claims that mate-
rials are not solid wastes or are condi-
tionally exempt from regulation. Re-
spondents in actions to enforce regula-
tions implementing subtitle C of RCRA
who raise a claim that a certain mate-
rial is not a solid waste, or is condi-
tionally exempt from regulation, must
demonstrate that there is a known
market or disposition for the material,
and that they meet the terms of the ex-
clusion or exemption. In doing so, they
must provide appropriate documenta-
tion (such as contracts showing that a
second person uses the material as an
ingredient in a production process) to
demonstrate that the material is not a
waste, or is exempt from regulation. In
addition, owners or operators of facili-
ties claiming that they actually are re-
cycling materials must show that they
have the necessary equipment to do so.
[50 FR 664, Jan. 4, 1985. as amended at 50 FR
33542, Aug. 20, 1985; 56 FR 7206, Feb. 21, 1991;
56 FR 32688. July 17. 1991; 56 FR 42512, Aug. 27,
1991; 57 FR 38564, Aug. 25. 1992; 59 FR 48042.
Sept. 19. 1994; 62 FR 6651, Feb. 12. 1997; 62 FR
26019, May 12, 1997; 63 FR 28636, May 26, 1998;
64 FR 24513, May 11, 1999; 67 FR 11253. Mar. 13,
2002)
§261.3 Definition of hazardous waste.
(a) A solid waste, as defined in §261.2,
is a hazardous waste if:
(1) It is not excluded from regulation
as a hazardous waste under §261.4(b);
and
(2) It meets any of the following cri-
teria:
(i) It exhibits any of the characteris-
tics of hazardous waste identified in
subpart C of this part. However, any
mixture of a waste from the extraction,
beneficiation, and processing of ores
and minerals excluded under
§261.4(b)(7) and any other solid waste
33
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§261.3
40 CFR Ch. I (7-1-03 Edition)
exhibiting a characteristic of haz-
ardous waste under subpart C is a haz-
ardous waste only if it exhibits a char-
acteristic that would not have been ex-
hibited by the excluded waste alone if
such mixture had not occurred, or if it
continues to exhibit any of the charac-
teristics exhibited by the non-excluded
wastes prior to mixture. Further, for
the purposes of applying the Toxicity
Characteristic to such mixtures, the
mixture is also a hazardous waste if it
exceeds the maximum concentration
for any contaminant listed in table I to
§261.24 that would not have been ex-
ceeded by the excluded waste alone if
the mixture had not occurred or if it
continues to exceed the maximum con-
centration for any contaminant ex-
ceeded by the nonexempt waste prior
to mixture.
(ii) It is listed in subpart D of this
part and has not been excluded from
the lists in subpart D of this part under
§§260.20 and 260.22 of this chapter.
(iii) [Reserved]
(iv) It is a mixture of solid waste and
one or more hazardous wastes listed in
subpart D of this part and has not been
excluded from paragraph (a) (2) of this
section under §§260.20 and 260.22, para-
graph (g) of this section, or paragraph
(h) of this section; however, the fol-
lowing mixtures of solid wastes and
hazardous wastes listed in subpart D of
this part are not hazardous wastes (ex-
cept by application of paragraph
(a)(2)(i) or (ii) of this section) if the
generator can demonstrate that the
mixture consists of wastewater the dis-
charge of which is subject to regulation
under either section 402 or section
307 (b) of the Clean Water Act (includ-
ing wastewater at facilities which have
eliminated the discharge of waste-
water) and;
(A) One or more of the following sol-
vents listed in §261.31—carbon tetra-
chloride, tetrachloroethylene, tri-
chloroethylene—Provided, That the
maximum total weekly usage of these
solvents (other than the amounts that
can be demonstrated not to be dis-
charged to wastewater) divided by the
average weekly flow of wastewater into
the headworks of the facility's waste-
water treatment or pretreatment sys-
tem does not exceed 1 part per million;
or
(B) One or more of the following
spent solvents listed in §261.31—meth-
ylene chloride, 1,1,1-trichloroethane,
chlorobenzene, o-dichlorobenzene,
cresols, cresylic acid, nitrobenzene,
toluene, methyl ethyl ketone, carbon
disulfide, isobutanol, pyridine, spent
chlorofluorocarbon solvents—provided
that the maximum total weekly usage
of these solvents (other than the
amounts that can be demonstrated not
to be discharged to wastewater) divided
by the average weekly flow of waste-
water into the headworks of the facili-
ty's wastewater treatment or
pretreatment system does not exceed
25 parts per million; or
(C) One of the following wastes listed
in §261.32, provided that the wastes are
discharged to the refinery oil recovery
sewer before primary oil/water/solids
separation—heat exchanger bundle
cleaning sludge from the petroleum re-
fining industry (EPA Hazardous Waste
No. K050), crude oil storage tank sedi-
ment from petroleum refining oper-
ations (EPA Hazardous Waste No.
K169), clarified slurry oil tank sedi-
ment and/or in-line filter/separation
solids from petroleum refining oper-
ations (EPA Hazardous Waste No.
K170), spent hydrotreating cata-
lyst(EPA Hazardous Waste No. K171),
and spent hydrorefining catalyst (EPA
Hazardous Waste No. K172); or
(D) A discarded commercial chemical
product, or chemical intermediate list-
ed in §261.33, arising from de minimis
losses of these materials from manu-
facturing operations in which these
materials are used as raw materials or
are produced in the manufacturing
process. For purposes of this paragraph
(a)(2)(iv)(D), "de minimis" losses in-
clude those from normal material han-
dling operations (e.g., spills from the
unloading or transfer of materials from
bins or other containers, leaks from
pipes, valves or other devices used to
transfer materials); minor leaks of
process equipment, storage tanks or
containers; leaks from well maintained
pump packings and seals; sample
purgings; relief device discharges; dis-
charges from safety showers and rins-
ing and cleaning of personal safety
equipment; and rinsate from empty
containers or from containers that are
rendered empty by that rinsing; or
34
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Environmental Protection Agency
§261.3
(E) Wastewater resulting from lab-
oratory operations containing toxic (T)
wastes listed in subpart D of this part,
Provided, That the annualized average
flow of laboratory wastewater does not
exceed one percent of total wastewater
flow into the headworks of the facili-
ty's wastewater treatment or pre-
treatment system or provided the
wastes, combined annualized average
concentration does not exceed one part
per million in the headworks of the fa-
cility's wastewater treatment or pre-
treatment facility. Toxic (T) wastes
used in laboratories that are dem-
onstrated not to be discharged to
wastewater are not to be included in
this calculation; or
(F) One or more of the following
wastes listed in §261.32—wastewaters
from the production of carbamates and
carbamoyl oximes (EPA Hazardous
Waste No. K157)—Provided that the
maximum weekly usage of formalde-
hyde, methyl chloride, methylene chlo-
ride, and triethylamine (including all
amounts that can not be demonstrated
to be reacted in the process, destroyed
through treatment, or is recovered,
i.e., what is discharged or volatilized)
divided by the average weekly flow of
process wastewater prior to any dilu-
tions into the headworks of the facili-
ty's wastewater treatment system does
not exceed a total of 5 parts per million
by weight; or
(G) Wastewaters derived from the
treatment of one or more of the fol-
lowing wastes listed in §261.32—organic
waste (including heavy ends, still bot-
toms, light ends, spent solvents, fil-
trates, and decantates) from the pro-
duction of carbamates and carbamoyl
oximes (EPA Hazardous Waste No.
K156).—Provided, that the maximum
concentration of formaldehyde, methyl
chloride, methylene chloride, and
triethylamine prior to any dilutions
into the headworks of the facility's
wastewater treatment system does not
exceed a total of 5 milligrams per liter.
(v) Rebuttable presumption for used oil.
Used oil containing more than 1000 ppm
total halogens is presumed to be a haz-
ardous waste because it has been mixed
with halogenated hazardous waste list-
ed in subpart D of part 261 of this chap-
ter. Persons may rebut this presump-
tion by demonstrating that the used oil
does not contain hazardous waste (for
example, by using an analytical meth-
od from SW-846, Third Edition, to show
that the used oil does not contain sig-
nificant concentrations of halogenated
hazardous constituents listed in appen-
dix VIII of part 261 of this chapter).
EPA Publication SW-846, Third Edi-
tion, is available for the cost of $110.00
from the Government Printing Office,
Superintendent of Documents, PO Box
371954, Pittsburgh, PA 15250-7954. 202-
512-1800 (document number 955-001-
00000-1).
(A) The rebuttable presumption does
not apply to metalworking oils/fluids
containing chlorinated paraffins, if
they are processed, through a tolling
agreement, to reclaim metalworking
oils/fluids. The presumption does apply
to metalworking oils/fluids if such oils/
fluids are recycled in any other man-
ner, or disposed.
(B) The rebuttable presumption does
not apply to used oils contaminated
with chlorofluorocarbons (CFCs) re-
moved from refrigeration units where
the CFCs are destined for reclamation.
The rebuttable presumption does apply
to used oils contaminated with CFCs
that have been mixed with used oil
from sources other than refrigeration
units.
(b) A solid waste which is not ex-
cluded from regulation under para-
graph (a)(l) of this section becomes a
hazardous waste when any of the fol-
lowing events occur:
(1) In the case of a waste listed in
subpart D of this part, when the waste
first meets the listing description set
forth in subpart D of this part.
(2) In the case of a mixture of solid
waste and one or more listed hazardous
wastes, when a hazardous waste listed
in subpart D is first added to the solid
waste.
(3) In the case of any other waste (in-
cluding a waste mixture), when the
waste exhibits any of the characteris-
tics identified in subpart C of this part.
(c) Unless and until it meets the cri-
teria of paragraph (d) of this section:
(1) A hazardous waste will remain a
hazardous waste.
(2)(i) Except as otherwise provided in
paragraph (c)(2)(ii), (g) or (h) of this
section, any solid waste generated from
the treatment, storage, or disposal of a
35
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§261.3
40 CFR Ch. I (7-1-03 Edition)
hazardous waste, including any sludge,
spill residue, ash emission control dust,
or leachate (but not including precipi-
tation run-off) is a hazardous waste.
(However, materials that are reclaimed
from solid wastes and that are used
beneficially are not solid wastes and
hence are not hazardous wastes under
this provision unless the reclaimed ma-
terial is burned for energy recovery or
used in a manner constituting dis-
posal.)
(ii) The following solid wastes are not
hazardous even though they are gen-
erated from the treatment, storage, or
disposal of a hazardous waste, unless
they exhibit one or more of the charac-
teristics of hazardous waste:
(A) Waste pickle liquor sludge gen-
erated by lime stabilization of spent
pickle liquor from the iron and steel
industry (SIC Codes 331 and 332).
(B) Waste from burning any of the
materials exempted from regulation by
§261.6(a)(3)(iii) and (iv).
(C)(7) Nonwastewater residues, such
as slag, resulting from high tempera-
ture metals recovery (HTMR) proc-
essing of K061, K062 or F006 waste, in
units identified as rotary kilns, flame
reactors, electric furnaces, plasma arc
furnaces, slag reactors, rotary hearth
furnace/electric furnace combinations
or industrial furnaces (as defined in
paragraphs (6), (7), and (13) of the defi-
nition for "Industrial furnace" in 40
CFR 260.10), that are disposed in sub-
title D units, provided that these resi-
dues meet the generic exclusion levels
identified in the tables in this para-
graph for all constituents, and exhibit
no characteristics of hazardous waste.
Testing requirements must be incor-
porated in a facility's waste analysis
plan or a generator's self-implementing
waste analysis plan; at a minimum,
composite samples of residues must be
collected and analyzed quarterly and/or
when the process or operation gener-
ating the waste changes. Persons
claiming this exclusion in an enforce-
ment action will have the burden of
proving by clear and convincing evi-
dence that the material meets all of
the exclusion requirements.
Constituent
Maximum for any
single composite
sample—TCLP
(mg/l)
Generic exclusion levels for K061 and K062 nonwastewater
HTMR residues
Lead
Nickel
Silver
0 10
050
76
0 010
0050
0,33
0 15
0009
1 0
0 16
0 30
0020
70
Generic exclusion levels for F006 nonwastewater HTWR
residues
Lead
Nickel
Silver
Zinc
0 10
0 50
76
0010
0050
0.33
1 8
0 15
0009
1.0
0.16
0.30
0020
70
(2) A one-time notification and cer-
tification must be placed in the facili-
ty's files and sent to the EPA region or
authorized state for K061, K062 or F006
HTMR residues that meet the generic
exclusion levels for all constituents
and do not exhibit any characteristics
that are sent to subtitle D units. The
notification and certification that is
placed in the generators or treaters
files must be updated if the process or
operation generating the waste
changes and/or if the subtitle D unit re-
ceiving the waste changes. However,
the generator or treater need only no-
tify the EPA region or an authorized
state on an annual basis if such
changes occur. Such notification and
certification should be sent to the EPA
region or authorized state by the end of
the calendar year, but no later than
December 31. The notification must in-
clude the following information: The
name and address of the subtitle D unit
receiving the waste shipments; the
EPA Hazardous Waste Number(s) and
36
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Environmental Protection Agency
§261.3
treatability group(s) at the initial
point of generation; and, the treatment
standards applicable to the waste at
the initial point of generation. The cer-
tification must be signed by an author-
ized representative and must state as
follows: "I certify under penalty of law
that the generic exclusion levels for all
constituents have been met without
impermissible dilution and that no
characteristic of hazardous waste is ex-
hibited. I am aware that there are sig-
nificant penalties for submitting a
false certification, including the possi-
bility of fine and imprisonment."
(D) Biological treatment sludge from
the treatment of one of the following
wastes listed in §261.32—organic waste
(including heavy ends, still bottoms,
light ends, spent solvents, filtrates,
and decantates) from the production of
carbamates and carbamoyl oximes
(EPA Hazardous Waste No. K156), and
wastewaters from the production of
carbamates and carbamoyl oximes
(EPA Hazardous Waste No. K157).
(E) Catalyst inert support media sep-
arated from one of the following wastes
listed in §261.32—Spent hydrotreating
catalyst (EPA Hazardous Waste No.
K171), and Spent hydrorefining catalyst
(EPA Hazardous Waste No. K172).
(d) Any solid waste described in para-
graph (c) of this section is not a haz-
ardous waste if it meets the following
criteria:
(1) In the case of any solid waste, it
does not exhibit any of the characteris-
tics of hazardous waste identified in
subpart C of this part. (However,
wastes that exhibit a characteristic at
the point of generation may still be
subject to the requirements of part 268,
even if they no longer exhibit a char-
acteristic at the point of land disposal.)
(2) In the case of a waste which is a
listed waste under subpart D of this
part, contains a waste listed under sub-
part D of this part or is derived from a
waste listed in subpart D of this part,
it also has been excluded from para-
graph (c) of this section under §§ 260.20
and 260.22 of this chapter.
(e) [Reserved]
(f) Notwithstanding paragraphs (a)
through (d) of this section and provided
the debris as defined in part 268 of this
chapter does not exhibit a char-
acteristic identified at subpart C of
this part, the following materials are
not subject to regulation under 40 CFR
parts 260, 261 to 266, 268, or 270:
(1) Hazardous debris as defined in
part 268 of this chapter that has been
treated using one of the required ex-
traction or destruction technologies
specified in Table 1 of §268.45 of this
chapter; persons claiming this exclu-
sion in an enforcement action will have
the burden of proving by clear and con-
vincing evidence that the material
meets all of the exclusion require-
ments; or
(2) Debris as defined in part 268 of
this chapter that the Regional Admin-
istrator, considering the extent of con-
tamination, has determined is no
longer contaminated with hazardous
waste.
(g)(l) A hazardous waste that is listed
in subpart D of this part solely because
it exhibits one or more characteristics
of ignitability as defined under §261.21,
corrosivity as defined under §261.22, or
reactivity as defined under §261.23 is
not a hazardous waste, if the waste no
longer exhibits any characteristic of
hazardous waste identified in subpart C
of this part.
(2) The exclusion described in para-
graph (g)(l) of this section also per-
tains to:
(i) Any mixture of a solid waste and
a hazardous waste listed in subpart D
of this part solely because it exhibits
the characteristics of ignitability,
corrosivity, or reactivity as regulated
under paragraph (a)(2)(iv) of this sec-
tion; and
(ii) Any solid waste generated from
treating, storing, or disposing of a haz-
ardous waste listed in subpart D of this
part solely because it exhibits the
characteristics of ignitability,
corrosivity, or reactivity as regulated
under paragraph (c)(2)(i) of this sec-
tion.
(3) Wastes excluded under this sec-
tion are subject to part 268 of this
chapter (as applicable), even if they no
longer exhibit a characteristic at the
point of land disposal.
(4) any mixture of a solid waste ex-
cluded from regulation under
§261.4(b)(7) and a hazardous waste list-
ed in subpart D of this part solely be-
cause it exhibits one or more of the
characteristics of ignitability,
37
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§261.4
40 CFR Ch. I (7-1-03 Edition)
corrosivity, or reactivity as regulated
under paragraph (a)(2)(iv) of this sec-
tion is not a hazardous waste, if the
mixture no longer exhibits any char-
acteristic of hazardous waste identified
in subpart C of this part for which the
hazardous waste listed in subpart D of
this part was listed.
(h)(l) Hazardous waste containing ra-
dioactive waste is no longer a haz-
ardous waste when it meets the eligi-
bility criteria and conditions of 40 CFR
part 266, Subpart N ("eligible radio-
active mixed waste").
(2) The exemption described in para-
graph (h)(l) of this section also per-
tains to:
(i) Any mixture of a solid waste and
an eligible radioactive mixed waste;
and
(ii) Any solid waste generated from
treating, storing, or disposing of an eli-
gible radioactive mixed waste.
(3) Waste exempted under this sec-
tion must meet the eligibility criteria
and specified conditions in 40 CFR
266.225 and 40 CFR 266.230 (for storage
and treatment) and in 40 CFR 266.310
and 40 CFR 266.315 (for transportation
and disposal). Waste that fails to sat-
isfy these eligibility criteria and condi-
tions is regulated as hazardous waste.
[57 FR 7632, Mar. 3, 1992; 57 FR 23063, June 1,
1992, as amended at 57 FR 37263, Aug. 18, 1992;
57 FR 41611, Sept. 10, 1992; 57 FR 49279, Oct.
30, 1992; 59 FR 38545, July 28. 1994; 60 FR 7848,
Feb. 9, 1995; 63 FR 28637, May 26, 1998; 63 FR
42184, Aug. 6, 1998; 66 FR 27297, May 16, 2001;
66 FR 50333, Oct. 3, 2001]
§261.4 Exclusions.
(a) Materials which are not solid
wastes. The following materials are not
solid wastes for the purpose of this
part:
(l)(i) Domestic sewage; and
(ii) Any mixture of domestic sewage
and other wastes that passes through a
sewer system to a publicly-owned
treatment works for treatment. "Do-
mestic sewage" means untreated sani-
tary wastes that pass through a sewer
system.
(2) Industrial wastewater discharges
that are point source discharges sub-
ject to regulation under section 402 of
the Clean Water Act, as amended.
[Comment: This exclusion applies only to the
actual point source discharge. It does not ex-
clude industrial wastewaters while they are
being collected, stored or treated before dis-
charge, nor does it exclude sludges that are
generated by industrial wastewater treat-
ment.]
(3) Irrigation return flows.
(4) Source, special nuclear or by-
product material as defined by the
Atomic Energy Act of 1954, as amend-
ed, 42 U.S.C. 2011 et seq.
(5) Materials subjected to in-situ
mining techniques which are not re-
moved from the ground as part of the
extraction process.
(6) Pulping liquors (i.e., black liquor)
that are reclaimed in a pulping liquor
recovery furnace and then reused in
the pulping process, unless it is accu-
mulated speculatively as defined in
§261.1(c) of this chapter.
(7) Spent sulfuric acid used to
produce virgin sulfuric acid, unless it is
accumulated speculatively as defined
in §261.1(c) of this chapter.
(8) Secondary materials that are re-
claimed and returned to the original
process or processes in which they were
generated where they are reused in the
production process provided:
(i) Only tank storage is involved, and
the entire process through completion
of reclamation is closed by being en-
tirely connected with pipes or other
comparable enclosed means of convey-
ance;
(ii) Reclamation does not involve
controlled flame combustion (such as
occurs in boilers, industrial furnaces,
or incinerators);
(iii) The secondary materials are
never accumulated in such tanks for
over twelve months without being re-
claimed; and
(iv) The reclaimed material is not
used to produce a fuel, or used to
produce products that are used in a
manner constituting disposal.
(9)(i) Spent wood preserving solutions
that have been reclaimed and are re-
used for their original intended pur-
pose; and
(ii) Wastewaters from the wood pre-
serving process that have been re-
claimed and are reused to treat wood.
(iii) Prior to reuse, the wood pre-
serving wastewaters and spent wood
38
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Environmental Protection Agency
§261.4
preserving solutions described in para-
graphs (a)(9)(i) and (a)(9)(ii) of this sec-
tion, so long as they meet all of the fol-
lowing conditions:
(A) The wood preserving wastewaters
and spent wood preserving solutions
are reused on-site at water borne
plants in the production process for
their original intended purpose;
(B) Prior to reuse, the wastewaters
and spent wood preserving solutions
are managed to prevent release to ei-
ther land or groundwater or both;
(C) Any unit used to manage
wastewaters and/or spent wood pre-
serving solutions prior to reuse can be
visually or otherwise determined to
prevent such releases;
(D) Any drip pad used to manage the
wastewaters and/or spent wood pre-
serving solutions prior to reuse com-
plies with the standards in part 265,
subpart W of this chapter, regardless of
whether the plant generates a total of
less than 100 kg/month of hazardous
waste; and
(E) Prior to operating pursuant to
this exclusion, the plant owner or oper-
ator submits to the appropriate Re-
gional Administrator or State Director
a one-time notification stating that
the plant intends to claim the exclu-
sion, giving the date on which the
plant intends to begin operating under
the exclusion, and containing the fol-
lowing language: "I have read the ap-
plicable regulation establishing an ex-
clusion for wood preserving
wastewaters and spent wood preserving
solutions and understand it requires
me to comply at all times with the
conditions set out in the regulation."
The plant must maintain a copy of
that document in its on-site records for
a period of no less than 3 years from
the date specified in the notice. The ex-
clusion applies only so long as the
plant meets all of the conditions. If the
plant goes out of compliance with any
condition, it may apply to the appro-
priate Regional Administrator or State
Director for reinstatement. The Re-
gional Administrator or State Director
may reinstate the exclusion upon find-
ing that the plant has returned to com-
pliance with all conditions and that
violations are not likely to recur.
(10) EPA Hazardous Waste Nos. K060,
K087, K141, K142, K143, K144, K145, K147,
and K148, and any wastes from the coke
by-products processes that are haz-
ardous only because they exhibit the
Toxicity Characteristic (TO) specified
in section 261.24 of this part when, sub-
sequent to generation, these materials
are recycled to coke ovens, to the tar
recovery process as a feedstock to
produce coal tar, or mixed with coal
tar prior to the tar's sale or refining.
This exclusion is conditioned on there
being no land disposal of the wastes
from the point they are generated to
the point they are recycled to coke
ovens or tar recovery or refining proc-
esses, or mixed with coal tar.
(11) Nonwastewater splash condenser
dross residue from the treatment of
K061 in high temperature metals recov-
ery units, provided it is shipped in
drums (if shipped) and not land dis-
posed before recovery.
(12) (i) Oil-bearing hazardous sec-
ondary materials (i.e., sludges, byprod-
ucts, or spent materials) that are gen-
erated at a petroleum refinery (SIC
code 2911) and are inserted into the pe-
troleum refining process (SIC code
2911—including, but not limited to, dis-
tillation, catalytic cracking, fraction-
ation, or thermal cracking units (i.e.,
cokers)) unless the material is placed
on the land, or speculatively accumu-
lated before being so recycled. Mate-
rials inserted into thermal cracking
units are excluded under this para-
graph, provided that the coke product
also does not exhibit a characteristic of
hazardous waste. Oil-bearing hazardous
secondary materials may be inserted
into the same petroleum refinery
where they are generated, or sent di-
rectly to another petroleum refinery,
and still be excluded under this provi-
sion. Except as provided in paragraph
(a)(12)(ii) of this section, oil-bearing
hazardous secondary materials gen-
erated elsewhere in the petroleum in-
dustry (i.e., from sources other than
petroleum refineries) are not excluded
under this section. Residuals generated
from processing or recycling materials
excluded under this paragraph
(a)(12)(i), where such materials as gen-
erated would have otherwise met a list-
ing under subpart D of this part, are
designated as F037 listed wastes when
disposed of or intended for disposal.
39
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§261.4
40 CFR Ch. I (7-1-03 Edition)
a way that prevents releases of the sec-
ondary materials into the environ-
ment. At a minimum, any building
used for this purpose must be an engi-
neered structure made of non-earthen
materials that provide structural sup-
port, and must have a floor, walls and
a roof that prevent wind dispersal and
contact with rainwater. Tanks used for
this purpose must be structurally
sound and, if outdoors, must have roofs
or covers that prevent contact with
wind and rain. Containers used for this
purpose must be kept closed except
when it is necessary to add or remove
material, and must be in sound condi-
tion. Containers that are stored out-
doors must be managed within storage
areas that:
(7) Have containment structures or
systems sufficiently impervious to con-
tain leaks, spills and accumulated pre-
cipitation; and
(2) Provide for effective drainage and
removal of leaks, spills and accumu-
lated precipitation; and
(3) Prevent run-on into the contain-
ment system.
(C) With each off-site shipment of ex-
cluded hazardous secondary materials,
provide written notice to the receiving
facility that the material is subject to
the conditions of this paragraph (a) (20).
(D) Maintain at the generator's or in-
termediate handlers's facility for no
less than three years records of all
shipments of excluded hazardous sec-
ondary materials. For each shipment
these records must at a minimum con-
tain the following information:
(1) Name of the transporter and date
of the shipment;
(2) Name and address of the facility
that received the excluded material,
and documentation confirming receipt
of the shipment; and
(3) Type and quantity of excluded
secondary material in each shipment.
(iii) Manufacturers of zinc fertilizers
or zinc fertilizer ingredients made from
excluded hazardous secondary mate-
rials must:
(A) Store excluded hazardous sec-
ondary materials in accordance with
the storage requirements for genera-
tors and intermediate handlers, as
specified in paragraph (a) (20) (ii) (B) of
this section.
(B) Submit a one-time notification to
the Regional Administrator or State
Director that, at a minimum, specifies
the name, address and EPA ID number
of the manufacturing facility, and
identifies when the manufacturer in-
tends to begin managing excluded,
zinc-bearing hazardous secondary ma-
terials under the conditions specified
in this paragraph (a) (20).
(C) Maintain for a minimum of three
years records of all shipments of ex-
cluded hazardous secondary materials
received by the manufacturer, which
must at a minimum identify for each
shipment the name and address of the
generating facility, name of trans-
porter and date the materials were re-
ceived, the quantity received, and a
brief description of the industrial proc-
ess that generated the material.
(D) Submit to the Regional Adminis-
trator or State Director an annual re-
port that identifies the total quantities
of all excluded hazardous secondary
materials that were used to manufac-
ture zinc fertilizers or zinc fertilizer in-
gredients in the previous year, the
name and address of each generating
facility, and the industrial process(s)
from which they were generated.
(iv) Nothing in this section preempts,
overrides or otherwise negates the pro-
vision in §262.11 of this chapter, which
requires any person who generates a
solid waste to determine if that waste
is a hazardous waste.
(v) Interim status and permitted
storage units that have been used to
store only zinc-bearing hazardous
wastes prior to the submission of the
one-time notice described inparagraph
(a) (20) (ii) (A) of this section, and that
afterward will be used only to store
hazardous secondary materials ex-
cluded under this paragraph, are not
subject to the closure requirements of
40 CFR Parts 264 and 265.
(21) Zinc fertilizers made from haz-
ardous wastes, or hazardous secondary
materials that are excluded under
paragraph (a) (20) of this section, pro-
vided that:
(i) The fertilizers meet the following
contaminant limits:
(A) For metal contaminants:
42
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Environmental Protection Agency
§261.4
Constituent
Arsenic
Cadmium
Chromium
Lead
Mercury
Maximum
Allowable
Total Con-
centration in
Fertilizer,
per Unit
(1%) of Zinc
(pprn)
0.3
1.4
0.6
2.8
0.3
(B) For dioxin contaminants the fer-
tilizer must contain no more than
eight (8) parts per trillion of dioxin,
measured as toxic equivalent (TEQ).
(ii) The manufacturer performs sam-
pling and analysis of the fertilizer
product to determine compliance with
the contaminant limits for metals no
less than every six months, and for
dioxins no less than every twelve
months. Testing must also be per-
formed whenever changes occur to
manufacturing processes or ingredients
that could significantly affect the
amounts of contaminants in the fer-
tilizer product. The manufacturer may
use any reliable analytical method to
demonstrate that no constituent of
concern is present in the product at
concentrations above the applicable
limits. It is the responsibility of the
manufacturer to ensure that the sam-
pling and analysis are unbiased, pre-
cise, and representative of the prod-
uct(s) introduced into commerce.
(iii) The manufacturer maintains for
no less than three years records of all
sampling and analyses performed for
purposes of determining compliance
with the requirements of paragraph
(a)(21)(ii) of this section. Such records
must at a minimum include:
(A) The dates and times product sam-
ples were taken, and the dates the sam-
ples were analyzed;
(B) The names and qualifications of
the person(s) taking the samples;
(C) A description of the methods and
equipment used to take the samples;
(D) The name and address of the lab-
oratory facility at which analyses of
the samples were performed;
(E) A description of the analytical
methods used, including any cleanup
and sample preparation methods; and
(F) All laboratory analytical results
used to determine compliance with the
contaminant limits specified in this
paragraph (a) (21).
(b) Solid wastes which are not haz-
ardous wastes. The following solid
wastes are not hazardous wastes:
(1) Household waste, including house-
hold waste that has been collected,
transported, stored, treated, disposed,
recovered (e.g., refuse-derived fuel) or
reused. "Household waste" means any
material (including garbage, trash and
sanitary wastes in septic tanks) de-
rived from households (including single
and multiple residences, hotels and
motels, bunkhouses, ranger stations,
crew quarters, campgrounds, picnic
grounds and day-use recreation areas).
A resource recovery facility managing
municipal solid waste shall not be
deemed to be treating, storing, dis-
posing of, or otherwise managing haz-
ardous wastes for the purposes of regu-
lation under this subtitle, if such facil-
ity:
(i) Receives and burns only
(A) Household waste (from single and
multiple dwellings, hotels, motels, and
other residential sources) and
(B) Solid waste from commercial or
industrial sources that does not con-
tain hazardous waste; and
(ii) Such facility does not accept haz-
ardous wastes and the owner or oper-
ator of such facility has established
contractual requirements or other ap-
propriate notification or inspection
procedures to assure that hazardous
wastes are not received at or burned in
such facility.
(2) Solid wastes generated by any of
the following and which are returned
to the soils as fertilizers:
(i) The growing and harvesting of ag-
ricultural crops.
(ii) The raising of animals, including
animal manures.
(3) Mining overburden returned to
the mine site.
(4) Fly ash waste, bottom ash waste,
slag waste, and flue gas emission con-
trol waste, generated primarily from
the combusion of coal or other fossil
fuels, except as provided by §266.112 of
this chapter for facilities that burn or
process hazardous waste.
(5) Drilling fluids, produced waters,
and other wastes associated with the
43
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§261.4
40 CFR Ch. I (7-1-03 Edition)
exploration, development, or produc-
tion of crude oil, natural gas or geo-
thermal energy.
(6)(i) Wastes which fail the test for
the Toxicity Characteristic because
chromium is present or are listed in
subpart D due to the presence of chro-
mium, which do not fail the test for
the Toxicity Characteristic for any
other constituent or are not listed due
to the presence of any other con-
stituent, and which do not fail the test
for any other characteristic, if it is
shown by a waste generator or by
waste generators that:
(A) The chromium in the waste is ex-
clusively (or nearly exclusively) tri-
valent chromium; and
(B) The waste is generated from an
industrial process which uses trivalent
chromium exlcusively (or nearly exclu-
sively) and the process does not gen-
erate hexavalent chromium; and
(C) The waste is typically and fre-
quently managed in non-oxidizing envi-
ronments.
(ii) Specific waste which meet the
standard in paragraphs (b)(6)(i) (A), (B),
and (C) (so long as they do not fail the
test for the toxicity characteristic for
any other constituent, and do not ex-
hibit any other characteristic) are:
(A) Chrome (blue) trimmings gen-
erated by the following subcategories
of the leather tanning and finishing in-
dustry; hair pulp/chrome tan/retan/wet
finish; hair save/chrome tan/retan/wet
finish; retan/wet finish; no beamhouse;
through-the-blue; and shearling.
(B) Chrome (blue) shavings generated
by the following subcategories of the
leather tanning and finishing industry:
Hair pulp/chrome tan/retan/wet finish;
hair save/chrome tan/retan/wet finish;
retan/wet finish; no beamhouse;
through-the-blue; and shearling.
(C) Buffing dust generated by the fol-
lowing subcategories of the leather
tanning and finishing industry; hair
pulp/chrome tan/retan/wet finish; hair
save/chrome tan/retan/wet finish;
retan/wet finish; no beamhouse;
through-the-blue.
(D) Sewer screenings generated by
the following subcategories of the
leather tanning and finishing industry:
Hair pulp/crome tan/retan/wet finish;
hair save/chrome tan/retan/wet finish;
retan/wet finish; no beamhouse;
through-the-blue; and shearling.
(E) Wastewater treatment sludges
generated by the following subcat-
egories of the leather tanning and fin-
ishing industry: Hair pulp/chrome tan/
retan/wet finish; hair save/chrome tan/
retan/wet finish; retan/wet finish; no
beamhouse; through-the-blue; and
shearling.
(F) Wastewater treatment sludes gen-
erated by the following subcategories
of the leather tanning and finishing in-
dustry: Hair pulp/chrome tan/retan/wet
finish; hair save/chrometan/retan/wet
finish; and through-the-blue.
(G) Waste scrap leather from the
leather tanning industry, the shoe
manufacturing industry, and other
leather product manufacturing indus-
tries.
(H) Wastewater treatment sludges
from the production of TiC>2 pigment
using chromium-bearing ores by the
chloride process.
(7) Solid waste from the extraction,
beneficiation, and processing of ores
and minerals (including coal, phos-
phate rock, and overburden from the
mining of uranium ore), except as pro-
vided by §266.112 of this chapter for fa-
cilities that burn or process hazardous
waste.
(i) For purposes of §261.4(b)(7)
beneficiation of ores and minerals is
restricted to the following activities;
crushing; grinding; washing; dissolu-
tion; crystallization; filtration; sort-
ing; sizing; drying; sintering;
pelletizing; briquetting; calcining to
remove water and/or carbon dioxide;
roasting, autoclaving, and/or
chlorination in preparation for leach-
ing (except where the roasting (and/or
autoclaving and/or chlorination)/leach-
ing sequence produces a final or inter-
mediate product that does not undergo
further beneficiation or processing);
gravity concentration; magnetic sepa-
ration; electrostatic separation; flota-
tion; ion exchange; solvent extraction;
electrowinning; precipitation; amal-
gamation; and heap, dump, vat, tank,
and in situ leaching.
(ii) For the purposes of §261.4(b)(7),
solid waste from the processing of ores
and minerals includes only the fol-
lowing wastes as generated:
44
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Environmental Protection Agency
§261.4
(A) Slag from primary copper proc-
essing;
(B) Slag from primary lead proc-
essing;
(C) Red and brown muds from bauxite
refining;
(D) Phosphogypsum from phosphoric
acid production;
(E) Slag from elemental phosphorus
production;
(F) Gasifier ash from coal gasifi-
cation;
(G) Process wastewater from coal
gasification;
(H) Calcium sulfate wastewater
treatment plant sludge from primary
copper processing;
(I) Slag tailings from primary copper
processing;
(J) Fluorogypsum from hydrofluoric
acid production;
(K) Process wastewater from
hydrofluoric acid production;
(L) Air pollution control dust/sludge
from iron blast furnaces;
(M) Iron blast furnace slag;
(N) Treated residue from roasting/
leaching of chrome ore;
(O) Process wastewater from primary
magnesium processing by the anhy-
drous process;
(P) Process wastewater from phos-
phoric acid production;
(Q) Basic oxygen furnace and open
hearth furnace air pollution control
dust/sludge from carbon steel produc-
tion;
(R) Basic oxygen furnace and open
hearth furnace slag from carbon steel
production;
(S ) Chloride process waste solids
from titanium tetrachloride produc-
tion;
(T) Slag from primary zinc proc-
essing.
(iii) A residue derived from co-proc-
essing mineral processing secondary
materials with normal beneficiation
raw materials or with normal mineral
processing raw materials remains ex-
cluded under paragraph (b) of this sec-
tion if the owner or operator:
(A) Processes at least 50 percent by
weight normal beneficiation raw mate-
rials or normal mineral processing raw
materials; and,
(B) Legitimately reclaims the sec-
ondary mineral processing materials.
(8) Cement kiln dust waste, except as
provided by §266.112 of this chapter for
facilities that burn or process haz-
ardous waste.
(9) Solid waste which consists of dis-
carded arsenical-treated wood or wood
products which fails the test for the
Toxicity Characteristic for Hazardous
Waste Codes D004 through D017 and
which is not a hazardous waste for any
other reason if the waste is generated
by persons who utilize the arsenical-
treated wood and wood product for
these materials' intended end use.
(10) Petroleum-contaminated media
and debris that fail the test for the
Toxicity Characteristic of §261.24 (Haz-
ardous Waste Codes D018 through D043
only) and are subject to the corrective
action regulations under part 280 of
this chapter.
(11) Injected groundwater that is haz-
ardous only because it exhibits the
Toxicity Characteristic (Hazardous
Waste Codes D018 through D043 only) in
§261.24 of this part that is reinjected
through an underground injection well
pursuant to free phase hydrocarbon re-
covery operations undertaken at petro-
leum refineries, petroleum marketing
terminals, petroleum bulk plants, pe-
troleum pipelines, and petroleum
transportation spill sites until January
25, 1993. This extension applies to re-
covery operations in existence, or for
which contracts have been issued, on or
before March 25, 1991. For groundwater
returned through infiltration galleries
from such operations at petroleum re-
fineries, marketing terminals, and
bulk plants, until [insert date six
months after publication]. New oper-
ations involving injection wells (begin-
ning after March 25, 1991) will qualify
for this compliance date extension
(until January 25, 1993) only if:
(i) Operations are performed pursu-
ant to a written state agreement that
includes a provision to assess the
groundwater and the need for further
remediation once the free phase recov-
ery is completed; and
(ii) A copy of the written agreement
has been submitted to: Waste Identi-
fication Branch (5304), U.S. Environ-
mental Protection Agency, 1200 Penn-
sylvania Ave., NW., Washington, DC
20460.
45
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§261.4
40 CFR Ch. I (7-1-03 Edition)
(12) Used chlorofluorocarbon refrig-
erants from totally enclosed heat
transfer equipment, including mobile
air conditioning systems, mobile re-
frigeration, and commercial and indus-
trial air conditioning and refrigeration
systems that use chlorofluorocarbons
as the heat transfer fluid in a refrigera-
tion cycle, provided the refrigerant is
reclaimed for further use.
(13) Non-terne plated used oil filters
that are not mixed with wastes listed
in subpart D of this part if these oil fil-
ters have been gravity hot-drained
using one of the following methods:
(i) Puncturing the filter anti-drain
back valve or the filter dome end and
hot-draining;
(ii) Hot-draining and crushing;
(iii) Dismantling and hot-draining; or
(iv) Any other equivalent hot-drain-
ing method that will remove used oil.
(14) Used oil re-refining distillation
bottoms that are used as feedstock to
manufacture asphalt products.
(15) Leachate or gas condensate col-
lected from landfills where certain
solid wastes have been disposed, pro-
vided that:
(i) The solid wastes disposed would
meet one or more of the listing descrip-
tions for Hazardous Waste Codes K169,
K170, K171, K172, K174, K175, K176, K177,
and K178, if these wastes had been gen-
erated after the effective date of the
listing;
(ii) The solid wastes described in
paragraph (b)(15)(i) of this section were
disposed prior to the effective date of
the listing:
(iii) The leachate or gas condensate
do not exhibit any characteristic of
hazardous waste nor are derived from
any other listed hazardous waste;
(iv) Discharge of the leachate or gas
condensate, including leachate or gas
condensate transferred from the land-
fill to a POTW by truck, rail, or dedi-
cated pipe, is subject to regulation
under sections 307(b) or 402 of the Clean
Water Act.
(v) As of February 13, 2001, leachate
or gas condensate derived from K169-
K172 is no longer exempt if it is stored
or managed in a surface impoundment
prior to discharge. After November 21,
2003, leachate or gas condensate de-
rived from K176, K177, and K178 will no
longer be exempt if it is stored or man-
aged in a surface impoundment prior to
discharge. There is one exception: if
the surface impoundment is used to
temporarily store leachate or gas con-
densate in response to an emergency
situation (e.g., shutdown of wastewater
treatment system), provided the im-
poundment has a double liner, and pro-
vided the leachate or gas condensate is
removed from the impoundment and
continues to be managed in compliance
with the conditions of this paragraph
(b)(15)(v) after the emergency ends.
(16) Sludges resulting from the treat-
ment of wastewaters (not including
spent plating solutions) generated by
the copper metallization process at the
International Business Machines Cor-
poration (IBM) semiconductor manu-
facturing facility in Essex Junction,
VT, are exempt from the F006 listing,
provided that:
(i) IBM provides the Agency with
semi-annual reports (by January 15 and
July 15 of each year) detailing con-
stituent analyses measuring the con-
centrations of volatiles, semi-volatiles,
and metals using methods presented in
part 264, appendix IX of this chapter of
both the plating solution utilized by,
and the rinsewaters generated by, the
copper metallization process;
(ii) IBM provides the agency with
semi-annual reports (by January 15 and
July 15 of each year), through the year
2004, or when IBM has achieved its fa-
cility-wide goal of a 40% reduction in
greenhouse gas emissions from a 1995
base year (when normalized to produc-
tion), whichever is first, that contain
the following:
(A) Estimated greenhouse gas emis-
sions, and estimated greenhouse gas
emission reductions. Greenhouse gas
emissions will be reported in terms of
total mass emitted and mass emitted
normalized to production; and
(B) The number of chemical vapor
deposition chambers used in the semi-
conductor manufacturing production
line that have been converted to either
low flow C2F& or NF3 during the report-
ing period and the number of such
chambers remaining to be converted to
achieve the facility goal for global
warming gas emission reductions.
(iii) No significant changes are made
to the copper metallization process
such that any of the constituents listed
46
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Environmental Protection Agency
§261.4
in 40 CFR part 261, appendix VII as the
basis for the F006 listing are introduced
into the process.
(17) [Reserved]
(18) By-products resulting from the
production of automobile air bag gas
generants at the Autoliv ASP Inc. fa-
cility in Promontory Utah, (Autoliv)
are exempt from the D003 listing, for a
period of five years from May 9, 2001,
provided that:
(i) The by-product gas generants are
processed on-site in Autoliv's Metal
Recovery Furnace (MRF).
(A) By-product gas generants must
only be fed to the MRF when it is oper-
ating in conformance with the State of
Utah, Division of Air Quality's Ap-
proval Order DAQE-549-97.
(B) Combustion gas temperature
must be maintained below 400 degrees
Fahrenheit at the baghouse inlet.
(ii) Prior to processing in the MRF,
the by-product gas generants are man-
aged in accordance with the require-
ments specified in 40 CFR 262.34.
(iii) The Autoliv facility and the
MRF are operated and managed in ac-
cordance with the requirements of 40
CFR Part 265, Subparts B, C, D, E, G,
H, I, and O.
(iv) Residues derived from the proc-
essing of by-product gas generants in
the MRF are managed in accordance
with the requirements specified in 40
CFR Parts 262 and 268.
(v) The following testing of the
MRF's stack gas emissions is con-
ducted:
(A) An initial test shall be conducted
within 30 operating days of starting
feed of by-product gas generants to the
MRF. EPA may extend this deadline,
at the request of Autoliv, when good
cause is shown. The initial test shall
consist of three duplicate runs sam-
pling for:
(/) Particulate matter using Method
5 as specified in 40 CFR Part 60, Appen-
dix A.
(2) The metals Aluminum, Arsenic,
Barium, Beryllium, Boron, Cadmium,
Chromium, Cobalt, Copper, Lead, and
Nickel using Method 29 as specified in
40 CFR Part 60, Appendix A.
(3) Polychlorinated di-benzo dioxins
and furans using Method 23 0023A as
specified in 40 CFR Part 60, Appendix
A.
(4) Carbon monoxide using Method 10
as specified in 40 CFR Part 60, Appen-
dix A.
(B) After the initial test is com-
pleted, an annual stack test (12 months
from the previous initial stack test) of
the MRF shall be conducted. The an-
nual tests shall consist of three dupli-
cate runs using Method 29 and Method
5 as specified in 40 CFR Part 60, Appen-
dix A.
(C) Testing shall be conducted while
by-product gas generants are fed to the
MRF at no less than 90% of the planned
maximum feed rate, and with the MRF
operating parameters within normal
ranges.
(D) Initial stack testing results and
additional project performance data
and information, including the quan-
tity of by-product gas generants proc-
essed and the operating parameter val-
ues during the test runs, will be sub-
mitted by Autoliv to the State of Utah
and EPA within 60 days of the comple-
tion of the initial stack test.
(E) Annual stack test results and ad-
ditional project performance data and
information, including the quantity of
by-product gas generants processed and
the operating parameter values during
the test runs, will be submitted by
Autoliv to EPA and the State of Utah
within 60 days of the completion of the
annual test.
(vi) Combustion gas discharged to the
atmosphere from the MRF meets the
following limits:
(A) Dioxin emissions do not exceed
0.4 ng per dry standard cubic meter on
a toxicity equivalent quotient (TEQ)
basis corrected to 7% Oxygen.
(B) Combined lead and cadmium
emissions do not exceed 240 ug per dry
standard cubic meter corrected to 7%
Oxygen.
(C) Combined arsenic, beryllium, and
chromium emissions do not exceed 97
ug per dry standard cubic meter cor-
rected to 7% Oxygen.
(D) Particulate matter emissions do
not exceed 34 mg per dry standard
cubic meter corrected to 7% Oxygen.
(E) If the limits specified in para-
graphs (b)(18)(vi)(A) through (D) of this
section are exceeded, Autoliv shall dis-
continue feeding gas generants to the
MRF until such time as Autoliv can
demonstrate to EPA and the state of
47
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§261.4
40 CFR Ch. I (7-1-03 Edition)
Utah satisfaction that the MRF com-
bustion gas emissions can meet the
limits specified in paragraphs
(b)(18)(vi) (A) through (D) of this sec-
tion
(vii) No by-product gas generants or
other pyrotechnic wastes generated off-
site will be received at the Autoliv fa-
cility in Promontory, Utah or proc-
essed in the MRF unless otherwise al-
lowed by law (permit or regulation).
(viii) Autoliv will provide EPA and
the state of Utah with semi-annual re-
ports (by January 30 and July 30 of
each year).
(A) The semi-annual reports will doc-
ument the amounts of by-product gas
generants processed during the report-
ing period.
(B) The semi-annual reports will pro-
vide a summary of the MRF Operating
Record during the reporting period, -in-
cluding information on by-product gas
generant composition, average feed
rates, upset conditions, and spills or re-
leases.
(ix) No significant changes are made
to the operating parameter production
values of Autoliv's production of air
bag gas generants such that any of the
constituents listed in appendix VIII of
this part are introduced into the proc-
ess.
(x) Autoliv reports to the EPA any
noncompliance which may endanger
health or the environment orally with-
in 24 hours from the time Autoliv be-
comes aware of the circumstances, in-
cluding:
(A) Any information of a release, dis-
charge, fire, or explosion from the
MRF, which could threaten the envi-
ronment or human health.
(B) The description of the occurrence
and its cause shall include:
(7) Name, address, and telephone
number of the facility;
(2) Date, time, and type of incident;
(3) Name and quantity of material(s)
involved;
(4) The extent of injuries, if any;
(5) An assessment of actual or poten-
tial hazards to the environment and
human health, and
(6) Estimated quantity and disposi-
tion of recovered material that re-
sulted from the incident.
(C) A written notice shall also be pro-
vided within five days of the time
Autoliv becomes aware of the cir-
cumstances. The written notice shall
contain a description of the non-com-
pliance and its cause; the period of
noncompliance including exact dates
and times, and if the noncompliance
has not been corrected, the anticipated
time it is expected to continue; and
steps taken or planned to reduce,
eliminate, and prevent reoccurrence of
the noncompliance. The EPA may
waive the five day written notice re-
quirement in favor of a written report
within fifteen days.
(xi) Notifications and submissions
made under paragraph (b)(18) of this
section shall be sent to the Regional
Assistant Administrator for the Office
of Partnerships and Regulatory Assist-
ance, U.S. EPA, Region 8 and the Exec-
utive Secretary of the Utah Solid and
Hazardous Waste Control Board.
(c) Hazardous wastes which are ex-
empted from certain regulations. A
hazardous waste which is generated in
a product or raw material storage
tank, a product or raw material trans-
port vehicle or vessel, a product or raw
material pipeline, or in a manufac-
turing process unit or an associated
non-waste-treatment-manufacturing
unit, is not subject to regulation under
parts 262 through 265, 268, 270, 271 and
124 of this chapter or to the notifica-
tion requirements of section 3010 of
RCRA until it exits the unit in which it
was generated, unless the unit is a sur-
face impoundment, or unless the haz-
ardous waste remains in the unit more
than 90 days after the unit ceases to be
operated for manufacturing, or for
storage or transportation of product or
raw materials.
(d) Samples. (1) Except as provided in
paragraph (d)(2) of this section, a sam-
ple of solid waste or a sample of water,
soil, or air, which is collected for the
sole purpose of testing to determine its
characteristics or composition, is not
subject to any requirements of this
part or parts 262 through 268 or part 270
or part 124 of this chapter or to the no-
tification requirements of section 3010
of RCRA, when:
(i) The sample is being transported to
a laboratory for the purpose of testing;
48
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Environmental Protection Agency
§261.4
(ii) The sample is being transported
back to the sample collector after test-
ing; or
(iii) The sample is being stored by
the sample collector before transport
to a laboratory for testing; or
(iv) The sample is being stored in a
laboratory before testing; or
(v) The sample is being stored in a
laboratory after testing but before it is
returned to the sample collector; or
(vi) The sample is being stored tem-
porarily in the laboratory after testing
for a specific purpose (for example,
until conclusion of a court case or en-
forcement action where further testing
of the sample may be necessary).
(2) In order to qualify for the exemp-
tion in paragraphs (d)(l) (i) and (ii) of
this section, a sample collector ship-
ping samples to a laboratory and a lab-
oratory returning samples to a sample
collector must:
(i) Comply with U.S. Department of
Transportation (DOT), U.S. Postal
Service (USPS), or any other applica-
ble shipping requirements; or
(ii) Comply with the following re-
quirements if the sample collector de-
termines that DOT, USPS, or other
shipping requirements do not apply to
the shipment of the sample;
(A) Assure that the following infor-
mation accompanies the sample:
(I) The sample collector's name,
mailing address, and telephone num-
ber;
(2) The laboratory's name, mailing
address, and telephone number;
(3) The quantity of the sample;
(4) The date of shipment; and
(5) A description of the sample.
(B) Package the sample so that it
does not leak, spill, or vaporize from
its packaging.
(3) This exemption does not apply if
the laboratory determines that the
waste is hazardous but the laboratory
is no longer meeting any of the condi-
tions stated in paragraph (d)(l) of this
section.
(e) Treatability Study Samples. (I) Ex-
cept as provided in paragraph (e)(2) of
this section, persons who generate or
collect samples for the purpose of con-
ducting treatability studies as defined
in section 260.10, are not subject to any
requirement of parts 261 through 263 of
this chapter or to the notification re-
quirements of Section 3010 of RCRA,
nor are such samples included in the
quantity determinations of §261.5 and
§262.34(d) when:
(i) The sample is being collected and
prepared for transportation by the gen-
erator or sample collector; or
(ii) The sample is being accumulated
or stored by the generator or sample
collector prior to transportation to a
laboratory or testing facility; or
(iii) The sample is being transported
to the laboratory or testing facility for
the purpose of conducting a treat-
ability study.
(2) The exemption in paragraph (e)(l)
of this section is applicable to samples
of hazardous waste being collected and
shipped for the purpose of conducting
treatability studies provided that:
(i) The generator or sample collector
uses (in "treatability studies") no
more than 10,000 kg of media contami-
nated with non-acute hazardous waste,
1000 kg of non-acute hazardous waste
other than contaminated media, 1 kg of
acute hazardous waste, 2500 kg of
media contaminated with acute haz-
ardous waste for each process being
evaluated for each generated waste
stream; and
(ii) The mass of each sample ship-
ment does not exceed 10,000 kg; the
10,000 kg quantity may be all media
contaminated with non-acute haz-
ardous waste, or may include 2500 kg of
media contaminated with acute haz-
ardous waste, 1000 kg of hazardous
waste, and 1 kg of acute hazardous
waste; and
(iii) The sample must be packaged so
that it will not leak, spill, or vaporize
from its packaging during shipment
and the requirements of paragraph A or
B of this subparagraph are met.
(A) The transportation of each sam-
ple shipment complies with U.S. De-
partment of Transportation (DOT),
U.S. Postal Service (USPS), or any
other applicable shipping require-
ments; or
(B) If the DOT, USPS, or other ship-
ping requirements do not apply to the
shipment of the sample, the following
information must accompany the sam-
ple:
(1) The name, mailing address, and
telephone number of the originator of
the sample;
49
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§261.4
40 CFR Ch. I (7-1-03 Edition)
(2) The name, address, and telephone
number of the facility that will per-
form the treatability study;
(3) The quantity of the sample;
(4) The date of shipment; and
(5) A description of the sample, in-
cluding its EPA Hazardous Waste Num-
ber.
(iv) The sample is shipped to a lab-
oratory or testing facility which is ex-
empt under §261.4(f) or has an appro-
priate RCRA permit or interim status.
(v) The generator or sample collector
maintains the following records for a
period ending 3 years after completion
of the treatability study:
(A) Copies of the shipping documents;
(B) A copy of the contract with the
facility conducting the treatability
study;
(C) Documentation showing:
(]) The amount of waste shipped
under this exemption;
(2) The name, address, and EPA iden-
tification number of the laboratory or
testing facility that received the
waste;
(3) The date the shipment was made;
and
(4) Whether or not unused samples
and residues were returned to the gen-
erator.
(vi) The generator reports the infor-
mation required under paragraph
(e)(v)(C) of this section in its biennial
report.
(3) The Regional Administrator may
grant requests on a case-by-case basis
for up to an additional two years for
treatability studies involving bio-
remediation. The Regional Adminis-
trator may grant requests on a case-
by-case basis for quantity limits in ex-
cess of those specified in paragraphs
(e)(2) (i) and (ii) and (f)(4) of this sec-
tion, for up to an additional 5000 kg of
media contaminated with non-acute
hazardous waste, 500 kg of non-acute
hazardous waste, 2500 kg of media con-
taminated with acute hazardous waste
and 1 kg of acute hazardous waste:
(i) In response to requests for author-
ization to ship, store and conduct
treatabilty studies on additional quan-
tities in advance of commencing treat-
ability studies. Factors to be consid-
ered in reviewing such requests include
the nature of the technology, the type
of process (e.g., batch versus contin-
uous), size of the unit undergoing test-
ing (particularly in relation to scale-up
considerations), the time/quantity of
material required to reach steady state
operating conditions, or test design
considerations such as mass balance
calculations.
(ii) In response to requests for au-
thorization to ship, store and conduct
treatability studies on additional quan-
tities after initiation or completion of
initial treatability studies, when:
There has been an equipment or me-
chanical failure during the conduct of a
treatability study; there is a need to
verify the results of a previously con-
ducted treatability study; there is a
need to study and analyze alternative
techniques within a previously evalu-
ated treatment process; or there is a
need to do further evaluation of an on-
going treatability study to determine
final specifications for treatment.
(iii) The additional quantities and
timeframes allowed in paragraph (e)(3)
(i) and (ii) of this section are subject to
all the provisions in paragraphs (e) (1)
and (e)(2) (iii) through (vi) of this sec-
tion. The generator or sample collector
must apply to the Regional Adminis-
trator in the Region where the sample
is collected and provide in writing the
following information:
(A) The reason why the generator or
sample collector requires additional
time or quantity of sample for treat-
ability study evaluation and the addi-
tional time or quantity needed;
(B) Documentation accounting for all
samples of hazardous waste from the
waste stream which have been sent for
or undergone treatability studies in-
cluding the date each previous sample
from the waste stream was shipped, the
quantity of each previous shipment,
the laboratory or testing facility to
which it was shipped, what treatability
study processes were conducted on
each sample shipped, and the available
results on each treatability study;
(C) A description of the technical
modifications or change in specifica-
tions which will be evaluated and the
expected results;
(D) If such further study is being re-
quired due to equipment or mechanical
failure, the applicant must include in-
formation regarding the reason for the
failure or breakdown and also include
50
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Environmental Protection Agency
§261.4
what procedures or equipment im-
provements have been made to protect
against further breakdowns; and
(E) Such other information that the
Regional Administrator considers nec-
essary.
(f) Samples Undergoing Treatability
Studies at Laboratories and Testing Fa-
cilities. Samples undergoing treat-
ability studies and the laboratory or
testing facility conducting such treat-
ability studies (to the extent such fa-
cilities are not otherwise subject to
RCRA requirements) are not subject to
any requirement of this part, part 124,
parts 262-266, 268, and 270, or to the no-
tification requirements of Section 3010
of RCRA provided that the conditions
of paragraphs (f) (1) through (11) of this
section are met. A mobile treatment
unit (MTU) may qualify as a testing fa-
cility subject to paragraphs (f) (1)
through (11) of this section. Where a
group of MTUs are located at the same
site, the limitations specified in (f) (1)
through (11) of this section apply to the
entire group of MTUs collectively as if
the group were one MTU.
(1) No less than 45 days before con-
ducting treatability studies, the facil-
ity notifies the Regional Adminis-
trator, or State Director (if located in
an authorized State), in writing that it
intends to conduct treatability studies
under this paragraph.
(2) The laboratory or testing facility
conducting the treatability study has
an EPA identification number.
(3) No more than a total of 10,000 kg
of "as received" media contaminated
with non-acute -hazardous waste, 2500
kg of media contaminated with acute
hazardous waste or 250 kg of other "as
received" hazardous waste is subject to
initiation of treatment in all treat-
ability studies in any single day. "As
received" waste refers to the waste as
received in the shipment from the gen-
erator or sample collector.
(4) The quantity of "as received" haz-
ardous waste stored at the facility for
the purpose of evaluation in treat-
ability studies does not exceed 10,000
kg, the total of which can include
10,000 kg of media contaminated with
non-acute hazardous waste, 2500 kg of
media contaminated with acute haz-
ardous waste, 1000 kg of non-acute haz-
ardous wastes other than contaminated
media, and 1 kg of acute hazardous
waste. This quantity limitation does
not include treatment materials (in-
cluding nonhazardous solid waste)
added to "as received" hazardous
waste.
(5) No more than 90 days have elapsed
since the treatability study for the
sample was completed, or no more than
one year (two years for treatability
studies involving bioremediation) have
elapsed since the generator or sample
collector shipped the sample to the lab-
oratory or testing facility, whichever
date first occurs. Up to 500 kg of treat-
ed material from a particular waste
stream from treatability studies may
be archived for future evaluation up to
five years from the date of initial re-
ceipt. Quantities of materials archived
are counted against the total storage
limit for the facility.
(6) The treatability study does not
involve the placement of hazardous
waste on the land or open burning of
hazardous waste.
(7) The facility maintains records for
3 years following completion of each
study that show compliance with the
treatment rate limits arid the storage
time and quantity limits. The fol-
lowing specific information must be in-
cluded for each treatability study con-
ducted:
(i) The name, address, and EPA iden-
tification number of the generator or
sample collector of each waste sample;
(ii) The date the shipment was re-
ceived;
(iii) The quantity of waste accepted;
(iv) The quantity of "as received"
waste in storage each day;
(v) The date the treatment study was
initiated and the amount of "as re-
ceived" waste introduced to treatment
each day;
(vi) The date the treatability study
was concluded;
(vii) The date any unused sample or
residues generated from the treat-
ability study were returned to the gen-
erator or sample collector or, if sent to
a designated facility, the name of the
facility and the EPA identification
number.
(8) The facility keeps, on-site, a copy
of the treatability study contract and
all shipping papers associated with the
transport of treatability study samples
51
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§261.5
40 CFR Ch. I (7-1-03 Edition)
to and from the facility for a period
ending 3 years from the completion
date of each treatability study.
(9) The facility prepares and submits
a report to the Regional Adminis-
trator, or State Director (if located in
an authorized State), by March 15 of
each year that estimates the number of
studies and the amount of waste ex-
pected to be used in treatability stud-
ies during the current year, and in-
cludes the following information for
the previous calendar year:
(i) The name, address, and EPA iden-
tification number of the facility con-
ducting the treatability studies;
(ii) The types (by process) of treat-
ability studies conducted;
(iii) The names and addresses of per-
sons for whom studies have been con-
ducted (including their EPA identifica-
tion numbers);
(iv) The total quantity of waste in
storage each day;
(v) The quantity and types of waste
subjected to treatability studies;
(vi) When each treatability study was
conducted;
(vii) The final disposition of residues
and unused sample from each treat-
ability study.
(10) The facility determines whether
any unused sample or residues gen-
erated by the treatability study are
hazardous waste under §261.3 and, if so,
are subject to parts 261 through 268,
and part 270 of this chapter, unless the
residues and unused samples are re-
turned to the sample originator under
the §261.4(e) exemption.
(11) The facility notifies the Regional
Administrator, or State Director (if lo-
cated in an authorized State), by letter
when the facility is no longer planning
to conduct any treatability studies at
the site.
(g) Dredged material that is not a haz-
ardous waste. Dredged material that is
subject to the requirements of a permit
that has been issued under 404 of the
Federal Water Pollution Control Act
(33 U.S.C.1344) or section 103 of the Ma-
rine Protection, Research, and Sanc-
tuaries Act of 1972 (33 U.S.C. 1413) is
not a hazardous waste. For this para-
graph (g), the following definitions
apply:
(1) The term dredged material has the
same meaning as defined in 40 CFR
232.2;
(2) The term permit means:
(i) A permit issued by the U.S. Army
Corps of Engineers (Corps) or an ap-
proved State under section 404 of the
Federal Water Pollution Control Act
(33 U.S.C. 1344);
(ii) A permit issued by the Corps
under section 103 of the Marine Protec-
tion, Research, and Sanctuaries Act of
1972 (33 U.S.C. 1413); or
(iii) In the case of Corps civil works
projects, the administrative equivalent
of the permits referred to in para-
graphs (g)(2)(i) and (ii) of this section,
as provided for in Corps regulations
(for example, see 33 CFR 336.1, 336.2,
and 337.6).
[45 FR 33119, May 19, 1980]
EDITORIAL NOTE: For FEDERAL REGISTER ci-
tations affecting §261.4, see the List of CFR
Sections Affected, which appears in the
Finding Aids section of the printed volume
and on GPO Access.
§261.5 Special requirements for haz-
ardous waste generated by condi-
tionally exempt small quantity gen-
erators.
(a) A generator is a conditionally ex-
empt small quantity generator in a cal-
endar month if he generates no more
than 100 kilograms of hazardous waste
in that month.
(b) Except for those wastes identified
in paragraphs (e), (f), (g), and (j) of this
section, a conditionally exempt small
quantity generator's hazardous wastes
are not subject to regulation under
parts 262 through 266, 268, and parts 270
and 124 of this chapter, and the notifi-
cation requirements of section 3010 of
RCRA, provided the generator complies
with the requirements of paragraphs
(f), (g), and 0) of this section.
(c) When making the quantity deter-
minations of this part and 40 CFR part
262, the generator must include all haz-
ardous waste that it generates, except
hazardous waste that:
(1) Is exempt from regulation under
40 CFR 261.4(c) through (f), 261.6(a)(3),
261.7(a)(l), or 261.8; or
(2) Is managed immediately upon
generation only in on-site elementary
52
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Environmental Protection Agency
§261.5
neutralization units, wastewater treat-
ment units, or totally enclosed treat-
ment facilities as defined in 40 CFR
260.10; or
(3) Is recycled, without prior storage
or accumulation, only in an on-site
process subject to regulation under 40
CFR261.6(c)(2); or
(4) Is used oil managed under the re-
quirements of 40 CFR 261.6(a)(4) and 40
CFR part 279; or
(5) Is spent lead-acid batteries man-
aged under the requirements of 40 CFR
part 266, subpart G; or
(6) Is universal waste managed under
40 CFR 261.9 and 40 CFR part 273.
(d) In determining the quantity of
hazardous waste generated, a generator
need not include:
(1) Hazardous waste when it is re-
moved from on-site storage; or
(2) Hazardous waste produced by on-
site treatment (including reclamation)
of his hazardous waste, so long as the
hazardous waste that is treated was
counted once; or
(3) Spent materials that are gen-
erated, reclaimed, and subsequently re-
used on-site, so long as such spent ma-
terials have been counted once.
(e) If a generator generates acute
hazardous waste in a calendar month
in quantities greater than set forth
below, all quantities of that acute haz-
ardous waste are subject to full regula-
tion under parts 262 through 266, 268,
and parts 270 and 124 of this chapter,
and the notification requirements of
section 3010 of RCRA:
(1) A total of one kilogram of acute
hazardous wastes listed in §§261.31,
261.32, or 261.33(e).
(2) A total of 100 kilograms of any
residue or contaminated soil, waste, or
other debris resulting from the clean-
up of a spill, into or on any land or
water, of any acute hazardous wastes
listed in §§261.31, 261.32, or 261.33(e).
[Comment: "Full regulation" means those
regulations applicable to generators of
greater than 1,000 kg of non-acutely haz-
ardous waste in a calendar month.]
(f) In order for acute hazardous
wastes generated by a generator of
acute hazardous wastes in quantities
equal to or less than those set forth in
paragraph (e) (1) or (2) of this section to
be excluded from full regulation under
this section, the generator must com-
ply with the following requirements:
(1) Section 262.11 of this chapter;
(2) The generator may accumulate
acute hazardous waste on-site. If he ac-
cumulates at any time acute hazardous
wastes in quantities greater than those
set forth in paragraph (e)(l) or (e)(2) of
this section, all of those accumulated
wastes are subject to regulation under
parts 262 through 266, 268, and parts 270
and 124 of this chapter, and the applica-
ble notification requirements of sec-
tion 3010 of RCRA. The time period of
§262.34(a) of this chapter, for accumula-
tion of wastes on-site, begins when the
accumulated wastes exceed the appli-
cable exclusion limit;
(3) A conditionally exempt small
quantity generator may either treat or
dispose of his acute hazardous waste in
an on-site facility or ensure delivery to
an off-site treatment, storage, or dis-
posal facility, either of which, if lo-
cated in the U.S., is:
(i) Permitted under part 270 of this
chapter;
(ii) In interim status under parts 270
and 265 of this chapter;
(iii) Authorized to manage hazardous
waste by a State with a hazardous
waste management program approved
under part 271 of this chapter;
(iv) Permitted, licensed, or registered
by a State to manage municipal solid
waste and, if managed in a municipal
solid waste landfill is subject to Part
258 of this chapter;
(v) Permitted, licensed, or registered
by a State to manage non-municipal
non-hazardous waste and, if managed
in a non-municipal non-hazardous
waste disposal unit after January 1,
1998, is subject to the requirements in
§§257.5 through 257.30 of this chapter; or
(vi) A facility which:
(A) Beneficially uses or reuses, or le-
gitimately recycles or reclaims its
waste; or
(B) Treats its waste prior to bene-
ficial use or reuse, or legitimate recy-
cling or reclamation; or
(vii) For universal waste managed
under part 273 of this chapter, a uni-
versal waste handler or destination fa-
cility subject to the requirements of
part 273 of this chapter.
(g) In order for hazardous waste gen-
erated by a conditionally exempt small
quantity generator in quantities of less
than 100 kilograms of hazardous waste
53
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§261.6
40 CFR Ch. I (7-1-03 Edition)
during a calendar month to be excluded
from full regulation under this section,
the generator must comply with the
following requirements:
(1) Section 262.11 of this chapter;
(2) The conditionally exempt small
quantity generator may accumulate
hazardous waste on-site. If he accumu-
lates at any time more than a total of
1000 kilograms of his hazardous wastes,
all of those accumulated wastes are
subject to regulation under the special
provisions of part 262 applicable to gen-
erators of between 100 kg and 1000 kg of
hazardous waste in a calendar month
as well as the requirements of parts 263
through 266, 268, and parts 270 and 124
of this chapter, and the applicable noti-
fication requirements of section 3010 of
RCRA. The time period of §262.34(d) for
accumulation of wastes on-site begins
for a conditionally exempt small quan-
tity generator when the accumulated
wastes exceed 1000 kilograms;
(3) A conditionally exempt small
quantity generator may either treat or
dispose of his hazardous waste in an
on-site facility or ensure delivery to an
off-site treatment, storage or disposal
facility, either of which, if located in
the U.S., is;
(i) Permitted under part 270 of this
chapter;
(ii) In interim status under parts 270
and 265 of this chapter;
(iii) Authorized to manage hazardous
waste by a State with a hazardous
waste management program approved
under part 271 of this chapter;
(iv) Permitted, licensed, or registered
by a State to manage municipal solid
waste and, if managed in a municipal
solid waste landfill is subject to Part
258 of this chapter;
(v) Permitted, licensed, or registered
by a State to manage non-municipal
non-hazardous waste and, if managed
in a non-municipal non-hazardous
waste disposal unit after January 1,
1998, is subject to the requirements in
§§257.5 through 257.30 of this chapter; or
(vi) A facility which:
(A) Beneficially uses or reuses, or le-
gitimately recycles or reclaims its
waste; or
(B) Treats its waste prior to bene-
ficial use or reuse, or legitimate recy-
cling or reclamation; or
(vii) For universal waste managed
under part 273 of this chapter, a uni-
versal waste handler or destination fa-
cility subject to the requirements of
part 273 of this chapter.
(h) Hazardous waste subject to the
reduced requirements of this section
may be mixed with non-hazardous
waste and remain subject to these re-
duced requirements even though the
resultant mixture exceeds the quantity
limitations identified in this section,
unless the mixture meets any of the
characteristics of hazardous waste
identified in subpart C.
(i) If any person mixes a solid waste
with a hazardous waste that exceeds a
quantity exclusion level of this section,
the mixture is subject to full regula-
tion.
(j) If a conditionally exempt small
quantity generator's wastes are mixed
with used oil, the mixture is subject to
part 279 of this chapter if it is destined
to be burned for energy recovery. Any
material produced from such a mixture
by processing, blending, or other treat-
ment is also so regulated if it is des-
tined to be burned for energy recovery.
|51 FR 10174, Mar. 24, 1986, as amended at 51
FR 28682, Aug. 8, 1986; 51 FR 40637, Nov. 7,
1986; 53 FR 27163, July 19, 1988; 58 FR 26424,
May 3, 1993; 60 FR 25541, May 11, 1995; 61 FR
34278, July 1, 1996; 63 FR 24968, May 6, 1998; 63
FR 37782, July 14, 1998]
§261.6 Requirements for recyclable
materials.
(a)(l) Hazardous wastes that are recy-
cled are subject to the requirements for
generators, transporters, and storage
facilities of paragraphs (b) and (c) of
this section, except for the materials
listed in paragraphs (a) (2) and (a) (3) of
this section. Hazardous wastes that are
recycled will be known as "recyclable
materials."
(2) The following recyclable mate-
rials are not subject to the require-
ments of this section but are regulated
under subparts C through O of part 266
of this chapter and all applicable provi-
sions in parts 270 and 124 of this chap-
ter:
(i) Recyclable materials used in a
manner constituting disposal (subpart
C);
(ii) Hazardous wastes burned for en-
ergy recovery in boilers and industrial
54
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Environmental Protection Agency
§261.6
furnaces that are not regulated under
subpart O of part 264 or 265 of this
chapter (subpart H);
(iii) Recyclable materials from which
precious metals are reclaimed (subpart
F);
(iv) Spent lead-acid batteries that
are being reclaimed (subpart G).
(v) U.S. Filter Recovery Services XL
waste (subpart O).
(3) The following recyclable mate-
rials are not subject to regulation
under parts 262 through parts 266 or
parts 268, 270 or 124 of this chapter, and
are not subject to the notification re-
quirements of section 3010 of RCRA:
(i) Industrial ethyl alcohol that is re-
claimed except that, unless provided
otherwise in an international agree-
ment as specified in §262.58:
(A) A person initiating a shipment
for reclamation in a foreign country,
and any intermediary arranging for the
shipment, must comply with the re-
quirements applicable to a primary ex-
porter in §§262.53, 262.56 (a)(l)-(4), (6),
and (b), and 262.57, export such mate-
rials only upon consent of the receiving
country and in conformance with the
EPA Acknowledgment of Consent as
defined in subpart E of part 262, and
provide a copy of the EPA Acknowledg-
ment of Consent to the shipment to the
transporter transporting the shipment
for export;
(B) Transporters transporting a ship-
ment for export may not accept a ship-
ment if he knows the shipment does
not conform to the EPA Acknowledg-
ment of Consent, must ensure that a
copy of the EPA Acknowledgment of
Consent accompanies the shipment and
must ensure that it is delivered to the
facility designated by the person initi-
ating the shipment.
(ii) Scrap metal that is not excluded
under §261.4(a)(13);
(iii) Fuels produced from the refining
of oil-bearing hazardous waste along
with normal process streams at a pe-
troleum refining facility if such wastes
result from normal petroleum refining,
production, and transportation prac-
tices (this exemption does not apply to
fuels produced from oil recovered from
oil-bearing hazardous waste, where
such recovered oil is already excluded
under §261.4(a)(12);
(iv)(A) Hazardous waste fuel produced
from oil-bearing hazardous wastes from
petroleum refining, production, or
transportation practices, or produced
from oil reclaimed from such haz-
ardous wastes, where such hazardous
wastes are reintroduced into a process
that does not use distillation or does
not produce products from crude oil so
long as the resulting fuel meets the
used oil specification under §279.11 of
this chapter and so long as no other
hazardous wastes are used to produce
the hazardous waste fuel;
(B) Hazardous waste fuel produced
from oil-bearing hazardous waste from
petroleum refining production, and
transportation practices, where such
hazardous wastes are reintroduced into
a refining process after a point at
which contaminants are removed, so
long as the fuel meets the used oil fuel
specification under §279.11 of this chap-
ter; and
(C) Oil reclaimed from oil-bearing
hazardous wastes from petroleum refin-
ing, production, and transportation
practices, which reclaimed oil is
burned as a fuel without reintroduction
to a refining process, so long as the re-
claimed oil meets the used oil fuel
specification under §279.11 of this chap-
ter.
(4) Used oil that is recycled and is
also a hazardous waste solely because
it exhibits a hazardous characteristic
is not subject to the requirements of
parts 260 through 268 of this chapter,
but is regulated under part 279 of this
chapter. Used oil that is recycled in-
cludes any used oil which is reused, fol-
lowing its original use, for any purpose
(including the purpose for which the oil
was originally used). Such term in-
cludes, but is not limited to, oil which
is re-refined, reclaimed, burned for en-
ergy recovery, or reprocessed.
(5) Hazardous waste that is exported
to or imported from designated mem-
ber countries of the Organization for
Economic Cooperation and Develop-
ment (OECD) (as defined in
§262.58(a)(l)) for purpose of recovery is
subject to the requirements of 40 CFR
part 262, subpart H, if it is subject to
either the Federal manifesting require-
ments of 40 CFR Part 262, to the uni-
versal waste management standards of
55
-------
§261.7
40 CFR Ch. I (7-1-03 Edition)
40 CFR Part 273, or to State require-
ments analogous to 40 CFR Part 273.
(b) Generators and transporters of re-
cyclable materials are subject to the
applicable requirements of parts 262
and 263 of this chapter and the notifica-
tion requirements under section 3010 of
RCRA, except as provided in paragraph
(a) of this section.
(c)(l) Owners and operators of facili-
ties that store recyclable materials be-
fore they are recycled are regulated
under all applicable provisions of sub-
parts A though L, AA, BB, and CC of
parts 264 and 265, and under parts 124,
266, 268, and 270 of this chapter and the
notification requirements under sec-
tion 3010 of RCRA, except as provided
in paragraph (a) of this section. (The
recycling process itself is exempt from
regulation except as provided in
§261.6(d).)
(2) Owners or operators of facilities
that recycle recyclable materials with-
out storing them before they are
rcycled are subject to the following re-
quirements, except as provided in para-
graph (a) of this section:
(i) Notification requirements under
section 3010 of RCRA;
(ii) Sections 265.71 and 265.72 (dealing
with the use of the manifest and mani-
fest discrepancies) of this chapter.
(iii) Section 261.6(d) of this chapter.
(d) Owners or operators of facilities
subject to RCRA permitting require-
ments with hazardous waste manage-
ment units that recycle hazardous
wastes are subject to the requirements
of subparts AA and BB of part 264 or 265
of this chapter.
[50 FR 49203, Nov. 29, 1985, as amended at 51
FR 28682, Aug. 8, 1986; 51 FR 40637, Nov. 7,
1986; 52 FR 11821, Apr. 13, 1987; 55 FR 25493,
June 21, 1990; 56 FR 7207, Feb. 21, 1991; 56 FR
32692, July 17, 1991; 57 FR 41612, Sept. 10, 1992;
59 FR 38545, July 28, 1994; 60 FR 25541, May 11,
1995; 61 FR 16309, Apr. 12, 1996; 61 FR 59950,
Nov. 25, 1996; 62 FR 26019, May 12, 1997; 63 FR
24968, May 6, 1998; 63 FR 42185, Aug. 6. 1998; 66
FR 28085, May 22, 2001]
§261.7 Residues of hazardous waste in
empty containers.
(a)(l) Any hazardous waste remaining
in either (i) an empty container or (ii)
an inner liner removed from an empty
container, as defined in paragraph (b)
of this section, is not subject to regula-
tion under parts 261 through 265, or
part 268, 270 or 124 of this chapter or to
the notification requirements of sec-
tion 3010 of RCRA.
(2) Any hazardous waste in either (i)
a container that is not empty or (ii) an
inner liner removed from a container
that is not empty, as defined in para-
graph (b) of this section, is subject to
regulation under parts 261 through 265,
and parts 268, 270 and 124 of this chap-
ter and to the notification require-
ments of section 3010 of RCRA.
(b)(l) A container or an inner liner
removed from a container that has held
any hazardous waste, except a waste
that is a compressed gas or that is
identified as an acute hazardous waste
listed in §§261.31, 261.32, or 261.33(e) of
this crtepter is empty if;
(i) All wastes have been removed that
can be removed using the practices
commonly employed to remove mate-
rials from that type of container, e.g.,
pouring, pumping, and aspirating, and
(ii) No more than 2.5 centimeters
(one inch) of residue remain on the bot-
tom of the container or inner liner, or
(iii) (A) No more than 3 percent by
weight of the total capacity of the con-
tainer remains in the container or
inner liner if the container is less than
or equal to 110 gallons in size, or
(B) No more than 0.3 percent by
weight of the total capacity of the con-
tainer remains in the container or
inner liner if the container is greater
than 110 gallons in size.
(2) A container that has held a haz-
ardous waste that is a compressed gas
is empty when the pressure in the con-
tainer approaches atmospheric.
(3) A container or an inner liner re-
moved from a container that has held
an acute hazardous waste listed in
§§261.31, 261.32, or 261.33(e) is empty if:
(i) The container or inner liner has
been triple rinsed using a solvent capa-
ble of removing the commercial chem-
ical product or manufacturing chem-
ical intermediate;
(ii) The container or inner liner has
been cleaned by another method that
has been shown in the scientific lit-
erature, or by tests conducted by the
generator, to achieve equivalent re-
moval; or
(iii) In the case of a container, the
inner liner that prevented contact of
the commercial chemical product or
56
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Environmental Protection Agency
§261.11
manufacturing chemical intermediate
with the container, has been removed.
[45 FR 78529, Nov. 25, 1980, as amended at 47
FR 36097, Aug. 18, 1982; 48 FR 14294, Apr. 1,
1983; 50 FR 1999, Jan. 14, 1985; 51 FR 40637,
Nov. 7, 1986]
§261.8 PCB wastes regulated under
Toxic Substance Control Act.
The disposal of PCB-containing di-
electric fluid and electric equipment
containing such fluid authorized for
use and regulated under part 761 of this
chapter and that are hazardous only
because they fail the test for the Tox-
icity Characteristic (Hazardous Waste
Codes D018 through D043 only) are ex-
empt from regulation under parts 261
through 265, and parts 268, 270, and 124
of this chapter, and the notification re-
quirements of section 3010 of RCRA.
[55 FR 11862, Mar. 29, 1990]
§261.9 Requirements for Universal
Waste.
The wastes listed in this section are
exempt from regulation under parts 262
through 270 of this chapter except as
specified in part 273 of this chapter
and, therefore are not fully regulated
as hazardous waste. The wastes listed
in this section are subject to regula-
tion under 40 CFR part 273:
(a) Batteries as described in 40 CFR
273.2;
(b) Pesticides as described in §273.3 of
this chapter;
(c) Thermostats as described in §273.4
of this chapter; and
(d) Lamps as described in §273.5 of
this chapter.
[60 FR 25541, May 11, 1995, as amended at 64
FR 36487, July 6, 1999]
Subpart B—Criteria for Identifying
the Characteristics of Haz-
ardous Waste and for Listing
Hazardous Waste
§261.10 Criteria for identifying the
characteristics of hazardous waste.
(a) The Administrator shall identify
and define a characteristic of haz-
ardous waste in subpart C only upon
determining that:
(1) A solid waste that exhibits the
characteristic may:
(i) Cause, or significantly contribute
to, an increase in mortality or an in-
crease in serious irreversible, or inca-
pacitating reversible, illness; or
(ii) Pose a substantial present or po-
tential hazard to human health or the
environment when it is improperly
treated, stored, transported, disposed
of or otherwise managed; and
(2) The characteristic can be:
(i) Measured by an available stand-
ardized test method which is reason-
ably within the capability of genera-
tors of solid waste or private sector
laboratories that are available to serve
generators of solid waste; or
(ii) Reasonably detected by genera-
tors of solid waste through their
knowledge of their waste.
(b) [Reserved]
§261.11 Criteria for listing hazardous
waste.
(a) The Administrator shall list a
solid waste as a hazardous waste only
upon determining that the solid waste
meets one of the following criteria:
(1) It exhibits any of the characteris-
tics of hazardous waste identified in
subpart C.
(2) It has been found to be fatal to
humans in low doses or, in the absence
of data on human toxicity, it has been
shown in studies to have an oral LD 50
toxicity (rat) of less than 50 milligrams
per kilogram, an inhalation LC 50 tox-
icity (rat) of less than 2 milligrams per
liter, or a dermal LD 50 toxicity (rab-
bit) of less than 200 milligrams per
kilogram or is otherwise capable of
causing or significantly contributing
to an increase in serious irreversible,
or incapacitating reversible, illness.
(Waste listed in accordance with these
criteria will be designated Acute Haz-
ardous Waste.)
(3) It contains any of the toxic con-
stituents listed in appendix VIII and,
after considering the following factors,
the Administrator concludes that the
waste is capable of posing a substantial
present or potential hazard to human
health or the environment when im-
properly treated, stored, transported or
disposed of, or otherwise managed:
(i) The nature of the toxicity pre-
sented by the constituent.
(ii) The concentration of the con-
stituent in the waste.
57
-------
§261.20
40 CFR Ch. I (7-1-03 Edition)
(iii) The potential of the constituent
or any toxic degradation product of the
constituent to migrate from the waste
into the environment under the types
of improper management considered in
paragraph (a)(3)(vii) of this section.
(iv) The persistence of the con-
stituent or any toxic degradation prod-
uct of the constituent.
(v) The potential for the constituent
or any toxic degradation product of the
constituent to degrade into non-harm-
ful constituents and the rate of deg-
radation.
(vi) The degree to which the con-
stituent or any degradation product of
the constituent bioaccumulates in eco-
systems.
(vii) The plausible types of improper
management to which the waste could
be subjected.
(viii) The quantities of the waste gen-
erated at individual generation sites or
on a regional or national basis.
(ix) The nature and severity of the
human health and environmental dam-
age that has occurred as a result of the
improper management of wastes con-
taining the constituent.
(x) Action taken by other govern-
mental agencies or regulatory pro-
grams based on the health or environ-
mental hazard posed by the waste or
waste constituent.
(xi) Such other factors as may be ap-
propriate.
Substances will be listed on appendix
VIII only if they have been shown in
scientific studies to have toxic, car-
cinogenic, mutagenic or teratogenic ef-
fects on humans or other life forms.
(Wastes listed in accordance with
these criteria will be designated Toxic
wastes.)
(b) The Administrator may list class-
es or types of solid waste as hazardous
waste if he has reason to believe that
individual wastes, within the class or
type of waste, typically or frequently
are hazardous under the definition of
hazardous waste found in section
1004(5) of the Act.
(c) The Administrator will use the
criteria for listing specified in this sec-
tion to establish the exclusion limits
referred to in§261.5(c).
[45 FR 33119, May 19, 1980, as amended at 55
FR 18726, May 4, 1990; 57 FR 14, Jan. 2, 1992]
Subpart C—Characteristics of
Hazardous Waste
§261.20 General.
(a) A solid waste, as defined in §261.2,
which is not excluded from regulation
as a hazardous waste under §261.4(b), is
a hazardous waste if it exhibits any of
the characteristics identified in this
subpart.
[Comment: §262.11 of this chapter sets forth
the generator's responsibility to determine
whether his waste exhibits one or more of
the characteristics identified in this subpart]
(b) A hazardous waste which is iden-
tified by a characteristic in this sub-
part is assigned every EPA Hazardous
Waste Number that is applicable as set
forth in this subpart. This number
must be used in complying with the no-
tification requirements of section 3010
of the Act and all applicable record-
keeping and reporting requirements
under parts 262 through 265, 268, and 270
of this chapter.
(c) For purposes of this subpart, the
Administrator will consider a sample
obtained using any of the applicable
sampling methods specified in appendix
I to be a representative sample within
the meaning of part 260 of this chapter.
{Comment: Since the appendix I sampling
methods are not being formally adopted by
the Administrator, a person who desires to
employ an alternative sampling method is
not required to demonstrate the equivalency
of his method under the procedures set forth
in §§260.20 and 260.21.)
[45 FR 33119, May 19, 1980, as amended at 51
FR 40636, Nov. 7, 1986; 55 FR 22684, June 1,
1990; 56 FR 3876, Jan. 31, 1991]
§261.21 Characteristic of ignitability.
(a) A solid waste exhibits the char-
acteristic of ignitability if a represent-
ative sample of the waste has any of
the following properties:
(1) It is a liquid, other than an aque-
ous solution containing less than 24
percent alcohol by volume and has
flash point less than 60 °C (140 °F), as
determined by a Pensky-Martens
Closed Cup Tester, using the test meth-
od specified in ASTM Standard D-93-79
or D-93-80 (incorporated by reference,
see §260.11), or a Setaflash Closed Cup
Tester, using the test method specified
58
-------
Environmental Protection Agency
§261.24
in ASTM Standard D-3278-78 (incor-
porated by reference, see §260.11), or as
determined by an equivalent test meth-
od approved by the Administrator
under procedures set forth in §§260.20
and 260.21.
(2) It is not a liquid and is capable,
under standard temperature and pres-
sure, of causing fire through friction,
absorption of moisture or spontaneous
chemical changes and, when ignited,
burns so vigorously and persistently
that it creates a hazard.
(3) It is an ignitable compressed gas
as defined in 49 CFR 173.300 and as de-
termined by the test methods described
in that regulation or equivalent test
methods approved by the Adminis-
trator under §§260.20 and 260.21.
(4) It is an oxidizer as defined in 49
CFR 173.151.
(b) A solid waste that exhibits the
characteristic of ignitability has the
EPA Hazardous Waste Number of D001.
[45 FR 33119, May 19, 1980, as amended at 46
FR 35247, July 7, 1981; 55 FR 22684, June 1,
1990]
§ 261.22 Characteristic of corrosivity.
(a) A solid waste exhibits the char-
acteristic of corrosivity if a represent-
ative sample of the waste has either of
the following properties:
(1) It is aqueous and has a pH less
than or equal to 2 or greater than or
equal to 12.5, as determined by a pH
meter using Method 9040 in "Test
Methods for Evaluating Solid Waste,
Physical/Chemical Methods," EPA
Publication SW-846, as incorporated by
reference in §260.11 of this chapter.
(2) It is a liquid and corrodes steel
(SAE 1020) at a rate greater than 6.35
mm (0.250 inch) per year at a test tem-
perature of 55 °C (130 °F) as determined
by the test method specified in NACE
(National Association of Corrosion En-
gineers) Standard TM-01-69 as stand-
ardized in "Test Methods for Evalu-
ating Solid Waste, Physical/Chemical
Methods," EPA Publication SW-846, as
incorporated by reference in §260.11 of
this chapter.
(b) A solid waste that exhibits the
characteristic of corrosivity has the
EPA Hazardous Waste Number of D002.
[45 FR 33119, May 19, 1980, as amended at 46
FR 35247, July 7, 1981; 55 FR 22684, June 1,
1990; 58 FR 46049, Aug. 31, 1993)
§ 261.23 Characteristic of reactivity.
(a) A solid waste exhibits the char-
acteristic of reactivity if a representa-
tive sample of the waste has any of the
following properties:
(1) It is normally unstable and read-
ily undergoes violent change without
detonating.
(2) It reacts violently with water.
(3) It forms potentially explosive
mixtures with water.
(4) When mixed with water, it gen-
erates toxic gases, vapors or fumes in a
quantity sufficient to present a danger
to human health or the environment.
(5) It is a cyanide or sulfide bearing
waste which, when exposed to pH con-
ditions between 2 and 12.5, can generate
toxic gases, vapors or fumes in a quan-
tity sufficient to present a danger to
human health or the environment.
(6) It is capable of detonation or ex-
plosive reaction if it is subjected to a
strong initiating source or if heated
under confinement.
(7) It is readily capable of detonation
or explosive decomposition or reaction
at standard temperature and pressure.
(8) It is a forbidden explosive as de-
fined in 49 CFR 173.51, or a Class A ex-
plosive as defined in 49 CFR 173.53 or a
Class B explosive as defined in 49 CFR
173.88.
(b) A solid waste that exhibits the
characteristic of reactivity has the
EPA Hazardous Waste Number of D003.
[45 FR 33119, May 19, 1980, as amended at 55
FR 22684, June 1, 1990]
§ 261.24 Toxicity characteristic.
(a) A solid waste (except manufac-
tured gas plant waste) exhibits the
characteristic of toxicity if, using the
Toxicity Characteristic Leaching Pro-
cedure, test Method 1311 in "Test
Methods for Evaluating Solid Waste.
Physical/Chemical Methods," EPA
Publication SW-846, as incorporated by
reference in §260.11 of this chapter, the
extract from a representative sample
of the waste contains any of the con-
taminants listed in table 1 at the con-
centration equal to or greater than the
respective value given in that table.
Where the waste contains less than 0.5
percent filterable solids, the waste
59
-------
§261.30
40 CFR Ch. I (7-1-03 Edition)
itself, after filtering using the method-
ology outlined in Method 1311, is con-
sidered to be the extract for the pur-
pose of this section.
(b) A solid waste that exhibits the
characteristic of toxicity has the EPA
Hazardous Waste Number specified in
Table I which corresponds to the toxic
contaminant causing it to be haz-
ardous.
TABLE 1—MAXIMUM CONCENTRATION OF CONTAMINANTS FOR
THE TOXICITY CHARACTERISTIC
EPAHW
No.1
D004
D005
D018
D006
D019
D020
D021
D022
D007
D023
D024
D025
D026
D016
D027
D028
D029
D030
D012
D031
D032
D033
D034
D008
D013
D009
D014
D035
D036
D037
O038
D010
D011
D039
D015
D040
D041
D042
D017
0043
Contaminant
Barium
Carbon tetrachloride
Chlorobenzene
Chloroform
o-Creso! :
m-Cresol
p-Creso!
Cresoi
24-D
1 ,4-Dichlorobenzene
1 ,2-Dich!oroethane
1,1-Dichloroethytene
2,4-Dinitrotoluene
Endrin
Heptachlor (and its ep-
oxide).
Hexachiorobenzene
Hexachlorobutadiene ....
Hexachloroethane
Lead
Mercury
Methyl ethyl ketone
Pentrachlorophenol
Silver
Tetrachloroethylene
Trichloroethylene
2,4,5-Trichlorophenol ....
2,4,6-TrichIorophenol ....
2 4 5-TP (Silvex)
Vinyl chloride
CAS No.2
7440-38-2
7440-39-3
71-43-2
7440-43-9'
56-23-5
57-74-9
108-90-7
67-66-3
7440-47-3
95-48-7
108-39-4
106-44-5
94-75-7
106-46-7
107-06-2
75-35-4
121-14-2
72-20-8
76-44-8
118-74-1
87-68-3
67-72-1
7439-92-1
58-89-9
7439-97-6
72-43-5
78-93-3
98-95-3
87-86-5
110-86-1
7782-49-2
7440-22-4
127-18-4
8001-35-2
79-01-6
95-95-4
88-06-2
93-72-1
75-O1-4
Regu-
latory
Level
(mg/L)
50
100.0
05
1 0
0.5
003
100.0
6.0
50
••200.0
"200.0
•>2000
"200.0
100
7.5
0.5
0.7
30.13
0.02
0.008
30.13
0.5
3.0
5.0
04
0.2
100
200.0
20
100.0
35.0
1 0
50
0.7
05
0.5
400.0
2.0
1 0
0.2
1 Hazardous waste number.
2 Chemical abstracts service number.
3Quantitatiort limit is greater than the calculated regulatory
level. The quantitation limit therefore becomes the regulatory
level.
4 If O-, m-, and p-Creso! concentrations cannot be differen-
tiated, the total cresol (D026) concentration is used. The regu-
latory level of total creso! is 200 mg/l.
[55 FR 11862, Mar. 29, 1990, as amended at 55
FR 22684, June 1, 1990; 55 FR 26987, June 29,
1990; 58 FR 46049, Aug. 31, 1993; 67 FR 11254,
Mar. 13, 2002]
Subpart D—Lists of Hazardous
Wastes
§261.30 General.
(a) A solid waste is a hazardous waste
if it is listed in this subpart, unless it
has been excluded from this list under
§§260.20 and 260.22.
(b) The Administrator will indicate
his basis for listing the classes or types
of wastes listed in this subpart by em-
ploying one or more of the following
Hazard Codes;
Ignitable Waste
Corrosive Waste
Reactive Waste
Toxicity Characteristic Waste ...
Acute Hazardous Waste
(D
(C)
(R)
(E)
(H)
Toxic Waste (T)
Appendix VII identifies the constituent
which caused the Administrator to list
the waste as a Toxicity Characteristic
Waste (E) or Toxic Waste (T) in §§261.31
and 261.32.
(c) Each hazardous waste listed in
this subpart is assigned an EPA Haz-
ardous Waste Number which precedes
the name of the waste. This number
must be used in complying with the no-
tification requirements of Section 3010
of the Act and certain recordkeeping
and reporting requirements under parts
262 through 265, 268, and part 270 of this
chapter.
(d) The following hazardous wastes
listed in §261.31 or §261.32 are subject to
the exclusion limits for acutely haz-
ardous wastes established in §261.5:
EPA Hazardous Wastes Nos. FO20,
FO21, FO22, FO23, FO26, and FO27.
[45 FR 33119, May 19. 1980, as amended at 48
FR 14294, Apr. 1, 1983; 50 FR 2000, Jan. 14,
1985; 51 FR 40636, Nov. 7, 1986; 55 FR 11863,
Mar. 29, 1990]
§261.31 Hazardous wastes from non-
specific sources.
(a) The following solid wastes are
listed hazardous wastes from non-spe-
cific sources unless they are excluded
under §§260.20 and 260.22 and listed in
appendix IX.
60
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Environmental Protection Agency
§261.31
Industry and EPA hazardous
waste No.
Hazardous waste
Hazard
code
Generic:
F001 ...
F006.
F007 ..
F008 ..
F009 .,
F010 ..
F011 .,
F012 .,
F019.
F020.
F021 .
The following spent hatogenated solvents used in degreasing: Tetrachloroethylene,
trichforoethylene, methylene chloride, 1,1,1-trichIoroethane, carbon tetrachloride,
and chlorinated fluorocarbons; all spent solvent mixtures/blends used in degreasing
containing, before use, a total of ten percent or more (by volume) of one or more
of the above halogenated solvents or those solvents listed in F002, F004, and
F005; and still bottoms from the recovery of these spent solvents and spent sol-
vent mixtures.
The following spent halogenated solvents: Tetrachloroethylene, methylene chloride,
trichloroethyiene, 1,1,1-trichloroethane, chlorobenzene, 1,1,2-trichloro-1,2,2-
triftuoroethane, ortho-dichlorobenzene, trichlorofluoromethane, and 1,1,2-trichloro-
ethane; all spent solvent mixtures/blends containing, before use, a total of ten per-
cent or more (by volume) of one or more of the above halogenated solvents or
those listed in F001, F004, or F005; and still bottoms from the recovery of these
spent solvents and spent solvent mixtures.
The following spent non-halogenated solvents: Xylene, acetone, ethyl acetate, ethyl
benzene, ethyl ether, methyl isobutyl ketone, n-butyl alcohol, cyclohexanone, and
methanol; all spent solvent mixtures/blends containing, before use, only the above
spent non-halogenated solvents; and all spent solvent mixtures/blends containing,
before use, one or more of the above non-halogenated solvents, and, a total of ten
percent or more (by voiume) of one or more of those solvents listed in F001, F002,
F004, and F005; and still bottoms from the recovery of these spent solvents and
spent solvent mixtures.
The following spent non-halogenated solvents: Cresols and cresylic acid, and
nitrobenzene; all spent solvent mixtures/blends containing, before use, a total of
ten percent or more (by volume) of one or more of the above non-halogenated sol-
vents or those solvents listed in F001, F002, and F005; and still bottoms from the
recovery of these spent solvents and spent solvent mixtures.
The following spent non-halogenated solvents: Toluene, methyl ethyl ketone, carbon
disulfide, isobutanol, pyridine, benzene, 2-ethoxyethanol, and 2-nitropropane; all
spent solvent mixtures/blends containing, before use, a total of ten percent or more
(by volume) of one or more of the above non-halogenated solvents or those sol-
vents listed in F001, F002, or F004; and still bottoms from the recovery of these
spent solvents and spent solvent mixtures.
Wastewater treatment sludges from electroplating operations except from the fol-
lowing processes: (1) Sulfuric acid anodizing of aluminum; (2) tin plating on carbon
steel; (3) zinc plating (segregated basis) on carbon steel; (4) aluminum or zinc-alu-
minum plating on carbon steel; (5) cleaning/stripping associated with tin, zinc and
aluminum plating on carbon steel; and (6) chemical etching and milling of alu-
minum.
Spent cyanide plating bath solutions from electroplating operations
Plating bath residues from the bottom of plating baths from electroplating operations
where cyanides are used in the process.
Spent stripping and cleaning bath solutions from electroplating operations where
cyanides are used in the process.
Quenching bath residues from oil baths from metal heat treating operations where
cyanides are used in the process.
Spent cyanide solutions from salt bath pot cleaning from metal heat treating oper-
ations.
Quenching waste water treatment sludges from metal heat treating operations where
cyanides are used in the process.
Wastewater treatment sludges from the chemical conversion coating of aluminum ex-
cept from zirconium phosphating in aluminum can washing when such phosphating
is an exclusive conversion coating process.
Wastes (except wastewater and spent carbon from hydrogen chloride purification)
from the production or manufacturing use (as a reactant, chemical intermediate, or
component in a formulating process) of tri- or tetrachlorophenol, or of intermediates
used to produce their pesticide derivatives. (This listing does not include wastes
from the production of Hexachlorophene from highly purified 2,4,5-trichlorophenol.).
Wastes (except wastewater and spent carbon from hydrogen chloride purification)
from the production or manufacturing use (as a reactant, chemical intermediate, or
component in a formulating process) of pentachtorophenol, or of intermediates
used to produce its derivatives.
Wastes (except wastewater and spent carbon from hydrogen chloride purification)
from the manufacturing use (as a reactant, chemical intermediate, or component in
a formulating process) of tetra-, penta-, or hexachlorobenzenes under alkaline con-
ditions.
Wastes (except wastewater and spent carbon from hydrogen chloride purification)
from the production of materials on equipment previously used for the production
or manufacturing use (as a reactant, chemical intermediate, or component in a for-
mulating process) of tri- and tetrachlorophenols. (This listing does not include
wastes from equipment used only for the production or use of Hexachlorophene
from highly purified 2,4,5-trichlorophenol.).
(T)
(I/O
(R.T)
(R,T)
(R,T)
(R,T)
(T)
(T)
(H)
(H)
(H)
(H)
61
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§261.31
40 CFR Ch, I (7-1-03 Edition)
Industry and EPA hazardous
waste No.
Hazardous waste
Hazard
code
F028 ..
F032 ..
F034 ....
F035.
Process wastes, including but not limited to, distillation residues, heavy ends, tars,
and reactor clean-out wastes, from the production of certain chlorinated aliphatic
hydrocarbons by free radical catalyzed processes. These chlorinated aliphatic hy-
drocarbons are those having carbon chain lengths ranging from one to and includ-
ing five, with varying amounts and positions of chlorine substitution. (This listing
does not include wastewaters, wastewater treatment sludges, spent catalysts, and
wastes listed in §261.31 or§261.32.).
Condensed light ends, spent filters and filter aids, and spent desiccant wastes from
the production of certain chlorinated aliphatic hydrocarbons, by free radical cata-
lyzed processes. These chlorinated aliphatic hydrocarbons are those having car-
bon chain lengths ranging from one to and including five, with varying amounts and
positions of chlorine substitution.
Wastes (except wastewater and spent carbon from hydrogen chloride purification)
from the production of materials on equipment previously used for the manufac-
turing use (as a reactant, chemical intermediate, or component in a formulating
process) of tetra-, penta-, or hexachlorobenzene under alkaline conditions.
Discarded unused formulations containing tri-, tetra-, or pentachforophenol or dis-
carded unused formulations containing compounds derived from these
chlorophenols. (This listing does not include formulations containing
Hexachtorophene sythesized from prepurified 2,4,5-trichlorophenol as the sole
component.).
Residues resulting from the incineration or thermal treatment of soil contaminated
with EPA Hazardous Waste Nos. F020, F021, F022, F023, F026, and F027.
Wastewaters (except those that have not come into contact with process contami-
nants), process residuals, preservative drippage, and spent formulations from wood
preserving processes generated at plants that currently use or have previously
used chlorophenolic formulations (except potentially cross-contaminated wastes
that have had the F032 waste code deleted in accordance with §261.35 of this
chapter or potentially cross-contaminated wastes that are otherwise currently regu-
lated as hazardous wastes (i.e., F034 or F035), and where the generator does not
resume or initiate use of chlorophenolic formulations). This listing does not include
K001 bottom sediment sludge from the treatment of wastewater from wood pre-
serving processes that use creosote and/or pentachlorophenol.
Wastewaters {except those that have not come into contact with process contami-
nants), process residuals, preservative drippage, and spent formulations from wood
preserving processes generated at plants that use creosote formulations. This list-
ing does not include K001 bottom sediment sludge from the treatment of waste-
water from wood preserving processes that use creosote and/or pentachlorophenol
Wastewaters (except those that have not come into contact with process contami-
nants), process residuals, preservative drippage, and spent formulations from wood
preserving processes generated at plants that use inorganic preservatives con-
taining arsenic or chromium. This listing does not include K001 bottom sediment
sludge from the treatment of wastewater from wood preserving processes that use
creosote and/or pentachlorophenol.
Petroleum refinery primary oil/water/solids separation sludge—Any sludge generated
from the gravitational separation of oil/water/solids during the storage or treatment
of process wastewaters and oil cooling wastewaters from petroleum refineries.
Such sludges include, but are not limited to, those generated in oil/water/solids
separators; tanks and impoundments; ditches and other conveyances; sumps; and
stormwater units receiving dry weather fiow. Sludge generated in stormwater units
that do not receive dry weather flow, sludges generated from non-contact once-
through cooling waters segregated for treatment from other process or oily cooling
waters, sludges generated in aggressive biological treatment units as defined in
§261.31(b)(2) (including sludges generated in one or more additional units after
wastewaters have been treated in aggressive biological treatment units) and K051
wastes are not included in this listing. This listing does include residuals generated
from processing or recycling otl-bearing hazardous secondary materials excluded
under §261.4(a)(12)(i), if those residuals are to be disposed of..
Petroleum refinery secondary (emulsified) oil/water/solids separation sludge—Any
sludge and/or float generated from the physical and/or chemical separation of oil/
water/solids in process wastewaters and oily cooling wastewaters from petroleum
refineries. Such wastes include, but are not limited to, all sludges and floats gen-
erated in: induced air flotation (IAF) units, tanks and impoundments, and all
sludges generated in DAF units. Sludges generated in stormwater units that do not
receive dry weather flow, sludges generated from non-contact once-through cool-
ing waters segregated for treatment from other process or oily cooling waters,
sludges and floats generated in aggressive biological treatment units as defined in
§261.31(b){2) (including sludges and floats generated in one or more additional
units after wastewaters have been treated in aggressive biological treatment units)
and F037, K048, and K051 wastes are not included in this listing.
(T)
(T)
(H)
(H)
(T)
(T)
(T)
(T)
(T)
(T)
62
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Environmental Protection Agency
§261.32
Industry and EPA hazardous
waste No.
F039
Hazardous waste
Leachate (liquids that have percolated through land disposed wastes) resulting from
the disposal of more than one restricted waste classified as hazardous under sub-
part D of this part. (Leachate resulting from the disposal of one or more of the fol-
lowing EPA Hazardous Wastes and no other Hazardous Wastes retains its EPA
Hazardous Waste Number(s): F020, F021, F022, F026, F027, and/or F028.).
Hazard
code
(T)
(b) Listing Specific Definitions: (1)
For the purposes of the F037 and F038
listings, oil/water/solids is defined as
oil and/or water and/or solids. (2) (i) For
the purposes of the F037 and F038 list-
ings, aggressive biological treatment
units are defined as units which em-
ploy one of the following four treat-
ment methods: activated sludge; trick-
ling filter; rotating biological con-
tactor for the continuous accelerated
biological oxidation of wastewaters; or
high-rate aeration. High-rate aeration
is a system of surface impoundments or
tanks, in which intense mechanical
aeration is used to completely mix the
wastes, enhance biological activity,
and (A) the units employ a minimum of
6 hp per million gallons of treatment
volume; and either (B) the hydraulic
retention time of the unit is no longer
than 5 days; or (C) the hydraulic reten-
tion time is no longer than 30 days and
the unit does not generate a sludge
that is a hazardous waste by the Tox-
icity Characteristic.
(ii) Generators and treatment, stor-
age and disposal facilities have the
burden of proving that their sludges
are exempt from listing as F037 and
F038 wastes under this definition. Gen-
erators and treatment, storage and dis-
posal facilities must maintain, in their
operating or other onsite records, docu-
ments and data sufficient to prove
that: (A) the unit is an aggressive bio-
logical treatment unit as defined in
this subsection; and (B) the sludges
sought to be exempted from the defini-
tions of F037 and/or F038 were actually
generated in the aggressive biological
treatment unit.
(3) (i) For the purposes of the F037
listing, sludges are considered to be
generated at the moment of deposition
in the unit, where deposition is defined
as at least a temporary cessation of
lateral particle movement.
(ii) For the purposes of the F038 list-
ing, (A) sludges are considered to be
generated at the moment of deposition
in the unit, where deposition is defined
as at least a temporary cessation of
lateral particle movement and (B)
floats are considered to be generated at
the moment they are formed in the top
of the unit.
[46 FR 4617, Jan. 16, 1981]
EDITORIAL NOTE: For FEDERAL REGISTER ci-
tations affecting §261.31, see the List of CFR
Sections Affected, which appears in the
Finding Aids section of the printed volume
and on GPO Access.
§ 261.32 Hazardous
eific sources.
wastes from spe-
The following solid wastes are listed
hazardous wastes from specific sources
unless they are excluded under §§260.20
and 260.22 and listed in appendix IX.
Industry and EPA hazardous
waste No.
Wood preservation: K001
Inorganic pigments:
K002
K003
K004
K005
K006
K007
K008
Organic chemicals:
K009
K010
Hazardous waste
Bottom sediment sludge from the treatment of wastewaters from wood preserving
processes that use creosote and/or pentachlorophenol.
ments.
{anhydrous and hydrated).
Distillation side cuts from the production of acetaldehvde from ethvlene
Hazard
code
("0
(T)
CO
(T)
CO
CO
CO
CO
CO
m
63
-------
§261.32
40 CFR Ch. I (7-1-03 Edition)
Industry and EPA hazardous
waste No.
Hazardous waste
Hazard
code
K011 Bottom stream from the wastewater stripper in the production of acrylonitrile (R, T)
K013 Bottom stream from the acetonitrile column in the production of acrylonitrile (R, T)
K014 Bottoms from the acetonitrile purification column in the production of acrylonitrile (T)
K015 Still bottoms from the distillation of benzyl chloride (T)
K01G Heavy ends or distillation residues from the production of carbon tetrachloride (T)
K017 Heavy ends (still bottoms) from the purification column in the production of (T)
epichlorohydrin.
K018 Heavy ends from the fractionation column in ethyl chloride production (T)
K019 Heavy ends from the distillation of ethylene dichloride in ethylene dichloride produc- (T)
tion.
K020 Heavy ends from the distillation of vinyl chloride in vinyl chloride monomer production (T)
K021 Aqueous spent antimony catalyst waste from fluoromelhanes production (T)
K022 Distillation bottom tars from the production of phenol/acetone from cumene (T)
K023 Distillation light ends from the production of phthalic anhydride from naphthalene (T)
K024 Distillation bottoms from the production of phthalic anhydride from naphthalene (T)
K025 Distillation bottoms from the production of nitrobenzene by the nitration of benzene ... (T)
K026 Stripping still tails from the production of methy ethyl pyridines (T)
K027 Centrifuge and distillation residues from toluene diisocyanate production (R, T)
K028 Spent catalyst from the hydrochlorinator reactor in the production of 1,1,1-trichloro- (T)
ethane.
K029 Waste from the product steam stripper in the production of 1,1,1-trichloroethane (T)
K030 Column bottoms or heavy ends from the combined production of trichioroethyfene (T)
and perchloroethylene.
K083 Distillation bottoms from aniline production (T)
K085 Distillation or fractionation column bottoms from the production of chlorobenzenes (T)
K093 Distillation light ends from the production of phthafic anhydride from ortho-xylene (T)
K094 Distillation bottoms from the production of phthalic anhydride from ortho-xylene (T)
K095 Distillation bottoms from the production of 1,1,1-trichforoethane (T)
K096 Heavy ends from the heavy ends column from the production of 1,1,1-trichtoroethane (T)
K103 Process residues from aniline extraction from the production of aniline (T)
K104 Combined wastewater streams generated from nitrobenzene/aniline production (T)
K105 Separated aqueous stream from the reactor product washing step in the production {T)
of chlorobenzenes.
K107 Column bottoms from product separation from the production of 1,1-dimethyl-hydra- (C,T)
zine (UDMH) from carboxylic acid hydrazines.
K108 Condensed column overheads from product separation and condensed reactor vent (I,T)
gases from the production of 1,1-dimethylhydrazine (UDMH) from carboxylic acid
hydrazides.
K109 Spent filter cartridges from product purification from the production of 1,1- (T)
dimethylhydrazine (UDMH) from carboxylic acid hydrazides.
K110 Condensed column overheads from intermediate separation from the production of (T)
1,1-dimethylhydrazine (UDMH) from carboxylic acid hydrazides.
K111 Product washwaters from the production of dinitrotoluene via nitration of toluene (C,T)
K112 Reaction by-product water from the drying column in the production of (T)
toluenediamine via hydrogenation of dinitrotoluene.
K113 Condensed liquid light ends from the purification of toluenediamine in the production (T)
of toluenediamine via hydrogenation of dinitrotoluene.
K114 Vicinals from the purification of toluenediamine in the production of toluenediamine (T)
via hydrogenation of dinitrotoluene.
K115 Heavy ends from the purification of toluenediamine in the production of (T)
toluenediamine via hydrogenation of dinitrotoiuene.
K116 Organic condensate from the solvent recovery column in the production of toluene (T)
diisocyanate via phosgenation of toluenediamine.
K117 Wastewater from the reactor vent gas scrubber in the production of ethylene (T)
dibromide via bromination of ethene.
K118 Spent adsorbent solids from purification of ethylene dibromide in the production of (T)
ethyfene dibromide via bromination of ethene.
K136 Still bottoms from the purification of ethyfene dibromide in the production of ethylene (T)
dibromide via bromination of ethene.
K149 Distillation bottoms from the production of alpha- (or methyl-) chlorinated toluenes, (T)
ring-chlorinated toluenes, benzoyl chlorides, and compounds with mixtures of these
functional groups, (This waste does not include still bottoms from the distillation of
benzyl chloride.).
K150 Organic residuals, excluding spent carbon adsorbent, from the spent chlorine gas (T)
and hydrochloric acid recovery processes associated with the production of alpha-
{or methy!-) chlorinated toluenes, ring-chlorinated toluenes, benzoyl chlorides, and
compounds with mixtures of these functional groups.
K151 Wastewater treatment sludges, excluding neutralization and biological sludges, gen- (T)
erated during the treatment of wastewaters from the production of alpha- (or meth-
yl-) chlorinated toluenes, ring-chlorinated toluenes, benzoy) chlorides, and com-
pounds with mixtures of these functional groups.
64
-------
Environmental Protection Agency
§261.32
Industry and EPA hazardous
waste No.
Hazardous waste
Hazard
code
K156
K157
K158 ....
K159
K161
K174
K175 ,
Inorganic chemicals:
K071
K106
K176
Pesticides:
K031
K032
K033
K034 .
K035 .
K036 .
K037 .
K038 .
K039 ,
K040
K041
K042
K043
K097
K098
K099
K123
K124
Organic waste (including heavy ends, still bottoms, light ends, spent solvents, fil-
trates, and decantates) from the production of carbamates and carbamoyl oximes.
(This listing does not apply to wastes generated from the manufacture of 3-iodo-2-
propynyl n-butylcarbamate.).
Wastewaters (including scrubber waters, condenser waters, washwaters, and separa-
tion waters) from the production of carbamates and carbamoyl oximes. (This listing
does not apply to wastes generated from the manufacture of 3-iodo-2-propynyl n-
butylcarbamate.).
Bag house dusts and filter/separation solids from the production of carbamates and
carbamoyl oximes. (This listing does not apply to wastes generated from the man-
ufacture of 3-iodo-2-propynyl n-butylcarbamate.).
Organics from the treatment of thiocarbamate wastes
Purification solids (including filtration, evaporation, and centrifugation solids), bag
house dust and floor sweepings from the production of dithiocarbamate acids and
their salts. (This listing does not include K125 or K126.)-
Wastewater treatment sludges from the production of ethylene dichloride or vinyl
chloride monomer (including sludges that result from commingled ethylene dichlo-
ride or vinyl chloride monomer wastewater and other wastewater}, unless the
sludges meet the following conditions: (i) they are disposed of in a subtitle C or
non-hazardous landfill licensed or permitted by the state or federal government; (ii)
they are not otherwise placed on the land prior to final disposal; and (iii) the gener-
ator maintains documentation demonstrating that the waste was either disposed of
in an on-site landfill or consigned to a transporter or disposal facility that provided
a written commitment to dispose of the waste in an off-site landfill. Respondents in
any action brought to enforce the requirements of subtitle C must, upon a showing
by the government that the respondent managed wastewater treatment sludges
from the production of vinyl chloride monomer or ethylene dichloride, demonstrate
that they meet the terms of the exclusion set forth above. In doing so, they must
provide appropriate documentation (e.g., contracts between the generator and the
landfill owner/operator, invoices documenting delivery of waste to landfill, etc.) that
the terms of the exclusion were met.
Wastewater treatment sludges from the production of vinyl chloride monomer using
mercuric chloride catalyst in an acetylene-based process.
Brine purification muds from the mercury cell process in chlorine production, where
separately prepurified brine is not used.
Chlorinated hydrocarbon waste from the purification step of the diaphragm cell proc-
ess using graphite anodes in chlorine production.
Wastewater treatment sludge from the mercury cell process in chlorine production ....
Baghouse filters from the production of antimony oxide, including filters from the pro-
duction of intermediates (e.g., antimony metal or crude antimony oxide).
Slag from the production of antimony oxide that is specuiatively accumulated or dis-
posed, including slag from the production of intermediates (e.g., antimony metal or
crude antimony oxide}.
Residues from manufacturing and manufacturing-site storage of ferric chloride from
acids formed during the production of titanium dioxide using the chloride-ilmenite
process.
By-product salts generated in the production of MSMA and cacodylic acid
Wastewater treatment sludge from the production of chlordane
Wastewater and scrub water from the chlorination of cyclopentadiene in the produc-
tion of chlordane.
Filter solids from the filtration of hexachlorocyclopentadiene in the production of
chlordane.
Wastewater treatment sludges generated in the production of creosote
Still bottoms from toluene reclamation distillation in the production of disulfoton
Wastewater treatment sludges from the production of disulfoton
Wastewater from the washing and stripping of phorate production
Filter cake from the filtration of diethylphosphorodithioic acid in the production of
phorate.
Wastewater treatment sludge from the production of phorate
Wastewater treatment sludge from the production of toxaphene
Heavy ends or distillation residues from the distillation of tetrachlorobenzene in the
production of 2,4,5-T.
2,6-Dichlorophenot waste from the production of 2,4-D
Vacuum stripper discharge from the chlordane chlorinator in the production of
chlordane.
Untreated process wastewater from the production of toxaphene
Untreated wastewater from the production of 2,4-D -.
Process wastewater (including supernates, filtrates, and washwaters) from the pro-
duction of ethylenebisdithiocarbamic acid and its salt.
Reactor vent scrubber water from the production of ethylenebisdithiocarbamic acid
and its salts.
(T)
(T)
(T)
(T)
(R,T)
(T)
(C,T)
65
-------
§261.32
40 CFR Ch. I (7-1-03 Edition)
Industry and EPA hazardous
waste No.
Hazardous waste
Hazard
code
K125 Filtration, evaporation, and centrifugation solids from the production of (T)
ethylenebisdithiocarbamic acid and its salts.
K126 Baghouse dust and floor sweepings in milling and packaging operations from the pro- (T)
duction or formulation of ethylenebisdithiocarbamic acid and its salts.
K131 Wastewater from the reactor and spent sulfuric acid from the acid dryer from the pro- (C, T)
duction of methyl bromide.
K132 Spent absorbent and wastewater separator solids from the production of methyl bro- (T)
mide.
Explosives:
K044 Wastewater treatment sludges from the manufacturing and processing of explosives (R)
K045 Spent carbon from the treatment of wastewater containing explosives (R)
K046 Wastewater treatment sludges from the manufacturing, formulation and loading of (T)
lead-based initiating compounds.
K047 Pink/red water from TNT operations (R)
Petroleum refining:
K043 Dissolved air flotation (DAF) float from the petroleum refining industry (T)
K049 Slop oil emulsion solids from the petroleum refining industry (T)
K050 Heat exchanger bundle cleaning sludge from the petroleum refining industry (T)
K051 API separator sludge from the petroleum refining industry (T)
K052 Tank bottoms (leaded) from the petroleum refining industry (T)
K169 Crude oil storage tank sediment from petroleum refining operations (T)
K170 Clarified slurry oil tank sediment and/or in-line filter/separation solids from petroleum (T)
refining operations.
K171 Spent Hydrotreating catalyst from petroleum refining operations, including guard beds (I,T)
used to desulfurize feeds to other catalytic reactors {this listing does not include
inert support media).
K172 Spent Hydrorefining catalyst from petroleum refining operations, including guard beds (I,T)
used to desulfurize feeds to other catalytic reactors (this listing does not include
inert support media).
Iron and steel:
K061 Emission control dust/sludge from the primary production of steel in electric furnaces (T)
KOG2 Spent pickle liquor generated by steel finishing operations of facilities within the iron (C.T)
and steel industry (SIC Codes 331 and 332).
Primary copper:
Primary lead:
Primary zinc:
Primary aluminum:
K088 Spent potliners from primary aluminum reduction (T)
Ferroalloys:
Secondary lead:
K069 Emission control dust/sludge from secondary lead smelting. (NOTE: This listing is (T)
stayed administratively for sludge generated from secondary acid scrubber sys-
tems. The stay will remain in effect until further administrative action is taken. If
EPA takes further action effecting this stay, EPA will publish a notice of the action
in the Federal Register.
K100 Waste leaching solution from acid leaching of emission control dust/sludge from sec- (T)
ondary lead smelting.
Veterinary Pharmaceuticals:
K084 Wastewater treatment sludges generated during the production of veterinary pharma- (T)
ceuticals from arsenic or organo-arsenic compounds.
K101 Distillation tar residues from the distillation of aniline-based compounds in the pro- (T)
duction of veterinary Pharmaceuticals from arsenic or organo-arsenic compounds.
K102 Residue from the use of activated carbon for decolorization in the production of vet- (T)
erinary Pharmaceuticals from arsenic or organo-arsenic compounds.
Ink formulation:
K086 Solvent washes and sludges, caustic washes and sludges, or water washes and (T)
sludges from cleaning tubs and equipment used in the formulation of ink from pig-
ments, driers, soaps, and stabilizers containing chromium and lead.
Coking:
K060 Ammonia still lime sludge from coking operations (T)
K087 Decanter tank tar sludge from coking operations (T)
K141 Process residues from the recovery of coal tar, including, but not limited to, collecting (T)
sump residues from the production of coke from coal or the recovery of coke by-
products produced from coal. This listing does not include K087 (decanter tank tar
sludges from coking operations).
K142 Tar storage tank residues from the production of coke from coal or from the recovery (T)
of coke by-products produced from coal.
K143 Process residues from the recovery of light oil, including, but not limited to, those (T)
generated in stills, decanters, and wash oil recovery units from the recovery of
coke by-products produced from coal.
K144 Wastewater sump residues from light oil refining, including, but not limited to, inter- (T)
cepting or contamination sump sludges from the recovery of coke by-products pro-
duced from coal.
66
-------
Environmental Protection Agency
§261.33
Industry and EPA hazardous
waste No.
K145
K147
K148
Hazardous waste
coke by-products produced from coal.
Tar storage tank residues from coal tar refining
Hazard
code
("0
(T)
rn
[46 FR 4618, Jan. 16, 1981]
EDITORIAL NOTE: For FEDERAL REGISTER ci-
tations affecting §261.32, see the List of CFR
Sections Affected, which appears in the
Finding Aids section of the printed volume
and on GPO Access.
§261.33 Discarded commercial chem-
ical products, off-specification spe-
cies, container residues, and spill
residues thereof.
The following materials or items are
hazardous wastes if and when they are
discarded or intended to be discarded
as described in §261.2(a)(2)(i), when
they are mixed with waste oil or used
oil or other material and applied to the
land for dust suppression or road treat-
ment, when they are otherwise applied
to the land in lieu of their original in-
tended use or when they are contained
in products that are applied to the land
in lieu of their original intended use, or
when, in lieu of their original intended
use, they are produced for use as (or as
a component of) a fuel, distributed for
use as a fuel, or burned as a fuel.
(a) Any commercial chemical prod-
uct, or manufacturing chemical inter-
mediate having the generic name listed
in paragraph (e) or (f) of this section.
(b) Any off-specification commercial
chemical product or manufacturing
chemical intermediate which, if it met
specifications, would have the generic
name listed in paragraph (e) or (f) of
this section.
(c) Any residue remaining in a con-
tainer or in an inner liner removed
from a container that has held any
commercial chemical product or manu-
facturing chemical intermediate hav-
ing the generic name listed in para-
graphs (e) or (f) of this section, unless
the container is empty as defined in
§261.7(b) of this chapter.
| Comment: Unless the residue is being bene-
ficially used or reused, or legitimately recy-
cled or reclaimed; or being accumulated,
stored, transported or treated prior to such
use, re-use, recycling or reclamation, EPA
considers the residue to be intended for dis-
card, and thus, a hazardous waste. An exam-
ple of a legitimate re-use of the residue
would be where the residue remains in the
container and the container is used to hold
the same commercial chemical product or
manufacturing chemical intermediate it pre-
viously held. An example of the discard of
the residue would be where the drum is sent
to a drum reconditioner who reconditions
the drum but discards the residue.]
(d) Any residue or contaminated soil,
water or other debris resulting from
the cleanup of a spill into or on any
land or water of any commercial chem-
ical product or manufacturing chem-
ical intermediate having the generic
name listed in paragraph (e) or (f) of
this section, or any residue or contami-
nated soil, water or other debris result-
ing from the cleanup of a spill, into or
on any land or water, of any off-speci-
fication chemical product and manu-
facturing chemical intermediate
which, if it met specifications, would
have the generic name listed in para-
graph (e) or (f) of this section.
[Comment: The phrase "commercial chemical
product or manufacturing chemical inter-
mediate having the generic name listed in .
. ." refers to a chemical substance which is
manufactured or formulated for commercial
or manufacturing use which consists of the
commercially pure grade of the chemical,
any technical grades of the chemical that
are produced or marketed, and all formula-
tions in which the chemical is the sole active
ingredient. It does not refer to a material,
such as a manufacturing process waste, that
contains any of the substances listed in para-
graph (e) or (f). Where a manufacturing proc-
ess waste is deemed to be a hazardous waste
because it contains a substance listed in
paragraph (e) or (f), such waste will be listed
in either §261.31 or §261.32 or will be identi-
fied as a hazardous waste by the characteris-
tics set forth in subpart C of this part.]
(e) The commercial chemical prod-
ucts, manufacturing chemical inter-
mediates or off-specification commer-
cial chemical products or manufac-
turing chemical intermediates referred
to in paragraphs (a) through (d) of this
67
-------
§261.33
40 CFR Ch. I (7-1-03 Edition)
section, are identified as acute haz-
ardous wastes (H) and are subject to be
the small quantity exclusion defined in
§261.5(e).
[Comment: For the convenience of the regu-
lated community the primary hazardous
properties of these materials have been indi-
cated by the letters T (Toxicity), and R (Re-
activity). Absence of a letter indicates that
the compound only is listed for acute tox-
icity.)
These wastes and their corresponding
EPA Hazardous Waste Numbers are:
Haz-
ardous
waste
No.
Chemical ab-
stracts No.
Substance
P023
P002
P057
P058
P002
POOS
P070
P203
P004
POOS
P006
P007
POOS
POOS
P119
P099
P010
P012
P011
P011
P012
P038
P036
P054
P067
P013
P024
P077
P028
P042
P046
P014
P127
P188
P001
P028
P015
P017
P018
P045
P021
P021
P189
P191
P192
P190
P127
P022
P095
P189
P023
P024
P026
P027
P029
P029
P202
P030
P031
107-20-0
591-O8-2
640-19-7
62-74-8
591-08-2
107-02-8
116-06-3
1646-88-4
309-00-2
107-18-6
20859-73-8
2763-96-4
504-24-5
131-74-8
7803-55-6
506-61-6
7778-39-4
1327-53-3
1303-28-2
1303-28-2
1327-53-3
692-42-2
696-28-6
151-56-4
75-55-8
542-62-1
106-47-8
100-01-6
100-44-7
122-09-8
108-98-5
1563-66-2
57-64-7
'81-81-2
100-44-7
7440-41-7
598-31-2
357-57-3
39196-18-4
592-01-8
592-O1-8
55285-14-8
644-64-4
119-38-0
1129-41-5
1563-66-2
75-1 5-O
75-44-5
55285-14-8
107-20-0
106-47-8
5344-82-1
542-76-7
544-92-3
544-92-3
64-00-6
460-19-5
Acetaldehyde, chloro-
Acetamide, N-(aminothioxomethyl)-
Acetamide, 2-fluoro-
Acetic acid, fluoro-, sodium salt
1 -AcetyI-2-lhiourea
Acrolein
Aldicarb
Aidicarb suifone.
Aldrin
Ally! alcohol
Aluminum phosphide (R,T)
5-(Aminomethy!)-3-isoxazolol
4-Aminopyridine
Ammonium picrate (R)
Ammonium vanadate
Argentate(l-), bis(cyano-C)-, potassium
Arsenic acid H3 AsO4
Arsenic oxide As2 O3
Arsenic oxide AS2 O$
Arsenic pentoxide
Arsenic trioxide
Arsine, diethyi-
Arsonous dichioride, phenyl-
Aziridine
Aziridine, 2-methyl-
Barium cyanide
Benzenamine, 4-chloro-
Benzenamine, 4-nitrc-
Benzene, (chloromethyl)-
1,2-Benzenedioi, 4-£1-hydroxy-2-(methylamino)ethyi]-, (R)-
Benzeneethanamine, alpha.alpha-dimethyl-
Benzenethiol
7-Benzofurano!, 2,3-dihydro-2,2-dimethyl-, methylcarbamate.
Benzoic acid, 2-hydroxy-, compd. with (3aS-cis)-1,2,3,3a,8,8a-hexahydro-1,3a,8-trimethyIpyrroIo[2,3-
b]indol-5-yl methylcarbamate ester (1:1).
2H-1-Benzopyran-2-one, 4-hydroxy-3-(3-oxo-1-phenylbutyI}-, & sails, when present at concentrations
greater than 0.3%
Benzyl chloride
Beryllium powder
Brornoacetone
Brucine
2-Butanone, 3,3-dimethyM -(methylthio)-,
O-fmethy!amino)carbonyl] oxime
Calcium cyanide
Calcium cyanide Ca(CN)2
Carbamic acid, [(dibutylamino)- thio]methyl-, 2,3-dihydro-2,2-dimethyl- 7-benzofuranyl ester.
Carbamic acid, dimethyl-, 1-[(dimethyl-amino)carbonyl]- 5-mefhyl-1H- pyra2ol-3-yl ester.
Carbamic acid, dimethyl-, 3-methyl-1- (1-methylethyl)-1H- pyrazol-5-yl ester.
Carbamic acid, methyl-, 3-methylphenyl ester.
Carbofuran.
Carbon disulfide
Carbonic dichioride
Carbosulfan.
Chloroacetaldehyde
p-Chloroaniline
1 -(o-Chlorophenyl)thiourea
3-Chloropropionitrife
Copper cyanide
Copper cyanide Cu(CN)
m-Cumenyl methylcarbamate.
Cyanides (soluble cyanide salts), not otherwise specified
Cyanogen
68
-------
Environmental Protection Agency
§261.33
Haz-
ardous
waste
No.
Chemical ab-
stracts No.
Substance
P033
P033
P034
P016
P036
P037
P038
P041
P040
P043
P004
P051
P044
P046
P191
P047
P048
P020
P085
P111
P039
P049
P185
P050
P088
P051
P051
P042
P031
P194
P066
P101
P054
P097
P056
P057
P058
P198
P197
P065
P059
P062
P116
P068
P063
P063
P096
P060
P192
P202
P007
P196
P196
P092
P065
P082
P064
P016
P112
P118
P198
P197
P050
506-77-4
506-77-4
131-89-5
542-88-1
696-28-6
60-57-1
692-42-2
311-45-5
297-97-2
55-91^1
309-00-2
172-20-8
60-51-5
122-09-8
644-64-4
1534-52-1
51-28-5
88-85-7
152-16-9
107-49-3
298-04-4
541-53-7
26419-73-8
115-29-7
145-73-3
72-20-8
72-20-8
51-43-4
460-19-5
23135-22-0
16752-77-5
107-12-0
151-56-4
52-85-7
7782^11-4
640-19-7
62-74-8
23422-53-9
17702-57-7
628-86-4
76-44-8
757-58-4
79-19-6
60-34-4
74-90-8
74-90-8
7803-51-2
465-73-6
119-38-0
64-00-6
2763-96-4
15339-36-3
15339-36-3
62-38-4
628-86-4
62-75-9
624-83-9
542-88-1
509-14-8
75-70-7
23422-53-9
17702-57-7
115-29-7
Cyanogen chloride
Cyanogen chloride (CN)C!
2-Cyclohexyl-4,6-dinitrophenol
Dichloromethyl ether
Dichiorophenylarsine
Dieldrin
Diethylarsine
Diethy]-p-nitropheny! phosphate
O,O-DiethyI O-pyrazinyl phosphorothioate
Diisopropylfluorophosphate (DFP)
1,4,5,8-Dimethanonaphthalene, 1,2,3,4,10,10-hexa- ch!oro-1,4,4a,5,8,8a,-hexahydro-,
(1alpha,4alpha,4abeta.5alpha,8alpha,8abeta)-
1,4,5,8-Dimethanonaphthalene, 1,2,3,4,10,10-hexa- chloro-1,4,4a,5,8,8a-hexahydro-,
(1alpha,4alpha,4abeta,5beta,8beta,8abeta)-
2,7:3,6-Dimethanonaphth[2,3-b]oxirene, 3,4,5,6,9,9-hexachloro-1a,2,2a,3,6,6a,7,7a-octahydro-,
(1aalpha,2beta,2aalpha,3beta,6beta,6aalpha,7beta, 7aalpha)-
2,7:3,6-Dimethanonaphth [2,3-b]oxirene, 3,4,5,6,9,9-hexachloro-1 a,2,2a,3,6,6a,7,7a-octahydro-,
(1aalpha,2beta,2abeta,3alpha,6alpha,6abeta,7beta, 7aalpha)-, & metabolites
Dimethoate
alpha.alpha-Dimethylphenethylamine
Dimetiian.
4,6-Dinitro-o-cresol, & salts
2,4-Dinitrophenol
Dinoseb
Diphosphoramide, octamethyl-
Diphosphoric acid, tetraethyt ester
Disulfoton
Dithiobiuret
1,3-DithioIane-2-carboxaIdehyde, 2,4-dimethy!-, O- [(methylamino)- carbonyl]oxime.
Endosulfan
Endothall
Endrin
Endrin, & metabolites
Epinephrine
Ethanedinitrile
Ethanimidothioc acid, 2-(dimethylamino)-N-[[(methylamino) carbonyl]oxy]-2-oxo-, methyl ester.
Ethanimidothioic acid,
N-[[(methylamino)carbonyt]oxy]-, methyi ester
Ethyl cyanide
Ethyleneimine
Famphur
Fluorine
Fluoroacetamide
Fluoroacetic acid, sodium salt
Formetanate hydrochforide.
Formparanate.
Fulminic acid, mercury(2+) salt (R,T)
Heptachlor
Hexaethy! tetraphosphate
Hydrazinecarbothioamide
Hydrazine, methyl-
Hydrocyanic acid
Hydrogen cyanide
Hydrogen phosphide
Isodrin
Isolan.
3-IsopropylphenyI N-methylcarbamate.
3(2H)-lsoxazolone, 5-(aminomethyl)-
Manganese, bis(dimethylcarbamodithioato-S,S')-,
Manganese dimethyldithiocarbamate.
Mercury, (acetato-O)pheny!-
Mercury fulminate (R,T)
Methanamine, N-methyl-N-nitroso-
Methane, isocyanato-
Methane, oxybisfchloro-
Methane, tetranitro- (R)
Methanethiol, trichloro-
Methanimidamide, N.N-dimethyf-N'-[3-[f(methyfamino)-carbony!]oxy]phenyl]-, monohydrochloride.
Methanimidamide, N,N-dimethyl-N'-[2-methyl-4-[[(methy!amino)carbonyI]oxy]phenyf]-
6,9-Methano-2,4,3-benzodioxathieptn, 6,7,8,9,10,10-
hexachloro-1,5,5a,6,9,9a-hexahydro-, 3-oxide
69
-------
§261.33
40 CFR Ch. I (7-1-03 Edition)
Haz-
ardous
waste
No.
P059
P199
P066
P068
P064
P069
P071
P190
P128
P072
P073
P073
P074
P074
P075
P076
P077
P078
P076
P078
P081
P082
P084
P085
P087
P087
P088
P194
P089
P034
P048
P047
P020
P009
P128
P199
P202
P201
P092
P093
P094
P095
P096
P041
P039
P094
P044
P043
P089
P040
P097
P071
P204
P188
P110
P098
P098
P099
P201
P070
P203
P101
P027
P069
P081
P017
P102
Chemical ab-
stracts No.
76-44-8
2032-65-7
16752-77-5
60-34-4
624-83-9
75-86-5
298-00-O
1129-41-5
315-8-4
86-88-4
13463-39-3
13463-39-3
557-19-7
557-19-7
'54-11-5
10102-43-9
100-01-6
10102-44-0
10102-13-9
10102-14-0
55-63-0
62-75-9
4549-40-0
152-16-9
20816-12-0
20816-12-0
145-73-3
23135-22-0
56-38-2
131-89-5
51-28-5
1 534-52-1
88-85-7
131-74-8
315-18-4
2032-65-7
64-00-6
2631-37-0
62-38-4
103-85-5
298-02-2
75-44-5
7803-51-2
311-15-5
298-04-4
298-02-2
60-51-5
55-91-4
56-38-2
297-97-2
52-85-7
298-00-0
57-47-6
57-64-7
78-00-2
151-50-8
151-50-8
506-61-6
2631-37-O
116-06-3
1646-88-4
107-12-0
542-76-7
75-86-5
55-63-O
598-31-2
107-19-7
Substance
4,7-Methano-1H-indene, 1,4,5,6,7,8,8-heptachloro-
3a,4,7,7a-tetrahydro-
Methiocarb.
Methomyl
Methyl hydrazine
Methyl isocyanate
2-MethylIactonitrile
Methyl parathion
Metolcarb.
Mexacarbate.
alpha-Naphthylthiourea
Nickel carbonyl
Nickel carbonyl Ni(CO)4, (T-4)-
Nickel cyanide
Nickel cynaide Ni(CN),
Nicotine, & salts
Nitric oxide
p-Nitroaniline
Nitrogen dioxide
Nitrogen oxide NO
Nitrogen oxide NOz
Nitroglycerine (R)
N-Nitrosodimethylamine
N-Nitrosomethylvinylamine
Octamethylpyrophosphoramide
Osmium oxide OsO4, (T-4)-
Osmium tetroxide
7-Oxabicyclo[2.2.1]heptane-2,3-dicarboxylicacid
Oxamyl.
Parathion
Phenol, 2-cyclohexyl-4,6-dinitro-
Phenol, 2,4-dinitro-
Phenol, 2-methyl-4,6-dinitro-, S salts
Phenol, 2-(1-methy]propyI)-4,6-dinitro-
Phenol, 2,4,6-trinitro-, ammonium salt (R)
Phenol, 4-(dimethyiamino)-3,5-dimethyl-, methylcarbarnate (ester).
Phenol, (3,5-dimethyl-4-(methylthio)-, methylcarbarnate
Phenol, 3-(1-methylethyI)-, methyl carbamate.
Phenol, 3-methyl-5-(1-methylethyl)-, methyl carbamate.
Phenylmercury acetate
Phenylthiourea
Phorate
Phosgene
Phosphine
Phosphoric acid, diethyl 4-nitrophenyI ester
Phosphorodithioic acid, O,O-diethyl
S-[2-(ethylthio)ethyl] ester
Phosphorodithioic acid, O,O-diethyl
S-[(ethylthio)methyl] ester
Phosphorodithioic acid, O,O-dimethyl S-[2-(methylamino)-2-oxoethyl] ester
Phosphorofluoridic acid, bis(l-methylethyl) ester
Phosphorothioic acid, O,O-diethyl O-(4-nitrophenyl) ester
Phosphorothioic acid, O,O-diethyl O-pyrazinyl ester
Phosphorothioic acid.
O-[4-[(dimethyIamino)suIfonyl]phenyl] O,O-dimethyl ester
Phosphorothioic acid, O,O,-dimethyl O-(4-nitrophenyl) ester
Physostigmine.
Physostigmine salicylate.
Plumbane, tetraethyl-
Potassium cyanide
Potassium cyanide K(CN)
Potassium silver cyanide
Promecarb
Propanal, 2-methyl-2-(methylthio}-,
O-[(methylamino)carbony!3oxime
Propanal, 2-methyl-2-(methyl-sulfonyl}-, O-[(methylamino)carbonyl] oxime.
Propanenitrile
Propanenitrile, 3-chloro-
Propanenitrile, 2-hydroxy-2-methyl-
1 ,2,3-Propanetriol, trinitrate (R)
2-Propanone, 1-bromo-
Propargyi alcohol
70
-------
Environmental Protection Agency
§261,33
Haz-
ardous
waste
No.
POOS
POOS
P067
P102
POOS
P075
P204
P114
P103
P104
P104
P105
P106
P106
P108
P018
P108
P115
P109
P110
P111
P112
P062
P113
P113
P114
P115
P109
P045
P049
P014
P116
P026
P072
P093
P185
P123
P118
P119
P120
P120
P084
P001
P205
P121
P121
P122
P205
Chemical ab-
stracts No.
107-O2-8
107-18-6
75-55-8
107-19-7
504-24-5
i 54-1 1-5
57-47-6
12039-52-0
630-10-4
506-64-9
50S-64-9
26628-22-8
143-33-9
143-33-9
'57-24-9
357-57-3
1 57-24-9
7446-18-6
3689-24-5
78-00-2
107-49-3
509-14-8
757-58-4
1314-32-5
1314-32-5
12039-52-0
7446-18-6
3689-24-5
39196-18-4
541-53-7
108-98-5
79-19-6
5344-82-1
86-88-4
103-85-5
26419-73-8
8001-35-2
75-70-7
7803-55-6
1314-62-1
1314-62-1
4549-40-0
'81-81-2
137-30-4
557-21-1
557-21-1
1314-84-7
137-30-4
Substance
2-PropenaJ
2-Propen-1-ol
1 ,2-Propylenimine
2-Propyn-1 -ol
4-Pyridinamine
Pyridine, 3-(1-rne!hyl-2-pyrrolidinyl)-, (S)-, & salts
Pyrrolo[2,3-b]indol-5-ol, 1 ,2,3,3a,8,8a-hexahydro-1 ,3a,8-trimethyl-.
methylcarbamate (ester), (3aS-cis)-.
Selenious acid, dithallium(1+) salt
Selenourea
Silver cyanide
Silver cyanide Ag(CN)
Sodium azide
Sodium cyanide
Sodium cyanide Na(CN)
Strychnidin-10-one, & salts
Strychnidin-10-one, 2,3-dimethoxy-
Strychnine, & salts
Sulfuric acid, ditha!lium(1+) salt
Tetraethyldithiopyropnosphate
Tetraethyl lead
Tetraethyl pyrophosphate
Tetranitromethane (R)
Tetraphosphoric acid, hexaethyl ester
Thallic oxide
Thallium oxide TI2 O,
ThalliurnO) selenite
Thalliurn(l) sultate
Thiodiphosphoric acid, tetraethyl ester
Thiofanox
Thioimidodicarbonic diamide [(H2 N)C(S)]2 NH
Thiophenol
Thiosemicarbazide
Thiourea, (2-chloropheny!)-
Thiourea, 1 -naphthalenyl-
Thiourea, phenyl-
Tirpate.
Toxaphene
Trichloromethanethiol
Vanadic acid, ammonium salt
Vanadium oxide V2 Os
Vanadium penloxide
Vinylamine, N-methyl-N-nitroso-
Warfarin, & salts, when present at concentrations greater than 0.3%
Zinc, bis(dimethylcarbamodithioato-S,S')-,
Zinc cyanide
Zinc cyanide Zn(CN)2
Zinc phosphide Znj P2, when present at concentrations greater than 10% (R,T)
Ziram.
1 CAS Number given for parent compound only.
(f) The commercial chemical prod-
ucts, manfacturing chemical inter-
mediates, or off-specification commer-
cial chemical products referred to in
paragraphs (a) through (d) of this sec-
tion, are identified as toxic wastes (T),
unless otherwise designated and are
subject to the small quantity generator
exclusion defined in §261.5 (a) and (g).
{Comment: For the convenience of the regu-
lated community, the primary hazardous
properties of these materials have been indi-
cated by the letters T (Toxicity), R (Reac-
tivity), I (Ignitability) and C (Corrosivity).
Absence of a letter indicates that the com-
pound is only listed for toxicity.J
These wastes and their corresponding
EPA Hazardous Waste Numbers are:
71
-------
§261,33
40 CFR Ch. I (7-1-03 Edition)
Haz-
ardous
waste
No.
U394
U001
U034
U187
U005
U240
U112
U144
U214
see
F027
U002
U003
U004
U005
U006
U007
U008
U009
U011
U012
U136
U014
U015
U010
Chemical ab-
stracts No.
30558-43-1
75-07-0
75-87-6
62-44-2
53-96-3
1 94-75-7
141-78-6
301-04-2
563-68-8
93-76-5
67-64-1
75-05-8
98-86-2
53-96-3
75-36-5
79-06-1
79-10-7
107-13-1
61-82-5
62-53-3
75-60-5
492-80-8
115-02-6
50-07-7
Substance
A2213.
Acetaldehyde (I)
Acetaldehyde, trichloro-
Acetamide, N-(4-ethoxypheny!)-
Acetamide, N-9H-fluoren-2-yl-
Acetic acid, (2,4-dichlorophenoxy)-, salts & esters
Acetic acid ethyl ester (!)
Acetic acid, lead(2+) salt
Acetic acid, thallium(U) salt
Acetic acid, (2,4,5-trichlorophenoxy)-
Acetone (I)
Acetonitrile (I,T)
Acetophenone
2-Acetylaminoftuorene
Acetyl chloride (C,R,T)
Acryiamide
Acrylic acid (I)
Acrylonitriie
Amitrole
Aniline (I,T)
Arsinic acid, dimethyl-
Auramine
Azaserine
Azirino[2',3':3,4]pyrrolo[1,2-a]indole-4,7-dione, 6-amino-8-J[(aminocarbonyi)oxyJmethyl]-1,1a,2,8,8a,8b-
hexahydro-8a-methoxy-5-methyI-, [1aS-(1aalpha, 8beta,8aalpha,8balpha)J-
U280 101-27-9 Barban.
U278 22781-23-3 Bendiocaib.
U364 22961-82-6 Bendiocarb phenol.
U271 17804-35-2 Benomyl.
U157 56-49-5 Benz[j]aceanthrylene, 1,2-dihydro-3-methyt-
U016 225-51-4 Benz[c]acridine
U017 98-87-3 Benzal chloride
U192 23950-58-5 Benzamide, 3,5-dichloro-N-(1,1-dimethyI-2-propynyl)-
U018 56-55-3 Benzfajanthracene
U094 57-97-6 Benz[a]anthracene, 7,12-dimethyl-
U012 62-53-3 Benzenamine (l,T)
U014 492-80-8 Benzenamine, 4,4'-carbonimidoyibisrN,N-dimethyl-
U049 3165-93-3 Benzenamine, 4-chloro-2-methyl-, hydrochloride
U093 60-11-7 Benzenamine, N,N-dimethy!-4-(phenyiazo)-
U328 95-53-4 Benzenamine, 2-methyl-
U353 106-49-0 Benzenamine, 4-methyl-
U158 101-14—4 Benzenamine, 4,4'-methylenebis[2-ch!oro-
U222 636-21-5 Benzenamine, 2-methyK hydrochloride
U181 99-55-8 Benzenamine, 2-methyl-5-nitro-
U019 71-43-2 Benzene (I,T)
U038 510-15-6 Benzeneacetic acid, 4-chloro-a!pha-(4-chlorophenyl)-alpha-hydroxy-, ethyl ester
U030 101-55-3 Benzene, 1 -bromo-4-phenoxy-
U035 305-03-3 Benzenebutanoic acid, 4-[bis(2-chloroethyl)amino]-
U037 108-90-7 Benzene, chloro-
U221 25376-45-8 Benzenediamine, ar-methyl-
U028 117-81-7 1,2-Benzenedicarboxy!ic acid, bis(2-ethylhexyl) ester
U069 84-74-2 1,2-BenzenedicarboxyIic acid, dibutyl ester
U088 84-66-2 1,2-Benzenedicarboxyiic acid, diethyi ester
U102 131-11-3 1,2-Benzenedicarboxylic acid, dimethyl ester
U107 117-84-0 1,2-Benzenedicarboxylic acid, diocty! ester
U070 95-50-1 Benzene, 1,2-dichIoro-
U071 541-73-1 Benzene, 1,3-dichloro-
U072 106-46-7 Benzene, 1,4-dichloro-
U060 72-54-8 Benzene, 1,1'-(2,2-dichloroethylidene)bis[4-chIoro-
U017 98-87-3 Benzene, (dichloromethyl)-
U223 26471-62-5 Benzene, 1,3-diisocyanatomethyl- (R,T)
U239 1330-20-7 Benzene, dimethyl- (I,T)
U201 108-46-3 1,3-Benzenediol
U127 118-74-1 Benzene, hexachloro-
U056 110-82-7 Benzene, hexahydro-(I)
U220 108-88-3 Benzene, methyl-
U105 121-14-2 Benzene, 1-methyl-2,4-dinitro-
U106 606-20-2 Benzene, 2-methyl-1,3-dinitro-
U055 98-82-8 Benzene, (1-methylethyl)- (I)
U169 98-95-3 Benzene, nitro-
U183 608-93-5 Benzene, pentachloro-
72
-------
Environmental Protection Agency
§261.33
Haz-
ardous
waste
No.
U185
U020
U020
U207
U061
U247
U023
U234
U021
U202
U278
U364
U203
U141
U367
U090
U064
U248
U022
U197
U023
U085
U021
U073
U091
U095
U225
U030
U128
U172
U031
U159
U160
U053
U074
U143
U031
U136
U032
U372
U271
U280
U238
U178
U373
U409
U097
U389
U387
U114
U062
U279
U372
U367
U215
U033
U156
U033
U211
U034
U035
U036
U026
U037
U038
U039
U042
Chemical ab-
stracts No.
82-68-8
98-O9-9
98-09-9
95-94-3
50-29-3
72-43-5
98-07-7
99-35-4
92-87-5
1 81-07-2
22781-23-3
22961-82-6
94-59-7
120-58-1
1563-38-8
94-58-6
189-55-9
'81-81-2
50-32-8
106-51^t
98-07-7
1464-53-5
92-87-5
91-94-1
119-90-»
119-93-7
75-25-2
101-55-3
87-68-3
924-16-3
71-36-3
78-93-3
1338-23-4
4170-30-3
764-41-0
303-34-4
71-36-3
75-60-5
13765-19-0
10605-21-7
17804-35-2
101-27-9
51-79-6
615-53-2
122-42-9
23564-05-8
79-44-7
2303-17-5
52888-80-9
'111-54-6
2303-16-4
63-25-2
10605-21-7
1563-38-8
6533-73-9
353-50-4
79-22-1
353-50-4
56-23-5
75-87-6
305-03-3
57-74-9
494-03-1
108-90-7
510-15-6
59-50-7
110-75-8
Substance
Benzene, pentachforonitro-
Benzenesulfonic acid chloride (C,R)
Benzenesulfonyl chloride (C,R)
Benzene, 1,2,4,5-tetrachloro-
Benzene, 1,1 '-{2,2,2-trichloroethyIidene)bis[4-ch!oro-
Benzene, 1,r-{2,2,2-trich[oroethy[idene)bis[4- methoxy-
Benzene, (trichloromethyl)-
Benzene, 1,3,5-trinitro
Benzidine
1,2-Benzisothiazol-3(2B)-one, 1,1-dioxide, & salts
l,3-Benzodioxol-4-ol, 2,2-dimethyl-, methyl carbamate.
1,3-Benzodioxol-4-ol, 2,2-dimelhyl-,
1,3-Benzodioxo!e, 5-(2-propeny!)-
1,3-Benzodioxoie, 5-(1-propenyl)-
7-Benzofuranol, 2,3-dihydro-2,2-dimethyl-
1,3-Benzodioxoie, 5-propyI-
Benzo[rst]pentaphene
2H-1-Benzopyran-2-one, 4-hydroxy-3-(3-oxo-1-phenyl-butyl)-, & salts, when present at concentrations
of 0.3% or less
Benzo[a]pyrene
p-Benzoquinone
Benzotrichloride (C.R.T)
2,2'-Bioxirane
[1,1'-Biphenyl]-4,4'-diamine
[1,r-BiphenyI]-4,4'-diamine, 3,3'-dichIoro-
[l ,1'-Biphenyl]-4,4'-diamine, 3,3'-dimethoxy-
j1,1'-Biphenyl]-4,4'-diamine, 3,3'-dimethyl-
Bromoform
4-Bromophenyl phenyl ether
1,3-Butadiene, 1,1,2,3,4,4-hexachloro-
1-Butanamine, N-butyl-N-nilroso-
1-Butanol (I)
2-Butanone (I,T)
2-Butanone, peroxide (R,T)
2-Butenal
2-Butene, 1,4-dichloro- (l,T)
2-Butenoic acid, 2-methyl-, 7-[[2,3-dihydroxy-
2-{1-methoxyethyl)-3-methyl-1-oxobutoxyjmethyl]-
2,3,5,7a-tetrahydro-1 H-pyrrotizin-1-yI ester,
[1 S-{1 alpha(Z),7(2S*,3R-)I7aalpha]]-
n-Butyl alcohol (I)
Cacodylic acid
Calcium chromate
Carbamic acid, 1 H-benzimidazot-2-y!, methyl ester.
Carbamic acid, [1-f(butylamino)carbonyl]-1H-benzimidazol-2-yl]-, methyl ester.
Carbamic acid, (3-chforophenyl)-, 4-chloro-2-butynyl ester.
Carbamic acid, ethyl ester
Carbamic acid, methylnitroso-, ethyf ester
Carbamic acid, phenyl-, 1 -methyfethyl ester.
Carbamic acid, [1,2-phenylenebis (iminocarbonothioy!)]bis-, dimethyl ester.
Carbamic chloride, dimethyl-
Carbamothiotc acid, bis{1-methylethyl)-, S-(2,3,3-trichloro-2-propenyl) ester.
Carbamothioic acid, dipropyl-, S-(phenylmethyl) ester.
Carbamodithioic acid, 1,2-ethanediylbis-t
salts & esters
Carbamothioic acid, bis(l-methylethyl)-, S-(2,3-dtch!oro-2-propenyI) ester
Carbaryl.
Carbendazim.
Carbofuran phenol-
Carbonic acid, ditha!lium(1-»-) salt
Carbonic difluoride
Carbonochloridic acid, methyl ester (I,T)
Carbon oxyfluoride (R,T)
Carbon tetrachloride
Chloral
Chlorambucil
Chlordane, alpha & gamma isomers
Chlornaphazin
Chlorobenzene
Chlorobenzilate
p-Chloro-m-cresol
2-Chloroethyl viny! ether
73
-------
§261.33
40 CFR Ch. I (7-1-03 Edition)
Haz-
ardous
waste
No.
U044
U046
U047
U048
U049
U032
U050
U051
U052
U053
U055
U246
U197
U056
U129
UOS7
U130
U058
U240
U059
U060
U061
U062
U063
U064
U066
U069
U070
U071
U072
U073
U074
U075
U078
U079
U025
U027
U024
U081
U082
U084
U08S
U108
U028
U395
U086
U087
U088
U089
U090
U091
U092
U093
U094
1)095
U096
U097
U098
U099
U101
U102
U103
U105
U108
U107
U108
U109
U110
U111
U041
U001
Chemical ab-
stracts No.
67-66-3
107-30-2
91-58-7
95-57-8
3165-93-3
1 3765-1 9-O
218-01-9
1319-77-3
4170-30-3
98-62-8
506-68-3
106-51-4
110-82-7
58-89-9
108-94-1
77-47-4
50-1 8-O
' 94-75-7
20830-81-3
72-54-6
50-29-3
2303-16-4
53-70-3
189-55-9
96-12-8
84-74-2
95-50-1
541-73-1
106-46-7
91-94-1
764-41-0
75-71-8
75-35-4
156-60-5
' -111^4-4
108-60-1
111-91-1
120-63-2
87-65-0
542-75-6
1464-53-5
123-91-1
117-81-7
5952-26-1
1615-80-1
3288-58-2
84-66-2
56-53-1
94-58-6
119-90-4
124-40-3
60-11-7
57-97-6
119-93-7
80-15-9
79-44-7
57-14-7
540-73-8
105-67-9
131-11-3
77-78-1
121-14-2
606-20-2
117-84-O
123-91-1
122-66-7
142-84-7
621-64-7
106-69-8
75-O7-0
Substance
Chloroform
Chloromethyl methyl ether
beta-Chloronaphthalene
o-Chlorophenol
4-ChIoro-o-toIutdine, hydrochloride
Chromic acid H3 CrO4, calcium salt
Chrysene
Creosote
Cresol (Cresylic acid)
Crotonaldehyde
Cumene (I)
Cyanogen bromide (CN)Br
2,5-Cyclohexadiene-1 ,4-dione
Cyclohexane (I)
Cyclohexane, 1 ,2,3,4,5,6-hexachloro-.
(1alpha,2atpha,3beta,4alpha,5alpha,6beta)-
Cyclohexanone (1)
1 ,3-Cyc!opentadiene, 1 ,2,3,4, 5,5-hexachloro-
Cyclophosphamide
2,4-D, salts & esters
Daunomycin
ODD
DDT
Diallate
Dibenz[a,hjanthracene
Dibenzora,i]pyrene
1 ,2-Dibromo-3-chioropropane
Dibutyl phthalate
o-Dichlorobenzene
m-Dichlorobenzene
p-Dichlorobenzene
3,3'-Dichlorobenzidine
1,4-Dichloro-2-butene (I,T)
Dichlorodifluoromethane
1,1-Dichloroethylene
1 ,2-Dichloroethylene
Dichloroethyl ether
Dichloroisopropyl ether
Dichloromethoxy ethane
2,4-Dichlorophenol
2,6-Dichlorophenol
1 ,3-Dichloropropene
1,2:3,4-Diepoxybutane (I,T)
1,4-Diethyleneoxide
Diethylhexyl phthalate
Diethylene glycol, dicarbamate.
N,N'-Diethylhydrazine
O.O-Diethyl S-methyl dithiophosphate
Diethyl phthalate
Diethylstilbesterol
Dihydrosafrole
3,3'-Dimethoxybenzidine
Dimethylamine (I)
p-Dimethylaminoazobenzene
7,12-Dimethylbenz[a]anthracene
3,3'-DimethyIbenzidine
alpha.alpha-Dimethylbenzylhydroperoxide (R)
Dimethylcarbamoyl chloride
1 , 1 -Dimethylhydrazine
1 ,2-Dimethylhydrazine
2,4-Dimethylphenol
Dimethyl phthalate
Dimethyl sulfate
2,4-Dinitrotoluene
2,6-Dinitrotoluene
Di-n-octyl phthalate
1 ,4-Dioxane
1 ,2-Diphenylhydrazine
Dipropylamine (1)
Di-n-propylnitrosamine
Epichlorohydrin
Ethanal (1)
74
-------
Environmental Protection Agency
§261.33
Haz-
ardous
waste
No.
U404
U174
U155
U067
U076
U077
U131
U024
U117
U025
U184
U208
U209
U218
U226
U227
U410
U394
U359
U173
U395
U004
U043
U042
U078
U079
U210
U228
U112
U113
U238
U117
U114
U067
U077
U359
U115
U116
U076
U118
U119
U120
U122
U123
U124
U125
U147
U213
U125
U124
U206
U206
U126
U163
U127
U128
U130
U131
U132
U243
U133
U086
U098
U099
U109
U134
U134
U135
U135
U096
U116
Chemical ab-
stracts No.
121^14-8
55-18-5
91-80-5
106-93-4
75-34-3
107-06-2
67-72-1
111-91-1
60-29-7
111-44-4
76-01-7
630-20-6
79-34-5
62-55-5
71-55-6
79-00-5
59669-26-0
30558-43-1
110-80-5
1116-54-7
5952-26-1
98-86-2
75-01^t
110-75-8
75-35-4
156-60-5
127-18-4
79-01-6
141-78-6
140-88-5
51-79-6
60-29-7
'111-54-6
106-93-4
107-06-2
110-80-5
75-21-8
96-45-7
75-34-3
97-63-2
62-50-0
206-44-0
50-00-O
64-18-6
110-00-9
98-01-1
108-31-6
109-99-9
98-01-1
110-00-9
18883-66-4
18883-66-4
765-34-4
70-25-7
118-74-1
87-68-3
77-47-4
67-72-1
70-30-4
1888-71-7
302-01-2
1615-80-1
57-14-7
540-73-8
122-66-7
7664-39-3
7664-39-3
7783-06-4
7783-06-4
80-15-9
96-45-7
Substance
Ethanamine, N,N-diethyl-
Ethanamine, N-ethyl-N-nitroso-
1 ,2-Ethanediamine, N,N-dimethyl-N'-2-pyridinyl-N'-(2-thienylmethyI)-
Ethane, 1,2-dibromo-
Ethane, 1,1-dichloro-
Ethane, 1 ,2-dichloro-
Ethane, hexachloro-
Ethane, 1,1'-[methylenebis{oxy}]bis[2-chloro-
Ethane, 1,1'-oxybis-(l)
Ethane, 1,1'-oxybis[2-chloro-
Ethane, pentachloro-
Ethane, 1,1,1,2-tetrachloro-
Ethane, 1,1,2,2-tetrachloro-
Ethanethioamide
Ethane, 1,1,1-trichloro-
Ethane, 1,1,2-trichtoro-
Ethanimidothioic acid, N,N'- [thiobis[(methylimino)carbonyloxy]]bis-, dimethyl ester
Ethanimidothioic acid, 2-(dimethylamino)-N-hydroxy-2-oxo-, methyl ester.
Ethanol, 2-ethoxy-
Ethanoi, 2,2'-(nitrosoimino)bts-
Ethanoi, 2,2'-oxybis-, dicarbamate.
Ethanone, 1-phenyl-
Ethene, chloro-
Ethene, (2-chloroethoxy)-
Ethene, 1,1-dichloro-
Ethene, 1,2-dichloro-, (E)-
Ethene, tetrachloro-
Ethene, trichloro-
Ethyl acetate (I)
Ethyl acrylate (I)
Ethyl carbamate (urethane)
Ethyl ether (I)
Ethylenebisdithiocarbamic acid, salts & esters
Ethylene dibromide
Ethylene dichloride
Ethylene glycot monoethyl ether
Ethylene oxide (I,T)
Ethylenethiourea
Ethylidene dichloride
Ethyl methacrylate
Ethyl methanesulfonate
Fluoranthene
Formaldehyde
Formic acid (C,T)
Furan (I)
2-Furancarboxaldehyde (I)
2,5-Furandione
Furan, tetrahydro-(l)
Furfural (I)
Furfuran (I)
Glucopyranose, 2-deoxy-2-(3-methyl-3-nitrosoureido)-, D-
D-Glucose, 2-deoxy-2-[[(methylnitrosoamino)-
carbonyljamino]-
Glycidylaldehyde
Guanidine, N-methyl-N'-nitrc-N-nitroso-
Hexachlorobenzene
Hexachlorobutadiene
Hexachlorocyclopentadiene
Hexachloroethane
Hexachlorophene
Hexachloropropene
Hydrazine (R,T)
Hydrazine, 1 ,2-diethyl-
Hydrazine, 1,1-dimethyl-
Hydrazine, 1 ,2-dimethyl-
Hydrazine, 1 ,2-diphenyl-
Hydrofluoric acid (C,T)
Hydrogen fluoride (C.T)
Hydrogen sulfide
Hydrogen sulfide H2 S
Hydroperoxide, 1-methy!-1-phenylethyl- (R)
2-lmidazolidinethione
75
-------
§261.33
40 CFR Ch. I (7-1-03 Edition)
Haz-
ardous
waste
No.
Chemical ab-
stracts No.
Substance
U137
U190
U140
U141
U142
U143
U144
U146
U145
U146
U129
U163
U147
U148
U149
U150
U151
U152
U092
U029
U045
U046
U068
U080
U075
U138
U119
U211
U153
U225
U044
U121
U036
U154
U155
U142
U247
U154
U029
U186
U045
U156
U226
U157
U158
U068
U080
U159
U160
U138
U161
U162
U161
U164
U010
U059
U167
U168
U026
U165
U047
U166
U236
U279
U166
U167
U168
U217
U169
U170
193-39-5
85-44-9
78-83-1
120-58-1
143-50-0
303-34-4
301-04-2
1335-32-6
7446-27-7
1335-32-6
58-89-9
70-25-7
108-31-6
123-33-1
109-77-3
148-82-3
7439-97-6
126-98-7
124-40-3
74-63-9
74-87-3
107-30-2
74-95-3
75-09-2
75-71-8
74-88-4
62-50-0
56-23-5
74-93-1
75-25-2
67-66-3
75-69-4
57-74-9
67-56-1
91-80-5
143-50-0
72-43-5
67-56-1
74-83-9
504-60-9
74-87-3
79-22-1
71-55-6
56-49-5
101-14-4
74-95-3
75-09-2
78-93-3
1338-23-4
74-88-4
108-10-1
80-62-6
108-10-1
56-04-2
50-07-7
20830-81-3
134-32-7
91-59-8
494-03-1
91-20-3
91-58-7
13O-15-4
72-57-1
63-25-2
130-15-4
134-32-7
91-59-8
10102-45-1
98-95-3
100-02-7
lndeno[1,2,3-cd]pyrene
1,3-lsobenzofurandione
Isobutyl alcohol (I,T)
Isosafrole
Kepone
Lasiocarpine
Lead acetate
Lead, bis(acetato-O)tetrahydroxytri-
Lead phosphate
Lead subacetate
Lindane
MNNG
Maleic anhydride
Maleic hydrazide
Malononitrile
Melphalan
Mercury
Methacrylonitrile (I, T)
Methanamine, N-methyi- (I)
Methane, bromo-
Methane, chloro- (I, T)
Methane, chloromethoxy-
Methane, dibromo-
Methane, dichloro-
Methane, dichlorodifluoro-
Methane, iodo-
Methanesulfonic acid, ethyl ester
Methane, tetracnloro-
Methanethiol (I, T)
Methane, tribromo-
Methane, trichloro-
Methane, trichlorofluoro-
4,7-Methano-1 H-indene, 1,2,4,5,6,7,8,8-octachloro-2,3,3a,4,7,7a-hexahydro-
Methanol (I)
Methapyrilene
1,3,4-Metheno-2H-cyclobuta[cd]pentalen-2-one, 1,1 a,3,3a,4,5,5,5a,5b,6-decachlorooctahydro-
Methoxychlor
Methyl alcohol (I)
Methyl bromide
1-Methylbutadiene (I)
Methyl chloride (I,T)
Methyl chlorocaroonate (I,T)
Methyl chloroform
3-Methy!choIanthrene
4,4'-Methylenebis(2-chloroaniIine)
Methylene bromide
Methylene chloride
Methyl ethyl ketone (MEK) (I.T)
Methyl ethyl ketone peroxide (R,T)
Methyl iodide
Methyl isobutyl ketone (I)
Methyl methacrylate (I,T)
4-Methyl-2-pentanone (I)
Methylthiouracil
Mitomycin C
5,12-Napnthacenedione, 8-acetyl-10-[{3-amino-2,3,6-trideoxy)-alpha-L-Iyxo-hexopyranosyl)oxy]-
7,8,9,10-tetrahydro-6,8,11-trihydroxy-1-methoxy-, (8S-cis)-
1 -Naphthalenamine
2-Naphthalenamine
Naphthalenamine, N,N'-bis(2-chtoroethyl)-
Naphthalene
Naphthalene, 2-chloro-
1,4-Naphthalenedione
2,7-Napnthalenedisulfonic acid, 3,3'-[(3,3'-
dimethyl[1,1 '-biphenyl]-4,4'-diyl)bis(azo)bis[5-amino-4-hydroxy]-T tetrasodium salt
1-NaphthalenoI, methylcarbamate.
1,4-Naphthoquinone
alpha-Naphthylamine
beta-Naphthylamine
Nitric acid, thallium(1+) salt
Nitrobenzene (t,T)
p-Nitrophenol
76
-------
Environmental Protection Agency
§261.33
Haz-
ardous Chemical ab-
waste stracts No.
No..
U171 79-46-9
U172 924-16-3
U173 1116-54-7
U174 55-18-5
U176 759-73-9
U177 684-93-5
U178 615-53-2
U179 100-75-4
U180 930-55-2
U181 99-55-8
U193 1120-71-4
U058 50-18-0
U115 75-21-8
U126 765-34-4
U041 106-89-8
2 123-63-7
U183 608-93-5
U184 76-01-7
U185 82-68-8
See 87-86-5
F027
U161 108-10-1
U186 504-60-9
U187 62-44-2
U188 108-95-2
U048 95-57-8
U039 59-50-7
U081 120-83-2
U082 87-65-0
U089 56-53-1
U101 105-67-9
U052 1319-77-3
U132 70-30-4
U411 114-26-1
U170 100-02-7
See 87-86-5
F027
See 58-90-2
F027
See 95-95-4
F027
See 88-06-2
F027
U150 148-82-3
U145 7446-27-7
U087 3288-58-2
U189 1314-80-3
U190 85-44-9
U191 109-06-8
U179 100-75-4
U192 23950-58-5
U194 107-10-8
U111 621-64-7
U110 142-84-7
U066 96-12-8
U083 78-87-5
U149 109-77-3
U171 79-46-9
U027 108-60-1
U193 1120-71-4
See 93-72-1
F027
U235 126-72-7
U140 78-83-1
U002 67-64-1
U007 79-06-1
U084 542-75-6
U243 1888-71-7
U009 107-13-1
U152 126-98-7
U008 79-10-7
Substance
2-Nitropropane (I,T)
N-Nitrosodi-n-butylamine
N-Nitrosodiethanotamine
N-Nitrosodiethylamine
N-Nitroso-N-ethylurea
N-Nitroso-N-methyiurea
N-Nitroso-N-methylurethane
N-Nitrosopiperidine
N-NitrosopyrroIidine
5-Nitro-o-toluidine
1 ,2-Oxathiolane, 2,2-dioxide
2H-1 ,3,2-Oxazaphosphorin-2-amine,
N,N-bis(2-chloroethyl)tetrahydro-, 2-oxide
Oxirane (I,T)
Oxiranecarboxyaldehyde
Oxirane, (chloromethyl)-
Paraldehyde
Pentachlorobenzene
Pentachloroe thane
Pentachloronitrobenzene (PCNB)
Pentachlorophenol
Pentanol, 4-methyl-
1 ,3-Pentadiene (I)
Phenacetin
Phenol
Phenol, 2-ch!oro-
Phenol, 4-chloro-3-methyl-
Phenol, 2,4-dichloro-
Phenol, 2,6-dichioro-
Phenol, 4,4'-(1 ,2-diethy]-1 ,2-ethenediyl)bis-, (E>-
Pheno!, 2,4-dimethyl-
Pheno!, methyl-
Phenol, 2,2'-methy!enebis[3,4,6-trichloro-
Phenol, 2-(1-methylethoxy)-, methylcarbamate.
Phenol, 4-nitro-
Phenol, pentachloro-
Phenol, 2,3,4,6-tetrachIoro-
Phenol, 2,4,5-lrichioro- .
Phenol, 2,4,6-trichloro-
L-Pheny!alanine, 4-[bis(2-chloroethyl)amino]-
Phosphoric acid, lead(2+) salt (2:3)
Phosphorodithioic acid, O,O-dtethyl S-methyl
Phosphorus sulfide (R)
Phthalic anhydride
2-Picoline
Piperidine, 1-nitroso-
Pronamide
1-Propanamine (I,T)
1 -Propanamine, N-nitroso-N-propy!-
1-Propanamine, N-propyl- (I)
Propane, 1 ,2-dtbromo-3-chioro-
Propane, 1 ,2-dichloro-
Propanedinitrile
Propane, 2-nitro- (1,T)
Propane, 2,2'-oxybis[2-chloro-
1 ,3-Propane sultone
Propanotc acid, 2-(2,4,5-trich!orophenoxy)-
1-Propanot, 2,3-dibromo-, phosphate (3:1)
1-Propanol, 2-methyl- (I,T)
2-Propanone (I)
2-Propenamide
1-Propene, 1 ,3-dichloro-
1-Propene, 1,1,2,3,3,3-hexachloro-
2-Propenenitrile
2-Propenenitrile, 2-methy!- (f,T)
2-Propenoic acid (I)
ester
77
-------
§261.33
40 CFR Ch. I (7-1-03 Edition)
Haz-
ardous
waste
No.
U113
U118
U162
U373
U411
U387
U194
U083
U148
U196
U191
U237
U164
U180
U200
U201
U202
U203
U204
U204
U205
U205
U015
See
F027
U206
U103
U189
See
F027
U207
U208
U209
U210
See
F027
U213
U214
U215
U216
U216
U217
U218
U410
U153
U244
U409
U219
U244
U220
U221
U223
U328
U353
U222
U389
U011
U227
U228
U121
See
F027
See
F027
U404
U234
U182
U235
U236
U237
U176
Chemical ab-
stracts No.
140-88-5
97-63-2
80-62-6
122-42-9
114-26-1
52888-80-9
107-10-8
78-87-5
123-33-1
110-86-1
109-06-8
66-75-1
56-04-2
930-55-2
50-55-5
108-46-3
1 81-07-2
94-59-7
7783-00-8
7783-00-8
7488-56-4
7488-56-4
115-02-6
93-72-1
18883-66-4
77-78-1
1314-80-3
93-76-5
95-94-3
630-20-6
79-34-5
127-18-4
58-90-2
109-99-9
563-68-8
6533-73-9
7791-12-0
7791-12-0
10102-45-1
62-55-5
59669-26-0
74-93-1
137-26-8
23564-05-8
62-56-6
137-26-8
108-88-3
25376-45-8
26471-62-5
95-53-4
106-49-O
636-21-5
2303-17-5
61-82-5
79-OO-5
79-01-6
75-69-4
95-95-4
88-O6-2
121-44-8
99-35-4
123-63-7
126-72-7
72-57-1
66-75-1
759-73-9
Substance
2-Propenoic acid, ethyl ester (I)
2-Propenoic acid, 2-methyl-, ethyl ester
2-Propenoic acid, 2-methyl-, methyl ester (I.T)
Propham.
Propoxur.
Prosulfocarb.
n-Propylamine (I.T)
Propyiene dichloride
3,6-Pyridazinedione, 1 ,2-dihydro-
Pyridine
Pyridine, 2-methyl-
2,4-(1 H,3H)-Pyrimidinedione, 5-[bis(2-
ch!oroethyl)amino]-
4(1 H)-Pyrimidinone, 2,3-dihydro-6-methyl-2-thioxo-
Pyrrolidine, 1-nitroso-
Reserpine
Resorcinol
Saccharin, & sails
Safrole
Selenious acid
Selenium dioxide
Selenium sulfide
Selenium sulfide SeS2 (R,T)
L-Serine, diazoacetate (ester)
Silvex (2,4,5-TP)
Streptozotocin
Sulfuric acid, dimethyl ester
Sulfur phosphide (R)
2,4.5-T
1 ,2,4,5-TetrachIorobenzene
1 ,1 ,1 ,2-Tetrachloroethane
1 ,1 ,2,2-Tetrachloroethane
Tetrachloroethylene
2,3,4,6-TetrachIorophenol
Tetrahydrofuran (I)
Thallium(I) acetate
Thalliurn(l) carbonate
Thallium(l) chloride
Thallium chloride Ticl
Thaliium(l) nitrate
Thioacetamide
Thiodicarb.
Thiomethanol (I.T)
Thioperoxydicarbonic diamide [(H, N)C(S)]2 S,, tetramethyl-
Thiophanate-methyl.
Thiourea
Thiram
Toluene
Toluenediamine
Toluene diisocyanate (R,T)
o-Toiuidine
p-To!uidine
o-Toiuidine hydrochloride
Trfallate.
1 H-1 ,2.4-Triazol-3-amine
1 , 1 ,2-Trichloroethane
Trichloroethylene
Trichloromonofluoromethane
2,4,5-Trichlorophenoi
2,4,6-Trichlorophenol
Triethylamine.
1 ,3,5-Trinitrobenzene (R,T)
1,3,5-Trioxane, 2,4,6-trimethyl-
Tris(2,3-dibromopropyl) phosphate
Trypan blue
Uraci! mustard
Urea, N-ethyl-N-nitroso-
78
-------
Environmental Protection Agency
§261.35
Haz-
ardous
waste
No.
U177
U043
U248
U239
U200
U249
Chemical ab-
stracts No.
684-93-5
75-01-4
'81-81-2
1330-20-7
50-55-5
1314-84-7
Substance
Urea, N-methy!-N-nitroso-
Vinyl chloride
Warfarin, & salts, when present at concentrations of 0.3% or Jess
Xylene (I)
Yohimban-16-carboxy!ic acid, 11,17-dimethoxy-18-[(3,4,5-trimethoxybenzoyl)oxy]-, methyl ester,
(3beta,16beta,17alpha,18beta,20a!pha)-
Zinc phosphide Zn3 P?, when present at concentrations of 10% or less
1 CAS Number given for parent compound only.
[45 FR 78529, 78541, Nov. 25, 1980]
EDITORIAL NOTE: For FEDERAL REGISTER ci-
tations affecting §261.33, see the List of CFR
Sections Affected, which appears in the
Finding Aids section of the printed volume
and on GPO Access.
§261.35 Deletion of certain hazardous
waste codes following equipment
cleaning and replacement.
(a) Wastes from wood preserving
processes at plants that do not resume
or initiate use of chlorophenolic pre-
servatives will not meet the listing def-
inition of F032 once the generator has
met all of the requirements of para-
graphs (b) and (c) of this section. These
wastes may, however, continue to meet
another hazardous waste listing de-
scription or may exhibit one or more of
the hazardous waste characteristics.
(b) Generators must either clean or
replace all process equipment that may
have come into contact with
chlorophenolic formulations or con-
stituents thereof, including, but not
limited to, treatment cylinders, sumps,
tanks, piping systems, drip pads, fork
lifts, and trams, in a manner that
minimizes or eliminates the escape of
hazardous waste or constituents, leach-
ate, contaminated drippage, or haz-
ardous waste decomposition products
to the ground water, surface water, or
atmosphere.
(1) Generators shall do one of the fol-
lowing:
(i) Prepare and follow an equipment
cleaning plan and clean equipment in
accordance with this section;
(ii) Prepare and follow an equipment
replacement plan and replace equip-
ment in accordance with this section;
or
(iii) Document cleaning and replace-
ment in accordance with this section.
carried out after termination of use of
chlorophenolic preservations.
(2) Cleaning Requirements.
(i) Prepare and sign a written equip-
ment cleaning plan that describes:
(A) The equipment to be cleaned;
(B) How the equipment will be
cleaned;
(C) The solvent to be used in clean-
ing:
(D) How solvent rinses will be tested;
and •
(E) How cleaning residues will be dis-
posed.
(ii) Equipment must be cleaned as
follows:
(A) Remove all visible residues from
process equipment;
(B) Rinse process equipment with an
appropriate solvent until dioxins and
dibenzofurans are not detected in the
final solvent rinse.
(iii) Analytical requirements.
(A) Rinses must be tested in accord-
ance with SW-846, Method 8290.
(B) "Not detected" means at or below
the lower method calibration limit
(MCL) in Method 8290, Table I.
(iv) The generator must manage all
residues from the cleaning process as
F032 waste.
(3) Replacement requirements.
(i) Prepare and sign a written equip-
ment replacement plan that describes:
(A) The equipment to be replaced;
(B) How the equipment will be re-
placed; and
(C) How the equipment will be dis-
posed.
(ii) The generator must manage the
discarded equipment as F032 waste.
(4) Documentation requirements.
(i) Document that previous equip-
ment cleaning and/or replacement was
performed in accordance with this sec-
tion and occurred after cessation of use
of chlorophenolic preservatives.
79
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§262.31
40 CFR Ch. I (7-1-03 Edition)
package the waste in accordance with
the applicable Department of Transpor-
tation regulations on packaging under
49 CFR parts 173, 178, and 179.
§262.31 Labeling.
Before transporting or offering haz-
ardous waste for transportation off-
site, a generator must label each pack-
age in accordance with the applicable
Department of Transportation regula-
tions on hazardous materials under 49
CFR part 172.
§262.32 Marking.
(a) Before transporting or offering
hazardous waste for transportation off-
site, a generator must mark each pack-
age of hazardous waste in accordance
with the applicable Department of
Transportation regulations on haz-
ardous materials under 49 CFR part 172;
(b) Before transporting hazardous
waste or offering hazardous waste for
transportation off-site, a generator
must mark each container of 110 gal-
lons or less used in such transportation
with the following words and informa-
tion displayed in accordance with the
requirements of 49 CFR 172.304:
HAZARDOUS WASTE—Federal Law Pro-
hibits Improper Disposal. If found, contact
the nearest police or public safety authority
or the U.S. Environmental Protection
Agency.
Generator's Name and Address .
Manifest Document Number .
§ 262.33 Placarding.
Before transporting hazardous waste
or offering hazardous waste for trans-
portation off-site, a generator must
placard or offer the initial transporter
the appropriate placards according to
Department of Transportation regula-
tions for hazardous materials under 49
CFR part 172, subpart F.
§ 262.34 Accumulation time.
(a) Except as provided in paragraphs
(d), (e), and (f) of this section, a gener-
ator may accumulate hazardous waste
on-site for 90 days or less without a
permit or without having interim sta-
tus, provided that:
(1) The waste is placed:
(i) In containers and the generator
complies with the applicable require-
ments of subparts I, AA, BB, and CC of
40 CFR part 265; and/or
(ii) In tanks and the generator com-
plies with the applicable requirements
of subparts J, AA, BB, and CC of 40
CFR part 265 except §§265.197(c) and
265.200; and/or
(iii) On drip pads and the generator
complies with subpart W of 40 CFR part
265 and maintains the following records
at the facility:
(A) A description of procedures that
will be followed to ensure that all
wastes are removed from the drip pad
and associated collection system at
least once every 90 days; and
(B) Documentation of each waste re-
moval, including the quantity of waste
removed from the drip pad and the
sump or collection system and the date
and time of removal; and/or
(iv) The waste is placed in contain-
ment buildings and the generator com-
plies with subpart DD of 40 CFR part
265, has placed its professional engineer
certification that the building com-
plies with the design standards speci-
fied in 40 CFR 265.1101 in the facility's
operating record no later than 60 days
after the date of initial operation of
the unit. After February 18, 1993, PE
certification will be required prior to
operation of the unit. The owner or op-
erator shall maintain the following
records at the facility:
(A) A written description of proce-
dures to ensure that each waste volume
remains in the unit for no more than 90
days, a written description of the waste
generation and management practices
for the facility showing that they are
consistent with respecting the 90 day
limit, and documentation that the pro-
cedures are complied with; or
(B) Documentation that the unit is
emptied at least once every 90 days.
In addition, such a generator is exempt
from all the requirements in subparts
G and H of 40 CFR part 265, except for
§§265.111 and 265.114.
(2) The date upon which each period
of accumulation begins is clearly
marked and visible for inspection on
each container;
(3) While being accumulated on-site,
each container and tank is labeled or
marked clearly with the words, "Haz-
ardous Waste"; and
164
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Environmental Protection Agency
§262.34
(4) The generator complies with the
requirements for owners or operators
in Subparts C and D in 40 CFR part 265,
with §265.16, and with 40 CFR
268.7(a)(5).
(b) A generator who accumulates haz-
ardous waste for more than 90 days is
an operator of a storage facility and is
subject to the requirements of 40 CFR
parts 264 and 265 and the permit re-
quirements of 40 CFR part 270 unless he
has been granted an extension to the
90-day period. Such extension may be
granted by EPA if hazardous wastes
must remain on-site for longer than 90
days due to unforeseen, temporary, and
uncontrollable circumstances. An ex-
tension of up to 30 days may be granted
at the discretion of the Regional Ad-
ministrator on a case-by-case basis.
(c)(l) A generator may accumulate as
much as 55 gallons of hazardous waste
or one quart of acutely hazardous
waste listed in §261.33(e) in containers
at or near any point of generation
where wastes initially accumulate,
which is under the control of the oper-
ator of the process generating the
waste, without a permit or interim sta-
tus and without complying with para-
graph (a) of this section provided he:
(i) Complies with §§265.171, 265.172,
and 265.173(a) of this chapter; and
(ii) Marks his containers either with
the words "Hazardous Waste" or with
other words that identify the contents
of the containers.
(2) A generator who accumulates ei-
ther hazardous waste or acutely haz-
ardous waste listed in §261.33(e) in ex-
cess of the amounts listed in paragraph
(c)(l) of this section at or near any
point of generation must, with respect
to that amount of excess waste, comply
within three days with paragraph (a) of
this section or other applicable provi-
sions of this chapter. During the three
day period the generator must con-
tinue to comply with paragraphs
(c) (1) (i) through (ii) of this section. The
generator must mark the container
holding the excess accumulation of
hazardous waste with the date the ex-
cess amount began accumulating.
(d) A generator who generates great-
er than 100 kilograms but less than 1000
kilograms of hazardous waste in a cal-
endar month may accumulate haz-
ardous waste on-site for 180 days or less
without a permit or without having in-
terim status provided that:
(1) The quantity of waste accumu-
lated on-site never exceeds 6000 kilo-
grams;
(2) The generator complies with the
requirements of subpart I of part 265 of
this chapter, except for §§265.176 and
265.178;
(3) The generator complies with the
requirements of §265.201 in subpart J of
part 265;
(4) The generator complies with the
requirements of paragraphs (a) (2) and
(a)(3) of this section, the requirements
of subpart C of part 265, the require-
ments of 40 CFR 268.7(a)(5); and
(5) The generator complies with the
following requirements:
(i) At all times there must be at least
one employee either on the premises or
on call (i.e., available to respond to an
emergency by reaching the facility
within a short period of time) with the
responsibility for coordinating all
emergency response measures specified
in paragraph (d)(5)(iv) of this section.
This employee is the emergency coor-
dinator.
(ii) The generator must post the fol-
lowing information next to the tele-
phone:
(A) The name and telephone number
of the emergency coordinator;
(B) Location of fire extinguishers and
spill control material, and, if present,
fire alarm; and
(C) The telephone number of the fire
department, unless the facility has a
direct alarm.
(iii) The generator must ensure that
all employees are thoroughly familiar
with proper waste handling and emer-
gency procedures, relevant to their re-
sponsibilities during normal facility
operations and emergencies;
(iv) The emergency coordinator or
his designee must respond to any emer-
gencies that arise. The applicable re-
sponses are as follows:
(A) In the event of a fire, call the fire
department or attempt to extinguish it
using a fire extinguisher;
(B) In the event of a spill, contain the
flow of hazardous waste to the extent
possible, and as soon as is practicable,
clean up the hazardous waste and any
contaminated materials or soil;
165
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§262.34
40 CFR Ch. 1 (7-1-03 Edition)
(C) In the event of a fire, explosion,
or other release which could threaten
human health outside the facility or
when the generator has knowledge that
a spill has reached surface water, the
generator must immediately notify the
National Response Center (using their
24-hour toll free number 800/424-8802).
The report must include the following
information:
(1) The name, address, and U.S. EPA
Identification Number of the generator;
(2) Date, time, and type of incident
(e.g., spill or fire);
(3) Quantity and type of hazardous
waste involved in the incident;
(4) Extent of injuries, if any; and
(5) Estimated quantity and disposi-
tion of recovered materials, if any.
(e) A generator who generates great-
er than 100 kilograms but less than 1000
kilograms of hazardous waste in a cal-
endar month and who must transport
his waste, or offer his waste for trans-
portation, over a distance of 200 miles
or more for off-site treatment, storage
or disposal may accumulate hazardous
waste on-site for 270 days or less with-
out a permit or without having interim
status provided that he complies with
the requirements of paragraph (d) of
this section.
(f) A generator who generates greater
than 100 kilograms but less than 1000
kilograms of hazardous waste in a cal-
endar month and who accumulates haz-
ardous waste in quantities exceeding
6000 kg or accumulates hazardous
waste for more than 180 days (or for
more than 270 days if he must trans-
port his waste, or offer his waste for
transportation, over a distance of 200
miles or more) is an operator of a stor-
age facility and is subject to the re-
quirements of 40 CFR parts 264 and 265
and the permit requirements of 40 CFR
part 270 unless he has been granted an
extension to the 180-day (or 270-day if
applicable) period. Such extension may
be granted by EPA if hazardous wastes
must remain on-site for longer than 180
days (or 270 days if applicable) due to
unforeseen, temporary, and uncontrol-
lable circumstances. An extension of
up to 30 days may be granted at the
discretion of the Regional Adminis-
trator on a case-by-case basis.
(g) A generator who generates 1,000
kilograms or greater of hazardous
waste per calendar month who also
generates wastewater treatment
sludges from electroplating operations
that meet the listing description for
the RCRA hazardous waste code F006,
may accumulate F006 waste on-site for
more than 90 days, but not more than
180 days without a permit or without
having interim status provided that:
(1) The generator has implemented
pollution prevention practices that re-
duce the amount of any hazardous sub-
stances, pollutants or contaminants
entering F006 or otherwise released to
the environment prior to its recycling;
(2) The F006 waste is legitimately re-
cycled through metals recovery;
(3) No more than 20,000 kilograms of
F006 waste is accumulated on-site at
any one time; and
(4) The F006 waste is managed in ac-
cordance with the following:
(i) The F006 waste is placed:
(A) In containers and the generator
complies with the applicable require-
ments of subparts I, AA, BB, and CC of
40 CFR part 265; and/or
(B) In tanks and the generator com-
plies with the applicable requirements
of subparts J, AA, BB, and CC of 40
CFR part 265, except §§265.197(c) and
265.200; and/or
(C) In containment buildings and the
generator complies with subpart DD of
40 CFR part 265, and has placed its pro-
fessional engineer certification that
the building complies with the design
standards specified in 40 CFR 265.1101
in the facility's operating record prior
to operation of the unit. The owner or
operator must maintain the following
records at the facility:
(1) A written description of proce-
dures to ensure that the F006 waste re-
mains in the unit for no more than 180
days, a written description of the waste
generation and management practices
for the facility showing that they are
consistent with the 180-day limit, and
documentation that the generator is
complying with the procedures; or
(2) Documentation that the unit is
emptied at least once every 180 days.
(ii) In addition, such a generator is
exempt from all the requirements in
subparts G and H of 40 CFR part 265,
except for §§265.Ill and 265.114.
(iii) The date upon which each period
of accumulation begins is clearly
166
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Environmental Protection Agency
§262.41
marked and visible for inspection on
each container;
(iv) While being accumulated on-site,
each container and tank is labeled or
marked clearly with the words, "Haz-
ardous Waste;" and
(v) The generator complies with the
requirements for owners or operators
in subparts C and D in 40 CFR part 265,
with 40 CFR 265.16, and with 40 CFR
268.7(a)(5).
(h) A generator who generates 1,000
kilograms or greater of hazardous
waste per calendar month who also
generates wastewater treatment
sludges from electroplating operations
that meet the listing description for
the RCRA hazardous waste code F006,
and who must transport this waste, or
offer this waste for transportation,
over a distance of 200 miles or more for
off-site metals recovery, may accumu-
late F006 waste on-site for more than 90
days, but not more than 270 days with-
out a permit or without having interim
status if the generator complies with
the requirements of paragraphs (g)(l)
through (g)(4) of this section.
(i) A generator accumulating F006 in
accordance with paragraphs (g) and (h)
of this section who accumulates F006
waste on-site for more than 180 days
(or for more than 270 days if the gener-
ator must transport this waste, or offer
this waste for transportation, over a
distance of 200 miles or more), or who
accumulates more than 20,000 kilo-
grams of F006 waste on-site is an oper-
ator of a storage facility and is subject
to the requirements of 40 CFR parts 264
and 265 and the permit requirements of
40 CFR part 270 unless the generator
has been granted an extension to the
180-day (or 270-day if applicable) period
or an exception to the 20,000 kilogram
accumulation limit. Such extensions
and exceptions may be granted by EPA
if F006 waste must remain on-site for
longer than 180 days (or 270 days if ap-
plicable) or if more than 20,000 kilo-
grams of F006 waste must remain on-
site due to unforeseen, temporary, and
uncontrollable circumstances. An ex-
tension of up to 30 days or an exception
to the accumulation limit may be
granted at the discretion of the Re-
gional Administrator on a case-by-case
basis.
|47 FR 1251, Jan. 11, 1982, as amended at 48
FR 14294, Apr. 1, 1983; 49 FR 49571, Dec. 20,
1984; 51 FR 10175, Mar. 24, 1986; 51 FR 25472,
July 14, 1986; 55 FR 22684, June 1, 1990; 55 FR
50483, Dec. 6, 1990; 56 FR 3877, Jan. 31, 1991; 56
FR 30195, July 1, 1991; 57 FR 37264, Aug. 18,
1992; 59 FR 62926, Dec. 6, 1994; 61 FR 4911, Feb.
9, 1996; 61 FR 59950, Nov. 25, 1996; 64 FR 3388,
Jan. 21, 1999; 64 FR 25414, May 11, 1999; 64 FR
56471, Oct. 20, 1999; 65 FR 12397, Mar. 8, 2000]
Subpart D—Recordkeeping and
Reporting
§262.40 Recordkeeping.
(a) A generator must keep a copy of
each manifest signed in accordance
with §262.23(a) for three years or until
he receives a signed copy from the des-
ignated facility which received the
waste. This signed copy must be re-
tained as a record for at least three
years from the date the waste was ac-
cepted by the initial transporter.
(b) A generator must keep a copy of
each Biennial Report and Exception
Report for a period of at least three
years from the due date of the report.
(c) A generator must keep records of
any test results, waste analyses, or
other determinations made in accord-
ance with §262.11 for at least three
years from the date that the waste was
last sent to on-site or off-site treat-
ment, storage, or disposal.
(d) The periods or retention referred
to in this section are extended auto-
matically during the course of any un-
resolved enforcement action regarding
the regulated activity or as requested
by the Administrator.
[45 FR 33142, May 19, 1980, as amended at 48
FR3981, Jan. 28, 1983]
§262.41 Biennial report.
(a) A generator who ships any haz-
ardous waste off-site to a treatment,
storage or disposal facility within the
United States must prepare and submit
a single copy of a Biennial Report to
the Regional Administrator by March 1
of each even numbered year. The Bien-
nial Report must be submitted on EPA
Form 8700-13A, must cover generator
activities during the previous year, and
must include the following informa-
tion;
167
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Environmental Protection Agency
§273.3
SOURCE: 60 FR 25542, May 11, 1995, unless
otherwise noted.
Subpart A—General
§273.1 Scope.
(a) This part establishes require-
ments for managing the following:
(1) Batteries as described in 40 CFR
273.2;
(2) Pesticides as described in §273.3;
(3) Thermostats as described in
§273.4; and
(4) Lamps as described in §273.5.
(b) This part provides an alternative
set of management standards in lieu of
regulation under 40 CFR parts 260
through 272.
[60 FR 25542, May 11, 1995, as amended at 64
FR 36488, July 6, 1999]
§ 273.2 Applicability—batteries.
(a) Batteries covered under 40 CFR part
273. (1) The requirements of this part
apply to persons managing batteries,
as described in §273.9, except those list-
ed in paragraph (b) of this section.
(2) Spent lead-acid batteries which
are not managed under 40 CFR part 266,
subpart G, are subject to management
under this part.
(b) Batteries not covered under 40 CFR
part 273. The requirements of this part
do not apply to persons managing the
following batteries:
(1) Spent lead-acid batteries that are
managed under 40 CFR part 266, sub-
part G.
(2) Batteries, as described in §273.9,
that are not yet wastes under part 261
of this chapter, including those that do
not meet the criteria for waste genera-
tion in paragraph (c) of this section.
(3) Batteries, as described in §273.9,
that are not hazardous waste. A bat-
tery is a hazardous waste if it exhibits
one or more of the characteristics iden-
tified in part 261, subpart C of this
chapter.
(c) Generation of waste batteries. (1) A
used battery becomes a waste on the
date it is discarded (e.g., when sent for
reclamation).
(2) An unused battery becomes a
waste on the date the handler decides
to discard it.
[60 FR 25542, May 11, 1995, as amended at 64
FR 36488, July 6. 1999]
§273.3 Applicability—pesticides.
(a) Pesticides covered under this part
273. The requirements of this part
apply to persons managing pesticides,
as described in §273.9, meeting the fol-
lowing conditions, except those listed
in paragraph (b) of this section:
(1) Recalled pesticides that are:
(i) Stocks of a suspended and can-
celed pesticide that are part of a vol-
untary or mandatory recall under
FIFRA Section 19(b), including, but not
limited to those owned by the reg-
istrant responsible for conducting the
recall; or
(ii) Stocks of a suspended or can-
celled pesticide, or a pesticide that is
not' in compliance with FIFRA, that
are part of a voluntary recall by the
registrant.
(2) Stocks of other unused pesticide
products that are collected and man-
aged as part of a waste pesticide collec-
tion program.
(b) Pesticides not covered under 40 CFR
part 273. The requirements of this part
do not apply to persons managing the
following pesticides:
(1) Recalled pesticides described in
paragraph (a)(l) of this section, and un-
used pesticide products described in
paragraph (a) (2) of this section, that
are managed by farmers in compliance
with 40 CFR 262.70. (40 CFR 262.70 ad-
dresses pesticides disposed of on the
farmer's own farm in a manner con-
sistent with the disposal instructions
on the pesticide label, providing the
container is triple rinsed in accordance
with 40 CFR 261.7(b)(3));
(2) Pesticides not meeting the condi-
tions set forth in paragraph (a) of this
section. These pesticides must be man-
aged in compliance with the hazardous
waste regulations in 40 CFR parts 260
through 272;
(3) Pesticides that are not wastes
under part 261 of this chapter, includ-
ing those that do not meet the criteria
for waste generation in paragraph (c) of
this section or those that are not
wastes as described in paragraph (d) of
this section; and
(4) Pesticides that are not hazardous
waste. A pesticide is a hazardous waste
if it is listed in 40 CFR part 261, subpart
D or if it exhibits one or more of the
characteristics identified in 40 CFR
part 261, subpart C.
409
-------
§273.4
40 CFR Ch. I (7-1-03 Edition)
(c) When a pesticide becomes a waste.
(I) A recalled pesticide described in
paragraph (a)(l) of this section be-
comes a waste on the first date on
which both of the following conditions
apply:
(i) The generator of the recalled pes-
ticide agrees to participate in the re-
call; and
(ii) The person conducting the recall
decides to discard (e.g., burn the pes-
ticide for energy recovery).
(2) An unused pesticide product de-
scribed in paragraph (a) (2) of this sec-
tion becomes a waste on the date the
generator decides to discard it.
(d) Pesticides that are not wastes. The
following pesticides are not wastes:
(1) Recalled pesticides described in
paragraph (a)(l) of this section, pro-
vided that the person conducting the
recall:
(i) Has not made a decision to discard
(e.g., burn for energy recovery) the pes-
ticide. Until such a decision is made,
the pesticide does not meet the defini-
tion of "solid waste" under 40 CFR
261.2; thus the pesticide is not a haz-
ardous waste and is not subject to haz-
ardous waste requirements, including
this part 273. This pesticide remains
subject to the requirements of FIFRA;
or
(ii) Has made a decision to use a
management option that, under 40 CFR
261.2, does not cause the pesticide to be
a solid waste (i.e., the selected option
is use (other than use constituting dis-
posal) or reuse (other than burning for
energy recovery), or reclamation).
Such a pesticide is not a solid waste
and therefore is not a hazardous waste,
and is not subject to the hazardous
waste requirements including this part
273. This pesticide, including a recalled
pesticide that is exported to a foreign
destination for use or reuse, remains
subject to the requirements of FIFRA.
(2) Unused pesticide products de-
scribed in paragraph (a) (2) of this sec-
tion, if the generator of the unused pes-
ticide product has not decided to dis-
card (e.g., burn for energy recovery)
them. These pesticides remain subject
to the requirements of FIFRA.
[60 FR 25542, May 11, 1995, as amended at 64
FR 36488, July 6, 1999]
§273.4 Applicability—mercury thermo-
stats.
(a) Thermostats covered under this part
273. The requirements of this part
apply to persons managing thermo-
stats, as described in §273.9, except
those listed in paragraph (b) of this
section.
(b) Thermostats not covered under 40
CFR part 273. The requirements of this
part do not apply to persons managing
the following thermostats:
(1) Thermostats that are not yet
wastes under part 261 of this chapter.
Paragraph (c) of this section describes
when thermostats become wastes.
(2) Thermostats that are not haz-
ardous waste. A thermostat is a haz-
ardous waste if it exhibits one or more
of the characteristics identified in 40
CFR part 261, subpart C.
(c) Generation of waste thermostats. (1)
A used thermostat becomes a waste on
the date it is discarded (e.g., sent for
reclamation).
(2) An unused thermostat becomes a
waste on the date the handler decides
to discard it.
[60 FR 25542, May 11, 1995, as amended at 64
FR 36488, July 6, 1999)
§ 273.5 Applicability—lamps.
(a) Lamps covered under this part 273.
The requirements of this part apply to
persons managing lamps as described
in §273.9, except those listed in para-
graph (b) of this section.
(b) Lamps not covered under this part
273. The requirements of this part do
not apply to persons managing the fol-
lowing lamps:
(1) Lamps that are not yet wastes
under part 261 of this chapter as pro-
vided in paragraph (c) of this section.
(2) Lamps that are not hazardous
waste. A lamp is a hazardous waste if it
exhibits one or more of the characteris-
tics identified in part 261, subpart C of
this chapter.
(c) Generation of waste lamps. (1) A
used lamp becomes a waste on the date
it is discarded.
(2) An unused lamp becomes a waste
on the date the handler decides to dis-
card it.
[64 FR 36488, July 6, 1999]
410
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Environmental Protection Agency
§273.9
§§273.6-273.7 [Reserved]
§ 273.8 Applicability—household and
conditionally exempt small quantity
generator waste.
(a) Persons managing the wastes list-
ed below may, at their option, manage
them under the requirements of this
part:
(1) Household wastes that are exempt
under §261.4(b)(l) of this chapter and
are also of the same type as the uni-
versal wastes defined at § 273.9; and/or
(2) Conditionally exempt small quan-
tity generator wastes that are exempt
under §261.5 of this chapter and are
also of the same type as the universal
wastes defined at §273.9.
(b) Persons who commingle the
wastes described in paragraphs (a)(l)
and (a) (2) of this section together with
universal waste regulated under this
part must manage the commingled
waste under the requirements of this
part.
[64 FR 36488, July 6, 1999]
§ 273.9 Definitions.
Battery means a device consisting of
one or more electrically connected
electrochemical cells which is designed
to receive, store, and deliver electric
energy. An electrochemical cell is a
system consisting of an anode, cathode,
and an electrolyte, plus such connec-
tions (electrical and mechanical) as
may be needed to allow the cell to de-
liver or receive electrical energy. The
term battery also includes an intact,
unbroken battery from which the elec-
trolyte has been removed.
Destination facility means a facility
that treats, disposes of, or recycles a
particular category of universal waste,
except those management activities
described in §273.13 (a) and (c) and
§273.33 (a) and (c). A facility at which a
particular category of universal waste
is only accumulated, is not a destina-
tion facility for purposes of managing
that category of universal waste.
FIFRA means the Federal Insecti-
cide, Fungicide, and Rodenticide Act (7
U.S.C. 136-136y).
Generator means any person, by site,
whose act or process produces haz-
ardous waste identified or listed in part
261 of this chapter or whose act first
causes a hazardous waste to become
subject to regulation.
Lamp, also referred to as "universal
waste lamp" is defined as the bulb or
tube portion of an electric lighting de-
vice. A lamp is specifically designed to
produce radiant energy, most often in
the ultraviolet, visible, and infra-red
regions of the electromagnetic spec-
trum. Examples of common universal
waste electric lamps include, but are
not limited to, fluorescent, high inten-
sity discharge, neon, mercury vapor,
high pressure sodium, and metal halide
lamps.
Large Quantity Handler of Universal
Waste means a universal waste handler
(as defined in this section) who accu-
mulates 5,000 kilograms or more total
of universal waste (batteries, pes-
ticides, thermostats, or lamps, cal-
culated collectively) at any time. This
designation as a large quantity handler
of universal waste is retained through
the end of the calendar year in which
5,000 kilograms or more total of uni-
versal waste is accumulated.
On-site means the same or geographi-
cally contiguous property which may
be divided by public or private right-of-
way, provided that the entrance and
exit between the properties is at a
cross-roads intersection, and access is
by crossing as opposed to going along
the right of way. Non-contiguous prop-
erties owned by the same person but
connected by a right-of-way which he
controls and to which the public does
not have access, are also considered on-
site property.
Pesticide means any substance or
mixture of substances intended for pre-
venting, destroying, repelling, or miti-
gating any pest, or intended for use as
a plant regulator, defoliant, or des-
iccant, other than any article that:
(a) Is a new animal drug under
FFDCA section 201 (w), or
(b) Is an animal drug that has been
determined by regulation of the Sec-
retary of Health and Human Services
not to be a new animal drug, or
(c) Is an animal feed under FFDCA
section 201 (x) that bears or contains
any substances described by paragraph
(a) or (b) of this section.
Small Quantity Handler of Universal
Waste means a universal waste handler
(as defined in this section) who does
411
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§273.10
40 CFR Ch. I (7-1-03 Edition)
not accumulate 5,000 kilograms or
more total of universal waste (bat-
teries, pesticides, thermostats, or
lamps, calculated collectively) at any
time.
Thermostat means a temperature con-
trol device that contains metallic mer-
cury in an ampule attached to a bi-
metal sensing element, and mercury-
containing ampules that have been re-
moved from these temperature control
devices in compliance with the require-
ments of 40 CFR 273.13(c)(2) or
273.33(c)(2).
Universal Waste means any of the fol-
lowing hazardous waste that are sub-
ject to the universal waste require-
ments of this part 273:
(1) Batteries as described in §273.2
(2) Pesticides as described in §273.3
(3) Thermostats as described in
§273.4; and
(4) Lamps as described in §273.5.
Universal Waste Handler:
(a) Means:
(1) A generator (as defined in this
section) of universal waste; or
(2) The owner or operator of a facil-
ity, including all contiguous property,
that receives universal waste from
other universal waste handlers, accu-
mulates universal waste, and sends
universal waste to another universal
waste handler, to a destination facil-
ity, or to a foreign destination.
(b) Does not mean:
(1) A person who treats (except under
the provisions of 40 CFR 273.13 (a) or
(c), or 273.33 (a) or (c)), disposes of, or
recycles universal waste; or
(2) A person engaged in the off-site
transportation of universal waste by
air, rail, highway, or water, including a
universal waste transfer facility.
Universal Waste Transfer Facility
means any transportation-related fa-
cility including loading docks, parking
areas, storage areas and other similar
areas where shipments of universal
waste are held during the normal
course of transportation for ten days or
less.
Universal Waste Transporter means a
person engaged in the off-site transpor-
tation of universal waste by air, rail,
highway, or water.
[60 FR 25542, May 11, 1995, as amended at 63
FR 71230, Dec. 24, 1998. Redesignated and
amended at 64 FR 36488, 36489, July 6, 1999]
Subpart B—Standards for Small
Quantity Handlers of Universal
Waste
§273.10 Applicability.
This subpart applies to small quan-
tity handlers of universal waste (as de-
fined in 40 CFR 273.9).
[64 FR 36489, July 6, 1999]
§273.11 Prohibitions.
A small quantity handler of universal
waste is:
(a) Prohibited from disposing of uni-
versal waste; and
(b) Prohibited from diluting or treat-
ing universal waste, except by respond-
ing to releases as provided in 40 CFR
273.17; or by managing specific wastes
as provided in 40 CFR 273.13.
§ 273.12 Notification.
A small quantity handler of universal
waste is not required to notify EPA of
universal waste handling activities.
§ 273.13 Waste management.
(a) Universal waste batteries. A small
quantity handler of universal waste
must manage universal waste batteries
in a way that prevents releases of any
universal waste or component of a uni-
versal waste to the environment, as
follows:
(1) A small quantity handler of uni-
versal waste must contain any uni-
versal waste battery that shows evi-
dence of leakage, spillage, or damage
that could cause leakage under reason-
ably foreseeable conditions in a con-
tainer. The container must be closed,
structurally sound, compatible with
the contents of the battery, and must
lack evidence of leakage, spillage, or
damage that could cause leakage under
reasonably foreseeable conditions.
(2) A small quantity handler of uni-
versal waste may conduct the following
activities as long as the casing of each
individual battery cell is not breached
and remains intact and closed (except
that cells may be opened to remove
electrolyte but must be immediately
closed after removal):
(i) Sorting batteries by type;
(ii) Mixing battery types in one con-
tainer;
412
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Environmental Protection Agency
§273.13
(iii) Discharging batteries so as to re-
move the electric charge;
(iv) Regenerating used batteries;
(v) Disassembling batteries or bat-
tery packs into individual batteries or
cells;
(vi) Removing batteries from con-
sumer products; or
(vii) Removing electrolyte from bat-
teries.
(3) A small quantity handler of uni-
versal waste who removes electrolyte
from batteries, or who generates other
solid waste (e.g., battery pack mate-
rials, discarded consumer products) as
a result of the activities listed above,
must determine whether the electro-
lyte and/or other solid waste exhibit a
characteristic of hazardous waste iden-
tified in 40 CFR part 261, subpart C.
(i) If the electrolyte and/or other
solid waste exhibit a characteristic of
hazardous waste, it is subject to all ap-
plicable requirements of 40 CFR parts
260 through 272. The handler is consid-
ered the generator of the hazardous
electrolyte and/or other waste and is
subject to 40 CFR part 262.
(ii) If the electrolyte or other solid
waste is not hazardous, the handler
may manage the waste in any way that
is in compliance with applicable fed-
eral, state or local solid waste regula-
tions.
(b) Universal waste pesticides. A small
quantity handler of universal waste
must manage universal waste pes-
ticides in a way that prevent releases
of any universal waste or component of
a universal waste to the environment.
The universal waste pesticides must be
contained in one or more of the fol-
lowing:
(1) A container that remains closed,
structurally sound, compatible with
the pesticide, and that lacks evidence
of leakage, spillage, or damage that
could cause leakage under reasonably
foreseeable conditions; or
(2) A container that does not meet
the requirements of paragraph (b)(l) of
this Section, provided that the unac-
ceptable container is overpacked in a
container that does meet the require-
ments of paragraph (b)(l) of this Sec-
tion; or
(3) A tank that meets the require-
ments of 40 CFR part 265 subpart J, ex-
cept for 40 CFR 265.197(c), 265.200, and
265.201; or
(4) A transport vehicle or vessel that
is closed, structurally sound, compat-
ible with the pesticide, and that lacks
evidence of leakage, spillage, or dam-
age that could cause leakage under rea-
sonably foreseeable conditions.
(c) Universal waste thermostats. A
small quantity handler of universal
waste must manage universal waste
thermostats in a way that prevents re-
leases of any universal waste or compo-
nent of a universal waste to the envi-
ronment, as follows:
(1) A small quantity handler of uni-
versal waste must contain any uni-
versal waste thermostat that shows
evidence of leakage, spillage, or dam-
age that could cause leakage under rea-
sonably foreseeable conditions in a
container. The container must be
closed, structurally sound, compatible
with the contents of the thermostat,
and must lack evidence of leakage,
spillage, or damage that could cause
leakage under reasonably foreseeable
conditions.
(2) A small quantity handler of uni-
versal waste may remove mercury-con-
taining ampules from universal waste
thermostats provided the handler:
(i) Removes the ampules in a manner
designed to prevent breakage of the
ampules;
(ii) Removes ampules only over or in
a containment device (e.g., tray or pan
sufficient to collect and contain any
mercury released from an ampule in
case of breakage);
(iii) Ensures that a mercury clean-up
system is readily available to imme-
diately transfer any mercury resulting
from spills or leaks from broken am-
pules, from the containment device to
a container that meets the require-
ments of 40 CFR 262.34;
(iv) Immediately transfers any mer-
cury resulting from spills or leaks from
broken ampules from the containment
device to a container that meets the
requirements of 40 CFR 262.34;
(v) Ensures that the area in which
ampules are removed is well ventilated
and monitored to ensure compliance
with applicable OSHA exposure levels
for mercury;
(vi) Ensures that employees remov-
ing ampules are thoroughly familiar
413
-------
§273.14
40 CFR Ch. I (7-1-03 Edition)
with proper waste mercury handling
and emergency procedures, including
transfer of mercury from containment
devices to appropriate containers;
(vii) Stores removed ampules in
closed, non-leaking containers that are
in good condition;
(viii) Packs removed ampules in the
container with packing materials ade-
quate to prevent breakage during stor-
age, handling, and transportation; and
(3)(i) A small quantity handler of uni-
versal waste who removes mercury-
containing ampules from thermostats
must determine whether the following
exhibit a characteristic of hazardous
waste identified in 40 CFR part 261,
subpart C:
(A) Mercury or clean-up residues re-
sulting from spills or leaks; and/or
(B) Other solid waste generated as a
result of the removal of mercury-con-
taining ampules (e.g., remaining ther-
mostat units).
(ii) If the mercury, residues, and/or
other solid waste exhibit a char-
acteristic of hazardous waste, it must
be managed in compliance with all ap-
plicable requirements of 40 CFR parts
260 through 272. The handler is consid-
ered the generator of the mercury, resi-
dues, and/or other waste and must
manage it is subject to 40 CFR part 262.
(iii) If the mercury, residues, and/or
other solid waste is not hazardous, the
handler may manage the waste in any
way that is in compliance with applica-
ble federal, state or local solid waste
regulations.
(d) Lamps. A small quantity handler
of universal waste must manage lamps
in a way that prevents releases of any
universal waste or component of a uni-
versal waste to the environment, as
follows:
(1) A small quantity handler of uni-
versal waste must contain any lamp in
containers or packages that are struc-
turally sound, adequate to prevent
breakage, and compatible with the con-
tents of the lamps. Such containers
and packages must remain closed and
must lack evidence of leakage, spillage
or damage that could cause leakage
under reasonably foreseeable condi-
tions.
(2) A small quantity handler of uni-
versal waste must immediately clean
up and place in a container any lamp
that is broken and must place in a con-
tainer any lamp that shows evidence of
breakage, leakage, or damage that
could cause the release of mercury or
other hazardous constituents to the en-
vironment. Containers must be closed,
structurally sound, compatible with
the contents of the lamps and must
lack evidence of leakage, spillage or
damage that could cause leakage or re-
leases of mercury or other hazardous
constituents to the environment under
reasonably foreseeable conditions.
[60 FR 25542, May 11, 1995, as amended at 64
FR 36489, July 6, 1999]
§ 273.14 Labeling/marking.
A small quantity handler of universal
waste must label or mark the universal
waste to identify the type of universal
waste as specified below:
(a) Universal waste batteries (i.e.,
each battery), or a container in which
the batteries are contained, must be la-
beled or marked clearly with any one
of the following phrases: "Universal
Waste—Battery (ies), or "Waste Bat-
tery(ies)," or "Used Battery(ies);"
(b) A container, (or multiple con-
tainer package unit), tank, transport
vehicle or vessel in which recalled uni-
versal waste pesticides as described in
40 CFR 273.3(a)(l) are contained must
be labeled or marked clearly with:
(1) The label that was on or accom-
panied the product as sold or distrib-
uted; and
(2) The words "Universal Waste-Pes-
ticide(s)" or "Waste-Pesticide(s);"
(c) A container, tank, or transport
vehicle or vessel in which unused pes-
ticide products as described in 40 CFR
273.3(a) (2) are contained must be la-
beled or marked clearly with:
(l)(i) The label that was on the prod-
uct when purchased, if still legible;
(ii) If using the labels described in
paragraph (c)(l)(i) of this section is not
feasible, the appropriate label as re-
quired under the Department of Trans-
portation regulation 49 CFR part 172;
(iii) If using the labels described in
paragraphs (c)(l) (i) and (ii) of this sec-
tion is not feasible, another label pre-
scribed or designated by the waste pes-
ticide collection program administered
or recognized by a state; and
(2) The words "Universal Waste-Pes-
ticide^)" or "Waste-Pesticide(s)."
414
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Environmental Protection Agency
§273.18
(d) Universal waste thermostats (i.e.,
each thermostat), or a container in
which the thermostats are contained,
must be labeled or marked clearly with
any one of the following phrases:
"Universal Waste—Mercury Thermo-
stat(s)," or "Waste Mercury Thermo-
stat^)," or "Used Mercury Thermo-
stat (s)".
(e) Each lamp or a container or pack-
age in which such lamps are contained
must be labeled or marked clearly with
one of the following phrases: "Uni-
versal Waste—Lamp(s)," or "Waste
Lamp(s)," or "Used Lamp(s)".
[60 FR 25542, May 11, 1995, as amended at 64
FR 36489, July 6, 1999J
§273.15 Accumulation time limits.
(a) A small quantity handler of uni-
versal waste may accumulate universal
waste for no longer than one year from
the date the universal waste is gen-
erated, or received from another han-
dler, unless the requirements of para-
graph (b) of this section are met.
(b) A small quantity handler of uni-
versal waste may accumulate universal
waste for longer than one year from
the date the universal waste is gen-
erated, or received from another han-
dler, if such activity is solely for the
purpose of accumulation of such quan-
tities of universal waste as necessary
to facilitate proper recovery, treat-
ment, or disposal. However, the han-
dler bears the burden of proving that
such activity is solely for the purpose
of accumulation of such quantities of
universal waste as necessary to facili-
tate proper recovery, treatment, or dis-
posal .
(c) A small quantity handler of uni-
versal waste who accumulates uni-
versal waste must be able to dem-
onstrate the length of time that the
universal waste has been accumulated
from the date it becomes a waste or is
received. The handler may make this
demonstration by:
(1) Placing the universal waste in a
container and marking or labeling the
container with the earliest date that
any universal waste in the container
became a waste or was received;
(2) Marking or labeling each indi-
vidual item of universal waste (e.g.,
each battery or thermostat) with the
date it became a waste or was received;
(3) Maintaining an inventory system
on-site that identifies the date each
universal waste became a waste or was
received;
(4) Maintaining an inventory system
on-site that identifies the earliest date
that any universal waste in a group of
universal waste items or a group of
containers of universal waste became a
waste or was received;
(5) Placing the universal waste in a
specific accumulation area and identi-
fying the earliest date that any uni-
versal waste in the area became a
waste or was received; or
(6) Any other method which clearly
demonstrates the length of time that
the universal waste has been accumu-
lated from the date it becomes a waste
or is received.
§273.16 Employee training.
A small quantity handler of universal
waste must inform all employees who
handle or have responsibility for man-
aging universal waste. The information
must describe proper handling and
emergency procedures appropriate to
the type(s) of universal waste handled
at the facility.
§ 273.17 Response to releases.
(a) A small quantity handler of uni-
versal waste must immediately contain
all releases of universal wastes and
other residues from universal wastes.
(b) A small quantity handler of uni-
versal waste must determine whether
any material resulting from the release
is hazardous waste, and if so, must
manage the hazardous waste in compli-
ance with all applicable requirements
of 40 CFR parts 260 through 272. The
handler is considered the generator of
the material resulting from the re-
lease, and must manage it in compli-
ance with 40 CFR part 262.
§ 273.18 Off-site shipments.
(a) A small quantity handler of uni-
versal waste is prohibited from sending
or taking universal waste to a place
other than another universal waste
handler, a destination facility, or a for-
eign destination.
(b) If a small quantity handler of uni-
versal waste self-transports universal
waste off-site, the handler becomes a
universal waste transporter for those
415
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§273.19
40 CFR Ch. I (7-1-03 Edition)
self-transportation activities and must
comply with the transporter require-
ments of subpart D of this part while
transporting the universal waste.
(c) If a universal waste being offered
for off-site transportation meets the
definition of hazardous materials under
49 CFR parts 171 through 180, a small
quantity handler of universal waste
must package, label, mark and placard
the shipment, and prepare the proper
shipping papers in accordance with the
applicable Department of Transpor-
tation regulations under 49 CFR parts
172 through 180;
(d) Prior to sending a shipment of
universal waste to another universal
waste handler, the originating handler
must ensure that the receiving handler
agrees to receive the shipment.
(e) If a small quantity handler of uni-
versal waste sends a shipment of uni-
versal waste to another handler or to a
destination facility and the shipment
is rejected by the receiving handler or
destination facility, the originating
handler must either:
(1) Receive the waste back when noti-
fied that the shipment has been re-
jected, or
(2) Agree with the receiving handler
on a destination facility to which the
shipment will be sent.
(f) A small quantity handler of uni-
versal waste may reject a shipment
containing universal waste, or a por-
tion of a shipment containing universal
waste that he has received from an-
other handler. If a handler rejects a
shipment or a portion of a shipment, he
must contact the originating handler
to notify him of the rejection and to
discuss reshipment of the load. The
handler must:
(1) Send the shipment back to the
originating handler, or
(2) If agreed to by both the origi-
nating and receiving handler, send the
shipment to a destination facility.
(g) If a small quantity handler of uni-
versal waste receives a shipment con-
taining hazardous waste that is not a
universal waste, the handler must im-
mediately notify the appropriate re-
gional EPA office of the illegal ship-
ment, and provide the name, address,
and phone number of the originating
shipper. The EPA regional office will
provide instructions for managing the
hazardous waste.
(h) If a small quantity handler of uni-
versal waste receives a shipment of
non-hazardous, non-universal waste,
the handler may manage the waste in
any way that is in compliance with ap-
plicable federal, state or local solid
waste regulations.
§273.19 Tracking universal waste
shipments.
A small quantity handler of universal
waste is not required to keep records of
shipments of universal waste.
§ 273.20 Exports.
A small quantity handler of universal
waste who sends universal waste to a
foreign destination other than to those
OECD countries specified in 40 CFR
262.58(a)(l) (in which case the handler is
subject to the requirements of 40 CFR
part 262, subpart H) must:
(a) Comply with the requirements ap-
plicable to a primary exporter in 40
CFR 262.53, 262.56(a) (1) through (4), (6),
and (b) and 262.57;
(b) Export such universal waste only
upon consent of the receiving country
and in conformance with the EPA Ac-
knowledgement of Consent as defined
in subpart E of part 262 of this chapter;
and
(c) Provide a copy of the EPA Ac-
knowledgment of Consent for the ship-
ment to the transporter transporting
the shipment for export.
[60 FR 25542, May 11, 1995, as amended at 61
FR 16315, Apr. 12, 1996]
Subpart C—Standards for Large
Quantity Handlers of Universal
Waste
§ 273.30 Applicability.
This subpart applies to large quan-
tity handlers of universal waste (as de-
fined in §273.9).
[64 FR 36489, July 6, 1999]
§273.31 Prohibitions.
A large quantity handler of universal
waste is:
(a) Prohibited from disposing of uni-
versal waste; and
416
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Environmental Protection Agency
§273.33
(b) Prohibited from diluting or treat-
ing universal waste, except by respond-
ing to releases as provided in 40 CFR
273.37; or by managing specific wastes
as provided in 40 CFR 273.33.
§ 273.32 Notification.
(a)(l) Except as provided in para-
graphs (a) (2) and (3) of this section, a
large quantity handler of universal
waste must have sent written notifica-
tion of universal waste management to
the Regional Administrator, and re-
ceived an EPA Identification Number,
before meeting or exceeding the 5,000
kilogram storage limit.
(2) A large quantity handler of uni-
versal waste who has already notified
EPA of his hazardous waste manage-
ment activities and has received an
EPA Identification Number is not re-
quired to renotify under this section.
(3) A large quantity handler of uni-
versal waste who manages recalled uni-
versal waste pesticides as described in
40 CFR 273.3(a)(l) and who has sent no-
tification to EPA as required by 40
CFR part 165 is not required to notify
for those recalled universal waste pes-
ticides under this section.
(b) This notification must include:
(1) The universal waste handler's
name and mailing address;
(2) The name and business telephone
number of the person at the universal
waste handler's site who should be con-
tacted regarding universal waste man-
agement activities;
(3) The address or physical location
of the universal waste management ac-
tivities;
(4) A list of all the types of universal
waste managed by the handler (e.g.,
batteries. pesticides, thermostats,
lamps);
(5) A statement indicating that the
handler is accumulating more than
5,000 kg of universal waste at one time
and the types of universal waste (e.g.,
batteries, pesticides, thermostats, and
lamps) the handler is accumulating
above this quantity.
(60 FR 25542, May 11, 1995, as amended at 64
FR 36489, July 6, 1999]
§ 273.33 Waste management.
(a) Universal waste batteries. A large
quantity handler of universal waste
must manage universal waste batteries
in a way that prevents releases of any
universal waste or component of a uni-
versal waste to the environment, as
follows:
(1) A large quantity handler of uni-
versal waste must contain any uni-
versal waste battery that shows evi-
dence of leakage, spillage, or damage
that could cause leakage under reason-
ably foreseeable conditions in a con-
tainer. The container must be closed,
structurally sound, compatible with
the contents of the battery, and must
lack evidence of leakage, spillage, or
damage that could cause leakage under
reasonably foreseeable conditions.
(2) A large quantity handler of uni-
versal waste may conduct the following
activities as long as the casing of each
individual battery cell is not breached
and remains intact and closed (except
that cells may be opened to remove
electrolyte but must be immediately
closed after removal):
(i) Sorting batteries by type;
(ii) Mixing battery types in one con-
tainer;
(iii) Discharging batteries so as to re-
move the electric charge;
(iv) Regenerating used batteries;
(v) Disassembling batteries or bat-
tery packs into individual batteries or
cells;
(vi) Removing batteries from con-
sumer products; or
(vii) Removing electrolyte from bat-
teries.
(3) A large quantity handler of uni-
versal waste who removes electrolyte
from batteries, or who generates other
solid waste (e.g., battery pack mate-
rials, discarded consumer products) as
a result of the activities listed above.
must determine whether the electro-
lyte and/or other solid waste exhibit a
characteristic of hazardous waste iden-
tified in 40 CFR part 261, subpart C.
(i) If the electrolyte and/or other
solid waste exhibit a characteristic of
hazardous waste, it must be managed
in compliance with all applicable re-
quirements of 40 CFR parts 260 through
272. The handler is considered the gen-
erator of the hazardous electrolyte and/
or other waste and is subject to 40 CFR
part 262.
(ii) If the electrolyte or other solid
waste is not hazardous, the handler
may manage the waste in any way that
417
-------
§ 273.33
40 CFR Ch. I (7-1-03 Edition)
is in compliance with applicable fed-
eral, state or local solid waste regula-
tions.
(b) Universal waste pesticides. A large
quantity handler of universal waste
must manage universal waste pes-
ticides in a way that prevents releases
of any universal waste or component of
a universal waste to the environment.
The universal waste pesticides must be
contained in one or more of the fol-
lowing:
(1) A container that remains closed,
structurally sound, compatible with
the pesticide, and that lacks evidence
of leakage, spillage, or damage that
could cause leakage under reasonably
foreseeable conditions; or
(2) A container that does not meet
the requirements of paragraph (b)(l) of
this section, provided that the unac-
ceptable container is overpacked in a
container that does meet the require-
ments of paragraph (b)(l) of this sec-
tion; or
(3) A tank that meets the require-
ments of 40 CFR part 265 subpart J, ex-
cept for 40 CFR 265.197(c), 265.200, and
265.201; or
(4) A transport vehicle or vessel that
is closed, structurally sound, compat-
ible with the pesticide, and that lacks
evidence of leakage, spillage, or dam-
age that could cause leakage under rea-
sonably foreseeable conditions.
(c) Universal waste thermostats. A
large quantity handler of universal
waste must manage universal waste
thermostats in a way that prevents re-
leases of any universal waste or compo-
nent of a universal waste to the envi-
ronment, as follows:
(1) A large quantity handler of uni-
versal waste must contain any uni-
versal waste thermostat that shows
evidence of leakage, spillage, or dam-
age that could cause leakage under rea-
sonably foreseeable conditions in a
container. The container must be
closed, structurally sound, compatible
with the contents of the thermostat,
and must lack evidence of leakage,
spillage, or damage that could cause
leakage under reasonably foreseeable
conditions.
(2) A large quantity handler of uni-
versal waste may remove mercury-con-
taining ampules from universal waste
thermostats provided the handler:
(i) Removes the ampules in a manner
designed to prevent breakage of the
ampules;
(ii) Removes ampules only over or in
a containment device (e.g., tray or pan
sufficient to contain any mercury re-
leased from an ampule in case of break-
age); .
(iii) Ensures that a mercury clean-up
system is readily available to imme-
diately transfer any mercury resulting
from spills or leaks from broken am-
pules, from the containment device to
a container that meets the require-
ments of 40 CFR 262.34;
(iv) Immediately transfers any mer-
cury resulting from spills or leaks from
broken ampules from the containment
device to a container that meets the
requirements of 40 CFR 262.34;
(v) Ensures that the area in which
ampules are removed is well ventilated
and monitored to ensure compliance
with applicable OSHA exposure levels
for mercury;
(vi) Ensures that employees remov-
ing ampules are thoroughly familiar
with proper waste mercury handling
and emergency procedures, including
transfer of mercury from containment
devices to appropriate containers;
(vii) Stores removed ampules in
closed, non-leaking containers that are
in good condition;
(viii) Packs removed ampules in the
container with packing materials ade-
quate to prevent breakage during stor-
age, handling, and transportation; and
(3)(i) A large quantity handler of uni-
versal waste who removes mercury-
containing ampules from thermostats
must determine whether the following
exhibit a characteristic of hazardous
waste identified in 40 CFR part 26!.
subpart C:
(A) Mercury or clean-up residues re-
sulting from spills or leaks; and/or
(B) Other solid waste generated as a
result of the removal of mercury-con-
taining ampules (e.g., remaining ther-
mostat units).
(ii) If the mercury, residues, and/or
other solid waste exhibit a char-
acteristic of hazardous waste, it must
be managed in compliance with all ap-
plicable requirements of 40 CFR parts
418
-------
Environmental Protection Agency
§273.35
260 through 272. The handler is consid-
ered the generator of the mercury, resi-
dues, and/or other waste and is subject
to 40 CFR part 262.
(iii) If the mercury, residues, and/or
other solid waste is not hazardous, the
handler may manage the waste in any
way that is in compliance with applica-
ble federal, state or local solid waste
regulations.
(d) Lamps. A large quantity handler
of universal waste must manage lamps
in a way that prevents releases of any
universal waste or component of a uni-
versal waste to the environment, as
follows:
(1) A large quantity handler of uni-
versal waste must contain any lamp in
containers or packages that are struc-
turally sound, adequate to prevent
breakage, and compatible with the con-
tents of the lamps. Such containers
and packages must remain closed and
must lack evidence of leakage, spillage
or damage that could cause leakage
under reasonably foreseeable condi-
tions.
(2) A large quantity handler of uni-
versal waste must immediately clean
up and place in a container any lamp
that is broken and must place in a con-
tainer any lamp that shows evidence of
breakage, leakage, or damage that
could cause the release of mercury or
other hazardous constituents to the en-
vironment. Containers must be closed,
structurally sound, compatible with
the contents of the lamps and must
lack evidence of leakage, spillage or
damage that could cause leakage or re-
leases of mercury or other hazardous
constituents to the environment under
reasonably foreseeable conditions.
[60 FR 25542, May 11, 1995, as amended at 64
FR 36489. July 6, 19991
§ 273.34 Labeling/marking.
A large quantity handler of universal
waste must label or mark the universal
waste to identify the type of universal
waste as specified below:
(a) Universal waste batteries (i.e.,
each battery), or a container or tank in
which the batteries are contained,
must be labeled or marked clearly with
the any one of the following phrases:
"Universal Waste—Battery(ies)," or
"Waste Battery(ies)," or "Used Bat-
tery (ies);"
(b) A container (or multiple con-
tainer package unit), tank, transport
vehicle or vessel in which recalled uni-
versal waste pesticides as described in
40 CFR 273.3(a)(l) are contained must
be labeled or marked clearly with:
(1) The label that was on or accom-
panied the product as sold or distrib-
uted; and
(2) The words "Universal Waste—Pes-
ticide(s)" or "Waste—Pesticide(s);"
(c) A container, tank, or transport
vehicle or vessel in which unused pes-
ticide products as described in 40 CFR
273.3(a)(2) are contained must be la-
beled or marked clearly with:
(l)(i) The label that was on the prod-
uct when purchased, if still legible:
(ii) If using the labels described in
paragraph (c)(l)(i) of this section is not
feasible, the appropriate label as re-
quired under the Department of Trans-
portation regulation 49 CFR part 172:
(iii) If using the labels described in
paragraphs (c) (l)(i) and (l)(ii) of this
section is not feasible, another label
prescribed or designated by the pes-
ticide collection program; and
(2) The words "Universal Waste—Pes-
ticide(s)" or "Waste—Pesticide(s)."
(d) Universal waste thermostats (i.e..
each thermostat), or a container or
tank in which the thermostats are con-
tained, must be labeled or marked
clearly with any one of the following
phrases: "Universal Waste—Mercury
Thermostat (s)," or "Waste Mercury
Thermostat (s)," or "Used Mercury
Thermostat (s).
(e) Each lamp or a container or pack-
age in which such lamps are contained
must be labeled or marked clearly with
any one of the following phrases:
"Universal Waste—Lamp(s)." or
"Waste Lamp(s)," or "Used Lamp(s)".
[60 FR 25542. May 11, 1995, as amended at 64
FR 36489, July 6, 1999)
§ 273.35 Accumulation time limits.
(a) A large quantity handler of uni-
versal waste may accumulate universal
waste for no longer than one year from
the date the universal waste is gen-
erated, or received from another han-
dler, unless the requirements of para-
graph (b) of this section are met.
(b) A large quantity handler of uni-
versal waste may accumulate universal
waste for longer than one year from
419
-------
§273.36
40 CFR Ch. I (7-1-03 Edition)
the date the universal waste is gen-
erated, or received from another han-
dler, if such activity is solely for the
purpose of accumulation of such quan-
tities of universal waste as necessary
to facilitate proper recovery, treat-
ment, or disposal. However, the han-
dler bears the burden of proving that
such activity was solely for the pur-
pose of accumulation of such quan-
tities of universal waste as necessary
to facilitate proper recovery, treat-
ment, or disposal.
(c) A large quantity handler of uni-
versal waste must be able to dem-
onstrate the length of time that the
universal waste has been accumulated
from the date it becomes a waste or is
received. The handler may make this
demonstration by:
(1) Placing the universal waste in a
container and marking or labeling the
container with the earliest date that
any universal waste in the container
became a waste or was received;
(2) Marking or labeling the individual
item of universal waste (e.g., each bat-
tery or thermostat) with the date it be-
came a waste or was received;
(3) Maintaining an inventory system
on-site that identifies the date the uni-
versal waste being accumulated be-
came a waste or was received;
(4) Maintaining an inventory system
on-site that identifies the earliest date
that any universal waste in a group of
universal waste items or a group of
containers of universal waste became a
waste or was received;
(5) Placing the universal waste in a
specific accumulation area and identi-
fying the earliest date that any uni-
versal waste in the area became a
waste or was received; or
(6) Any other method which clearly
demonstrates the length of time that
the universal waste has been accumu-
lated from the date it becomes a waste
or is received.
S 273.36 Employee training.
A large quantity handler of universal
waste must ensure that all employees
are thoroughly familiar with proper
waste handling and emergency proce-
dures, relative to their responsibilities
during normal facility operations and
emergencies.
S 273.37 Response to releases.
(a) A large quantity handler of uni-
versal waste must immediately contain
all releases of universal wastes and
other residues from universal wastes.
(b) A large quantity handler of uni-
versal waste must determine whether
any material resulting from the release
is hazardous waste, and if so, must
manage the hazardous waste in compli-
ance with all applicable requirements
of 40 CFR parts 260 through 272. The
handler is considered the generator of
the material resulting from the re-
lease, and is subject to 40 CFR part 262.
5 273.38 Off-site shipments.
(a) A large quantity handler of uni-
versal waste is prohibited from sending
or taking universal waste to a place
other than another universal waste
handler, a destination facility, or a for-
eign destination.
(b) If a large quantity handler of uni-
versal waste self-transports universal
waste off-site, the handler becomes a
universal waste transporter for those
self-transportation activities and must
comply with the transporter require-
ments of subpart D of this part while
transporting the universal waste.
(c) If a universal waste being offered
for off-site transportation meets the
definition of hazardous materials under
49 CFR 171 through 180, a large quan-
tity handler of universal waste must
package, label, mark and placard the
shipment, and prepare the proper ship-
ping papers in accordance with the ap-
plicable Department of Transportation
regulations under 49 CFR parts 172
through 180;
(d) Prior to sending a shipment of
universal waste to another universal
waste handler, the originating handler
must ensure that the receiving hancller
agrees to receive the shipment.
(e) If a large quantity handler of uni-
versal waste sends a shipment of uni-
versal waste to another handler or to a
destination facility and the shipment
is rejected by the receiving handler or
destination facility, the originating
handler must either:
(1) Receive the waste back when noti-
fied that the shipment has been re-
jected, or
420
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Environmental Protection Agency
§273.40
(2) Agree with the receiving handler
on a destination facility to which the
shipment will be sent.
(f) A large quantity handler of uni-
versal waste may reject a shipment
containing universal waste, or a por-
tion of a shipment containing universal
waste that he has received from an-
other handler. If a handler rejects a
shipment or a portion of a shipment, he
must contact the originating handler
to notify him of the rejection and to
discuss reshipment of the load. The
handler must:
(1) Send the shipment back to the
originating handler, or
(2) If agreed to by both the origi-
nating and receiving handler, send the
shipment to a destination facility.
(g) If a large quantity handler of uni-
versal waste receives a shipment con-
taining hazardous waste that is not a
universal waste, the handler must im-
mediately notify the appropriate re-
gional EPA office of the illegal ship-
ment, and provide the name, address,
and phone number of the originating
shipper. The EPA regional office will
provide instructions for managing the
hazardous waste.
(h) If a large quantity handler of uni-
versal waste receives a shipment of
non-hazardous, non-universal waste,
the handler may manage the waste in
any way that is in compliance with ap-
plicable federal, state or local solid
waste regulations.
S 273.39 Tracking universal waste
shipments.
(a) Receipt of shipments. A large quan-
tity handler of universal waste must
keep a record of each shipment of uni-
versal waste received at the facility.
The record may take the form of a log,
invoice, manifest, bill of lading, or
other shipping document. The record
for each shipment of universal waste
received must include the following in-
formation:
(1) The name and address of the origi-
nating universal waste handler or for-
eign shipper from whom the universal
waste was sent;
(2) The quantity of each type of uni-
versal waste received (e.g., batteries,
pesticides, thermostats);
(3) The date of receipt of the ship-
ment of universal waste.
(b) Shipments off-site. A large quan-
tity handler of universal waste must
keep a record of each shipment of uni-
versal waste sent from the handler to
other facilities. The record may take
the form of a log, invoice, manifest,
bill of lading or other shipping docu-
ment. The record for each shipment of
universal waste sent must include the
following information:
(1) The name and address of the uni-
versal waste handler, destination facil-
ity, or foreign destination to whom the
universal waste was sent;
(2) The quantity of each type of uni-
versal waste sent (e.g., batteries, pes-
ticides, thermostats);
(3) The date' the shipment of uni-
versal waste left the facility.
(c) Record retention. (I) A large quan-
tity handler of universal waste must
retain the records described in para-
graph (a) of this section for at least
three years from the date of receipt of
a shipment of universal waste.
(2) A large quantity handler of uni-
versal waste must retain the records
described in paragraph (b) of this sec-
tion for at least three years from the
date a shipment of universal waste left
the facility.
S 273.40 Exports.
A large quantity handler of universal
waste who sends universal waste to a
foreign destination other than to those
OECD countries specified in 40 CFR
262.58(a)(l) (in which case the handler is
subject to the requirements of 40 CFR
part 262, subpart H) must:
(a) Comply with the requirements ap-
plicable to a primary exporter in 40
CFR 262.53, 262.56(a)(l) through (4), (6),
and (b) and 262.57;
(b) Export such universal waste only
upon consent of the receiving country
and in conformance with the EPA Ac-
knowledgement of Consent as defined
in subpart E of part 262 of this chapter:
and
(c) Provide a copy of the EPA Ac-
knowledgement of Consent for the
shipment to the transporter trans-
porting the shipment for export.
[60 FR 25542, May 11, 1995, as amended at 61
FR 16316, Apr. 12, 19961
421
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Appendix V to Part 264—Examples of Potentially Incompatible Waste
Many hazardous wastes, when mixed with other waste or materials at a hazardous waste
facility, can produce effects which are harmful to human health and the environment,
such as (1) heat or pressure, (2) fire or explosion, (3) violent reaction, (4) toxic dusts,
mists, fumes, or gases, or (5) flammable fumes or gases.
Below are examples of potentially incompatible wastes, waste components, and
materials, along with the harmful consequences which result from mixing materials in
one group with materials in another group. The list is intended as a guide to owners or
operators of treatment, storage, and disposal facilities, and to enforcement and permit
granting officials, to indicate the need for special precautions when managing these
potentially incompatible waste materials or components.
This list is not intended to be exhaustive. An owner or operator must, as the regulations
require, adequately analyze his wastes so that he can avoid creating uncontrolled
substances or reactions of the type listed below, whether they are listed below or not.
It is possible for potentially incompatible wastes to be mixed in a way that precludes a
reaction (e.g., adding acid to water rather than water to acid) or that neutralizes them
(e.g., a strong acid mixed with a strong base), or that controls substances produced (e.g.,
by generating flammable gases in a closed tank equipped so that ignition cannot occur,
and burning the gases in an incinerator).
In the lists below, the mixing of a Group A material with a Group B material may have
the potential consequence as noted.
Group I—A
Acetylene sludge Alkaline caustic liquids Alkaline cleaner Alkaline corrosive liquids
Alkaline corrosive battery fluid Caustic wastewater Lime sludge and other corrosive
alkalies Lime wastewater Lime and water Spent caustic
Group 1—B
Acid sludge Acid and water Battery acid Chemical cleaners Electrolyte, acid Etching acid
liquid or solvent Pickling liquor and other corrosive acids Spent acid Spent mixed acid
Spent sulfuric acid
Potential consequences: Heat generation; violent reaction.
Group 2—A
Aluminum Beryllium Calcium Lithium Magnesium Potassium Sodium Zinc powder
Other reactive metals and metal hydrides
-------
Group 2—B
Any waste in Group 1-A or
1-B
Potential consequences: Fire or explosion; generation of flammable hydrogen gas.
Group 3-A
Alcohols Water
Group 3-B
Any concentrated waste in Groups 1-A or 1-B Calcium Lithium Metal hydrides
Potassium SO2 C12, SOC12, PC13, CH3 SiC13 Other water-reactive waste
Potential consequences: Fire, explosion, or heat generation; generation of flammable or
toxic gases.
Group 4-A
Alcohols Aldehydes Halogenated hydrocarbons Nitrated hydrocarbons Unsaturated
hydrocarbons Other reactive organic compounds and solvents
Group 4-B
Concentrated Group 1-A or 1-B wastes Group 2-A wastes
Potential consequences: Fire, explosion, or violent reaction.
Group 5-A
Spent cyanide and sulfide solutions
Group 5-B
Group 1-B wastes
Potential consequences: Generation of toxic hydrogen cyanide or hydrogen sulfide gas.
Group 6—A
Chlorates Chlorine Chlorites Chromic acid Hypochlorites Nitrates Nitric acid, fuming
Perchlorates Permanganates Peroxides Other strong oxidizers
-------
Group 6-B
Acetic acid and other organic acids Concentrated mineral acids Group 2—A wastes Group
4-A wastes Other flammable and combustible wastes
Potential consequences: Fire, explosion, or violent reaction.
Source: "Law, Regulations, and Guidelines for Handling of Hazardous Waste."
California Department of Health, February 1975.
1 These include counties, city-county consolidations, and independent cities. In the case
of Alaska, the political jurisdictions are election districts, and, in the case of Hawaii, the
political jurisdiction listed is the island of Hawaii.
[46 FR 2872, Jan. 12, 1981]
Appendix V to Part 265—Examples of Potentially Incompatible Waste
Many hazardous wastes, when mixed with other waste or materials at a hazardous waste
facility, can produce effects which are harmful to human health and the environment,
such as (1) heat or pressure, (2) fire or explosion, (3) violent reaction, (4) toxic dusts,
mists, fumes, or gases, or (5) flammable fumes or gases.
Below are examples of potentially incompatible wastes, waste components, and materials,
along with the harmful consequences which result from mixing materials in one group
with materials in another group. The list is intended as a guide to owners or operators of
treatment, storage, and disposal facilities, and to enforcement and permit granting
officials, to indicate the need for special precautions when managing these potentially
incompatible waste materials or components.
This list is not intended to be exhaustive. An owner or operator must, as the regulations
require, adequately analyze his wastes so that he can avoid creating uncontrolled
substances or reactions of the type listed below, whether they are listed below or not.
It is possible for potentially incompatible wastes to be mixed in a way that precludes a
reaction (e.g., adding acid to water rather than water to acid) or that neutralizes them (e.g.,
a strong acid mixed with a strong base), or that controls substances produced (e.g., by
generating flammable gases in a closed tank equipped so that ignition cannot occur, and
burning the gases in an incinerator).
In the lists below, the mixing of a Group A material with a Group B material may have
the potential consequence as noted.
-------
Potential consequences: Fire, explosion, or violent reaction.
Group 5-A Group 5-B
Spent cyanide and sulfide solutions Group 1-B wastes
Potential consequences: Generation of toxic hydrogen cyanide or hydrogen sulfide gas.
Group 6-A Group 6-B
Chlorates Acetic acid and other organic
acids
Chlorine Concentrated mineral acids
Chlorites Group 2-A wastes
Chromic acid Group 4-A wastes
Hyphochlorites Other flammable and combustible
wastes
Nitrates
Nitric acid, fuming
Perchlorates
Permanganates
Peroxides
Other strong oxidizers
Potential consequences: Fire, explosion, or violent reaction.
Source: "Law, Regulations, and Guidelines for Handling of Hazardous Waste.
California Department of Health, February 1975.
-------
Wednesday,
May 16, 2001
Part II
Environmental
Protection Agency
40 CFR Part 266
Storage, Treatment, Transportation, and
Disposal of Mixed Wastes; Final Rule
40 CFR Parts 261 and 268
Hazardous Waste Identification Rule
(HWIR); Revisions to Mixture and
Derived-From Rules; Final Rule
-------
27218
Federal Register/Vol. 66, No. 95/Wednesday, May 16, 2001/Rules and Regulations
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 266
[FRL-6975-1]
RIN 2050-AE45
Storage, Treatment, Transportation,
and Disposal of Mixed Waste
AGENCY: Environmental Protection
Agency (EPA).
ACTION: Final rule.
SUMMARY: The Environmental Protection
Agency (EPA) is today finalizing its
proposal to provide increased flexibility
to facilities that manage low-level mixed
waste (LLMW) and technologically
enhanced naturally occurring and/or
accelerator-produced radioactive
material (NARM) containing hazardous
waste. The final rule reduces dual
regulation of LLMW, which is subject to
the Resource Conservation and
Recovery Act (RCRA) and to the Atomic
Energy Act (AEA). This final rule
conditionally exempts from RCRA
hazardous waste management low-level
mixed wastes during storage and
treatment. The storage and treatment
exemption in today's rule requires the
use of tanks or containers to store or
treat the waste and applies only to low-
level mixed waste that meets the
specified conditions and is generated
under a single Nuclear Regulatory
Commission (NRC) or NRC Agreement
State license.
Today's rule also exempts LLMW and
hazardous NARM waste from RCRA
manifest, transportation, and disposal
requirements when specified conditions
are met. Under this conditional
exemption, the waste remains subject to
manifest, transport, and disposal
requirements under the NRC (or NRC
Agreement State) regulations for low-
level radioactive waste (LLW) or eligible
NARM.
DATES: This final rule is effective
November 13, 2001.
ADDRESSES: Supporting materials are
available for viewing in the RCRA
Information Center (RIG) located at
Crystal Gateway One, First Floor, 1235
Jefferson Davis Highway, Arlington,
Virginia. The Docket Identification
Number is F-2001-ML2F-FFFFF. The
RIG is open from 9:00 a.m. to 4:00 p.m.,
Monday through Friday, except for
Federal holidays. To review docket
materials you should make an
appointment by calling (703) 603-9230.
You may copy up to 100 pages from any
regulatory docket at no charge.
Additional copies cost $0.15/page. The
index and some supporting materials
are available electronically. See the
SUPPLEMENTARY INFORMATION section for
information on accessing them.
FOR FURTHER INFORMATION CONTACT: For
general information, contact the RCRA
Hotline at (800) 424-9346 (toll free), or
TDD (800) 553-7672 (hearing impaired).
In the Washington, DC metropolitan
area call (703) 412-9810 or TDD (703)
412-3323 (hearing impaired). For
information on this rule, contact Nancy
Hunt at (703) 308-8762 or Chris Rhyne
at (703) 308-8658. They are in the
Office of Solid Waste (5303W), U.S.
Environmental Protection Agency, 1200
Pennsylvania Avenue, NW.,
Washington, DC 20460.
SUPPLEMENTARY INFORMATION: Use this
address to access the rule electronically
on the Internet: http://www.epa.gov/
epaoswer/hazwaste/radio/:
The official record for this rule will be
kept in paper form. Accordingly, EPA
transferred all comments received
electronically into paper form and
placed them in the official record,
which also includes all comments
submitted directly in writing. The
official record is the record maintained
at the RCRA Docket Information Center.
See the ADDRESSES section above.
EPA responses to comments on the
March 1, 1999 Advance Notice of
Proposed Rulemaking (64 FR 10063)
and the November 19, 1999 Storage,
Treatment, Transportation, and Disposal
of Mixed Waste; Proposed Rule (64 FR
63464) are in a response to comments
document placed in the official record
for this rulemaking.
Table of Contents
I. References
A. Acronyms used in this preamble
B. Definition of terms used in the preamble
C. Who is potentially affected by this rule?
D. What is the legal authority for today's
final rule?
II. Summary of today's action
A. How does this rule affect the storage and
treatment of LLMW?
B. How does this rule affect transportation
and disposal of LLMW and Eligible
NARM?
III. Why are we issuing this rule?
A. Response to dual regulation concerns
and inadequate capacity
B. Response to HWIR consent decree
C. Response to petition from USWAG and
concerns of other mixed waste generators
IV. Precedent for regulatory flexibility
A. Military Munitions Rule
B. Applying the conditional exemption
concept to mixed waste
1. Evaluation of NRC storage and treatment
requirements
2. Review of NRC disposal requirements
V. How are the final storage and treatment
provisions different from the proposal?
A. Streamlined language
B. Eligibility revisions
C. Clarifications related to inventory and
treatment
D. Recordkeeping requirements
E. Implementation
VI. Discussion and response to major
comments on the storage and treatment
conditional exemption
A. Storage and treatment—general
discussion of provisions
1. What wastes are eligible for the storage
and treatment conditional exemption?
(§266.225)
a. Eligibility provisions and changes from
proposed regulatory language
i. Waste is a LLMW (Excludes NARM)
ii. Waste is generated and managed by you
under a single NRC license
b. Differences from proposed eligibility for
storage and treatment exemption
c. Treatment and storage facilities
managing LLMW from other generators
2. What conditions must you meet to
qualify for and maintain a storage and
treatment exemption? (§ 266.230)
a. Initial condition to qualify—you must
notify the Director of your claim.
i. Cross reference to proposed rule
ii. Comments we received on storage and
treatment notification
b. Conditions to maintain the storage and
treatment exemption
i. Store Waste in a tank or container in
compliance with storage requirements of
your NRC or NRC agreement state
license.
ii. Store waste in compliance with
chemical compatibility requirements.
iii. Certify that personnel are trained in
hazardous waste management.
iv. Inventory and inspect your waste.
v. Maintain an accurate emergency plan.
c. Modifications to proposed storage and
treatment conditions
3. Treatment (§ 266.235)
a. Treatment clarification
b. Comments received on treatment
i. EPA should reconsider allowing
treatment
ii. EPA should broaden the scope of
treatment in the storage and treatment
exemption
4. Implementation of the storage and
treatment conditional exemption
a. Self-implementation
b. Loss of the storage and treatment
conditional exemption (§ 266.240)
c. If you lose your storage and treatment
exemption can it be reclaimed?
(§266.245)
d. Recordkeeping requirements for storage
and treatment exemption (§ 266.250)
e. Return to RCRA of LLMW no longer
eligible for the storage and treatment
exemption (§266.255)
i. How does the storage and treatment
exemption facilitate decay-in-storage?
ii. Change from proposed language
iii. Comments received on storage time
limits and decay-in-storage
iv. Effect on biennial reporting
f. Enforcement and enforcement policy
g. Storage unit closure
B. Discussion and response to comments
on storage background studies
1. Review of NRC licensing requirements
2. Research on compliance records of NRC
and NRC Agreement State licensees
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3. Comparison of regulatory and
management requirements of EPA and
NRC
4. Conclusions based on our studies
5. Comments received on our studies
VII. How are the final transportation and
disposal provisions different from the
proposal?
VIII. Discussion and response to major
comments on the transportation and
disposal conditional exemption rule
A. What is the basis of the transportation
and disposal conditional exemption?
B. What wastes are eligible for the
transportation and disposal conditional
exemption?
C. What conditions must you meet to
qualify for and maintain the
transportation and disposal conditional
exemption?
1. Land Disposal Restriction treatment
standards
2. Manifest and transportation
a. If you are subject to NRC or NRC
Agreement State regulation
b. If you are not directly subject to NRC or
NRC Agreement State regulation
3. Container requirement
4. Waste disposal designation
D. What other provisions must you meet?
1. Notification
2. Recordkeeping
E. When does the transportation and disposal
exemption take effect?
F. Implementation
1. How will the transportation and disposal
conditional exemption be implemented?
2. Loss of transportation and disposal
conditional exemption
3. Reclaiming the transportation and
disposal conditional exemption
G. How did we conduct our technical
assessment for the disposal of treated
waste at low-level radioactive waste
disposal facilities?
1. Synergistic Effects
2. Groundwater monitoring
3. Site-specific variance
H. Why is financial assurance beyond 10
CFR 61 not necessary?
IX. Regulatory Impacts
A. What are the regulatory benefits of this
rule?
B. What are the costs of this rule?
C. What are the economic impacts of this
rule?
X. State Authorization
XI. Relationship with other RCRA and
Environmental Programs
A. What is the relationship of this rule
with other RCRA regulatory programs?
1. Does this rule change how you
determine if a waste is hazardous?
2. Can LLMW or Eligible NARM be a
nonhazardous waste under this rule?
3. How does the LLMW Conditional
Exemption differ from delisting under 40
CFR 260.22?
4. Will my waste analysis plan for my
RCRA-permitted TSDF change?
5. Will the final rule change how the RCRA
closure requirements apply to my
disposal facility?
6. How does the conditional exemption
relate to RCRA air emission standards?
B. What is the relationship of this rule to
other environmental programs?
1. How are CERCLA actions affected by
today's rule?
2. How might Clean Air Act regulations be
affected?
3. How might Clean Water Act regulations
be affected?
XII. Effective Date
XIII. Regulatory Assessment Requirements
A. Executive Order 12866: Determination
of Significance
B. Executive Order 13132: Federalism
C. Executive Order 12898: Environmental
Justice
D. Executive Order 13045: Protection of
Children from Environmental Health
Risks and Safety Risks
E. Executive Order 13175: Consultation
and Coordination with Indian Tribal
Governments
F. The Regulatory Flexibility Act as
Amended by the Small Business
Regulatory Enforcement Fairness Act of
1996
G. Unfunded Mandates Reform Act
H. National Technology Transfer and
Advancement Act of 1995
I. Paperwork Reduction Act
J. Congressional Review Act
XIV. Supporting Documents
I. References
A. Acronyms Used in This Preamble
AEA—Atomic Energy Act of 1954, as
amended
ALARA—As Low As Reasonably Achievable
ANPRM—Advance Notice of Proposed
Rulemaking
ARAR—Applicable or Relevant and
Appropriate Requirements
BOAT—Best Demonstrated Available
Technology
CBI—Confidential Business Information
CERCLA—Comprehensive Environmental
Response, Compensation, and Liability Act
DOD—Department of Defense
DOE—Department of Energy
EEI—Edison Electric Institute
EPA—Environmental Protection Agency
(referred to as "we" throughout this
document)
FFCA—Federal Facilities Compliance Act
FUSRAP—Formerly Utilized Sites Remedial
Action Program
GWRL—Groundwater Risk Levels
HSWA—Hazardous and Solid Waste
Amendments of 1984
HWIR—Hazardous Waste Identification Rule
ICR—Information Collection Request
LDR—Land Disposal Restrictions
LLW—Low-Level Radioactive Waste
LLMW—Low-Level Mixed Waste
LLRWDF—Low-Level Radioactive Waste
Disposal Facility
MMR—Military Munitions Rule
NAAG—National Association of Attorneys
General
NARM-Technologically Enhanced Naturally
Occurring and/or Accelerator-produced
Radioactive Material
NGA—National Governors' Association
NNPP—Naval Nuclear Propulsion Program
NRC—Nuclear Regulatory Commission
NTTAA—National Technology Transfer and
Advancement Act
OMB—Office of Management and Budget
OSW—Office of Solid Waste
OSWER—Office of Solid Waste and
Emergency Response
RCRA—Resource Conservation and Recovery
Act
RFA—Regulatory Fairness Act
RIG—RCRA Information Center
RQ—Reportable Quantity
SARA—Superfund Amendments and
Reauthorization Act
SBREFA—Small Business Regulatory
Enforcement Fairness Act
SQG—Small Quantity Generator
TC—Toxicity Characteristic
TRI—Toxics Release Inventory
TSDF—Treatment, Storage and Disposal
Facility
UHC—Underlying Hazardous Constituent
UMRA—Unfunded Mandates Reform Act of
1995
UMTRCA—Uranium Mill Tailings Radiation
Control Act
USWAG—Utility Solid Waste Activities
Group
UTS—Universal Treatment Standards
B. Definition of Terms Used in the
Preamble
Agreement State means a state that
has entered into an agreement with the
NRC under subsection 274b of the
Atomic Energy Act of 1954, as amended
(68 Stat. 919), to assume responsibility
for regulating within its borders
byproduct, source, or special nuclear
material in quantities not sufficient to
form a critical mass.
ANPRM (Advance Notice of Proposed
Rulemaking) refers in this document to
the advance notice published in the
Federal Register on March 1, 1999 (64
FR 10063) on mixed waste storage.
Certified Delivery means certified mail
with return receipt requested, or
equivalent courier service or other
means that provides the sender with a
receipt confirming delivery.
Director refers to the definition in 40
CFR 270.2.
"Eligible Naturally Occurring and/or
Accelerator-produced Radioactive
Material (NARM)" is NARM that is
eligible for the Transportation and
Disposal Conditional Exemption. It is a
NARM waste that contains RCRA
hazardous waste, meets the waste
acceptance criteria of, and is allowed by
State NARM regulations to be disposed
of at a LLRWDF licensed in accordance
with 10 CFR part 61 or NRC Agreement
State equivalent regulations.
Exempted waste means a waste that
meets the eligibility criteria in § 266.225
and meets all of the conditions in
§ 266.230, or meets the eligibility
criteria in § 266.310 and complies with
all of the conditions in § 266.315. Such
waste is conditionally exempted from
the regulatory definition of hazardous
waste described in 40 CFR 261.3.
Generator refers to the definition in
40 CFR 260.10.
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Hazardous waste means any material
which is defined to be hazardous waste
in accordance with 40 CFR 261.3,
"Definition of Hazardous Waste."
Legacy waste means waste that was
generated by past activities and has
been in storage beyond RCRA
accumulation time periods in 40 CFR
262.34 because appropriate treatment
technologies have not been developed,
or treatment and disposal capacity has
not been available.
License means a license issued by the
Nuclear Regulatory Commission, or
NRC Agreement State, to users that
manage radionuclides regulated by
NRC, or NRC Agreement States, under
authority of the Atomic Energy Act of
1954, as amended.
Low-Level Mixed Waste (LLMW)
means a waste that contains both low-
level radioactive waste and RCRA
hazardous waste.
Low-Level Radioactive Waste (LLW) is
a radioactive waste which contains
source, special nuclear, or byproduct
material, and which is not classified as
high-level radioactive waste, transuranic
waste, spent nuclear fuel, or byproduct
material as defined in sectionlle.(2) of
the Atomic Energy Act. (See also NRC
definition of "waste" at 10 CFR 61.2)
Mixed Waste defined in RCRA as
amended by the Federal Facility
Compliance Act of 1992, means a waste
that contains both RCRA hazardous
waste and source, special nuclear, or
byproduct material subject to the
Atomic Energy Act of 1954, as amended.
Naturally Occurring and/or
Accelerator-produced Radioactive
Material (NARM) means radioactive
materials that (1) Are naturally
occurring and are not source, special
nuclear, or byproduct materials (as
defined by the AEA) or (2) are produced
by an accelerator. NARM is regulated by
the States under State law, or by DOE
(as authorized by the AEA) under DOE
orders.
NRC or NRC Agreement State license
means a license issued by the Nuclear
Regulatory Commission or an NRC
Agreement State under authority
granted by the AEA.
NUREG refers to Nuclear Regulatory
Commission publications and
documents that include formal staff
reports, which cover a variety of
regulatory, technical and administrative
subjects; brochures, which include
manuals, procedural guidance,
directories and newsletters; conference
proceedings and papers presented at a
conference or workshop; and books,
which serve a technical purpose or an
industry -wide needs. Many of the
NUREG documents are listed on the
NRC Home Page (http://www.nrc.gov).
On-site is defined in the RCRA
regulations at 40 CFR 260.10, et seq.
Tie-down conditions include NRC
guidance documents and policies
concerning storage and treatment of
LLW which become part of the NRC or
NRC Agreement State radioactive
materials license by reference.
We or us within this preamble means
the EPA.
You means a generator, treater, or
other handler of low-level mixed waste
or Eligible NARM.
C. Who Is Potentially Affected by This
Rule?
The conditional exemption for low-
level mixed waste (LLMW) storage and
treatment applies to any mixed waste
generator that has an NRC or NRC
Agreement State license to possess
radioactive material or to operate a
nuclear reactor, so long as the waste is
eligible and the generator can satisfy the
conditions set forth in today's rule.
The transportation and disposal
exemption applies to generators of
LLMW and Eligible NARM so long as
they meet all specified conditions.
Facilities potentially affected by this
action include those identified in Table
1.
TABLE 1.—FACILITIES POTENTIALLY AFFECTED
Category
Examples of facilities
Nuclear Utilities
Universities/Academic Institutions
Medical Facilities
Industrial Establishments
Government Facilities
Disposal facilities
Firms that generate electricity using nuclear fuel as the source of energy and that
are licensed by the NRC.
Academic institutions at all levels that are licensed by NRC, or an NRC Agree-
ment State, to use radionuclides for academic, biomedical, and research pur-
poses.
Hospitals, medical laboratories, doctors' offices, or clinics that are licensed by
NRC or an NRC Agreement State to use radionuclides for health care pur-
poses.
Private companies and institutions, including pharmaceutical companies, and re-
search and development institutions that are licensed by NRC or an NRC
Agreement State to use radionuclides.
Facilities, installations and laboratories operated by State Agencies, and by some
Federal Agencies, including, but not limited to, the National Institutes of Health,
the National Institute of Standards and Technology, the Veterans Administra-
tion and the Department of Defense (except the Naval Nuclear Propulsion Pro-
gram).
Low-level radioactive waste disposal facilities licensed under 10 CFR part 61 or
by an NRC Agreement State.
The preceding table is not intended to
be exhaustive, but rather to provide
examples of facilities likely to be
affected by this rule. To determine
whether you are affected by this
regulatory action, you should carefully
examine the applicability criteria in this
preamble. If you have any questions
regarding the applicability of this
section to a particular entity, consult the
persons listed under FOR FURTHER
INFORMATION CONTACT.
D. What Is the Legal Authority for
Today's Final Rule?
The statutory basis for this rule is in
sections 1006, 2002(a), 3001-3009 and
3013 of the Solid Waste Disposal Act of
1970, as amended by the Resource
Conservation and Recovery Act of 1976
(RCRA), the Hazardous and Solid Waste
Amendments of 1984 (HSWA), and the
Federal Facility Compliance Act of 1992
(FFCA), 42 U.S.C. 6905, 6912(a), 6921-
6929 and 6934.
II. Summary of Today's Action
In today's rule we are promulgating a
conditional exemption for the storage,
treatment, transportation, and disposal
of low-level mixed waste (LLMW), and
Eligible NARM where specified. As a
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waste generator and handler who meets
certain conditions specified in 40 CFR
266.230 or 266.315, (a) your LLMW
could be exempt from most RCRA
Subtitle C storage and treatment
regulations, and (b) your LLMW and
Eligible NARM could be exempt from
most RCRA Subtitle C manifesting,
transportation, and disposal regulations.
Thus, LLMW, and Eligible NARM where
specified, may be conditionally
exempted from most RCRA Subtitle C
requirements through much of the waste
management process.
To claim a conditional exemption you
must notify the regulatory agencies
specified that you meet the conditions.
However, if information you provide on
your notification is incomplete or
inaccurate, your claim for a conditional
exemption is nullified subjecting your
waste to RCRA Subtitle C regulation.
A. How Does This Rule Affect the
Storage and Treatment of LLMW?
Our rule will allow qualified
generators of LLMW to claim a
conditional exemption from the
regulatory RCRA definition of
hazardous waste for mixed wastes
stored and treated by the generator
under a single NRC or NRC Agreement
State license. This conditional
exemption acknowledges that NRC
regulation for low-level waste (LLW)
provides protective regulation of storage
and treatment of mixed waste in tanks
and containers. This regulatory
flexibility applies only to generators of
low-level mixed waste who are licensed
by NRC or an NRC Agreement State.
Once your LLMW is removed from
storage or treatment for transportation or
disposal, it is subject to RCRA Subtitle
C regulation unless it qualifies for the
transportation and disposal exemption.
Under this rule, if you fail to meet any
of the conditions in § 266.230, your
LLMW is no longer exempted from the
regulatory definition of hazardous
waste. As a hazardous waste, your
LLMW is subject to RCRA Subtitle C
regulation.
B. How Does This Rule Affect
Transportation and Disposal of LLMW
and Eligible NARM?
Today's rule will allow generators of
LLMW and Eligible NARM to claim a
conditional exemption from the RCRA
regulatory definition of hazardous waste
for the manifesting, transportation, and
disposal of these wastes. (Throughout
this document when we refer to the
conditional exemption for manifest,
transportation and disposal of LLMW,
we also mean Eligible NARM.) If your
wastes meet the eligibility requirements
and if you meet the specified conditions
for the transportation and disposal
exemption, then you may manage your
wastes as you would solely radioactive
wastes. This conditional exemption
acknowledges the protection provided
by NRC and NRC Agreement States
requirements for the manifest,
transportation and disposal of the
radioactive portion of the eligible waste.
III. Why Are We Issuing This Rule?
A. Response to Dual Regulation
Concerns and Inadequate Capacity
Mixed waste is regulated under
multiple authorities: RCRA (for the
hazardous component), as implemented
by EPA or Authorized States; and AEA
(for the source, special nuclear, or by-
product material component), as
implemented by the NRC or NRC
Agreement States (for commercially-
generated mixed wastes), or the
Department of Energy (DOE) (for
defense-related mixed waste generated
by DOE activities). NARM-contaminated
hazardous waste is also regulated under
multiple authorities: RCRA (for the
hazardous component); and State law
(for the NARM component), as
implemented by a State agency
designated by State law. EPA and NRC
recognize that joint oversight of mixed
waste has been cumbersome, in part
because of the different regulatory
approaches of the agencies, and has
complicated safe management and
disposal of mixed waste. With this rule
we are responding to the concerns of
mixed waste generators regarding the
burden and duplication of dual
regulation, as well as concerns about
reducing the radiation exposures of
workers managing mixed wastes. (See
discussion related to decay-in-storage in
section VI. A. 4. e. i.)
In addition, mixed waste generators
have expressed concerns about limited
LLMW treatment and disposal options
which can put them in violation of
RCRA. These concerns originated
because RCRA section 3004(j) generally
prohibits the storage of hazardous
wastes that are also subject to RCRA
land disposal restrictions unless the
storage is "solely for the purpose of the
accumulation of such quantities of
hazardous waste as are necessary to
facilitate proper recovery, treatment or
disposal." Under EPA's regulation
codifying RCRA section 3004(j), we
presume that the initial year of
hazardous waste storage is for the sole
purpose of accumulating a quantity
necessary to facilitate treatment and
disposal. However, if you store LLMW
on-site for more than one year, you have
the burden of proving that the storage is
for the allowed purpose.
Based on our information collection
effort in the ANPRM, published March
1, 1999 in the Federal Register, and
information from mixed waste
generators, we found that treatment
technology and disposal capacity for
certain LLMW are not always available.
We also found that, in some cases,
commercial mixed waste treatment
facilities have not been willing to accept
LLMW for treatment unless there are
also disposal options. When disposal
options do not exist, generators of
LLMW store the waste beyond a year.
Because of limited LLMW disposal
capacity, we believe it is appropriate to
provide safe and legal alternatives for
the disposal of LLMW.
We assessed NRC regulations for
management of LLW and compared
them with EPA's regulations for
hazardous waste storage, treatment,
transportation, and disposal. Our review
found that given the NRC's regulatory
controls, human health and
environmental protection from chemical
risks would not be compromised if we
deferred to many of the NRC low-level
radioactive waste management
practices. Given NRC waste
management, we do not believe that the
addition of RCRA Subtitle C regulation
is necessary to protect human health or
the environment. Through this rule, we
are providing regulatory relief intended
to facilitate the disposal of certain
LLMW (such as legacy waste requiring
long-term storage due to lack of
treatment technology and disposal
capacity), that has been stored on-site by
NRC licensees as mixed waste subject to
both RCRA permitting and NRC
licensing requirements.
Ninety individuals and organizations
commented on the proposal. In general,
utilities, nuclear trade organizations,
industry, universities, and some States
supported the rule; private citizens,
waste treatment and disposal facilities,
environmental groups, and other States
and universities opposed the rule or
expressed concerns. We discuss the
major comments of both supporting and
opposing views by topic below.
In the preamble of the proposal we
specifically sought comment on dual
regulation. (See 64 FR 63469.) Of the 90
total comments, 77 from organizations
or individuals addressed dual
regulation, 61 of which expressed
support for a conditional exemption of
mixed waste. Several stated that the
exemption would provide important
and necessary regulatory flexibility for
LLMW. Others stated that EPA has
developed a sound and compelling
technical record for both the storage and
treatment of LLMW, as well as for off-
site transportation and disposal of
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LLMW and Eligible NARM in qualified
low-level radioactive waste disposal
facilities.
Our approach for addressing the issue
of dual regulation of LLMW was
opposed in whole or part by 16
commenters. Three commenters felt that
EPA should establish a Memorandum of
Understanding (MOU) with the Nuclear
Regulatory Commission to transfer
regulatory authority for mixed waste to
NRC and Agreement States. However,
an MOU would not allow EPA to
relinquish jurisdiction over the
hazardous portion of mixed waste. In
addition, these commenters did not
suggest how the NRC management
framework might be changed to provide
safer treatment and disposal of
hazardous wastes. Our regulatory
approach provides flexibility for mixed
waste storage, treatment, transportation
and disposal which addresses dual
regulation concerns, and received the
support of many generators who have
raised the issue of dual regulation to us
in the past.
B. Response to HWIR Consent Decree
The Edison Electric Institute (EEI), the
Utility Solid Waste Activities Group
(USWAG), and the Nuclear Energy
Institute (NEI)—trade groups
representing commercial nuclear power
plants—were parties to settlement
discussions regarding the deadline for
the final Hazardous Waste Identification
Rulemaking, ETC v. Browner, C.A. No.
94-2119 (TFH) (D.D.C.). On April 11,
1997, the court entered a consent decree
which required EPA to propose
revisions to the mixture and derived-
from rules, 40 CFR 261.3(a)(2)(iv) and
(c)(2)(i), and to seek comment on eleven
items listed in the decree with respect
to those revisions. (See EPA Consent
Decree, Ref. 1.) One of the eleven items
concerns an exemption from RCRA
hazardous waste disposal regulations for
low-level mixed waste generated by
nuclear power plants where such waste
is also subject to regulation by the
Nuclear Regulatory Commission. (See
Side-bar letter, Ref. 2.) The consent
decree required that the proposal also
request comment on other regulatory
relief for these wastes, if EPA finds that
any other relief would be appropriate.
(See ANPRM for further information.)
This decree requires that EPA take final
action on the proposal by April 30,
2001.
Today's rule provides regulatory relief
to LLMW generators and other
regulatory relief as described in this
document. In a separate notice, EPA is
revising the mixture and derived-from
rules. (See Docket #F-2001-WHWF-
FFFFF.) The revision includes an
exemption from the mixture and
derived-from rule for low-level mixed
waste that is managed in compliance
with the requirements in part 266,
subpart N. These two final rules satisfy
EPA's obligations under the consent
decree.
C. Response to Petition From USWAG
and Concerns of Other Mixed Waste
Generators
The Utility Solid Waste Activities
Group (USWAG), a national
organization of power companies,
petitioned the U.S. EPA on January 13,
1992 to amend RCRA Subtitle C
regulations governing storage of mixed
wastes. The USWAG organization cited
difficulties in complying with RCRA
Subtitle C regulations because of limited
treatment technology and disposal
capacity for some mixed wastes. (See
discussion in ANPRM for additional
information.) Today's action is our
response to the USWAG petition.
Policy of Lower Enforcement Priority for
Mixed Waste
Recognizing the limitations of
available technology and capacity, in
1991 EPA issued a policy on a lower
priority for enforcement of the storage
prohibition contained in 3004(j) of
RCRA for certain waste streams. (See 56
FR 42730; August 29, 1991.) Section
3004(j) prohibits storage of a waste
restricted from land disposal (including
the hazardous component of mixed
waste), except for the purposes of the
accumulation of such quantities of
hazardous waste necessary to facilitate
proper recovery, treatment, or disposal.
The lack of adequate treatment
technology or disposal capacity for
some mixed waste streams necessitated
mixed waste storage in violation of land
disposal restrictions. The policy stated
that violators who were faced with the
impossibility of complying with the
RCRA regulations, had a RCRA storage
permit, and were storing their wastes in
an environmentally responsible manner
would be a low enforcement priority for
EPA. Because treatment technology or
disposal capacity was still unavailable
for some mixed wastes, we extended
this policy in 1994, 1996 and again in
1998. The policy expires on October 31,
2001. (See 63 FR 59989, November 6,
1998.)
This rulemaking is intended to
provide flexibility to generators of
mixed waste where EPA requirements
are to a large extent duplicative of
performance standards required by the
NRC or NRC Agreement States. With the
promulgation of this rule, EPA is stating
its determination that facilities that
comply with certain criteria can safely
store mixed waste at NRC licensed
facilities. The prohibition for storage in
3004(j) will not apply to waste that both
meets the eligibility criteria of, and is
stored in accord with the conditions of,
this rule. Thus, the federal government
is providing with this rule a potential
option for mixed waste generators to
store mixed wastes legally. We
recognize that States are not required to
become authorized for this rule. States
may choose to be more stringent than
the federal RCRA program. However,
since many States have followed EPA's
lead on the enforcement policy, we
anticipate that most states will choose to
address the storage problem of concern
to mixed waste generators by adopting
this rulemaking.
IV. Precedent for Regulatory Flexibility
A. Military Munitions Rule
The flexibility of this rule is modeled
on the conditional exemption developed
for waste military munitions in the
Military Munitions Rule published
February 12, 1997 (62 FR 6622-6657).
(See 40 CFR part 266, subpart M.) The
Military Munitions Rule (MMR)
identifies when conventional and
chemical military munitions become
hazardous wastes subject to RCRA
Subtitle C. In the MMR, EPA developed
a conditional exemption to provide
regulatory flexibility to storers and
transporters of non-chemical waste
military munitions. EPA provided the
exemption for waste military munitions
because the Defense Department
Explosives Safety Board (DDESB)
standards apply to and are binding on
the military, and there is an institutional
oversight process within the military.
(See 62 FR at 6636.) Under the
conditional exemption, non-chemical
waste military munitions that normally
meet the definition of "hazardous
waste" are exempt from the regulatory
definition of hazardous wastes under
RCRA Subtitle C so long as the facilities
storing or transporting munitions meet
all of the conditions listed in the rule.
(For the complete text of the Military
Munitions Rule preamble, see 62 FR
6621, February 12, 1997.)
The U.S. Court of Appeals for the D.C.
Circuit upheld all aspects of the MMR
in Military Toxics Project v. EPA, 146
F.3d 948 (D.C. Cir. 1998). The court
agreed with EPA that "Congress has not
spoken directly to the issue of
conditional exemption," and upheld as
reasonable EPA's interpretation that
3001(a), which requires the
Administrator to promulgate criteria for
identifying and listing wastes that
should be subject to Subtitle C
requirements, allows the use of
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conditional exemptions. (Id.) The court
also agreed with EPA that "where a
waste might pose a hazard only under
limited management scenarios, and
other regulatory programs already
address such scenarios, EPA is not
required to classify a waste as hazardous
waste subject to regulation under
Subtitle C." (Id. at 958.) For a more
complete explanation of the legal basis
for establishing a conditional exemption
under RCRA, see the preamble to the
Military Munitions Rule at 62 FR 6636.
Today's final rule recognizes the
safeguards which the NRG or NRG
Agreement State regulatory program for
low-level radioactive wastes already
provides during storage, treatment,
transportation and disposal. State
radiation programs address NARM
wastes under separate authorities.
B. Applying the Conditional Exemption
Concept to Mixed Waste
In the Military Munitions Rule, EPA
conditionally exempted from RCRA
Subtitle C regulation stored waste
military munitions and waste military
munitions transported from one military
owned or operated facility to another
that are subject to DDESB standards. We
take a comparable approach for
generators of LLMW in this rule, which
provides a conditional exemption for
the storage, treatment, transportation,
and disposal of LLMW that is subject to
NRG or NRG Agreement State
regulation. The exemption is based on
the NRG or the NRG Agreement State
licensing process and regulatory
requirements, and their adequacy in
addressing risks from both radioactivity
and RCRA hazardous constituents. By
promulgating a conditional exemption,
we can eliminate redundant or dual
requirements where wastes are managed
safely; the NRG-required safeguards are
in place (for example, inspection,
recordkeeping, reporting); and penalties
or other consequences may be imposed
if the governing regulatory framework is
not followed. Taking these features
together, EPA concludes that these
wastes should not be regulated under
Subtitle C, because the NRG regulatory
framework ensures protection of human
health and the environment.
1. Evaluation of NRG Storage and
Treatment Requirements
The NRG was created as an
independent agency by the Energy
Reorganization Act of 1974, which
abolished the Atomic Energy
Commission (AEG) and moved the
AEC's regulatory function to NRG. This
act, along with the Atomic Energy Act
of 1954, as amended, provides the
foundation for regulation of the nation's
commercial nuclear power industry.
The NRC's scope of responsibility
includes regulation of commercial
nuclear power reactors; non-power
research, test, and training reactors; fuel
cycle facilities; medical, academic, and
industrial uses of nuclear materials; and
the transport, storage, and disposal of
nuclear materials and waste.
NRG regulations are issued under the
United States Code of Federal
Regulations (CFR) Title 10, Chapter 1.
Regulation of LLMW is addressed
through the issuance of regulations
including those found in 10 CFR parts
20, 30, 35, 40, 50, 61, 70, and 71. NRG
interprets these regulations and offers
guidance on how licensees should
comply with them through numerous
Criteria, Regulatory Guides, Generic
Communications, and NRG Reports.
Licenses that are issued on the basis
of NRC's regulatory system allow
entities to manage nuclear materials
including wastes. Conditions of these
licenses are enforced by NRC's Office of
Enforcement, which oversees, manages,
and directs the development and
implementation of policies and
programs for enforcement of NRG
requirements. The system in place
provides a comprehensive framework
for the safe management of the various
forms of waste generated by the nuclear
industry, including LLMW. The NRG
shares with EPA a common
responsibility to protect the public
health and safety.
In considering a conditional
exemption from RCRA Subtitle C
regulation for storage and treatment of
low-level mixed waste generated by an
NRG or NRG Agreement State licensee,
we evaluated certain key factors. First,
we reviewed the licensing requirements
and NRG standards for the storage and
treatment of LLW to determine whether
NRG regulation of stored low-level
waste adequately protects against
possible risks from RCRA hazardous
constituents in mixed waste. Although
NRG regulation and oversight are
designed primarily to address risks
posed by radiation, the NRG, the
regulated industry, and others have
argued that these standards largely
duplicate RCRA requirements and also
protect against risks to human health
and the environment posed by
hazardous waste.
Second, we compared NRG low-level
waste and EPA hazardous waste storage
and treatment requirements. (See Ref. 4,
EPA Comparison of Storage and
Treatment Requirements, for details.)
We found that activities performed by a
licensee to safely store, treat, or address
the release of the radioactive component
of mixed waste also resulted in the safe
management of the hazardous waste of
the LLMW matrix. This result is
attributable to the nature of mixed
wastes—that is, migration of hazardous
constituents does not occur except in
the presence of radionuclides. Our
analysis was conducted independently
of similar studies performed by
USWAG, the Electric Power Research
Institute, and the Nuclear Management
and Resources Council, Inc. (who
represent members of the power
generation industry). (See proposal F-
1999-ML2P-FFFFF, Ref. 6 and 16 for
the industry studies.) These other
studies concluded that the technical
design and operating standards of the
NRC meet or exceed RCRA standards in
virtually all respects, though the other
studies note differences in
implementation and emphasis (for
example, NRC requirements are
performance based whereas EPA's
requirements under RCRA are
prescriptive. NRC licenses are
specifically tailored to the site, whereas
RCRA permits are based on national
standards.)
Third, we reviewed the compliance
history of licensed facilities. We
investigated a variety of NRC produced
violation summaries for the years 1993-
1998. These reports included: Office of
Enforcement Annual Report-Fiscal Year
1996; Office of Enforcement Annual
Report-Fiscal Year 1997; and Escalated
Enforcement Actions Issued Since
March 1996 for Reactor Licensees (Last
Updated August 14, 1998). For
Agreement States, Integrated Materials
Performance Evaluation Program NRC
Reviews were analyzed for 17 States.
We looked at these and other records for
documentation of incidents involving
the storage and on-site treatment of
radioactive wastes by LLMW generators
who are licensed users of radionuclides.
Our review found that, with few
exceptions, the sampled NRC licensed
facilities had excellent low-level waste
management safety records. (See
proposal F-1999-ML2P-FFFFF, Ref. 3,
EPA's compliance record review.) Based
on our evaluation of these factors, we
concluded that low-level mixed wastes
stored and treated at these facilities are
safely managed and not likely to pose a
threat to human health and the
environment.
Two environmental groups suggested
that EPA should undertake research on
the potential synergistic effects of
radioactive and hazardous constituents
in wastes with the goal of making
exposure standards for protecting
individuals more restrictive. We note
that NRC requires licensed facilities to
manage LLW (in both the design of the
facility and in its standard operating
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procedures) to prevent releases,
explosions, fume generation, accidental
ignition, and reaction of ignitable wastes
that could result from improper mixing
or from instability of some LLW. In
addition, one of the conditions for the
storage exemption is that generators
must store low-level wastes in tanks or
containers in compliance with chemical
compatibility requirements, to prevent
chemical interactions. (See § 266.230
[b][2].) Management of the waste
adhering to these requirements will
avoid potential synergistic effects
during storage, or avoid impairment to
human health or the environment. The
disposal exemption requires both
treatment to the levels specified in the
Land Disposal Restrictions, and
placement in specific types of
containers prior to disposal at a Low-
Level Radioactive Waste Disposal
Facility. Moreover, existing NRG
requirements prohibit the disposal of
liquid wastes in LLRWDFs. The Agency
concludes that potential synergistic
effects have been addressed because
these conditions must be met to qualify
for and maintain a conditional
exemption, and the conditions are
designed to ensure no contact, or
minimal contact, between the waste
materials and human and
environmental receptors. Finally, EPA is
not aware of any such synergistic effects
being documented for the waste types
being exempted, and has no reason to
suspect them. The current system of
dual regulation does not take any such
effects into account. Should EPA
determine in the future that such effects
exist, it could re-evaluate the
protectiveness of the NRC regime. In the
meantime, EPA believes the conditional
exemption will be as protective as the
current system.
2. Review of NRC Disposal
Requirements
In considering the transportation and
disposal conditional exemption, we also
evaluated certain key factors. First, we
compared EPA's and DOT's hazardous
waste manifest and transportation
requirements with NRC's and DOT's
low-level radioactive waste manifest
and transportation requirements. We
found that the waste tracking and
transportation requirements for LLW are
either equal to or more restrictive than
those required by EPA for treated RCRA
hazardous waste. DOT concurred with
our assessment that the transportation
requirements for LLW are equivalent, if
not more restrictive than, the
transportation requirements for a RCRA
hazardous waste that has been treated
and has met LDR treatment standards.
(See Ref. 19, Discussion with DOT on
Mixed Waste Transportation on August
1999.) As a result, requiring compliance
with RCRA hazardous waste manifest
and transportation requirements would
be redundant and, therefore,
unnecessary.
Second, we compared EPA's disposal
requirements with NRC's LLW disposal
practices and requirements. We
reviewed NRC requirements and the
practices of low-level waste disposal
facilities to determine if NRC provides
levels of human health and
environmental protection similar to
RCRA Subtitle C protection for
permitted disposal facilities. (See
proposal F-1999-ML2P-FFFFF, Ref. 7,
Technical assessment of LLRWDFs.)
Our review indicates that NRC
regulations for disposal facilities
provide protection comparable to that
provided by RCRA particularly given
that we are requiring that the RCRA
hazardous constituents be treated to
LDR treatment standards, and that the
waste be placed in certain types of
containers prior to disposal. We believe
that LLMW and Eligible NARM treated,
placed in containers, and disposed of at
these facilities are not likely to pose a
threat to human health and the
environment. Therefore, RCRA Subtitle
C regulation for these wastes is not
necessary to ensure protection of human
health and the environment.
V. How Are the Final Storage and
Treatment Provisions Different From
the Proposal?
The final rule contains a number of
language changes to respond to
comments, including changes to make
the wording for storage and treatment
exemption more closely parallel to the
wording for transportation and disposal
exemption. However, the final rule
maintains the conditional exemption for
storage, treatment, transportation, and
disposal. The changes to our proposal
for storage and treatment are highlighted
below, and are discussed in greater
detail in Section VI of this preamble.
The changes to our proposal for
transportation and disposal are
highlighted in Section VII, and are
discussed in greater detail in Section
VIII of this preamble.
A. Streamlined Language
In the final rule we have streamlined
the eligibility criteria and conditions to
remove overlapping and, according to
some commenters, redundant language.
For example, in our proposal we had
said that to be eligible for this
conditional exemption LLMW must be
managed under an NRC or NRC
Agreement State license. We also had
listed a condition that you must have a
valid NRC license. We have dropped
this overlapping language. In another
example, our proposal included a
condition which stated that you must
meet the eligibility criteria. However, it
is obvious that if you do not meet the
eligibility criteria you cannot claim the
exemption. The condition was not
necessary as the threshold eligibility
criteria must be met first. We note that
while eligibility criteria are considered
threshold matters, your waste must
continue to meet the eligibility criteria
to remain exempt.
We moved two of the eligibility
criteria we specified in our proposal.
(See 64 FR 63498, § 266.225.) These
criteria were related to waste storage
which meets the requirements of your
license for storing LLW and storage in
compliance with chemical compatibility
requirements. These provisions appear
in the final rule in § 266.230 as
conditions that you must meet and
maintain.
B. Eligibility Revisions
In the final rule we have specified
that LLMW eligible for the exemption
must be generated and managed by you
under a single NRC or NRC Agreement
State license. This language replaces the
proposed language "stored on-site." The
change was based upon comments
received on this provision. (See in-
depth discussion in Section VI of this
preamble.)
C. Clarifications Related to Inventory
and Treatment
Commenters indicated the language
we used in the proposal related to the
frequency of inventory and the types of
acceptable treatment was not clear. In
the final rule we have clarified that an
annual, not quarterly, inventory is
required. Regarding treatment, we have
clarified that types of treatment
allowable are those that can be done in
a tank or container and are allowed
under the terms of the NRC or NRC
Agreement State license. These
clarifications have been made in
§266.230 and §266.235.
D. Recordkeeping Requirements
In our proposal, recordkeeping
requirements appeared in two places.
We have removed the recordkeeping
requirement under the inventory
condition proposed as § 266.230(f) and
consolidated all recordkeeping
requirements in § 266.250 of the final
rule. Commenters had found the
references in our proposal redundant
and unclear. We have also clarified that
you must keep records relating to
meeting the eligibility criteria, and
meeting and maintaining the conditions.
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These records form the basis of your
claim for the exemption.
In addition, compliance with NRC or
NRC Agreement State recordkeeping
provisions relating to the storage of your
waste is no longer a condition in
§ 266.230. Instead, we are requiring you
to keep these records as a RCRA
requirement in § 266.250 under the
authority of sections 2002 and 3007 of
RCRA. This change responds to
comments received, and means that you
no longer automatically lose the
conditional exemption for your waste
for failure to maintain records, though
you may be subject to enforcement to
ensure compliance and may be assessed
RCRA fines and penalties if your
records are not complete and accurate.
If you fail to meet the recordkeeping
requirements, you must take prompt
action to return to compliance and to
correct inaccurate information in your
records. You must be able to
demonstrate with your records that your
waste is eligible and you meet the
conditions for the exemption. In
addition we included in § 266.240
language from the proposal (at
§ 266.245) relating to terminating your
conditional exemption for serious or
repeated noncompliance with any
requirement of subpart N. (See further
recordkeeping discussion in Section
VI.A.4.d.)
E. Implementation
Commenters were confused regarding
how RCRA closure applied to existing
storage units. We have clarified that
interim status and permitted facilities
that have storage units which are used
only for storage of conditionally exempt
low-level mixed waste do not need to go
through RCRA closure, but should seek
modification of their permits or revise
their interim status closure plans after
the date this conditional exemption goes
into effect. (See detailed discussion in
VI.A.4.g.)
VI. Discussion and Response to Major
Comments on the Storage and
Treatment Conditional Exemption
A. Storage and Treatment—General
Discussion of Provisions
We are promulgating today a
conditional exemption from RCRA
Subtitle C requirements for storage and
treatment of low-level mixed waste in
qualified tanks or containers. (See 51 FR
10168, March 24, 1986 regarding waste
treatment in tanks or containers.) This
regulatory flexibility for storage and
treatment applies to any generator of
LLMW who is licensed by NRC or an
NRC Agreement State to manage
radioactive materials. Note, the storage
and treatment conditional exemption is
available only to low-level mixed wastes
generated under a single NRC or NRC
Agreement State license. The
conditional exemption for LLMW
applies only while the waste is stored
and/or treated in tanks or containers by
the generator, and exempts the stored or
treated waste from the regulatory
definition of hazardous waste found in
40 CFR 261.3. Prior to storage and/or
treatment, all relevant regulations
related to hazardous waste generators in
40 CFR part 262 apply. In most cases,
where exempted wastes are immediately
placed in storage, subpart A would
apply. When waste is removed from
storage or treatment and is transported
to any facility with another NRC license
(other than to a LLRWDF under the
provisions of 40 CFR 266.305), 40 CFR
262.30 through 262.34 and part 262
subpart D will apply.
LLMW must be eligible under
§ 266.225, and generators must meet the
conditions listed in § 266.230. The
storage and treatment exemption will be
valid only as long as the eligibility
criteria and conditions are met.
During storage or allowable treatment
of conditionally exempted LLMW, the
generator will not be required to have a
RCRA permit for the conditionally
exempt waste or meet other RCRA
Subtitle C requirements. The storage
and treatment conditional exemption
applies only to LLMW and does not
affect other RCRA hazardous wastes a
licensee may generate. A RCRA permit
may be required for management of
those other wastes depending on the
circumstances. In such cases, facilities
might decide to identify and locate
conditionally exempt stored wastes
separately from other stored wastes
(whether storage by the generator for
less than 90 days or permitted storage).
In the regulatory language, we
describe which wastes are eligible for
the storage and treatment conditional
exemption (§ 266.225), what conditions
a generator must meet to qualify for the
exemption (§ 266.230), and how the
exemption will be implemented
(§ 266.240 through § 266.260). Under
this rule, if you fail to meet the specified
conditions, your LLMW is no longer
exempted from regulation as a
hazardous waste.
1. What Wastes Are Eligible for the
Storage and Treatment Conditional
Exemption? (§ 266.225)
Low-level mixed waste meeting the
definition in § 266.210 is eligible for a
storage and treatment conditional
exemption if it is generated and
managed by you under a single NRC or
NRC Agreement State license. Mixed
waste generated at a facility with a
different license number and shipped to
your facility for storage or treatment
requires a RCRA permit and is ineligible
for this exemption. The types of
facilities that may have LLMW eligible
for the storage and treatment exemption
include nuclear power plants, fuel cycle
facilities, pharmaceutical companies,
medical and research laboratories,
universities and academic institutions,
hospitals, and some industrial facilities.
a. Eligibility provisions and changes
from storage and treatment proposed
regulatory language. The eligibility
provision covers two prerequisites that
must be met for the waste to be eligible
for the storage and treatment
conditional exemption:
1. The waste must be a LLMW;
2. The waste must be generated and
managed by you under a single NRC or
NRC Agreement State license.
We realize there may be instances
where one NRC or NRC Agreement State
license number might apply to more
than one non-contiguous unit. (For
example, a generator such as a
university may have a storage unit that
is not contiguous to the main generating
campus, but has the same NRC license
number.) In the event that a generator
must ship to another non-contiguous
storage area under the same NRC
license, the rule allows for the shipment
of the waste either from the point of
generation to the storage location, or
from one storage point to another
storage or treatment point with the same
NRC license number. In the event of a
shipment, the hazardous waste
manifesting requirements remain in
effect, as the eligible waste is still a
hazardous waste until such time as it is
place in the accumulation storage area.
Storage areas will not need a RCRA
permit in the case where only LLMW is
stored. However, shipment of exempted
waste to these storage areas may occur
as they will be considered designated
facilities for the purpose of this rule,
since they continue to be safely
regulated under their NRC licenses. (See
letter from Elizabeth Cotsworth to J.D.
Givens, dated March 27, 1998, Ref. 20.)
Storage may, therefore, be either at the
generating site or at your accumulation
storage unit with the same NRC or NRC
Agreement State license number as that
under which the waste was generated.
i. Waste is a LLMW (Excludes
NARM). We are finalizing a conditional
exemption for LLMW because of the
dual regulation to which it is subject.
NARM does not meet the definition in
§ 266.210 of low-level mixed waste. We
heard from several commenters on
NARM. Some assumed we had included
NARM as eligible for the storage
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exemption; others suggested we do so.
To clarify what we intended, eligible
NARM in the proposal applied only to
the conditional exemption for
transportation and disposal. NARM is
not included as a waste eligible for the
storage and treatment conditional
exemption because that exemption is
based upon our study of NRG or NRG
Agreement State management practices
for stored waste. NARM is not regulated
by NRG but by individual states or other
federal agencies. We did not study State
licensing procedures for managing
NARM. Therefore, we have not included
NARM waste containing hazardous
waste in the storage and treatment
conditional exemption because it was
beyond the scope of our research
relating to safe storage and treatment of
LLMW.
ii. Waste is generated and managed by
you under a single NRG license. In the
proposal, we stated that having an NRG
license was a condition. However, we
now recognize that it was redundant to
require an NRG license provision as
both a prerequisite for eligibility and a
condition. Therefore, we have deleted
the license provision as a condition, and
retained it as a prerequisite for
eligibility. If, at any time, a facility
ceases to be subject to an NRG or NRG
Agreement State license, then LLMW
managed at the facility would become
ineligible for the storage and treatment
conditional exemption and would
become subject to RCRA Subtitle C
regulation. Similarly, if the waste has
decayed to background levels, and
ceases to be subject to LLW regulation,
then the waste becomes subject to RCRA
Subtitle C. (See VI.A.4.e.) The
conditional exemption is predicated on
our finding that NRG regulations and
oversight provide the controls necessary
to ensure that the hazardous portion of
an exempted waste will not be
mismanaged. It is the NRG license or
NRG Agreement State license, issued
and enforced by an independent
government agency, that assures proper
management during exempt storage. A
majority of commenters agreed with the
appropriateness of requiring an NRG
license.
Many commenters specified that the
storage and treatment conditional
exemption should not apply to DOE
wastes because DOE is not subject to
oversight by an independent regulatory
agency. States expressed similar
concerns in comments submitted to us.
In addition, based on site treatment
plans resulting from the Federal Facility
Compliance Act of 1992, DOE and
States have reached agreement on
compliance orders regarding
management of mixed wastes at DOE
facilities. We do not intend to affect or
disrupt these compliance orders. We
continue to believe that DOE's storage
and treatment of low-level mixed wastes
raises additional and more complex
issues. Therefore, as proposed, we are
not extending the storage and treatment
conditional exemption to DOE.
In this rulemaking, we have relied
upon our thorough studies of the safety
of generator management of LLW at
facilities operating under a single NRG
or NRG Agreement State license. These
studies indicate that management of the
hazardous component of LLMW under
an NRG or NRG Agreement State license
is unlikely to pose a threat to human
health and the environment. We have
changed the eligibility criteria from
LLMW generated "on-site" (as stated in
our proposal) to "under a single NRG or
NRG Agreement State license." This
change from a prescribed RCRA
definition of location to an NRG
definition is in keeping with the
flexibility we have sought in
management of stored mixed waste
under one regulatory framework. Our
study did not focus on licensees who
commercially store and treat waste for
other generators. We therefore allow
LLMW you generate under a single NRG
or NRG Agreement State license to be
eligible for a storage and treatment
conditional exemption.
b. Differences from proposed
eligibility for storage and treatment
exemption. These final eligibility
criteria differ from those proposed in
§ 266.225 for stored low-level mixed
waste. Our proposal said LLMW "is
eligible for a conditional exemption if
managed subject to NRG or Agreement
State regulations, and if it is: (a)
Generated at your facility * * *; (b)
stored on-site in a tank or container
meeting the requirements of your NRG
or Agreement State license for storing
low-level waste; and (c) stored in
compliance with chemical compatibility
requirements. * * *"
We have moved the references in the
proposal at § 266.225(b) "stored in a
tank or container" and (c) "stored in
compliance with chemical compatibility
requirements." These provisions are
combined as a condition in the final
rule language at § 266.230(b)(2). The
condition must be met initially and
maintained in order to keep the
exemption. The exemption is
automatically lost if the conditions are
not met. (See discussion related to loss
of the exemption in § 266.240.)
Similarly, the proposed eligibility
criteria in §266.225(b), "* * * meeting
the requirements of your NRG or
Agreement State license for storing low-
level waste," has been moved. In the
final rule it is at § 266.230(b)(l) and
refers specifically to the requirements of
your license that apply to proper storage
of low-level radioactive waste. Note that
the requirements of your license which
relate solely to recordkeeping are
identified under the reporting
requirements in § 266.250. This
separation of safe management of the
waste from the records relating to waste
management was based on comments
received, which argued that the
automatic loss of the conditional
exemption should be for improper
management, and not solely for failure
to maintain records.
Another change in the final rule
language at § 266.225 relates to the
replacement of "on-site" with "under a
single NRG or NRG Agreement State
license." We received numerous
comments relating to the question of
limiting the conditional exemption to
LLMW stored "on-site." We had
specifically requested comment related
to use of the term "on-site" to describe
stored wastes meeting our proposed
condition and the "appropriateness of
extending a conditional exemption to
facilities that own or operate
consolidated storage facilities that do
not meet our current definition of "on-
site." (See 64 FR 63472.) In our
preamble, we had also sought comment
on a related issue—"whether the
conditional exemption should include a
storage facility which serves as a
consolidation point for a single entity."
(See 64 FR 63472.)
We received a large number of
comments in response to these requests.
Most of them recommended that we
include, within the scope of the
conditional exemption, storage of
LLMW at facilities that do not meet the
RCRA definition of "on-site" in 40 CFR
260.10. Commenters gave several
reasons. Several commenters in support
of centralized facilities (and commercial
TSDFs) believed that consolidation of
waste storage would reduce risks to the
public because, unlike accumulation
areas, centralized facilities are designed
for longer term storage. Some of the
commenters indicated that applying the
RCRA "on-site" definition to limit the
exemption would result in operational
and administrative inefficiencies. These
inefficiencies include the need for
multiple storage facilities each with its
own inventory and inspection schedules
and emergency plan. Some commenters
indicated that organizations, such as
universities and medical institutions,
store LLMW at generator owned and
operated facilities and under their NRG
licenses are able to store LLW for decay.
However, the consolidation points these
organizations use may not meet the "on-
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site" definition, nor have a single RCRA
permit number. A few of the total
commenters noted that consolidation
areas were covered by their NRC
licenses and were not considered
commercial facilities. Several stated that
a license under NRG may cover several
non-contiguous facilities or generation
points that all are owned by one
institution.
We agree with these commenters that
the consolidation of LLMW in a
specially designed and operated
consolidation facility will enhance
protectiveness and is more efficient than
maintaining multiple storage facilities.
A number of commenters recommended
that we allow LLMW to be transferred
from the point of generation (even if off-
site) to a centralized waste management
facility. We agree as long as the mixed
waste is managed under the same NRG
or NRG Agreement State license
number. This approach will promote the
safe handling of LLW in centralized
waste management facilities designed
for radioactive waste management and
decay-in-storage and facilitate
compliance with ALARA principles,
which seek to reduce exposures and
which govern NRG LLW management.
(For further discussion see background
documents, Ref. 3, "Review? of Waste
Management Practices" and Ref. 4
"Comparison of EPA's RCRA and NRC's
Licensing Requirements.")
We also received a small number of
comments opposing an expansion of the
exemption to consolidation areas or
storage facilities that do not meet the
"on-site" definition. (See 40 CFR
260.10.) Some of these commenters
maintained that EPA had not explained
why management of LLMW should be
different from hazardous waste. Others
stated that covering off-site generated
wastes may cause generators to lose
control of their wastes and may create
opportunities for abuse. We disagree
with these reasons for not expanding
our rule to include off-site consolidation
points under a single NRC license
within the storage conditional
exemption. The overall NRC mandate is
for protective management of LLW. (See
Energy Reorganization Act of 1974,
Public Law 93-438, 42 U.S.C. 5801(a).)
We explained in our proposal that the
NRC management framework is
imposed on the waste generator by
virtue of their NRC or the NRC
Agreement State license. Since it is the
controls imposed by this license that
provide the basis for the exemption, it
makes most sense to have the scope of
the exemption be the same as the scope
of the license. The "on-site" concept in
RCRA serves principally to govern the
scope of the RCRA permit exemption for
hazardous wastes that are accumulated
by a generator for a limited time period
with limited controls. That concept has
no bearing on this rule since the basis
for the exemption created today is the
protectiveness afforded by another
regulatory program.
Further, we do not believe a generator
will lose control of the waste. The
LLMW must be generated and
consolidated in a storage area operated
under the same NRC license as the
waste was generated. First, as stated
above, the waste must be manifested
from the generation point to the storage
site. In addition, control is maintained
by the license and by the conditions that
the waste be inventoried annually and
inspected quarterly. The NRC or NRC
Agreement State framework provides
safe management of both the chemical
and radiological hazards associated with
LLMW. Such management is provided
in addition to the license and "tie-
down" conditions by adherence to
NUREG-0933, "A Prioritization of
Generic Safety Issues," and by
regulations like 10 CFR 61.56, which
include many features related to the
physical and chemical characteristics of
the waste. This management framework
provides safeguards against abuse as
expressed in the concerns of these
commenters. In short, the NRC, or NRC
Agreement State, licensing scheme
provides substantial controls over waste
managed under an NRC license. The
commenter here provided no basis to
believe that the NRC scheme fails to
control the movement of waste, and
EPA is not aware of any basis.
c. Treatment and storage facilities
managing LLMW from other generators.
We are not extending the conditional
exemption to those mixed waste
facilities that manage wastes from other
licensees. We requested comment on
whether we should include in the
conditional exemption for storage and
treatment those mixed waste facilities
that manage wastes from other
generators. (See 64 FR 63473.) Some of
the commenters addressed the issue of
whether the scope of the conditional
storage exemption should be expanded
to include waste treatment and storage
facilities that manage wastes from other
generators. Many of those who did
comment urged EPA to allow
commercial storage and treatment
facilities that manage LLMW from other
generators the opportunity to claim the
conditional storage exemption. These
commenters cited several reasons to
support their position. One reason given
was the need of small businesses (for
example, one-time or sporadic LLMW
generators) who lack sufficient space for
storage and decay to have a place to
store their waste. A second reason was
that the NRC and NRC Agreement State
regulatory framework, which safely
addresses storage, should also be
sufficient for storage or treatment of
wastes off-site, provided the off-site
facility meets the conditions of the
exemption. Commenters arguing the
second position said that storage
facilities would be able to accept wastes
for storage that they currently cannot
accept due to regulatory restrictions.
Other commenters, however, maintain
that EPA should not expand eligibility
for the conditional storage exemption to
commercial storage facilities. These
commenters believe NRC regulations are
not as protective of human health as are
RCRA waste management requirements;
NRC provides less rigorous oversight of
storage facilities as compared with
nuclear power plants; NRC lacks
enforcement authority over hazardous
constituents; and storage facilities
would have difficulty keeping track of
exempt waste and separating it when
necessary. One commenter indicated
that commercial storage facilities
already have RCRA permits so there
would be little burden reduction if they
were to operate under a conditional
storage exemption. Other commenters
stated that allowing storage facilities to
operate under the storage exemption
would place an additional burden on
the host communities. Because
commercial storage facilities are in the
"business of managing such materials
for compensation," some commenters
maintained the commercial storage
facilities should have RCRA permits and
not be eligible for the conditional
exemption.
While there may be some small
businesses that would benefit as a result
of an expansion of the conditional
exemption to commercial storage
facilities, small businesses that generate
only small quantities of waste are
eligible under RCRA regulations for
conditionally exempt small quantity
generator (CESQG) status. (See 40 CFR
261.5.) If it is eligible for CESQG status,
a small business may be conditionally
exempt from RCRA regulatory
requirements based on the very small
volume of hazardous wastes or acutely
hazardous wastes which they generate.
If it is not a small quantity generator,
commercial storage facilities (without
an exemption) are still available for
waste storage (up to one year) and
treatment under current regulations.
We also disagree with some of the
reasons offered by commenters
opposing extending the conditional
exemption to waste managed at
commercial storage facilities. The focus
of this regulatory effort from its
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inception has been limited to a response
to expressed concerns of generators
regarding overlapping regulation of
mixed waste still under their control
(i.e., at their licensed facility). We did
not comprehensively evaluate
commercial storage facilities storing
wastes for other licensees given the
focus of the rule and limitations of time.
While we asked for information
regarding the relevance of the rule to
commercial facilities that manage
wastes from other generators, we did not
receive data to support opening the
exemption to commercial facilities.
Although we believe that the quantities
of waste shipped to these facilities
could be small, some question still
remains as to the long-term effect of
commercial storage facilities on the
management of LLMW. For example,
while we do not establish a time limit
on the storage of conditionally exempt
waste, we continue to believe that it is
highly desirable to have a system under
which waste is stored for short periods
of time before being sent for treatment
and disposal. Even without a regulatory
time limit, a generator has incentives
(such as capacity limitations,
management costs and the rising trend
in disposal costs) to move waste stored
at its facility from storage to treatment
and disposal. (See section VI.A.4.e.iii.)
A commercial storage facility may have
reduced incentives to minimize storage
time, since a commercial facility is more
likely to have excess capacity to account
for fluctuations in waste shipments. In
addition, since storage is the main
business of such facilities, they are less
likely to view waste storage as an
ancillary operation to be kept to a
minimum. We agree with those who
argue that most commercial TSDFs are
permitted and should remain so. In
addition, by limiting the scope of the
exemption to storage and treatment at
facilities operating under the same NRC
or NRC Agreement State license, the
compliance orders which DOE has
signed with States pursuant to the FFCA
will not be affected. In summary,
because we did not thoroughly evaluate
commercial facilities, and the other
issues associated with these facilities, at
this time we are not expanding the
storage and treatment conditional
exemption to include storage facilities
in the business of treating and storing
other licensees' wastes.
2. What Conditions Must You Meet To
Qualify for and Maintain a Storage and
Treatment Exemption? (§ 266.230)
a. Initial condition to qualify—you
must notify the Director of your claim.
Under § 266.230(a), to qualify for the
storage and treatment conditional
exemption, you must notify the Director
in writing by certified delivery that you
are claiming a conditional exemption
for a storage unit containing low-level
mixed waste. Your notification must be
signed by your authorized
representative, as defined in 40 CFR
260.10, who certifies that the
information in the notification is true,
accurate, and complete. You must notify
the RCRA regulatory authority of your
claim either within 90 days of the
effective date of this rule in your State,
or within 90 days of when a storage unit
is first used to store conditionally
exempt LLMW.
You, as the party claiming the
conditional exemption, must be able to
demonstrate that your waste and storage
unit meet the eligibility criteria and all
the conditions. Notification is necessary
because it provides the Director with a
record of your claim for the exemption.
Your notification is self-implementing,
although we may use our inspection and
information collection authorities to
verify whether you are meeting the
conditions. You will not receive a notice
of approval from EPA or the Director.
i. Cross reference to proposed rule.
The rule language is reordered, but the
wording related to notification is
substantively the same as in proposed
§ 266.230(d). We reordered the language
to improve the clarity of the final rule.
(See 64 FR 63472.)
ii. Comments we received on storage
and treatment notification. We received
a number of comments regarding storage
and treatment notification. The majority
asked that we require generators to
notify either the EPA Regional
Administrator or the Director. Several
commenters mentioned a preference
that state hazardous waste programs be
notified. Other commenters thought the
notification should also be sent to NRC.
These commenters also thought that we
should require additional information in
the notice, such as:
• The scope of activities and type of
mixed waste,
• Radiological and chemical
characteristics,
• The RCRA waste codes,
• The expected length and method of
storage (container or tank type),
• Where waste storage and treatment
will take place,
• The type of treatment, and
• A copy of the emergency plan and
the NRC license, including the license
number and expiration date of the NRC
license.
As a result of these comments, we
have more clearly spelled out in the
notification language in § 266.230(a)
basic information which is readily
available to a mixed waste generator and
which specifically identifies that
generator, waste code(s), and storage
unit(s). In the final rule, the dated
notification must include your name
and address, RCRA identification
number, NRC or NRC Agreement State
license number, the waste code(s) and
storage unit(s) for which you are seeking
an exemption, and a statement that you
meet the conditions of subpart N. We
note that some of the information
requested by commenters is
unnecessary and could change after the
initial notification. The purpose of the
notification is to identify and notify, not
to provide a management plan for the
waste. Based on our studies, we can
confidently rely on the NRC
management framework for
conditionally exempted LLMW. The
Director will have access to information
substantiating your claim in the records
you are required to keep. We do not find
it is necessary to impose a requirement
to provide all of this information in the
notification. In particular, providing a
copy of the NRC license would be
burdensome as it is readily available for
a site inspection and is generally quite
lengthy. In addition, today's conditional
exemption is based on the
protectiveness of the NRC regulatory
scheme, not on a license-by-license
review?. In any event, much of this
information will be available to a RCRA
inspector during a site visit from records
that a generator is required to maintain.
Of course, after the Director receives
your initial notification, information
may be requested using information
gathering authorities if needed for any
reason.
One commenter suggested an annual
status report with projected dates for
treatment, shipment, and disposal. We
do not agree with this suggestion
because a status report adds a recurring
reporting burden that is not necessary to
protect human health and the
environment. Since projected dates for
treatment, shipment, and disposal may
change a status report does not provide
useful information regarding safe
management. The information is also
irrelevant to any of the conditions for
the exemption. The fact that a RCRA
inspector may follow-up at any time on
the claim of exemption to verify that the
conditions are met should provide
sufficient opportunity to gather needed
information. The notification, coupled
with the management of this waste
under NRC or equivalent NRC
Agreement State regulations, provides
information on who is managing exempt
waste and assurance regarding its safe
management. If a generator fails to
comply with the eligibility criteria, or
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27229
any of the conditions, the generator
must notify the Director of the failure
under § 266.240(a).
b. Conditions to maintain the storage
and treatment exemption (§ 266.230(b)).
i. Store waste in tank or container in
compliance with storage requirements
of your NRC or NRC Agreement State
license.
In the final rule, we state that you
must "store your low-level mixed waste
in tanks or containers in compliance
with the requirements of your license
that apply to the proper storage of low-
level radioactive waste (not including
those license requirements that relate
solely to recordkeeping)." This
condition had been an eligibility
provision in the proposed rule at
§ 266.225(b). In the final rule, the waste
management aspects of this condition
(relating to storage under your NRG or
NRG Agreement State license) have been
separated from the recordkeeping
aspects related to storage of your LLW.
We believe that adherence to NRG
licensing requirements is important to
the safe storage of the hazardous portion
of the LLMW stream. In the proposal,
we requested comment on whether this
condition should include the loss of the
exemption if any LLW storage
requirement of the NRG license is not
met; or restrict loss of the exemption to
those violations which may result in an
environmental impact. (See 64 FR
63472.)
Comments Received on Compliance
With License Storage Requirements
We received numerous comments on
this aspect of the rule. Most of these
comments expressed the view that the
storage and treatment conditional
exemption should be lost only when
NRG license noncompliance is
specifically related to waste
management, and only in situations that
may result in adverse environmental
impact. Many reasons were given for
this view. Commenters expressed
concerns for cycling in and out of the
exemption because of minor non-
compliance such as misspelled names
or incorrect phone listings in the
emergency plan. Commenters pointed
out that NRC can cite a licensee for
failure to comply with the licensee's
own internal procedures, so a licensee
could be in violation of an NRC license
condition without any adverse health or
environmental impact, or release of
hazardous constituents.
Commenters compared failure to meet
the requirements of the NRC license
with failure to meet RCRA permit
requirements. Correction of the failure is
required, and the Director may impose
a fine or penalty, but the permit is not
automatically lost for such a failure.
(However, the Director does have the
ability to revoke a permit for significant
non-compliance. See 40 CFR 270.41 and
270.43.) Commenters indicated that
many kinds of errors can be easily
corrected, and should not trigger the
loss of the exemption nor subject the
generator to RCRA Subtitle C regulation.
Conversely, other commenters thought a
generator should lose the exemption for
failing to meet any NRC LLW storage
requirement. These commenters said
that it would provide a powerful
incentive for generators to comply with
the conditions.
We believe that the loss of the
exemption for failure to meet any NRC
LLW storage requirement, including
minor requirements not directly related
to safe storage, is unwarranted and not
necessary to protect human health and
the environment. As noted above, the
consequence of failure to meet a RCRA
permit requirement is not the automatic
loss of the permit. Based upon
comments supporting a specific
condition relating to waste management,
and the difficult situations which
commenters have brought to our
attention, we have revised the condition
in§266.230(b)(l)toread, "* * * in
compliance with the requirements of
your license that apply to proper storage
of low-level radioactive waste.* * *"
The final rule does not limit the loss of
the exemption to events causing adverse
environmental impact, but strikes a
balance by specifying a loss of the
exemption when noncompliance with
the condition is related to waste
management. We believe it would create
considerable uncertainty and great
difficulties for purposes of enforcement
and compliance assurance, if the RCRA
status of the waste turned on the
judgment of whether a particular
violation might cause an adverse
environmental impact.
The recordkeeping requirements
related to your NRC license have been
moved to section § 266.250. Upon
consideration of the comments, we have
concluded that reporting compliance is
better treated as a requirement rather
than a condition. First, given the logic
of the conditional exemption, it seems
artificial to say that a waste which is not
"hazardous" under the RCRA regulatory
definition becomes "hazardous" if a
report contains an inaccuracy, even if
the waste is still being properly
managed. In addition, we agree with the
commenters that we should not create a
system under which the storage and
treatment exemption can be easily lost
for minor or inadvertent infractions.
Finally, we believe the final rule scheme
retains a strong incentive for
compliance with recordkeeping
requirements. Again, in striking a
balance based on comments we
received, we provide language in
§ 266.240(b) that the Director may
terminate an exemption, or specify
additional conditions, for repeated or
serious noncompliance with the
requirements of subpart N. (See
proposal at § 266.245(b).)
ii. Store waste in compliance with
chemical compatibility requirements.
You must "store your low-level mixed
waste in tanks or containers in
compliance with chemical compatibility
requirements of a tank or container in
40 CFR 264.177, or 264.199, or 40 CFR
265.177, or 265.199." The rule requires
that the waste be compatibly stored in
tanks or containers. This condition is
found in § 266.230(b)(2) in the final
rule. For clarity, this provision has been
moved from § 266.225(c) in our
proposed rule where it was required for
eligibility. The proposed rule language
stated LLMW is eligible "if it is: * * *
(c) Stored in compliance with chemical
compatibility requirements of a tank or
container (See § 264.177, or § 264.199 of
this chapter), or (§ 265.177, or § 265.199
of this chapter)." The language in the
final rule is essentially the same as in
the proposal. We received a number of
comments on eligibility provisions in
the proposal. However, none was
directed at the proposed eligibility
requirement in § 266.225(c) relating to
compliance with chemical compatibility
requirements. We have therefore
retained this provision as a condition
and emphasize the importance of
meeting this condition to retain the
conditional exemption for storage.
iii. Certify that personnel are trained
in hazardous waste management. You
must certify that facility personnel who
manage stored mixed waste are trained
in a manner which ensures that the
conditionally exempt waste is safely
managed and includes training in
hazardous waste management and
hazardous materials incidents response
that meets the personnel training
standards found in 40 CFR
265.16(a)(3)." Personnel managing the
waste must be trained in identifying and
providing initial response to a release of
hazardous constituents as well as in
managing radioactive waste. As part of
the notification process, you must
certify by a written statement that
personnel managing stored LLMW are
appropriately trained. This condition at
§ 266.230(b)(3) is the same as our
proposal where it appeared at
§266.230(e).
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Comments on Storage and Treatment
Related to Training
We received a comment that similar
training was already required by NRC or
an NRG Agreement State license; the
commenter felt that the training
condition could be deleted. Other
commenters believed that proper
training was critical, and that the
training condition as written in the
proposal was reasonable. We
determined, based on our studies, that
added training in chemical waste
management was important to assure
protection of human health and the
environment. We, therefore, agree with
these latter commenters. One
commenter objected to the need to
certify that personnel had been trained,
and recommended we drop the
certification. We used the word
"certify" because we believe that
training in hazardous waste
management is critical. The certification
ensures that the LLMW facility will
verify compliance with the training
requirements. It provides an assurance
to commenters who expressed concerns
about the ability of personnel trained in
safe management of radioactive
materials also to manage hazardous
wastes safely, and respond to hazardous
materials incidents. The certification
also ensures that a record is available for
review by an inspector, enabling
verification that all personnel involved
in managing or handling the exempt
stored wastes are aware of the potential
hazards of the hazardous portion of
these wastes.
iv. Inventory and inspect your waste.
You must "conduct an inventory of your
stored low-level mixed waste at least
annually and inspect it at least quarterly
for compliance with this paragraph (part
266 subpart N)." An important part of
assuring that you comply with the
conditions in today's rule is the
condition that you perform regular
inspections of the areas in which you
store exempted waste, as well as an
annual inventory of the waste to detect
any loss or other mismanagement. We
received comments that the proposal
was unclear as to what inventory
frequency we intended.
Revision to Inventory Language From
Proposed Storage and Treatment
Exemption
In our November 1999 proposal, at
§ 266.230(f), we said, "Inventory your
stored low-level mixed waste at least
annually; inspect it at least quarterly for
compliance with the other conditions of
the paragraph; update your inventory
records of conditionally exempt LLMW
quarterly; and maintain records for three
years.*
*" Several commenters
requested that we clarify the inventory
frequency; they did not know if we
meant an annual or quarterly inventory.
We had intended that generators
conduct an inventory annually.
Therefore, we have deleted the reference
to "update your inventory records of
conditionally exempt LLMW quarterly."
The annual inventory records, copies of
the generator's notification of additional
claims for conditional exemption of
storage units, and records of all
shipments for treatment or disposal
since the annual inventory will be
available to an inspector. These records
will enable an inspector to gain access
to a complete file of all conditionally
exempt LLMW storage units and to
verify the amount stored at any given
time. Our proposal addressed records
requirements in § 266.230(f) and
§ 266.250. We have consolidated
required records maintenance in
§266.250.
v. Maintain an accurate emergency
plan (§ 266.230[b][5]). You must
"maintain an accurate emergency plan
and provide it to all local authorities
who may have to respond to a fire,
explosion, or release of hazardous waste
or hazardous constituents. Your plan
must describe emergency response
arrangements with local authorities;
describe evacuation plans; list the
names, addresses, and telephone
numbers of all facility personnel
qualified to work with local authorities
as emergency coordinators; and list
emergency equipment." In our proposal,
nearly identical language was found in
§ 266.230(g). However, in proposed
§ 266.230(g) we also provided at the end
of the paragraph the following reference:
"(See 40 CFR part 265, subpart D.)." The
reference caused confusion. We had
intended this reference to serve to
identify those aspects of a contingency
plan and emergency procedures
necessary for managing hazardous
wastes during an emergency. Several
commenters interpreted that reference
as serving as guidance in the
development and maintenance of an
emergency plan; others interpreted the
reference as a requirement. Because we
enumerate, within the rule language, the
essential components of the RCRA
emergency plan, we have dropped the
reference. However, the regulations at
40 CFR part 265, subpart D can continue
to provide guidance concerning the
necessary elements of a comprehensive
emergency plan.
c. Modifications to proposed storage
and treatment conditions. We have
modified the storage and treatment
exemption conditions listed at § 266.230
in the proposed rule as described below.
First, we moved the proposed
condition to have a valid NRC or
Agreement State license (proposed as
§ 266.230[a]) from the conditions
section to the eligibility section
(§ 266.225). We made this change
because this is best described under
eligibility. Before your waste can qualify
for the conditional exemption, your
waste must be eligible, i.e. managed
under an NRC or NRC Agreement State
license. If your waste is not eligible, it
cannot be conditionally exempt from
RCRA Subtitle C regulation. Eligibility
criteria are threshold provisions.
Second, we deleted the condition to
meet the eligibility criteria (proposed as
§ 266.230[c]) because we determined
that this was basic. A generator could
not claim the exemption without first
meeting (and maintaining) the eligibility
criteria.
Third, we maintained the condition
that you notify the regulatory authority
in writing by certified delivery that you
are claiming a conditional exemption
for your low-level mixed waste
(proposed as § 266.230(d) and finalized
as § 266.230(a)). Your notification must
be signed by an authorized
representative of your establishment
who certifies that the information in the
notification is true, accurate, and
complete. You must notify your
regulatory authority of your claim either
within 90 days of the effective date of
this rule in your State, or within 90 days
of when a storage unit is first used to
store conditionally exempt low-level
mixed waste. Your dated notification
must include identifying information
such as your name and address, your
RCRA generator ID number, your NRC
license number, and the name of your
authorized representative signing the
notice. In addition, your notification
must indicate that you meet all the
conditions for the exemption, and
indicate the waste and storage unit for
which you are claiming the exemption.
Fourth, both to streamline the
regulatory language, and to make clear
the conditions that you must meet and
maintain for your waste to qualify for
the conditional exemption, we
combined and moved the eligibility
criteria proposed in § 266.225(b) and (c)
to § 266.230(b). Based on comments we
clarified these conditions that must be
met and maintained.
We received considerable comment
on whether claimants should be
required to comply with all the
requirements of their NRC or NRC
Agreement State license, or with just
those provisions that related to the
management of conditionally exempt
LLW (i.e., those provisions, which if
violated, could result in an
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environmental impact from the
exempted waste). In response, we
modified the proposed condition that
claimants must be in compliance with
the requirements of their license for
storing LLMW (proposed as
(§ 266.230[b]). This modification
resulted in the condition
((§ 266.230[b][l]), which requires you to
store your LLMW in tanks or containers
in compliance with the requirements of
your license that apply to the proper
storage of LLW (not including those
license requirements that relate solely to
recordkeeping).
The remaining conditions—proposed
as § 266.230(e), (f), and (g)—are being
finalized as § 266.230(b)(3), (4), and (5),
respectively. Specifically, claimants still
must:
• Certify that facility personnel who
manage stored conditionally exempt
LLMW have been trained in a manner
that ensures that the conditionally
exempt waste is safely managed and
includes training in chemical waste
management and hazardous materials
incidents response that meets the
personnel training standards found in
40CFR265.16(a)(3);
• Conduct an inventory of your stored
conditionally exempt LLMW at least
annually and inspect it at least quarterly
for compliance with part 266 subpart N;
and
• Maintain an accurate emergency
plan and provide it to all local
authorities who may have to respond to
a fire, explosion, or release of hazardous
waste or hazardous constituents. Your
plan must describe emergency response
arrangements with local authorities;
describe evacuation plans; list the
names, addresses, and telephone
numbers of all facility personnel
qualified to work with local authorities
as emergency coordinators; and list
emergency equipment.
3. Treatment (§266.235)
a. Treatment Clarification. In the
proposed § 266.235, we allowed
treatment of LLMW by generators in a
tank or container covered by the
provisions of their NRC or NRC
Agreement State licenses, but we
excluded "thermal treatment, such as
incineration." The proposal was
intended to make the storage and
treatment conditional exemption
consistent with the types of treatment
NRC currently allows in a tank or
container. By excluding thermal
treatment we inadvertently have
excluded some treatment (for example,
drying processes) which the NRC has
allowed in tanks or containers. It was
not our intent to limit treatment
currently allowable in tanks and
containers. We, therefore, revised the
regulatory language in § 266.235. Our
clarification reflects the level of
flexibility originally intended. As we
explain below, however, forms of
treatment that are done in units other
than tanks and containers are not
exempt from RCRA Subtitle C
requirements. Treatments such as
incineration, molten salt and super
critical water oxidation would not be
exempt and would require a RCRA
permit.
b. Comments received on treatment.
We heard from a number of commenters
regarding the conditional exemption for
treatment of LLMW in tanks and
containers. As discussed below, the
majority of the commenters approved of
the conditional exemption for treating
LLMW at a generator's NRC licensed
facility in tanks and containers, many
noting that this option would provide a
valuable opportunity to process waste at
their facilities for safer storage and
disposal. However, a number of
commenters requested that we consider
expanding the scope of the exemption to
include thermal treatment, while a few
commenters requested that we not allow
generators to conduct any form of
treatment without a RCRA permit.
i. EPA should reconsider allowing
treatment. We heard from several
commenters who specifically requested
that EPA reconsider any exemption of
any storage or treatment activities
involving LLMW from the RCRA
permitting requirements. One
commenter believed that when it comes
to LLW and LLMW, the NRC appears to
be more concerned with radionuclides
than the potential chemical hazards.
Thus the commenter said EPA should
consider which treatment and storage
processes, as defined under RCRA,
require permitting and which processes
may be exempted due to small scale,
low risk of personal or environmental
hazard, or similar concerns.
Another commenter, citing experience
as a fully licensed and permitted mixed
waste TSDF, is concerned that the
treatment, transportation, and disposal
exemptions are premised upon a
generator being able to treat its waste
properly to meet LDR requirements. The
commenter stated that experience has
proven treatment to be a highly
technical process requiring the proper
equipment, the proper treatment
formulae, and careful monitoring. The
commenter noted that a treatment
failure could result in the subsequent
closing of the "disposal facility as a
RCRA Subtitle C facility, if the waste
cannot be retrieved or if its hazardous
constituents cannot be delisted."
Another commenter stated the
treatment exemption is redundant
because generators already are allowed
to treat and store RCRA wastes
(including LLMW) without a RCRA
permit within 90 days, and questioned
whether we intended to capture the
spectrum of legacy wastes. The
commenter opposed our extension of
the conditional exemption to legacy
wastes. The commenter alleged that
many wastes have already been stored
for numerous years despite existing
treatment and disposal capacity because
of cost reasons. The commenter stated
that the exemption would allow LLMW
generators to further delay the treatment
and disposal of legacy wastes. The
commenter concluded that extended
treatment and storage of LLMW is in no
way protective of human health or the
environment.
We disagree with the commenters'
assertions that the storage and treatment
conditional exemption is not protective
of human health and the environment.
We agree that the NRC licensing
framework for storage and treatment of
LLMW is geared primarily to protection
against radiological hazards through
treatment and containment of
radionuclides. However, one of
Congress' purposes in establishing the
NRC is to "advance the goals of
restoring, protecting, and enhancing
environmental quality, and to assure
public health and safety." (See Energy
Reorganization Act of 1974, Pub. L. 93-
438, 42 U.S.C. 5801(a)).
This statutory purpose is reflected in
NRC's mission statement. "The mission
of the U.S. Nuclear Regulatory
Commission (NRC) is to ensure
adequate protection of the public health
and safety, the common defense and
security, and the environment in the use
of nuclear materials in the United
States." (See http://www.nrc.gov.)
Therefore, EPA and NRC share a
common mandate to protect human
health and the environment.
Moreover, we conducted studies and
analyses to determine the protectiveness
of the NRC's regulatory framework for
managing LLW. (See 64 FR 63497;
Section VII., Supporting Documents.)
We determined that the various
management requirements with regard
to treatment, primary and secondary
containment, inspections, etc., provide
protection for the hazardous
constituents in the mixed waste that is
comparable to the protection provided
by RCRA. We found that NRC has
extensive experience with waste
compatibility and stability. For
example, NRC requires facilities to
consider the chemical properties
(including ignitable, reactive, and
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explosive properties) of their LLW both
in the design of the LLW facility, and in
writing the standard operating
procedures for the facility and
associated waste handling systems,
storage containers, and storage areas to
prevent accidental mixing of
incompatible wastes. The intent of the
NRC licensing and EPA RCRA programs
are equivalent in that both programs
require the anticipation, recognition,
and prevention of accidental ignition,
reaction of reactive wastes, releases,
explosions, and fume generation
resulting from improper mixing
procedures or from the inherent
instability of some wastes.
Our studies also included a review of
the storage and treatment compliance
record of a number of licensees.
Violation rates at these facilities
compared favorably with RCRA
facilities and demonstrate that NRG
licensed facilities operate under a
regulatory scheme that assures that
waste is protectively managed. Based on
our studies we concluded that NRG
storage and treatment regulations and
license requirements regarding storage
and treatment are at least as stringent
and protective of human health and the
environment as RCRA's Subtitle C
system. (See "Comparison of the EPA's
RCRA Requirements and the NRC's
Licensing Requirements for the
Treatment [In Tanks & Containers] and
Storage of Low-Level Mixed Wastes at
Nuclear Facilities," Final Document,
April 2001, Ref. 4.) Therefore, we will
allow NRC licensees to treat LLMW in
tanks and containers. We note that
today's rule is consistent with existing
RCRA regulatory interpretation which
allows treatment in tanks and containers
by a generator without a permit. (See 51
FR 10168.)
With regard to the commenter who
was concerned with generators' being
able to treat their wastes to the
applicable LDRs and the potential
consequences a LLRWDF, we note that
the majority of the volume reduction
and chemical stabilization and
encapsulation processes that these
generators currently conduct at their
facilities in tanks and containers are no
different from the treatment processes
used at RCRA permitted commercial
TSDFs. While some generators may
have to request a license modification to
change their current processes (for
example, add a stabilization step) to
meet the LDRs, this adjustment would
be approved under the auspices of the
generator's license. In addition, an NRC
or NRC Agreement State licensed
LLRWDF may require testing data, and/
or conduct verification testing itself, to
document that wastes meet the
applicable LDR treatment standards
prior to the acceptance and subsequent
disposal of these treatment residues. In
any event, there are potentially
significant enforcement consequences if
the waste does not attain LDRs,
providing a strong incentive for the
parties involved to meet LDR levels. If
a generator is uncertain of its ability to
treat its waste to comply with LDRs, the
generator has the option of sending the
waste to a permitted TSDF for
treatment, or of continuing to store the
waste until permitted treatment capacity
exists.
We disagree with the commenter's
characterization of legacy wastes as
wastes that could have been treated
years ago, but were not because of cost
issues. As the commenter noted, many
of these wastes have been in storage for
several decades; these wastes remained
in storage because legacy wastes, by
definition, are wastes for which
treatment or disposal capacity does not
exist. Although the federal government
and industry have conducted significant
research on innovative waste treatment
and management methods, much more
needs to be done before acceptable
treatment processes and management
methods are developed for all legacy
wastes. In addition, siting of new low-
level radioactive waste disposal
facilities continues to be difficult.
Finally, there appears to be some
confusion on the part of commenters as
to the time period allowed for treatment
by a generator under this exemption.
Today's rule allows generators to treat
their mixed waste in tanks and
containers at their facilities in
accordance with the terms of their NRC
or NRC Agreement State license without
a permit and without a time constraint,
in view of the protection afforded by the
NRC scheme.
ii. EPA should broaden the scope of
treatment in the storage and treatment
conditional exemption. We heard from
a number of commenters who
specifically requested that we consider
widening the scope of the conditional
exemption to approve thermal treatment
if allowed under the generator's NRC or
NRC Agreement State license. Many of
these commenters were concerned that
the prohibition proposed in § 266.235
on conducting any form of thermal
treatment would inappropriately bar
otherwise sound LDR treatment options
for mixed waste containing organic
constituents. Though these commenters
did not raise objections to our ban on
incineration, they believed that the
practical effect of the thermal treatment
prohibition was that treatment of any
mixed waste containing organic
constituents would have to be
conducted off-site at RCRA permitted
mixed waste commercial treatment,
storage, and disposal facilities,
assuming any are available. Some of
these commenters noted that there are
numerous thermal technologies that are
not, or do not rely on incineration or
"open flame combustion," including
evaporation, steam reforming, high
temperature catalytic oxidation, super
critical water oxidation, and molten salt
technology. Several of these
commenters stated that a blanket
prohibition against thermal treatment
could deter the development of new and
innovative treatment processes. They
argued that a complete ban on any type
of thermal treatment was overly broad
and unnecessary, limiting otherwise
viable, cost effective, and
environmentally sound treatments
available to NRC licensees. These
commenters further suggested that the
exemption should provide for a risk-
based variance mechanism from any
thermal treatment prohibition because
they believe such an approach would
provide a strong incentive for
innovative waste treatment vendors to
develop new and protective treatment
methods.
We also heard from several
commenters who wanted any treatment
option approved in an NRC or NRC
Agreement State license to be
permissible under the storage
exemption. They suggested that we
clarify treatment to reflect this. Some of
these commenters noted that
clarification is necessary because the
text proposed in § 266.235 could be
misinterpreted to limit treatment types
to solidification, neutralization, or
stabilization, when in fact, additional
forms of treatment (other than thermal
treatment) may be allowed under the
NRC or NRC Agreement State license.
Another commenter recommended that
we remove ambiguity by specifying
exactly what treatment options the
generator can expect to apply. That is,
the EPA should specify by code which
treatment options are considered
allowable treatment technologies, or
prohibited treatment technologies. Two
of the commenters also recommended
that EPA either delete the specific
examples referenced in the second
sentence of proposed § 266.235 or,
alternatively, make clear that they are
only examples to eliminate ambiguity.
Commenters also suggested that the
conditional exemption should be
modified to allow for treatment in other
than tanks and containers, provided that
it is carried out within a controlled area
such as a laboratory, is performed under
NRC or NRC Agreement State
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27233
regulations and approval, and that there
are no uncontrolled releases of
hazardous substances to the
environment. These commenters believe
that the NRC safeguards are an adequate
alternative to EPA permit requirements
for most aspects of treatment facility
operations.
We agree that the scope of the
conditional exemption should include
any type of treatment that generators
can conduct in tanks and containers at
their facilities in accordance with the
terms of their NRC or NRC Agreement
State license. As stated, we have revised
the regulation language to drop the
blanket restriction on thermal treatment
since we had not intended in the
proposal to limit the forms of treatment
that could be conducted in licensed
tanks or containers.
We are not, however, extending the
storage and treatment conditional
exemption to all forms of treatment that
might be allowed under a generator's
NRC or NRC Agreement State license.
We did a thorough comparison of NRC's
requirements for storage and treatment
in tanks and containers with RCRA
Subtitle C's requirements and
concluded that our regulations and
guidance governing generator storage
and treatment in tanks and containers
and NRC's are generally equivalent. (See
our background document "Comparison
of the EPA's RCRA Requirements and
the NRC's Licensing Requirements for
the Treatment [In Tanks and Containers]
and Storage of Low-Level Mixed Wastes
at Nuclear Facilities.") We did not do a
comparative study comparing what NRC
would require for treatment that occurs
outside of tanks and containers with
RCRA subtitle C requirements. For
example, we did not evaluate the
requirements NRC would impose on a
LLW incinerator with the requirements
that EPA would impose under 40 CFR
part 264 subpart O on a hazardous waste
incinerator.
For these reasons, consistent with
current regulations for accumulation of
waste in tanks and containers, we are
limiting the allowable forms of
treatment under the conditional
exemption for storage of LLMW to only
those forms that can occur in tanks and
containers. Treatment that could qualify
includes, but is not limited to, those
treatment types that occur within a tank
or container, such as certain forms of
thermal treatment, neutralization,
solidification, or other forms of
stabilization. The rule no longer cites
these examples, since they may appear
exclusive. We do not want to exclude all
technologies that might rely on some
degree of heat.
Finally, because this conditional
exemption relies upon waste handlers
monitoring their compliance with the
conditions, we do not believe that a
risk-based variance approach is
appropriate. Specifically, we do not
have the authority to require the NRC or
NRC Agreement States to implement the
risk-based variance approach for
specific treatment technologies (such as
incineration). Generators seeking
authority to construct and operate a
complex treatment process unit such as
an incinerator can apply for a RCRA
treatment permit under the current
regulatory system. Therefore, a variance
process would duplicate the current
RCRA permitting program.
4. Implementation of the storage and
treatment conditional exemption
a. Self-implementation. The storage
and treatment conditional exemption is
triggered by the claimant who generates
and stores the waste. To be eligible for
a conditional exemption for stored low-
level mixed waste you must notify the
Director of your claim for exemption of
your storage unit containing low-level
mixed waste and of your compliance
with all the conditions in § 266.230.
You do not need to wait for approval
from the State or Region with
jurisdiction over the RCRA mixed waste
program. However, you must be able to
demonstrate that your claim is accurate,
that your waste is eligible, and that you
meet the conditions and other
requirements specified in this rule. The
Director may use inspection and
information collection authorities to
verify whether your waste met the
eligibility provisions, you are meeting
the conditions, and you are complying
with all of the requirements.
RCRA section 3008(a) gives the
Director the authority to take
enforcement actions when you fail to
meet any of the provisions of the
conditional exemption. The appropriate
regulatory authority can take a direct
enforcement action against you when
you fail to meet a specific RCRA
requirement for your waste under this
conditional exemption such as the
notification or recordkeeping
requirement. When you lose your
exemption for your waste due to failure
to meet a condition of the exemption,
your waste is no longer exempted and
it becomes a RCRA hazardous waste.
The appropriate regulatory authority
can take enforcement action against you
for managing a hazardous waste without
complying with RCRA hazardous waste
requirements. As is the case under
current RCRA regulations, concerned
citizens also can bring to the regulator's
attention any circumstance that might
aid the authorities in monitoring and
enforcement efforts. A concerned citizen
also may file a suit under RCRA section
7002 against a generator for failure to
meet any of the provisions of the
conditional exemption. Lastly, the
Director can take actions using authority
under section 7003 and section 3013 of
RCRA, 42 U.S.C. 6973, when it is
determined that there may be an
imminent and substantial endangerment
to human health or the environment.
Comments Regarding Self-
Implementation
We received few comments on self-
implementation. One commenter who
supported our approach indicated it was
a practical way to implement the
exemption and consistent with other
EPA exemption programs, such as the
Military Munitions Rule. We agree.
Another commenter objected to self-
implementing rules as not protective,
and suggested we clearly specify
enforcement and penalty provisions.
Our studies conclude that regulation by
NRC or NRC Agreement States of low-
level radioactive waste protects human
health and the environment during
storage and treatment. In addition, our
approach requires reporting of any
failure to comply with the conditions of
the exemption and the automatic loss of
the exemption. We note this is similar
to the current system under RCRA in
which we rely upon reporting
requirements and inspections for
oversight.
The Director continues to have
authority to inspect or collect
information to verify independently the
safe management of stored exempt
waste. If a licensee reclaims a lost
exemption, any violation must be
corrected prior to the reclaim of the
exemption, and an explanation of steps
taken to prevent recurrence must be
described in the reclaim notification.
The Director can impose additional
requirements or conditions on a licensee
reclaiming an exemption, if appropriate.
If violations of conditions or
requirements demonstrate repeated and
serious failure to comply, the Director
may revoke a claim or reclaim of the
conditional exemption. We expect that
revocation would be an unusual event.
b. Loss of the storage and treatment
conditional exemption (§ 266.240). If
you previously claimed a storage and
treatment conditional exemption from
hazardous waste regulations and then
fail to meet a condition listed at
§ 266.230, we continued to require at
§ 266.240 that you report the specific
condition to the Director, and the NRC
or NRC Agreement State in writing by
certified delivery within 30 days of
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learning of the failure. Your report must
be signed by your authorized
representative certifying that the
information is true, accurate, and
complete. This report must include the
condition(s) you failed to meet, a
description of the LLMW and storage
location at the facility; and the date(s)
on which you failed to meet the
condition(s). If the failure to meet any
of the conditions may endanger human
health or the environment, you must
also immediately notify the Director
orally (within 24 hours), and follow up
with written notification within five
days. Failures that may endanger human
health or the environment include, but
are not limited to, discharge of a
CERCLA reportable quantity or other
leaking or exploding tanks or
containers, or detection of radionuclides
or hazardous constituents in the
leachate collection system of a storage
area. If the failure may endanger human
health or the environment, you must
follow the provisions of your emergency
plan. Note that failure to meet
recordkeeping and other requirements
may subject you to an enforcement
action requiring compliance, fines and
penalties, or both.
We also clarified in § 266.240(b) that
the Director may terminate your
conditional exemption or add
conditions to your exemption for
serious or repeated noncompliance with
any requirement(s) of subpart N. This
language had appeared under
§ 266.245(b) in the proposal.
Under § 266.240, your waste
automatically loses the storage and
treatment exemption when you fail to
meet any of the conditions in § 266.230.
If your stored waste no longer meets one
or more of the exemption conditions,
that waste will be fully regulated under
RCRA Subtitle C as a hazardous waste.
The conditions set forth in § 266.230 are
important, in conjunction with your
NRG license, to ensure that LLMW is
properly managed to avoid potential
adverse impact on human health or the
environment. In addition, the Director
may terminate your ability to claim a
conditional exemption for your waste
and storage unit, or require you to meet
additional conditions to claim a
conditional exemption, for serious or
repeated noncompliance with any
requirement(s) of subpart N. The
potential loss of the exemption resulting
from failure to meet a condition will
provide a strong incentive to properly
manage the waste.
Response to Comments on Loss of the
Storage and Treatment Conditional
Exemption
We heard from a number of
commenters in response to our specific
request on whether the conditional
storage and treatment exemption should
be lost when any of the LLW storage
requirements of the NRC or NRC
Agreement State license are not met, or
only when violations have occurred
which may result in an adverse health
or environmental impact. Several of
these commenters supported losing the
storage and treatment exemption when
any of the LLMW storage requirements
of the NRC or NRC Agreement State
license are violated. These commenters
believed that such a provision was a
strong incentive for ensuring that the
waste was managed properly. One of
these commenters also requested that
we retain a broad list of exemption
violations because a limited list
effectively suggests regulatory
compliance is unimportant. A different
commenter urged us to define the
exemption conditions as specifically as
possible to improve enforceability.
The majority of commenters,
however, opposed our proposal that the
generator would lose the storage and
treatment exemption when any of the
conditions of the exemption were
violated. These commenters asked that
we increase our specificity and limit the
loss of exemption to violations resulting
in actual endangerment of human health
or the environment. Many of these
commenters were concerned that the
storage and treatment conditional
exemption could be lost due to
relatively minor administrative
violations. In addition, although one of
these commenters agreed that generator
requirements are necessary to
demonstrate that the waste has been
properly managed, others believed that
the failure to comply with
recordkeeping requirements does not
represent an imminent threat to public
health and safety.
We also heard from a number of
commenters who believed that we
should build upon this concept of not
automatically terminating a storage and
treatment exemption for failure to
comply with all of the provisions of the
NRC or NRC Agreement State license to
preclude also the automatic termination
of an exemption for failure to meet any
of the conditions listed in § 266.230(a)-
(g). These commenters believed that we
should not revoke an exemption
because there was a violation of a
condition only. One of these
commenters cited our own research,
which indicated that NRC inspections
would ensure protection of human
health and the environment during the
storage period.
These commenters raised a number of
valid points. Specifically, we agree that
generators should not lose their
exemption because of violations of their
NRC or NRC Agreement State licenses
that do not bear directly on whether the
waste is being managed protectively on
a day-to-day basis. Also, we have
defined the exemption conditions
specifically to improve enforceability.
We note that NRC or NRC Agreement
States can also enforce if LLW is
improperly stored.
We did not intend to create a system
that would render waste "hazardous"
even though it is being managed in
conformance with all the substantive
conditions that EPA found to be
protective. Although the potential for
immediate return to RCRA regulation is
consistent with the Military Munitions
Rule, and may be necessary in some
instances, we believe that recordkeeping
violations (such as maintaining
paperwork on training certifications)
that you could promptly remedy, should
not result in automatically subjecting
you to all applicable RCRA permitting
requirements. We have modified the
conditions of the exemption so that you
do not lose the storage and treatment
conditional exemption automatically for
a violation of a recordkeeping
requirement associated either with your
NRC or NRC Agreement State license, or
today's rule. However, recordkeeping is
important. Violations will subject you to
enforcement, and repeated and serious
violation of recordkeeping or other
requirements could result in revocation
of your claim or reclaim of a storage and
treatment conditional exemption.
Finally, many commenters also
suggested a 30-day time period (or other
period of time as agreed to by the
agency) to reestablish compliance before
a generator risks losing the exemption.
The commenters noted that failure to
meet exemption conditions subjects the
waste generator to enforcement actions
from the regulatory agency having
jurisdiction. Many of these commenters
stated that the NRC or NRC Agreement
State regulations or license conditions
in effect during this time period should
be sufficient to ensure protection of
human health and the environment.
Two of these commenters said this 30-
day time period (or another time period
agreed to by EPA) and the opportunity
to reestablish regulatory compliance
should be allowed even in situations
where noncompliance results in
endangering human health or the
environment. We disagree; however,
facilities have other options for
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27235
reclaiming the storage and treatment
conditional exemption as soon as
practicable.
As we discussed above, we modified
the list of conditions so that only those
provisions that we believe pertain
directly to safe management of the waste
are included. As a result of these
changes, the storage and treatment
conditional exemption will not be lost
automatically for failure to meet a
recordkeeping requirement (unless the
Director determines that it indicates a
serious or recurring problem or decides
to revoke the reclaimed exemption
under § 266.245[b]). We have concluded
the conditions are, however, the
minimum necessary to ensure that
LLMW will be properly managed. We
believe that the threat of losing the
exemption for failure to meet any one of
the conditions listed at § 266.230 will
provide a strong incentive to properly
manage the waste. We note that if you
lose the storage and treatment
exemption, the affected waste would
return to the RCRA system as hazardous
waste, and you would have 90 days (or
up to 270 days if you are a small
quantity generator) to accumulate the
waste before it must be either shipped
off-site for treatment and disposal or
stored in a RCRA permitted storage unit.
You could also reclaim your storage and
treatment exemption, as long as you
again meet the conditions in § 266.230
and submit the required reclaim
notification.
c. If you lose your storage and
treatment exemption can it be
reclaimed? (§ 266.245). This conditional
exemption final rule creates a process
for the claim of a storage and treatment
exemption, for the loss of the exemption
in § 266.240, and for reclaim of the
exemption in § 266.245. The storage and
treatment exemption is automatically
lost at the time of noncompliance with
a condition. The Director does not need
to take action to revoke the exemption.
However, you may reclaim a lost
conditional exemption if you again meet
the conditions in § 266.230. You must
send notification of the loss of the
storage and treatment exemption due to
a failure to meet a condition before you
can reclaim the exemption. To reclaim,
you must send the Director a notice by
certified delivery that you are
reclaiming the exemption. Your notice
must be signed by your authorized
representative certifying that the
information contained in your reclaim
notice is true, accurate, and complete. In
your notice you must do the following:
• Explain the circumstances of the
failure;
• Certify that you have corrected each
failure that caused you to lose the
exemption and that the waste again
meets all conditions as of the date you
specify;
• Describe plans you have
implemented listing specific steps you
have taken to ensure that the conditions
are met in the future; and
• Include any other information you
want the Director to consider when
reviewing your notice reclaiming the
exemption.
The storage and treatment exemption
is automatically restored if you reclaim
the exemption and meet these
conditions. However, the Director may
terminate a reclaimed conditional
exemption if he finds that your claim is
inappropriate based on factors
including, but not limited to, the
following: you have failed to correct the
problem; you explained the
circumstances of the failure
unsatisfactorily; or you failed to
implement a plan with steps to prevent
another failure to meet the conditions of
§ 266.230. In reviewing a reclaimed
conditional exemption under this
section, the Director may add conditions
to the exemption to ensure waste
management during storage and
treatment of the LLMW will protect
human health and the environment. The
language of the final rule has been
reworded slightly for clarity, but is very
similar to the proposal.
Comments Received on Reclaiming a
Storage and Treatment Exemption
Many of the commenters who
addressed the issue of reclaiming a
storage and treatment exemption
suggested that we provide a 30-day
period during which a failure to meet a
condition could be corrected without
loss of the exemption. A small number
of commenters suggested we impose a
90-day waiting period before a lost
exemption could be reclaimed. One
reason given for this waiting period was
to allow regulators time to review
documentation and conduct inspections
before reinstating the exemption. A few
commenters stated that the exemption
should be maintained unless the
violations endanger public health and
safety. Another commenter stated the
reclaimed exemption should apply both
automatically and retroactively from the
date of the loss. Yet another commenter
stated that a licensee who loses a
conditional exemption should not be
allowed to reclaim it, and that the rule
should contain heavy penalties for
failure to meet one or more of the
conditions.
Based on our studies of NRC storage
requirements coupled with the
conditions we have specified, we find
that LLMW will be safely managed as
LLW. We believe that because the
reinstatement is available, it is
appropriate that a licensee who fails to
meet a condition is required not only to
correct the failure, but also to
implement procedures that would
prevent such a failure from recurring. A
large quantity generator of hazardous
waste generally has 90 days to ship
waste to a treatment or disposal facility
before a permit for storage is required.
This time period should provide
sufficient time to correct most violations
of the conditions. We have also
indicated that the Director may revoke
the reclaimed exemption if he finds the
reclaim to be inappropriate. In addition,
the Director may add conditions which
must be met for a reclaimed exemption
if deemed necessary to protect human
health and the environment. Thus, we
believe that the approach we have
developed here, which allows EPA to
devote its attention to facilities that
raise particular concerns (for example,
through inspections following the
receipt of a reclaim notification), is
protective, and more appropriate, than a
scheme that would impose a 90-day
waiting period on all facilities
reclaiming the exemption. Such a
scheme would make it very difficult for
the generator to obtain reinstatement
before becoming subject to the
requirement to obtain a RCRA permit—
a result that is unnecessary and
undesirable since the NRC scheme is
protective without a RCRA permit, and
since EPA does not anticipate that it
would typically choose to expend the
resources to inspect and review reclaim
requests during the proposed 90-day
period. After the failure has been
discovered by the generator or an
inspector, but before a reclaimed
exemption is in place, the generator may
be subject to an enforcement action
requiring compliance, or monetary
sanctions, or both for violations that
occur as a result of the loss of the
exemption.
We also disagree with the commenter
who stated that a licensee who loses a
conditional exemption should not be
allowed to reclaim it. Safeguards
provided by NRC or NRC Agreement
State oversight, coupled with the
reclaim process we have outlined will
provide both appropriate enforcement
and a mechanism to correct any failure
of the conditions. We believe these
safeguards will deter noncompliance
and will ensure that any violations are
quickly corrected.
d. Recordkeeping requirements for the
storage and treatment exemption
(§266.250).
An important part of assuring that a
generator is complying with the
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conditions in today's rule is mandating
the generator perform quarterly
inspections of the units and drums or
containers storing exempted waste, as
well as conduct an inventory of the
waste to prevent loss or other
mismanagement. You must keep records
of these activities to assure the Director
of consistent compliance with
exemption conditions. The annual
inventory records, coupled with records
of wastes placed in storage and records
of shipments for treatment or disposal,
will enable an inspector or other
regulator to view a complete file of all
conditionally exempt LLMW stored.
In our proposal, we used language
similar to § 266.230 in § 266.250. Our
intent was to ensure the availability of
a complete record for inspectors to
account for all stored conditionally
exempt LLMW. Because this language
appeared in two places in the
proposal—§§ 266.230(f) and 266.250—it
caused confusion. In the final rule we
have eliminated the redundancy and
combined all requirements relating to
recordkeeping in § 266.250. Generators
are responsible for demonstrating that
the conditions have been and are being
met, and must retain the necessary
records to substantiate that claim.
Violations of recordkeeping or other
requirements could subject you to
penalties and enforcement actions and,
if violations are repeated and serious,
could result in the revocation of your
storage and treatment conditional
exemption claim.
Comments Received on Recordkeeping
for the Storage and Treatment
Exemption
A few commenters addressed the
types of records we are requiring. One
commenter recommended we delete this
section because NRG and Agreement
States already have requirements for
inventory and records management,
objected that the frequency may conflict
with keeping occupational exposures
low, and requested an explanation for
three-year record retention if not
required by NRG. In response, we are
retaining § 266.250 because these
records relate to conditionally exempt
waste which can only be identified
through these records. We have clarified
that the frequency of inventory is
annual, thus minimizing the potential
for occupational exposure. The rule
requires record retention for three years
after disposal of the waste because this
is the general standard for RCRA record
retention. In the absence of the
conditional exemption ( for example, if
you lose the exemption), the waste
would have to be managed under RCRA
Subtitle C and records relating to the
waste need to be available. Note that in
some instances, NRC may require record
retention for longer periods, in which
case the records must be retained for the
time specified by NRC requirements
under 10 CFR part 20 (or NRC
Agreement State requirements). NRC
requirements always apply.
e. Return to RCRA of LLMW no longer
eligible for the storage and treatment
exemption (§ 266.255). For LLMW
containing short-lived radionuclides,
the storage and treatment conditional
exemption will be in effect only until
the radionuclide in the mixed waste has
decayed to a point that it is no longer
subject to NRC license requirements.
After the decay-in-storage process is
completed, the waste becomes subject to
RCRA Subtitle C requirements. Under
§ 266.255 of the final rule, your waste is
no longer eligible for the conditional
exemption when one of two things
occurs: (a) When "your LLMW has met
the requirements of your NRC or NRC
Agreement State license for decay-in-
storage and can be disposed of as non-
radioactive waste * * * " or (b) when
"your conditionally exempt LLMW,
which has been generated and stored
under a single NRC or NRC Agreement
State license, is removed from storage.
* * * However, your waste may be
eligible for the transportation and
disposal conditional exemption at
§ 266.305." In the first instance, our
intent with this language is to clarify the
applicability of the conditional
exemption during a decay-in-storage
time period and identify when RCRA
Subtitle C jurisdiction resumes. In the
second instance, we seek to make clear
that all RCRA regulatory requirements
apply during transport to a treatment or
disposal facility, unless the waste
qualifies for the transportation and
disposal exemption at § 266.305.
i. How does the storage and treatment
exemption facilitate decay-in-storage?
NRC generally allows research, medical,
and other facilities to store low-level
wastes containing radionuclides with
half-lives of less than 65 days (or more
under an amended license) until 10
half-lives have elapsed, and the
radiation emitted from the unshielded
surface of the waste (as measured with
an appropriate monitoring equipment)
is indistinguishable from background
levels. This process is known as decay-
in-storage. Our final rule facilitates
decay-in-storage by allowing LLMW
with short-lived radionuclides to remain
in storage until it is indistinguishable
from background levels of radioactivity.
The time allowed for LLW decay-in-
storage is based on the radionuclides
(and their half-lives) specified in a low-
level waste generator's NRC license.
Such management of LLW reduces
worker exposures to radionuclides since
workers are not exposed to wastes in
containers during preparation or
shipment to treatment and disposal
facilities. Once the specified
radionuclide decay has occurred, the
waste may be disposed of as non-
radioactive waste after you ensure that
all radioactive material labels are
rendered unrecognizable. (See 10 CFR
35.92 and 10 CFR 20.2001.) On that
date, your waste is subject to hazardous
waste regulation under the relevant
sections of 40 CFR parts 260-271, and
the time period for accumulation of a
hazardous waste as specified in 40 CFR
262.34 begins.
ii. Change from proposed language.
This language is essentially unchanged
from the proposed storage and treatment
exemption with the exception of the
reference to "under a single NRC or
NRC Agreement State license," where
the proposal stated "when your waste is
transported off-site." The change was
incorporated here to be consistent with
the eligibility requirements in § 266.225
of the final rule. We discuss the reason
for this change in this preamble under
section VI.A.l.
iii. Comments received on storage
time limits and decay-in-storage. The
comments we received on time limits
for storage and decay-in-storage focused
upon addressing the three areas on
which we requested comment in the
preamble. They are discussed below.
Determining RCRA Reentry for
Radioactive Decayed Waste
In our proposal, we stated that "We
would appreciate comments regarding
the standard to use for determining
when the decayed waste would reenter
RCRA Subtitle C management." (See 64
FR 63471.)
In both the proposed and final rule at
§ 266.255(a), the standard for
determining RCRA reentry is when your
LLMW has met the requirements of your
NRC or NRC Agreement State license for
decay-in-storage and can be disposed of
as non-radioactive waste. At that point,
management of any radionuclide in the
waste is no longer required by the NRC
or NRC Agreement State license. We
picked this time frame because it is at
this point that dual regulation ceases. It
is also familiar to NRC licensees.
Implementation will be clear, and will
not conflict with NRC regulations.
A number of commenters wrote to us
on this question. All but two supported
our proposal, which indicated our
reliance on NRC management during
decay-in-storage, and transfer to EPA's
RCRA Subtitle C oversight when decay
is complete for the radionuclides
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allowable under the NRC or NRC
Agreement State license provisions. The
two commenters who did not support
the time frame we proposed were
opposed to any conditional exemption
of LLMW from RCRA Subtitle C
management. These commenters believe
that having waste exit the RCRA cradle-
to-grave management system is contrary
to the fundamentals of RCRA.
The other commenters agreed the
transfer should occur on the date when
NRC considers the decay complete—
when the radionuclide with the longest
half-life in a container has decayed as
specified in the license (generally ten
half-lives), and when the radiation
emitted from the unshielded surface of
the waste is not above background
levels when measured by appropriate
monitoring equipment. One commenter
suggested that RCRA regulations should
apply when the licensee removes the
radiation label from the container—
when the radiation emitted is
indistinguishable from background
levels—since RCRA reentry on this date
would ensure continuous regulatory
oversight.
We appreciate the support of the
commenters who agree with our use of
the NRC standard for decay-in-storage.
Once the waste can be disposed of as
non-radioactive waste, the waste is
subject to hazardous waste regulation,
and time periods for accumulation
apply. We do not agree with the
commenters who broadly oppose any
conditional exemption because, as
stated earlier, we have found that NRC
or NRC Agreement State management of
this waste during storage, coupled with
the conditions we have specified in
§ 266.230, will ensure safe storage. In
the final rule, we have retained the
language in the proposal. We also
believe that the lower cost of disposing
of hazardous waste rather than LLMW,
coupled with RCRA Subtitle C generator
time limits (90-270 days depending on
applicable regulations) will ensure
timely waste management.
Appropriateness of Time Limit for
Storage and Treatment Exemption
In our proposal, we made the
following statement,
We are considering whether a general
storage exemption time limit should be
imposed. A time limit may affect both
facilities with untreatable legacy wastes and
future treatment and disposal capacity. We
invite comment on whether a time limit may
be appropriate, and, if so, on what basis that
time limit might be established. (See 64 FR
63471.)
The time limit for decay-in-storage is
established by the terms of the NRC
license. Under a decay-in-storage
scenario, LLMW is no longer subject to
NRC regulation when it has met the
requirements of your license for decay-
in-storage and can be disposed of as
non-radioactive waste. On that date
your waste is subject to hazardous waste
regulation under the relevant sections of
40 CFR parts 260-271, and the time
period for accumulation of a hazardous
waste as specified in 40 CFR 262.34
begins. If the decayed waste still
exhibits a RCRA hazardous waste
characteristic or is a listed hazardous
waste, then it must be shipped promptly
off-site for treatment, if needed, to meet
LDR treatment standards, and disposed
of at a RCRA compliant facility. Thus,
the RCRA accumulation time for a
formerly mixed—now solely
hazardous—waste begins when the
radionuclide with the longest half-life in
a container has decayed as specified in
the license (generally ten half-lives), and
the radiation emitted from the
unshielded surface of the waste is not
above background levels as measured by
appropriate monitoring equipment as
specified by NRC.
Some radionuclides take longer than
10 half-lives to decay to levels that are
indistinguishable from background. If
we limit the time for decay to ten half-
lives only, then some portion of LLMW
that is being stored may still emit
radiation levels above background. To
minimize radiation exposures, we have
used "and" in § 266.255 to ensure that
the LLMW does not emit radiation that
is above background levels as measured
by appropriate monitoring equipment.
In the final rule language, we defer to
the NRC practice for determining when
the waste can be managed as non-
radioactive and radioactive labels can be
removed.
For those mixed wastes which are not
undergoing decay-in-storage, the
majority of commenters, including one
State, agreed that the length of time that
a LLMW could be stored under the
conditional exemption should be that
which is allowed for LLW under a
facility's NRC or NRC Agreement State
license, because of the significant
management safeguards in place while
the mixed waste is subject to NRC or
NRC Agreement State regulations. Some
commenters indicated that the cost of
long-term storage and the rising trend in
disposal costs would provide an
incentive for generators to dispose of the
waste in a timely manner to limit their
overall costs for waste management.
One commenter stated the following,
"Limiting the conditional exemption by an
artificial clock will not improve on the safe
and responsible management of LLMW under
the NRC's jurisdiction. Instead it will * * *
divert limited resources. * * *"
A few commenters, including several
States, provided suggestions for time
limits we should impose for storage.
They suggest lengths of time from one
year, to two years, to three years, to an
unspecified limit based upon the
availability of treatment and disposal
capacity, particularly for legacy wastes.
Another commenter suggested a 5-year
limit be imposed. An organization of
state regulators commented that the
quantity of waste accumulated is
affected by the time period allowed and
suggested that EPA set a limit either of
time (3 years) or of capacity (volume).
Other commenters suggested we set a
capacity limitation of up to 10 kg
because the disposal of small quantities
of LLMW can be inefficient and
extremely costly. Another commenter
suggested that time limits be imposed
through site-specific variances, in
combination with capacity limitations
and conditions for storage.
We also heard from two commenters,
including one State, who believed a
time limit was inappropriate because
they opposed any exemption from
RCRA Subtitle C regulations, and
because NRC does not limit the volume
of waste that can be stored on-site. A
third commenter noted that RCRA
prohibits storage of mixed wastes
beyond specified periods, and no such
storage prohibition exists in AEA-based
regulations.
We agree with the large number of
commenters who stated that we should
adopt the NRC approach and not
establish a limit on the length of time
during which conditionally exempt
LLMW may be stored. Their underlying
argument was that the waste is safely
stored if provisions of storage in the
generator's NRC or NRC Agreement
State license are being met. Our study
of radioactive material storage indicated
that NRC requires a licensee to maintain
sufficient storage space to safely manage
these wastes. For example, a generator
must maintain sufficient aisle space for
inspections and emergency response
actions, and safeguards to limit
exposures to ALARA. While NRC does
not specifically limit the volume of
waste stored, it does place a maximum
on the radioactivity a licensee can
manage. This provision of an NRC
license serves to limit storage volumes.
In addition, NRC discourages the
accumulation of wastes that can be
treated and/or disposed of. (See Generic
Letter 81-38, "Storage of Low-Level
Radioactive Wastes at Power Reactor
Sites.") This fact, combined with cost
considerations—that long term storage
has associated management costs, and
that the rising trend in disposal costs
serves to encourage immediate rather
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than delayed disposal—provides an
incentive to generators to treat and
dispose of wastes and avoid
accumulation.
Another factor encouraging
immediate disposal is the present
uncertainty regarding access to existing
LLRWDFs for many generators, given
the present LLW Compact system. Our
analyses of the protectiveness of the
NRC regulatory framework for managing
LLW indicated that LLMW would be
stored in a manner that provided
protection to human health and the
environment equivalent to that based on
EPA's RCRA Subtitle C system. To limit
the storage time for wastes, including
legacy wastes, further than time periods
allowed by NRC or NRC Agreement
States would subject generators to
extraneous regulation without
significantly reducing the likelihood of
human health or environmental threats
arising from stored LLMW. Commenters
did not provide data which would assist
us in establishing a non-arbitrary basis
for choosing a time period for storage.
Potential Gap in Regulatory Coverage for
Decayed Waste
In our proposal, we invited comment
on whether waste being stored for decay
under 10 CFR 20.2001(a)(2) and 10 CFR
part 35 can be completely decayed
while at the same time reenter RCRA
Subtitle C without a gap in time during
which the waste is not regulated as
either hazardous or radioactive. We also
requested that you do the following.
"* * * [I] ndicate in your comment what
mixed wastes you generate that have
radionuclides with activity levels which
would not qualify for the conditional
exemption we are proposing if it were based
on whichever occurred first—ten half-lives of
decay or not registering above background
levels. Also indicate how this limitation
would affect your management of the waste."
(See 64 FR 63471.)
We note that an NRC licensee is not
required to monitor the waste
immediately after decay of 10 half-lives
to determine if the radiation emitted is
indistinguishable from background
levels. Prior to monitoring, there may be
an interval when the waste is hazardous
only. However, it is only when the
waste is monitored and the radiation
emitted declared indistinguishable from
background levels that the radioactive
waste labels on each container must be
removed. Our final rule indicates in
§ 266.255 that the waste would then be
subject to RCRA Subtitle C jurisdiction
for the hazardous wastes it contains.
A number of commenters responded
to our request regarding a gap in
coverage for decay-in-storage wastes.
Some of them asserted there would be
no gap if we relied on NRC provisions
which require the generator to obliterate
the container's radiation label once the
container has been surveyed by
appropriate monitoring equipment, and
the radiation level is determined to be
indistinguishable from background
levels. One commenter noted that NRC
requires documenting the release of the
material from NRC regulation. Such
documentation provides a date on
which appropriate RCRA Subtitle C
accumulation time periods would start.
Three commenters stated that if we
did not conditionally exempt LLMW
from the regulatory definition of
hazardous waste, then no gap in
coverage would occur. One of these
commenters did note that for decay-in-
storage waste, if we finalized a
conditional exemption, "RCRA control
would be gained upon destruction of the
radioactive label affixed on the waste
* * *"
We appreciate hearing the suggestions
of these commenters on eliminating a
potential gap in regulation, and we
agree that the date of the obliteration of
the radioactive label (as the NRC
requires) provides a documented and
certain date for applying RCRA
accumulation time periods.
iv. Effect on biennial reporting. Under
40 CFR 262.41, a generator who ships
any hazardous waste off-site to a
treatment, storage or disposal facility; or
who treats, stores or disposes of
hazardous waste on-site must submit a
biennial report covering those wastes.
Newly generated low-level mixed
wastes that are exempted under this rule
may be subject biennial reporting in
accordance with 262.41 since, as
generated, they are hazardous. Wastes
only become nonhazardous when they
meet the eligibility criteria and
conditions of subpart N. Wastes that are
exempted under today's storage and
treatment exemption may, as with other
RCRA wastes, again be subject to the
reporting requirements of 262.41 if the
waste is further managed outside the
scope of the exemption. The Hazardous
Waste Report Forms and Instructions
booklet (EPA Form 8700-13 A/B) for the
required reporting year explains who
must file the hazardous waste report,
and can be found at http://
www.epa.gov/epaoswer/hazwaste/data/
brsOl/forms.html
Finally, it should be noted that
today's final rule does not change the
ability of states to impose reporting
requirements above and beyond the
Federal requirements, e.g., annual
reporting or additional information
about the generated, treated, recycled, or
disposed hazardous waste.
f. Enforcement and enforcement
policy. You, as the RCRA generator and
NRC licensee, must be able to document
that your claim for an exemption is
accurate, that your waste is eligible, and
that you meet the conditions and
requirements specified in this rule. The
Director may use inspection and
information collection authorities to
verify whether you have met and
continue to meet the eligibility criteria,
the requirements, and the conditions.
Facilities that fail to meet any of the
conditions in § 266.230 for exemption
will be subject to RCRA Subtitle C from
the time that failure occurs. Utilities or
other LLMW generators that claim the
storage and treatment conditional
exemption, but fail to store and/or treat
the LLMW in compliance with the
conditions of the exemption, no longer
will be exempt from the applicable
provisions of RCRA. Failure to meet
requirements (in §§ 266.225 and
266.250) may result in an enforcement
action to ensure compliance, penalties
and fines. Moreover, imminent and
substantial endangerment provisions
under section 7003 of RCRA will
continue to apply to conditionally
exempt mixed waste as a safeguard
since the waste remains a statutory solid
and hazardous waste, so EPA can act in
the unlikely event of circumstances
which may pose a health or
environmental threat. All RCRA
statutory authorities that hinge on a
waste's being a statutory solid and
hazardous waste still apply (for
example, sections 3007, 3013). We
anticipate that most generators will be
able to correct a failure to meet the
conditions within a 90-day period and
reclaim the exemption, thus avoiding
any practical effect of losing the storage
and treatment exemption and becoming
subject to RCRA subtitle C regulation.
The storage exemption is based upon
the NRC's regulatory framework
governing the low-level radioactive
waste component of LLMW. The NRC
has a "General Statement of Policy and
Procedure for NRC Enforcement
Actions" (NUREG-1600) which states
the NRC's policy regarding enforcement.
This policy specifies significant
consequences for violating NRC or
license requirements and takes into
consideration the specific circumstances
of a particular case. For example, if a
nuclear power plant violates an NRC
license, or tie-down conditions of a
license (see definition at the beginning
of this preamble), the nuclear power
plant (and the responsible person) may
be subject to substantial civil and
criminal penalties. Based on NRC
regulations and this policy, licensed
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facilities have a strong incentive to
manage stored waste properly.
EPA Enforcement Policy Expiration
We intend to allow the mixed waste
enforcement policy to expire on October
31, 2001. Several commenters have
stated that EPA should extend the
"Policy on Enforcement of RCRA
Section 3004(j) Storage Prohibition at
Facilities Generating Mixed
Radioactive-Hazardous Waste" for
sufficient time to allow authorized
states to adopt the rule we are
promulgating today. Commenters have
expressed concern that EPA may
rescind the mixed waste enforcement
policy or that facilities may be subjected
to "unreasonable enforcement actions,"
including citizen suits, before they have
the opportunity to obtain the
exemption.
Commenters are correct that it may
take some time for states (who choose to
do so) to become authorized for this rule
allowing a storage and treatment
conditional exemption from RCRA
Subtitle C for mixed waste. This
rulemaking is intended to provide
flexibility to generators of mixed waste
where EPA requirements duplicate
performance standards required by the
NRC or NRC Agreement States. With the
promulgation of this rule, EPA is
expressing its view that facilities that
comply with certain criteria can safely
store mixed waste at NRC licensed
facilities. Thus, the federal government
is providing with this rule a potential
option for mixed waste generators to
store mixed wastes legally. We
recognize that States are not required to
become authorized to implement this
rule. States may choose to be more
stringent than the federal RCRA
program. Although we do not intend at
this time to extend the enforcement
policy, we will monitor the
implementation of today's final rule.
Since States have generally followed
EPA's lead on the enforcement policy,
we anticipate a good number will
choose to address dual regulation of
mixed waste generators by acting on this
rulemaking. States which do not adopt
the rule may provide an enforcement
policy within their states.
g. Storage unit closure. We received
two comments indicating that our
proposal may have generated some
confusion as to how the conditional
exemption would affect a facility's
closure obligations for mixed waste
storage units already regulated under
RCRA. For example, one commenter
requested that EPA develop a
streamlined closure guidance for
applicable facilities that are NRC
licensed and can demonstrate an
excellent compliance history. Another
commenter specifically asked us to
clarify that a generator would be exempt
not only from the requirement to obtain
a permit, but also from closure
requirements. On reviewing these
comments, we realized that we had not
explicitly addressed closure of
previously regulated units, although it
was our intent to treat these units the
same way the proposal would treat new
units storing exempt waste, which is to
say that they would be subject only to
NRC decommissioning requirements,
and not also to RCRA closure
requirements. This is clear for new
units, since the waste would not be
hazardous and would not trigger closure
requirements.
Thus, we are modifying the final rule
to add § 266.260 to exclude LLMW
storage units containing conditionally
exempt waste from RCRA Subtitle C
closure requirements. Without this
modification, the rule could be read to
require that facilities currently
managing low-level mixed waste in
permitted or interim status units to
close these units because they no longer
would be receiving hazardous waste.
See 40 CFR 264.113 and 265.113. It was
not our intent to require LLMW storage
tanks or containers to be emptied and
decontaminated to comply with RCRA
closure requirements merely to be
refilled with the same waste (now
conditionally exempt). Such closure
would run contrary to our conclusion
that mixed waste managed under NRC
regulation renders RCRA Subtitle C
regulation, including closure,
unnecessary. We also see no human
health or environmental rationale for
treating previously regulated units
differently from new units in this
regard. Finally, we believe that
requiring RCRA closure before the unit
can manage the same waste under NRC
standards could unnecessarily increase
worker exposures to the radionuclides.
Therefore, a facility with a permitted
tank or container that is storing only
conditionally exempt LLMW, and has
stored only LLMW prior to the effective
date of this rule, is not subject to RCRA
closure requirements, and may
terminate their RCRA closure
obligations as to that unit by modifying
the facility permit under 40 CFR 270.42.
Similarly, an interim status storage
facility with a unit that has stored only
LLMW will not be subject to RCRA
closure requirement, and should amend
the facility closure plan when the stored
LLMW becomes conditionally exempt
after the effective date of this rule.
Without a modification to a facility's
permit or closure plan, a facility would,
arguably, still be required to close
exempted units under RCRA. Of course,
a storage unit that also stores non-
exempt hazardous waste, either prior to
or after the effective date of this rule,
will remain subject to the closure
requirements of 40 CFR 264.110 and
265.110 as applicable for areas storing
the non-exempt hazardous waste.
These changes related to closure of a
permitted or interim status storage unit,
as described above, do not affect the
applicability of corrective action
authorities that the EPA or authorized
State may have to address releases from
these units (or from other solid waste
management units at the facility). For
these facilities, all hazardous wastes
will be addressed either through the
NRC requirements for decommissioning
and decontamination (D&D) or through
the use of our corrective action
authorities. We note that current NRC
guidance states that when an NRC
inspector is preparing to inspect any
facility that is undergoing
decommissioning, the inspector should
coordinate with the U.S. Environmental
Protection Agency, or the appropriate
State agency if the decommissioning
involves hazardous waste. (See NRC
Inspection Manual, Chapter 2602, 2602-
05 General Guidance, 05.05 Inspection
Coordination.) EPA commits to working
with NRC to ensure that coordination
with EPA or the appropriate state
agency continues on these previously
regulated units undergoing
decommissioning.
B. Discussion and Response to
Comments on Storage Background
Studies
The storage and treatment provisions
of our proposed and final rule are based
on studies which we cited in the
preamble to the proposal. These studies
are available as supporting documents
to provide background information to
the public and to commenters on this
rulemaking. These studies are "Review
of Waste Management Practices and
Compliance History at Nuclear Power
Plants and Other Entities that Generate
Low-Level Mixed Waste." (April 12,
1999); and "Comparison of the EPA's
RCRA Requirements and the NRC's
Licensing Requirements for the
Treatment (In Tanks and Containers)
and Storage of Low-Level Mixed Wastes
at Nuclear Facilities" (April 2001). To
determine the protectiveness of NRC
management requirements for LLMW,
we researched the LLW storage and
treatment provisions of NRC and
material licenses, reviewed NRC
compliance data on violations related to
storage and treatment of LLW, and
compared the regulatory framework of
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EPA and NRC related to waste
management. We found that safeguards
were in place which would protect
human health and the environment
during storage and treatment of LLW
and LLMW.
1. Review of NRG Licensing
Requirements
We researched NRC's regulatory and
licensing framework under which low-
level radioactive waste (LLW), and
therefore LLMW, is stored and treated
by waste generators. We examined
provisions concerning the on-site
storage and treatment of LLW to assess
whether these requirements are
protective of human health and the
environment with respect to preventing
releases of hazardous constituents. We
found that NRC and NRG Agreement
States regulate licensees through the
issuance of performance-based
regulations, regulatory guides, generic
communications (Generic Letters and
Information Notices), and NUREGs.
These documents work together to
enable the NRC and Agreement States to
ensure that nuclear power facilities and
other licensees are operating in a safe
manner. NRC uses these tools to guide
licensees on how to meet the
performance requirements in the
regulations, and to impose an effective
and enforceable regime to ensure
protectiveness of the management of
radioactivity.
For example, on November 10, 1981,
NRC issued Generic Letter 81-38,
"Storage of Low-Level Radioactive
Wastes at Power Reactor Sites," and
enclosure, "Radiological Safety
Guidance for Onsite Contingency
Storage Capacity." In this generic letter,
NRC discussed its position on proposed
increases in storage capacity for low-
level wastes generated by normal reactor
operation and maintenance, and stated
that the safety of the proposed increase
in capacity must be evaluated by the
licensee under the provisions of 10 CFR
50.59. The NRC also attached a
radiological safety guide to this letter.
This guide was developed for the design
and operation of interim contingency
low-level waste storage facilities, and
stated that necessary design features and
administrative controls would be
dictated by such factors as the waste
form, concentrations of radioactive
material in individual waste containers,
a total amount of radioactivity to be
stored, and retrievability of waste. NRC
also noted that this guidance document
should be used in the design,
construction and operation of storage
facilities, and that the NRC would judge
the adequacy of 10 CFR 50.59
evaluations based on compliance with
the guidance. (NRC also referenced IE
Circular No. 80-19, dated August 22,
1980, as providing information on
preparing 50.59 evaluations for changes
to radioactive waste treatment systems.)
NRC regulations concerning the
generation, storage, and treatment of
LLW are performance-based (for
example, no releases or leaks), whereas
RCRA regulations are more prescriptive
(where types of containers and waste
management are specified to prevent
leaks). Based on our review, the NRC-
enforceable tie-down conditions found
in individual licenses protect human
health and the environment from
exposure to hazardous wastes during
storage comparable to RCRA regulatory
requirements. A compilation of the NRC
documents that we reviewed can be
found in the docket. (See Ref. 3, EPA's
compliance history review?.)
2. Research on Compliance Records of
NRC and NRC Agreement State
Licensees
In addition to comparing NRC's
storage requirements to EPA's, we
researched compliance records related
to NRC radiation controls for nuclear
power plants and other licensees, to
determine if there were storage-related
releases or mismanagement of LLW. To
provide a baseline for the comparison of
NRC LLW violations, we queried two of
EPA's generator information
management systems—the Biennial
Reporting System (BRS) and the
Resource Conservation and Recovery
Information System (RCRIS)—to obtain
the number of RCRA violations.
Using BRS data for 1995, 18,497
facilities were identified as having
generated hazardous waste (including
small quantity generators). These
records were merged with the
information from RCRIS, and then
sorted by RCRIS violation area codes.
The violations were sorted by group
(generator, other, treatment, and
transporter) and by state. Based on this
process, we identified a total of 4,547
violations by a total of 1,352 facilities
(or 7.3% of the 18,497 facilities). Of the
4,547 violations, 3,355 resulted from
noncompliance with the generator
requirements (manifesting,
recordkeeping, time-in-storage,
reporting, etc.); of the 3,355 generator
violations, 142 involved mixed waste.
To review? the NRC facility
compliance records, we reviewed a
number of enforcement reports for both
NRC-enforced and Agreement State-
enforced licensing programs. (See
IV.B.l. for a summary of reports
reviewed.) The number of violations
reported (on a percentage basis) by NRC
for both nuclear power reactors (directly
licensed by NRC) and material licensees
(generally licensed by NRC Agreement
States) compares favorably with the
percentage of violations reported by
EPA. Fines, penalties, and other
consequences assessed by NRC and NRC
Agreement States serve to deter
violations. Based upon the compliance
data, the industries' record is good and
will serve to protect human health and
the environment. In addition, the record
suggests that there will be relatively few
instances of violations of conditions
leading exempt LLMW to become
hazardous. We conclude that regulation
under Subtitle C is unlikely to improve
that record significantly. For further
information on applicable NRC
regulations refer to 10 CFR part 20
subpart I. Information regarding NRC's
regulations, or guidance documents may
be obtained by either contacting the
NRC Public Document Room, at 11555
Rockville Pike, Room 0-1F21, Rockville,
MD 20852 (301-415-4737 or 800-397-
4209, Monday through Friday, 7:30 a.m.
to 4:15 p.m.), or by visiting NRC's
Internet web page at http://www.nrc.gov.
3. Comparison of Regulatory and
Management Requirements of EPA and
NRC
We compared NRC documents used
in license preparation with the
permitting framework established under
RCRA. The technical design and
operating standards of the NRC
licensing program meet or exceed RCRA
standards in virtually all respects,
though there were differences in certain
procedural requirements and in areas
unrelated to actual releases of hazardous
waste from storage. Based on our
review?, we do not believe these
differences undermine protection of
human health and the environment, or
that the super-imposition of RCRA
specific standards significantly
increases protection. (See Ref. 4, EPA's
comparison of EPA and NRC storage
and treatment requirements.)
Relevant NRC licensing criteria are in
the docket for the NPRM, and also may
be obtained by contacting the NRC
public document room at 301-415-
4737, or accessing the NRC web site at
http://www.nrc.gov. These criteria,
while designed primarily to minimize
radiation risk, also address risk posed
by byproduct material in general,
including hazardous constituents.
Because of the unique nature of mixed
wastes, migration of hazardous
constituents does not occur except in
the presence of radionuclides.
Therefore, activities performed by a
licensee to safely store or address the
release of the radioactivity of mixed
waste will also result in the safe storage
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of the chemical components of the
LLMW matrix. The applicability of NRG
licensing standards to mixed waste in
storage is the major reason for our
finding that, under specified conditions,
it is not necessary to also subject these
wastes to RCRA storage regulation also.
4. Conclusions Based on Our Studies
We reviewed the requirements of NRG
licenses, looked into the compliance
records of NRC and NRC Agreement
State licensees, and compared the
regulatory and waste management
requirements of EPA and NRC. Based on
these studies, we conclude that NRC
regulatory and licensing requirements
will effectively control risks from
hazardous constituents as well as
radioactive material. We found that
there are NRC regulatory safeguards in
place which will apply during the
storage and treatment of conditionally-
exempt LLMW in tanks and containers.
Therefore, because NRC and NRC
Agreement State controls effectively
address the mismanagement of LLMW,
RCRA Subtitle C regulation is not
necessary for those wastes. As the court
explained in Military Toxics Project v.
EPA, 146 F.3d 948 (B.C. Cir. 1998),
"where a waste might pose a hazard
only under limited management
scenarios, and other regulatory
programs already address such
scenarios, EPA is not required to
classify a waste as hazardous waste
subject to regulation under Subtitle C."
We find that NRC and NRC Agreement
State regulations governing LLW
address scenarios where LLMW may
pose a hazard.
5. Comments Received on Our Studies
We received several comments related
to the studies we completed prior to our
proposal. We heard from a number of
commenters regarding our comparison
of NRC's and EPA's regulatory and
management requirements. A number of
commenters concurred, indicating that
the technical record for proposing the
conditional exemption was compelling.
Some of them stated that our
comparison was comprehensive, and
supported our rulemaking proposal.
Others commenting on the
comparison encouraged us to conduct
additional research regarding whether a
single regulatory framework provides
sufficient protection to safeguard human
health and the environment. Some of
these commenters were concerned about
NRC monitoring for radiation but not
chemical releases. They also wondered
if NRC has "sufficient expertise to
properly deal with many of the issues
related to storage and disposal of
hazardous materials." Another
commenter suggested that we require a
minimum secondary containment
volume for stored liquid LLMW. This
commenter wanted us to define
requirements for segregating chemically
incompatible wastes, and thought that
quarterly inspections were not
protective and should be re-evaluated.
Another commenter cited a 1986
chemical accident at a uranium
conversion facility as evidence that NRC
management of chemical hazards is
deficient.
We disagree with those commenters
who believe that the conditional
exemption we proposed is not
protective of human health and the
environment because of NRC's focus on
radiation. Our thorough studies do not
support these concerns. Because
exempted LLMW is mixed, the same
management practices that address
concerns for containment of
radionuclides will also address
concerns for the containment of the
hazardous constituent. For example,
NRC requires that chemically
incompatible wastes be segregated to
prevent the release of not only
radionuclides, but also hazardous
constituents. In another example,
secondary containment for radionuclide
release accomplishes the containment of
hazardous constituents at the same time.
Further, if, or when, a chemical release
should occur, radionuclides are also
released. Radiation release detection as
required by the license will
simultaneously alert personnel of a
release of the chemical matrix in which
the radionuclides exist. Therefore,
management practices including
treatment, primary and secondary
containment, inspections, emergency
responses, and others, that reduce the
risk of radionuclide release will also
mitigate the release of hazardous
constituents. In summary, the expertise
required to manage LLW is very similar
to that necessary to manage hazardous
waste. The NRC management framework
provides protection for the hazardous
constituents contained in mixed waste.
(Note that 10 CFR 61.56 includes many
features related to the physical and
chemical characteristics of the waste.)
As we indicated in our studies, minor
differences exist between NRC's and
EPA's regulatory frameworks (including
inspection frequencies); the latter is
more prescriptive and the former more
performance based. However, taken
together, the systems are equivalent.
Both prevent releases, expeditiously
address releases that may occur, avoid
exposures, and protect human health
and the environment.
We also disagree with commenters
who believe our evaluation of the NRC
framework was incomplete (i.e., that
additional research was necessary to
determine the sufficiency of a single
regulatory framework). Rather, we agree
with those commenters whose review?
concluded that our comparison was
comprehensive. Based on our previous
discussion, and on the written record
we reviewed, we do not believe that
additional research is necessary, or
would yield information contrary to the
conclusions we reached as a result of
our studies.
In order to ensure that the hazardous
portion of LLMW receives special
management attention, we have made
final the conditions in § 266.230 that
address both personnel training in
chemical waste management and
hazardous materials incidents response,
and emergency planning comparable to
RCRA.
One commenter's reference to a 1986
radiation accident is not compelling
evidence to support delaying this rule.
Firstly, the date cited for the incident
does not take into account guidance or
operating procedures addressing such
events at facilities which NRC has
subsequently developed to prevent such
accidents. Two examples of NRC's
attempt to address problems with
facilities as they arise are the NRC
document NUREG-0933, "A
Prioritization of Generic Safety Issues,"
which provides priority rankings to
resolve safety issues that have a
significant potential for reducing risk,
and NUREG-1601, "Chemical Process
Safety at Fuel Cycle Facilities, August
1997, which specifically addresses the
handling of chemicals such as the one
involved in the 1986 accident.
Secondly, our review of waste
management practices at NRC and NRC
Agreement state licensed facilities in
recent years, demonstrates an excellent
record of safety, even when compared to
hazardous waste management under
RCRA. Thirdly, the accident cited by the
commenter was not a waste
management accident, but a chemical
processing accident (allegedly caused by
negligence). Finally, a single example of
an accident that occurred 15 years ago
does not lead us to conclude that the
two regulatory schemes do not provide
equivalent protection.
VII. How Are the Final Transportation
and Disposal Provisions Different From
the Proposal?
The final rule contains a number of
language changes to respond to
comments, and to make the storage and
treatment exemption, and transportation
and disposal exemption more consistent
with each other. However, the final rule
maintains conditional exemptions for
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storage and treatment, and
transportation and disposal. The
changes to our proposal for
transportation and disposal are
highlighted below, and are discussed in
greater detail in Section VIII of this
preamble.
Streamlined Language
In the final rule we have streamlined
our discussion of what the
transportation and disposal conditional
exemptions do and what the eligibility
requirements are (§ 266.305 and
§ 266.310, respectively). These changes
were made for clarity, and do not
represent a substantive modification.
Specification Related to Containers
The language we used in the proposal
was not clear as it related to the types
of containers that must be used prior to
placing the exempted waste in a
disposal cell. We have specified in the
final language that the container must
be: a carbon steel drum, an alternative
container with containment
performance in the disposal
environment equivalent to a carbon
steel drum, or a high integrity container
as defined by NRC. We made this
clarification in § 266.340.
Notification
The proposed rule required you to
notify multiple regulators and the
LLRWDF during implementation of the
conditional exemption. We proposed
that you notify three separate regulators
with various waste information. In
addition, we also proposed that you
notify the same agencies of any change
in information presented in the initial
notification, including a claim for the
exemption of any waste stream not
identified in the initial notification. In
response to public comments, we
streamlined the requirement of notifying
the regulators. In the final rule, you
must notify your RCRA regulatory
agency. However, you are not required
to notify the RCRA regulatory authority
at the state where the LLRWDF resides,
or NRG or NRG Agreement states that
licensed the LLRWDF as proposed. In
addition, we simplified the notification
so that it is a one-time notice in order
to identify who is claiming the
exemption. As a result, you are no
longer required to provide information
such as the process that generated the
waste, or the volume of the waste. You
are also not required to notify your
RCRA regulatory agency of changes
from initial notice.
We modified slightly the proposed
shipment-specific notice to a LLRWDF.
It now incorporates a couple of elements
that were previously in the notice to
regulatory agencies (treatment standard
verification and a signature
requirement). We also added a
statement indicating that the exempted
waste must be placed in a container for
disposal.
In the proposed rule, we proposed
that you notify your RCRA regulatory
agency in writing within 30 days of
learning of your failure to satisfy any of
the conditions and RCRA requirements
under the conditional exemption. In
response to comments, the final rule
does not require reporting of
noncompliance with paper work and
administrative types of RCRA
requirements such as notification and
recordkeeping. However, we do require
reporting of noncompliance with
conditions in § 266.315.
Recordkeeping Requirements
We removed the proposed
recordkeeping requirements associated
with the notice of change to the
regulatory agency, since this notification
is not required in the final rule. We
revised the duration you must keep your
exempted waste manifest records from
"until closure of the disposal facility or
closure of your facility" to reliance on
the existing NRC or NRC Agreement
State requirement. We also revised your
recordkeeping duration for the notice to
the LLRWDF from "until closure of the
disposal facility or closure of your
facility" to "for three years after the
exempted waste is sent for disposal."
Point of Exemption
The point at which a waste meeting
land disposal restriction (LDR)
treatment standards is conditionally
exempted from RCRA regulatory
requirements remains unchanged from
the proposal. However, we changed one
of the elements that described the point
of exemption (§ 266.330[b]) from
"receiving return receipts from the
regulators" to "receiving return receipts
from the LLRWDF."
Loss of Exemption
In the final rule, we do not require
maintaining records or providing notice
as conditions of keeping the exemption.
Notice or recordkeeping becomes a
RCRA regulatory requirement instead.
Failure to meet either a recordkeeping,
or a notice requirement will not result
in the automatic loss of the exemption
of the waste. However, the Director may
terminate the conditional exemption for
your waste or add additional conditions
to the exemption for serious or repeated
noncompliance with any of the RCRA
requirements of Subpart N. In addition,
such a failure may subject you to an
enforcement action requiring
compliance, monetary sanctions, or
both.
In another change, we specified
minimum reporting requirements in
§ 266.355(a) when you report the loss of
an exemption.
Finally, in § 266.355(a) we added the
provision of orally notifying your RCRA
regulatory agency within 24 hours of
discovery of failure to meet any of the
conditions if the failure may endanger
human health or the environment. This
oral notice must be followed up with a
written notice within 5 days.
Reclaiming the Transportation and
Disposal Exemption
In the final rule, we have slightly
modified the procedure you must follow?
to reclaim an exemption for your waste.
You are required to send a notice to
your RCRA regulatory agency, by
certified delivery with return receipt
requested, that you are reclaiming the
exemption for your waste. In the final
rule, the reclaimed exemption becomes
effective after you receive the return
receipt from this reclaim notice. This
procedure is different from the proposal,
which allowed the reclaimed exemption
to become effective as soon as you meet
the reclaim requirements for your waste.
In addition, you may initiate the reclaim
process for your waste only after you
have received the return receipt from
your RCRA regulatory agency
confirming that it has received your
notice that you have lost the exemption
for your waste. We made these change
in response to comments received on
our question on whether there should be
a waiting period prior to a reclaimed
exemption becoming effective.
VIII. Discussion and Response to Major
Comments on the Transportation and
Disposal Conditional Exemption
In today's rule, we are finalizing a
conditional exemption from RCRA
Subtitle C regulation for hazardous
wastes containing LLW and/or NARM
that are transported and disposed of
subject to NRC or NRC Agreement State
regulation. Eligible wastes (LLMW or
Eligible NARM) that are managed in
accordance with the conditions under
§ 266.315 are exempt from the RCRA
regulatory definition of hazardous
waste. The conditional exemption takes
effect once specified actions have
occurred. You then may manage your
wastes as you would solely radioactive
wastes. Since the point of exemption
takes place when a waste is placed on
a transportation vehicle destined for a
low-level radioactive waste disposal
facility (LLRWDF) for disposal, the
exempted waste need not comply with
RCRA Subtitle C transport and disposal
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requirements. This conditional
exemption acknowledges the protection
provided by NRC and NRC Agreement
States regulations for the manifest,
transportation, and disposal of the
radioactive portion of the eligible waste.
The conditions for the transportation
and disposal exemption are listed in
§ 266.315, and include the following:
• The wastes must meet LDR
treatment standards;
• Waste shipments from those of you
who are not already subject to NRC or
NRC Agreement State manifest and
transportation regulation must comply
with the NRC (or NRC Agreement State)
manifest and transportation regulations;
• The wastes must be disposed of at
a LLRWDF licensed by NRC (or
Agreement State); and
• The wastes must be disposed of in
containers that meet specified minimum
requirements.
Your waste automatically loses its
transportation and disposal exemption
if you failed to meet any of the
conditions specified in § 266.315. You
must notify your RCRA regulatory
agency when your waste loses its
exemption. You may be subject to an
enforcement action requiring
compliance, monetary sanctions, or both
for any violations that occur as a result
of this loss of exemption. You may
reclaim your transportation and
disposal conditional exemption for your
waste if it again meets the conditions
specified in § 266.315, and you notify
your RCRA regulatory agency that you
are reclaiming the exemption for your
waste.
A. What Is the Basis of the
Transportation and Disposal
Conditional Exemption?
We determined that a conditional
exemption from RCRA Subtitle C
regulation for the transportation and
disposal of eligible waste is appropriate
because we concluded that management
of eligible waste under NRC and NRC
Agreement State regulations coupled
with the additional conditions set forth
in today's rule provide a comparable
level of protection for the RCRA
constituents. We reached this
conclusion after a thorough analysis
comparing NRC transportation and
disposal requirements to RCRA
hazardous waste regulations. We believe
that this analysis demonstrates that NRC
regulations effectively protect human
health and the environment for the
circumstances allowed under today's
conditional exemption. Thus, we do not
believe the waste managed under these
conditions should be subject to Subtitle
C, since Subtitle C controls are not
necessary to protect human health and
the environment. For a complete
explanation of the legal basis for
establishing a conditional exemption
under RCRA see the preamble to the
Military Munition Rule at 62 FR 6636
(February 12, 1997). See also MTPvs
EPA, 146 F3rd 948 (B.C. Cir.1998)
upholding EPA authority to establish
conditional exemptions under RCRA.
We received comments both
supporting and opposing the general
approach of our proposed rule. Forty-
nine commenters—including generators,
some states, RCRA facilities, members of
the public, and the NRC—supported our
overall approach. They believed that our
proposal was sound and would provide
the important and necessary regulatory
protection and flexibility for the
management of the eligible waste.
Of the commenters that questioned
our proposed rule, some stated that
NRC's regulations and requirements
were established to protect against
radioactive hazards and not against
hazards posed by RCRA hazardous
waste. Therefore, they believed that it is
not appropriate to rely on NRC
regulations for protection against
chemical hazards. We agree that NRC
and NRC Agreement State regulations
were not established for the primary
purpose of protecting against risks
posed by RCRA hazardous waste.
However, we disagree with the
conclusion that it is not appropriate to
rely on these regulations for protection
against hazards posed by RCRA wastes.
Specifically, concerning the
transportation of hazardous material,
EPA and NRC have expressly adopted
DOT regulations governing the
transportation of hazardous material.
The Department of Transportation
(DOT) packaging and transportation
requirements for a LW provide adequate
protection against chemical hazard
during the transportation of an eligible
waste meeting the LDR treatment
standards. DOT Hazardous Material
Regulations (HMR; 49 CFR parts 100
through!99) contain requirements for
transporting hazardous materials. DOT
HMR contains packaging, labeling,
documenting, placarding, and other
requirements for transporting hazardous
material. The DOT hazard classification
system includes materials that are
explosive, flammable, reactive, toxic,
infectious, corrosive, radioactive, and
gases. Hazardous materials subject to
the HMR must, at a minimum, be
packaged in strong tight containers that
can safely survive transportation
incidents. EPA has adopted DOT
regulations governing the transportation
of hazardous materials to protect human
health and the environment in the
transportation of hazardous waste. NRC
LLW packaging and transportation
regulations have also adopted DOT
regulations for transporting radioactive
material. Under this conditional
exemption, the exempted waste is
required to meet the LDR treatment
standards and therefore no longer
exhibits the flammable, corrosive, and
reactive characteristics. As a result, the
transportation packaging requirement
for the exempted waste do not need to
consider these hazards. The remaining
hazard of concern of the exempted
waste is the toxicity of the waste. We
consulted with DOT who stated, and we
agreed, that the transportation
packaging requirement for the
transportation of the LLW is adequate
for the protection against the toxic
hazard that would remain in the waste
that has met LDR treatment standards.
(See Ref. 19, Discussion with DOT on
mixed waste transportation.) Therefore,
the exempted waste, once meeting the
LDR treatment standards, will be
properly managed if it is packaged and
transported as a LLW. For these reasons,
we concluded that packaging and
transportation controls that apply to a
LLW are adequate, appropriate, and will
ensure safe management of the
exempted waste during transportation.
Concerning tracking of hazardous
waste, the exempted waste (a
radioactive waste) is subject to NRC or
NRC Agreement State equivalent
manifest regulations. We conducted a
detailed comparison between RCRA and
NRC manifest regulations that track the
movement of the exempted waste (See
Ref. 12, Comparison of NRC and EPA's
Waste Tracking.) We determined that
NRC's waste tracking regulations are at
least as stringent as RCRA regulations.
Most notably, both RCRA and NRC
manifests were developed to be
consistent with the DOT shipping paper
regulations at 49 CFR 172.200.
Therefore, RCRA and NRC manifests
share many basic elements, including
closed-loop notification and tracking,
exception reporting, and mandatory
retention of manifests. However, the
NRC manifest regulations exceed the
RCRA Subtitle C manifest regulations in
several areas, such as requiring longer
manifest retention times in certain cases
and specifying more stringent schedules
for generators to investigate shipments
for which they have not received the
LLRWDF's acknowledgment of receipt.
Therefore, we believe that NRC
regulations for tracking low-level waste
meet our needs to ensure that the
exempted waste arrives at the
appropriate licensed LLRWDF, and that
NRC provides adequate mechanisms for
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Federal or state oversight of the waste
shipments.
We also reviewed NRC regulations (10
CFR part 61) and the practices of low-
level waste disposal facilities to
determine if they provide levels of
human health and environmental
protection comparable to RCRA Subtitle
C permitted disposal facility
requirements. (See proposal F-1999-
ML2P-FFFFF, Ref. 7, Technical
assessment of LLRWDFs.) This analysis
included the elements of siting, disposal
cell engineering and design, and
management control. Our assessment
indicates that NRG regulations for
disposal facilities provide protection
comparable to that provided by RCRA
Subtitle C regulations, particularly given
that we are requiring that the RCRA
hazardous constituents be treated to
LDR treatment standards and that the
waste be placed in certain types of
containers prior to disposal. More
detailed discussion of this technical
analysis can be found in section VIII.G.
of today's document.
In summary, our analysis of NRC
transportation and disposal regulations
leads us to conclude that the NRC
regulations coupled with a few
additional conditions provide adequate
protection of human health and the
environment, and that regulation under
RCRA Subtitle C is not necessary. The
fact that NRC regulations were designed
primarily for the purpose of protecting
against radioactive waste is largely
irrelevant since the regulations are
designed to ensure protective
transporting, tracking, and containment
of the waste, which will protect against
chemical hazards as well as radiation
hazards.
B. What Wastes Are Eligible for the
Transportation and Disposal
Conditional Exemption?
As we proposed it, the transportation
and disposal conditional exemption
would apply only to LLMW that meets
the waste acceptance criteria of a
LLRWDF and Eligible NARM. A LLMW
is a RCRA hazardous waste as defined
in 40 CFR part 261, containing a low-
level radioactive waste as defined in 10
CFR 61.2. A table identifying the types
of RCRA hazardous waste commonly
found in LLMW is provided as
background material in the RCRA
Docket (See Ref. 10, RCRA Hazardous
Constituents and Waste Codes.) In the
final rule, Eligible NARM is defined as
a NARM waste that contains RCRA
hazardous waste, and meets the waste
acceptance criteria of, and is allowed by
State NARM regulations to be disposed
at a LLRWDF licensed in accordance
with 10 CFR 61 or NRC Agreement State
equivalent regulations.
NARM is defined by its origin of
generation rather than by the level of its
radioactivity. The manner in which
NARM waste is managed depends on
the radioactive content of the material.
In most cases, NARM waste is
radiologically similar to low-level
radioactive waste. Because today's rule
applies to LLMW, we are extending the
exemption to NARM only when its
radioactive content is comparable to
LLW and is managed as such. A
LLRWDF is required to establish waste
acceptance criteria as part of its license
requirements to ensure protection of
human health and the environment. The
waste acceptance criteria are derived
from the performance criteria of the
disposal facility and ensure that only
those wastes that can be accepted and
properly managed at the LLRWDFs are
accepted. Therefore, we are requiring
that in order to be eligible for the
transportation and disposal exemption,
your Eligible NARM waste must meet
the waste acceptance criteria of a
LLRWDF and therefore will be properly
managed.
In the proposed rule, we solicited
comments on the applicability of this
conditional exemption to hazardous
waste contaminated with NARM. We
received comments that both supported
and questioned the inclusion of NARM
contaminated with RCRA hazardous
waste for the exemption. Those who
supported including this waste stated
that we should not exclude NARM
waste solely because it is not regulated
under the Atomic Energy Act (AEA).
They also stated that the source of
generation of the radioactive material,
under which NARM is defined, should
not have bearing on whether the NRC or
Agreement State equivalent regulations
provide a sufficient level of protection
for the waste. They stated that NARM is
similar to LLW, and should be eligible
for the conditional exemption.
Those who opposed the inclusion
believe that the NRC has no regulatory
authority over NARM. We note that
although NRC does not have regulatory
authority over NARM, the States may
regulate this material. Some states have
laws and regulations in place for
managing this material. We note that all
three states that license the existing
LLRWDFs have such authority. In the
case of Non-NRC Agreement states,
where the NRC implements the
radioactive material management
regulations, the States may enact
additional laws and regulations to
regulate NARM. However, to ensure that
there will not be regulatory gap under
this conditional exemption for NARM,
we are specifying that you can claim
this exemption for your Eligible NARM
waste and dispose of the NARM waste
at a LLRWDF only if state laws and
regulations governing that LLRWDF
allow the disposal of NARM waste. In
addition, as discussed earlier the waste
acceptance criteria of a LLRWDF will
ensure that any NARM accepted at a
LLRWDF will meet the licensing
requirement and will be properly
managed. Therefore, there is no
regulatory gap in managing NARM
waste even though the NRC does not
have regulatory authority over this
waste.
We received two comments
requesting that DOE waste be excluded
from the exemption due to oversight
concerns. Rather than excluding DOE
waste from eligibility for the conditional
exemption, we fashioned the
conditional exemption to ensure
external oversight of DOE waste. First,
to be exempt, eligible waste must be
disposed of at an NRC or NRC
Agreement State licensed LLRWDF.
Second, DOE must follow the NRC or
NRC Agreement State equivalent
manifest and transportation regulations.
These conditions ensure that any
exempted DOE wastes are under the
oversight of an external regulatory
agency. (As explained below, in the case
of the manifest and transportation
provisions, the agency would be the
RCRA regulatory agency, by virtue of a
condition contained in the final rule.)
C. What Conditions Must You Meet for
Your Waste To Qualify for and Maintain
the Transportation and Disposal
Conditional Exemption?
1. Land Disposal Restriction Treatment
Standards
As we proposed, eligible waste must
meet the RCRA Land Disposal
Restriction (LDR) treatment standards
before it is transported and disposed of
as an exempted waste. You can find the
RCRA LDR treatment standards in 40
CFR part 268, subpart D.
In HSWA, Congress prohibited the
land disposal of hazardous waste unless
the waste is treated to minimize threats
to human health and the environment.
The statute required EPA to establish
treatment standards that will
substantially diminish the toxicity or
mobility of hazardous waste to
minimize short and long-term threats to
human health and the environment. We
have developed a series of treatment
standards for hazardous waste based on
the best demonstrated available
technology (BOAT) for treating the
waste. The LDR treatment standards
ensure that the organic constituents are
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destroyed or substantially reduced and
the mobility of the toxic metals are
stabilized to minimize threats to human
health and the environment. In contrast,
the approach to waste treatment for a
radioactive waste is stabilization and
containment while the waste undergoes
radioactive decay. We could not
confidently conclude that NRC waste
stabilization requirements for
radioactive waste assure long term
protection of human health and the
environment from all types of RCRA
hazardous waste. Therefore, we have
decided to maintain the LDR treatment
requirements as a condition of the
exemption.
In some instances, a RCRA hazardous
waste becomes a nonhazardous waste
when it is treated to the designated LDR
treatment standards. These situations
involve treatment standards for
ignitable, corrosive, and reactive
characteristic wastes, and most
standards for the toxic characteristic
wastes. Some of the treatment standards
for hazardous debris also allow the
treated debris to be managed as a
nonhazardous waste. In addition, there
are other processes (e.g. delisting under
40 CFR 260.20 and 260.22) through
which a RCRA hazardous waste can
become a nonhazardous waste. Under
these situations when your LLMW or
Eligible NARM waste is no longer a
RCRA hazardous waste, you do not need
to claim the transportation and disposal
conditional exemption in order to
manage and/or dispose of the resulting
waste as a LLW or a NARM waste. The
resulting waste would be regulated as a
radioactive waste only. You should
contact your RCRA regulatory agency if
you have questions concerning the
treatment standards or the processes
which may allow your LLMW or
Eligible NARM waste to be regulated as
non-hazardous waste.
You must continue to comply with all
other provisions associated with the
LDR treatment regulations (e.g.
sampling and analysis to determine
compliance with LDR treatment
standards or certifying such
compliance). Additionally, recognizing
the public's concern over potential
radiation exposure from mixed waste
testing we developed a mixed waste
testing guidance. The guidance was
developed in close coordination with
NRC, and is titled "Joint NRC/EPA
Guidance on Testing Requirements for
Mixed Radioactive and Hazardous
Waste." You can find this guidance at
EPA's mixed waste web site at
(www.epa.gov/radiation/mixed-waste/).
The primary purpose of the guidance
document is to assist you in the
characterization of mixed waste in
accordance with RCRA regulations,
while keeping radiation exposure as low
as reasonably achievable (ALARA). The
guidance document emphasizes
flexibility in the RCRA testing
requirements to incorporate the ALARA
concept.
In the proposed rule, we solicited
comments on whether we should
exclude LDR Phase IV alternative soil
treatment standards from the LDR
treatment standards that eligible waste
must meet for you to claim the
conditional exemption. The majority of
the commenters supported including
the alternative soil treatment standard
as part of the LDR treatment standards
which must be met to qualify for the
conditional exemption. The Association
of State and Territorial Solid Waste
Management Officials commented that
this decision should rest with the States
in which the disposal will occur.
We believe that it is appropriate to
include the alternative soil treatment
standards under this conditional
exemption. We promulgated the
alternative soil treatment standards
under the LDR Phase IV Rule found at
§ 268.49 to provide flexibility for
remediation activities. The LDR Phase
IV Rule can be found at [63 FR 28602-
28622, May 26, 1998]. In the LDR Phase
IV Rule, we determined that the
technology-based treatment standard (90
percent reduction capped by 10 times
the Universal Treatment Standards) for
contaminated soil is sufficiently
stringent to satisfy the core requirement
of RCRA § 3004(m) that short and long-
term threats to human health and the
environment are minimized. The
alternative soil treatment standards also
consider the need to encourage
remediation of contaminated soil which
involves excavation and treatment of the
soil. In the case of this conditional
exemption, wastes treated to LDR
treatment standards, including the
alternative soil treatment standards,
must be placed in a container for
disposal. We believe the soil treatment
and waste container requirement, in
conjunction with the protection
provided by the radioactive waste
disposal facility, ensure protection to
human health and the environment. We
note that states may impose more
stringent requirements when they adopt
this rule. In conclusion, the final rule
does not exclude the alternative soil
treatment standard in § 268.49 from the
LDR treatment standard in today's
transportation and disposal conditional
exemption.
2. Manifest and Transportation
a. If you are subject to NRC or NRC
Agreement State regulation: Today's
final rule relies on NRC or NRC
Agreement State manifest and
transportation regulations (which also
refer to DOT regulations at 49 CFR parts
100-199) to control the manifesting and
transportation of the exempted waste
shipment. If your exempted waste
streams are already subject to these
externally regulated manifest and
transportation requirements, you have
no additional transportation and
manifest requirements or conditions
under today's rule. The Agency believes
it is unnecessary to impose additional
requirements on you because your waste
shipments already are subject to NRC,
NRC Agreement State, or DOT
enforcement actions if you failed to
meet the manifest or transportation
regulations.
b. If you are not directly subject to
NRC or NRC Agreement State
regulation: Today's rule imposes a
condition on facilities, such as DOE
facilities, whose radioactive waste
shipments are not directly subject to
NRC or NRC Agreement State manifest
and transportation requirements. The
condition requires these facilities to
comply with the manifest requirements
at 10 CFR part 20 (or NRC Agreement
State equivalent regulations), and/or the
transportation requirements under 10
CFR part 71 (or NRC Agreement State
equivalent regulations). This condition
is necessary because such facilities are
not subject to enforcement actions by
NRC or an NRC Agreement State in the
event they fail to meet the NRC or NRC
Agreement State specified requirements.
Hence, as an alternative to NRC or NRC
Agreement State oversight, when such a
facility fails to meet this condition in
today's rule, the facility's waste will
automatically lose its exemption. This
facility may become subject to an EPA
(or RCRA-authorized State) enforcement
action requiring compliance, monetary
sanctions, or both, thus providing an
external enforcement mechanism that
would otherwise not exist. This
approach addresses concerns regarding
shipment of conditionally exempted
waste by facilities who are not already
subject to NRC or NRC Agreement State
manifest and transportation regulatory
requirements. This condition also
ensures the consistent application of the
manifest and transportation
requirements for the exempted waste.
This exemption is contingent upon
waste disposal in an NRC, or NRC
Agreement State, licensed LLRWDF.
Therefore, it is important that a
mechanism be in place to track all
exempted waste in transit and confirm
that the exempted waste arrives at the
appropriate disposal facility. This
exemption also relies on the added
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protection provided by the NRG, or NRC
Agreement State regulations for the
transportation of the exempted waste.
We do not believe this condition will
impose an unreasonable burden on
these facilities who are not directly
subject to NRG or NRG Agreement State
manifest and transportation
requirements. Therefore, we are
maintaining this condition as proposed.
Some commenters expressed a broad
concern that reliance on the LLW
manifest would not provide carriers or
emergency responders with the
information they need to respond to
transportation incidents involving the
exempted waste. We note that even
though the LLW manifest does not
contain specific information of the
chemical constituent of the exempted
waste, the emergency response
procedures for an incident involving
radioactive material are very rigorous
and similar to the procedures used in
responding to an incident involving a
chemical material. In addition, an NRG
or NRG Agreement State LLW manifest
also contains an emergency contact
telephone number allowing the
emergency responder to contact the
shipper for additional information on
the waste contained in the particular
shipment if needed.
It is important to note that the
exempted waste will be treated to meet
the RCRA LDR treatment standards. In
particular, the acute hazards related to
the reactivity, corrosivity, and
ignitability characteristics of the RCRA
characteristic waste that are of primary
concern during transportation, will be
eliminated when a waste is treated to
LDR treatment standards. The chronic
toxicity of the toxic characteristic and
listed wastes will also be greatly
reduced. Also, the exempt waste will
not contain free liquids, which will
significantly enhance containment of
the waste.
A professional emergency responder
is trained to manage a wide variety of
transportation incidents. The
responders will approach radioactive
wastes with the same care and caution
as they would use in approaching a
LLMW. Radioactive constituents
generally have similar exposure
pathways to humans (e.g. dermal
contact, ingestion, or inhalation) as
RCRA hazardous constituents do.
Therefore, emergency response
personnel would take the same
precautions as they would for a RCRA
hazardous waste such as wearing
protective clothing and carrying
supplied air. Also, because radioactive
wastes present a risk based on the
responder's proximity to the waste
package, emergency responders also
will limit their proximity and time near
the waste as they would for a RCRA
hazardous waste. Therefore, we believe
the concern raised by these commenters
is properly addressed due to the nature
of the waste and the procedures and
precautions that will be taken for
responding to a radioactive waste
transportation incident.
3. Container Requirement
Today's rule requires placing the
exempted waste in a container before
disposal. The container must be one of
the three types specified under
§266.340:
• A carbon steel drum;
• A container with equivalent
containerization performance in the
disposal environment as a carbon steel
drum; or
• A high integrity container as
defined by NRC.
It is your responsibility to make the
appropriate arrangements and ensure
that the exempted waste is placed in a
container for disposal.
The proposed rule did not require
specific types of containers, but instead
specified that the container "cannot be
cardboard or fiberboard boxes."
However, a commenter indicated that
they did not believe that this standard
was prescriptive enough to ensure
appropriate containment of the waste.
We agree with this comment. In
response, we have specified in the final
rule the acceptable types of containers
which are consistent with the technical
analysis performed during the
rulemaking process.
In the proposed rule, we noted that
both EPA and NRC disposal facility
requirements provide similar features to
isolate waste from its disposal
environment. An NRC disposal facility
is not required to have a synthetic liner,
whereas a RCRA facility is. To ensure an
equally protective disposal environment
for purposes of the conditional
exemption, we compared the
performance of the RCRA hazardous
waste landfill synthetic liner to the
performance of a carbon steel drum and
a high integrity container (as defined by
NRC). We found that the performance of
these specific containment devices are
comparable for the purpose of retaining
the integrity of the waste in the disposal
cell (See Ref. 7, Technical Evaluation.)
The Agency based its proposed
container requirement on the landfill
liner and container comparison
analysis, but now realizes that the
proposed regulatory language could
allow disposal alternatives that do not
provide the same protections as we
intended. The proposal language
specified that the container cannot be
cardboard or fiberboard boxes. Some
commenters noted that the description
would allow paper boxes or wooden
crates that are also unacceptable.
The final requirement is still flexible
in that it allows for alternatives to
carbon steel drums as long as the
container used achieves equivalent
performance. We also allow the use of
high integrity containers (HICs) since
they must pass a series of rigorous tests
as specified by NRC to demonstrate that
they will retain their structural integrity
for 300 years or more. These HICs are
more often used by LLRWDFs to
stabilize and contain wastes with higher
radioactivity than LLMW. We decided
to codify HICs for purposes of this
conditional exemption because they
provide containment equivalent to
carbon steel drums.
4. Waste Disposal Destination
Today's final rule requires that the
exempted waste must be disposed of
only at a LLRWDF licensed and
regulated by NRC, or an NRC Agreement
State, in accordance with 10 CFR part
61 or NRC Agreement State equivalent
regulations. It is your responsibility to
make the appropriate arrangements to
dispose of the exempted waste at the
designated LLRWDF. This provision is
unchanged from the proposal.
Some commenters stated that NRC
shallow land burial facilities are
"designed to fail," and cited past
failures at such facilities. Our
investigation indicated that the facilities
cited by the commenters were designed
and operated prior to NRC's codification
of regulations for LLRWDFs in 1982 at
10 CFR part 61. NRC promulgated these
requirements in response to the failures
and problems cited by the commenters.
Since that time, the NRC and the NRC
Agreement States have worked
aggressively with the LLRWDF licensees
to ensure that the LLRWDFs meet
current regulatory requirements and
additional NRC technical guidance
specified in technical position papers.
In particular, the NRC waste form
technical position paper "Technical
Position on Waste Form (Revision 1)"
contains specific criteria on how the
waste should be stabilized prior to
disposal at LLRWDF. The waste form
criteria are generally incorporated into
the LLRWDF's license as waste
acceptance criteria. In addition, since
1982, NRC regulation has prohibited
disposal of liquid waste. Based on EPA's
analysis of NRC and NRC Agreement
State LLRWDFs, EPA concludes that
LLMW treated to LDR standards will be
safely managed at such facilities. (See
discussion in VIII. G.)
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Prior to our proposed rule, States
expressed concern about DOE's self-
regulating status for managing the
radioactive material. Generally, States
that regulate radioactive material have
no regulatory oversight authority for
DOE's radioactive material. However,
NRG and NRG Agreement States have
regulatory authority over commercial
and other non-self regulating federal
facilities that manage radioactive
materials. Therefore, in today's rule, we
are exempting only those wastes
disposed of at an LLRWDF that is
licensed and regulated by NRG or an
NRG Agreement State. This approach
will ensure that all exempted waste
(radioactive waste) remains under an
external regulatory framework and
enforcement authority. DOE may take
advantage of the transportation and
disposal exemption if it disposes of its
exempted waste in LLRWDFs licensed
and regulated by NRG or an NRG
Agreement State. This approach
addresses the States' concern and allows
DOE to take advantage of the exemption.
All of the comments on this provision
supported the Agency's proposed
approach.
D. What Other Provisions Must You
Meet?
The Agency is finalizing the RCRA
notification and recordkeeping
requirements for this rule. These RCRA
requirements are obligations that you
must meet at all times. If you fail to
meet these RCRA requirements, you
must take prompt actions to return to
compliance with these RCRA
requirements. Your waste will not
automatically lose the transportation
and disposal conditional exemption if
you fail to meet these RCRA
requirements for your waste. However,
your RCRA regulatory agency may
terminate a conditional exemption or
add additional conditions to an
exemption for serious or repeated
noncompliance with any of the RCRA
requirements of subpart N. In addition,
you could be subject to an enforcement
action requiring compliance, monetary
sanctions, or both under RCRA 3008(a)
enforcement authority for failure to
comply with any of the RCRA
requirement(s) of subpart N for your
waste.
1. Notification
Today's rule requires you to provide
a one time notice to your RCRA
regulatory agency under § 266.345(a)
prior to the initial shipment of an
exempted waste from your facility to a
LLRWDF to claim the transportation
and disposal conditional exemption.
The notification must include your
facility name, address, telephone
number, and your RCRA ID number.
You need not notify your RCRA
regulatory agency again for subsequent
shipments of the same or a different
waste stream from your facility. The
purpose of this notice is to identify to
the RCRA regulatory agency those of
you who are claiming the conditional
exemption.
Today's rule also requires you to
notify the LLRWDF receiving your
exempted waste before each shipment of
your waste. Your notification must
provide the information required under
§ 266.345(b) which includes:
• A statement that you have claimed
the exemption for your waste;
• A statement that the waste meets all
applicable LDR treatment standards;
• A statement identifying your
facility name, address, and RCRA ID
number;
• All applicable RCRA waste codes
for the waste before the waste was
exempted;
• A statement that the exempted
waste must be placed in a container for
disposal;
• The manifest number of the
shipment that will contain the
exempted waste; and
• A certification that the information
provided is true, accurate and complete.
We expect that most, although not all,
of the information on this notice to a
LLRWDF will remain the same from
shipment to shipment, especially when
the same waste stream is continuously
being shipped for disposal. Therefore, a
previous notice to the LLRWDF can
easily be updated and used as the new
notice. Alternatively, you also can
choose to develop your own standard
notice to an LLRWDF with unchanging
information already filled in.
The notice in § 266.345(b) serves
several important purposes. First, it will
allow the LLRWDF receiving the
exempted waste to identify the waste
and place it in a container for disposal.
Since the exempted waste would be
managed and identified as any other
radioactive waste after the point of
exemption (See discussion in section
VIII. E.), a mechanism is needed to
allow the identification of the exempted
waste at the LLRWDF. The manifest
number of a shipment that contains
exempted waste will enable such
identification. In the case of the
standard NRC Uniform Low-Level
Radioactive Waste Manifest Form 541,
the manifest number appears in block
number 2.
Second, the notice informs the
LLRWDF that it is receiving a
conditionally exempted waste, and
allows it to take actions that it may
deem appropriate. A LLRWDF's
willingness to receive the exempted
waste is essential in obtaining the
benefit of this rule. During the proposal
stage of this rulemaking, owners and
operators of LLRWDFs indicated that
they want to know when they would be
receiving an exempted waste. (See Ref.
9, Notes of meeting with LLRWDFs.)
They want to be able to decide, on an
operational basis, whether to take
precautionary actions such as screening
for specific constituents in a shipment
or screening for LDR compliance. The
information regarding the RCRA
hazardous waste codes of the waste
stream before it was exempted will
allow the LLRWDFs to be aware of the
content of the waste and take proactive
steps as they deem appropriate. In
addition, you may only ship the
exempted waste to an LLRWDF after
you have received the return receipt
from the LLRWDF confirming that it has
received your notice. This provision
ensures that the LLRWDF will have
advance notice of the arrival of the
exempted waste so that the LLRWDF
can ensure that the exempted waste is
handled accordingly.
Finally, this notice, in conjunction
with the recordkeeping requirement,
also will provide information to
facilitate inspection and other oversight
activities. You are required to keep
records of this notice, and make these
records available during inspection or
upon request.
The notification requirements in
today's final rule differ from the
proposed rule in several respects:
• Simplified initial notices to
regulatory agencies when claiming an
exemption;
• Added notification elements in the
notice to LLRWDF to ensure proper
handling of the exempted waste at the
LLRWDF;
• Removed notices to regulatory
agencies of changes in information
submitted in the initial notice;
• Removed notices to regulatory
agencies of failure to satisfy
recordkeeping or notification
requirements; and
• Changed status of the notice to your
RCRA regulatory agency when claiming
the conditional exemption from a
condition of the rule to a RCRA
requirement. (See loss of exemption
discussion in Sec. VIII.F.2.)
We received comments that both
supported and opposed the multiple
notifications to the regulators and the
LLRWDFs. Some commenters stated
that proper notification to the LLRWDF
will allow the LLRWDF to prepare for
receipt of waste and ensure compliance.
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To address the concern raised
regarding multiple notices, we
evaluated the proposed notification
requirements. We found difficulties and
burdens associated with multiple
notifications and broad notification
requirements. Consequently, we
simplified the notification requirement
by reducing the number of regulators
you must notify and the amount of
information you must provide. In the
final rule, you need only notify the
RCRA regulatory authority. You are no
longer required to provide information
such as the exempted waste volume and
the process that generated the waste.
The re-notification of changes from the
initial notice to the regulator also is not
required. The intention of the proposed
notices to the regulators was to identify
those of you who are claiming the
conditional exemption, and to provide
information on the exempted waste. The
revised notice to your RCRA regulatory
agency in today's final rule will
continue to serve these purposes while
reducing unnecessary burden. The
notice will identify those of you who are
claiming the conditional exemption. In
addition, even though the notice will
not contain information about the
exempted waste, the regulatory agency
can still obtain information related to
the waste or other aspect of the
exemption from you when necessary
because you are required to keep
records related to the exemption.
We also evaluated the notice to the
LLRWDF. We modified this shipment-
by-shipment notification requirement to
ensure that the exempted waste will be
properly managed at the LLRWDF. We
slightly expanded this notice
requirement to include the following
additional information: a statement that
you have claimed the exemption; a
statement that the waste meets the LDR
treatment standards; and a statement
that the exempted waste must be placed
in a container for disposal. This
information can be included in a
standard form letter. Therefore, we do
not expect that the additional
information requested will increase the
reporting burden. This notice to a
LLRWDF will continue to include
identification information including
your facility and the RCRA waste code
of the waste stream. We believe this
notification requirement will provide
the mechanism to ensure proper
handling of the exempted waste at the
LLRWDF.
Notices to your RCRA regulatory
authority and the LLRWDF, in
conjunction with the recordkeeping
requirement, will provide adequate
information to facilitate inspection and
enforcement activities. You are required
to maintain records of the exempted
waste, and must make records available
during an inspection or upon request.
(See Sec. VIII. D. 2. of this preamble.)
The state regulator who licensed the
LLRWDF can obtain information about
the exempted waste from the RCRA
regulatory authority where the LLRWDF
is located or where you are located.
In the proposed rule, we required you
to report to your RCRA regulatory
agency when you fail to satisfy
administrative and paper work
requirements, such as notification or
recordkeeping. Many commenters said
that this provision is unnecessarily
broad and should focus only on
reporting noncompliance that would
endanger human health and the
environment. The commenters believed
that broader reporting requirements
would impose an undue burden on the
regulated community and provide
information of little or no value to the
regulators. We considered this comment
and agree that reporting noncompliance
with administrative requirements (such
as recordkeeping) is unnecessary. We
believe that human health and the
environment will be protected provided
facilities meet the technical conditions
and standards necessary to ensure safe
management of the waste. However, you
are required to make the appropriate
notifications, maintain records, and
ensure that records are accurate and
complete. You also are required to make
these records available either during an
inspection or as requested. If the records
are found to be incomplete or
inaccurate, then you are subject to an
enforcement action requiring
compliance, monetary sanctions, or
both. These penalties can be significant.
Therefore, we believe that there is a
strong incentive for you to satisfy the
RCRA notification and recordkeeping
requirements, and make the necessary
corrections promptly. As a result, we no
longer require you to report
noncompliance with notice and
recordkeeping requirements.
2. Recordkeeping
Today's rule includes recordkeeping
provisions in § 266.350 as follows:
• Records in § 266.350(a) reference
the existing RCRA recordkeeping
requirements necessary to demonstrate
compliance with the LDR treatment
standards.
• Records in § 266.350(b), (c) and (d)
are necessary to demonstrate
compliance with the RCRA notification
requirement and waste container
condition of the conditional exemption.
• Records in § 266.350(d) are also
necessary to document that exempted
waste was disposed of at the designated
disposal facility. It enables regulators to
track and identify the shipment of low-
level radioactive waste that contained
exempted waste.
• Records in § 266.350(e) are
necessary to document and demonstrate
compliance with the manifest and
transportation condition for the
facilities who are not directly subject to
NRC or NRC Agreement State manifest
and transportation regulations.
These records will provide the
regulatory agency with information
during inspections to determine
whether you are complying with all of
the conditions and RCRA requirements
of the rule. It is important that you
maintain a complete and accurate set of
the required records, and that you make
them available when requested. The
recordkeeping provision is now a RCRA
requirement instead of a condition for
the exemption. Your waste will not
automatically lose the exemption if you
fail to meet the recordkeeping
requirements. However, you could be
subject to an enforcement action
requiring compliance, monetary
sanctions, or both.
We received comments both
supporting and questioning the
proposed duration of the recordkeeping
requirements. Specifically, some
commenters voiced concern over
requiring a generator or treater to retain
records for the radioactive waste
manifest and the notice to LLRWDF
until closure of the LLRWDF or closure
of the generator's or treater's facility.
These commenters stated that such
requirements are overly burdensome
and inconsistent with existing
regulations, and indicated that the
proposed recordkeeping timeframes
could result in record retention for
decades after a waste was shipped. They
pointed out that both NRC (10 CFR part
30) and EPA (40 CFR part 262)
regulations require a generator or treater
to retain records for only three years. In
addition, they stated that 10 CFR 61
already requires a LLRWDF to maintain
records of the LLW manifest until
termination of the LLRWDF license
activities.
We reexamine the proposed
recordkeeping duration requirement and
agreed with the commenters that it is
not necessary for a generator or treater
to maintain records beyond three years
after the waste is sent for disposal.
Therefore, the final rule requires the
records be retained for three years. In
the case of maintaining LLW records
such as the LLW manifest, this time
period is consistent with NRC
regulations under 10 CFR part 20, or
equivalent NRC Agreement State
regulations which generally is also three
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years for generators and treaters. For
disposal facilities, the NRC manifest
records are maintained by the facility
until closure of the LLRWDF or closure
of the generator's or treater's facility.
Although not required by today's rule,
we recommend and encourage
LLRWDF's to similarly maintain their
copy of the exempt-waste notices until
facility closure since these records
could be useful in the future for
identifying the exempted waste that was
disposed at the facility.
Today's recordkeeping requirement
changed from the proposed rule as
noted below.
• In the proposal we had required
you to keep NRC manifest records until
closure of the disposal facility or closure
of your facility. In the final rule you
only need to keep records of the NRC
manifest for the time period required by
NRC.
• In the proposal we had required
you to keep your notices to LLRWDFs
until closure of the disposal facility or
closure of your facility. The final rule
only requires you to keep the records for
three years after the exempted waste is
sent for disposal.
• The recordkeeping requirement is a
RCRA requirement under the authority
of sections 2002 and 3007 of RCRA
instead of a condition of the rule. (See
loss of exemption discussion in Sec.
VIII.F.2.)
• You are not required to report
noncompliance related to recordkeeping
requirements. (See Sec. VIII.D.l.
notification discussion.)
• The recordkeeping requirements
associated with the re-notification to
regulator of changes have been removed
because this notice no longer exists.
(See notification discussion in Sec.
VIII.D.l.)
E. When Does the Transportation and
Disposal Exemption Take Effect?
Today's rule conditionally exempts
eligible waste from RCRA Subtitle C
manifest, transportation, and disposal
requirements because we found that
RCRA Subtitle C regulation is not
necessary if waste meeting LDR
treatment standards and containerized
prior to disposal is managed according
to NRC manifest, transportation, and
disposal requirements for the
management of the radioactive
component of the waste (See our
technical evaluation, Ref. 7, and our
comparison of NRC and EPA waste
tracking, Ref. 12.) The Agency has
chosen to exempt the waste from the
RCRA regulatory definition of
hazardous waste at the point where your
waste meets LDR treatment standards;
you have completed NRC or NRC
Agreement State equivalent packaging,
preparation for shipment, and manifest
requirements; and you have placed the
waste on a transportation vehicle
destined for an LLRWDF licensed by
NRC or an Agreement State. Once the
exempted waste has been placed on a
transportation vehicle for disposal, the
waste may not be taken to other
facilities for further management
purposes. Stops during transportation to
pick up additional wastes, or to transfer
wastes (including radioactive waste
transporters using their transfer
facilities to consolidate radioactive
waste shipments) are not considered
"further management."
Thus when:
• Your eligible waste meets LDR
treatment standards;
• You have received return receipts
confirming that you have notified your
RCRA regulatory agency and the
receiving LLRWDF;
• You have completed the Packaging
and Preparation for Shipment
requirements for the eligible waste
according to NRC Packaging and
Transportation regulations found under
10 CFR part 71 (or NRC Agreement State
equivalent regulations);
• You have manifested the treated
waste according to NRC manifest
regulations found under 10 CFR 20.2006
(or NRC Agreement State equivalent
regulations); and
• You have placed the waste on a
transportation vehicle destined for the
receiving LLRWDF,
then the exempted waste may be
transported as a LLW or NARM. Once
properly containerized at the disposal
facility, the exempted waste may also be
disposed of as LLW or NARM.
We received comments describing
complications if the point of exemption
occurs when the waste has been placed
on a truck destined for a disposal
facility. The commenter indicated that
facilities often use centralized waste
staging areas to package, label, inspect,
and manifest wastes in preparation for
transportation. According to the
commenter, placing the point of
exemption after the waste is placed on
the transportation vehicle would require
meeting both RCRA hazardous waste
and NRC radioactive waste packaging
and labeling regulations instead of
meeting just the NRC radioactive waste
packaging and labeling regulations.
However, this was not our intention
because we found that the NRC or
Agreement State packaging, preparation
for shipment, and manifest
requirements are adequate for the
shipping and tracking of the treated
waste. Therefore, we are clarifying that
it is not necessary to package, label, and
manifest the waste as RCRA hazardous
waste when preparing the waste for
transportation to disposal. The
exemption will start at the moment
waste is placed on the transportation
vehicle if you claim and qualify for this
conditional exemption.
Another commenter expressed
concern over the proposed requirement
that exempted waste not go to any other
facility en route to the designated
LLRWDF, other than to a transfer
facility. The commenter stated that this
requirement would not allow a
transporter to pick up waste from more
than one facility and would
unnecessarily increase the shipping cost
and waste shipping traffic. We agree
with the commenter and are changing
the final rule language to clarify that
such stops are acceptable.
F. Implementation
1. How Will the Transportation and
Disposal Conditional Exemption Be
Implemented?
The transportation and disposal
conditional exemption we are
promulgating today will require no prior
governmental approval or review? of
documentation before your waste exits
RCRA Subtitle C regulations. This basic
framework is consistent with other
hazardous waste exemptions. It also is
consistent with the LDR program. The
LDR program allows a generator or
treater to certify that their hazardous
waste meets LDR treatment standards
and qualifies for land disposal without
prior governmental approval.
We are allowing this approach
because we believe that there is no
significant benefit to requiring approval
for an exemption. Furthermore, the
waste exiting RCRA Subtitle C
requirements will continue to be
managed under an alternate regulatory
program (NRC or NRC Agreement State
regulations) that provides appropriate
protection for human health and the
environment. This also is true for those
of you who self-regulates under the
AEA, because your waste also must be
disposed of at an LLRWDF regulated by
NRC or NRC Agreement State.
Therefore, we conclude that under the
proposed method, the waste will
continue to be properly managed while
the regulatory burden is reduced. In
addition, such implementation has the
following advantages:
• The exemption can take effect more
quickly;
• It reduces your burden associated
with acquiring the approval; and
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• It does not impose a burden on the
regulatory agency to review and approve
the exemption.
However, this approach does not
mean that the appropriate regulatory
authority does not have a role in
overseeing the conditional exemption.
You must keep records of the exemption
and make them available to the
appropriate regulatory authority during
inspection or upon request. The
appropriate regulatory authority may
conduct inspections, audit records,
obtain samples, and perform any other
information gathering activities
authorized under RCRA, including
under 3007, 42 U.S.C. 6927, to
determine whether you are in
compliance with all of the provisions of
this exemption. Nothing in subpart N
shall be interpreted or applied to restrict
any inspection or enforcement authority
under RCRA, 42 U.S.C. 6901, et seq.
RCRA 3008(a) gives the appropriate
regulatory agency the authority to take
enforcement actions when you fail to
meet any of the provisions of the
conditional exemption. The appropriate
regulatory authority can take a direct
enforcement action against you when
you fail to meet a specific RCRA
requirement for your waste under this
conditional exemption such as the
notification or recordkeeping
requirement. When you lose your
exemption for your waste due to failure
to meet a condition of the exemption,
your waste is no longer exempted and
it becomes a RCRA hazardous waste.
The appropriate regulatory authority
can take enforcement action against you
for managing a hazardous waste without
complying with RCRA hazardous waste
requirements. However, note that a loss
of exemption can be reclaimed (see
discussion in the following section).
Depending on the situation that led to
the loss of exemption, an exemption
could be quickly reclaimed in order to
avoid any significant consequences.
Today's rule also does not change the
ability of citizens to inform regulators of
any circumstance that might aid in
monitoring and enforcement efforts. A
concerned citizen also may file a suit
under RCRA 7002 against you for failure
to meet any of the provisions of the
conditional exemption. Lastly, the
appropriate regulatory agency can take
actions using authority under 7003 and
3013 of RCRA, 42 U.S.C. 6973, when it
determines that there may be an
imminent and substantial endangerment
to human health or the environment.
2. Loss of Transportation and Disposal
Conditional Exemption
Under today's final rule, any waste
will automatically lose its transportation
and disposal conditional exemption if
you do not manage it in accordance
with all of the conditions specified in
§ 266.315. Depending on which
condition or conditions you failed to
meet and the circumstances
surrounding the failure, the affected
waste could be a single drum, a number
of drums, a treated waste stream
containing specific waste codes, or a
number of treated waste streams with
specific waste codes. The exemption is
lost at the time of noncompliance. The
appropriate regulatory authority need
not take action to remove the
exemption. The conditions of the
exemption are the technical conditions
and standards that we have determined
to be necessary to achieve proper
management of the waste and ensure
protection of human health and the
environment. Therefore, we believe it is
appropriate that a waste automatically
lose its exemption if you do not manage
it in accordance with these technical
conditions and standards.
You must report to your RCRA
regulatory agency when any of your
waste loses its exemption. Your report
must be in writing, by certified delivery,
within 30 days of learning of the failure.
In your report you must describe at a
minimum: any specific condition(s) that
you failed to meet for your waste,
information (e.g. name, waste code, and
quantity) regarding the waste stream
that lost the exemption, and the date(s)
on which the condition(s) were not met.
The report will allow the appropriate
regulatory agency to be aware of any
noncompliance and to take appropriate
actions, if necessary. The appropriate
regulatory authority may request
additional information from you to
facilitate the investigation. If the failure
to meet any of the conditions may
endanger human health or the
environment, then you also must report
such failure to your RCRA regulatory
agency orally within 24 hours of
learning of the failure. A written notice
must follow? your oral notification
within 5 days.
You also may lose the transportation
and disposal conditional exemption for
your waste for serious or repeated
noncompliance with any of the RCRA
requirement(s) (e.g. notification or
recordkeeping) of Subpart N. In this
situation, the appropriate regulatory
authority may terminate your ability to
claim the conditional exemption for
your waste. The appropriate regulatory
authority also may require you to meet
additional conditions in order to claim
a conditional exemption. This provision
gives the appropriate regulatory
authority the ability to revoke a
conditional exemption from you if you
have serious and repeated compliance
problems related to the notification or
reporting requirements.
When you lose the exemption for your
waste, you may also be subject to an
enforcement action requiring
compliance, monetary sanctions, or both
for any violation of RCRA Subtitle C
regulations.
Today's loss of exemption provision
changed from the proposed rule in
several respects:
• In the final rule, notice to regulator
and recordkeeping are RCRA
requirements instead of conditions of
the exemption. Noncompliance with
these RCRA requirements will not result
in automatic loss of exemption;
• You can lose your ability to claim
a conditional exemption for serious or
repeated noncompliance with any of the
RCRA requirements (e.g. notice to
regulator or recordkeeping) of Subpart
N;
• We have specified minimum
reporting requirements for reporting a
failure to meet a condition; and
• We have added one reporting
requirement stating that when a waste
loses its exemption, if the failure to
meet any of the conditions may
endanger human health or the
environment, you must orally notify
EPA or the Director within 24 hours of
discovery of failure and follow up with
a written notice within 5 days.
We received comments that both
supported and opposed the proposed
loss of exemption provision. The
commenters who supported the
provision believed that an automatic
loss of exemption was a strong incentive
for ensuring that waste would be
properly managed. However, the
majority of comments expressed
concern over losing the exemption due
to relatively minor administrative
violations such as incorrect spelling of
a facility name.
Upon further evaluation, we believe
that the commenters raised a valid
issue. We recognize the undue
difficulties and burdens associated with
the automatic loss of exemption due to
failure to comply with administrative
requirements alone. In the proposed
rule, the exemption conditions included
both technical conditions and standards
necessary to ensure safe management of
the waste, and administrative type of
requirements such as notification and
recordkeeping. As proposed, when an
exemption is lost due to failure to meet
the administrative requirement alone,
you would have to manage the waste as
RCRA hazardous waste while correcting
the infraction and then reclaim the
exemption. However, the technical
conditions and standards of the
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conditional exemption necessary to
ensure safe waste management would
continue to be met. We believe that it
is appropriate to impose the automatic
loss of exemption when technical
conditions and standards for safe
management of the waste are not met
and could by itself directly lead to
impact to human health and the
environment. However, we do not
believe that automatic loss of exemption
is warranted for errors related to
administrative requirements, such as
recordkeeping, which by themselves are
unlikely to lead to environmental harm.
We evaluated the proposed conditions
and made modifications so that the
administrative requirements, such as
recordkeeping, are RCRA requirements
instead of conditions of the exemption.
The conditions as specified under 40
CFR 266.315 of today's rule are the
technical conditions and standards
necessary to maintain the exemption.
We believe this is more consistent with
the overall approach of today's rule,
which is that eligible waste is not
"hazardous" for Subtitle C purposes if
properly managed. Although it is
important that EPA be able to enforce
paperwork violations, we do not think
these violations alone support the
conclusion that the waste becomes
hazardous for Subtitle C purposes. As a
result, the automatic loss of exemption
will only apply to noncompliance with
technical conditions and standards, and
not to failure to meet the RCRA
requirements of this rule such as
recordkeeping.
Nevertheless, the notification and
recordkeeping requirements serve an
important function in the
implementation of the conditional
exemption. These RCRA requirements
also play an important role in
compliance determination. Therefore,
we want to maintain a mechanism that
will provide the appropriate regulatory
authority with the ability to revoke the
exemption for failure to comply with
these RCRA requirements where
necessary. In the final rule, the
appropriate regulatory authority may
terminate your ability to claim a
transportation and disposal conditional
exemption for your waste for serious
and repeated noncompliance with the
RCRA requirements of Subpart N. We
do not expect this provision to be used
casually. We view it as a means to
ensure that you take the reporting and
recordkeeping requirements seriously
and that you comply with these RCRA
requirements at all times. Revocation of
the transportation and disposal
conditional exemption would be
effective after the Director takes this
action and would only affect subsequent
waste shipments.
We also received comments regarding
the requirement to report
noncompliance with the conditions and
RCRA requirements of the rule. Two
commenters urged us to consider
requiring the facility to orally report a
condition that endangers human health
and the environment within 24 hours.
We agree with the commenter and note
that it is a standard RCRA requirement
that an oral report, followed up with a
written notice within five days, be made
for situations that threaten human
health and the environment. Therefore,
we have modified the final rule to
incorporate this provision.
3. Reclaiming the Transportation and
Disposal Conditional Exemption
Under the final rule, any waste will
automatically lose its exemption if it is
not managed in accordance with the
conditions under § 266.315. However,
you may reclaim the exemption for your
waste if it is again managed in
accordance with all of the conditions
under § 266.315. You may initiate the
reclaim process for your waste only after
you have received the return receipt
from your RCRA regulatory agency
confirming that it has received your loss
of exemption notice that you have lost
the exemption for your waste. When
reclaiming a lost exemption, you must
notify your RCRA regulatory agency that
you are reclaiming the conditional
exemption for your waste. In this
reclaim notice, you must do the
following:
• Explain the circumstance of each
failure to meet a condition;
• Certify that each failure that caused
the waste to lose the exemption has
been corrected and that the waste again
meets all of the conditions as of the date
you specified; and
• Demonstrate that each failure is not
likely to recur, listing the specific steps
that you have implemented to ensure
the conditions will be met.
You also may provide any other
information that you want your RCRA
regulatory agency to consider when it
reviews your notice reclaiming the
exemption.
We are requiring a notice to reclaim
an exemption because the conditions of
the exemption represent those technical
conditions and standards which will
ensure safe management of the waste.
Therefore, we believe that it is
important that you notify your RCRA
regulatory agency of events that led to
the loss of the exemption so that it can
take steps, if necessary, to ensure that
waste will be managed properly. The
appropriate regulatory authority can
review your records, collect additional
information, or conduct site visits. This
communication and information will
allow your RCRA regulatory agency to
work with you to correct the problems
that led to the non-compliance with the
conditions. The appropriate regulatory
authority may add additional
conditions, where appropriate, to the
exemption to ensure proper
management of the waste to protect
human health and the environment.
The reclaimed transportation and
disposal exemption becomes effective
when you have received the return
receipt confirming that your RCRA
regulatory agency has received your
reclaim notice. The return receipt can be
a certified U.S. Postal receipt or a
certified receipt from a mail delivery
service. Additionally, as proposed, the
appropriate regulatory authority may
terminate a reclaimed conditional
exemption if it finds that the claim is
inappropriate.
Today's transportation and disposal
exemption reclaim requirement is
changed from the proposed rule in one
area. We added a new requirement that
you may initiate the reclaim process for
your waste only after you have received
the return receipt confirming that your
RCRA regulatory agency has received
your notice that you have lost the
exemption for your waste. This
provision is not required under the
storage and treatment exemption. This
slight variation is designed to ensure
that a waste, for which the lost
exemption is being reclaimed, will not
be transported to a LLRWDF before your
RCRA regulatory authority is made
aware that you have lost the exemption
for your waste.
We received comments on the issue of
whether a transportation and disposal
exemption could be reclaimed after it
has been lost. Some commenters
supported the proposed rule that
allowed the exemption to be reclaimed.
Some commenters noted that requiring
notification to reclaim is burdensome
and unnecessary. One commenter urged
the Agency to disallow the reclaiming of
an exemption.
In general, we believe that you should
be allowed to reclaim a lost exemption.
We believe that even a responsible
generator or other waste handler may,
on rare occasion, be in noncompliance
with the conditions of the exemption.
Because the consequence of the loss of
the exemption for a waste is potentially
the full imposition of the RCRA Subtitle
C regulation, we believe a permanent
loss of exemption would unduly
penalize responsible generators and
other waste handlers and downstream
handlers. However, we want to
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emphasize that failure to meet the
conditions can result in RCRA
enforcement actions, fines, penalties,
and the permanent loss of exemption.
Thus, the mechanism to discourage
violation of the conditions is in place.
Therefore, we are allowing you the
opportunity to reclaim the exemption
for its waste when the infraction has
been corrected and is not likely to recur.
We note that other RCRA rules
provide a similar provision for
reclaiming a lost exemption. We
established a conditional exemption
from the RCRA transportation and
storage requirements for persons that
transport or store nonchemical waste
military munitions in accordance with
40 CFR 266.203 or 266.205,
respectively. Under that conditional
exemption, we established procedures
for persons to reclaim a lost
transportation or storage exemption (see
§ 266.203[b] and § 266.205[c]). The final
rule is consistent with the provisions of
§266.203 and §266.205.
In addition, as stipulated in
§ 266.360(b), the appropriate regulatory
authority may terminate a reclaimed
exemption if warranted. This provision
allows the appropriate regulatory
authority to deal with repeat or serious
offenders. Therefore, we believe that the
final rule is adequately flexible to
enable the appropriate regulatory
authority to react to violations in a
manner that is commensurate with the
severity of the violation. The final rule
not only ensures protection of the
environment, but also motivates
facilities to meet the exemption
conditions.
In the proposed rule, we solicited
comments as to whether we should
impose a waiting period before the
exemption could be reclaimed. We
asked whether we should provide a 90-
day waiting period before the reclaimed
exemption is effective. We solicited
input on whether a waiting period is
necessary to allow time for the
appropriate regulatory authority to
review the reclaim notification, and to
deal with repeat or serious offenders.
The majority of the commenters
believed that a 90-day waiting period
was unnecessary. They believed that
you should be able to reclaim the
conditional exemption for your waste as
soon as the noncompliance with the
conditions is corrected with reasonable
assurance that the noncompliance
would not recur. Several commenters
noted that further delay in reclaiming
the exemption would serve no purpose
and could potentially result in uncertain
regulatory status and/or unreasonable
enforcement action. Other commenters
stated that the appropriate regulatory
authority could conduct an inspection
at any time and take actions if
necessary. Some states believed that
there should not be a binding time
period for the review?. Lastly, one
commenter stated that without a waiting
period, you would be motivated to
correct the noncompliance that resulted
in the loss of conditional exemption as
quickly as possible in order to minimize
penalties and return to exempt
operations. However, several
commenters indicated their support for
a 90-day waiting period before allowing
licensees to reclaim a lost transportation
and disposal exemption so that there
would be time to review documentation,
conduct an inspection, and/or hold a
public hearing before reinstating the
exemption.
After considering the comments, we
do not believe that it is necessary to
require a waiting period before the
exemption is reinstated if the violation
has been corrected. This approach is
generally consistent with the current
RCRA regulatory program. For example,
under the LDR program, hazardous
waste generators or treaters can send the
waste for disposal after self-certifying
that the waste has met the LDR
treatment standard without a waiting
period.
Today's rule also provides the
appropriate regulatory authority with
flexibility regarding the amount of time
it has to review a request to reclaim an
exemption. It can, at any time, review
the notification, request additional
information, or conduct a site
inspection to verify the validity of the
reclaim or the purported successfulness
of measures designed to prevent the
recurrence of a failure. By not specifying
a time period for review?, we are
providing regulators flexibility and the
ability to evaluate any reclaim notice at
any time and to focus their attention
and limited resources as they deem
most appropriate. This mechanism also
avoids the implication that a reclaim is
approved if the appropriate regulatory
authority was not able to review the
reclaim and respond before the end of
the waiting period. We note that the
appropriate regulatory authority will
continue to maintain a broad range of
inspection, and information collection
authorities to ensure compliance with
the exemption conditions under RCRA
3007, 42 U.S.C. 6927. Thus, the
appropriate regulatory authority has the
ability to conduct an inspection at any
time, and can take enforcement actions,
and assess fines and penalties if you are
found to be in noncompliance with the
reclaim requirements.
We believe that these requirements
are sufficient for the appropriate
regulatory authority to track compliance
and conduct enforcement activities.
Most importantly, today's rule provides
the appropriate regulatory authority
with adequate means to discover,
evaluate, and, if necessary, terminate an
exemption (for example, determine that
the claim is inappropriate because the
claimant failed to correct the problem).
The appropriate regulatory authority
can terminate the reclaimed exemption
at any time for violations and does not
need a waiting period to do so.
Therefore, the final rule does not require
a waiting period before you can reclaim
an exemption for your waste. However,
we want to ensure that the appropriate
regulatory authority is aware that you
have lost the conditional exemption for
your waste before you reclaim the
exemption. Therefore, you may not
reclaim the exemption for your waste
until after you have received a return
receipt confirming that the Director has
received your notification of loss of
exemption. This requirement will allow
the appropriate regulatory authority to
initiate action, if necessary, while
minimizing your burden.
G. How Did We Conduct Our Technical
Assessment for the Disposal of Treated
Waste at Low-Level Radioactive Waste
Disposal Facilities?
We conducted a technical assessment
to evaluate the protectiveness afforded
by a combination of the conditions of
the exemption and NRC criteria for the
LLRWDF. We considered a number of
factors in the analysis:
• LDR treatment and waste container
conditions;
• NRC waste form requirement;
• NRC/EPA disposal site properties
comparison;
• Disposal unit engineering design
and performance;
• NRC groundwater monitoring;
• Other NRC/EPA regulatory
comparisons.
We made our technical determination
on the comparability between the NRC
and EPA disposal systems based on the
consideration of all of the above factors.
This determination is not based solely
on any one factor, but on the aggregation
of all the factors considered.
In our technical assessment, we
considered these factors and the
potential for release of chemical
constituents from LLMW disposed of in
LLRWDFs, and concluded that the
threat of such a release would not be
significant. Several significant factors
that helped support this conclusion are
briefly summarized below?. More detail
on these factors, and a discussion of
other factors that we considered, is
provided in the proposed rule preamble
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and the technical background
document. (See Technical Evaluation,
Ref. 7.)
We assessed the likelihood of a
chemical release from the disposal of
waste in a LLRWDF under the
conditions of this rulemaking. The
intent of RCRA LDR treatment standards
is to significantly reduce the toxicity
and mobility of chemical constituents.
We performed a screening risk analysis
to assess the potential for leachate
releases of these constituents from
wastes treated to LDR levels. We
concluded that the potential threat to
drinking water would be insignificant.
In addition, prior to disposal the treated
waste must be containerized. Therefore,
we concluded, based on the treatment to
LDR for both RCRA and as a condition
of this rule, and container conditions
along with the LLRWDF cap design
performance comparable to RCRA
Subtitle C performance, the potential
threat to drinking water would be very
low, if any.
We also assessed the protection
afforded by NRC waste form criteria.
NRC waste form criteria for low level
waste stipulates that the waste be
stabilized to ensure the structural
integrity of the waste for the duration
when the radioactive waste is
undergoing decay. The requirement for
waste form is to minimize the potential
for waste/liquid contact and subsequent
leachate production. Depending on the
radioactivity of the waste, the structural
integrity of the waste is required to last
up to 500 years. The waste must pass a
series of American Society of Testing
Methods (ASTM) tests to demonstrate
its compliance with the waste form
criteria. These tests provide indication
of waste form performance in the area
of, among other things, structural
integrity and resistance to corrosion.
We evaluated NRC's LLRWDF siting
requirements and compared them to
RCRA hazardous waste disposal facility
siting requirements. We found that the
siting requirements are very similar,
with NRC siting requirements being
more stringent in certain respects. The
NRC siting requirement for LLRWDFs
are designed to enhance the
protectiveness of the disposal unit and
minimize releases to the environment.
These regulations ban location of
disposal facilities in environmentally
sensitive locations such as, 100-year
flood plains, wetlands, and coastal high
hazard areas. These requirements also
mandate restrictions for ground water to
surface water connectivity on-site.
We assessed NRC LLRWDF
engineering design and performance
requirements and concluded they will
effectively minimize water infiltration
and waste migration from the disposal
cell. The LLRWDFs must be designed to
limit human exposure to a specified
level of radioactivity and intrusion by
humans and animals. NRC LLRWDF
disposal regulations require that the
engineered landfill design system
integrate both the site properties
(climate, soil geology) along with the
performance of the cover system.
LLRWDFs must be designed to provide
assurance that concentrations of
radioactive material that may be
released to ground water, surface water,
air, soil, plants, or animals not result in
exposures to humans above specified
health-based levels. NRC and EPA
disposal regulations require a final
cover with low permeability to
minimize infiltration of precipitation
and contact of waste with infiltrated
water. NRC LLRWDF disposal
regulations also require a landfill design
that promotes short liquid/waste
residence time which would minimize
the potential leachate generation at
LLRWDFs.
NRC's ground water monitoring
regulations require that groundwater be
monitored to allow for early detection
and mitigation of radiological
contamination. In practice, the NRC
Agreement States have also included
requirements in the LLRWDFs license to
monitor for selected chemical
constituents.
We also estimated the annual amount
of mixed waste that is expected to be
disposed of at LLRWDFs under this
conditional exemption. Commercial
sources of mixed waste would
constitute less than 0.5% of the annual
total waste volume at these sites. This
amount of disposal volume is expected
to contribute very limited volumes of
hazardous waste.
In addition to the major technical
factors outlined above, we also analyzed
other aspects of the NRC regulatory and
licensing program for LLRWDFs. This
analysis is described in detail in the
technical background document. (See
Technical Evaluation, Ref. 7.) Some of
the key findings include:
• The NRC licensing process provides
for public participation and scrutiny of
potential disposal facilities, which plays
an important role in not only the siting
of a facility but also in prescribing
conditions governing its final operation.
• NRC prohibits disposal of waste
with free liquids greater than 1% by
volume, waste contaminated with
reactive, explosive, volatile, and
corrosive materials, and LLW that is
incompatible with containers used for
disposal of LLW.
• NRC regulations require active care
disposal facility surveillance for up to
100 years under governmental control
and government ownership.
• NRC's LLRWDF disposal
regulations require corrective measures
for the disposal of radioactive waste to
assure that corrective measures are
taken if a radiation hazard becomes a
groundwater concern.
We received 15 comments pertaining
to our overall technical analysis and
conclusions. The eleven comments
supporting the technical approach came
from industry associations, generators,
academia, and some government
agencies. They felt that the approach
was thorough and presented compelling
analysis supporting the conditional
exemption. They agreed that the
combination of LDR treatment in
conjunction with the stringent controls
already in place at the LLRWDFs were
protective of human health and the
environment. Some commenters argued
that dual regulation is not appropriate
and only seems to hinder the timely
disposal of waste. Based on our analysis
that disposal of LLMW would be
properly managed in a LLRWDF,
without degradation to human health
and the environment, the redundant
regulation by RCRA adding additional
cost and time to permit the facility does
not seem prudent.
In contrast, we also received four
negative reactions to the technical
approach from environmental groups
and some State agencies. Some of the
comments related to the uncertainties
inherent in the analysis. Another
commenter believed that we need to
address all contingencies and technical
aspects before making our final
decision. Although there are always
uncertainties associated with complex
environmental analysis, we are
confident of the conclusions of our
technical analysis that indicate the
RCRA exemption conditions coupled
with the NRC performance requirements
will be protective of human health and
the environment. Our comfort derives
from having designed a waste
management scheme with multiple
redundant systems and conditions that
will limit contaminant movement.
These include waste treatment, waster
form, containers, cover performance,
monitoring, and site-specific public
participation. We believe that we have
addressed all major technical aspects
and waste management contingencies in
making our decision on the
comparability of the two regulatory
programs.
Our responses to major comments on
specific technical issues are presented
in the following sections.
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1. Synergistic Effects
Commenters indicated that the
radioactive portion of the waste could
negatively influence the nature and
mobility of the hazardous portion of the
waste and similarly the hazardous
portion could possibly enhance the
mobility of the radioactive constituents.
Commenters also raised concerns
regarding potential toxicological
interaction between the hazardous and
radioactive fractions in mixed waste.
Interaction between radioactive and
hazardous waste components that
enhance the mobility or toxicity of
constituents is referred to as "synergy."
The agency acknowledges that
interaction between the waste
components may be possible. There is
not an adequate scientific
understanding of such processes (e.g.,
synergy and cumulative interactions)
that would allow EPA to design
additional, and appropriate,
management standards, if needed. In
addition, the current regulatory schemes
do not explicitly account for such
effects. Our redundant control systems
would make the possibility of such
effects remote and go beyond current
management practices. From a practical
perspective, we concluded that the
synergistic effects between radioactive
and hazardous constituents would be
minimal due to treatment requirements
minimizing the hazardous constituents,
waste form requirements, container
conditions of the waste minimizing
radioactive and hazardous interaction,
and cover requirements resulting in the
lack of liquid to generate leachate.
Indeed, the container condition will
enhance protectiveness over the current
scheme, under which LLMW could
interact more readily in a landfill with
other radioactive or hazardous wastes.
2. Groundwater Monitoring
Today's final rule does not require
LLRWDFs that accept LLMW under the
provisions of today's transportation and
disposal exemption to conduct
groundwater monitoring for chemical
constituents. These facilities already are
required to conduct groundwater
monitoring for radioactive material and
other indicators which include selected
hazardous constituents. We believe that
this monitoring will provide adequate
warning if there is a breach of the
containment systems at the disposal
facility.
A significant number of commenters
agreed with the Agency's approach to
not require groundwater monitoring for
the RCRA constituents as one of the
conditions of the disposal exemption
because they believed the current NRG
and Agreement provisions adequately
address the monitoring needs for
disposal sites. One commenter pointed
out that the Agreement States have the
authority to require groundwater
monitoring for non-radiological
constituents in the license for hazardous
constituents under NRG regulations.
This commenter noted that additional
monitoring (if needed) can be best
established as part of the site license
condition with the Agreement State and
be tailored to the local environmental
conditions and the nature of the waste
being accepted for disposal. EPA's
analysis supports this contention. All
three existing LLRWDFs licensed by the
Agreement States have groundwater
monitoring for RCRA hazardous
constituents in their licenses. We
believe this data will supplement the
groundwater monitoring data of the
radioactive constituents in providing
the necessary warning sign when there
may be a breach of containment at the
disposal facility. Further, we found no
evidence to suggest that these facilities
have ground water contamination above
regulatory levels for hazardous
constituents as a result of disposal unit
design problems or management.
In the proposed rule we specifically
asked if commenters knew of reasons
why we should include groundwater
monitoring requirements for RCRA
hazardous constituents as part of the
conditional exemption. Some
commenters believed that we had not
adequately supported our assumption
that controlling radionuclides will also
adequately control hazardous
constituents, because hazardous
constituents may be more mobile than
radionuclides. One commenter added
that monitoring requirements should be
based on the contents of the disposal
cells; that is, if there are hazardous
constituents in the disposal cell, they
should be included on the list of
analytes to be monitored.
The concerns expressed by these
comments are addressed first and
foremost by the preconditions
established in today's rule for the
exempted wastes. Specifically, the
LLMW will be treated. Organics will be
destroyed and metals will be
immobilized through meeting the LDR
standards. There will be no free liquid.
The waste will then be containerized, at
a minimum in carbon steel drums, prior
to being placed in the disposal
environment. Stable Class-A waste that
is mixed with more active Class-B or C
waste will meet the NRC requirement of
high integrity containers (HICs) (e.g.,
concrete casks). This system of controls
should preclude both transport alluded
to by the commenter (e.g., organic
solvents either moving faster than other
constituents or promoting transport of
inorganic constituents) and
uncontrolled leaching of inorganic
constituents (e.g., the inorganic
constituents will be immobilized and
unavailable for leaching, if not already
destroyed by thermal treatment, and
will be contained).
Although we believe the likelihood of
hazardous constituent releases is
minimal for the reasons presented
above, we still believe that ground water
monitoring is a prudent safeguard. The
NRG/Agreement States already require
LLRWDFs to conduct groundwater
monitoring for radionuclides and other
indicators (including selected hazardous
constituents) using traditional analytical
methods. The NRC/Agreement States
ensure that the monitoring protocols
established by the LLRWDFs are based
on the wastes and constituents disposed
of in the facility. Therefore, the list of
analytes will include indicator
constituents that are representative of
the materials in the facility. In general,
the migration of metals, whether as
hazardous constituents or radioactive,
will migrate in a similar way. We note
that the detection of an indicator
radioisotope (e.g., Cr-51, Cu-64, Pb-201,
Se-75, Tl-201, or Zn-63) would also
serve as an indicator of migration of the
chemical portion of the waste. For
example, if mixed waste contains
hazardous chromium and radioactive
CR—51 and groundwater monitoring
detects CR-51, it would be reasonable to
expect that hazardous chromium is also
present in groundwater. As noted above,
the three operating LLRWDFs monitor
for RCRA constituents, including metals
and some of the more mobile organic
constituents (e.g., benzene, xylene). In
conclusion, we are satisfied that the
NRC ground water monitoring program
will provide adequate protections for
the exempted wastes managed under
today's rule.
3. Site-Specific Variance
The Agency solicited comment on the
use of a "site-specific, risk-based
variance" approach to determine the
waste disposal eligibility. We proposed
this alternative to the conditional
exemption based on States' interest to
factor in site properties into the risk
determination. In addition to the site-
specific approach, the Agency also
solicited comment on the need for
guidance in support of performing site-
specific risk assessments. Today's final
rule regarding the "conditional
exemption" for disposal does not
include the site-specific, risk-based
variance approach as an alternative
method for exemption. The
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requirements identified in the final rule
and the existing NRC and Agreement
State regulations, guidance, and licences
were deemed to be adequate and
protective for the management of these
wastes.
We received more than forty
comments on the use of site-specific,
risk-based variances for the
determination of waste disposal
acceptability. The comments
represented a wide disparity of
positions. Many comments from States
supported the use of the site-specific
risk-based alternative to the conditional
exemption. The commenters expressed
the concern that efforts outside of site-
specific modeling would not properly
reflect the conditions at a specific site,
either by overestimating or
underestimating disposal performance.
The commenters argued that using a
national approach would tend to
average site conditions and not truly
represent any specific site resulting in
uncertainty around the conclusion
regarding the qualifications of natural
and engineered site conditions.
A set of industry comments did not
support the use of site-specific, risk-
based analysis, in lieu of the conditional
exemption. Their position was that the
conditional exemption was technically
sound and was instantly available,
whereas the site-specific alternative
would take time to perform and delay
decisionmaking.
One environmental commenter
opposed the use of site-specific, risk-
based analysis completely on the
grounds that the state of the science was
not appropriate and too much
uncertainty surrounded this type of
analysis.
We have decided not to include the
site-specific, risk-based alternative in
the final rule. We concluded that the
disposal of LLMW in LLRWDFs would
be protective and be properly managed
based on the benefits derived from
siting, LDR treatment and waste form
requirements, and the protection
afforded by LLRWDFs licensed pursuant
to 10 CFR part 61. Our review of NRC
regulations, guidance, and licenses
indicated that disposal facilities provide
adequate protection for the disposal of
LLMW so long as the additional
conditions and requirements of this rule
are met. In summary, the approach
adopted in this rule will ensure that any
potential risks that arise as a
consequence of site-specific
circumstances will be thoroughly
reviewed and mitigated through the
NRC licensing process.
H. Why Is Financial Assurance Beyond
10 CFR Part 61 Not Necessary?
You are not required to provide
additional financial assurance beyond
what NRC requires under 10 CFR part
61 or an NRC Agreement State requires
under the state equivalent regulations.
This decision is based on our review?
and comparison of EPA and NRC
financial assurance regulations. (See
comparison document, Ref. 18.) Both
EPA and NRC financial assurance
regulations require a disposal facility to
provide sufficient funding to enable a
third-party to conduct closure and post-
closure care activities. Financial
assurance for closure and post-closure
activities are the key elements of
financial assurance requirements under
both EPA and NRC regulations. Based
on our comparison and analysis of EPA
and NRC financial assurance
regulations, we have determined that
the financial assurance provided by the
NRC regulations will ensure that
sufficient funds will be available to
conduct the similar closure and post-
closure care activities at a LLRWDF as
required under RCRA. We note that
there are variations between EPA and
NRC financial assurance requirements.
However, we conclude that as a whole,
the NRC financial assurance
requirements for the LLRWDF are
adequately protective, making
additional EPA financial assurance
requirements for a LLRWDF
unnecessary.
Similar to the financial assurance
requirements set out under 40 CFR part
264 subpart H for a RCRA hazardous
waste disposal facility, 10 CFR part 61
requires a LLRWDF to establish
financial assurance that will provide
funding for activities such as
decommissioning and closure of the
facility, cover placement over the
disposal unit, post-closure care, and
monitoring. NRC and NRC Agreement
States do not issue licenses to facilities
that cannot obtain financial assurance
and these regulatory authorities will
revoke licenses from facilities that
cannot maintain adequate coverage.
For post-closure care, the NRC and
NRC Agreement States require the
LLRWDFs to provide financial
assurance for an initial monitoring
period of five years (or longer if deemed
necessary by the regulatory authority)
followed by a period of institutional
control. At the completion of the five-
year (or longer) initial post-closure
monitoring period, the license of the
LLRWDF is transferred from the
disposal facility operator to the State or
other Federal Agency who is the
property owner. At that time, the next
phase of the post-closure care period
begins. This second phase of the post-
closure care period is the institutional
control period. The activities conducted
under the institutional control period
include monitoring, maintenance of
cover, and access control. The NRC or
NRC Agreement States also require that
the LLRWDF licensees' financial
assurance include all the costs
associated with the institutional control
phase of the post-closure care period.
Specifically, prior to the issuance of the
license, the applicant needs to provide
for NRC review and approval, a copy of
a binding arrangement between the
applicant and the disposal site owner
that ensures that sufficient funds will be
available to cover the costs of
monitoring and any required
maintenance during the institutional
control period. (See 10 CFR part 61.)
The NRC or NRC Agreement State
reviews this arrangement periodically to
ensure that changes in inflation,
technology, and disposal facility
operations are reflected in the
arrangements. Thus, the responsibility
for funding the institutional control
period belongs to the licensee and is
assured prior to the issuance of the
license and subsequent transfer of the
license to the State or Federal Agency
for institutional control of the LLRWDF.
The institutional control period may last
up to 100 years thus providing financial
assurance for a considerably long period
of time. In comparison, EPA requires
RCRA land disposal facilities to provide
for 30 years of post-closure monitoring
unless the permitting authority modifies
the monitoring period.
Although we determined that the EPA
and NRC financial assurance
requirements are not identical under a
requirement-by-requirement
comparison, we believe that the overall
NRC financial assurance requirements
are adequately protective of human
health and the environment for a
LLRWDF receiving the exempted waste.
However, we requested public comment
on whether we should require
LLRWDFs to provide additional RCRA
financial assurance as part of the
conditional exemption.
Some commenters supported our
proposal of not imposing the RCRA
financial assurance requirement for
LLRWDFs, because they believed
adequate financial assurance exists
under NRC regulations. Some of these
commenters noted that further financial
assurance requirements could
discourage LLRWDFs from accepting
the exempted wastes. Other commenters
believed that it is necessary to impose
the additional RCRA financial assurance
requirement on a disposal facility
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receiving the exempted waste to address
the chemical constituents that will be
disposed of there.
As discussed above, our analysis
showed that the NRC or NRC Agreement
State provisions for financial assurance
will ensure that sufficient funds will be
available to conduct closure and post-
closure care activities which are the key
elements of RCRA financial assurance
requirements. We do not expect the cost
for closure activities such as cover
placement and post-closure
maintenance activities, at a LLRWDF
receiving the exempted waste to differ
from the cost for the same activities at
the same LLRWDF if it did not receive
the exempted waste. Because NRC
regulations already require financial
assurance for closure and post-closure
activities, additional funding
requirements for the same activities
would be redundant.
We also believe that the NRC financial
assurance requirement for
decommissioning activities is adequate
for a LLRWDF that accepted the
exempted waste. We note that NRC
guidance has a provision that requires
cost estimates for decommissioning to
include the management of mixed waste
(which includes the RCRA chemical
constituents) during the
decommissioning process. (See "NMSS
Decommissioning Standard Review Plan
[NUREG/SR-1727]".) Therefore, we
believe that the NRC financial assurance
requirement is adequate, and we do not
need to require additional RCRA
financial assurance requirements.
IX. Regulatory Impacts
We anticipate that implementation of
this rule will result in positive net
benefits, resulting from cost savings and
risk reductions. We have based our
assessment on the best data available;
full references and details are available
in the Regulatory Impact Analysis
which accompanies today's rule. (See
Ref. 14.)
The primary benefit of this rule is in
facilitating treatment and disposal of
mixed wastes, by addressing problems
caused by dual regulation of these
wastes. We estimate quantified net
benefits of this rule to range between
$4.1 million and $5.9 million per year.
Sections A and B below provide further
detail on benefits and costs associated
with this rule; Section C addresses
economic impacts. We base assessment
of benefits and costs on a comparison of
waste management after implementation
of this final rule compared with waste
management in the absence of this rule.
Significant uncertainties make it
unusually difficult to estimate the
impacts of this rulemaking. In addition
to uncertainties about the quantities of
LLMW generated in the U.S. there are
also questions about the eventual
disposition of these wastes. Although
this rulemaking creates opportunities
for disposal of much of this waste, these
opportunities also depend on as-yet
undetermined action by State regulatory
agencies, low-level radioactive waste
disposal facilities, and the generators
themselves. These uncertainties and
assumptions, however, do not affect the
Agency's projection of positive net
benefits stemming from this rule; they
only affect the magnitude of that net
benefit. To the extent that any
generators can take advantage of storage
or disposal provisions of this proposal,
net benefits will accrue.
A. What Are the Regulatory Benefits of
This Rule?
The storage component of the rule
provides the most significant benefits of
this rule, from administrative cost
savings and from allowing certain
mixed wastes to decay-in-storage. Dollar
savings from the disposal portion of this
rulemaking are likely to be low, even
more so if the LLRWDFs (especially
Envirocare) do not accept the exempted
waste for disposal as LLRW. To estimate
the impact of the rule, EPA first needed
to characterize generation and
management of low-level waste and
low-level mixed waste in the nation.
In 1990, EPA, NRC and the Oak Ridge
National Laboratory conducted a survey
of commercially generated low-level
mixed waste. A report of the survey
findings was published in 1992 under
the title National Profile on
Commercially Generated Low-Level
Radioactive Mixed Waste. (See Ref. 8.)
As stated in the Executive Summary,
"The * * * objective of the work was to
compile a national profile on the
volumes, characteristics, and treatability
of commercially generated low-level
mixed waste * * * by major facility
categories * * * [including] academic,
industrial, medical, and * * *
government facilities and nuclear
utilities."
"The industrial category was
estimated to be the largest generator and
accumulator of mixed waste, with more
than 36% of the generation* * * of the
total mixed waste in the United States
in 1990." (Ref. 8, National Profile, p.
40). Nuclear utilities accounted for
roughly 10 percent of the total
commercially generated LLMW volume
in the United States.
Based on our discussions with the
regulated community, we understand
that commercial generators of LLMW
have taken a number of steps, including
pollution prevention, waste
minimization, and source reduction
(such as using water-based scintillation
cocktails as opposed to the solvent-
based formulations), to reduce
quantities of LLMW they generate. Also,
nuclear power plants have instituted
steps for controlling the use of organic
solvents (for example, establishing
procedures to track quantities of organic
solvents purchased, used, and left over
and discarded). Therefore, despite
industrial growth over the intervening
years, we believe that the LLMW
volumes generated today may be similar
to those reported in 1992.
Based on this research and site visits
in 1998, we believe that there are a
number of LLMW generators, who could
benefit from this rulemaking. Using the
National Profile we estimated that the
national generation rate of mixed waste
was 108,000 cubic feet per year. (See
Regulatory Impact Analysis, Ref. 14, and
Regulatory Impact Analysis,
Background Documents, Ref. 17.) Some
federal facilities also generate LLMW.
The total volume of LLMW generated
annually by DOE facilities far exceeds
the volume generated by the commercial
sector.
Benefits from this rule may accrue in
the following areas.
• Permitting cost savings. Those
generators needing RCRA permits only
for storage or treatment of their mixed
wastes will save these permitting costs
and associated corrective action costs.
These cost savings are approximated at
$2.7 million per year.
• Other administrative cost savings.
Generators of mixed waste and Federal
and State RCRA regulating agencies are
expected to save approximately
$700,000 in administrative burden and
costs because of this rule.
• Decay-in-storage cost savings. The
rule will allow facilities to store certain
wastes while the radioactivity decays.
These wastes can then be treated and
disposed of as hazardous waste, which
is less expensive than LLMW treatment
and disposal. EPA estimates aggregate
cost savings from these waste streams
will be between $800,000 and $2.6
million per year.
• Other disposal cost savings. This
rule will facilitate disposal of wastes in
LLRWDFs, depending on approval by
state regulatory agencies and the
willingness of LLRWDFs to accept the
wastes, as well as limitations of the low-
level waste disposal compact system.
These limitations mean that the savings
from the disposal exemption are
expected to be at most $100,000 per
year. EPA has not estimated savings
resulting from reduced storage costs.
• Risk Reductions. EPA anticipates
that generators will take advantage of
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27257
this rule to allow certain LLMW to
undergo decay-in-storage. NRG or the
NRG Agreement State approves a decay-
in-storage process which allows certain
short-lived radionuclides in these
wastes to decay to background levels.
The remaining decayed waste no longer
meets the definition of radioactive
under the AEA. Since EPA does not
expect these wastes to be treated or
handled during the radioactive decay
process, waste handlers in treatment
and transportation will not be exposed
to this radioactivity. Generators who
comply with existing RCRA regulations
are handling this waste while still
radioactive. This decrease in exposure
translates to an unquantified risk
reduction, attributable to the relaxed
RCRA storage restrictions in this rule.
DOE may also save on transportation
and disposal costs, to the extent that it
chooses to meet the conditions for
exemption and dispose of wastes in
commercial disposal facilities licensed
by NRC or an NRG Agreement State.
DOE would not gain permitting or
storage cost savings, since the storage
and treatment conditional exemption
regulations in this rule do not apply to
DOE facilities.
B. What Are the Costs of This Rule?
Generators taking advantage of storage
or disposal exemptions will incur costs
to meet notification conditions. EPA
estimates these costs to be
approximately $200,000 per year, in the
aggregate.
Under this rule, there will also be
some increased costs to EPA and RCRA
authorized States overseeing
management of mixed wastes. We
expect these entities to incur costs
associated with notification conditions
for generators and treaters of exempted
LLMW sending their waste for disposal
at LLRWDFs and related
implementation costs. This will result
in a small increase in costs for these
regulating bureaus estimated at $5,000
per year, in the aggregate.
C. What Are the Economic Impacts of
This Rule?
Economic impacts of this rulemaking
are expected to be minimal. Generators
who are not meeting regulatory
requirements for disposal will incur
spending for treatment and disposal of
wastes that previously had been
stranded in storage. These costs are
expected to total about $300,000 in
aggregate across the nation. These are
not true social costs, though, since these
generators are already liable for costs of
treatment and disposal of these wastes.
The effect of this rule will be to open
up disposal capacity for these wastes
which currently do not meet the waste
acceptance criteria of the existing
LLMW disposal facility. Without this
rulemaking, these legacy wastes might
simply continue to be stored on-site
indefinitely, leaving the generators in
violation of RCRA requirements. These
generators would incur not only storage
costs, but social costs associated with
being in violation of RCRA.
By allowing LLMW to be disposed of
as LLW, this rule may have impacts on
the national market for disposal of LLW,
although we have not specifically
modeled these impacts. The larger the
volume to be added to the disposal
market, the greater the effects are likely
to be. The largest volumes of LLW
potentially to be disposed of at
commercial LLRWDFs are those
generated by the Department of Energy,
including wastes from site cleanup and
remediation activities. Wastes from
commercial LLMW alone are not likely
to have any significant impact on these
markets.
The only possible negative impact
may fall upon the single mixed waste
disposal facility which currently accepts
some LLMW for disposal. By allowing
LLRWDFs to dispose of the LLMW that
meets Land Disposal Restrictions, this
rule may introduce some competition
into the market for disposal of LLMW.
X. State Authorization
As of December 2000, a total of 43
states and one territory were authorized
to implement RCRA mixed waste
regulations of 1986 (51 FR 24504),
which provide for the hazardous
components of mixed waste to be
managed under RCRA Subtitle C.1
Today's rule will apply to the hazardous
component of mixed waste in a State
that has mixed waste authorization, but
only when the State amends its State
law and becomes authorized to
implement this final rule containing a
new conditional exemption. The
effective date will be the date the State
is authorized for this final rule. This
rulemaking affects the RCRA base
program implementing the Resource
Conservation and Recovery Act of 1976.
Therefore, authorization for this rule is
not automatic, but depends upon State
action. In addition, since the flexibility
provided by a conditional exemption for
disposal and permitting is considered
less stringent than the current RCRA
1 The District of Columbia, Massachusetts,
Maryland, Rhode Island and West Virginia are
RCRA authorized States that have adopted mixed
waste regulations under State law but have not yet
been authorized to implement the mixed waste
regulations. This rule will become effective in these
jurisdictions when the State adopts and is
authorized for the final rule.
program, States are not required to
adopt this final rule. When choosing to
adopt this rule, States have the option
of being more stringent than a federal
requirement where they deem it
appropriate. (See 40 CFR 271.l(i).)
In Alaska, Hawaii, Iowa, Puerto Rico,
and the Virgin Islands, which are
jurisdictions not authorized to
implement any part of the RCRA
program, the federal government
implements the RCRA program. In these
jurisdictions, this final rule will become
effective 180 days after the date of
publication of this rule.
We encourage States and territories to
adopt this conditional exemption. The
conditional exemption does not
preclude regulation or enforcement by
States against generators who are not
eligible for the exemption or who do not
meet the conditions or requirements of
the exemption. Under this regulatory
framework, States retain their regulatory
oversight and RCRA enforceability
provisions over a noncompliant
claimant. The flexibility provided by
this rule is conditional. A LLMW
generator must meet the eligibility
provisions and conditions to qualify for
and maintain the exemption from
hazardous waste storage and disposal
regulations. Failure to meet the
conditions results in automatic loss of
the exemption; failure to meet the
requirements may result in fines and
penalties under the RCRA hazardous
waste enforcement program. In addition,
since the transportation and disposal
exemption may involve interstate
transportation of conditionally exempt
waste, the exemption must be
authorized in both the State of the
generator and the State where the
disposal site is located.
Note: If the waste is transported through a
State which considers the waste to be
hazardous, the transporter must be in
compliance with 40 CFR part 263, including
manifest provisions. EPA recommends that
the initiating facility note that the waste is
subject to today's exemption in block 15 of
the manifest.
XI. Relationship With Other RCRA and
Environmental Programs
A. What Is the Relationship of Today's
Rule With Other RCRA Regulatory
Programs?
1. Does This Rule Change How You
Determine if a Waste Is Hazardous?
No, the hazardous waste
determination remains unchanged. This
rule is a conditional exemption from the
RCRA regulatory definition of
hazardous waste. Under current RCRA
regulations, if you generate a solid
waste, you must determine if it is a
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hazardous waste as outlined in 40 CFR
262.11, Hazardous Waste
Determination. A generator of LLMW
must also determine if the waste is
excluded from regulation under 40 CFR
261.4, Exclusions. Next, a generator
must determine whether the waste
meets the regulatory description for a
listed hazardous waste in subpart D of
part 261, Lists of Hazardous Wastes. If
the waste is not a listed hazardous
waste, the generator must then
determine if the waste exhibits a
characteristic defined in subpart C of
part 261.
2. Can LLMW or Eligible NARM Be a
Non-Hazardous Waste Under This Rule?
LLMW, or Eligible NARM, meeting
the eligibility criteria and all the
conditions under the storage and
treatment or transportation and disposal
conditional exemption, will be
conditionally exempt from the
regulatory definition of hazardous waste
under RCRA Subtitle C, and therefore
managed as non-hazardous waste under
this rule.
3. How does the LLMW conditional
exemption differ from delisting under
40 CFR 260.22?
The evaluation criteria used for
delisting differ from today's rule. In the
conditional exemption, the evaluation
criteria are national and categorical.
This contrasts with the evaluation
criteria for delisting, which are based
upon a designated waste stream and are
case specific. In delisting, we evaluate
the processes generating a specific waste
stream to determine the constituents
likely to be present, as well as the
potential variability in the waste. In
addition, conditionally exempt LLMW
must be managed in accordance with
applicable NRC regulations. Delisted
waste is generally managed as an
industrial solid waste.
4. Will My Waste Analysis Plan of My
RCRA-Permitted TSDF Change?
No, your waste analysis plan will not
change. If you are a generator or an
owner or an operator of a RCRA-
permitted or interim status TSDF, also
licensed by the NRC for managing LLW,
and plan to claim a conditional
exemption, you remain subject to the
waste analysis and waste analysis plan
requirements of 40 CFR part 268. If you
treat to Land Disposal Restriction
standards, you must have a waste
analysis plan. This includes DOE
treatment facilities treating LLMW to
meet the conditions for the disposal
exemption.
5. Will the Final Rule Change How the
RCRA Closure Requirements Apply to
My Disposal Facility?
If you have a disposal facility subject
to NRC or NRC Agreement State
regulations for disposal of LLW, and
you accept conditionally exempt waste
under this rule, the hazardous waste
facility closure requirements do not
apply to any units at your facility
receiving only conditionally exempt
LLMW.
6. How Does the Conditional Exemption
Relate to RCRA Air Emission Standards?
RCRA Air Emission Standards do not
apply to a LLRWDF where conditionally
exempt LLMW or Eligible NARM waste
has been disposed of.
B. What Is the Relationship of This Rule
to Other Environmental Programs?
1. How Are CERCLA Actions Affected
by Today's Rule?
The affect of today's rule on
Comprehensive Environmental
Response, Compensation, and Liability
Act (CERCLA) actions depends on
whether the waste will be managed on
or off the CERCLA site. Off-site disposal
of CERCLA remediation waste must
comply with all conditions of today's
final rule for a generator to take
advantage of the exemption provided,
including that the waste must be
disposed of at a LLRWDF that is
licensed by the NRC or an NRC
Agreement State, and is in compliance
with the 10 CFR part 61 or equivalent
State regulations. Off-site rule
requirements in 40 CFR part 300
continue to apply to CERCLA
remediation wastes.
Mixed waste managed during on-site
waste remediation must meet all
applicable or relevant and appropriate
requirements of Federal or State
environmental laws or justify a waiver
from those standards. This rule requires
that the disposal facility be licensed and
overseen by the NRC or NRC Agreement
State. On-site CERCLA response action
must comply with the substantive
provisions of environmental regulations
and standards, but not the
administrative provisions. Therefore, no
permit or license is required for on-site
activities. In accordance with the
National Contingency Plan and
CERCLA, today's regulation is not
expected to be an applicable
requirement at most CERCLA sites
managing LLMW. However, relevant
and appropriate determinations are site-
specific and these may or may not be
deemed relevant and appropriate given
site-specific conditions. In general, we
expect that most CERCLA sites will
meet both the substantive provisions of
the RCRA Subtitle C landfill
requirements as well as the 10 CFR part
61 requirements for a LLRWDF.
2. How Might Clean Air Act Regulations
Be Affected?
This rule will not affect Clean Air Act
regulations. LDR treatment of LLMW or
Eligible NARM remains subject to the
air emission standards applicable to
hazardous waste treatments under
RCRA.
3. How Might Clean Water Act
Regulations Be Affected?
This rule will not affect Clean Water
Act regulations.
XII. Effective Date November 13, 2001
XIII. Regulatory Assessment
Requirements
A. Executive Order 12866:
Determination of Significance
Under Executive Order (E.O.) 12866,
(58 FR 51,735 October 4, 1993) EPA
must determine whether the regulatory
action is "significant," and therefore,
subject to OMB review? and the
requirements of the Executive Order
The Executive Order defines
"significant regulatory action" as one
that is likely to result in a rule that may:
• Have an annual effect on the
economy of $100 million or more or
adversely affect in a material way the
economy, a sector of the economy,
productivity, competition, jobs, the
environment, public health or safety, or
State, local, or tribal governments or
communities;
• Create a serious inconsistency or
otherwise interfere with an action taken
or planned by another agency;
• Materially alter the budgetary
impact of entitlements, grants, user fees,
or loan programs or the rights and
obligations of recipients thereof; or
• Raise novel legal or policy issues
arising out of legal mandates, the
President's priorities, or the principles
set forth in the Executive Order
Under the terms of Executive Order
12866, it has been determined that this
rule is a "significant regulatory action"
because it raises novel legal or policy
issues arising out of legal mandates, the
President's priorities, or the principles
set forth in the Executive Order This
rule addresses problems caused by dual
regulation of mixed wastes, and
facilitates treatment and disposal of
mixed wastes. We estimate quantified
net benefits of this rule to range between
$4.1 million and $5.9 million per year.
As a significant regulatory action this
rule was submitted to OMB for review.
Changes made in response to OMB
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suggestions or recommendations will be
documented in the public record.
Under the terms of Executive Order
12866, EPA must prepare for any
significant regulatory action an
assessment of the action's potential
costs and benefits. If that action satisfies
the first of the criteria listed above, this
assessment must include, to the extent
feasible, a quantification of these costs
and benefits, the underlying analyses
supporting such quantification, and an
assessment of the costs and benefits of
reasonably feasible alternatives to the
planned regulation. This final rule is not
economically significant, although it is
expected to yield net benefits to society
because of reduced waste management
and administrative costs for both
generators of mixed waste and
regulatory agencies, and reduced worker
exposures. A summary description of
costs and benefits associated with this
final rule appears in section IX of this
preamble. A regulatory impact analysis
has been prepared and is available in
the docket for today's final rulemaking.
B. Executive Order 13132: Federalism
Executive Order 13132, entitled
"Federalism" (64 FR 43255, August 10,
1999), requires EPA to develop an
accountable process to ensure
"meaningful and timely input by State
and local officials in the development of
regulatory policies that have federalism
implications." "Policies that have
federalism implications" is defined in
the Executive Order to include
regulations that have "substantial direct
effects on the States, on the relationship
between the national government and
the States, or on the distribution of
power and responsibilities among the
various levels of government."
This final rule will not have
substantial direct effects on the States,
on the relationship between the national
government and the States, or on the
distribution of power and
responsibilities among the various
levels of government as specified in
Executive Order 13132, because the rule
will not impose any requirements on
States or any other level of government.
As explained above, today's final rule
may provide regulatory flexibility for
generators and treaters of LLMW by
establishing a conditional exemption
from RCRA Subtitle C requirements,
which States are not required to adopt.
Thus, the requirements of the Executive
Order do not apply to this rule.
C. Executive Order 12898:
Environmental Justice
Under Executive Order 12898,
"Federal Actions to Address
Environmental Justice in Minority
Populations and Low-Income
Populations' as well as through EPA's
April 1995, "Environmental Justice
Strategy, OSWER Environmental Justice
Task Force Action Agenda Report" and
National Environmental Justice
Advisory Council, EPA has undertaken
to incorporate environmental justice
into its policies and programs. EPA is
committed to addressing environmental
justice concerns, and is assuming a
leadership role in environmental justice
initiatives to enhance environmental
quality for all residents of the United
States. The Agency's goals are to ensure
that no segment of the population—
regardless of race, color, national origin,
or income—bears disproportionately
high and adverse human health and
environmental effects as a result of
EPA's policies, programs, and activities.
To address this goal, EPA considered
the impacts of this rule on low-income
populations and minority populations.
This waste would be stored according to
other regulatory authorities (NRG or
NRG Agreement States) which offer
comparable protection to RCRA Subtitle
C. We evaluated the demographics of
the areas surrounding the three existing
commercial low-level radioactive waste
disposal facilities. We did not find
disproportionate populations of
minority groups residing in the
surrounding area. Most importantly, we
do not expect adverse environmental
impact as a result of the disposal rule.
The RCRA exempted waste will have
been treated, for example, to destroy
hazardous organic constituents and
stabilize toxic metals. The waste would
then be placed in a container, managed,
and disposed of, in an environmentally
sound manner according to NRC or NRC
Agreement State equivalent regulations
for disposal of low-level radioactive
waste. Therefore, we believe there will
not be disproportionately high and
adverse environmental or economic
impacts on any minority or low-income
group, or on any community.
D. Executive Order 13045: Protection of
Children From Environmental Health
Risks and Safety Risks
Protection of Children from
Environmental Health Risks and Safety
Risks (62 FR 19885, April 23, 1997)
applies to any rule that is determined to
be "economically significant" as
defined under Executive Order 12866,
and concerns an environmental health
or safety risk that EPA has reason to
believe may have a disproportionate
effect on children. If the regulatory
action meets both criteria, the Agency
must evaluate the environmental health
or safety effects of the planned rule on
children, and explain why the planned
regulation is preferable to other
potentially effective and reasonably
feasible alternatives considered by the
Agency.
This rule is not subject to Executive
Order 13045 because it is not an
economically significant rule as defined
by Executive Order 12866, and because
the Agency does not have reason to
believe the environmental or health and
safety risks addressed by this action
present a disproportionate risk to
children. We find that waste
management under NRC regulations for
radioactive waste could diminish (not
increase) concerns regarding
environmental health or safety risks for
all, including children.
E. Executive Order 13175: Consultation
and Coordination With Indian Tribal
Governments
On November 6, 2000, the President
issued Executive Order 13175 (65 FR
67249) entitled, "Consultation and
Coordination with Indian Tribal
Governments." Executive Order 13175
took effect on January 6, 2001, and
revoked Executive Order 13084 (Tribal
Consultation) as of that date. EPA
developed this final rule, however,
during the period when Executive Order
13084 was in effect; thus, EPA
addressed tribal considerations under
Executive Order 13084. Under
Executive Order 13084, EPA may not
issue a regulation that is not required by
statute, that significantly or uniquely
affects the communities of Indian tribal
governments, and that imposes
substantial direct compliance costs on
those communities, unless the Federal
government provides the funds
necessary to pay the direct compliance
costs incurred by the tribal
governments, or EPA consults with
those governments. This Executive
Order requires EPA to provide to OMB,
in a separately identified section of the
preamble to the rule, a description of
the extent of EPA's prior consultation
with representatives of affected tribal
governments, a summary of the nature
of their concerns, and a statement
supporting the need to issue the
regulation. In addition, Executive Order
13084 requires EPA to develop an
effective process that permits elected
officials and other representatives of
Indian tribal governments "to provide
meaningful and timely input in the
development of regulatory policies on
matters that significantly or uniquely
affect their communities."
Prior to the publication of the
November 1999 proposal, we briefed
two organizations with an interest in
tribal environmental issues on both the
storage and disposal exemptions we
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were proposing. The organizations were
the American Indian Environmental
Office, and the executive director and
staff of the Tribal Association of Solid
Waste and Emergency Response
(TASWER). TASWER staff indicated
that there was an annual tribal
conference the following week and the
representatives of tribes in attendance
would be informed about our proposed
rule and encouraged to comment. None
of the comments received were
identified by the sender as representing
tribes. Based on the discussion at our
meetings with tribal organizations, we
do not expect this rule to significantly
or uniquely affect the communities of
Indian tribal governments. Accordingly,
the requirements of Section 3(b) of
Executive Order 13084 do not apply to
this rule.
F. The Regulatory Flexibility Act (RFA)
as Amended by the Small Business
Regulatory Enforcement Fairness Act of
1996 (SBREFA) (5 U.S.C. 601 et seq.)
The RFA generally requires an agency
to prepare a regulatory flexibility
analysis of any rule subject to notice
and comment rulemaking requirements
under the Administrative Procedure Act
or any other statute unless the agency
certifies that the rule will not have a
significant economic impact on a
substantial number of small entities.
Small entities include small businesses,
small organizations, and small
governmental jurisdictions.
For purposes of assessing the impacts
of today's rule on small entities, small
entity is defined as: (1) A small business
that meets the Small Business
Administration size standards
established for industries as described
in the North American Industry
Classification System (see http://
www.sba .gov/size/NAICS-cover-
page.html); (2) a small governmental
jurisdiction that is a government of a
city, county, town, school district or
special district with a population of less
than 50,000; and (3) a small
organization that is any not-for-profit
enterprise which is independently
owned and operated and is not
dominant in its field.
After considering the economic
impacts of today's final rule on small
entities, I certify that this action will not
have a significant economic impact on
a substantial number of small entities.
In determining whether a rule has a
significant economic impact on a
substantial number of small entities, the
impact of concern is any significant
adverse economic impact on small
entities, since the primary purpose of
the regulatory flexibility analysis is to
identify and address regulatory
alternatives "which minimize any
significant economic impact of the
proposed rule on small entities." (5
U.S.C. 603 and 604.) Thus, an agency
may certify that a rule will not have a
significant economic impact on a
substantial number of small entities if
the rule relieves regulatory burden, or
otherwise has a positive economic effect
on all of the small entities subject to the
rule.
The overall economic effect of this
regulation has been determined to be a
net savings to all regulated entities that
choose to avail themselves of a
conditional exemption for storage or
disposal of the mixed wastes they
generate. This rule will not impose
additional costs on any entities. We
have therefore concluded that today's
final rule will relieve regulatory burden
for all small entities.
G. Unfunded Mandates Reform Act
Title II of the Unfunded Mandates
Reform Act of 1995 (UMRA), Public
Law 104—4, establishes requirements for
Federal agencies to assess the effects of
their regulatory actions on State, local,
and tribal governments and the private
sector. Under section 202 of the UMRA,
EPA must prepare a written statement,
including a cost-benefit analysis, for
proposed and final rules with "Federal
mandates" that may result in
expenditures to State, local, and tribal
governments, in the aggregate, or to the
private sector, of $100 million or more
in any one year.
Before promulgating an EPA rule for
which a written statement is needed,
section 205 of the UMRA generally
requires EPA to identify and consider a
reasonable number of regulatory
alternatives and adopt the least costly,
most cost-effective or least burdensome
alternative that achieves the objectives
of the rule. The provisions of sec. 205
do not apply when they are inconsistent
with applicable law. Moreover, sec. 205
allows EPA to adopt an alternative other
than the least costly, most cost-effective,
or least burdensome alternative if the
Administrator publishes with the final
rule an explanation why that alternative
was not adopted.
Before EPA establishes any regulatory
requirements that may significantly or
uniquely affect small governments,
including tribal governments, it must
have developed under 203 of the UMRA
a small government agency plan. The
plan must provide for notifying
potentially affected small governments,
enabling officials of affected small
governments to have meaningful and
timely input in the development of EPA
regulatory proposals, and informing,
educating, and advising small
governments on compliance with the
regulatory requirements.
Today's rule contains no Federal
mandates (under the regulatory
provisions of Title II of the UMRA) for
State, local, or tribal governments or the
private sector because it imposes no
enforceable duty on any State, local, or
tribal governments or the private sector.
Thus, today's rule is not subject to the
requirements of sections 202 and 205 of
UMRA.
H. National Technology Transfer and
Advancement Act of 1995
Section 12(d) of the National
Technology Transfer and Advancement
Act of 1995 ("NTTAA"), Public Law No.
104-113 Section 12(d) (15 U.S.C. 272
note), directs EPA to use voluntary
consensus standards in its regulatory
activities, unless to do so would be
inconsistent with applicable law or
otherwise impractical. Voluntary
consensus standards are technical
standards (for example, materials
specifications, test methods, sampling
procedures, and business practices) that
are developed or adopted by voluntary
consensus standards bodies. The
NTTAA directs EPA to provide
Congress, through OMB, with
explanations when the Agency decides
not to use available and applicable
voluntary consensus standards. This
final rule does not involve technical
standards. In 1997, EPA and NRC
published in the Federal Register joint
testing guidance for sampling and
testing of mixed waste. Facilities subject
to this rule may continue to use that
guidance, which allows analysis of
smaller samples and reduces exposure
of workers to radiation hazards.
I. Paperwork Reduction Act
Under the implementing regulations
for the Paperwork Reduction Act (44
U.S.C. 3501 et seq.), an agency is
required to certify that any agency-
sponsored collection of information
from the public is necessary for the
proper performance of its functions, has
practical utility, does not unnecessarily
duplicate information otherwise
reasonably accessible to the agency, and
reduces to the extent practicable and
appropriate the burden on those
required to provide the information. (5
CFR 1320.9.) Any proposed collection of
information must be submitted, along
with this certification, to the Office of
Management and Budget (OMB) for
approval before the collection of
information goes into effect.
The information collection
requirements in this final rule have been
submitted for approval to OMB under
the Paperwork Reduction Act. An
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Information Collection Request (ICR)
document has been prepared by EPA
(ICR No. 1922.01), and a copy may be
obtained from Sandy Farmer, Office of
Environmental Information, Collection
Strategies Division, U.S. Environmental
Protection Agency (2137), 1200
Pennsylvania Ave., NW., Washington,
DC 20460 or by calling (202) 260-2740.
This information collection is
required to provide documentation of
conditional exemption from RCRA
Subtitle C requirements. The
exemptions from RCRA Subtitle C under
today's action would require no
government approval before being
effective. For this final rule, information
collection, maintenance, and reporting
issues are especially important.
Successful implementation of today's
rule will depend upon the
documentation, certification, and
verification provided by the information
collection.
The general authority for this rule is
1006, 2002(a), 3001-3009 and 3013 of
the Solid Waste Disposal Act of 1970, as
amended by the Resource Conservation
and Recovery Act of 1976 (RCRA), and
the Hazardous and Solid Waste
Amendments of 1984 (HSWA), and the
Federal Facility Compliance Act of 1992
(FFCA), 42 U.S.C. 6905, 6912(a), 6921-
6929 and 6934. To the extent that this
rule imposes any information collection
requirements under existing RCRA
regulations promulgated in previous
rulemakings, those requirements have
been approved by OMB under the
Paperwork Reduction Act, and have
been assigned one of the following OMB
control numbers: 2050-0009 (ICR no.
1573, Part B Permit Application, Permit
Modifications, and Special Permits);
2050-0120 (ICR 1571, General Facility
Hazardous Waste Standards); 2050-
0028 (ICR 261, Notification of
Hazardous Waste Activity); 2050-0034
(ICR 262, RCRA Hazardous Waste
Permit Application and Modification,
Part A); 2050-0039 (ICR 801,
Requirements for Generators,
Transporters, and Waste Management
Facilities under the Hazardous Waste
Manifest System); 2050-0035 (ICR 820,
Hazardous Waste Generator Standards);
and 2050-0024 (ICR 976, 1997
Hazardous Waste Report).
An Agency may not conduct or
sponsor, and a person is not required to
respond to a collection of information
unless it displays a currently valid OMB
control number. The OMB control
numbers for EPA's regulations are listed
in 40 CFR parts 9 and 48 CFR chapter
15. This rule includes new information
collection requirements subject to OMB
review under the Paperwork Reduction
Act. To be eligible for a conditional
exemption for stored low-level mixed
waste, facilities must notify EPA or the
RCRA Authorized State of their claims
for a conditional exemption for their
LLMW and storage units. If they do not
choose to claim a conditional
exemption, generators will have to
comply with the existing Subtitle C
recordkeeping requirements for the low-
level mixed wastes they generate.
This rule also includes notification
requirements for generators or treaters of
LLMW and Eligible NARM seeking a
conditional exemption from the
definition of hazardous waste, which
would allow disposal of the waste
meeting the conditions for exemption in
a low-level radioactive waste disposal
facility licensed by NRC or an NRC
Agreement State. If the generator or
treater of LLMW chooses not to claim an
exemption, it remains subject to the
existing hazardous waste disposal
requirements.
Some of the requirements contained
in today's final action entail new
reporting and recordkeeping
requirements for members of the
regulated public, if an exemption is
claimed. The requirements have
practical utility in that they are
necessary to ensure that the disposal of
conditionally exempted low-level mixed
waste is safely managed. If generators
choose to avail themselves of the
regulatory flexibility discussed in this
final rule, they will be subject to the
notification and recordkeeping
requirements described above. However,
such notification and recordkeeping
would replace the paperwork burden
required for treatment and storage
permits for their low-level mixed wastes
if they did not claim a conditional
exemption. States (but not Tribes)
would have additional recordkeeping
requirements for receiving a generator's
notice to claim a conditional exemption,
and for reviewing a generator's notice to
reclaim a conditional exemption.
We have prepared a full ICR in
support of today's final rule. We
estimate the total annual public burden
associated with the storage and
treatment conditional exemption to
average 3.5 hours per respondent. We
estimate the reporting burden to average
1.9 hours per respondent annually,
including time for reading the
regulations, and preparing and
submitting notifications. We estimate
the recordkeeping burden to average 1.6
hours per respondent annually,
including the time for recording the
results of inventories and inspections,
and maintaining records pertaining to
the mixed waste exemption.
The total public burden associated
with the transportation and disposal
exemption is estimated to average 3.9
hours per respondent. We estimate the
reporting burden to average 2.9 hours
per respondent annually, including time
for reading the regulations, and
preparing and submitting notifications.
The annual recordkeeping burden is
estimated to average 1.0 hours per
respondent and includes the time for
maintaining records pertaining to the
mixed waste exemption.
Burden means the total time, effort, or
financial resources expended to
generate, maintain, retain, disclose, or
provide information to or for a Federal
agency. Burden includes the time
needed to:
• Review? instructions;
• Develop, acquire, install, and utilize
technology and systems for the purposes
of collecting, validating, and verifying
information, processing and
maintaining information, and disclosing
and providing information;
• Adjust the existing methods to
comply with any previously applicable
instructions and requirements;
• Train personnel to be able to
respond to a collection of information;
• Search data sources;
• Complete and review the collection
of information; and
• Transmit or otherwise disclose the
information.
We received no public comment on
the proposed information collection.
/. The Congressional Review Act
The Congressional Review Act, 5
U.S.C. 801 et seq., as added by the Small
Business Regulatory Enforcement
Fairness Act of 1996, generally provides
that before a rule may take effect, the
agency promulgating the rule must
submit a rule report, which includes a
copy of the rule, to each House of the
Congress and to the Comptroller General
of the United States. EPA will submit a
report containing this rule and other
required information to the U.S. Senate,
the U.S. House of Representatives, and
the Comptroller General of the United
States prior to publication of the rule in
the Federal Register. A Major rule
cannot take effect until 60 days after it
is published in the Federal Register.
This action is not a "major rule" as
defined by 5 U.S.C. 804(2). This rule
will be effective November 13, 2001.
XIV. Supporting Documents
1. EPA Consent Decree, HWIR Settlement
Agreement, April 11, 1997.
2. EPA Side-bar letter to EEI/USWAG dated
April 7, 1997.
3. "Review of Waste Management Practices
and Compliance History at Nuclear
Power Plants and Other Entities that
Generate Low-Level Mixed Waste." April
12, 1999.
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4. "Comparison of the EPA's RCRA
Requirements and the NRC's Licensing
Requirements for the Treatment (In
Tanks and Containers) and Storage of
Low-Level Mixed Wastes at Nuclear
Facilities", April 2001.
5. Comment Summary Document—Approach
to Reinventing Regulations of Storing
Mixed Low-Level Radioactive Waste;
Advance Notice of Proposed Rulemaking
(ANPRM), September 21,1999.
6. Report to Utility Solid Waste Activities
Group and Utility Nuclear Waste
Management Group on Comparative
Assessment of the Environmental
Protection Agency's Regulations for
Hazardous Waste Tank Systems (40 CFR
part 265, subpart J) and Comparable
Nuclear Regulatory Commission
Requirements, July 1988.
7. Technical Evaluation on Document for the
Disposal of Mixed Waste at Low-Level
Radioactive Waste Disposal Facilities,
Draft Technical Background Document,
July 1999.
8. National Profile on Commercially
Generated Low-Level Radioactive Mixed
Waste, NUREG/CR-5938, December
1992.
9. Meeting Notes for EPA Meeting with Low-
Level Radioactive Waste Disposal
Facilities, December 7, 1998.
10. RCRA Hazardous Constituents and Waste
Codes Associated with Mixed Waste,
December 1997.
11. Joint State/EPA Workshop on Mixed
Waste Rulemaking, October 7-9, 1998,
Meeting Summary.
12. Comparison of NRG and EPA's Waste
Tracking and Related Record Keeping
Requirements, July 1999.
13. Technical Alternatives Considered for
Evaluating Protectiveness of Low-Level
Waste Disposal Facilities, July 21, 1999.
14. Regulatory Impact Analysis: Storage,
Treatment, Transportation, and Disposal
of Mixed Waste, February 2001.
15. Summary of Public Comments on
"Contingent Management of Mixed
Waste" Submitted in Response to the
1995 HWIR Proposal, July 1999.
16. The Management of Mixed Low-Level
Radioactive Waste in the Nuclear Power
Industry, NUMARC/NESP-006, Nuclear
Management Resources Council, Inc.,
Washington, D.C., January 1990.
17. Regulatory Impact Analysis: Storage,
Treatment, Transportation, and Disposal
of Mixed Waste—Supplemental
Documents, February 2001.
18. Comparison of Financial Assurance
Requirements Under EPA and NRG
Regulations, November, 2000.
19. Discussion with DOT on Mixed Waste
Transportation on August 1999.
20. Letter from Elizabeth A. Cotsworth,
Director, Office of Solid Waste, to J. Dale
Givens, State of Louisiana, Department
of Environmental Quality, March 27,
1998.
Note that this is a list of supporting
documents for both the proposed and
final rules. Reference documents
numbered 5, 11, 13, and 15 were
referred to in the proposed rule but not
in the final rule.
List of Subjects in 40 CFR Part 266
Environmental protection, Hazardous
waste, Reporting and recordkeeping
requirements, Waste treatment and
disposal.
Dated: April 30, 2001.
Christine Todd Whitman,
Administrator.
For the reasons set forth in the
preamble 40 CFR part 266 is amended
as follows:
PART 266—STANDARDS FOR THE
MANAGEMENT OF SPECIFIC
HAZARDOUS WASTES AND SPECIFIC
TYPES OF HAZARDOUS WASTE
MANAGEMENT FACILITIES
1. The authority citation for part 266
is revised to read as follows:
Authority: 42 U.S.C. 1006, 2002(a), 3001-
3009, 3014, 6905, 6906, 6912, 6921, 6922,
6924-6927, 6934, and 6937.
2. Part 266 is amended by adding
subpart N to read as follows:
Subpart N—Conditional Exemption for Low-
Level Mixed Waste Storage, Treatment,
Transportation and Disposal
Terms
Sec.
266.210 What definitions apply to this
subpart?
Storage and Treatment Conditional
Exemption and Eligibility
266.220 What does a storage and treatment
conditional exemption do?
266.225 What wastes are eligible for the
storage and treatment conditional
exemption?
266.230 What conditions must you meet for
your LLMW to qualify for and maintain
a storage and treatment exemption?
Treatment
266.235 What waste treatment does the
storage and treatment conditional
exemption allow?
Loss of Conditional Exemption
266.240 How could you lose the
conditional exemption for your LLMW
and what action must you take?
266.245 If you lose the storage and
treatment conditional exemption for
your LLMW, can the exemption be
reclaimed?
RecordKeeping
266.250 What records must you keep at
your facility and for how long?
Reentry Into RCRA
266.255 When is your low-level mixed
waste no longer eligible for the storage
conditional exemption?
Storage Unit Closure
266.260 Do closure requirements apply to
units that stored LLMW prior to the
effective date of subpart N?
Transportation and Disposal Conditional
Exemption
266.305 What does the transportation and
disposal conditional exemption do?
Eligibility
266.310 What wastes are eligible for the
transportation and disposal conditional
exemption?
Conditions
266.315 What are the conditions you must
meet for your waste to qualify for and
maintain the transportation and disposal
exemption?
266.320 What treatment standards must
your eligible waste meet?
266.325 Are you subject to the manifest and
transportation condition in § 266.315(b)?
266.330 When does the transportation and
disposal exemption take effect?
266.335 Where must your exempted waste
be disposed of?
266.340 What type of container must be
used for disposal of exempted waste?
Notification
266.345 Whom must you notify?
Recordkeeping
266.350 What records must you keep at
your facility and for how long?
Loss of Transportation and Disposal
Conditional Exemption
266.355 How could you lose the
transportation and disposal conditional
exemption for your waste and what
actions must you take?
266.360 If you lose the transportation and
disposal conditional exemption for a
waste, can the exemption be reclaimed?
Subpart N—Conditional Exemption for
Low-Level Mixed Waste Storage and
Disposal
Terms
§266.210 What definitions apply to this
subpart?
This subpart uses the following
special definitions:
Agreement State means a state that
has entered into an agreement with the
NRC under subsection 274b of the
Atomic Energy Act of 1954, as amended
(68 Stat. 919), to assume responsibility
for regulating within its borders
byproduct, source, or special nuclear
material in quantities not sufficient to
form a critical mass.
Certified delivery means certified mail
with return receipt requested, or
equivalent courier service, or other
means, that provides the sender with a
receipt confirming delivery.
Director refers to the definition in 40
CFR 270.2.
Eligible Naturally Occurring and/or
Accelerator-produced Radioactive
Material (HARM) is NARM that is
eligible for the Transportation and
Disposal Conditional Exemption. It is a
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27263
NARM waste that contains RCRA
hazardous waste, meets the waste
acceptance criteria of, and is allowed by
State NARM regulations to be disposed
of at a low-level radioactive waste
disposal facility (LLRWDF) licensed in
accordance with 10 CFR part 61 or NRG
Agreement State equivalent regulations.
Exempted waste means a waste that
meets the eligibility criteria in 266.225
and meets all of the conditions in
§ 266.230, or meets the eligibility
criteria in 40 CFR 266.310 and complies
with all the conditions in § 266.315.
Such waste is conditionally exempted
from the regulatory definition of
hazardous waste described in 40 CFR
261.3.
Hazardous Waste means any material
which is defined to be hazardous waste
in accordance with 40 CFR 261.3,
"Definition of Hazardous Waste."
Land Disposal Restriction (LDR)
Treatment Standards means treatment
standards, under 40 CFR part 268, that
a RCRA hazardous waste must meet
before it can be disposed of in a RCRA
hazardous waste land disposal unit.
License means a license issued by the
Nuclear Regulatory Commission, or
NRC Agreement State, to users that
manage radionuclides regulated by
NRC, or NRC Agreement States, under
authority of the Atomic Energy Act of
1954, as amended.
Low-Level Mixed Waste (LLMW) is a
waste that contains both low-level
radioactive waste and RCRA hazardous
waste.
Low-Level Radioactive Waste (LLW) is
a radioactive waste which contains
source, special nuclear, or byproduct
material, and which is not classified as
high-level radioactive waste, transuranic
waste, spent nuclear fuel, or byproduct
material as defined in section lie.(2) of
the Atomic Energy Act. (See also NRC
definition of "waste" at 10 CFR 61.2)
Mixed Waste means a waste that
contains both RCRA hazardous waste
and source, special nuclear, or
byproduct material subject to the
Atomic Energy Act of 1954, as amended.
Naturally Occurring and/or
Accelerator-produced Radioactive
Material (NARM) means radioactive
materials that:
(1) Are naturally occurring and are
not source, special nuclear, or
byproduct materials (as defined by the
AEA) or
(2) Are produced by an accelerator.
NARM is regulated by the States under
State law, or by DOE (as authorized by
the AEA) under DOE orders.
NRC means the U. S. Nuclear
Regulatory Commission.
We or us within this subpart, means
the Director as defined in 40 CFR 270.2.
You means a generator, treater, or
other handler of low-level mixed waste
or eligible NARM.
Storage and Treatment Conditional
Exemption and Eligibility
§ 266.220 What does a storage and
treatment conditional exemption do?
The storage and treatment conditional
exemption exempts your low-level
mixed waste from the regulatory
definition of hazardous waste in 40 CFR
261.3 if your waste meets the eligibility
criteria in § 266.225 and you meet the
conditions in § 266.230.
§ 266.225 What wastes are eligible for the
storage and treatment conditional
exemption?
Low-level mixed waste (LLMW),
defined in § 266.210, is eligible for this
conditional exemption if it is generated
and managed by you under a single NRC
or NRC Agreement State license. (Mixed
waste generated at a facility with a
different license number and shipped to
your facility for storage or treatment
requires a permit and is ineligible for
this exemption. In addition, NARM
waste is ineligible this exemption.)
§ 266.230 What conditions must you meet
for your LLMW to qualify for and maintain
a storage and treatment exemption?
(a) For your LLMW to qualify for the
exemption you must notify us in writing
by certified delivery that you are
claiming a conditional exemption for
the LLMW stored on your facility. The
dated notification must include your
name, address, RCRA identification
number, NRC or NRC Agreement State
license number, the waste code(s) and
storage unit(s) for which you are seeking
an exemption, and a statement that you
meet the conditions of this subpart.
Your notification must be signed by
your authorized representative who
certifies that the information in the
notification is true, accurate, and
complete. You must notify us of your
claim either within 90 days of the
effective date of this rule in your State,
or within 90 days of when a storage unit
is first used to store conditionally
exempt LLMW.
(b) To qualify for and maintain an
exemption for your LLMW you must:
(1) Store your LLMW waste in tanks
or containers in compliance with the
requirements of your license that apply
to the proper storage of low-level
radioactive waste (not including those
license requirements that relate solely to
recordkeeping);
(2) Store your LLMW in tanks or
containers in compliance with chemical
compatibility requirements of a tank or
container in 40 CFR 264.177, or 264.199
or 40 CFR 265.177, or 265.199;
(3) Certify that facility personnel who
manage stored conditionally exempt
LLMW are trained in a manner that
ensures that the conditionally exempt
waste is safely managed and includes
training in chemical waste management
and hazardous materials incidents
response that meets the personnel
training standards found in 40 CFR
265.16(a)(3);
(4) Conduct an inventory of your
stored conditionally exempt LLMW at
least annually and inspect it at least
quarterly for compliance with subpart N
of this part; and
(5) Maintain an accurate emergency
plan and provide it to all local
authorities who may have to respond to
a fire, explosion, or release of hazardous
waste or hazardous constituents. Your
plan must describe emergency response
arrangements with local authorities;
describe evacuation plans; list the
names, addresses, and telephone
numbers of all facility personnel
qualified to work with local authorities
as emergency coordinators; and list
emergency equipment.
Treatment
§ 266.235 What waste treatment does the
storage and treatment conditional
exemption allow?
You may treat your low-level mixed
waste at your facility within a tank or
container in accordance with the terms
of your NRC or NRC Agreement State
license. Treatment that cannot be done
in a tank or container without a RCRA
permit (such as incineration) is not
allowed under this exemption.
Loss of Conditional Exemption
§ 266.240 How could you lose the
conditional exemption for your LLMW and
what action must you take?
(a) Your LLMW will automatically
lose the storage and treatment
conditional exemption if you fail to
meet any of the conditions specified in
§ 266.230. When your LLMW loses the
exemption, you must immediately
manage that waste which failed the
condition as RCRA hazardous waste,
and the storage unit storing the LLMW
immediately becomes subject to RCRA
hazardous waste container and/or tank
storage requirements.
(1) If you fail to meet any of the
conditions specified in § 266.230 you
must report to us and the NRC, or the
oversight agency in the NRC Agreement
State, in writing by certified delivery
within 30 days of learning of the failure.
Your report must be signed by your
authorized representative certifying that
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the information provided is true,
accurate, and complete. This report
must include:
(i) The specific condition(s) you failed
to meet;
(ii) A description of the LLMW
(including the waste name, hazardous
waste codes and quantity) and storage
location at the facility; and
(iii) The date(s) on which you failed
to meet the condition(s).
(2) If the failure to meet any of the
conditions may endanger human health
or the environment, you must also
immediately notify us orally within 24
hours and follow up with a written
notification within five days. Failures
that may endanger human health or the
environment include, but are not
limited to, discharge of a CERCLA
reportable quantity or other leaking or
exploding tanks or containers, or
detection of radionuclides above
background or hazardous constituents
in the leachate collection system of a
storage area. If the failure may endanger
human health or the environment, you
must follow the provisions of your
emergency plan.
(b) We may terminate your
conditional exemption for your LLMW,
or require you to meet additional
conditions to claim a conditional
exemption, for serious or repeated
noncompliance with any requirement(s)
of subpart N of this part.
§ 266.245 If you lose the storage and
treatment conditional exemption for your
LLMW, can the exemption be reclaimed?
(a) You may reclaim the storage and
treatment exemption for your LLMW if:
(1) You again meet the conditions
specified in § 266.230; and
(2) You send us a notice by certified
delivery that you are reclaiming the
exemption for your LLMW. Your notice
must be signed by your authorized
representative certifying that the
information contained in your notice is
true, complete, and accurate. In your
notice you must do the following:
(i) Explain the circumstances of each
failure.
(ii) Certify that you have corrected
each failure that caused you to lose the
exemption for your LLMW and that you
again meet all the conditions as of the
date you specify.
(iii) Describe plans that you have
implemented, listing specific steps you
have taken, to ensure the conditions
will be met in the future.
(iv) Include any other information you
want us to consider when we review?
your notice reclaiming the exemption.
(b) We may terminate a reclaimed
conditional exemption if we find that
your claim is inappropriate based on
factors including, but not limited to, the
following: you have failed to correct the
problem; you explained the
circumstances of the failure
unsatisfactorily; or you failed to
implement a plan with steps to prevent
another failure to meet the conditions of
§ 266.230. In reviewing a reclaimed
conditional exemption under this
section, we may add conditions to the
exemption to ensure that waste
management during storage and
treatment of the LLMW will protect
human health and the environment.
Recordkeeping
§ 266.250 What records must you keep at
your facility and for how long?
(a) In addition to those records
required by your NRC or NRC
Agreement State license, you must keep
records as follows:
(l) Your initial notification records,
return receipts, reports to us of failure(s)
to meet the exemption conditions, and
all records supporting any reclaim of an
exemption;
(2) Records of your LLMW annual
inventories, and quarterly inspections;
(3) Your certification that facility
personnel who manage stored mixed
waste are trained in safe management of
LLMW including training in chemical
waste management and hazardous
materials incidents response; and
(4) Your emergency plan as specified
in§266.230(b).
(b) You must maintain records
concerning notification, personnel
trained, and your emergency plan for as
long as you claim this exemption and
for three years thereafter, or in
accordance with NRC regulations under
10 CFR part 20 (or equivalent NRC
Agreement State regulations), whichever
is longer. You must maintain records
concerning your annual inventory and
quarterly inspections for three years
after the waste is sent for disposal, or in
accordance with NRC regulations under
10 CFR part 20 (or equivalent NRC
Agreement State regulations), whichever
is longer.
Reentry Into RCRA
§ 266.255 When is your LLMW no longer
eligible for the storage and treatment
conditional exemption?
(a) When your LLMW has met the
requirements of your NRC or NRC
Agreement State license for decay-in-
storage and can be disposed of as non-
radioactive waste, then the conditional
exemption for storage no longer applies.
On that date your waste is subject to
hazardous waste regulation under the
relevant sections of 40 CFR parts 260
through 271, and the time period for
accumulation of a hazardous waste as
specified in 40 CFR 262.34 begins.
(b) When your conditionally exempt
LLMW, which has been generated and
stored under a single NRC or NRC
Agreement State license number, is
removed from storage, it is no longer
eligible for the storage and treatment
exemption. However, your waste may be
eligible for the transportation and
disposal conditional exemption at
§266.305.
Storage Unit Closure
§266.260 Do closure requirements apply
to units that stored LLMW prior to the
effective date of Subpart N?
Interim status and permitted storage
units that have been used to store only
LLMW prior to the effective date of
subpart N of this part and, after that
date, store only LLMW which becomes
exempt under this subpart N, are not
subject to the closure requirements of 40
CFR parts 264 and 265. Storage units (or
portions of units) that have been used to
store both LLMW and non-mixed
hazardous waste prior to the effective
date of subpart N or are used to store
both after that date remain subject to
closure requirements with respect to the
non-mixed hazardous waste.
Transportation and Disposal
Conditional Exemption
§ 266.305 What does the transportation
and disposal conditional exemption do?
This conditional exemption exempts
your waste from the regulatory
definition of hazardous waste in 40 CFR
261.3 if your waste meets the eligibility
criteria under § 266.310, and you meet
the conditions in § 266.315.
Eligibility
§266.310 What wastes are eligible for the
transportation and disposal conditional
exemption?
Eligible waste must be:
(a) A low-level mixed waste (LLMW),
as defined in § 266.210, that meets the
waste acceptance criteria of a LLRWDF;
and/or
(b) An eligible NARM waste, defined
in §266.210.
Conditions
§266.315 What are the conditions you
must meet for your waste to qualify for and
maintain the transportation and disposal
conditional exemption?
You must meet the following
conditions for your eligible waste to
qualify for and maintain the exemption:
(a) The eligible waste must meet or be
treated to meet LDR treatment standards
as described in § 266.320.
(b) If you are not already subject to
NRC, or NRC Agreement State
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27265
equivalent manifest and transportation
regulations for the shipment of your
waste, you must manifest and transport
your waste according to NRC
regulations as described in § 266.325.
(c) The exempted waste must be in
containers when it is disposed of in the
LLRWDF as described in § 266.340.
(d) The exempted waste must be
disposed of at a designated LLRWDF as
described in §266.335.
§ 266.320 What treatment standards must
your eligible waste meet?
Your LLMW or eligible NARM waste
must meet Land Disposal Restriction
(LDR) treatment standards specified in
40 CFR part 268, subpart D.
§ 266.325 Are you subject to the manifest
and transportation condition in
§266.315(b)?
If you are not already subject to NRG,
or NRC Agreement State equivalent
manifest and transportation regulations
for the shipment of your waste, you
must meet the manifest requirements
under 10 CFR 20.2006 (or NRC
Agreement State equivalent regulations),
and the transportation requirements
under 10 CFR 1.5 (or NRC Agreement
State equivalent regulations) to ship the
exempted waste.
§ 266.330 When does the transportation
and disposal exemption take effect?
The exemption becomes effective
once all the following have occurred:
(a) Your eligible waste meets the
applicable LDR treatment standards.
(b) You have received return receipts
that you have notified us and the
LLRWDF as described in § 266.345.
(c) You have completed the packaging
and preparation for shipment
requirements for your waste according
to NRC Packaging and Transportation
regulations found under 10 CFR part 71
(or NRC Agreement State equivalent
regulations); and you have prepared a
manifest for your waste according to
NRC manifest regulations found under
10 CFR part 20 (or NRC Agreement State
equivalent regulations), and
(d) You have placed your waste on a
transportation vehicle destined for a
LLRWDF licensed by NRC or an NRC
Agreement State.
§ 266.335 Where must your exempted
waste be disposed of?
Your exempted waste must be
disposed of in a LLRWDF that is
regulated and licensed by NRC under 10
CFR part 61 or by an NRC Agreement
State under equivalent State regulations,
including State NARM licensing
regulations for eligible NARM.
§ 266.340 What type of container must be
used for disposal of exempted waste?
Your exempted waste must be placed
in containers before it is disposed. The
container must be:
(a) A carbon steel drum; or
(b) An alternative container with
equivalent containment performance in
the disposal environment as a carbon
steel drum; or
(c) A high integrity container as
defined by NRC.
Notification
§266.345 Whom must you notify?
(a) You must provide a one time
notice to us stating that you are claiming
the transportation and disposal
conditional exemption prior to the
initial shipment of an exempted waste
from your facility to a LLRWDF. Your
dated written notice must include your
facility name, address, phone number,
and RCRA ID number, and be sent by
certified delivery.
(b) You must notify the LLRWDF
receiving your exempted waste by
certified delivery before shipment of
each exempted waste. You can only
ship the exempted waste after you have
received the return receipt of your
notice to the LLRWDF. This notification
must include the following:
(1) A statement that you have claimed
the exemption for the waste.
(2) A statement that the eligible waste
meets applicable LDR treatment
standards.
(3) Your facility's name, address, and
RCRA ID number.
(4) The RCRA hazardous waste codes
prior to the exemption of the waste
streams.
(5) A statement that the exempted
waste must be placed in a container
according to § 266.340 prior to disposal
in order for the waste to remain exempt
under the transportation and disposal
conditional exemption of subpart N of
this part.
(6) The manifest number of the
shipment that will contain the
exempted waste.
(7) A certification that all the
information provided is true, complete,
and accurate. The statement must be
signed by your authorized
representative.
Recordkeeping
§ 266.350 What records must you keep at
your facility and for how long?
In addition to those records required
by your NRC or NRC Agreement State
license, you must keep records as
follows:
(a) You must follow the applicable
existing recordkeeping requirements
under 40 CFR 264.73, 40 CFR 265.73,
and 40 CFR 268.7 of this chapter to
demonstrate that your waste has met
LDR treatment standards prior to your
claiming the exemption.
(b) You must keep a copy of all
notifications and return receipts
required under §§ 266.355, and 266.360
for three years after the exempted waste
is sent for disposal.
(c) You must keep a copy of all
notifications and return receipts
required under § 266.345(a) for three
years after the last exempted waste is
sent for disposal.
(d) You must keep a copy of the
notification and return receipt required
under § 266.345(b) for three years after
the exempted waste is sent for disposal.
(e) If you are not already subject to
NRC, or NRC Agreement State
equivalent manifest and transportation
regulations for the shipment of your
waste, you must also keep all other
documents related to tracking the
exempted waste as required under 10
CFR 20.2006 or NRC Agreement State
equivalent regulations, including
applicable NARM requirements, in
addition to the records specified in
§ 266.350(a) through (d).
Loss of Transportation and Disposal
Conditional Exemption
§ 266.355 How could you lose the
transportation and disposal conditional
exemption for your waste and what actions
must you take?
(a) Any waste will automatically lose
the transportation and disposal
exemption if you fail to manage it in
accordance with all of the conditions
specified in §266.315.
(1) When you fail to meet any of the
conditions specified in § 266.315 for any
of your wastes, you must report to us,
in writing by certified delivery, within
30 days of learning of the failure. Your
report must be signed by your
authorized representative certifying that
the information provided is true,
accurate, and complete. This report
must include:
(i) The specific condition(s) that you
failed to meet for the waste;
(ii) A description of the waste
(including the waste name, hazardous
waste codes and quantity) that lost the
exemption; and
(iii) The date(s) on which you failed
to meet the condition(s) for the waste.
(2) If the failure to meet any of the
conditions may endanger human health
or the environment, you must also
immediately notify us orally within 24
hours and follow up with a written
notification within 5 days.
(b) We may terminate your ability to
claim a conditional exemption for your
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waste, or require you to meet additional
conditions to claim a conditional
exemption, for serious or repeated
noncompliance with any requirement(s)
of subpart N of this part.
§ 266.360 If you lose the transportation
and disposal conditional exemption for a
waste, can the exemption be reclaimed?
(a) You may reclaim the
transportation and disposal exemption
for a waste after you have received a
return receipt confirming that we have
received your notification of the loss of
the exemption specified in § 266.355(a)
and if:
(1) You again meet the conditions
specified in § 266.315 for the waste; and
(2) You send a notice, by certified
delivery, to us that you are reclaiming
the exemption for the waste. Your
notice must be signed by your
authorized representative certifying that
the information provided is true,
accurate, and complete. The notice
must:
(i) Explain the circumstances of each
failure.
(ii) Certify that each failure that
caused you to lose the exemption for the
waste has been corrected and that you
again meet all conditions for the waste
as of the date you specify.
(iii) Describe plans you have
implemented, listing the specific steps
that you have taken, to ensure that
conditions will be met in the future.
(iv) Include any other information you
want us to consider when we review?
your notice reclaiming the exemption.
(b) We may terminate a reclaimed
conditional exemption if we find that
your claim is inappropriate based on
factors including, but not limited to: you
have failed to correct the problem; you
explained the circumstances of the
failure unsatisfactorily; or you failed to
implement a plan with steps to prevent
another failure to meet the conditions of
§ 266.315. In reviewing a reclaimed
conditional exemption under this
section, we may add conditions to the
exemption to ensure that transportation
and disposal activities will protect
human health and the environment.
[FR Doc. 01-11408 Filed 5-15-01; 8:45 am]
BILLING CODE 6560-50-P
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Parts 261 and 268
[FRL-6975-2]
RIN 2050-AE07
Hazardous Waste Identification Rule
(HWIR): Revisions to the Mixture and
Derived-From Rules
AGENCY: Environmental Protection
Agency (EPA).
ACTION: Final rule.
SUMMARY: Today's action finalizes the
retention of the mixture rule and the
derived-from rule in the Resource
Conservation and Recovery Act (RCRA),
with two revisions. The mixture and
derived-from rules ensure that
hazardous wastes that are mixed with
other wastes or that result from the
treatment, storage or disposal of
hazardous wastes do not escape
regulation and thereby cause harm to
human health and the environment.
EPA is finalizing two revisions to the
mixture and derived-from rules. These
revisions would narrow the scope of the
mixture and derived-from rules,
tailoring the rules to more specifically
match the risks posed by particular
wastes. The first revision is an
expanded exclusion for mixtures and/or
derivatives of wastes listed solely for the
ignitability, corrosivity, and/or
reactivity characteristics. The second
revision is a new conditional exemption
from the mixture and derived-from rules
for "mixed wastes" (that is, wastes that
are both hazardous and radioactive).
DATES: These final regulations are
effective on August 14, 2001.
ADDRESSES: Supporting materials are
available for viewing in the RCRA
Information Center (RIG), located at
Crystal Gateway I, First Floor, 1235
Jefferson Davis Highway, Arlington, VA.
The Docket Identification Number is F-
2001-WHWF-FFFFF. The RIG is open
from 9 a.m. to 4 p.m., Monday through
Friday, excluding federal holidays. To
review? docket materials, it is
recommended that the public make an
appointment by calling 703 603-9230.
The public may copy a maximum of 100
pages from any regulatory docket at no
charge. Additional copies cost $0.15/
page. The index and some supporting
materials are available electronically.
See the "Supplementary Information"
section for information on accessing
them.
FOR FURTHER INFORMATION CONTACT: For
general information, contact the RCRA
Hotline at 800 424-9346 or TDD 800
553-7672 (hearing impaired). In the
Washington, DC, metropolitan area, call
703 412-9810 or TDD 703 412-3323.
For more detailed information on
specific aspects of this rulemaking,
contact Tracy Atagi, Office of Solid
Waste 5304W, U.S. Environmental
Protection Agency, 1200 Pennsylvania
Avenue, NW., Washington, DC 20460-
0002,703-308-8672,
atagi.tracy@epa.gov.
SUPPLEMENTARY INFORMATION: The index
and many of the supporting materials
are available on the Internet. You can
find these materials at
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Wednesday
February 12, 1997
Part II
Environmental
Protection Agency
40 CFR Part 260, et al.
Military Munitions Rule: Hazardous Waste
Identification and Management;
Explosives Emergencies; Manifest
Exemption for Transport of Hazardous
Waste on Right-of-Ways on Contiguous
Properties; Final Rule
6621
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Federal Register / Vol. 62, No. 29 / Wednesday, February 12, 1997 / Rules and Regulations 6645
treatment is legitimately part of the
emergency response.
Because of this need for safe treatment
sites, some EOD ranges may be regularly
used to destroy explosives during
emergency responses. The issue has
been raised (and previous EPA guidance
suggests) that some level of "routine"
use of a particular range should trigger
RCRA permit requirements. In EPA's
view, however, the question of whether
a permit is necessary hinges on the
nature of each individual response (i.e.,
whether or not it involves an
emergency), rather than on the number
of times a given area is used for
emergency responses. As long as the
response to each individual incident
was an emergency response, a RCRA
permit would not be required.
Q. Manifest Exemption for Transport of
Hazardous Waste in Lieu of "On-Site"
Redefinition
In the November 8, 1995 proposal,
EPA proposed to reduce the burden on
generators and TSDFs situated on
contiguous properties that are split by
public or private right-of-ways (e.g.,
roads) by proposing that the definition
of "on-site" found at 40 CFR 260.10 be
modified.6 Based on the comments
received and the complex issues raised
related to the definition of "on-site," the
Agency has determined that an
alternative approach is warranted to
reduce the burden associated with
shipments of hazardous waste to
contiguous properties under the same
ownership.
Under the current RCRA Subtitle C
regulations, if a waste movement
remains "on-site," the waste is not
required to be accompanied by a
manifest during transportation, and the
40 CFR part 263 transporter
requirements do not apply to the waste.
See 40 CFR 262.20(a), and 263.10 (a)
and (b). However, under the current
regulations, waste generated at one
location and transported along a
publicly accessible road for temporary
consolidated storage or treatment on a
contiguous property also owned by the
same person is not considered "on-site"
transport and would require a Uniform
Hazardous Waste Manifest (form 8700-
22A) and must be transported by a
transporter with an EPA Identification
number. These requirements for
6The current definition is: "On-site" means the
same or geographically contiguous property which
may be divided by public or private right-of-way,
provided the entrance and exit between the
properties is at a cross-roads intersection, and
access is by crossing as opposed to going along, the
right-of-way. Non-contiguous properties owned by
the same person but connected by a right-of-way
which he controls and to which the public does not
have access, is also considered on-site property."
manifesting and transporting hazardous
waste do not apply if the wastes are
transported directly across, rather than
along, the public road. The proposed
modifications would have expanded the
definition of "on-site" to include
contiguous properties divided by public
or private right-of-ways even if access to
the properties is by traveling along (as
opposed to across) the right-of-way to
gain entry.
The proposed change to the definition
of "on-site" arose in the context of
military munitions because many
military installations are on properties
that are, under the DOD "open" base
policy, split by "public" roads. Because
many other facilities (e.g., universities
or industrial complexes) are also located
on large parcels of land divided by
public or private right-of-ways, the
proposed change was extended to
hazardous waste generators and TSDFs
in general.
EPA received extensive comment on
the proposed modification to the
definition of "on-site." These comments
are discussed in more detail in the
response to comments section below.
While almost all commenters were
supportive of the concept of allowing
transportation without a manifest
between contiguous properties
controlled by the same person, a
number of commenters raised questions
related to the effect changing the
definition of "on-site" would have on
other issues such as the assigning of
EPA Identification Numbers to
generators, generator status, and other
RCRA regulations and definitions. As
stated in the proposal, the Agency did
not intend to affect requirements other
than those directly related to the
manifest and transportation. See 60 FR
56483-56484 (November 8, 1995). In
considering the original purpose of the
proposed change to the definition of
"on-site" and the complexity of the
questions that were raised by
commenters, the Agency has identified
an alternative method of finalizing the
requirements for transportation without
a manifest between contiguous
properties controlled by the same
person, that avoids the concerns raised
by commenters.
Therefore, the Agency is not finalizing
the proposed modification of the
definition of "on-site." Instead, the
Agency is adding new § 262.20(f) to 40
CFR Part 262, subpart B to exempt from
the manifest requirements shipments of
hazardous waste on right-of-ways on or
between contiguous properties and
along the perimeter of contiguous
properties controlled by the same
person. This manifest exemption is
applicable to all generators, both
military and non-military. Section
262.20(f) also restates the exemption
found in the current definition of "on-
site," i.e., manifests are also not
required for transport between non-
contiguous property when the
properties are owned and controlled by
the same person, and connected by a
right-of-way to which the public does
not have access. The Agency is not
changing regulations regarding transport
on public roads between non-
contiguous properties.
40 CFR Part 262, subpart B lays out
the general manifesting requirements
that apply to generators who transport,
or offer for transportation, hazardous
waste for off-site treatment, storage, or
disposal. (Subpart B also contains an
exemption for generators of 100—1000
kilograms of hazardous waste per month
from all of the requirements of subpart
B of Part 262 with respect to the
Uniform Hazardous Waste Manifest,
provided the waste is reclaimed under
certain conditions. See 40 CFR
262.20(e).
New 40 CFR § 262.20(f) adds another
exemption from the manifesting
requirements, for the movement of
hazardous waste on public roads within
or along the border of contiguous
property that is divided by a public or
private right-of-way. Additionally,
under 40 CFR 263.10(a), use of a
transporter with a Hazardous Waste
Identification number is not required for
the movement of hazardous waste
because of this manifest exemption. At
the same time, the Agency recognizes
that generators and TSDFs taking
advantage of this exemption must be
able to respond to an emergency should
one occur during the movement of
hazardous waste on public roads within,
between, or bordering contiguous
properties. As a result, under
§ 262.20(f), the Agency is specifying that
the transporter requirements found at
§263.30 and §263.31 concerning
responding to discharges of hazardous
waste on a public right-of-way will
continue to apply to any discharge of
hazardous waste on a public right-of-
way.
Further, the Agency has established
contingency and emergency response
protocols that require facilities to be
prepared for emergencies that occur on-
site. 40 CFR 262.34(a)(4) requires large
quantity generators to comply with the
requirements for owners or operators
found at 40 CFR part 265 subparts C
(Preparedness and Prevention) and D
(Contingency Plan and Emergency
Procedures), with the requirements at
§ 265.16 for personnel training, and
with the waste analysis plan
requirements at 40 CFR 268.7(a)(4).
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6646 Federal Register / Vol. 62, No. 29 / Wednesday, February 12, 1997 / Rules and Regulations
Similarly, small quantity generators are
subject to reduced emergency
preparedness, response, and reporting
requirements that are laid out in
§ 262.34(d)(5) and are also subject to the
preparedness and prevention
requirements found at 40 CFR part 265,
subpart C.
These contingency and emergency
response protocols include measures
that are designed to ensure that
emergencies that take place are handled
efficiently and effectively. They include
the designation of an emergency
coordinator who is accessible and who
is knowledgeable about the operations
and activities at the location and who
can coordinate emergency response
measures. These provisions also require
that all employees at a site are familiar
with the proper waste handling and
emergency response procedures relevant
to their responsibilities during normal
facility operations and emergencies.
Large quantity generators are
responsible for developing a
contingency plan that, among other
things, must contain a description of
emergency arrangements agreed to by
local police departments, fire
departments, hospitals, contractors, and
State and local emergency response
teams to coordinate emergency services.
This plan must be reviewed and
immediately amended under certain
circumstances as specified in 40 CFR
265.54, including when the applicable
regulations are revised and when the
facility changes in a way that materially
increases the potential for fires,
explosions, or releases of hazardous
waste or changes the response necessary
in an emergency. Additionally, should
an emergency occur, the emergency
coordinator must be able to assess any
hazards from the release, and help
appropriate officials decide whether
local areas should be evacuated.
Generators taking advantage of the
manifest exemption being finalized
today must, therefore, consider how the
emergency coordinator is to be kept
informed of waste movement activities
under the new circumstances involving
shipments on public roads without a
manifest, and how an emergency on a
public road within, between, or on the
perimeter of contiguous properties is to
be managed so that it minimizes
exposure to local areas surrounding the
property.
Whether waste no longer subject to
the manifest and transportation
requirements described above is subject
to Department of Transportation (DOT)
hazardous material shipping
requirements will depend on whether
that material is regulated under any
DOT hazard class other than materials
classified by DOT as "hazardous waste."
As mentioned in the proposed rule, the
Hazardous Materials Regulations (HMR,
49 CFR parts 171-180) define a
hazardous waste as any material that is
subject to the Uniform Hazardous Waste
Manifest Requirements of the EPA
specified in 40 CFR part 262 [49 CFR
171.8]. If a material is not subject to
EPA's RCRA manifest requirements, it is
not considered a "hazardous waste" by
DOT. However, such material is still
regulated as a "hazardous material" and
is subject to the HMR if it meets the
defining criteria for one or more of the
DOT hazard classes. Therefore, for these
shipments on public right-of-ways,
generators and/or TSDFs must decide if
the waste falls under any of the other
DOT hazard classes in order to
determine if compliance with the DOT
requirements under CFR parts 171-180
is required.
EPA believes that this exemption from
the Uniform Hazardous Waste Manifest
will result, on balance, in an increase in
protection of human health and the
environment. EPA believes that the
current requirement that a manifest be
completed and that a hazardous waste
transporter be used to transport
shipments between contiguous
properties may be discouraging
consolidation within a generator's or
TSDF's site, resulting in more locations
where potential exposure to hazardous
waste exists and more expense by the
generator or TSDF. Removing barriers to
consolidation of waste in one central
area should reduce the possibility that
the public and the environment could
come into contact with hazardous waste
because one area is easier to control and
can be better located than numerous
smaller areas.
EPA also believes that facilitating
central consolidation will allow
generators and TSDFs to locate such
consolidation sites in more remotely
located areas or in areas allowing faster
emergency response than they would if
confined to the boundaries within right-
of-ways, thereby increasing public
safety should an accident occur. The
new exemption at 40 CFR 262.20(f)
gives generators and TSDFs such as
military bases and universities more
flexibility to determine where
consolidation areas are situated. In
addition, EPA believes, along with
numerous commenters, that this
exemption will have the added benefit
of facilitating the building of safer
accumulation areas because generators
and TSDFs may be more likely with
limited resources to exceed regulatory
requirements for consolidation areas if
they are responsible for fewer
consolidation sites overall.
Since 40 CFR part 263, under
§ 263.10(a), only applies to transporters
subject to a manifest under part 262, the
persons transporting wastes under
today's § 262.20(f) are exempt from part
263 (most notably from the § 263.11
requirement for a transporter
identification number), except as
discussed above, § 262.20(f) requires
compliance with §§ 263.30 and 263.31
for immediate action in response to a
discharge.
Today's rule also exempts the
generator from § 262.32(b) for certain
container marking requirements, but not
from the DOT packaging, labeling,
marking, or placarding requirements of
§§ 262.30, 262.31, 262.32, and 262.33
because these public roads are still
considered by EPA to be "off-site"; nor
from the § 262.34(a)(2) and (3), (c)(l)(ii)
and (2), (d)(4), and (e) container and
tank labeling requirements. Section
262.34 regarding accumulation time is
not affected by today's rule because the
definition of "on-site" is not being
changed. Section 262.40 regarding
requirements to keep copies of
manifests is not included in the rule
because it is not applicable since the
manifest is not required. The biennial
report requirements in § 262.41 are
likewise unchanged by today's rule.
EPA believes the totality of these
changes regarding the applicability of
the "manifest system" (when
considered with the existing emergency
prevention and response, etc.
requirements, the continued
applicability of §§ 263.30 and 263.31,
the facilitated storage consolidations,
the marking requirements in § 262.34,
the continued applicability of the DOT
hazardous materials standards, in most
cases, and the fact that this
transportation is on or along contiguous
property controlled by the same person,
as discussed above), are consistent with
the directives in RCRA sections 3002(a)
and 3003(a) that EPA establish
regulations "as may be necessary" to
protect human health and the
environment.
Response to Comments
The Agency received numerous
comments on the proposed redefinition
of "on-site" in two main areas: (1) The
proposed change to the basic definition
of "on-site" and its impact on current
hazardous waste management practices
and (2) issues associated with
Department of Transportation (DOT)
and CERCLA protectiveness on public
access roads separating a larger facility.
EPA also requested comments on
whether other requirements of the
RCRA program would be affected by a
redefinition of "on-site."
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Federal Register / Vol. 62, No. 29 / Wednesday, February 12, 1997 / Rules and Regulations 6647
With respect to the proposed changes
to the definition of "on-site," almost all
the commenters supported the concept
behind the proposed redefinition—the
manifest exemption. (Many of these,
however, suggested simplified language
for redefining "on-site.") Only one
commenter (associated with the
transporters) opposed the proposal,
although three commenters suggested
postponing the final rule until a more
thorough analysis could be done. Even
so, the Agency received many
comments raising issues about other
requirements unrelated to the manifest
that might be affected by changing the
definition of "on-site." For example,
many of the commenters who supported
the idea of changing the definition of
"on-site" raised questions about how
the change would affect EPA
Identification Numbers, Land Disposal
Restrictions paper work requirements,
corrective action, and generator status.
One of the most common questions was
whether the proposed change to the
definition of "on-site" would cause a
change in generator status due to the
merging of several individual locations
into one larger location under the new
definition.
One commenter who questioned the
proposed change to the definition of
"on-site" expressed concerns about the
redesignation of sites based on the new
definition and specifically asked
whether adjacent military facilities (e.g.,
Army and Air Force) would be
considered "on-site" under the new
definition. The commenter also
expressed concern over the effect such
a redefinition would have on sites
currently on the National Priorities List
(NPL) that are contiguous to properties
not on the NPL. Another commenter
who questioned the proposed change
argued that some universities wanting a
permit to store hazardous waste for
more than 90 days may find that the
entire campus is subject to corrective
action because of a change in the
definition of "on-site." Several
commenters argued for a more thorough
evaluation of the impacts on the related
terms "site" and "off-site," the effects of
the proposed definitional change on
definitions such as "facility," the
relationship to the term "designated
facility" found at § 260.10, the impact
on accumulation provisions found at
§ 262.34 and the impact on the current
definition of "transfer facility" found at
§260.10.
The Agency agrees with these
commenters that a change to the
definition of "on-site" could cause a
great deal of confusion in many areas of
RCRA and CERCLA that are based on
the concept of "site" and "facility." In
addition to causing confusion, such a
change might also inadvertently make
substantive changes to a number of parts
of the RCRA program other than
manifesting and transportation. As
stated in the proposal, EPA did not
intend to affect requirements other than
the requirement that a manifest
accompany hazardous waste shipments
and whether part 263 transportation
requirements apply. Therefore, after
reviewing the comments received on
this issue, EPA has decided to avoid the
potential for unforeseen, adverse
consequences and is not changing the
definition of "on-site."
The Agency does, however, continue
to believe that it is appropriate to revise
the regulations to allow transport along
public and private right-of-ways that
divide contiguous properties without
manifests and the need to use hazardous
waste transporters. Thus, the Agency
has identified an alternative way to
make this change to the regulations
without causing potentially unintended
consequences of changing the definition
of "on-site." This alternative modifies
40 CFR Part 262, subpart B, to exempt
shipments of hazardous waste on and
along the perimeter of contiguous
properties controlled by the same
person from the manifest requirements.
This change avoids any revision to the
definition of "on-site." The Agency
reiterates that this revision is a change
only to the applicability of manifesting
and 40 CFR 263 requirements and does
not make any changes to the existing
concepts of "on-site," "site," "facility"
or related terms for any other purpose
in the RCRA or CERCLA programs.
Also, it does not affect the definition of
"contiguous" orEPA's interpretations as
to whether "contiguous properties" are
owned or under the control of the same
person. For example, EPA considers
different agencies within the Federal
government and different services to be
different "persons." Therefore, in the
example cited by one commenter,
wastes could not be transported
between adjacent Army and Air Force
bases without a manifest.
EPA received numerous comments
requesting clarification on how
generator identification numbers would
be affected and the related effect on
generator status a change in the
definition of on-site would create. The
Agency understands that the policy
regarding issuing generator
identification numbers is not explicit in
Federal regulations, and thus flexibility
exercised by authorized States may
result in differing interpretations of this
policy by State implementers. However,
the Agency only intended to address the
applicability of the manifest and related
transportation requirements and did not
intend to address the issue of generator
identification numbers as part of this
rulemaking. Eliminating State flexibility
could have significant impacts on
particular facilities, and those impacts
could be viewed as either positive or
negative. Examples of all kinds were
cited by commenters. Though EPA
acknowledges the potential for
confusion and different application of
identification number assignments, the
Agency has not analyzed the potential
impacts fully and is not changing either
Federal regulation or policy on this
issue.
The definition of "on-site"
historically has been used in many
States to determine when a manifest
should accompany a shipment of
hazardous waste and when part 263
transporter requirements apply. While
the Agency establishes this relationship
in several preamble discussions (see 45
FR 12723, February, 26, 1980 and 45 FR
33069, May 19, 1980), no similar
preamble discussion exists on the
nature of the relationship of the term
"on-site" to generator identification
numbers.
EPA's past policy interpretations have
tended to associate generator
identification numbers with sites for
which an effective connecting right-of-
way exists. In many cases the Agency
has used the definition of "on-site" as
the delimiting tool for determining
when an identification number is
needed. However, exceptions exist
where there may be, for example, more
than one independent business
operating on a contiguous property and
where a cogenerator relationship exists.
EPA has relied on each State
implementing agency to establish its
own method of issuing generator
identification numbers and to make site
specific determinations where
appropriate. The Agency understands
that variations may exist in the method
used to issue generator identification
numbers and therefore recommends that
a generator contact the state in which
the site is located when obtaining an
identification number and with any
questions regarding an individual
location.
Some commenters requested more
detailed information on travel distances.
For example, a commenter questioned
what was meant by a "short" stretch of
road (public right-of-way) in the
proposed preamble discussion,
contrasting the benefits of consolidation
to the transportation without a manifest
along a short stretch of road to which
the public has access. Another argued
that a limit should be placed on how far
a shipment could travel along a road,
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6648 Federal Register / Vol. 62, No. 29 / Wednesday, February 12, 1997 / Rules and Regulations
and suggested that waste be allowed to
be moved only two miles. The Agency
sees no reason to limit the length of
movement along roads on (or on the
boundary of) property owned by the
same person since many generators
taking advantage of the new exemptions
are located on very large properties that
routinely require them to travel for more
than two miles. One purpose of the
manifest requirement is to assure receipt
of the waste, an object that is
independent of shipping distance, but
enhanced in this case because the
shipper and the receiver are the same,
and the material remains within, or on
the border of, the properties owned or
operated by the shipper/receiver.
Commenters asked for clarification
about the transportation routes allowed
under the proposed rule. Five
commenters suggested that EPA clarify
that waste can be transported along the
perimeter of the property. The Agency
is finalizing this exemption for
movement on roads along the perimeter
as well as within the contiguous
properties because, as discussed above,
it is persuaded that there are adequate
safeguards related to emergency
response and cleanup provided by
today's final rule. Further, if a discharge
of hazardous waste should occur on a
perimeter public road, the generator
and/or TSDF property still borders the
right-of-way, which would lead to better
control of the remediation process. Also,
the purpose of the manifest is to assure
that waste gets to the receiving unit, an
object that is independent of whether
the road is on the perimeter or within
the property, and that is enhanced when
the contiguous property is controlled by
the same person.
Three commenters suggested EPA
specifically include contiguous
properties "touching corners" or
"diagonally across" from each other.
EPA considers such examples to be
contiguous properties separated by a
right-of-way and, therefore, included in
today's rule. Also, access would
generally be gained by travel along the
perimeter of the properties so the
inclusion of the "along the border"
language enables the diagonal corners
situation to benefit by today's rule.
Four commenters expressed a desire
for the Agency to expand the scope of
"on-site" to include nearby non-
contiguous areas owned or under the
control of the same person, suggesting
that EPA limit the distance to two miles,
several miles, or some other distance.
The Agency did not intend to change
the regulations regarding the
transportation of hazardous waste along
public roads to non-contiguous
properties. The current definition of
"on-site" already allows for the
movement of waste to non-contiguous
areas without a manifest as long as the
public does not have access to the right-
of-way that joins the two properties.
Beyond this, the Agency does not agree
that movement of wastes between non-
contiguous properties along right-of-
ways to which the public has access is
warranted given the increased
possibility that the public could come in
contact with the waste should a
discharge occur under this scenario and
the generator would no longer have
control over bordering property.
The proposal also requested comment
on whether or not the authorities under
CERCLA and/or DOT are sufficient to
protect human health and the
environment as they relate to the
management of potential spills of waste
that, as a result of this new exemption,
would not be manifested under RCRA as
previously required and would not be
subject to the requirements of Part 263.
The Agency requested comments on
whether or not the RCRA requirements
in 40 CFR 263.30 and 263.31 should
continue to apply to any discharge of
hazardous waste during transportation
of hazardous waste on a public right-of-
way when the waste is transported
within a contiguous property without a
manifest. Sections 263.30 and 263.31
require that immediate action be taken
in the event of a discharge including
notifying local authorities and the
National Response Center and cleaning
up the discharge. Most of the
commenters believed that the alternate
authorities of CERCLA and DOT are
protective enough and that the pressure
of public awareness and corporate
liability concerning spills would help
ensure that spills are prevented, and if
they occur are contained and cleaned up
quickly. However, the Agency also
received comments supporting the
suggested alternative approach of
requiring the "on-site" hauler using a
public right-of-way to follow 40 CFR
263.30 and 263.31. One commenter
cited that response times for cleanup
actions under CERCLA do not promote
an expeditious cleanup and that DOT
regulations are inadequate. DOT and
CERCLA reporting requirements would
apply to such releases, but those
authorities do not necessarily require an
actual cleanup of the release.
In reviewing the options and the
comments received, the Agency has
decided that the requirements found at
§§ 263.30 and 263.31 will continue to
apply to any discharge of hazardous
waste on a public right-of-way even if it
is not accompanied by a manifest and is
not subject to the other transport
requirements found at 40 CFR part 262,
subparts B and C and 40 CFR part 263.
The Agency is concerned here not with
overall RCRA requirements to clean up
a spill, since RCRA does apply when
hazardous waste is disposed of or
discharged onto the ground, but with
the timeliness of response action needed
to contain and remediate a spill which
will be enhanced by the clarity of
responsibility such references afford.
V. State Authority
Under RCRA section 3006, EPA may
authorize a State to administer and
enforce the RCRA hazardous waste
program. See 40 CFR part 271. After
receiving authorization, the State
administers the program in lieu of the
Federal government, although EPA
retains enforcement authority under
RCRA sections 3008, 3013, and 7003.
Because the new Federal requirements
in today's final rule are non-HSWA,
they are not Federally enforceable in an
authorized State until the necessary
changes to a States' authorization have
been approved by EPA.7 See RCRA
section 3006, 42 U.S.C. 6926.
Under RCRA, authorized States are
required to review and, if necessary, to
modify their programs when EPA
promulgates Federal standards that are
more stringent or broader in scope than
existing Federal standards. This is
because under RCRA section 3009,
States are barred from implementing
requirements that are less stringent than
the Federal program. See also 40 CFR
271.21.
In two respects, EPA considers
today's final rule to be more stringent
than current Federal requirements: (1)
the requirement that military
installations retrieve munitions fired
off-range or keep a record of the event
(§ 266.202(d)), and (2) the requirement
that military personnel responding to
immediate threats involving military
munitions maintain records of the
response (§§ 264.1(g)(8)(iv),
265.1(c)(ll)(iv), and 270.1(c)(3)(iii)).
Authorized States must adopt these
requirements as part of their State
programs and apply to EPA for approval
of their program revisions. Section
271.21 sets forth the procedures and
deadlines for State program revisions.
RCRA section 3009, however, allows
States to impose standards that are more
'Under section 3006(g) of RCRA, enacted as part
of the Hazardous and Solid Waste Amendments
(HSWA) of 1984, new requirements imposed by
HSWA take effect in authorized States at the same
time as they do in unauthorized States—as long as
the new requirements are more stringent than the
previous requirements. EPA implements these new
requirements until the State is authorized for them.
Since today's proposal is not issued under HSWA
authority, however, section 3006(g) does not come
into play.
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Solid Waste and Emergency Response
(5305W)
EPA530-K-05-011
Introduction to
Generators
(40 CFR Part 262)
United States
Environmental Protection
Agency
September 2005
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GENERATORS
CONTENTS
1. Introduction 1
2. Regulatory Summary 2
2.1 Hazardous Waste Determination 2
2.2 Definition of Generator 3
2.3 Three Generator Classifications 4
2.4 Counting Waste 5
2.5 Accumulation Standards 6
2.6 Pre-Transport Requirements 10
2.7 Reporting and Recordkeeping 11
2.8 Export and Import Requirements 12
2.9 Farmers 13
3. Special Issues 14
3.1 Active Management 14
3.2 Closure Standards 14
3.3 Waste Minimization 15
3.4 Air Emission Standards 15
3.5 Standards for Generators of F006 Waste 15
4. Regulatory Developments 16
4.1 Revisions to the Hazardous Waste Manifest 16
4.2 Burden Reduction Initiative 16
4.3 Hazardous Waste Generator Program Evaluation 17
4.4 Performance Track Large Quantity Generators 17
5. Generator Summary Chart 18
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Generators - 1
1. INTRODUCTION
The Resource Conservation and Recovery Act (RCRA) sets forth an approach for handling the
volumes of waste generated in the United States each year. Based on the authority granted by
RCRA Subtitle C, EPA developed regulations for the cradle-to-grave management of hazardous
waste. Persons who produce hazardous waste, called hazardous waste generators, are the first
link in this cradle-to-grave system. The RCRA regulations establish basic hazardous waste
management standards for generators. The generator regulations ensure that hazardous waste is
appropriately identified and handled safely to protect human health and the environment, while
minimizing interference with daily business operations. A solid foundation in the generator
regulations is critical to a thorough understanding of the regulations governing the management
of hazardous waste from the moment it is produced, or the point of generation, through final
disposition.
When you have completed this module, you will be able to explain the definitions and
regulations that apply to generators of hazardous waste. Specifically, you will be able to:
• define the terms "generator" and "co-generator"
• list the three classes of generators, outline the different generation and accumulation
limits, and provide specific regulatory citations
define episodic generation
• explain the use of EPA identification (ID) numbers and manifests
• outline the accumulation standards, define "empty tank" and "start time" for waste
accumulation purposes, and identify regulations pertaining to accumulation in tanks,
containers, containment buildings, and on drip pads
define "satellite accumulation" and provide the applicable Federal Register citations
• cite the CFR section covering recordkeeping and reporting requirements for generators
• recognize copies of notification forms and manifests, and explain how they are obtained.
Use this list of objectives to check your knowledge of this topic after you complete the training
session.
The information in this document is not by any means a complete representation of EPA's regulations or policies,
but is an introduction to the topic used for training purposes.
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2 - Generators
2. REGULATORY SUMMARY
The RCRA regulations establish a comprehensive hazardous waste management system under
the authority of RCRA Subtitle C. RCRA regulates hazardous waste from its point of generation
through its point of final disposal. Hazardous waste generators are the first link in the cradle-to-
grave hazardous waste management system. Pursuant to the authority granted by RCRA
§3002(a), EPA has developed generator standards that address on-site accumulation of
hazardous waste, cradle-to-grave tracking (manifest system), labeling, and recordkeeping and
reporting requirements. These standards are found in 40 CFR Part 262.
Recognizing that generators produce waste in different quantities, Congress established three
categories of generators in the statute: large quantity generators (LQGs), small quantity
generators (SQGs), and conditionally exempt small quantity generators (CESQGs). The extent
of regulation to which hazardous waste generators are subject depends on the volume of
hazardous waste each generator produces. This module defines the three classifications of
generators and explains the varying degree of regulation to which each is subject.
In order to fully understand the responsibilities of hazardous waste generators, we first need to
review the hazardous waste determination process.
2.1 HAZARDOUS WASTE DETERMINATION
As discussed in other modules, §262.11 requires generators to determine if their wastes are
hazardous. The hazardous waste determination requirement applies to all generators of solid
waste. Section 262.11 sets forth the following three-step hazardous waste determination process
that any person who generates a solid waste, as defined in §261.2, must follow. First, the
generator must determine if the solid waste is excluded from RCRA regulation in §261.4.
Second, if the waste is not excluded, the generator must determine if it is listed in Subpart D of
Part 261. Third, for purposes of compliance with the land disposal restrictions or if the waste is
not listed in Subpart D of Part 261, the generator must identify all relevant hazardous waste
characteristics in Subpart C of Part 261. The modules entitled Hazardous Waste Identification,
Definition of Solid Waste and Hazardous Waste Recycling, and Solid and Hazardous Waste
Exclusions together present the process of hazardous waste determination in detail. It is the
generator's responsibility to determine if his or her wastes are defined as hazardous and therefore
subject to regulation under Subtitle C. As discussed in Sections 2.3 and 2.4 of this module, once
a generator determines a material meets the definition of a hazardous waste, the generator must
determine the extent of regulation to which he or she is subject.
Generators are not required to perform analytical testing to identify their wastes. They are,
however, required to accurately characterize their wastes. This means they may make a
hazardous waste determination by testing or applying their knowledge of the waste's chemical
and physical properties as specified in §262.11 (e.g., knowledge of the process, inputs, reactions,
or operating status for the day).
The information in this document is not by any means a complete representation of EPA's regulations or policies,
but is an introduction to the topic used for training purposes.
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Generators - 3
2.2 DEFINITION OF GENERATOR
Section 260.10 defines a generator as "any person, by site, whose act or process produces
hazardous waste identified or listed in Part 261 or whose act first causes a hazardous waste to
become subject to regulation." This definition contains three important terms you need to
understand to apply the generator regulations.
The first term, "by site," refers to where a hazardous waste is generated. The regulations do not
explicitly define the term "site." EPA tracks hazardous waste generation on a site-specific basis
or by "individual generation site." To do this, EPA issues unique identification numbers to
identify generators by site. Activities occurring under the control of an owner or operator on a
single piece of property should be evaluated collectively for hazardous waste generation. For
example, if Company A operates three laboratories on a single piece of property, all three
laboratories may share one EPA ID number, and the waste from all three laboratories may be
evaluated together. If, however, Company A operates three laboratories at three different
locations that are not considered to be on contiguous property, each laboratory is viewed as a
separate potential generator and is required to obtain an individual EPA ID number.
The second term is "person." Person is defined in §260.10 as "an individual, trust, firm, joint
stock company, federal agency, corporation (including a government corporation), partnership,
association, state, municipality, commission, political subdivision of a state, or any interstate
body." The definition of person encompasses any entity involved with a process that generates
hazardous waste.
The third key component of the generator definition is the phrase "act or process." Because a
generator is defined as the person whose act or process first causes a hazardous waste to become
subject to regulation, sometimes the generator of a waste may not necessarily be the person who
actually produced the waste. For example, if a cleaning service removes residues from a product
storage tank excluded in §261.4(c), the person removing the residues is the first person to cause
the waste to become subject to regulation, not the owner of the tank (i.e., the person who
produced the waste).
CO-GENERATORS
In the above residue removal example, the person removing the waste from the unit is not the
owner or operator of the unit, but he or she may be considered a generator. The owner or
operator of the unit may also be considered a generator since the act of operating the unit led to
the generation of the hazardous waste. In other words, both the remover of the waste and the
owner or operator of the tank are considered to be co-generators. In cases where one or more
persons meet the definition of generator, all persons are jointly and severally liable for
compliance with the generator regulations. The parties may through a mutual decision have one
party assume the duties of generator, but in the event that a violation occurs, all persons meeting
the definition of generator could be held liable for the improper management of the waste (45 FR
72024, 72026; October 30, 1980).
The information in this document is not by any means a complete representation of EPA's regulations or policies,
but is an introduction to the topic used for training purposes.
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4 - Generators
2.3 THREE GENERATOR CLASSIFICATIONS
The original generator regulations, published on May 19, 1980, set forth comprehensive
requirements for those persons who generated 1,000 kg or more of hazardous waste in a calendar
month (45 FR 33142). These regulations also included generators who produced more than 1 kg
of acute hazardous waste in a calendar month. Persons generating less than 1,000 kg of
hazardous waste (or less than or equal to 1 kg of acute hazardous waste) in a calendar month
were granted a conditional exemption and subject to reduced regulatory requirements.
Congress amended the definition of generator in the Hazardous and Solid Waste Amendments of
1984 (HSWA), requiring EPA to regulate more stringently persons who generate between 100
and 1,000 kg of hazardous waste in a calendar month. On March 24, 1986, EPA issued final
regulations establishing a third class of generators (persons generating 100-1,000 kg per month),
and narrowed the scope of the conditional exemption to include only persons generating 100 kg
or less of hazardous waste in a calendar month (51 FR 10146). Generators who produce 1 kg or
less of an acute hazardous waste were also granted the conditional exemption.
Generators now fall into one of three general groups according to the amount of waste generated
in a calendar month. The three classes of generators are described in Table 1. Since the
regulations become increasingly stringent as the volume of waste generated grows, accurate
counting of the waste is critical. This complex counting issue will be addressed in the next
section of the module.
Table 1
QUANTITY DETERMINES WHICH REGULATIONS APPLY
Generator
Quantity
Regulation
Large Quantity (LQG)
> 1,000 kg/month
(approximately 2,200 Ibs)
> 1 kg/month acute
(approximately 2.2 Ibs)
> 100 kg residue or contaminated
soil from cleanup of acute
hazardous waste spill
All Part 262 Requirements
Small Quantity (SQG)
Between 100-1,000 kg/month
(approximately 220-2200 Ibs)
Part 262, Subparts A, B, C
(§262.34(d) is specific to SQGs);
and Subparts E, F, G, H if
applicable; and portions of
Subpart D as specified in
§262.44
Conditionally Exempt
Small Quantity (CESQG)
< 100 kg/month
< 1 kg acute
< 100 kg residue or contaminated
soil from cleanup of acute
hazardous waste spill
§261.5
The information in this document is not by any means a complete representation of EPA's regulations or policies,
but is an introduction to the topic used for training purposes.
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Generators - 5
LARGE QUANTITY GENERATOR
LQGs produce 1,000 kg or more of hazardous waste per calendar month, or more than 1 kg of
acutely hazardous waste (i.e., waste codes denoted with the hazard code "H" and all P-listed
wastes). Wastes from these generators are subject to full regulation in Part 262.
SMALL QUANTITY GENERATOR
SQGs produce between 100 and 1,000 kg of hazardous waste per calendar month and are subject
to modified regulations found in Part 262. Generally, SQGs must comply with some but not all
of the regulations that apply to LQGs. Simplified requirements are specified for SQGs in place
of some LQG requirements.
CONDITIONALLY EXEMPT SMALL QUANTITY GENERATOR
CESQGs produce 100 kg or less of hazardous waste per calendar month. In addition, generators
who produce 1 kg or less of acutely hazardous waste, or 100 kg or less of contaminated soil,
waste, or debris resulting from the cleanup of an acute hazardous waste spill, are CESQGs.
CESQGs are exempt from Parts 262 through 270 if they comply with the requirements in
§261.5.
EPISODIC GENERATORS
Generators may periodically exceed or fall below their normal generation limits in any given
calendar month. If the amount of waste generated in a given calendar month places the generator
in a different category, he or she is responsible for complying with all applicable requirements of
that category for all waste generated during that calendar month. For example, if a generator
produces 300 kg of hazardous waste in March, that waste must be managed in accordance with
the SQG regulations; if the same generator produces 1,500 kg of hazardous waste in April, that
waste must be managed in accordance with the LQG regulations (51 FR 10146, 10153; March
24, 1986).
2.4 COUNTING WASTE
Generators must count the quantity of hazardous waste generated each month in order to
determine their generator classification. The regulations stating which hazardous wastes are
counted in a generator's monthly quantity determination are found in §261.5(c) and (d). All
generators must comply with the counting requirements found in §261.5(c) and (d), even though
the counting requirements are found in the section of the regulations that primarily applies to
CESQGs.
A generator must include all hazardous waste that it generates, except hazardous waste that:
• is exempt from regulation in §§261.4(c) through (f), 261.6(a)(3), 261.7(a)(l), or 261.8
• is managed immediately upon generation only in on-site elementary neutralization units,
The information in this document is not by any means a complete representation of EPA's regulations or policies,
but is an introduction to the topic used for training purposes.
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6 - Generators
wastewater treatment units, or totally enclosed treatment facilities as defined in §260.10
• is recycled, without prior storage or accumulation, only in an on-site process subject to
regulation in §261.6(c)(2)
• is used oil managed under the requirements in §261.6(a)(4) and Part 279
• is spent lead-acid batteries managed under the requirements in Part 266, Subpart G
• is universal waste managed pursuant to §261.9 and Part 273.
To avoid double counting, §261.5(d) states that the following types of waste need not be counted
when determining generator classification. All of these wastes have already been counted when
they were initially generated:
• hazardous waste when removed from on-site storage
• hazardous waste produced by on-site treatment (including reclamation) as long as the
hazardous waste was counted once
spent materials generated, reclaimed, and subsequently reused on site, as long as the
spent material is counted once during the calendar month.
2.5 ACCUMULATION STANDARDS
Storage of hazardous waste generally requires a permit under the RCRA regulations. There are,
however, provisions under RCRA that allow generators to "accumulate" hazardous waste on site
without a permit as long as they comply with certain management standards for their
accumulation unit(s) and for their facility, such as a contingency plan and personnel training
requirements. The length of time a generator is allowed to accumulate his or her waste will vary
depending on the generator's classification, as illustrated in Table 2. The regulations pertaining
to accumulation of hazardous waste on site are found in §262.34 for LQGs and SQGs, and in
§261.5forCESQGs.
Table 2
TYPE OF GENERATOR DETERMINES LENGTH OF ACCUMULATION TIME
Generator
Large Quantity
Small Quantity
On-site Accumulation Time
< 90 days on site
< 180 days on site or
< 270 days if shipped
200 miles or more
On-site
Quantity Limit
No Limit
6,000 kg
The information in this document is not by any means a complete representation of EPA's regulations or policies,
but is an introduction to the topic used for training purposes.
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Generators - 7
Conditionally Exempt
Small Quantity
N/A
1,000 kg
1 kg acute
100 kg residue or contaminated
soil from cleanup of acute
hazardous waste spill
ACCUMULATION UNITS
LQGs accumulating hazardous wastes pursuant to §262.34 may only do so in containers, tanks,
containment buildings, or on drip pads. SQGs may only accumulate waste in tanks or
containers. If SQGs wish to accumulate waste in containment buildings or on drip pads, then
they must meet the LQG standards. While these units do not need RCRA storage permits when
used for generator accumulation, they must comply with certain standards found in the Part 265
requirements for interim status units, such as release detection and prevention requirements.
Generators who accumulate hazardous waste in containers must comply with certain sections in
Part 265, Subpart I. Generators who accumulate hazardous waste in tanks must comply with
certain sections in Part 265, Subpart J, potentially including secondary containment and release
detection. Generators who accumulate hazardous waste in containment buildings must comply
with Part 265, Subpart DD. Generators who accumulate hazardous waste on drip pads must
comply with Part 265, Subpart W; only generators managing wood preserving wastes may use
drip pads for hazardous waste accumulation. All accumulation containers and tanks must be
labeled or marked "Hazardous Waste" (§262.34(a)(3)). Finally, LQGs must comply with the air
emission control requirements in Part 265, Subparts AA, BB, and CC, for accumulation tanks
and containers (§262.34(a)(l)(i) and (ii)). The modules entitled Tanks, Containers, Drip Pads,
Containment Buildings, and Air Emissions provide additional information on the hazardous
waste unit standards.
The time period for generator waste accumulation starts when waste is first placed in or on the
empty accumulation unit (e.g., tank, container, drip pad, or containment building). Tanks and
containers must be marked with the date accumulation begins (51 FR 10146, 10160; March 24,
1986). In order to avoid exceeding the time limits when accumulating in a tank, the generator
should fully empty the tank every 90, 180, or 270 days, as appropriate (47 FR 1248; January 11,
1982). All wastes must be removed from drip pads and their associated collection systems at
least once every 90 days (§262.34(a)(l)(iii)(A)).
SATELLITE ACCUMULATION
Prior to consolidation in the generator's waste accumulation area, §262.34(c) allows generators
to accumulate hazardous waste at or near the point where it is initially generated and collected
during daily operations (49 FR 49568; December 20, 1984). A person may accumulate up to 55
gallons of hazardous waste or 1 quart of acute hazardous waste at each satellite accumulation
area, if it is under the control of the person operating the process that generates the waste.
Limited standards, such as labeling and maintaining the container in good condition, apply to
satellite areas (§262.34(c)(l)(i) and (ii)). Once the 55-gallon or 1 quart limit is exceeded at the
satellite area, the excess waste must be dated and moved within three days to the central
accumulation area where §262.34 standards apply (or the waste can be shipped directly off site).
The accumulation limit is 55 gallons, regardless of the size of the container used.
The information in this document is not by any means a complete representation of EPA's regulations or policies,
but is an introduction to the topic used for training purposes.
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! - Generators
ACCUMULATION TIME LIMITS
Pursuant to §262.34(a), an LQG is allowed to accumulate hazardous waste on site for up to 90
days in specified units without obtaining a storage permit or interim status, provided he or she
complies with Part 265 management standards for specific units as specified in §262.34. (It is
important to note, however, that generators that accept waste from other generators or from off-
site locations are owners or operators of storage facilities subject to Parts 264 and 265.)
An SQG may accumulate up to 6,000 kg of hazardous waste for 180 days or less without a
storage permit or interim status if he or she complies with the modified standards in §262.34(d).
If the TSDF is 200 miles or more away, the generator may accumulate hazardous waste for 270
days or less (§262.34(e)). Note that these extended time limits only apply to SQGs accumulating
waste in tanks or containers. SQGs who accumulate waste in containment buildings or on drip
pads are subject to the accumulation standards for LQGs.
Generators may receive a 30-day extension to their 90-day, 180-day, or 270-day accumulation
period if uncontrollable and unforeseen circumstances cause them to accumulate waste on site
for longer than the allowed time period. Such an extension may be granted by a Regional
Administrator or authorized state on a case-by-case basis (§262.34(b) and (f)). An example of
an uncontrolled or unforeseen circumstance is a truckers' strike preventing the shipment of waste
off site.
LQGs and SQGs accumulating waste beyond the authorized time limits for their categories
become subject to the requirements in Parts 264 and 265, and the permitting provisions in Part
270. An SQG who accumulates more than 6,000 kg during the authorized period is also subject
to the applicable storage facility regulations in Parts 264 and 265, and the permitting provisions
of Part 270.
TREATMENT WITHOUT A PERMIT
EPA interprets the accumulation provisions in §262.34 as allowing generators to accumulate
their waste for the allotted time period and to treat their waste in the accumulation unit, provided
the generator complies with the requirements in §262.34 as well as the unit-specific requirements
in Part 265 for tanks, containers, or containment buildings. This interpretation allows generators
to treat hazardous waste on site without obtaining a permit or interim status (51 FR 10146,
10168; March 24, 1986, and 57 FR 37194; August 18, 1992). Some states interpret
"accumulation" to include only storage and not treatment, however, and these states may require
the generator to obtain a permit in order to conduct treatment. Generators who treat wastes in
accumulation tanks, containers, or containment buildings to meet the Part 268 land disposal
restriction treatment standards must comply with §268.7(a)(5) and have a waste analysis plan on
site (discussed further in the module entitled Land Disposal Restrictions). EPA has not extended
the interpretation of accumulation to allow generators of wood preserving wastes to treat waste
on drip pads because drip pads are intended to serve solely as a means of conveying treated
wood drippage and other related wastes to an associated collection system. In addition, there is
no definitive federal interpretation of accumulation to allow treatment in satellite accumulation
units; thus, the decision should be made by the appropriate implementing agency. (Please note,
however, that the regulations and policy letters that discuss generator treatment do not directly
The information in this document is not by any means a complete representation of EPA's regulations or policies,
but is an introduction to the topic used for training purposes.
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Generators - 9
address satellite accumulation units, and the structure of the regulations does not explicitly
provide for it).
The information in this document is not by any means a complete representation of EPA's regulations or policies,
but is an introduction to the topic used for training purposes.
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10 - Generators
GENERAL ACCUMULATION STANDARDS
LQGs accumulating hazardous waste on site pursuant to §262.34(a) must comply with the
preparedness and prevention procedures in Part 265, Subpart C. These requirements include
having an emergency coordinator and testing and maintaining emergency equipment. SQGs are
also subject to the preparedness and prevention procedures in Part 265, Subpart C
(§262.34(d)(4)).
LQGs must develop and maintain a contingency plan on site, as found in Part 265, Subpart D,
which outlines the response procedures necessary to minimize the hazards posed by fires,
explosions, or unplanned releases of hazardous waste from the facility (§262.34(a)(4)). Such a
plan is not required for SQGs, although §262.34(d)(5)(iv) outlines appropriate response
procedures.
LQGs must comply with the personnel training requirements referenced in §265.16. These
regulations require facility personnel to complete classroom or on-the-job training to become
familiar with proper hazardous waste management and emergency procedures for the wastes
handled at the facility. SQGs must follow modified personnel training requirements in
§262.34(d)(5)(iii).
CESQGs
Hazardous waste generated by a CESQG is not subject to specific management standards (Parts
262-270) for accumulation under the federal hazardous waste regulations provided the CESQG
does not accumulate more than 1,000 kg of hazardous waste (or more than 1 kg of acute
hazardous waste, or more than 100 kg of spill residue from an acute hazardous waste) on site at
any time. A CESQG who exceeds the 1,000 kg limit for hazardous waste becomes subject to the
SQG requirements in §262.34(d) (§261.5(g)). On the other hand, a CESQG becomes subject to
full regulation (i.e., large quantity generator regulations) when the quantity of waste accumulated
exceeds any of the limits specified for acute hazardous wastes (§261.5(f)).
Section 261.5(f)(3) and (g)(3) state that CESQGs may either treat or dispose of their waste in an
on-site facility, or ensure delivery to an off-site treatment, storage, or disposal facility. The on-
site or off-site facility, if located in the United States, must be one of the following:
• a federally permitted or interim status hazardous waste treatment, storage, or disposal
facility
a facility that is located in an authorized state and that is authorized to manage hazardous
waste
a facility permitted, licensed, or registered by a state to manage municipal or non-
municipal, non-hazardous solid waste
• a facility that beneficially uses, reuses, or reclaims the waste
a universal waste handler or destination facility subject to the requirements in Part 273.
The information in this document is not by any means a complete representation of EPA's regulations or policies,
but is an introduction to the topic used for training purposes.
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Generators - 11
2.6 PRE-TRANSPORT REQUIREMENTS
Before shipping hazardous waste off site to a RCRA facility for treatment, storage, or disposal, a
generator must comply with numerous pre-transport requirements. These requirements include
obtaining an EPA ID number, preparing a Uniform Hazardous Waste Manifest (EPA Form 8700-
22), and complying with several Department of Transportation (DOT) requirements.
EPA IDENTIFICATION NUMBERS
A generator must obtain an EPA ID number before treating, storing, disposing, or transporting
(or offering for transport) hazardous waste. EPA ID numbers are site-specific numbers assigned
to generators, transporters, and treatment, storage, or disposal facilities, and need only be
obtained once, although the generator should update the state or Region if his or her waste
activities change. CESQGs, however, are not required to obtain EPA ID numbers.
Each EPA ID number consists of twelve alphanumeric characters. The first two letters are
simply the two-letter abbreviation for the state in which the facility is located; whereas, the third
character is either a number or letter indicating the "type" of ID number (e.g., automatically
generated by RCRAInfo). A nine-digit number uniquely associated with the site follows these
first three characters. Emergency EPA ID numbers are also available in certain situations (45 FR
85022; December 24, 1980).
EPA ID numbers are obtained by filing Form 8700-12, "Notification of Regulated Waste
Activity," with the appropriate EPA Regional or authorized state RCRA office. The notification
forms are obtained from state or Regional offices or via the Internet.
MANIFEST (EPA FORM 8700-22)
Generally, a generator who transports, or offers for transportation, hazardous waste for off-site
treatment, storage, or disposal must prepare a Uniform Hazardous Waste Manifest. The manifest
is a multiple-copy tracking document for hazardous waste shipments that is required by DOT
and EPA. The manifest tracks the chain of custody for the waste from the point it leaves the
generator to final disposition at a hazardous waste TSDF or a recycling facility. Each party that
manages the waste signs the manifest and retains a copy, providing critical continuity between
the generator and the receiving facility (Part 262, Subpart B). Once the chain is complete, the
receiving facility returns a signed copy of the manifest to the generator. If a generator does not
receive a copy of the manifest signed by the designated facility owner or operator within 45 days
of the date the waste was accepted by the initial transporter (60 days for a SQG), he or she must
file an exception report (§262.42). SQGs that have tolling agreements with recycling facilities
and CESQGs are not required to use a manifest when shipping their waste off site. Additionally,
the manifest requirements do not apply to the transportation of hazardous wastes on rights-of-
way on or between contiguous properties, and along the perimeter of contiguous properties
controlled by the same person (§262.20(f)).
A copy of the manifest forms and instructions for completing it are found in the Appendix to Part
262. All numbered sections on the manifest must be completed to meet federal requirements.
The lettered sections are options that may be required by the generator's or receiving facility's
The information in this document is not by any means a complete representation of EPA's regulations or policies,
but is an introduction to the topic used for training purposes.
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12 - Generators
state. Since states may customize the manifest, §262.21 explains which state's manifest must be
used when waste transportation is interstate. Federal EPA does not require hazardous waste
codes to be included on the manifest, however state law may require waste codes.
DESIGNATED FACILITY
According to §262.20, a generator must designate one facility on the manifest that is permitted to
handle the waste described on the manifest. A designated facility, as defined in §260.10, is a
federally or state-permitted treatment, storage, or disposal facility or a recycling facility as regulated
pursuant to §261.6(c)(2) or Part 266, Subpart F. The generator may also designate an alternate
facility in case the transporter cannot deliver the waste to the primary designated facility. If the
transporter is unable to deliver the shipment to either facility on the manifest, the generator must
designate a third facility.
"ON-SITE" TRANSPORTATION
The Part 262 manifesting requirements do not apply to "on-site" transportation of hazardous
waste. "On-site" is defined in §260.10 as:
contiguous property — property that is one continuous plot of land or several plots of
adjoining land
• noncontiguous properties with a private right-of-way under the control of the owner of
the properties
contiguous property divided by a road (public or private) with the property entrance and
exit directly across from each other and perpendicular to the road (crossroads
intersection).
In addition, manifests are not required for shipments of hazardous waste on rights-of-way on or
between contiguous properties, and along the perimeter of contiguous properties controlled by the
same person to facilitate transport of hazardous waste between contiguous sites that must be
accessed by driving along a public road (e.g., university campuses, military bases) (§262.20(f)).
DEPARTMENT OF TRANSPORTATION REQUIREMENTS
DOT requires that generators of hazardous waste subject to manifesting meet several
requirements before transporting or offering hazardous waste for transport off site, including
packaging (§262.30), labeling (§262.31), marking (§262.32), and placarding (§262.33). The
DOT regulations are found in 49 CFR Parts 172 through 179.
2.7 REPORTING AND RECORDKEEPING
Generators have several recordkeeping and reporting responsibilities in Subpart D of Part 262.
These requirements specify the records a generator must keep and the length of time a generator
must retain these records. In addition, SQGs have special requirements identified in §262.44.
The information in this document is not by any means a complete representation of EPA's regulations or policies,
but is an introduction to the topic used for training purposes.
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Generators - 13
REPORTING REQUIREMENTS
LQGs who ship hazardous waste off site to a TSDF, or who treat, store, or dispose of hazardous
waste on site, must submit a Biennial Report (EPA Form 8700-13 A/B) to EPA by March 1 of
each even-numbered year (§262.41). The Biennial Report compiles data collected from off-site
shipments of waste during the previous calendar year. The report includes information such as
the EPA ID number, name, and address of the generator; the EPA ID number of each TSDF in
the United States to which waste was sent during the period (as well as the quantity of hazardous
waste sent); and the manner in which the waste will be treated.
As stated earlier, LQGs and SQGs may also need to submit exception reports pursuant to the
requirements in §262.42. Finally, EPA may require the generator to submit additional reports or
information pursuant to §262.43.
RECORDKEEPING REQUIREMENTS
Under §262.40, the generator must keep a signed copy of the manifest for at least three years
from the date the waste was accepted by the initial transporter. The generator must also retain a
copy of each Biennial Report and Exception Report for a period of three years from the due date
of the report. In addition to these requirements, a generator must keep records of any test results,
waste analyses, or other determinations made in accordance with §262.11 for at least three years.
These time periods are extended automatically during the course of any enforcement action.
2.8 EXPORT AND IMPORT REQUIREMENTS
Part 262 contains several provisions that apply to exporters and importers of hazardous waste.
Part 262, Subpart E, applies to exporters of hazardous waste and is designed to ensure that
hazardous waste is not exported to a foreign country without that country's prior consent. Part
262, Subpart F, contains the regulations that apply to importers of hazardous waste. Part 262,
Subpart H, contains the regulations implementing the Organization for Economic Cooperation
and Development (OECD) Decision Concerning the Control of Transfrontier Movements of
Wastes Destined for Recovery Operations.
EXPORTS
A person who is defined as a primary exporter per §262.51 must follow the requirements
outlined in §§262.50 through 262.58, including specific notification of intent to export (§262.53)
and proper notification as required by the land disposal restrictions program. Exporters must
also ensure that they are in compliance with any applicable international trade agreements.
IMPORTS
Any person who imports hazardous waste is considered the generator of the waste and must
comply with the requirements in Part 262, as well as the special importer regulations in Subpart
F. These special regulations require the importer to use the name and address of the foreign
generator and the importer's name, address, and EPA ID number on the manifest. The
The information in this document is not by any means a complete representation of EPA's regulations or policies,
but is an introduction to the topic used for training purposes.
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14 - Generators
transporter and the U.S. facility arranging for the importation of the waste are both considered
importers; however, the parties must agree on which one of the two will assume the generator
duties.
OECD DECISION
On April 12, 1996, EPA published a final rule establishing regulations to implement the OECD
Decision (61 FR 16289). The OECD Decision requires member countries to establish
regulations for hazardous waste exported to or imported from other member countries for
recycling. As required by the OECD Decision, the regulations establish a graduated system
(green, amber, red) of procedural and substantive controls when wastes move across national
borders within the OECD for recovery (Part 262, Subpart H). Green-listed wastes are subject to
basic controls for international commercial shipments. Amber- and Red-listed wastes require
special notification to the destination and transit OECD member countries and also require extra
information on tracking forms.
On May 21, 2002, OECD published a decision based upon that made revisions to the controls of
transboundary movements of waste destined for recovery operations in order to harmonize
procedures and requirements and to avoid duplicative activities with the Basel Convention.
These revisions were made as a result of texts adopted by the Council at its June 14, 2001, and
February 28, 2002, sessions. As part of these revisions, OECD incorporated the red list into the
green and amber lists. EPA is considering changes to the existing regulations in Part 262,
Subpart H, to address these revisions.
2.9 FARMERS
Part 262, Subpart E, contains a special provision for farmers managing waste pesticides. A
farmer disposing of waste pesticides from his or her own use which are hazardous wastes is not
required to comply with the standards in Part 262 or with the standards in Parts 264, 265, 268, or
270 for those wastes, provided he or she triple rinses the containers in accordance with
§261.7(b)(3), and disposes of the pesticide residue and rinsate on his or her own farm in a
manner consistent with the disposal instructions on the pesticide label. If the label does not
contain disposal instructions, the farmer may not dispose of the pesticide or rinsate on his or her
property and must comply with Subtitle C regulations for disposal (45 FR 12722, 12732;
February 26, 1980).
The information in this document is not by any means a complete representation of EPA's regulations or policies,
but is an introduction to the topic used for training purposes.
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Generators - 15
3. SPECIAL ISSUES
A discussion of several complex generator topics can be found below.
3.1 ACTIVE MANAGEMENT
In some instances, a waste may have been disposed of prior to becoming subject to hazardous
waste regulation (e.g., a waste disposed prior to the effective date of the original Subtitle C
regulations). Regardless of when a waste was generated or when it was disposed, any waste that
exhibits a characteristic of hazardous waste or meets a hazardous waste listing description is a
RCRA Subtitle C hazardous waste; the determining factor is whether the waste is "actively
managed" on or after the date that the waste becomes subject to hazardous waste regulation (57
FR 37194, 37298; August 18, 1992). The term active management means physically disturbing
wastes within a waste management unit or disposing of additional hazardous waste in existing
units containing previously disposed wastes (57 FR 37194, 37298; August 18, 1992). For
example, an F001 waste that was disposed in 1950 became a hazardous waste as of November
19, 1980, the effective date of the F001 listing. However, the waste is not subject to hazardous
waste regulation unless the waste is physically disturbed (e.g., exhumed). Once a person
excavates the waste, he or she is considered the generator since his or her act first caused the
waste to become subject to hazardous waste regulation (refer back to the definition of generator
in §260.10), and is subject to all applicable Part 262 requirements. This also applies to farmers
who exhume waste on their property (See Section 2.9). Note that excavation of contaminated
soil during routine construction operations, such as pipeline installation, may not be considered
active management if the soil is redeposited into the same excavated area. Site-specific
situations should be discussed with the implementing agency.
3.2 CLOSURE STANDARDS
For each accumulation unit, generators must comply with certain disposal and decontamination
requirements once they cease operating these units. These are known as closure requirements.
LQGs must comply with the generic closure requirements in §§265.11 l(a) and (b) and 265.114,
and the unit-specific closure requirements found in Part 265, Subpart I (containers), Subpart J
(tanks), Subpart W (drip pads), and Subpart DD (containment buildings). The closure
requirements include removing and decontaminating all contaminated equipment, structures, and
soil to minimize the need for further maintenance and prevent post-closure escape of hazardous
waste. There are no specific closure requirements for SQGs and CESQGs, except that SQGs are
subject to special requirements for accumulating hazardous waste in tanks, including closure.
The information in this document is not by any means a complete representation of EPA's regulations or policies,
but is an introduction to the topic used for training purposes.
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16 - Generators
3.3 WASTE MINIMIZATION
One of the mandates of RCRA is to reduce or eliminate the generation of hazardous waste as
expeditiously as possible (RCRA §1003(b)). Hazardous waste generators, when preparing a
manifest, are required to certify that they have taken steps to minimize the amount of hazardous
waste that they generate. LQGs must certify that they have "a program in place" to reduce the
volume and toxicity of the hazardous waste they generate; SQGs must certify that they have
made a good faith effort to minimize their waste generation. EPA outlined six basic elements
that should be included in a waste minimization program in the May 28, 1993, Federal Register
(58 FR 31114).
3.4 AIR EMISSION STANDARDS
Generators accumulating hazardous waste in tanks and containers may have to comply with
requirements for controlling hazardous air emissions from these units. With the promulgation of
the Subpart CC air emission standards (59 FR 62896; December 6, 1994) and amendments (61
FR 59932; November 25, 1996; and 62 FR 64636; December 8, 1997; and 64 FR 3382; January
21, 1999), LQGs must comply with all applicable air emission standards in Part 265, Subparts
AA, BB, and CC. These regulations are discussed in detail in the module entitled Air Emissions.
3.5 STANDARDS FOR GENERATORS OF F006 WASTE
In order to promote legitimate recycling of metal-bearing electroplating sludges EPA
promulgated less stringent regulations for generators of F006 waste (65 FR 12378; March 8,
2000). LQGs are allowed to accumulate F006 sludges up to 180 days (270 days if the waste
must be shipped more than 200 miles) without a permit provided that they meet certain
conditions. Specifically, LQGs must:
• recycle the F006 by metals recovery
• implement pollution prevention practices that reduce the amount of hazardous
substances, pollutants and contaminants contained in the F006 waste prior to recycling
• accumulate no more than 20,000 kg of F006 on site at any one time
comply with all of the management standards in §262.34(g).
The information in this document is not by any means a complete representation of EPA's regulations or policies,
but is an introduction to the topic used for training purposes.
-------
Generators - 17
4. REGULATORY DEVELOPMENTS
4.1 REVISIONS TO THE HAZARDOUS WASTE MANIFEST
On March 4, 2005, EPA announced modifications to the Uniform Hazardous Waste Manifest
System (70 FR 10776). The revisions establish new manifest tracking procedures for certain
hazardous waste shipments and revise the manifest and continuation sheet forms (Forms 8700-22
and 22a) used to track hazardous waste from a generator's site to the site of waste disposition.
The revisions announced in the final rule will:
• standardize the content and appearance of the manifest form and continuation sheet
(Forms 8700-22 and 22a)
• make the manifest form available from a greater number of sources
adopt new procedures for tracking certain types of waste shipments with the manifest,
including waste that a destination facility rejects, wastes consisting of residues from non-
empty hazardous waste containers, and wastes entering or leaving the United States.
There will be an 18-month transition to the new form. During this 18-month periods, handler
and states will only use the old form. They will continue to acquire the old forms from the
sources they use now. After September 5, 2006, only the new manifest form and requirements
established under this rule will be valid and acceptable for use.
Handlers will obtain new forms from any source that has registered with EPA to print and
distribute the form. EPA will not distribute forms; rather, the Agency will oversee the printing
requirements and ensure that registered printers follow them. EPA will maintain a list of entities
that have been approved to print/distribute the form, so that the public may acquire the forms
from one of the approved printers. Some large waste firms are expected to register to print their
own forms so that they can use them wherever they do business, instead of having to buy the
manifests from different States, as is the current practice. States may also register to print the
new form, but State rules cannot establish the state as the exclusive source of the forms. A
handler may use a manifest from any registered source.
The proposed revisions to the Uniform Hazardous Waste Manifest System included an option to
complete, send, and store the manifest information electronically (66 FR 28240; May 22, 2001).
However, EPA decided to separate the e-manifest from the form revisions portion of the final
rulemaking. As a result, the March 4, 2005, rule finalizes only the manifest form revisions.
Final action on the e-manifest will be based on the results of continuing analysis and outreach on
several key rulemaking issues that are fundamental to the ultimate decision regarding whether
EPA will adopt the e-manifest.
4.2 BURDEN REDUCTION INITIATIVE
On January 17, 2002, EPA proposed to reduce the recordkeeping and reporting burden imposed
by RCRA on the states, the public, and the regulated community to meet the federal government-
wide goal established by the Paperwork Reduction Act (PRA) (67 FR 2518). The PRA
The information in this document is not by any means a complete representation of EPA's regulations or policies,
but is an introduction to the topic used for training purposes.
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18 - Generators
establishes a federal government-wide goal of reducing burden 40 percent from the total burden
imposed annually on September 30, 1995. If finalized, the Burden Reduction Initiative will
reduce the reporting requirements for generators and TSDFs by eliminating or modifying non-
essential paperwork.
EPA proposes to reduce the self-inspection frequency for hazardous waste tanks from daily to
weekly and to eliminate the RCRA overlap with Occupational Safety and Health Administration
(OSHA) training requirements. Additionally, EPA proposes to change the land disposal
restrictions (LDR) paperwork requirements by eliminating the need for generators to conduct the
waste determination required in §268.7(a)(l) and eliminating the need for treatment and
recycling facilities to send notifications and certifications required in §268.7(b)(6) to EPA,
provided the information is kept in facility records.
4.3 HAZARDOUS WASTE GENERATOR PROGRAM EVALUATION
On April 22, 2004, EPA published an advanced notice of proposed rulemaking (ANPRM)
seeking information from stakeholders to evaluate the effectiveness of the RCRA hazardous
waste generator regulatory program and identify areas for potential improvement (69 FR 21800).
EPA, along with the states, will use the information to determine whether changes to the
hazardous waste generator program are appropriate. If changes are necessary, EPA will develop
and implement a strategy to improve program effectiveness, foster a pollution prevention
stewardship philosophy, and reduce compliance cost where practicable. As part of this effort,
EPA held a series of public meetings in the spring of 2004 to discuss possible changes to the
hazardous waste generator program.
4.4 PERFORMANCE TRACK LARGE QUANTITY GENERATORS
On April 22, 2004, EPA published the National Environmental Performance Track Program final
rule (69 FR 21737). This rule allows large quantity generators (LQGs) who are members of
Performance Track to accumulate hazardous waste on site for up to 180 days, or up to 270 days
in certain cases, without obtaining a RCRA permit or interim status (§262.34(j)). In order to
qualify for the extended accumulation time, the generator must meet the requirements in
§262.34(j), including but not limited to the following :
• notify EPA or the authorized state of their intent to store waste in excess of 90 days
• provide secondary containment for containers accumulating waste
accumulate no more than 30,000 kg of hazardous waste at any one time
• submit an Annual Performance Report.
The information in this document is not by any means a complete representation of EPA's regulations or policies,
but is an introduction to the topic used for training purposes.
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Generators - 19
5. GENERATOR SUMMARY CHART
Quantity Limits
EPA ID Number
On-Site
Accumulation
Quantity
Accumulation Time
Limits
Storage
Requirements
Off-site Management
of Waste
Manifest
Biennial Report
Personnel Training
Contingency Plan
Emergency
Procedures
DOT Transport
Requirements
CESQG
< < 100 kg/month
<< 1 kg/month of acute
hazardous waste
<< 100 kg/month of acute
spill residue or soil
§§261.5(a)and(e)
Not required
§261.5
<< 1,000 kg
< <1 kg acute
< < 100 kg acute spill residue
§§261.5(f)(2)and(g)(2)
None
§261.5
None
§261.5
State approved or RCRA
permitted/interim status facility
§§261.5(f)(3)and(g)(3)
Not required
§261.5
Not required
§261.5
Not required
§261.5
Not required
261.5
Not required
§261.5
Yes
(if required by DOT)
SQG
between 100-1,000 kg/month
§262.34(d)
Required
§262.12
< 6000 kg
§262.34(d)(l)
<1 80 days or
<270 days (if > 200 miles)
§§262.34(d)and(e)
Basic requirements with
technical standards for tanks or
containers
§§262.34(d)(2)and(3)
RCRA permitted/interim status
facility
§262.20(b)
Required
§262.20
Not required
§262.44
Basic training required
§262.34(d)(5)(m)
Basic plan
§262.34(d)(5)(i)
Required
§262.34(d)(5)(iv)
Yes
§§262.30-262.33
LQG
>1 000 kg/month
> 1 kg/month of acute
hazardous waste
> 100 kg/month of acute
spill residue or soil
Part262and§261.5(e)
Required
§262.12
No Limit
<90 days
§262.34(a)
Full compliance for
management of tanks,
containers, drip pads, or
containment buildings
§262.34(a)
RCRA permitted/interim status
facility
§262.20(b)
Required
§262.20
Required
§262.41
Required
§262.34(a)(4)
Full plan required
§262.34(a)(4)
Required
§262.34(a)(4)
Yes
§§262.30-262.33
The information in this document is not by any means a complete representation of EPA's regulations or policies,
but is an introduction to the topic used for training purposes.
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REQUIREMENTS FOR REGULATED HEALTH CARE FACILITIES
The following table presents an overview of the federal RCRA regulatory requirements for hospitals that are either LQGs, SQGs, CESQGs, SQHUWs, or LQHUWs. These
regulations are found in the Code of Federal Regulations (CFR), Title 40; specific part numbers are provided below where regulations apply. As noted, your state might have different
or more stringent requirements.
RCRA REGULATORY REQUIREMENTS BY GENERATOR STATUS
REGULATORY
REQUIREMENT
EPA Identification
Number
LOG SQG CESQG SQHUW LQHUW IMPLEMENTATION EXPLANATION
Hazardous Waste
Identification
Used Oil Standards
Waste Counting
Accumulation Area
Other Accumulation
Areas (Time and
Quantity Limits)
Storage Unit
Requirements
Air Emissions
Preparedness and
Prevention
Contingency Plan
Personnel Training
DOT Packaging
262.12
262.11
279.1
262.11
262.34
262.34
NA
265.171
264
subpart
DD
264
subpart
AA
andBB
264
subpart
C
264
subpart
D
262.34
(iii)
49
CFR
173,
178,
179
262.12
262.11
279.1
262.11
262.34
262.34
(d)
NA
265.171
264
subpart
DD
NA
264
subpart
C
264
subpart
D
262.34
(iii)
262.34
CFR
173,
178,
179
NA
262.11
261 .6(3)
(4) 279
262.11
261.5
NA
261.5
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
273.16
273.52(a)
273.32
NA
NA
NA
NA
NA
NA
NA
NA
273.36
273.52(a)
• Obtain an EPA identification number for each facility within your company. EPA and states use this 12-
character identification number to track hazardous waste activities.
• Obtain an EPA identification number by submitting form 8700-12 (Notification of Regulated Waste
Activity), which is provided by your state hazardous waste agency. This is a one-time notification. Contact
your state regarding the need for renotification if circumstances at your facility change.
• Universal Waste - LQHUW must have sent written notification of universal waste management to the
Regional Administrator, and received an EPA Identification Number, before meeting or exceeding the
5,000 kilogram storage limit.
• Identify whether you generate hazardous waste to determine if you are subject to the RCRA hazardous
waste regulations. Usually, hospitals generate listed hazardous wastes, including P-listed acutely haz-
ardous wastes (such as epinephrine (P042), ethylene oxide (U115), expired Pharmaceuticals, and
chemotherapy drugs (seven are P-listed). See 40 CFR Part 261.33.
• Hospitals may generate used oil from maintenance of fleet vehicles such as ambulances.
• Determine how much hazardous waste you generate to determine your generator status.
• You can accumulate waste in a "satellite accumulation area" with minimal regulatory burden. This area
must be at or near the point of generation and under the control of the operator of the process generating
the waste. For hospitals, separately-located doctors' offices, morgues, dentists' offices, and outpatient
facilities are some examples of satellite areas.
• There is no time limit on accumulation in the satellite accumulation area for waste under 55 gallons.
• There is a 55-gallon accumulation limit in the satellite accumulation area. Excess waste beyond the 55-
gallon limit must be moved from the satellite accumulation area within 3 days.
• You must accumulate the waste in containers.
• Waste containers must be marked with the words "Hazardous Waste" or other words that identify their
contents.
• This waste is exempt from other accumulation provisions while in the satellite accumulation area.
• If waste accumulation does not meet the requirements for satellite accumulation, it is subject to more
stringent requirements. LQGs can accumulate waste on site for up to 90 days without a permit. SQGs
can accumulate waste for 180 days, or 270 days if the SQG must transport the waste more than 200
miles to a destination facility.
• Begin counting accumulation time when waste is first placed in the accumulation unit.
• Waste must be put in an exempt unit, recycled, or sent off site within the proper time period stated above.
• If an LQG accumulates wastes beyond the allotted time period, the facility is fully subject to the require-
ments of a hazardous waste storage facility unless granted an exemption. SQGs cannot accumulate
more than 6,000 kg of hazardous waste at any time.
• CESQGs cannot accumulate more than 1,000 kg of hazardous waste, more than 1 kg of acutely haz-
ardous waste, or 100 kg of spill residue from acutely hazardous waste at any time.
• Universal Waste - SQHUWs and LQHUWs may accumulate universal waste for no longer than one year
from the date the universal waste is generated, or received from another handler.
• Accumulate waste only in units that are in good condition, remain closed except when adding or remov-
ing waste, are inspected at least weekly, are compatible with the types of waste, and meet special stan-
dards for ignitable waste and incompatible waste.
• LQGs can use accumulation tanks and containers that have been assessed for integrity, have a second-
ary containment system, and are inspected each operating day. SQGs can use certain accumulation
tanks as well.
• LQGs can use containment buildings as well.
• For all units, the date that the accumulation period begins must be clearly marked and visible on each
container. All containers and tanks must be clearly marked or labeled with the words "Hazardous Waste"
and accumulation units must be shut down and closed permanently in accordance with standards at the
end of the unit life.
• LQGs and SQGs can treat their waste without a RCRA storage permit in accumulation units that meet
standards.
• LQGs must comply with air emissions requirements. Hospitals with incinerators must comply with Clean
Air Act requirements for Hospital/Medical/lnfectious Waste Incinerators.
• LQGs and SQGs must comply with preparedness and prevention requirements, including the following.
—An adequate internal alarm or communications system.
—A device capable of summoning emergency personnel.
— Portable fire control equipment.
—Adequate water pressure to operate fire control systems
—Adequate testing and maintenance of all emergency systems.
—Access to communication or alarm systems during waste handling activities.
—Adequate aisle space for emergency response.
—An arrangement with local emergency response authorities.
• LQG facilities must prepare a facility contingency plan in accordance with regulations.
• The contingency plan must be designed to minimize hazards from fires, explosions, or any unplanned
release of hazardous waste or constituents.
• A copy of the contingency plan must be kept on site and an additional copy must be submitted to all local
emergency services providers.
• LQGs and SQGs must have an emergency coordinator on site or on call at all times to respond to emer-
gencies.
• Emergency response information must be posted next to the telephone.
• In the event of a fire, explosion, or release that could threaten human health outside the facility or when a
spill has reached surface water, the emergency coordinator must notify the National Response Center at
800 424-8802.
• LQGs must have a personnel training program in accordance with regulatory standards.
— Training must instruct facility personnel about hazardous waste management procedures and emer-
gency response.
— Training must be completed within 6 months from the applicability of requirements.
— The facility must undertake an annual review of initial training.
• SQGs must ensure that all employees are thoroughly familiar with proper waste handling and emergency
procedures relevant to their responsibilities.
• Universal Waste - SQHUW must inform all employees who handle UW of the proper handling and emer-
gency procedures appropriate to the type(s) of universal waste. LQHUWs must ensure that all employees
are thoroughly familiar with proper waste handling and emergency procedures.
• Before being transported, waste must be packaged, labeled, and marked in accordance with applicable
DOT requirements. Call the DOT hazardous materials information line at 202 366-4488 for more informa-
tion.
• Universal Waste - All UW handlers must comply with all applicable U.S. Department of Transportation
regulations in 49 CFR part 171 to 180.
(Continued)
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REQUIREMENTS FOR REGULATED HEALTH CARE FACILITIES (CONTINUEL
RCRA REGULATORY REQUIREMENTS BY GENERATOR STATUS
REGULATO
REQUIREM
Offsite Management
of Waste
Onsite Management
of Waste
Manifest
Land Disposal
Restrictions
Notification
Hazardous Waste
Minimization
Biennial Report
Recordkeeping
SQG CESQG SQHUW LQHUW IMPLEMENTATION EXPLANATION
262.30-
262.20-
262.20
262.42
(RCRA
Sec.10
03[b],
1984)
262.40
262.41
262.40
262.30-
262.20
(e)
262.23
RCRA
Sec.10
03[b],
1984)
NA
262.40
NA
261 .5(2)
NA
NA
NA
NA
NA
273.55
273.13
NA
NA
NA
NA
NA
273.55
273.33
NA
NA
NA
NA
NA
• Hazardous waste sent off site for handling may only be sent to a hazardous waste TSDF or recycling
facility unless otherwise exempt.
• CESQGs - See Onsite Management of Waste below.
• Universal Waste - Universal waste transporters are prohibited from transporting the universal waste to a
place other than a universal waste handler, a destination facility, or a foreign destination.
• CESQGs may either treat waste on site, if it qualifies as one of the following types of facilities, or ensure
delivery of waste to one of the following types of facilities: 1) permitted RCRA TSDF; 2) interim status
TSDF; 3) facility authorized to handle hazardous waste by a state with an approved hazardous waste
program; 4) facility permitted, licensed, or registered by state to handle municipal solid waste according to
standards; 5) facility permitted, licensed, or registered by state to handle non-municipal waste in accor-
dance with standards; 6) facility that beneficially uses or reuses, or legitimately recycles or reclaims its
waste; 7) facility that treats its waste prior to beneficial use, reuse, or legitimate recycling or reclamation;
or 8) a universal waste handler in accordance with standards.
• Hazardous waste sent off site must be accompanied by a manifest, a multipage form that documents the
waste's progress through treatment, storage, and disposal. It can be obtained from your state agency.
• The manifest must have enough copies to provide the generator, each transporter, and the destination
facility with one copy for their records and a second copy to be returned to the generator after completion
by the destination facility operator.
• SQGs that have a contractual agreement with a waste reclaimer that specifies the types and frequencies
of shipments do not need to manifest the wastes if they retain a copy of the agreement in their files.
• Your waste must meet certain treatment standards under the LDR program. Waste must be treated to
reduce the hazardous constituents to levels set by EPA or the waste must be treated using a specified
technology. All waste sent off site for treatment, storage, and disposal must be accompanied by appropri-
ate LDR program notifications and certifications. There are no required forms, but these papers must indi-
cate whether or not wastes meet treatment standards or whether the waste is excluded from the defini-
tion of hazardous or solid waste, or is otherwise exempt.
• To encourage generators to produce less hazardous waste, LQGs are required to have a program in
place to reduce the volume and toxicity of waste generated to the degree economically practicable, and
must select a currently available treatment, storage, or disposal method that minimizes present and
future threats.
• LQGs and SQGs must sign a certification of hazardous waste minimization on the manifest.
• SQGs must make a good faith effort to minimize waste generation and to select the best available waste
management method that they can afford.
• LQGs must submit biennial reports of waste generation and management activity by March 1of every
even-numbered year. EPA, other agencies, and the public use this information to track trends in haz-
ardous waste management.
• LQGs must maintain personnel training records until the facility closes.
• LQGs must keep copies of each biennial report for 3 years.
• LQGs and SQGs must keep a copy of each manifest for 3 years.
• LQGs and SQGs must keep records of test results, waste analyses, and other hazardous waste determi-
nations for 3 years.
An overview of the federal RCRA regulatory requirements
for hospitals that are either LQGs, SQGs, CESQGs,
SQHUWs, or LQHUWs.
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REQUIREMENTS FOR REGULATED HEALTH CARE FACILITIES (CONTINUE]
RCRA REGULATORY REQUIREMENTS BY GENERATOR STATUS
REGULATO
REQUIREM
Offsite Management
of Waste
Onsite Management
of Waste
Manifest
Land Disposal
Restrictions
Notification
Hazardous Waste
Minimization
Biennial Report
Recordkeeping
SQG CESQG SQHUW LQHUW IMPLEMENTATION EXPLANATION
262.30-
262.33
262.20-
262.20
262.42
(RCRA
Sec.10
03[b],
1984)
262.40
262.41
262.30-
262.33
262.20
(e)
262.23
RCRA
Sec.10
03[b],
1984)
NA
NA
261.5(2)
NA
NA
NA
NA
NA
273.55
NA
NA
NA
NA
NA
273.55
NA
NA
NA
NA
NA
• Hazardous waste sent off site for handling may only be sent to a hazardous waste TSDF or recycling
facility unless otherwise exempt.
• CESQGs - See Onsite Management of Waste below.
• Universal Waste - Universal waste transporters are prohibited from transporting the universal waste to a
place other than a universal waste handler, a destination facility, or a foreign destination.
• CESQGs may either treat waste on site, if it qualifies as one of the following types of facilities, or ensure
delivery of waste to one of the following types of facilities: 1) permitted RCRA TSDF; 2) interim status
TSDF; 3) facility authorized to handle hazardous waste by a state with an approved hazardous waste
program; 4) facility permitted, licensed, or registered by state to handle municipal solid waste according to
standards; 5) facility permitted, licensed, or registered by state to handle non-municipal waste in accor-
dance with standards; 6) facility that beneficially uses or reuses, or legitimately recycles or reclaims its
waste; 7) facility that treats its waste prior to beneficial use, reuse, or legitimate recycling or reclamation;
or 8) a universal waste handler in accordance with standards.
• Hazardous waste sent off site must be accompanied by a manifest, a multipage form that documents the
waste's progress through treatment, storage, and disposal. It can be obtained from your state agency.
• The manifest must have enough copies to provide the generator, each transporter, and the destination
facility with one copy for their records and a second copy to be returned to the generator after completion
by the destination facility operator.
• SQGs that have a contractual agreement with a waste reclaimer that specifies the types and frequencies
of shipments do not need to manifest the wastes if they retain a copy of the agreement in their files.
• Your waste must meet certain treatment standards under the LDR program. Waste must be treated to
reduce the hazardous constituents to levels set by EPA or the waste must be treated using a specified
technology. All waste sent off site for treatment, storage, and disposal must be accompanied by appropri-
ate LDR program notifications and certifications. There are no required forms, but these papers must indi-
cate whether or not wastes meet treatment standards or whether the waste is excluded from the defini-
tion of hazardous or solid waste, or is otherwise exempt.
• To encourage generators to produce less hazardous waste, LQGs are required to have a program in
place to reduce the volume and toxicity of waste generated to the degree economically practicable, and
must select a currently available treatment, storage, or disposal method that minimizes present and future
threats.
• LQGs and SQGs must sign a certification of hazardous waste minimization on the manifest.
• SQGs must make a good faith effort to minimize waste generation and to select the best available waste
management method that they can afford.
• LQGs must submit biennial reports of waste generation and management activity by March 1of every
even-numbered year. EPA, other agencies, and the public use this information to track trends in haz-
ardous waste management.
• LQGs must maintain personnel training records until the facility closes.
• LQGs must keep copies of each biennial report for 3 years.
• LQGs and SQGs must keep a copy of each manifest for 3 years.
• LQGs and SQGs must keep records of test results, waste analyses, and other hazardous waste determi-
nations for 3 years.
HEALTH CARE FACILITIES
7
••Mi
LH overview of the federal RCRA regulatory requirements
for hospitals that are either LQGs, SQGs, CESQGs,
SQHUWs, or LQHUW"
-------
about \^/
Aehncftfic
^nWPBP^Sl^PWyP^P
F Spring, 2001
Asbestos-Containing Materials in Schools
Congress passed the Asbestos Hazard Emergency Response Act (AHERA) in 1986 to
protect school children and school employees from exposure to asbestos in school
buildings. If asbestos fibers are inhaled, they can lead to health problems such as
cancer and asbestosis; it may be 20 years or more before symptoms appear. Failure to
comply with AHERA regulations can result in penalties of up to $5,500 per day, per
school.
Asbestos is used extensively in building materials
because of its insulating, sound absorbing, and
fire retarding capabilities. Intact and undisturbed
asbestos materials generally do not pose a health
risk. The mere presence of asbestos in a school
does not mean that the health of its occupants is
endangered. However, when asbestos-containing
materials release fibers due to damage or
deterioration over time, they become hazardous.
What Buildings Are Covered Under AHERA?
Any elementary or secondary school building
owned or leased by a local education agency
(public school district, charter school, or private,
non-profit school) must follow requirements under
AHERA.
What Is Required Under AHERA?
• Maintain updated management plans that
address asbestos hazards and potential
hazards
• Maintain management plans and subsequent
response actions on record
• Make management plans available to the public
upon request
• Disseminate annual notifications of asbestos-
related activities
• Ensure that only AHERA-accredited personnel
perform inspections, develop management
plans, and conduct response actions
• Ensure that an AHERA-accredited professional
conducts a reinspection every three years
How Does One Become Accredited Under
AHERA?
AHERA accreditation courses are offered by
course providers who have been approved either
by the EPA or the appropriate state agency. A list
of these approved course providers is available on
the web site listed below or by calling the number
listed below.
What Can You Do To Help?
As a superintendent or maintenance director, the
most important thing you can do is to learn about
your school's asbestos management plan. By
becoming familiar with this plan, you will know if
asbestos materials are in your school, what plans
exist for managing the asbestos, and when these
activities are scheduled to occur.
More Questions?
Additional information is available at:
www.epa.gov/r1 Dearth/asbestos, htm
Or contact Al Wasse at 2p6-553-1417
or the Asbestos Ombudsman Hotline at 1-800-368-5888.
-------
about
Indoor Air Quality
Spring, 2001
Indoor Air Quality in Your School
Poor indoor air quality (IAQ) has been shown to be a leading cause of asthma and other
respiratory problems in both children and adults. Asthma attacks alone account for
over 10 million missed schools days a year, nationwide. A lack of attention to IAQ can
also accelerate deterioration and reduce efficiency of heating/cooling equipment, strain
relationships between school administrators, parents, and staff, and lead to liability
issues.
What steps can you take right now to improve
Indoor Air Quality in your school?
• Obtain a copy of the IAQ Tools for Schools Action Kit
and videos (info below)
• Ensure that an adequate amount of outdoor air is
being supplied to classrooms and offices
• Test for radon
• Reduce use of products that require ventilation e.g.,
adhesives, floor-care products, pesticides, art
supples, and other chemicals
• Maintain relative humidity at a level below 60%
indoors
• Clean up mold and control moisture and leaks
• Control other possible asthma triggers, including
animals, pests, and dust mites
How can EPA help you improve the Indoor
Air Quality in your school?
EPA's "IAQ Tools for Schools" program works with
school staff to:
• Resolve existing IAQ problems and prevent new
ones
• Identify practical, low cost solutions to fixing IAQ
problems.
Participation in the program is FREE!
How much will it cost to improve IAQ in your
school?
The majority of the activities promoted in the Tools for
Schools program have been designed to be either low
cost or no cost. While some fixes, such as major leaks
or problems with ventilation systems can be more
expensive to repair, school districts make their own
decisions about which course of action to follow after
discovering a problem.
Do schools have to follow this guidance?
The guidance is voluntary, and can be followed or
modified, depending on your school's needs. EPA does
not regulate general indoor air quality in schools.
How can You get an IAQ Tools for Schools
Kit and Video?
The IAQ Tools for Schools Kit, IAQ Problem Solving
Wheels, and "Taking Action" and "Ventilation Basics"
videos are available free of charge and can be obtained
by calling the IAQ Information Clearinghouse at 1-800-
438-4318.
The entire Kit (except for the videos and the IAQ
Problem Solving Wheel) can be downloaded in PDF or
HTML from EPA's website at
www.epa.gov/iaq/schools
More Questions?
For general information on Indoor Air Quality,
call EPA's IAQ INFO Hotline at
(800)438-4318.
For information on receiving technical assistance in implementing the
Tools for Schools program in your school, call
Ann Wawrukiewicz at 206-553-2589 or toll free at 1-800-424-4372 x2589.
-------
LEAD
Spring, 2001
Schools and Lead-Based Paint Activities
Children Run Better Unleaded
During renovation projects, chips and dust from lead-based paint can create a health
hazard. Lead exposure can be dangerous, especially to children under 6 years old.
Even a low level of lead exposure can cause learning disabilities and other serious
health effects. To protect people from exposure to lead in paint, dust, and soil,
Congress passed the Residential Lead-Based Paint Hazard Reduction Act of 1992, also
known as Title X. Under Title X, EPA developed a rule to ensure that contractors who
inspect, assess, or remove lead-based paint are well qualified, trained and certified to
conduct these activities.
What Do Schools Need to Do?
School administrators and maintenance staff need
to determine if their renovation project requires
certified contractors. If so, they need to ensure
that their contractors are certified for lead work
and that appropriate work practice standards are
followed. Hire a certified professional for a safer
school.
When Is Certification Required?
Training and certification are required for
contractors who do lead-based paint inspection,
risk assessment, and abatement in kindergarten
classrooms, day-care centers, and preschools.
What Buildings Are Covered?
Contractors doing lead inspection, risk
assessment and abatement work in "child-
occupied facilities" are required to obtain training,
receive certification and follow work practice
standards. A child-occupied facility is a
building, or a portion of a building,
constructed prior to 1978, that is visited
regularly by the same child, under the age of
six. Such facilities include kindergarten
classrooms, day-care centers, and preschools.
What Are Work Practice Standards?
Work practice standards ensure that lead-based
paint activities are conducted safely, reliably and
effectively. The following is an example of a
restricted work practice during an abatement:
"Machine sanding or grinding or abrasive blasting
or sandblasting of lead-based paint is prohibited
unless used with High Efficiency Paniculate Air
exhaust control." Clearance testing is required
after abatement projects. Dust wipe samples, for
example, assure occupants that lead dust hazards
have been removed.
More Questions?
Information on lead certification and on lead and children is available at
www.epa.gov/r10earth/lead.htm or by calling the
National Lead Information Center at 1-800-424-5323.
For more information, contact Bob Kirkland at 1-800-424-4372 or at (206) 553-8282.
-------
^
- . -.. ^ 1 "
«||j\ 000 W* V
P PCBs
Spring, 2001
Managing PCB-Containing Wastes in
Your School District
Prior to 1979, PCBs (polychlorinated biphenyls) were widely used in electrical
equipment such as fluorescent light ballasts, transformers, and capacitors. Although
PCBs are no longer used in manufacturing, there are still millions of pieces of
equipment in operation that contain PCBs. When not handled and disposed of properly,
PCBs can be harmful to children and adults. In addition, failure to follow the laws for
managing PCB-containing wastes can result in federal penalties, which can cost your
school district thousands of dollars.
How Do I Know If It Contains PCBs?
The type of PCB-containing waste you are most likely to
find in your school district are fluorescent light ballasts.
Almost all fluorescent light fixtures made before July
1979 have an electrical component, known as a ballast,
that contains small amounts of highly concentrated
PCBs. Sometimes the ballast has the date of
manufacture on it, and sometimes it is marked "No
PCBs" by the manufacturer. If the light fixture has no
manufacture date and is not marked "No PCBs,"
assume that the ballast contains PCBs.
What Should I Do If A Ballast Is Leaking?
When ballasts fail, PCBs can leak out. It is important to
routinely check your light fixtures to see what condition
the ballasts are in. Since PCBs can be easily absorbed
through your skin, be sure to protect yourself while
inspecting light fixtures by wearing rubber gloves and
goggles to protect your eyes. If you find a leaking
ballast, replace it immediately and dispose of it properly.
How Do I Dispose Of Ballasts Properly?
Leaking ballasts that contain PCBs must be securely
packaged in a container approved for PCB disposal.
The container must be marked "Contains PCBs" and
have an accompanying manifest to track its disposal.
The package must be shipped by an authorized PCB
transporter to a licensed PCB disposal facility. Check in
the yellow pages under "Environmental Consultants" for
a listing of licensed transporters and disposal facilities.
The Toxic Substances and Control Act (TSCA) and the
federal PCB regulations (40 CFR Part 761) describe the
legal requirements for use, storage, and disposal that
apply to light ballasts and other PCB-containing wastes.
The regulations can be found at the EPA website listed
below.
More Questions?
In addition to fluorescent light ballasts, there are other wastes you may handle that contain PCBs, such as
electrical transformers and capacitors, and some waste oils. For more information about managing
PCB-containing wastes, visit EPA's website at
www.epa.gov/r1 Oearth/pcb.htm
If you have questions or concerns, you can call EPA's PCB staff:
Daniel Duncan at 206-553-6693
Ray Nye at 206-553-4226
Bernie Pribish at 206-553-5293
Or call toll-free at 1-800-424-4372
-------
I I
^_ ^_ ^_ ^dwrtS^
icides
Spring, 2001
Integrated Pest Management in Schools
Failure to manage pests and/or the inappropriate use of pesticides can lead to adverse
health problems including allergic reactions, asthma exacerbation, and increased risk
of cancer and neurological damage in children.
What is Integrated Pest Management (1PM) ? What is the role of EPA ?
Integrated Pest Management is a holistic
approach to pest control. It is a decision making
process that begins with identifying the pest,
examining conditions of the site and possible
causes of pest buildup, identifying ways to
manage the pest (such as improving plant health
or excluding pests) and finally, selecting the best
option for the site. Pesticides are often not
needed or are used as a last resort. When
pesticides are needed, the least toxic pesticide is
selected and carefully applied to prevent negative
impact on children or the environment.
Why is 1PM good for schools and kids?
• IPM focuses on growing healthy plants and
maintaining healthy environments.
• IPM reduces exposure to the adverse effects of
both pests and pesticides.
• IPM can provide valuable job training for
students, when they are involved in the
process.
• IPM often results in cost savings over the long
term.
• To ensure that school personnel understand and
follow national laws regulating pesticides use.
• To provide short term funding support for IPM
demonstration projects or educational
materials.
• To provide information, training, and technical
assistance to schools interested in IPM.
• To facilitate pesticide applicator training and
recertification programs.
What resources are available from EPA for
an IPM Program in my school?
EPA's voluntary IPM in Schools Program offers
technical assistance and limited grant funding for
demonstration IPM projects. "IPM for Schools: A
How-To Manual" and "Pest Control and School
Environment: Adopting IPM" are available from the
EPA Public Environmental Resource Center, 206-
553-1200*. Additional publications, videos, training
materials, and slides on IPM in Schools are also
available through EPA and are listed on the
webpage below.
More Questions?
Information on pest management certification and on pesticides and children is available at
www.epa.gov/pesticides or by calling 1-800-424-5323.
For more information on resources or on starting an IPM program at your school,
contact Donald Priest at priest.donald@epa.gov. (206) 553-2584*.
For technical information on pests,
contact Sharon Collman at collman.sharon@epa.gov or 206-552-2876*.
*Outside of the (206) area code, dial toll free at: 1-800-424-4EPA (4372)
-------
about
Grants &
Resources
What Funding Sources Exist?
Spring, 2001
What Federal Funding is Available?
EPA Environmental Education grants are available on
an annual basis. Projects of $25,000 and under are
awarded at the regional level under seven funding
priorities, including: "Health: Educating teachers,
students, parents, community leaders, or the public about
human-health threats from environmental pollution,
especially as it affects children..." A call for proposals is
distributed annually in mid to late August.
Contact:
Sally Hanft, Environmental Education Grants
Coordinator: (206)553-1207
hanft.sally ©epa.gov
Or visit: www.epa.gov/r10earth
and choose "education" from the navigation bar.
EPA EnvironmentalJustice grants are available on an
annual basis. Small grants of $15,000 and under are
awarded under many environmental statutes including the
TSCA (hazardous waste), FIFRA (pesticides), the Clean
Air Act, and the Clean Water Act. This program lists as a
focus area "Projects which address public health concerns
and issues in minority/low-income communities."
For more information, contact:
Victoria Plata, Environmental Justice Grants
Coordinator: (206)553-8580
plata.victoria@epa.gov
or visit: http://es.epa.gov/oeca/oej/grlink1 .html
EPA Pollution Prevention grants are awarded in
amounts up to $75,000 under one of four funding priorities
including, "Helping Small Businesses and Institutions
Prevent Pollution in Communities".
For more information:
Call: (703)841-0483
or visit: http://www.epa.gov/opptintr/ejp2/ejp2_2001 .pdf
U.S. Department of Education has announced 1.2 billion
dollars for urgent school health and safety repairs to be
made available through state governments.
Contact your State Department of Education.
What Other
Potential Funding Sources Exist*?
Community Toolbox for Children's Environmental
Health offers grants of up to $40,000 to non-profit
community-based organizations. PTA organizations are
eligible, among others.
Contact:
Janna Rolland at (206)706-6490
toolbox @ teleport.com
Or visit www.communitytoolbox.org
Clarence E. Heller Charitable Foundation has funded
environmental health projects of up to $600,000 "To
prevent serious risk to human health from toxic
substances and other environmental hazards..."
Inquire at:
(415)989-9839 info@cehcf.org
Or visit: www.cehcf.org
Public Welfare Foundation funds environmental projects
aimed at protecting human health. Average grant award is
$42,000.
Inquire at: (202)965-1800
Info at: www.publicwelfare.org/funding/index.html
W.Alton Jones Foundation funds projects aimed at
protecting children's health.
Inquire at:
W. Alton Jones Foundation / 232 East High Street /
Charlottesville, Virginia 22902-5718
(804)295-2134 or sustainable@wajones.org
Or visit:
www.wajones.org/programs/sustainable/goals/
childhealth.htm
North American Commission for Environmental
Cooperation (NACEC) funds projects that relate to
children's health and the environment.
Call: (541)350-4300
Or visit: www.cec.org
Healthy Schools
Network
Helpful Organizations and Web Resources.
Children's
Environmental Health Network
EPA's Office of
Children's Health
www.healthyschools.org
www.cehn.org
www.epa.gov/children/index.htm
*Disclaimer: This information is provided for your convenience. The EPA does not endorse any private sector
organization, product, or service nor does it exercise any control over the information they distribute.
-------
federal
Electronics
lectron ics
p One Byte @ A Time
Monthly FEC Partner Call:
How to Purchase Environmentally
Preferable Electronic Products & Services
February 3,2005
ff
^
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v ™^*JX
-------
AGENDA
February 3,2005
Part 1: Environmentally Preferable
Purchasing 101
Part 2: Steps and tools to build
environmental factors in purchasing
decisions
Part 3: Guest Speakers ~ "Greening
Interior's Electronics Purchase"
-------
PART 1:
ENVIRONMENTAL
PURCHASING 101
-------
WHAT IS ENVIRONMENTAL
PURCHASING?
/Y/V
-------
WHAT IS ENVIRONMENTAL
PURCHASING?
Buying products that
have/are:
- Recycled content
- Energy efficient
- Less packaging
- Upgradeable
- Recyclable
Buying Products that
do not have/are not:
- Heavy metals
- Carcinogens
- Ozone Depleting
Chemicals
- Toxics
Choosing to NOT BUY!
-------
GREENING PROCUREMENT
INVOLVES: a OF 2)
Gathering information about "green" products
and EOL services
Structuring evaluation criteria that reflect
"green"
Requiring green aspects in purchases which
can facilitate EOL management
•For example, requiring vendor take-back can minimize
volume and toxicity of used equipment to manage
-------
GREENING PROCUREMENT
INVOLVES: (2 OF 2)
Ensuring "green" clauses are implemented by
vendors in the post-award phase
Selecting and overseeing recyclers and waste
haulers who can manage electronics in a
responsible manner after they leave the federal
sector.
-------
HOWEVER
Procurement staff cannot and will not bear all of the
responsibility for making EPP happen
- They are enablers, not sole actors
The "need" for environmentally preferable products and
services should originate from the requestors:
- Program Managers
- IT Managers
- Property managers
- End-users
Ensure responsibility is shared across professional disciplines
from beginning to end
-------
Questions?
i) Federal
Electronics
A Timi
-------
WHY BUY GREEN?
Statutory and Executive Order requirements
Reduce Liability
Achieve Cost Savings
Help drive the marketplace towards greener
electronics
Help achieve FEC Goals
It's the right thing to do!
-------
WHY BUY GREEN?
IT'S REQUIRED
Statutory and Executive Order Requirements
- Pollution Prevention Act
- Energy Policy Act
- Resource Conservation and Recovery Act Section 6002
- Farm Bill Section 9002
- Greening the Government Executive Orders
• Executive Order 13101, "Greening the Government Through Waste Prevention,
Recycling, and Federal Acquisition"
• Executive Order 13123, "Greening the Government Through Energy Efficient
Management"
• Executive Order 13221, "Energy Efficient Standby Power Devices"
• Executive Order 13148, "Greening the Government Through Leadership in
Environmental Management"
For additional details, see:
httD://www.federalelectronicschallenge.net/Tools/fec regs.odf
FAR Requirements
For additional details, see:
httD://www.federalelectronicschallenge.net/Tools/farDrov.Ddf
-------
WHY BUY GREEN PRODUCTS?
Reduce Liability of Electronics
> Electronic equipment can
contain hazardous and toxic
substances such as lead,
mercury, chromium, and
cadmium.
Electronics designated as a
hazardous waste under
RCRA.
Federal agencies can purchase
electronics that minimize use of these
hazardous substances
-------
WHY BUY GREEN SERVICES?
Reduce Liability of Electronics
Liability exposure results from improper disposal
and recycling practices. ("The Six O'Clock
News" factor.)
- US Department of Health and Human Services (Boston,
MA Office) received Notice Of Violation for improper
disposal of electronic equipment:
• Threatened with a $27,500 penalty per violation (they had 7) if
the alleged violations were not corrected; they corrected the
problem and were not fined.
Federal agencies can purchase services of recyclers
who manage electronics in a responsible manner
-------
WHY BUY GREEN?
Achieve Cost Savings
Federal, state, and local governments could save at
least $139 million annually if they purchase and
enable ENERGY STAR labeled products.
= preventing over 4.1 million metric tons of carbon by the
year 2010
= lighting more than 17.7 million homes per year
One office of DOE purchased and activated Energy
Star features in 312 monitors and saved
$5300/year.
• Projected savings of $120,000/year if implemented
across all of US DOE
-------
WHY BUY GREEN?
WE CAN DRIVE THE
MARKETPLACE
"The large scale, systematic approach that
most institutions take in their purchasing
can have large ripple effects on which
products are used by hundreds or even
thousands of individuals."
Purchasing Power: Harnessing Institutional Procurement
for People and the Planet, Worldwatch Institute, 2003
-------
WHY BUY GREEN?
EXERCISE YOUR SPHERE OF
INFLUENCE
PLAYERS
- R&D/Designers
0
- Manufacturers
- Retailers
- Purchasers
- End Users
- End-of-life managers
Send clear market signals of
agencies' preference for
environmentally preferable
electronic equipment
-------
WHY BUY GREEN?
HELP ACHIEVE FEC GOALS
Goal of FEC: Achieve cost-effective, environmentally
responsible electronics management
Specifically that by 2008,
• 100% of units purchased will include multiple
environmental attributes. (A/P)
• 100% of units purchased will have an average life span
of 4 years or greater. (A/P)
• Energy Star features will be enabled on 95% of units.
(O/M)
• 100% of non-reusable units are recycled using
Environmentally Sound Management. (EOL)
Acquisition and procurement plays a crucial role in
realizing all of our goals.
-------
WHY BUY GREEN?
-------
AND WHAT GOOD REASONS
•
-------
Questions?
i) Federal
Electronics
A Timi
-------
PART 2: RESOURCES TO
HELP YOU BUY GREEN
-------
HOW ARE FEDS CURRENTLY
BUYING ELECTRONIC PRODUCTS?
• GSA Schedule 70
• Government-wide Acquisition Contracts (GWACs) (e.g.,
NASA SEWP, NIH ICS, DOC's COMMITS)^
• Individual department and/or agencywide contracts
equipment through:
- Retail/Open Market
- Small Business Set-Asides
• Decentralized contracts with an Agency/department
Some agencies purchase while others lease their equipment
-------
HOW DO YOU DETERMINE
IF IT'S "GREEN"?
" Green" based on:
- Government standards or guides (e.g., Energy Star)
- Third Party standards (e.g., TCO, Canada's
Environmental Choice, ECMA)
- Vendor claims about its products or practices
- Organization-unique standards
How these criteria are manifested:
- Approved supplier lists
- Approved product lists
- Solicitations that reflect existing or organization-
specific standards (DOI, Western States Contracting
Alliance, Massachusetts, Denver, Seattle)
-------
THIRD PARTY (ECO-LABEL)
PROGRAMS
Ener
y Star - Energy rating system.
TCP - Swedish labeling system for electronics.
Nordic Swan - Eco-label for electronics and other
products.
EMCA -self-evaluated industry standard for
electronics.
EPEAT - U.S. based project to develop an electronics
environmental evaluation system (under
development).
-------
TOOL: FACT SHEET ON ECO-LABELS
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-1c« Ut" pJkf IITUIOV >K m 5 ^lU^ilktJ jtlird pi-ff-V tttd tUL^ll ui! ! il-i t',
' rlu trr
L nkiMUAiicK. siics: i-ji i j uaijistail Ubeltaij pi»>jcrdiu Ittrcit* lit I LM±d Slil^r. M~J IAC L^JI ;.».'k li.w jriis
J.cnuid ^ur^qv. jitj *.i|^ia r-if cxnni|ik« r.i L^c-litn^L. ,dxl llii; ^
httD://www.federalelectronicschallenge.net/Tools/ecolabel.Ddf
-------
ELECTRONIC PRODUCTS
ENVIRONMENTAtASSESSMENT TOOL
(EPEATK
• An environmental procurement tool designed to
help institutional purchasers to evaluate, compare,
and select desktop computers, laptops, and
monitors based on their environmental
performance
• Draft criteria agreed upon by multi-stakeholder
group representing purchasers, manufacturers,
trade associations, recyclers, environmental
advocacy groups, academia
-------
ELECTRONIC PRODUCTS
ENVIRONMENTAL ASSESSMENT
TOOL\
(EPEAT)N
Criteria cover energy conservatio
materials selection, environmentall1
•* •
sensitive materials, design for end of life,
product longevity/life cycle extension, end
of life management, corporate performance,
and packaging
Feb 2005 - Draft criteria available
Early 2006 - Final criteria and verification
of vendor self declarations available
-------
INTEGRATE ENVIRONMENTAL FACTORS
INTO ALL PHASES OF ACQUISITION (1 of 2)
Acquisition plannim
- Include key staff at beginning of process
- Do you need the new equipment?
- Can you reuse (all or part of) existing equipment?
- Can you plan for extended life?
- Are there smaller, less toxic, less energy consuming options?
- Use the Acquisition/Procurement Checklist
Market Research
- Include questions about environmental aspects of electronics.
- Use the Product Environmental Information Sheet!
Solicitation Development
- Structure RFP to include environmental factors.
- Give sufficient weight to environmental factors.
- Include environmental experts when deciding what
environmental factors to include in selection criteria
-------
INTEGRATE ENVIRONMENTAL FACTORS
INTO ALL PHASES OF ACQUISITION (2 of 2)
Proposal Evaluation
- Include environmental experts on evaluation team.
Contract Award
- Award based on pre-defined criteria that included
environmental considerations.
- Communicate to all bidders importance of environmental
factors in the award of contract.
Contract Administration/Oversight
- Ensure environmental clauses are being followed by vendors.
- Obtain sales figures of products meeting specified
environmental criteria from vendors.
Remember, your green purchasing & environmental experts
can help you throughout these acquisition steps
-------
TOOL: ACQUISITION &
PROCUREMENT CHECKLISTS
ftcquielton Planning • Procurement
Checklist
(3o1d Partner
Afbon
HVbtHMW
VE4ds Assessment
li,'.. :il.lip_lH Lciiil::. jn :«I;^LI|I_ i
VFSorW mike 1
lis
I Mhcr'-*
uS" UDU
Jltil; CUTTCnL tj-.1%c >.V [.uriAlAJi'tAt; 'If
I ' 11 N" I CoDlncI i i-iHiL'c
information Qattierfng I MaiKet Survey
X&KUSI. -i«li «uuin; 0f»ipiiiuni i endure ihi np:< I 11 ^ i Prngram <
' Vlf-" I II " I LijcltatU
i "In..-:
'.I. dli L'
1.—I fimlniL-
Lllii;;
| ,, , | N | PhTpmOBisB.-
1 __ll__l Coilradsilllki:
OutrBach to Ki-qLMienrwnti'I'roCjrdm Offtces
,
"
IFm^ram OfTiao
i. vinoii;!-! Qlliee
Ollwr"
ii i-lVi*:-; L> uke 'Jii-lfcw if1?
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http://www.federalelectronicschallen2e.net/acauisit.htm
-------
TOOL: KEY ENVIRONMENTAL
ATTRIBUTES TO CONSIDER
Key Environmental Attributes to consider September
under the f edera* Electronics Challenge 2003
Purpose:
or a |ir infer U.'ixrt-1 Duic ttnu ut%i± diiwvc/ tt* lib qucsikii. »5ul Ilk
*afut Ley ~canzMl*tl .iltrftuifi Ic Lurcu&r ttfiaa Tflfftlli
j t liull«iftL iwvL. In wiKfllDali. irtJ i J^-Rifv i^iVin.uiiwiiLilFi [t,-d::nrf>li. aid
i.fl>:*ii-cibc* 'n clir piodi j*iiw.. D-C anJ dtafmMuf dccfmnio ei^aqiUKflL 'Ion «tritiii!>>.
atrihulc* lid! fp^ciflc p«*liiCK -titirli .. • : • -h'.ni.' .v 'iif ->-i' •. -i .-.t ••• i> .ivaiLil'li.
E'^bnob.^
.e- uu1Hfl,'rij;ciniitn-jTi=nLiJ .iluiteii^x
jnj|)h£ti, in tb; 4'lir.TMi^-: tijio /uidiLKtui jif. inainxm
' t iiw Diuicj.K'.iL'cr. %in , L IL- nt.tn IJ
Top 10 Environments! Attributes grouped b>- lite cycle
Design impacts Use Impacts
Cnb C->n «.-.-»• JU;
/bDWy f^i Kocytllug
£niiknlfir^. adfiifltpo; . Lrtrtuiu lo^c chcniiii^ ^ULli **mcnMr> L-AL Ladnitiii^. ai-il
HU|ICIMU&. jfl 'jf nwith ;an |-»n.- a LUI^H lo thu er AIIUWU^U ja£ tenner, li^ilth il (Im
.aicriik' al ttn- unJ- u* llxiif iKulol lav f'aJwal ptrLtuhcn iiUan;dUi.i: IhsH-iitrJil*^
i KvirffruU tr, >nrtin£ cunk^bji liji oo wi ojuiaiii i at a ILUSJ r
•.:>:< i K
rtU' << iiviiJl r-im-iiuii^i; tits. j:n.«_nt m lit
/.iliibk- iiuunu«j.ni w iftt- &« wf huniiKl
• Reduce Toxics Constituents
• Increased Recycled Content
• Design for Recycling
• Reduced Materials use
• Promote Energy Conservation
• Extend Product Life
• Reduce Packaging
• Promote environmentally sound
recycling
• Promote take-back options
• Reward corporate environmental
policy
http://www.federalelectronicschallen2e.net/Tools/topenv.pdf
-------
TOOL: PRODUCT ENVIRONMENTAL
INFORMATION SHEET
Product Environmental
Information Sheet
D1-Aiia-33
"i> in in in in Ha i»i>
r ji *tir!i h nfcta •
tlr .mr fia^li »r ImaJTj •
Product Name:
I Ji i«f
Product Mate na Is Information
Recycled Content:
E&. ilocs llm praditM K*I
IE IJott din pcndutd eo«Ui* autcriit dcnviiJ ifi-d f
i>aiaiiMiul*i* ii
i '
i '
httD://www.federalelectronicschallenae.net/Tools/Drodinfo.Ddf
-------
MORE PROCUREMENT TOOLS TO
COME...
All of the tools referenced in this presentation can be
found at:
httD://www.federalelectronicschallen2e.net/acauisit.htm
Other tools will be added over time.
What other tools would vou like to see added?
-------
OTHER ENVIRONMENTAL
PURCHASING RESOURCES
Electronic Industry Alliance's website:
www.eia.on
Product Stewardship Institutes' EPP Guide:
httD://www.DroductstewardshiDinstitute.net/EPP.html#Electronics
Center for New American Dream's Buy Clean Computer
Network:
htto ://www. newdream. ors/Drocure/Droducts/comDuters .html
Silicon Valley Toxics Coalition Clean Computer
Campaign:
htto ://www. svtc.org/cleancc/index.html
-------
Questions?
i) Federal
Electronics
A Timi
-------
PART 3: CASE STUDY -
DEPARTMENT OF THE
INTERIOR'S COMPUTER
CONTRACT
-------
DEPARTMENT OF THE INTERIOR
SOLICITATION FOR DESKTOPS AND
LAPTOPS: A CASE STUDY
> Guest speaker:
- Catherine Cesnik Courtney,
DOI, Office of Environmental Policy and Compliance
History - from Decentralized to Centralized
Computer Purchase
Bulk Purchase Agreement - Current Contract (1 1A
years) = - 20,000 desktops, 4,000 laptops as well as
servers and printers = $4.5million
- Indicated Environmental Preference Would Be Included
for Next Contract
-------
The Recompete: DOI BPA
Developing New Contract - want to include
environmental clauses based on EPEAT
Market Survey - Based on Draft EPEA
Criteria (Posted on FedBizOps last week
due at Vendor's Day or Feb 15)
-------
GUEST SPEAKER CONTACT
INFORMATION
Catherine Cesnik, POC for market survey, Office
of Environmental Policy and Compliance, the
Department of the Interior
Catherine cesnick@ios.doi.gov
(650)329-5186
John Sherman, Contracting Officer, Bureau of
Land Management, Department of the Interior
John ShermanfSblm.gov
(303)236-0225
-------
Questions?
i) Federal
Electronics
A Timi
-------
Federal
Electronics
Electronics Stewardship One Byte @ A Time
FEC Contact Information
httD://www.federalelectronicschallen2e.net
httD://www.ofee. eov
Juan Lopez, OFEE, 202-564-1297
Viccy Salazar, EPA HQ, 703-308-8647
Holly Elwood, EPA HQ, 202-564-8854
Chris Beling, EPA Region 1, 617-918-1792
Chris Newman, EPA Region 5, 312-353-8402
Adrienne Priselac, EPA Region 9, 415-972-3285
-------
Thank you
Federal
Electronics
Electronics Stewardship One Byte @ A Time
Remember - Sign up as a partner to
continue to participate in these calls
-------
APPENDIX:
RECAP OF FEC
REQUIREMENTS RELATED*
ACQUISTION & PROCUREMENT
-------
T A GLANCE:
FEC REQUIREMENTS
BRONZE
^Complete Survey
^Set Goals
^Select 1 of 3 LC Phases:
•Procurement
•Use
•End-of-life
'Complete mandatory items
in chosen LC phase
^Choose and implement
2 optional items
^Report progress
SILVER
^Complete Survey
^Set Goals
^Select 2 of 3 LC Phases:
•Procurement
| *Use
•End-of-life
'Complete mandatory items
in 2 chosen LC phases
^Choose and implement
3 optional items
^Report progress
GOLD
t Complete Survey
^Set Goals
^Integrate 3 LC Phases:
I •Procurement
•Use
I •End-of-life
'Complete mandatory items
in all 3 LC phases
. ^Choose and implement
4 optional items
^Report progress
^Mentor 2 others
-------
FEC REQUIREMENTS: ACQUISITION
AND PROCUREMENT
BRONZE LEVEL
Ensure that at least 50 percent of al
monitors (CRTs and LCDs) purchas
ENERGY STAR® compliant.
Require vendors to complete a Product
Information Sheet.
Procurement Checklist.
-------
FEC REQUIREMENTS: ACQUISITION
AND PROCUREMENT
SILVER LEVEL
Bronze level requirements AND
Include end-of-life management in solicitation
OR include operation and maintenance provision;
in solicitations.
Consider and include at least three environmentaJ
attributes in purchasing specifications.
-------
FEC REQUIREMENTS: ACQUISITION
AND PROCUREMENT
GOLD LEVEL
Bronze level requirements; AND
Silver level requirements; AND
Use life-cycle costing (AKA: total cost of ownership) [add
to tool]'
Include environmental factors in determining "best value" for contract
Purchase third-party eco-labeled products or include criteria from
third party eco-labeling program;
Require vendors to incorporate information about environmental
features of their products in existing training programs/materials [ad(
hyperlink to contract language].
-------
Integrating Green Purchasing Into Your
Environmental Management System (EMS)
April 2005
EPA742-R-05-001
Pollution Prevention Division
Office of Pollution Prevention and Toxics
U.S. Environmental Protection Agency
(7409)
1200 Pennsylvania Avenue, N.W.
Washington DC, 20460
-------
ORGANIZATION OF GREEN PURCHASING MODULE
Section Page
1. Introduction 1
2. Integrating Green Purchasing into your Environmental Management System (EMS)
Environmental Policy 3, 9
Environmental Aspects 3,11
Legal and Other Requirements 4, 12
Objectives and Targets 4, 14
Environmental Management Programs 5, 18
Structure and Responsibility 5, 21
Training, Awareness and Competence 5, 22
Communication 6,24
Document Control 6, 25
Operational Control 6, 26
Emergency Preparedness and Response 6, 30
Monitoring and Measurement 7, 30
Nonconformance and Corrective and Preventive Action 7, 33
Records 8,34
EMS Audits 8, 34
Management Review 8, 35
3. Background Information
Genesis of this Report 36
Definitions and Acronyms 36
What is Green Purchasing? 38
Federal Green Purchasing Preference Program Requirements 38
Green Purchasing Training Resources 40
Green Purchasing Resources 41
4. Conclusion 43
Acknowledgments 44
Disclaimer 47
5. Appendices
Appendix A
Products and Services Purchased at ESC 49
Appendix B: Examples of Agency Procedures
Operational Controls: EPA, Region 1 52
Objectives and Targets: EPA Region 5 55
Environmental Management Program: ESC 57
Objectives and Targets for Electronics, EPA Region 10 67
Some of the links in this document are to information external to the EPA.gov domain. Please
review EPA's External Link Disclaimer page for more information from EPA about external links.
-------
Integrating Green Purchasing into your EMS: Final Draft October, 2004
INTRODUCTION
The Federal government is one of the largest
The goal of this report is to help Federal
facilities integrate green purchasing into
their EMS. The intended audience
includes those tasked with implementing
an EMS, reducing environmental
impacts, meeting green purchasing
requirements and/or buying products and
services in a Federal facility.
purchasers in the world. In fiscal year 2002, Federal
agencies spent more than $250 billion for goods and
services to support the activities of approximately 1.7
million employees in 60 agencies. In addition,
Federal agencies spent another $15 billion on small
purchases via purchase cards. * Purchasing decisions
can significantly influence the environmental
performance of Federal facilities. By including environmental considerations in Federal
purchasing decisions, government procurement and contracting processes can be used to
purchase products and services that reduce an organization's environmental impacts.
Since 1976, requirements for green purchasing have been incorporated into Federal regulations
and Executive Order requirements,2 with a goal of integrating environmental considerations into
all stages of the Federal purchasing process. However, based on reporting by Federal agencies
on their green purchasing activities, it is evident that Federal agencies are encountering
challenges in fully implementing these requirements. Potential environmental costs and benefits
associated with choosing one product or service over another may not be routinely factored into
purchasing decisions. Different organizations within a facility may have differing perceptions of
who is responsible for ensuring that the facility is buying green products and services.3
Environmental staff may be familiar with green purchasing requirements and benefits, but they
may find it difficult to initiate facility or agency-wide purchase of green products without the
cooperation and support of upper management and those responsible for the purchase and use of
these products. Procurement personnel may be familiar with green purchasing requirements but
hampered by a lack of requests for green products and services from the user community.
Procurement personnel and product users also may not know how to locate green products and
services to evaluate their performance and compare their environmental attributes. The EMS
process creates an opportunity for environmental and procurement personnel to work together
with product users to determine the most effective mechanisms to ensure that staff understands
the economic and environmental benefits of green purchasing.
To reduce the Federal government's environmental footprint and improve the implementation of
green purchasing and other greening the government initiatives, the President mandated that all
appropriate Federal facilities implement Environmental Management Systems (EMS) by
December, 2005.4 As a result, Federal facilities across the country now are endeavoring to
1 Federal Procurement Data System, 2002 Report, < http://www.fpdc.gov/fpdc/fpr2002.htm >
2 Green purchasing requirements include the Federal Acquisition Regulation (FAR) Parts 7, 11,23; RCRA Section
6002; Section 9002 of the 2002 Farm Bill, Section 303 of the Energy Policy Act of 1992; Section 613 of the
Clean Air Act, EO 13101,andEO 13123. See the Federal Green Purchasing Preference Program
Requirements section of this module.
1
;tion401 (b) of Executive Order (EO) 13148, Gra
Management. Text of EO 13148 is available at < http://ceq.eh.doe.gov/nepa/regs/eos/eol3148.html >
4 Section 401 (b) of Executive Order (EO) 13148, Greening the Government Through Leadership in Environmental
-------
Integrating Green Purchasing into your EMS: Final Draft October, 2004
develop and implement EMS to improve their environmental performance. The goal of this
report is to help Federal facilities integrate green purchasing into their EMS.5 The intended
audiences include Federal facility staff tasked with implementing an EMS, reducing
environmental impacts of facility activities, meeting green purchasing requirements and/or
buying products and services in a Federal facility.
Federal organizations can take advantage of the increased emphasis on environmental
performance and enhanced internal communication associated with an EMS to expand and
encourage green purchasing. Procurement and contracting personnel can play an important role
on EMS implementation teams. By using EMS procedures to establish green purchasing
objectives and targets and develop operational controls to ensure that the environmental impacts
of products and services are included in the criteria for procurement and contracting decisions,
agencies can encourage implementation of an effective green purchasing program, reduce their
organization's environmental footprint and encourage progress toward sustainable operations.
This report is organized around the 17 elements of an EMS that conforms to the International
Organization for Standardization (ISO) 14001 (1996) Standard,6 because Federal agencies
interviewed for this report indicated that they were either using the elements of ISO 14001 as
the structure for their EMS or were familiar with these elements. As a result, ISO requirements
are mentioned throughout. While ISO requirements are not mandatory for all EMS developers to
follow, those who have chosen to use the ISO framework, as the majority of the 2500 Federal
facilities creating EMSs have elected to do, will want to be aware of these requirements. To
make the module easy to use, it is provided as an electronic document with both internal and
external links.
Section 2, Integrating Green Purchasing into Your EMS is the core of the report and provides:
• Key information about the requirements associated with each element of ISO 14001;
• Practical guidance and potential language for integrating green purchasing into
procedures for each ISO 14001 element; and
* Links to Federal facility examples for each element.
Section 3 provides links to additional information on the genesis of this report, EMS, Federal
green purchasing program requirements, green product resources, and green purchasing training
resources. Contact information for Federal facility staff who participated in the development of
this report is available in the Acknowledgments. This document can be found on the web at
Federal agencies are encouraged to contact U.S. standards
development organizations in order to alert them to the need for standards to meet green
purchasing and EMS goals. A partial list of US organizations can be found at www.ansi.org.
Consistent with OMB Circular A-l 19, agencies are further encouraged to participate in the
development of voluntary standards through such organizations.
5 Information on how to develop an EMS is available from: EPA , the Office of the
Federal Environmental Executive (OFEE) , and the Joint Service P2 Technical
Library
6 < http://www.iso.org >
-------
Integrating Green Purchasing into your EMS: Final Draft
October, 2004
2. INTEGRATING GREEN PURCHASING INTO YOUR EMS
By targeting enhanced green purchasing within the EMS, a facility or installation can comply
with Federal green purchasing legal and other requirements, raise awareness of procurement as a
pollution prevention tool, and facilitate continual improvement in environmental performance
through proactive green purchasing and contracting activities. The table below addresses the
elements of ISO 14001 in the context of green purchasing and provides links to examples and
success stories from Federal government organizations that support recommendations for
integrating green purchasing into your EMS.
* Click on the name of the element to link to further information on the ISO 14001 (1996)
requirements.
* Click on the name of a Federal agency or facility to link to examples of how this element
has been successfully integrated into the organization's EMS.
* Click here for a list of acronyms used in this module.
EMS Element (ISO 14001)
Green Purchasing Component
Federal Facility Examples
4.2 Environmental Policy
A conforming Federal Facility Environmental
Policy Statement can include green purchasing,
by reference, in the commitments to compliance
with legal and other requirements and
prevention of pollution. An organization also may
include a more direct green purchasing
commitment, such as:
[Facility] will consider environmental factors in
all purchasing decisions and will give preference
to those products and services designated by or
recommended in Federal green purchasing
preference programs, as well as those products
and services that have a lesser or reduced effect
on human health and the environment when
compared with competing products or services
that serve the same purpose.
US Department of Agriculture
(USDA), Agricultural Research
Service (ARS), Beltsville Area
Department of the Interior (DOI),
National Park Service (NPS)
DOI, NPS, Intermountain Region
DOI, NPS Concession
Environmental Management
Program (CoEMP)
EPA Environmental Science
Center (ESC) at Fort Meade, MD
EPA Region 3 ( Mid-Atlantic
Region)
National Aeronautics and Space
Administration (NASA)
Pentagon
4.3.1 Environmental
Aspects
The procedure to identify environmental aspects
and significant impacts must be applied to
procurement (purchasing) and contracting as
activities you control or influence. Other
activities also may have procurement-related
aspects, such as the purchase of products or
services that consume resources and/or
generate wastes.
Include procurement and contracting personnel
and key purchasers on the EMS Cross
Functional Team identifying and ranking aspects
and impacts.
DOI, NPS, Grand Canyon
National Park
DOI, NPS, Grand Canyon
National Park, Xanterra Parks
and Resorts
DOI, NPS, CoEMP
EPA Region 9
USDA, ARS, Beltsville Area
Environmental Agency of Great
Britain
-------
Integrating Green Purchasing into your EMS: Final Draft
October, 2004
EMS Element (ISO 14001)
Green Purchasing Component
Federal Facility Examples
Consider Including compliance with
procurement-related legal and other
requirements among the criteria for determining
significance.
4.3.2 Legal and Other
Requirements
A conforming legal and other requirements
procedure should identify all procurement-related
laws, regulations, and Executive Orders. Any
agency-specific procurement requirements,
including your agency's Affirmative Procurement
Plan and Green Purchasing Strategic Plan7 are
considered "other requirements" and should be
incorporated into any list or register of legal and
other requirements for the EMS.
DOD, U.S. Army, Ft. Lewis WA
NASA
USDA, ARS, Beltsville Area
EPA, ESC, Fort Meade, MD
DOI, NPS, CoEMP
4.3.3 Objectives and
Targets
Determine realistic green purchasing objectives
for each appropriate significant aspect, based on
the commitment to pollution prevention, legal
and other requirements, significant aspects, and
mission requirements. Consider targeting all
purchases over a threshold amount, based on
environmental impact and the amount of
influence your facility has over the product or
service provider(s) (See Environment Agency of
Great Britain).
Establish measurable green purchasing targets
that can be accomplished within a reasonable
timeframe.
For example:
Objective: Improve green purchasing practices.
Targets:
• Provide green purchasing training to
procurement staff.
. Identify opportunities to purchase green
products and services.
. Consider requiring the use of FAR clause
52.223-10 in all relevant service contracts.
. Create Green Purchasing SOPs for Buildings,
Power, Electronics, Vehicle Fleets, Office
DOI
DOI, NPS, Cape Cod National
Seashore (CACO)
DOD, U.S. Army, Fort Lewis WA
DOI, Fish and Wildlife Service,
Bosque de Apache National
Wildlife Refuge, NM
DOI, NPS, CoEMP
EPA
EPA Region 1
EPA Region 10
California EPA
The Environment Agency of
Great Britain
Section 6002 of the Resource Conservation and Recovery Act requires agencies to establish affirmative
procurement programs to implement the buy recycled requirements of that section. EO 13101 repeats this
requirement in section 402. Section 9002 of the Farm Security and Rural Investment Act requires agencies to
establish affirmative procurement programs to implement the bio-based requirements of that section. The White
House's Office of the Federal Environmental Executive strongly recommends that all Federal agencies create green
purchasing plans which cover all their green purchasing activities,
-------
Integrating Green Purchasing into your EMS: Final Draft
October, 2004
EMS Element (ISO 14001)
Green Purchasing Component
Federal Facility Examples
Supplies, Copy Paper, Cleaning Products,
Meetings, and Landscaping and provide
management emphasis to these initiatives.
. Conduct employee awareness training on the
purchase and use of green products and
services and participation in recycling
programs.
Remember, objectives and targets are
documented and reviewed and updated on an
established schedule.
4.3.4 Environmental
Management Programs
Establish programs to pursue green purchasing
objectives and targets and define a timeframe
within which each should be achieved. Identify
both human and financial resources to ensure
that green purchasing programs are effective, as
well as metrics to determine progress.
Establish a procedure to review new and
modified contracts and contract renewals to
ensure the contract language includes
requirements for green purchasing.8
U.S. Postal Service
EPA Region 1
EPA Region 5
EPA Region 9, APP
EPA Region 9, EMP
4.4.4 Structure and
Responsibility
Include procurement and contracting personnel
on the EMS Implementation Team. Designate
staff responsible for green purchasing program
management and establish reporting
relationships within the program, with the EMS
Manager and with top management.
Assign staff to identify the products and services
currently purchased to support your activities,
who purchases them and how they are
purchased. See the EPA ESC procurement
summary in Appendix A.
Assign responsibility and resources for
Environmental Management Programs to
achieve green purchasing objectives and
targets.
EPA, Region 1
EPA, Region 9
USDA, ARS, Beltsville Area
DOD, U.S. Army, Ft. Lewis, WA
DOI, NPS, CoEMP
4.4.2 Training, Awareness
and Competence
Identify procurement training needs based on
significant aspects and legal and other
requirements for Federal green purchasing
preference programs. Train procurement and
contracting staff and product users on green
purchasing and encourage them to request
goods and services that reduce environmental
impacts and meet performance standards.
Consider requiring that key procurement and
contracting personnel take the Office of
NASA
USDA, ARS, Beltsville Area
EPA Headquarters
EPA Region 9
EPA, ESC. Fort Meade MD
DOD, U.S. Army, Fort Lewis WA
DOI, NPS, CoEMP
' To access green purchasing contract language and specifications used by Federal agencies visit
-------
Integrating Green Purchasing into your EMS: Final Draft
October, 2004
EMS Element (ISO 14001)
Green Purchasing Component
Federal Facility Examples
Personnel Management's "What is Green
Purchasing, Anyway?" training course available
at the Gov Online Learning Center web site:
9 The DOD Green
Procurement Strategy10 offers a list of green
purchasing training resources.
4.4.3 Communication
The Communication Procedure should include
guidance on who is responsible for internal
communication on significant aspects, including
those related to green purchasing, as well as
how, how often and to whom information will be
disseminated.
EPA Region 9
DOI, Intermountain Region
DOI, NPS, Grand Canyon
National Park
DOI, NPS, CoEMP
USDA, ARS, Beltsville Area
4.4.5 Document Control
Document control procedures will apply to all
green purchasing documentation, including
Affirmative Procurement and EPP plans,
specifications, purchase orders and contracts
and lists of green products approved for
purchase.
Procedures and responsibilities for creation and
modification of purchasing documents may be
applicable.
DOD, U.S. Army, Ft. Lewis WA
DOI, NPS, Grand Canyon
National Park
DOI, NPS, CoEMP
4.4.6 Operational Control
Ensure that all significant aspects related to
green procurement are addressed by
operational controls. Develop and implement
control procedures to ensure that product users,
specification writers and the procurement and
contracting personnel include an evaluation of
environmental considerations, along with price,
performance and availability, in the criteria for
purchasing decisions. Green contract language
for more than 600 products and services is
available at
Operational control procedures should ensure
that purchases of designated and mission-
appropriate green products and services support
the environmental policy, legal and other
requirements and green purchasing objectives
and targets.
Communicate green purchasing procedures and
requirements to suppliers and contractors,
EPA Region 1
EPA ESC Ft. Meade MD
USDA, ARS, Beltsville Area
DOI, NPS, CoEMP
To register for the Green Purchasing course, log on with your email and password . Click on the Full Catalog button on the top
navigation bar, then click on the Free Catalog category and select the Legislatively Mandated and Agency Required Topics
category. Choose "What is Green Purchasing, Anyway?" (Course ID OPM008), by clicking on its title.
The Department of Defense Green Procurement Strategy can be accessed at
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EMS Element (ISO 14001)
4.4.7 Emergency Response
4.5.1 Monitoring and
Measurement
4.5.2 Corrective and
Green Purchasing Component
especially those that provide goods and services
for activities that have significant environmental
aspects.
Emphasize the purchase of environmentally
preferable products to reduce the potential for
incidents requiring emergency response.
Consider including green spill response material
specifications in the Emergency Response
Procedure.
A conforming procedure will document what
green purchasing data to collect and how to
collect and manage the data related to
significant environmental aspects and
requirements for reporting on green purchasing.
Per Federal green purchasing program
requirements, monitor purchases of recycled
content products, bio-based products, alternative
fueled vehicles, alternative fuels, and non-ozone
depleting products. Your organization may also
want to monitor purchases of any other product
or service that has a reduced impact on the
environment when compared with competing
products that serve the same purpose.
When possible, measurements should quantify
positive environmental impacts as well as
progress toward meeting established green
purchasing objectives and targets. For example,
measure reductions in solid waste associated
with purchases of environmentally preferable
products, reductions in hazardous waste
disposal associated with substitution of less toxic
products, as well as reductions in energy and
water use associated with products to increase
efficiency.
Designate responsibility for investigating and
Federal Facility Examples
» USDA, ARS, Beltsville Area
» NASA
» DOD, U.S. Army, Ft. Lewis WA
» EPA, ESC, Ft. Meade MD
» EPA Region 9
» USPS
» DOI, NPS, CoEMP
» OTHER RESOURCES
The paper calculator at
allows the user to
compare the environmental impacts of
papers made with different levels of
postconsumer recycled content,
ranging from 0% (i.e., virgin paper) to
100%.
Greenhouse gas measurement tools
are available at
The DOD Green Procurement
Strategy includes a description of
DOD Green Procurement Metrics
httD://www.ofee.aov/aD/QDDStrat.Ddf
The ENERGYSTAR® Program offers a
calculator to demonstrate how much
new energy efficiency equipment you
can purchase with anticipated energy
savings at www.enerqystar.qov
» EPA, ESC, Ft. Meade MD
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EMS Element (ISO 14001)
Green Purchasing Component
Federal Facility Examples
Preventive Action
correcting findings of non conformance with the
green purchasing EMS requirements, in
accordance with facility corrective action
procedures.
DOD, U.S. Army, Ft. Lewis WA
4.5.3 Records
Identify green purchasing records, such as
training, purchases of specific products, reports
to management and government agencies and
audits. Maintain these environmental records in
accordance with facility EMS procedures.
EPA ESC Ft. Meade MD
4.5.4 EMS Audit
Ensure that green purchasing EMS elements are
included in the activities to be considered in
either internal or external audits of the EMS.
EPA ESC Ft. Meade MD
4.6 Management Review
Ensure that progress toward achieving green
purchasing objectives and targets and any green
purchasing operational controls are discussed
as part of the EMS Management Review.
Ensure that the management review considers
recommendations to improve facility green
purchasing efforts.
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ENVIRONMENTAL POLICY
ISO 14001 Element
Section 4.2 of the ISO 14001 Standard requires that Top Management define the organization's
environmental policy and ensure that it:
1. Is appropriate to the nature, scale and environmental impacts of the organization's
activities, products or services.
2. Includes a commitment to continual improvement and prevention of pollution.
3. Includes a commitment to comply with relevant environmental legislation and
regulations, and with other requirements to which the organization subscribes.
4. Provides a framework for setting and reviewing environmental objectives and targets.
5. Is documented, implemented, maintained, and communicated to all employees.
6. Is available to the public.
Annex A.2 of 14001 notes that "top management" may consist of an individual or a group of
individuals with executive responsibility for the organization.
Federal Facility Examples
Federal Agency/Facility
Environmental Policy
US Department of Agriculture
(USDA), Agricultural
Research Service (ARS),
Beltsville Area
USDA's ARS Beltsville Area operation already has implemented a
separate EPP Policy in support of its EMS. BA Policy #03-04,
Environmentally Preferable Products and Affirmative Procurement
Policy, dated February 6, 2003 states: "It is the responsibility of all
employees of the Beltsville Area to ensure that environmentally
preferable products and services are actively pursued when
purchasing. Green purchasing/affirmative procurement includes, but
is not limited to, recycled-content products, biobased products, and
energy-efficient products. This applies to all purchases including
micro-purchases (less then $2,500)."
Department of the Interior
(DOI), National Park Service
(NPS)
The National Park Service expects each park-level organization to
adopt and implement an EMS according to guidance provided in The
National Park Service Park-level Model Environmental Management
System. This guidance document states that each facility shall
develop and document a commitment statement affirming the
facility's intent to strive for exemplary environmental management.
The statement must include a commitment to environmental
leadership by "incorporating pollution prevention, waste reduction,
best management practices, and environmentally preferable
purchasing in all park management activities."
http://www.doi.gov/greening/NPS/The Park Level Model EMS new
.pdf
DOI, NPS, Intermountain
Region
As part of their model EMS, each national park in the Region must
develop a "green purchasing" park policy that expresses the
Superintendent's commitment to establishing criteria for "green"
products and a directive to avoid hazardous products altogether.
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Federal Agency/Facility
Environmental Policy
Department of the Interior
(DOI), National Park Service
(NFS), Concession
Environmental Management
Program (CoEMP)
Concession contracts issued by the NPS to businesses
(concessioners) to provide visitor services, such as retail, food and
lodging services, in the national parks, include a requirement to
develop and implement an EMS. While NPS concessioners are not
subject to EO and FAR requirements, the EMS policy requires that
each concessioner provide a clear statement of the commitment to
Best Management Practices in its operation, construction,
maintenance, acquisition, provision of visitor services and other
activities. The BMPs may include environmentally preferable
purchasing and reduction in the purchase and use of hazardous
substances.
Environmental Protection
Agency (EPA), Environmental
Science Center (ESC) at Fort
Meade, MD
The EPA Environmental Science Center (ESC) at Fort Meade, MD
issued an Environmental Policy statement that includes a
commitment to consider environmental factors when making
planning, purchasing, and operating decisions. 11 This commitment
is supported by the statement: "We will adopt cost-effective practices
that eliminate, minimize or mitigate environmental impacts and we
will use environmentally preferred materials if those materials meet
technical specifications."
Environmental Protection
Agency (EPA), Region 3 (Mid-
Atlantic Region)
EPA Region 3 (Mid-Atlantic Region) issued an Environmental Policy
on September 16, 2003. This policy includes a commitment to
"Consider environmental impacts when making planning, purchasing
and operating decisions."
National Aeronautics and
Space Administration (NASA)
The NASA Environmental Management Policy (NPD 8800.16, April
6, 2000), Section 1 c, includes language directing consideration of
environmental factors in selection of materials and processes. NASA
Centers and other organizations are required to consider
environmental factors throughout the life cycle of a program,
including planning, development, execution, and disposition
activities. Examples of environmental factors include the proposed
use of hazardous materials, the potential for waste generation, and
the overall environmental preferability of selected materials and
processes.12
Department of Defense (DOD)
The Pentagon's Affirmative Procurement Plan includes the following:
"The Engineering & Technical Services Division (ETSD) and the
Defense Facilities Contracting Office (DFCO) are committed to the
implementation of a procurement program that ensures compliance
with all applicable laws, executive orders, instructions and
regulations for the acquisition of Environmentally Preferable and
Energy-Efficient Products and Service (EPP). The intent of the
program is to meet the Department of Defense policy on
procurement of EPA-designated items. That policy states that 100%
of such purchases will meet or exceed the guideline standards
unless written justification is made part of the procurement file . . ."
ESC Environmental Policy Statement is included as Appendix 1 to the ESC Environmental Management
System Manual
12 < http://nodis3.gsfc.nasa.gov/main lib.html >
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ENVIRONMENTAL ASPECTS
ISO 14001 Element
Environmental Aspects are the components of a Federal facility's activities, products, or services
that can have an impact, beneficial or adverse, on the environment. Environmental impacts are
the changes that take place in the environment as a result of the aspect. For example, stormwater
runoff is an aspect; the resulting environmental impacts may include erosion and degradation of
surface waters. Solid waste generation or disposal is an aspect with impacts including
degradation of the land and air quality.
Section 4.3.1 of ISO 14001 requires that an organization establish and maintain procedures to
identify the environmental aspects of its activities, products or services that it can control and
over which it can be expected to have an influence. Aspects are identified to determine those
that have or can have significant impacts on the environment. The Standard further requires that
the organization ensure that the aspects determined to be significant are considered in setting
environmental objectives.
Federal Facility Examples
Federal facilities have determined that procurement and contracting activities can have an impact
on the environment. Many Federal facilities have defined all procurement activities as an
environmental aspect or have defined procurement of specific products or services as aspects. In
addition, compliance with procurement-related legal and other requirements and identification of
the potential to reduce or eliminate environmental impacts through product substitution, new
equipment or changes to contractual requirements may be included in the criteria used to
determine the significance of environmental impacts. Examples of these approaches are
included in the chart, below:
Federal Agency/Facility
DOI, NFS, Grand Canyon
National Park
DOI, NFS, Grand Canyon
National Park, Xanterra
Parks and Resorts
DOI, NPS, CoEMP
EPA Region 9
Environmental Aspects
Dr. Mary Ann McCloskey, Environmental Protection Specialist at the
Grand Canyon noted that procurement was identified as a significant
aspect during the EMS Team's first aspect/impacts analysis. One of the
team's main concerns was the reduction of hazardous waste and the
use and storage of hazardous materials. Dr. McCloskey noted, "The
team felt that we needed to go to the source — procurement and
reducing materials stored in the warehouse."13
Xanterra Parks and Resorts, the concessioner providing some visitor
services for the South Rim of Grand Canyon National Park, identified
Recycled and Reused Materials Use as a significant environmental
aspect for their EMS.
Environmental aspects of concessioners providing visitor services, such
as retail, food and lodging, at National Parks include generation of solid
waste, generation of hazardous waste, and purchasing activities.
Heather White of EPA Region 914 noted that in determining the
significance of their environmental aspects, Region 9 considered the life
; Personal communication, Mary Ann McCloskey, February 4, 2004.
' Personal communication, Heather White, November 6, 2003
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Federal Agency/Facility
USDA, ARS, Beltsville Area
Environmental Aspects
cycle of activities and services and their potential impact on the
biosphere. Because Region 9 plans to use its EMS to move toward
sustainability, they evaluated significance based on four system
conditions derived from The Natural Step15, three of which address
material use: SC#1 Material Use: Materials that originate from the
Earth's crust (i.e. metals, petroleum products); SC#2 Material Use:
Materials of a synthetic origin (i.e. manmade chemicals, plastics, and
other synthetic products); SC#3 Material Use: Materials that originate
from the biosphere (i.e. paper); and SC#4 Community/Employee
Concerns: Issues of concern for the well-being of community
stakeholders and/or our employees.
David Prevar from USDA, ARS, Beltsville Area states that green
purchasing was among the criteria used to evaluate the significance of
their environmental aspects. The aspects and impacts analysis allowed
them to identify opportunities to create an alliance between their
ongoing agricultural research and the use of biobased products in their
day-to-day operations.
LEGAL AND OTHER REQUIREMENTS
ISO 14001 Element
Section 4.3.2 of ISO 14001 requires that an organization establish and maintain a procedure to
identify and have access to legal and other requirements to which the organization subscribes
that are applicable to the environmental aspects of its activities, products, or services.
The procedure for review of legal and other requirements should effectively identify all of the
Federal green purchasing preference program legal and other requirements listed in the chart,
below. In addition, local environmental requirements, such as recycling programs, are
considered other requirements and should be included in the list or register of legal and other
requirements for the EMS.
FEDERAL GREEN PURCHASING LEGAL AND OTHER REQUIREMENTS
Product Category
Recycled Content
Environmentally Preferable
Legal and Other Requirements
Section 6002 of the Resource Conservation and
Recovery Act(RCRA); EO 13101, Greening the
Government through Waste Prevention,
Recycling and Federal Acquisition; Federal
Acquisition Regulation (FAR), Parts 7, 11, 23.
EO 1 31 01 , Greening the Government through
Waste Prevention, Recycling and Federal
Acquisition; FAR, Parts 7,11, 23.
'
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FEDERAL GREEN PURCHASING LEGAL AND OTHER REQUIREMENTS
Product Category
Energy efficient
Biobased
Alternative fuels
Fuel efficiency
Non-ozone depleting substances
Legal and Other Requirements
EO 13123, Greening the Government through
Efficient Energy Management; Federal
Acquisition; Federal Acquisition Regulations
(FAR), Part 23; EO 13221 , Energy Efficient
Standby Power Devices
Section 9002 of the 2002 Farm Security and
Rural Investment Act; EO 13101, Greening the
Government through Waste Prevention,
Recycling and Federal Acquisition
Section 303 of The Energy Policy Act of 1992
(EPAct); Executive Order 13149, Greening the
Government through Federal Fleet and
Transportation Efficiency
Section 613 of the Clean Air Act
Federal Facility Examples
Federal Agency/Facility
Legal and Other Requirements
DOD, U.S. Army, Ft. Lewis
WA
The Fort Lewis WA Legal and Other Requirements Procedure requires
Program Managers to "Maintain a list of the legal and other
requirements that are applicable to your program(s); communicate this
list to the EMS Management Representative. Monitor legal and other
requirements applicable to your program(s) for new requirements and
actual or proposed changes. Use pertinent information sources as
needed." The list of legal and other requirements includes Executive
Orders that address green procurement requirements.
NASA
NASA includes its list of applicable legal requirements as an Appendix
to its EMS Policy documentation. The list includes all relevant laws,
regulations, and Executive Orders as well as NASA requirements
including NPG 8830.1, Affirmative Procurement Plan for
1 fi
Environmentally Preferable Products.
USDA, ARS, Beltsville Area
The Agricultural Research Service's Beltsville Area specifically calls out
its Drivers for Affirmative Procurement stating, "Laws, regulations, and
Executive Orders combine to provide the authority and requirements for
Federal AP programs."17 The drivers cited include: the Resource
Conservation and Recovery Act, Executive Order 13101,
Comprehensive Procurement Guidelines, 40 CFR, Part 247, the Federal
Acquisition Regulation, and Public Law 107-171 and OFPP Policy Letter
92-4.
http ://nodis3. gsfc .nasa. gov/main lib .html
USDA Beltsville Area, Agricultural Research Service. A Guide to Green Purchasing. (2003) pp. 2-6.
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Federal Agency/Facility
Legal and Other Requirements
EPA, ESC, Fort Meade MD
ESC progress in meeting Executive Orders applicable to environmental
management at Federal facilities included environmentally-preferable
paper and recycling goals listed in E.O. 13101, "Greening the
Government through Waste Prevention, Recycling, and Federal
Acquisition," and E.O. 13148, "Greening the Government through
Leadership in Environmental Management," as well as other applicable
EPA directives.18
DOI, NPS, CoEMP
Concession contracts issued by the NPS for visitor services such as
retail, food and lodging, include a requirement to develop and implement
an EMS. Each concessioner must describe how its staff will maintain
knowledge of applicable laws and Best Management Practices (BMPs).
Both NPS contracts and BMPs may include requirements for
environmentally preferable purchasing and reduction in the purchase
and use of hazardous substances.
OBJECTIVES AND TARGETS
ISO 14001 Element
Section 4.3.3 of ISO 14001 requires that an organization shall establish and maintain
documented environmental objectives and targets at each relevant function and level within the
organization. It further requires that when establishing these objectives, legal and other
requirements, the significant environmental aspects, technological options and the financial and
operational requirements of the business shall be considered. Further, the standard states that the
views of interested parties shall be considered in the selection process. The objectives and
targets shall be consistent with the organization's environmental policy and must include the
commitment to pollution prevention.
Federal Facility Examples
These agencies have included a commitment to green purchasing in their Environmental Policy,
identified procurement as a significant aspect and established formal, green purchasing
objectives and targets.
Federal Agency/Facility
Objectives and Targets
DOI
DOI has included green purchasing goals in EMS implementation and
environmental auditing at a variety of field sites. In the Strategic Plan for
Greening the Department of the Interior through Waste Prevention,
Recycling and Federal Acquisition™ and in the Department's Annual
Performance Plan, the focus is on increasing purchases of nine targeted
products, which are viewed both as high priorities for wide-spread use as
well as indicators of broader compliance with green purchase program
objectives. The nine targeted products include: Re-refined engine
lubricating oil, Reclaimed engine coolant, Retread tires, Copy paper
ESC. The EPA Environmental Science Center Environmental Management System Results Summary From FY 03,
First Year After Registration, p. 4.
'
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Federal Agency/Facility
Objectives and Targets
(recycled content and made without chlorine bleaching), Bathroom tissue
(recycled content and made without chlorine bleaching), Paper towels
(recycled content and made without chlorine bleaching), Plastic trash
bags (recycled content), Carpeting (recycled content or refurbishable, and
Biobased, biodegradable lubricating and hydraulic oils20
DOI, NFS, Cape Cod
National Seashore (CACO)
Cape Cod National Seashore (CACO) included the following Procurement
and Purchasing Goal in their EMS Environmental Goals and Action Plan
for FY 04:
Goal I: Reduce wastes generated through improved procurement
practices. A goal champion is assigned to oversee the following targets:
» Develop Authorized Use List of products approved for purchase and
use by park staff;
» Conduct employee awareness training on green products; and
» Create a Green Procurement SOP and provide management
emphasis to this initiative.
21
DOD, U.S. Army, Fort
Lewis WA
The Fort Lewis EMS is part of a larger Installation Sustainability Program.
Current Fort Lewis EMS Objectives and Targets support Green
Purchasing.
Objective: Cycle all material use to achieve zero net waste by 2025.
» Target: Change procurement practices to introduce only cyclable22
materials to Fort Lewis.
» Target: Achieve 100% cradle-to-cradle hazardous material
management.
» Target: Achieve 40% reduction in waste stream leaving Fort Lewis by
the end of calendar year 2005
Objective: Reduce installation traffic congestion and traffic air emissions
by 85% by 2025.
» Target: Purchase 25 Neighborhood Electric Vehicles (NEV) for on
post use by 2007.
» Target: 50% of the GSA fleet will be alternate fuel vehicles (CNG,
Bio-Diesel, E-85) by 2007
Objective: Sustain all activities on post using renewable energy sources
and generate all electricity on post by 2025.
» Target: Encourage innovative use of energy systems by developers.
» Target: Encourage acceptance and use of innovative energy systems
» Target: Generate 20% energy on post by 2008
» Target: 25% of electricity from renewable sources by 2008
DOI, Fish and Wildlife
Service, Bosque de
Apache National Wildlife
Refuge, NM
The Fish and Wildlife Service's Bosque de Apache National Wildlife
Refuge in New Mexico established the following EMS green procurement
goals:
» Use reduced mercury (e.g., "Green Tip" Phillips Alto brand)
fluorescent lamps as new lamps are installed or replaced.
Personal communication, Heather Davies, DOI, November 3, 2003.
Cape Cod National Seashore, EMS Environmental Goals and Action Plan, July, 2003.
! At Fort Lewis, the term cyclable refers to items that are reused, made of recovered/recyclable material, made of
renewable resources, or can be diverted into another beneficial use after its original intended use has been
exhausted. To be classified as cyclable, the entire life cycle of product has to be considered from
acquisition of raw materials, through manufacture, distribution, use and disposal.
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Federal Agency/Facility
Objectives and Targets
Conduct pilot study to evaluate use of bio-diesel fuel in vehicles and
equipment at Refuge.
Conduct pilot study to evaluate use of biobased lubricants and
hydraulic fluid for vehicles and equipment.
Conduct pilot study to evaluate use of "green" parts cleaning solvent
at Mechanics Shop.
Emphasize the use of "recycled and other "green" materials in all
remodeling and new construction (e.g. Fire House office expansion,
proposed new visitors center).
Continue to work with the Friends of the Bosque to identify and sell
environmentally preferable bookstore products such as organic
cotton clothing and other materials. Work with the Friends of the
Bosque to provide interpretive signage for products being sold.
Review and revise if opportunities exist, current purchasing
procedures to enhance centralized purchasing and/or approval
process in order to reduce purchase of duplicate materials, minimize
hazardous material stock, maintain hazardous materials inventories
and MSDSs, and encourage environmentally preferable materials.
23
DOI, NFS, CoEMP
Concession contracts issued by NPS for visitor services, including retail,
food, and lodging, include a requirement to develop and implement an
EMS. Each concessioner is required to identify environmental goals
consistent with legal and other requirements and Best Management
Practices. Each concessioner also must identify specific targets to
achieve these goals, incorporating measurable results and schedules.
Targets include environmentally preferable purchasing including organic
and locally grown foods, green cleaners, energy- and water- efficient
appliances, recycled content products, and reduced purchase and use of
hazardous substances.
EPA
To reduce EPA's environmental footprint by increasing and promoting
recycling, reducing materials entering EPA's waste stream, promoting and
achieving increased and preferential use of materials with recycled
content and emphasizing and increasing the purchase and use of
environmentally preferable products. Specific goals in the following
categories: green buildings, green janitorial/maintenance services, green
copy paper/publications, green meetings, green office supplies, green
electronics, green fleets, green landscaping, green power, and waste
prevention can be reviewed at
EPA, Region 1, New
England
EPA Region 1's Green Team has established a goal of purchasing green
substitutes for three high impact janitorial products.
EPA, Region 5
EPA Region 5 will reduce life-cycle environmental impacts associated with
purchased office furnishings and equipment with a target of incorporating
"green" specifications into market surveys and bid requirements for
electronic equipment purchased post FY 2004. Text of the procedure,
Appendix B.
EPA Region 10
EPA Region 10 has established objectives for energy use and hazardous
waste reduction. Targets provide for staff to include Energy Star
Personal communication, Heather Davies, DOI, November 3, 2003.
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Federal Agency/Facility
Objectives and Targets
requirements in the special terms and conditions in 30% of all grants and
contracts and use environmental factors, including Energy Star
compliance, in determining which electronic equipment to purchase.
California EPA
(State Example)
In support of their EMS Environmental Policy, Cal EPA has established
the following green purchasing goals, endorsed by top management of the
Boards, Departments, and Offices of Cal/EPA:
» Achieve gold or higher certification for headquarters building from
United States Green Building Council (USGBC) Leadership in
Energy and Environmental Design (LEED) Existing Building program
by end of 2003.
» Procure 100% postconsumer content and process chlorine free
printer/copier paper by early 2004.
» Formally adopt EPP, Energy, and Transportation policies supporting
EMS Environmental Policy by early 2004.
» Fully comply with SABRC reporting requirements (California Statute)
in paper categories by FY 2003/2004 and provide written
explanations for noncompliance in other categories
» Adopt initial agency-wide electronic equipment procurement, use,
and end-of-life management standards by 2004.
» Reduce greenhouse gas emissions by 20% by 2010 in partnership
with the Sustainable Silicon Valley Initiative and continue
participation in California Climate Action Registry.
» Divert 75% of our headquarters waste stream by 2010 with a future
goal of zero waste.
24
Environment Agency of Great Britain
The Environment Agency of Great Britain has implemented an EMS and, since the Agency
spends more than half of its budget on supplies and services, identified procurement as a
significant aspect. Their Agency Environmental Procurement Strategy includes the following
objectives and targets:
* Conduct Environmental Risk Assessments on all Contracts over £15K (approximately
$38K);
* Green all purchases that have large environmental and social impacts over which the
Environment Agency has leverage;
* Conduct detailed environmental audits for the top 25 suppliers; and
* Conduct environmental telephone interviews of the top 500 suppliers.
The Agency conducted an Agency Environmental Risk Assessment which identified the
following key procurement targets:
Personal communication, P.K. Wohl, CIWMB, November 13, 2003.
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Strategic Security
Chemicals
Hardwood Groynes
Monitoring Instruments
Lab Consumables
Tactical Acquisition
1 00% PCW Paper
Furniture
Eco Stationery
LPG Fuel for Hybrids
£125K
£500K
£870K
£980K
£320K
£900K
£990K
£800K
Strategic Critical
Construction
Energy
Vehicles/Plant
IT Hardware
Tactical Profit
Consultancy
Cartography
Software
FSC Softwood
£120M
£3.5M
£18M
£15M
£70M
£1M
£12M
£1M
Key suppliers must respond to the following questions:
* Does your organization have an environmental policy?
* Does your organization have anyone responsible for its environmental performance and
management?
* Has your organization undertaken any assessment of the environmental impacts of
operations?
* Has your organization set any targets for reducing environmental impacts?
* Does your organization produce any publicly available information on environmental
performance?
* Does your organization have a system in place for managing environmental
performance?
ENVIRONMENTAL MANAGEMENT PROGRAM
ISO 14001 Element
Section 4.3.4 of ISO 14001 requires that the organization establish and maintain programs for
achieving its objectives and targets. These plans include the designation of responsibility for
achieving the objective and meeting the target at each relevant function and level of the
organization. The standard further requires that the plans define the means and time frame by
which this is to be achieved. The standard also states that if a project relates to new development
and new or modified activities, products, or services, programs shall be amended where relevant
to ensure that environmental management applies to such projects.
Federal Facility Examples
Federal Agency/Facility
U
.S. Postal Service (USPS)
Environmental Management Programs
Chapters of the US Postal Service Handbook AS-552, Pollution
Prevention Guide (August 1996) discusses the link between pollution
prevention and purchasing, and provides guidance on participating in
USPS's affirmative procurement program. It explains the concept of
affirmative procurement and provides information sources for
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Federal Agency/Facility
Environmental Management Programs
identifying products with recycled materials. The AS-552 Guide
highlights DSPS policy and "addresses goals and objectives that
should go into facility plans and procedures. Official adoption of these
at the facility level, either by reference to AS-552 or by restating them
in a plan or SOP, is what becomes part of the EMS for the facility.
,,25
EPA, Region 1
The EPA Region 1 Green Team focuses on the objectives and targets
established by the Agency's EMS. The Regional Administrator has
allocated 0.05 FTE to each Green Team Member, thus Green Team
participation is included in each member's performance review. The
Green Team is tasked with the following activities:
» Continue to coordinate with the development of the EMS
» Launch a Green Cleaning Pilot Project
» Establish an Affirmative Purchasing Policy
» Take advantage of the BPA for an E-catalog and ordering
system for Office Supplies
» Report on procurement of recycled content products
» Assist the purchasing department in addressing environmental
issues.26
EPA, Region 5
Region 5 has established an Environmental Management Program to
achieve documented objectives and targets for the purchase of
electronic equipment. Elements of the EMP:
Green specifications in requests for bids from vendors include
-Reduction in toxins (lead, mercury, cadmium, chromium),
-Postconsumer recycled content.
-Large plastic components are labeled and not painted or varnished.
-No mechanical tools are required to remove batteries.
-The use of non-separable connections is minimized.
-IT representatives trained in green electronics
-Identify products that have received certification by third party eco-
label organizations, received a manufacturer's internal self-
certification, or have an eco-declaration.
-Total cost of ownership will be used in the procurement decision.
See Appendix B.
EPA, Region 9
To meet their green purchasing objectives and targets, Region 9 has
established a cross-functional Affirmative Procurement team including
two Affirmative Procurement Coordinators, one from the Facilities
Program Office and one from the Contracts Office, as well as staff
from P2, Solid Waste and the EMS Team. The Team reviews current
procurements and develops lists of products currently purchased,
their environmental attributes (recycled content levels, energy and
water efficiency, low VOC, etc.), and approximate annual purchases
using budget and purchasing records. The Team meets to determine
research needs and priorities. The Team will conduct research and
25 Personal communication, Ron Robbins, USPS, March, 2004.
26 Personal communication, Rob Guillemin, Region 1, November, 2003.
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Federal
Agency/Facility
Environmental Management Programs
develop
services
vendor lists and specifications on priority products
27
and
Environmental Management Program (DRAFTMay 27th)28
EPA Region 9 also developed the following Environmental Management Program to designate
responsibility and time frames for achieving its Environmentally Preferable Purchasing (EPP)
objectives and targets. For additional information, visit their website:
Waste - Environmental Preferable Purchasing (EPP)
EMP 5B-03
Dept: R9 EMS Team Responsible Person: Heather White
Implementation Start Date: March 15, 2003
Objectives:
Study EPP priorities for FY04
Study best approach for inclusion of green meeting clause in all R9 contracts
Target:
Complete studies and plans by December 31, 2003
Strategy
Develop partnership with WasteWise (WW); study best areas / products to focus on; determine
baseline; identify best approach for inclusion of green meeting clause in all contracts; work with
PMD on green meeting language / policy; work with PMD to educate bank card holders on EPP.
27 Region 9, Affirmative Procurement Plan, p. 6.
28 Personal Communication, Heather White, EPA Region 9, November, 2003.
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Actions to Achieve Objective and Target:
1) Create Waste Team
2) Meet with WasteWise and Affirmative Procurement to discuss
common goals
3) Identify study plan and measurement methods
4) Confirm approach with EMS Team & Advisory Committee
5) Meet with WasteWise and Affirmative Procurement to gather
information on background
6) Document EPP purchases to establish a baseline
7) Study which products will be priorities in FY04
8) Study best way to incorporate green meeting language in all
contracts
9) Work with PMD and HQ to write green meeting language/policy
forR9
1 0) Work with PMD to research best way to educate bank card
holders
11) Present EPP information/requirements at AO meeting
12) Present EPP information/requirements at bank card training
13) Prepare study
14) Review EMP and revise as needed
Target Date:
1) March 15th
2) March 20th
3) May 5th
4) May 29th
5) May 15th
6) June 2nd -Sept. 19th
7) May 7th -Sept. 1st
8) Aug. 20th
9) Sept. 1st
10) July 15th
11) Aug. 29th
12) Sept. 1st
13) Sept. 1st
14) Sept 15th
Completion
1) March 1st
2) March 11th
3) May 22nd
4) May 29th
5) April 23rd
6) Ongoing
7) Nov. 19th
8) May 1st -ongoing
9) May 1st -ongoing
10) July 17th (mtg.
with B. Bycsek)
11) Sept. 10th
12) On going-
A O\
13)
A A \
14)
STRUCTURE AND RESPONSIBILITY
ISO 14001 Element
Section 4.4.1 of ISO 14001 requires that roles, responsibilities and authorities shall be defined,
documented, and communicated to facilitate effective environmental management systems.
Management must provide resources essential to implementation and control of the EMS. The
organization's top management must appoint a specific management representative who shall
have the defined role, responsibility and authority to ensure that the EMS requirements are
established, implemented and maintained in accordance with the standard and must report on the
performance of the EMS to top management.
Federal Facility Examples
Government agencies wisely have included procurement and contracting personnel on their EMS
Team. This allows the personnel with purchasing responsibilities for the organization to become
aware of the potential for green purchasing solutions to pollution prevention challenges. It also
is important to designate responsibility for pursuing and achieving each green purchasing
objective and target.
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Federal Agency/Facility
Structure and Responsibility
EPA Region 9
Region 9 has an Affirmative Procurement/EMS Team consisting of
Affirmative Procurement Leads from Purchasing and Contracts as well as
representatives from the Office of Pollution Prevention and Solid Waste
and the EMS staff person responsible for EPP. Management has
provided documented support for EPP, even if the costs are higher, and
offers awards and recognition for EPP leadership.
EPA Region 1
Rob Guillemin of EPA Region 1 notes that "more communication needs to
take place between the Green Team/EMS efforts and the purchasing
department." Originally, the head of the purchasing department was on
the EPP subgroup but she was unable to attend meetings due to her
hectic schedule. Consequently, full buy-in and coordination has yet to
occur with the purchasing office. This is a major issue. Ideally, I would
like to see a regular meeting schedule between members of the Green
Team's EPP group and the purchasing office to identify areas of concern
and identify areas where the EPP group could bring their time and
expertise.29
USDA, ARS, Beltsville Area
David Prevar notes, "The EMS at BA brings together all components of
the research center into an alliance aimed at environmental protection.
All employees and programs are directed to comply with affirmative
procurement requirements, under a policy promulgated by the Area
Director. The Biobased Products Program is integral with the
Environmentally Preferable Products and Affirmative Procurement
Program. In essence, all elements of the EMS involve green purchasing.
DOD, U.S. Army, Ft. Lewis
WA
Ft. Lewis found that staff lacked understanding of the Affirmative
Procurement Program and how to effectively integrate it into the EMS.
They also found that organizations and activities outside the
environmental program were not taking responsibility for green
procurement.30 To address this concern, an individual is appointed as
the Program Management Team Lead for each objective.
DOI, NPS, CoEMP
The NPS Concession Environmental Management Program has
emphasized that individuals responsible for purchasing should participate
in the EMS. Concessioners have following through by appointing central
purchasing representatives to EMS teams.
TRAINING, AWARENESS AND COMPETENCE
ISO 14001 Element
Section 4.4.2 of the ISO 14001 standard requires that the organization must identify training
needs. It further requires that all personnel whose work may create a significant impact upon the
environment receive the appropriate training. The organization shall further establish and
maintain procedures to make its employees at each relevant function and level aware of: the
importance of conformance with the environmental policy and procedures and with the
requirements of the EMS; the significant environmental impacts, actual or potential, of their
Personal communication, R. Guillemin, EPA Regionl, November, 2003.
Personal communication, H. Fleming, Ft. Lewis, November, 2003.
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work activities and the environmental benefit of improved personal performance; their particular
roles and responsibilities in achieving conformance including emergency response; and the
potential consequences of departure from specified operating procedures. The standard further
states that personnel performing the tasks that can cause significant environmental impact shall
be competent on the basis of appropriate education, training, and experience.
Federal Facility Examples
Federal agencies traditionally have identified and implemented training to meet regulatory
responsibilities. The EMS encourages evaluation of training responsibilities based on employee
awareness of the environmental impacts of job performance, as well as knowledge of the
organization's significant impacts and objectives and targets.
Federal Agency/Facility
NASA
USDA, ARS, Beltsville Area
EPA Headquarters
EPA, Region 9
EPA, ESC, Fort Meade, MD
Training
Christel Van Arsdale, EMS Manager for NASA's Ames Research
Center says, "We are doing training across the Center to achieve our
objectives of improved CPG compliance and promotion of the 100%
recycled paper product." Training is conducted for targeted groups as
well as one-on-one with bank card holders.31
To enforce the Beltsville Agricultural Research Center's Affirmative
Procurement Program, staff developed an online training program.
This APP training assures that all BA government purchase card users
are aware of and participate in the Program. Names of employees
completing the training are monitored by the Safety, Occupational
Health and Environmental staff to assure that everyone is "on board."
A manual detailing the program to serve as a reference for decision
makers, such as procurement and contracting officials, has been
developed and distributed.32
To meet the stated goal of buying all office supplies through EPA's
tailored green online ordering system by 2005, EPA Headquarters has
provided electronic and face-to-face training on how to use the online
ordering system for all EPA credit card holders and office supply
33
purchasers.
The Region 9 Affirmative Procurement Plan states, "The Solid Waste
Program will provide training to PMD on environmentally preferable
purchasing resources and guides to enable PMD to share research
responsibilities beyond the first year of the program. In addition, both
PMD Affirmative Procurement Coordinators and Solid Waste Program
Staff will attend at least one outside training program on
environmentally preferable purchasing annually to learn about new
products and procurement practices. The Team will provide training to
other procurement staff, purchase card holders, and program staff."34
The Environmental Science Center's Procedure for EPP includes in its
scope a statement that "The ESC will train its staff to purchase goods
Personal communication, Christel Van Arsdale, Ames Research Center, November, 2003.
Personal communication, David Prevar, December, 2003.
Personal communication, Holly Elwood, OPPT/EPP, July, 2004.
EPA Region 9, Affirmative Procurement Plan. p. 6.
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Federal Agency/Facility
DOD, U.S. Army, Fort Lewis,
WA
DOI, NPS, CoEMP
Training
and services that reduce impacts associated with ESC's identified
significant environmental aspects. The ESC will communicate specific
procedures and requirements to those suppliers and contractors that
provide goods and services associated with significant environmental
aspects." The Procedure also includes the following training
commitment: "Members of the EMS Team will train all ESC staff who
make purchases (all types of purchases, including contracts) on this
procedure, EPA's EPP Goals, the resources covered in this procedure,
and reporting of environmentally-preferable purchases to the EMS
Team."35
The Fort Lewis Director of Contracting conducts a training course for all
individuals designated as purchase card holders. The class includes a
section on Affirmative Procurement requirements.36
NPS concession contracts for visitor services, including retail, food and
lodging, include a requirement for EMS training. Each concessioner
must describe the training program, including staff to be trained,
training subjects, including environmentally preferable purchasing,
frequency of training and how training will be documented.
COMMUNICATION
ISO 14001 Element
Section 4.4.3 of the ISO 14001 standard requires that: with regard to its environmental aspects
and its EMS, the organization shall establish and maintain procedures for internal
communication among the various levels and functions of the organization; receiving,
documenting, and responding to relevant communication from external interested parties; and
that it shall consider processes for external communication of its significant environmental
aspects and record its decision.
Federal Facility Examples
Federal Agency/Facility
Communication
EPA Region 9
The Region 9 Affirmative Procurement Plan states:" The Affirmative
Procurement Program will be publicized by the Affirmative Procurement
Team through EMS, WasteWise, and Pollution Prevention speakers on
environmentally preferable purchasing, and through affirmative
procurement training for credit card holders and contracting officers. An
electronic Affirmative Procurement Annual Report will be provided to the
Region, and significant purchases will be publicized in electronic
WasteWise Bulletins. Information on environmentally preferable
purchasing practices or products tested will be shared by the Affirmative
Procurement Team, as appropriate, with EPA headquarters, other EPA
regions, and Region 9 stakeholders."
EPA ESC Draft Procedure ESC-EP08 September 9, 2003. p. 6.
Personal communication, Harry Fleming, December, 2003.
EPA Region 9, Affirmative Procurement Plan, Section III (C), p. 6-7.
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Federal Agency/Facility
Communication
DOI, NPS
Intermountain Region
The National Park Service Intermountain Region developed a Green
Purchasing Program (GPP) based on quantifiable criteria for what a
product must be to be "green." Staff is trained in the use of an internet-
based program that lists products that have been screened and
organized by category for easy access. Special emphasis is given to
GSA, JWOD, and DLA-listed products. The program also provides
features for a user to screen new products.
38
DOI, NPS
Grand Canyon
At the Grand Canyon, green purchasing was the first initiative selected for
implementation by the EMS Team. The Team is developing a pamphlet
for park-wide distribution to visitors, staff, employees and concessionaires
with information on recycled content products and how they can be
purchased.
39
DOI, NPS, CoEMP
NPS concession contracts for visitor services including retail, food and
lodging, include a requirement that each concessioner describe how the
environmental policy, goals, targets, responsibilities and procedures will
be communicated throughout the concessioner's organization. Each
concessioner also must describe and implement a system for reporting
environmental information to the Director.
USDA, ARS, Beltsville
Area
The Beltsville Guide to Affirmative Procurement describes the promotion
program for location employees and potential contractors or vendors:
Familiarize all purchasers with APP requirements; Conduct workshops or
training sessions to educate employees about their responsibilities under
the APP; Distribute APP policies to all organizations along with APP
training resources; Publish a list of local vendors of recycled content and
biobased products that meet EPA's CPG requirements or comply with
USDA's biobased product guidance; Publish articles in organizational
newsletters; Update local operating instructions to include APP
requirements; Seek volunteer organizations for limited trials of new
products, get feedback on the cost and performance of the products, and
publicize the results location wide; Consider using a facility construction
or renovation project as a showcase for recycled-content and biobased
building materials; Provide periodic updates through the e-mail system;
Recognize outstanding efforts of personnel toward AP.
40
DOCUMENT CONTROL
ISO 14001 Element
Section 4.4.5 of the ISO 14001 standard requires that procedures must be established and
maintained for controlling documents required by the standard to ensure that: the documents can
be located; the documents are periodically reviewed, revised as necessary, and approved for
adequacy by the authorized personnel; the current versions of relevant documents are available at
all locations where operations essential to the effective functioning of the system are performed;
obsolete documents are promptly removed from all points of issue and use, or otherwise assured
' Personal communication, J.Craig Erickson, November, 2003.
' Dr. Mary Ann McCloskey, Personal Communication, November, 2003.
1 DOI, ARS, Beltsville Area Guide to Affirmative Procurement. (January, 2003) Section 2.2.1.2, p. 12.
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against unintended use; and any obsolete documents retained for legal and/or knowledge
preservation purposes are properly identified.
Federal Facility Examples
This element ensures that documentation, including, for example, product specifications,
purchase and contract documents, justification for the purchase of green products and/or lists of
green products approved for purchase is readily available to product users and procurement and
contracting personnel.
Federal Agency/Facility
Document Control
DOD, U.S. Army, Fort
Lewis WA
At Fort Lewis, the EMS Implementation Team placed all EMS
documentation, such as plans, manuals, procedures, and forms, onto the
Public Works Intranet. No paper copies are maintained, and all changes
are updated and communicated automatically. The Document Manager
estimates that hundreds of labor hours and reams of paper have been
saved through avoidance of annual document updates and changes.
This approach has been so successful that other, non-environmental
programs have adopted the EMS document control model within their
programs.
DOI, NPS, Grand Canyon
Xanterra Parks and Resorts maintains the official copy of its EMS on the
Company intranet site. Any paper copies printed from this site are
designated unofficial copies.
DOI, NPS, CoEMP
Concession contracts issued by NPS for visitor services include a
requirement for an EMS that includes a Document Control and
Information Management System. Each concessioner should identify
how it will manage environmental information including plans, permits,
certifications, reports and correspondence. NPS recommends that
concessioners maintain specifications for all products purchased,
especially those that are environmentally preferable, and make these
specifications readily available to employees responsible for purchasing.
OPERATIONAL CONTROL
ISO 14001 Element
Section 4.4.6 of the ISO 14001 Standard requires that operations and activities associated with
the identified significant environmental aspects must be identified in line with policy, objectives,
and targets. These operations and activities, including maintenance, must be planned in order to
ensure that they are carried out under specified conditions by: establishing and maintaining
documented procedures to cover situations where their absence could lead to deviations from the
environmental policy and the objectives and targets, stipulating operating criteria in the
procedures and establishing and maintaining procedures related to the identifiable significant
environmental aspects of goods and services used by the organization, and communicating
relevant procedures and requirements to suppliers and contractors.
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Federal Facility Examples
Many organizations have established Operational Controls for green purchasing and contracting
activities. These procedures include boilerplate contract language and product specifications to
ensure that green purchasing activities are implemented.
Federal Agency/Facility
Operational Control
EPA Region 1
EPA Region 1 identified significant aspects including use of resources,
use of energy, and air emissions. For three activities, Fleet Management,
Environmentally Preferable Electronics and Environmentally Preferable
Purchasing, Region 1 has established formal operational controls to
ensure green purchasing. The Operational Control Procedure directs
Managers to use environmental considerations as the basis for award, as
appropriate. Fleet Management staff is directed to "select and procure
fleet vehicles based on fuel efficiency, usage requirements and costs and
national and regional policies." Purchasers of electronic equipment are
directed to purchase only Energy Star compliant computers and to
purchase duplex printers for networks. Paper purchases are limited to
100% recycled content paper for printers and copiers. Recycled paper is
required for business cards and name tags and recycled content for
plaques and awards. These operational controls ensure that EPA New
England's staff has clear direction on how to carry out green purchasing
activities that may control significant aspects and reduce or eliminate
environmental impacts. The complete EPA Region 1 Operational
Controls Procedure is included in Appendix B.
EPA Region 5
Region 5 established the following requirements for procurement of
electronic equipment:
Reduction in toxins: (lead, mercury, cadmium, chromium)
Postconsumer recycled content
Large plastic components are labeled
Plastic components are not painted or varnished
No mechanical tools are required to remove batteries
The use of non-separable connections is minimized
Processor can be upgraded
Memory can be upgraded
Storage devices can be upgraded
Spare parts are available for at least 5 years after the end of production
Total cost of ownership will be used in the procurement decision
EPA, ESC, Ft. Meade, MD
EPA's Environmental Science Center at Fort Meade, MD has developed
an Operational Control Procedure specific to the process of
communicating with suppliers and contractors. The procedure is
designed to help ESC staff purchase goods and services that reduce
impacts associated with identified significant environmental aspects and
to communicate information and/or requirements related to the identifiable
significant environmental aspects of goods and services used by the ESC
to suppliers and contractors in accordance with the requirements of the
ESC Environmental Management System (EMS).41 The procedure
includes green purchasing criteria for specific products and services. For
example, under Janitorial Services, contractors are directed to consult a
Environmental Science Center: ESC-EP08, Environmentally-Preferable Purchases, Communicating with
Suppliers and Contractors, (DRAFT, September, 2003) p. 1.
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Federal Agency/Facility
Operational Control
variety of resources, including Green Seal's Choose Green Report,
"General Purpose Cleaners," March 1998, GSA's Environmental Products
and Services Guide: "Cleaning Products" and "Hardware Products:
Miscellaneous" sections (and any other applicable sections). In addition,
the Facility Manager is directed to consult the Pennsylvania Green
Building Operations and Maintenance Manual, "Cleaning Procedures"
section to identify additional environmentally-preferable janitorial practices
to possibly include as clauses in future ESC janitorial services contracts.
This manual incorporates ASTM's Cleaning Stewardship for Community
Buildings Standard.
ESC's procedure also includes the following boiler plate language
required in all ESC contracts: "Each company offering a cost proposal
should provide information on its environmental management system
(EMS) and whether it is an EPA National Environmental Performance
Track42 member to the ESC. The ESC will use this information as part of
its selection criteria."43 The full text of ESC-EP08, Environmentally-
Preferable Purchases, Communicating with Suppliers and Contractors,
(DRAFT, September, 2003) may be found in Appendix B.
USDA, ARS, Beltsville Area
The Beltsville Area's Affirmative Procurement Guide includes the following
specific operational controls for procurement:
» Contracts awarded by executive agencies after September 14, 1998
shall include provisions that obligate the contractor to comply with
EO 13101 within the scope of their operations.
» When USDA completes the biobased product designation, every
designated biobased product that is purchased will automatically
become part of this AP program.
» If a purchaser finds that a biobased product is more preferable due to
environmental attributes, technical performance, or price, it can be
selected in place of a similar recycled-content product.
» Recycled-content products meeting EPA guidelines will always be
purchased unless they are not available competitively within a
reasonable period of time; at reasonable prices; or to meet
reasonable performance standards in the specifications. A written
determination by technical or requirements personnel of the
performance standard's reasonableness must be included with the
justification. The technical and requirements personnel must base
their determination on National Institute of Standards and
Technology (NIST) guidelines, if available. If a product is more
expensive, but has non-financial environmental or operational
benefits, the purchaser is not required to claim the "reasonable price"
exemption.
44
Department of Defense
(DOD)
The has incorporated green purchasing operational controls into contracts
for custodial services and O & M as well as Design-Build Task Orders.
Custodial contracts include requirements for an environmental
stewardship plan, which includes an Affirmative Procurement program for
EPA's Performance Track program information http://www.epa.gov/performancetrack/program/ems.htm
Ibid., Attachment 1.
Beltsville Agricultural Center. Guide to Affirmative Procurement. (January, 2003) Section 2.2.1.2, pp. 6-9.
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Federal Agency/Facility
DOI, NPS, CoEMP
Operational Control
EPP, use of products specified in the Comprehensive Procurement
Guidelines (CPG), and a waste minimization and recycling program. The
following specific requirements are included: "For the following product
types, the Contractor shall use only products with the specified material
contents or attributes:
(1) Bathroom tissue -The bathroom tissue shall contain at least 100%
recovered materials and 50% postconsumer content.
(2) Toilet Seat Covers - Toilet seat covers shall contain at least 100%
recovered materials and 50% postconsumer content.
(3) Paper Towels - The paper towels shall contain at least 100%
recovered materials and 40% postconsumer content.
(4) General Purpose Industrial Wipes -The general purpose industrial
wipes shall contain at least 100% recovered materials and 40%
postconsumer content.
(5) Plastic trash bags - Plastic trash bags shall contain at least 25%
postconsumer content.
Waste Collection Carts and Containers. Carts and containers used for
the collection and/or storage of waste material shall be of noncombustible
or flame resistant construction, shall be constructed of environmentally-
preferable materials ....
O & M Contracts include requirements for energy efficiency, conformance
to the APP, and meeting the goals and objectives stated in Executive
Order 13101. Other contracts include the following language:
The Contractor shall integrate the use [of] EPP into the selection process
for all materials used in this contract. EPP are products that reduce effects
on human health and the environment which consider raw material
source, production, manufacturing, packaging, distribution, use of
recovered materials, reuse of product, operation, maintenance, disposal,
and recyclability. These attributes shall also be balanced with overriding
goals of durability, cost effectiveness (based on life cycle cost analysis),
and reliability. The Contractor shall comply with requirements of the
comprehensive procurement guidelines . . .
The NPS Concession Environmental Management Program encourages
concessioners to establish, document and maintain and train employees
on procedures that should be followed regarding environmentally
preferable purchasing.
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EMERGENCY PREPAREDNESS AND RESPONSE
ISO 14001 Element
Section 4.4.7 of ISO 14001 requires that an organization establish and maintain procedures to
identify the potential for accidents and emergency situations, respond to accidents and
emergency situations, and prevent and mitigate any associated environmental impacts. The
procedure should be reviewed and revised if necessary, particularly after an occurrence of an
accident or emergency situation. The procedure must be tested periodically where practical. This
procedure must take into account both normal and abnormal operational conditions.
Federal Facility Examples
Federal Agency/Facility
Emergency Preparedness
USDA ARS Beltsville Area
David Prevar notes that, "On occasion, spills of petroleum products
occur, despite our spill prevention plans. When this happens, spill
kits that are made of environmentally friendly products are used for
cleanup. If a larger spill occurs, environmentally friendly containment
and absorbent materials are used. One of the absorbent products
used is derived from recycled corn cobs. After use on a spill, the
cleanup material, instead of being disposed of as hazardous waste,
is picked up by a recycling plant for use as a higher BTU fuel. This is
a prime example of how products are chosen for life cycle
environmental attributes. Even the Radiation Safety Unit uses a
biobased product, for surface contamination cleanups.
Environmental preferability is part of the culture at BARC.
MONITORING AND MEASUREMENT
ISO 14001 Element
Section 4.5.1 of the ISO 14001 Standard requires that documented procedures be established and
maintained to routinely monitor and measure key characteristics of operations and activities that
can have a significant impact on the environment. Information should be recorded to track
performance, relevant operational controls, and performance with the objectives and targets.
Monitoring equipment must be calibrated, maintained, and records of this process must be
retained. Furthermore, a documented procedure for periodically evaluating compliance with
relevant environmental requirements must be established and maintained.
Federal agencies are required to submit annual reports on their green purchasing activities as
described in the chart, below:
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Green Purchasing Reporting Requirements
Legal Requirement
RCRA Section 6002
EO 13101
Energy Policy Act of
1992(EPAct)
Farm Security and
Rural Investment Act
of 2002
EO 13123
Reporting Requirements
Annual report on:
Purchases of EPA-designated recycled content products
Progress in solid waste prevention, composting, and recycling
Progress in purchasing environmentally preferable products
Progress in purchasing biobased products other than fuels
Policy or procedure for implementation of the Affirmative Procurement
Program (APP)
APP Training
APP compliance audits
Agency goals
Annual alternative fuel vehicle (AFV) acquisition report
Requirements for reporting on purchases of designated biobased products to
be determined
Annual implementation plan, energy scorecard, and energy management
data report to the President and Congress
Federal Facility Examples
Federal Agency/Facility
Monitoring and Measurement
NASA
EMS staff at NASA's Ames Research Center tracks the use of 100%
postconsumer, processed chlorine-free paper to measure progress toward
achieving their goal of increasing use of this paper to 10% of total office
paper purchases.
DOD, U.S. Army, Ft.
Lewis WA
At Fort Lewis, when objectives and targets are identified, a set of metrics
is also developed to measure achievement of the objective. The Program
Team Manager for the objective is responsible for providing quarterly
progress reports to the Organizational EMS Representative who then
provides the information to Management.
EPA ESC Fort Meade MD
The ESC included the following measurement requirement in their EPP
Procedure: Reporting/Measurement of ESC Environmentally-Preferable
Purchases - Whenever a purchase of environmentally-preferable goods is
made, the amount purchased (not cost data) should be reported to the
EMS Team for inclusion in a spreadsheet or database that will keep track
of ESC's annual "green" purchases. This information will help EPA
determine its progress in meeting its EPP goals and can also be used in
ESC's Annual Environmental Report.
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EPA Region 9
EPA Region 9's Affirmative Procurement Plan has been incorporated into
their EMS. The APP states that PMD Affirmative Procurement
Coordinators will have primary responsibility for overseeing program
tracking. The Affirmative Procurement Team will be responsible for
compiling and summarizing the information in an electronic Affirmative
Procurement Annual Report which will include information on: Type of
Product, Verified Recycled Content, Other Environmental Attributes, Total
Cost, and any Affirmative Procurement Preference Costs. The Annual
Report will also summarize the total dollar amount spent on Affirmative
Procurement Products and the portion of the Affirmative Procurement
Budget spent. The quantity and environmental characteristics of major
purchases under this Plan will be tracked for annual reporting purposes.
Purchases that go beyond the minimum requirements for environmentally
preferable procurements also will also be tracked.
US PS
The Postal Service Northeast Region receives annual reports on
purchases of retread tires and re-refined lubricating oil from each Vehicle
Maintenance Facility.
DOI, NPS, CoEMP
NPS concession contracts for visitor services such as retail, food and
lodging include a requirement that concessioners monitor and measure
their environmental purchasing performance against established EMS
goals and targets.
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NONCONFORMANCE AND CORRECTIVE AND PREVENTIVE ACTION
ISO 14001 Element
Section 4.5.2 ISO of the ISO 14001 Standard requires that an organization establish and maintain
procedures for defining responsibility and authority for handling and investigating non-
conformances, taking action to mitigate any impact caused and for initiating and completing
corrective and preventive action. Any corrective or preventive action taken to eliminate the
causes of actual and potential nonconformance shall be appropriate to the magnitude of the
problems and commensurate with the environmental impact. The standard further states that the
organization must implement and record any changes in the documented procedures resulting
from corrective or preventive action.
Federal Facility Examples
Federal Agency/Facility
Nonconformance and Corrective Action
EPA ESC Ft. Meade, MD
EPA's Environmental Science Center at Ft. Meade, MD has an
objective and target for Paper Consumption which states that the
ESC will "develop a strategy to reduce paper consumption while
increasing the recycled content and the percentage of paper
recycled." During FY03, all of ESC 's copy paper was changed
from 30% recycled-content to 100% recycled-content, process
chlorine free paper. When the switch was first made, departmental
representatives communicated many complaints that the paper
jammed copiers and printers. In response, staff placed individual
logs next to all the copiers and printers and people were asked to
document when jams occurred. This data was used in conjunction
with a "paper consultant" from Boise Cascade, who was able to
work with the individual machine settings to reduce the number of
jams experienced by ESC staff.
45
DOD, U.S. Army, Ft. Lewis, WA
At Ft. Lewis, during an EMS Internal Audit, document control and
operational procedures are reviewed. If an auditor finds that a
given documented procedure is not being followed, a Preventive
Corrective Action Report (PCAR) is written and the activity not
adhering to the procedure has to conduct an investigation and
recommend a corrective action. Once the root cause of the
problem has been determined and a correction implemented, it is
verified by the EMS Representative and the PCAR is closed out.
46
ESC
H. Fleming, personal communication, November, 2003.
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Integrating Green Purchasing into your EMS: Final Draft
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RECORDS
ISO 14001 Element
Section 4.5.3 of ISO 14001 states that procedures must be established and maintained for the
identification, maintenance, and disposition of environmental records. The records must include
training records, and results of audits and reviews. Records should be legible, identifiable, and
easily traceable and protected against damage and loss. Records must be maintained to
demonstrate compliance with the requirements of the standard and the EMS.
Federal Agency/Facility
Records
EPA ESC Ft. Meade, MD
ESC included requirements for records management in their
Environmentally-Preferable Purchases Procedure. Written
communications with ESC suppliers and contractors will be
retained in the EMS records. When this procedure is reviewed,
records will be maintained on suggested changes, including
procedural changes or tools, and why the changes were or were
not included. Data on ESC environmentally-preferable purchases
also will be retained in the EMS records.47
DOI, NPS, CoEMP
Concession contracts issued by NPS for visitor services, including
retail, food and lodging, include a requirement that, as part of their
EMS, concessioners identify records maintained to comply with
applicable laws and Best Management Practices. These include
training records for environmentally preferable purchasing and
receipts for purchases of environmentally preferable products.
ENVIRONMENTAL MANAGEMENT SYSTEM AUDITS
ISO 14001 Element
Per the requirements of Section 4.5.4 of ISO 14001, an organization shall establish and maintain a
program(s) and procedures for periodic environmental management system audits to be carried out in
order to: determine whether or not the EMS conforms to planned arrangements for environmental
management, including the requirements of the standard and the EMS documentation; and determine
whether the EMS has been properly implemented and maintained and to provide information on audit
results to management.
Federal Agency/Facility
EPA
ESC Ft. Meade, MD
EMS Audits
ESC includes requirements for annual review in its EPP
Procedures. Specifically, the EMS Team will meet to review the
procedure and EPA's EPP Goals. The EMS Team will discuss
the procedure's effectiveness, whether it should be modified, and
whether tools (e.g., web site or forms) should be developed to
facilitate environmentally-preferable purchasing at ESC. To
Environmental Science Center. ESC-EP08, Environmentally-Preferable Purchases, Communicating with
Suppliers and Contractors, (DPvAFT, September, 2003) p. 8.
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Integrating Green Purchasing into your EMS: Final Draft October, 2004
prepare for the discussion, the EMS Team should survey
purchasers and meeting planners at the ESC to discuss the
effectiveness of the procedure.
MANAGEMENT REVIEW
ISO 14001 Element
Section 4.6 of ISO 14001 requires that top management periodically review the EMS to ensure its
continual suitability, adequacy and effectiveness. The review process must ensure that all necessary
information is collected for the evaluation. The review must be documented. The review will address
possible needs for changes to the policy, objectives, and the EMS with consideration for EMS audit
results, changing circumstances, and the commitment to continual improvement.
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SECTION 3: BACKGROUND INFORMATION
GENESIS OF THIS REPORT
This report was developed by the EPA's Environmentally Preferable Purchasing Team in
response to requests from, and in partnership with, stakeholders, including EPA's Federal
Facilities Enforcement Office, Office of Policy, Economics and Innovation, Design for the
Environment (DfE) Program, the White House Office of the Federal Environmental Executive,
and several Federal facilities. The report is informed by information from multiple interviews
with representatives of Federal facilities whose staff incorporated green purchasing into the
elements of their EMS. The Acknowledgements page provides a list of those individuals whose
input, knowledge and experience contributed to the value of this report.
DEFINITIONS AND ACRONYMS
Definitions http://ceq.eh.doe.gov/nepa/re2s/eos/eol3148.html
Affirmative Procurement
Biobased product
A program to increase green purchasing activities in Federal agencies.
AP Programs originally focused on the purchase of products
manufactured from recovered/recycled materials; however, AP concepts
have expanded to include other environmental considerations.
A commercial or industrial product (other than food or feed) that uses
biological products or renewable domestic agricultural (plant, animal,
and marine) or forestry materials.
Environmentally Preferable Products or services that have a lesser or reduced effect on human health
and the environment when compared with competing products or
services that serve the same purpose. This comparison may consider raw
materials acquisition, production, manufacturing, packaging, distribution,
reuse, operation, maintenance, or disposal of the product or service.
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Integrating Green Purchasing into your EMS: Final Draft
Acronyms
AFV Alternate Fuel Vehicle
ARS Agricultural Research Service
CPG Comprehensive Procurement Guidelines
DOD Department of Defense
DOT Department of the Interior
EMS Environmental Management Systems
EO Executive Order
EPA Environmental Protection Agency
ESC Environmental Science Center
EPP Environmentally Preferable Purchasing
FAR Federal Acquisition Regulation
FEMP Federal Energy Management Program
FWS Fish and Wildlife Service
GSA General Services Administration
ISO International Organization for Standardization
JWOD Javits Wagner O'Day Act
OFPP Office of Federal Procurement Policy
OFEE Office of the Federal Environmental Executive
NASA National Aeronautics and Space Administration
NFS National Park Service
RCRA Resource Conservation and Recovery Act
RMAN Recovered Material Advisory Notice
USDA U.S. Department of Agriculture
USPS U.S. Postal Service
October, 2004
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What Is Green Purchasing?
Green Purchasing refers to the practice of preventing waste and pollution by considering
environmental impacts, along with price, performance, and other traditional selection factors,
when making purchasing decisions. Green purchasing often is included within the definition of
pollution prevention, since the selection and use of green products can reduce both the quantity
and toxicity of waste streams. All Federal procurement officials are required by the Federal
Acquisition Regulation (FAR and Executive Order (EO)13101, Greening the Government
through Waste Prevention, Recycling and Federal Acquisition, to assess and give preference to
green products and services. Part 23 of the FAR addresses acquisition policies and procedures
for protecting and improving the environment by controlling pollution, managing energy and
water use in government facilities efficiently, using renewable energy and renewable energy
technologies, and acquiring energy- and water-efficient products and services, environmentally
preferable products, and products that use recovered materials.48
EO 13101 requires agencies to consider the following factors in acquisition planning for all
procurements and in the evaluation and award of contracts: "elimination of virgin material
requirements; use of biobased products; use of recovered materials; reuse of product; life cycle
cost; recyclability; use of environmentally preferable products; waste prevention (including
toxicity reduction or elimination); and ultimate disposal."49
Federal green purchasing preference programs are designed to provide agencies with reliable
product information to support and encourage their efforts to purchase green products and
services. Currently, Federal green purchasing preference programs include:
* Products manufactured from recovered materials (Recycled content products),
* Environmentally preferable products
* Energy efficient products,
* Biobased products,
* Alternative fuels and fuel efficient vehicles,
* Non-ozone depleting substances, and
* Priority chemicals.
Federal Green Purchasing Program Requirements
To provide additional direction for purchasing decisions, EPA has developed guidance for Green
Purchasing.50 Section 503 (c) of EO 13101 directs Executive agencies to "use the principles and
concepts in the EPA Guidance on Acquisition of Environmentally Preferable Products and
Services ... in identifying and purchasing environmentally preferable products and services" and
to "modify their procurement programs as appropriate."51 In addition, Section 23.704 of the FAR
48 Access the full text of the Federal Acquisition Regulation at http ://www. arnet gov/far/
49 EO 13101, Section 401
50 Visit
51 Access the text of Executive Order 13101 and the FAR at
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Integrating Green Purchasing into your EMS: Final Draft
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requires agencies to "affirmatively implement" the objective of "obtaining products and services
considered to be environmentally preferable (based on EPA-issued guidance)." EPA's guiding
principles are:
* Include environmental considerations as part of the normal purchasing process.
* Emphasize pollution prevention as part of the purchasing process.
* Examine multiple environmental attributes throughout the product or service's life cycle.
* Compare environmental impacts when selecting products and services.
* Collect accurate and meaningful information about the environmental performance of
products and services.
FEDERAL GREEN PURCHASING LEGAL AND OTHER REQUIREMENTS
Product Category
Recycled Content
Environmentally Preferable
Energy efficient
Biobased
Alternative fuels
Fuel efficiency
Non-ozone depleting substances
Legal and Other Requirements
Section 6002 of the Resource Conservation and
Recovery /Acf (RCRA); EO 13101, Greening the
Government through Waste Prevention,
Recycling and Federal Acquisition; Federal
Acquisition Regulation (FAR), Parts 7, 11, 23.
EO 1 31 01 , Greening the Government through
Waste Prevention, Recycling and Federal
Acquisition; FAR, Parts 7,11, 23.
EO 13123, Greening the Government through
Efficient Energy Management; Federal
Acquisition; Federal Acquisition Regulations
(FAR), Part 23; EO 13221 , Energy Efficient
Standby Power Devices
Section 9002 of the 2002 Farm Security and
Rural Investment Act; EO 13101, Greening the
Government through Waste Prevention,
Recycling and Federal Acquisition
Section 303 of The Energy Policy Act of 1992
(EPAct); Executive Order 13149, Greening the
Government through Federal Fleet and
Transportation Efficiency
Section 613 of the Clean Air Act
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Integrating Green Purchasing into your EMS: Final Draft October, 2004
Green Purchasing Training Resources
OFEE offers green purchasing training to contracting, environmental, and facilities staff. The
training primarily addresses purchasing of recycled content, biobased, and environmentally
preferable products and also touches on purchasing of energy efficient products. It discusses the
legal framework underlying the green purchasing programs, the pertinent Federal Acquisition
Regulation provisions, the common myths about green purchasing, the specifics of the green
purchasing programs, Federal facility green purchasing examples, and product sources, including
mandatory sources.
OFEE and the U.S. Army Center for Health Promotion and Preventive Medicine (USACHPPM)
developed a green purchasing train-the-trainer program, which has been presented to more than
30 Federal agency environmental and procurement staff. The program consists of a PowerPoint
presentation and an accompanying script. In addition to addressing the units discussed in OFEE's
green purchasing training, it discusses the types of training appropriate for different audiences,
compliance, program implementation, and goals and metrics.
The Defense Logistics Agency offers Buying Green: A Multi Functional Approach to Pollution
Prevention. To order the manual or obtain more information on training call (614)692-5969,
1-800-458-7903, or (269) 961-7046 or fax (269) 961-7055.
"What is Green Purchasing, Anywayl" is an online training course providing an introduction to
the Federal green purchasing program for contracting personnel, purchase card holders, facility
and fleet managers. The course is organized into modules and provides examples, resources, and
reference web sites. Course duration ranges from 1 !/2 hours for purchase card holders to
approximately 2 1A hours for contracting officers and contracting officer representatives.
Completion of the course satisfies the Executive Order 13101 requirement that agencies provide
training to contracting and program personnel. It is available on the Office of Personnel
Management's Gov Online Learning Center located at www.golearn.gov.
To register for the Green purchasing course, log on with your email and password. Next, click
on the Full Catalog button on the top navigation bar. Click on the Free Catalog category and
select Legislatively Mandated and Agency Required Topics. Choose " What is Green
Purchasing, AnywayT' (Course ID OPM008) by clicking on its title.
Please contact Dana Arnold at arnold.dana@ofee.gov if you would like to arrange for a green
purchasing or train-the-trainer presentation.
For additional green purchasing training resources visit
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Integrating Green Purchasing into your EMS: Final Draft October, 2004
Green Purchasing Resources
. Environmentally Preferable Purchasing (EPP) information from EPA
. EPA's EPP Database - Database of environmental information on products and services
. EPPnet listserv providing subscribers with quick access to information such as: availability of
product specifications, vendors of particular products, pricing information, and strategies to
achieve procurement goals
. Green Purchasing tools and resources from OFEE
. Searchable database of vendors who sell or distribute CPG-designated products with recycled
content.
. Biobased Products Purchasing Program (Proposed 2003)
< http://www.biobased.oce.usda.gov/public/about_us.cfm>
. Energy efficient product information from the Federal Energy Management Program (FEMP)
. Technical assistance from FEMP
. Draft Federal Guide for Green Construction Specs
. EPA's Green Building Site -
. EPA Green Meetings
Ocean Blue Foundation for Green Meetings
<.http://bluegreenmeetings.org>
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Integrating Green Purchasing into your EMS: Final Draft October, 2004
• EPA's Green Power Partnership - Provides assistance and recognition to organizations that
demonstrate environmental leadership by choosing green power.
. EPA's Greenscapes - Guidance on environmentally preferable landscaping
. EPA's Smartway Transport Program - challenges companies shipping products and the truck
and rail companies delivering these products, to improve the environmental performance of
their freight operations.
. Federal Electronics Challenge - a voluntary partnership program that encourages Federal
facilities and agencies to purchase greener electronic products, reduce impacts of electronic
products during use, and manage obsolete electronics in an environmentally safe way.
. Significant New Alternative Policy (SNAP) Program
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Integrating Green Purchasing into your EMS: Final Draft October, 2004
4. CONCLUSION
The Federal agencies who participated in the development of this report have incorporated green
procurement into their EMS policy and procedures. This is appropriate, since procurement and
contracting activities are responsible for as much as 25%52 of an agency's budget and act as the
gatekeeper for products and services that have the potential to contribute to diverse
environmental impacts. By using EMS procedures to identify procurement as an environmental
aspect and initiate operational controls to address these environmental impacts, agencies can
encourage the use of green products and the implementation of sustainable operations.
Thus, the EMS can increase and focus efforts of product users, and the procurement and
contracting personnel who support them, to seek out green products and processes that can
provide similar or better performance quality than those products or processes currently in use.
For example, buying low emissions vehicles to improve air quality, or choosing renewable
energy sources to reduce CO2 emissions and their contribution to climate change, or specifying
Integrated Pest Management and green landscaping services to reduce the impacts of pesticides
and fertilizers on local rivers lakes and streams all can help to reduce a facility's overall
environmental impacts. Monitoring and measuring the purchase and use of green products
documents progress toward improved environmental performance and facilitates compliance
with reporting requirements. Since purchase agreements are of limited duration, expiring
contracts can drive a system toward continuous improvement by compelling an organization to
consider green purchasing opportunities with each new purchase or contract renewal.53
Patty Wohl of California EPA sums up her agency's experience stating, "During this past year,
we have experienced directly how EMS-based management increases the benefits of a green
purchasing program by improving regulatory compliance and environmental performance;
increasing efficiency; enhancing accountability; reducing costs; and enhancing morale through
aligning actions with good intentions and formal commitments."
52 Federal Procurement Data System, 2002 Report, < http://www.fpdc.gov/fpdc/fpr2002.htm >
53 Personal communication, Rob Guillemin, EPA Region 1, November, 2003.
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ACKNOWLEDGMENTS
Development of this module has been a group effort, from beginning to end. The Environmental
Protection Agency (EPA) would like to thank all of the agencies and individuals who shared
lessons learned during the EMS implementation process, provided examples of successful
incorporation of Green Procurement into their EMS, and/or provided valuable editorial
comments.
Agencies and individuals whose expertise informed the contents of this report include:
Agency
Defense Logistics Agency
(DLA)
Defense Logistics Agency
(DLA)
Department of Agriculture
(USDA)
Department of Commerce
(DOC)
Department of Defense
(DOD)
Department of Defense
(DOD)
Department of Defense
(DOD)
Department of Defense
(DOD)
Department of Defense
(DOD)
Department of Defense
(DOD)
Department of Defense
(DOD)
Department of Energy (DOE)
Department of Energy (DOE)
Department of Energy (DOE)
Facility
Headquarters
Defense Reutilization and
Marketing Service (DRMS)
Beltsville Area,
Agricultural Research Service
Headquarters
Office of the Secretary of Defense
(Installations and Environment)
Pentagon
Engineering & Technical Service
Division
U.S. Air Force
Eglin AFB, FL
Air Force Center for
Environmental Excellence
(AFCEE)
U.S. Army
Fort Lewis, WA
U.S. Army
Fort Eustis, VA
U.S. Army
Tobyhanna Army Depot, PA
Alternate Fueled Vehicle Program
Federal Energy Management
Program (FEMP)
Pacific Northwest National
Laboratories (PNNL)
Contact
Patti Wilson
Randy Smith
Randolph J.Smith@dla. mil
David Prevar
prevard@ba.ars.usda.qov
Pete Wixted
PWixted@doc.qov
John Coho
iohn.coho@osd.mil
Alan Smith
AlanSmith@ref.whs.mil
Karen Winnie
karen.winnie@ealin.af.mil
Karen Kivela
Karen.Kivela@brooks.af.mil
Harry Fleming
harry.s.fleminq@us.armv.mil
Shonia Holloway
shonia.hollowav@us.army.mil
Craig Coffman
craiq.coffman@us.army.mil
Shab Fardanesh
Shabnam.Fardanesh@ee.doe.qov
Alison Thomas
alison.thomas@ee.doe.qov
Sandra Cannon
sd cannon@pnl.qov
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Department of Homeland
Security (DHS)
Department of the Interior
(DOI)
Department of the Interior
(DOI)
Department of the Interior
(DOI)
Department of the Interior
(DOI)
Department of the Interior
(DOI)
Department of Transportation
Department of Veterans
Affairs
Executive Office of the
President
Environmental Protection
Agency (EPA)
Environmental Protection
Agency (EPA)
Environmental Protection
Agency (EPA)
Environmental Protection
Agency (EPA)
Environmental Protection
Agency (EPA)
Environmental Protection
Agency (EPA)
Environmental Protection
Agency (EPA)
Environmental Protection
Agency (EPA)
U.S. Coast Guard
Office of Environmental Policy and
Compliance
National Park Service
Grand Canyon National Park
National Park Service
Intermountain Region
National Park Service
Grand Canyon National Park
Xanterra Resorts
National Park Service
Concession Environmental
Management Program
Office of the Secretary of
Transportation
Office of the Deputy Under
Secretary for Health for
Operations and Management
Office of the Federal
Environmental Executive (OFEE)
Office of Policy, Economics, and
Innovation (OPEI)
Office of the Federal
Environmental Executive (OFEE)
Office of Pollution Prevention &
Toxics: Design for the
Environment
Office of Pollution Prevention &
Toxics: EPP-Federal Electronics
Challenge
Environmental Science Center,
Fort Meade, MD
Region 1
Region 5
Region 9
Ken Malmberg
KMalmberq(S>,comdt. uscq.mil
Heather Davies
heather davies@ios.doi.qov
Dr. Mary Ann McCloskey
marv ann mccloskev@nDS.qov
J. Craig Erickson (consultant)
craiq@mesllc.net
Lisa McNeilly
lmcneillv(S>,xanterra.com
Christine Chui
Christine chui(S>,contractor.nps.qov
Catherine Johnson
Catherine.Johnson(S>,ost.dot.qov
Jack Staudt
iack.staudt@hq.med.va.qov
Ed Pinero
pinero.ed@ofee.qov
Tim Stuart (retired)
Dana Arnold
arnold.dana(S>,ofee.qov
Karen Chu
chu.karen@epa.qov
Christopher Kent
kent.christopher(S>,epa.qov
Greg Allen
alien, qreq@epa.qov
Lynda Podhorniak
podhorniak.lynda@epa.qov
Robert Guillemin
quillemin.robert@eDa.qov
Jean Holbrook
holbrook.iean@ epa.qov
Christopher M. Newman
newman.christopherm@epa.qov
Lucy Stanfield
stanfield.lucv@epa.qov
Heather White
white. heather@epa.qov
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Environmental Protection
Agency (EPA)
National Aeronautics and
Space Administration (NASA)
State of California
U.S. Postal Service (USPS)
Region 10
Ames Research Center
California Integrated Waste
Management Board (CIWMB)
Northeast Region
Viccy Salazar
Salazar.viccv(S)epa.qov
Bruce Stapleton
staDleton.bruce(S)eDa.qov
Jonell Allamano
Allamano.ionell(S>,epa.qov
Christel VanArsdale
christel.i.vanarsdale(S>,nasa.qov
Patty Wohl
pwohl(S>,ciwmb.ca.qov
Ron Robbins
ronald.f.robbins(S>,email.usps.qov
46
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DISCLAIMER
This report provides an overview of recent Federal government initiatives that incorporate green
procurement into an Environmental Management System (EMS). References to specific
products and technologies do not constitute endorsement of or recommendation for use of these
products by the U.S. Environmental Protection Agency (EPA). This report features
representative Federal government activities in green procurement and EMS. It does not
represent the efforts of every Federal government agency initiating an EMS and it does not
describe every activity initiated by the agencies highlighted.
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Appendix A
Products and Services Purchased at ESC: Implementing Environmentally-Preferable Purchasing (EPP) Draft: 8/26/2003
Type of Purchase
Products and Services Purchased,
Value of Products and Services
Current ESC Operational
Controls for EPP and
Communicating with
Contractors and Suppliers
Barriers to EPP and
Communicating with
Contractors and Suppliers
Bank card purchase (small
purchase)
Consumable Lab Supplies (standards,
reagents, disposable glassware and
plasticware, compressed gases), Lab
Systems (equipment calibration
services, NIST references, laboratory
equipment), Training (health services
training), Analytical Services, Office
Services (photocopying, labels and
tags), Office Supplies (posters,
stationery), Boat Supplies, Facility
Supplies (hardware, recycling bins),
Computer Supplies & Services
(software, printers and printer supplies,
computer hardware), Information
Products (NTIS products), Barcoding
Supplies, Travel/Meetings, Safety
Supplies
Environmental attributes generally
considered on an ad hoc basis.
EMS target included strategy for
addressing impacts related to
paper consumption, which led ESC
to purchase 100% recycled-
content paper.
Requirement to purchase from a
variety of vendors
Purchase requisitions (PR)
OPP: maintenance agreement,
equipment, supplies
Region III: capital equipment, onsite
contractors, library records management,
CIS support, COOP contractors
Overall Facility: contract based services
(performance-based contracts) include
ESAT contract, capital equipment,
records management, computer support,
LAN support, hazardous waste
management (EMSI), landscaping/lawn
In its contracts, ESC uses a lot of
standard clauses provided by EPA
headquarters that covers
implementation of the "seegreening
Executive Orders -
http://www.fedcenter.gov/programs
I
Contractor orientation to EMS for
contractors working at ESC long-
term.
Contract for hazardous waste
EMS/#regs
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Type of Purchase
Products and Services Purchased,
Value of Products and Services
Current ESC Operational
Controls for EPP and
Communicating with
Contractors and Suppliers
Barriers to EPP and
Communicating with
Contractors and Suppliers
maintenance, security system, operation
& maintenance, janitorial/snow removal,
mail, boats, telephone, library services;
subcontracts include water conditioning,
emergency generator, building
automation system, fire sprinkler, fire
pumps, BSC system, uninterruptible
power supply (UPS), and fume hood
certification.
disposal includes EPP language.
Next contract for copiers will
consider paper reduction benefits
of digital copiers.
Blanket Purchase
Agreement (BPA)
Note: BPAs are being used
less often.
OPP: BPA with Fisher for glassware and
gloves, lab consumables (they receive a
discount when using the BPA)
ASQAB: BPA with Roberts Oxygen for
gases and with Sigma-Aldrich (formerly
Supelco) for chemical standards, internal
standards, surrogate compounds, vials,
syringes, etc.
Overall Facility: maintenance
agreements under BPAs, including those
for copiers, fax machines, security
systems, and fire systems.
Miscellaneous Obligation
Documents (MODs)
Overall Facility: utility purchases,
FedEx, bank card authorizations.
Reimbursable Work
Agreements (RWAs)
Overall Facility: vehicle renting (and
associated maintenance) from GSA,
providing security services (guards).
Outside Contracts (B&F,
SHEM)
Overall Facility: telecommunications
support, voicemail system, Pbranch
Xchange, medical monitoring (through an
interagency agreement - IAG)
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APPENDIX B : Examples of Agency Procedures
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Green Purchasing Operational Controls, EPA Region 1, New England
EPA-NE BOSTON OFFICE ENVIRONMENTAL OPERATING CONTROL
TITLE: Environmentally Preferable Procurement
Document No: OC-2004-04
Prepared By:
Jean Holbrook
Date: 9/15/04
Approved By:
James Owens, Director OARM
Date:
PURPOSE
The purpose of this operational control is to include environmental considerations in procurement
decisions at the EPA-NE Boston Office.
POLICY COMMITMENT
• Meet or go beyond compliance with all applicable Federal, State, and local environmental laws and
regulations.
. Prevent pollution before it is produced, reduce the amount of waste at our office, re-use and recycle
whenever possible, and support pollution prevention by our customers and suppliers.
ACTIVITIES COVERED
General Office Work: Use of: Computers, Printers, faxes and copiers, Office supplies such as cartridges,
clips, staplers, etc, Use of Paper; Report Generation; Record and File Storage
OPERATIONAL CONTROLS
1. Paper Procurement
a. 100% recycled content paper for printers and copiers (exceeds Federal requirements)
b. Recycled paper for business card and name tags (Procured by Purchase card holders)
c. Recycled content plaques and awards ((Procured by Purchase card holders)
2. Procurement Practices
a. Recycled content for external printing exceeds requirements (procured by Facilities
through GPO)
b. GSA Advantage Purchasing (assists in identifying EPP products)
c. Desktop/Office Supply purchasing consolidated under Facilities for better control and
reduced waste
d. Utilize FedBizOpps for electronic posting of Requirements and Synopsis (>$ 100,000)
e. Grant terms and conditions include recycled content and EPP conditions (40 CFR part 30
and 31)
3. Electronics Procurement
a. Procurement of Electronic Equipment is described under the Operational Control
Environmentally Preferable Electronics
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RESPONSIBILITIES:
Contracts and
Procurement
Manager:
. Acting as approval official, and overseeing contracting staff assures Purchase
Requisitions conform to regulations and Regional policies
• Assures Use of credit cards by Purchase Card holders conforms to regulations and
Regional policies
• Uses environmental considerations as basis for award as appropriate
. Provides training and assistance to purchase card holders, which includes Green
Purchasing
• Encourages use of GSA Advantage paperless/paper minimizing purchasing
. Maintains awareness of National and Regional requirements as well as
opportunities to exceed requirements through OARM/MCP website,
communication with Green Team, and other sources.
. Communicates requirements and opportunities to staff.
Staff:
• Assures Purchase Requisitions conform to regulations and regional policies
» Uses environmental considerations as basis for award as appropriate
Facilities
Manager: Incorporates national and Regional environmental policies in procurement
decisions and oversees and directs staff in activities as follows:
Customer Service purchasing specialist:
• Uses GSA Advantage
• Initiates Purchase Requisitions for all office supplies (including 100% recycled
content paper), incorporating national and Regional environmental policies
(including EO 13101)
. Communicates with Green Team leaders regarding national and Regional
requirements as well as opportunities to exceed requirements
Regional Printing Officer:
• Contracts high volume copying externally through GPO. Reviews requests and
classifies as routine copying or specialized. Routine work routed through GPO
contract using recycled content paper (currently 80%)
• For specialized print requests, jointly with Information Systems Desktop
Publishing Team advises requestors regarding product design to optimize product
for environmentally preferable production
• Initiates Request for Quotation for Specialized print jobs through GPO
incorporating environmental considerations
» Coordinates with Communication Workgroup as appropriate
Information
Services Group
Managers of Computing Technology and Information Resources: jointly oversee and
direct staff in activities as follows:
. Technical support to equipment incorporating specialized considerations for use
of recycled paper
• Desktop Publishing Team assists requestors of specialized print products in
product design and advises regarding product design to optimize product for
environmentally preferable production; coordinates with Customer Service staff
regarding contract requirements for external printing
• Support to GSA Advantage paperless/paper-minimizing purchasing as required
• IS Staff: Execute assigned job responsibilities consistent with these procedures
Grants
Management
Manager: Oversees staff in processing grants
Staff: Includes Recycling and EPP terms and conditions
53
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Integrating Green Purchasing into your EMS: Final Draft
October, 2004
Office
Office of Regional
Administrator
Other EPA-NE
Offices
Green Team
Deputy Regional Administrator: Supports programs Region wide
Director of Public Affairs: Directs staff in procurement of recycled content awards
and plaques
Staff: Procures recycled content awards and plaques
Office Directors: Support programs, ensure employee awareness and use.
Team Members:
• Assist in promoting employee awareness
• Assist in disseminating Green Purchasing information and opportunities to
purchasers, card holders and Contracts and Procurement staff
EPA-NE BEST PRACTICES: Environmentally beneficial practices implemented by individual offices
• Human Resources: Recommends contracted training firms provide any handouts 2-sided
REFERENCE(S): No specific references are defined for this control.
SIGNIFICANT ASPECTS: Use of Resources
MAINTENANCE PLAN(S) FOR THIS OPERATIONAL CONTROL: See Common Requirements for
all Operational Controls.
ACTIONS TO BE TAKEN IF CONTROLS FAIL: See Common Requirements for All Operational
Controls.
RECORD(S) No specific records are defined for this control.
COMPETENCE OF PERSONNEL RESPONSIBLE TO CARRY OUT THESE PROCEDURES: See
Common Requirements for All Operational Controls.
54
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Integrating Green Purchasing into your EMS: Final Draft
Environmental Management Program, EPA Region 5
October, 2004
Environmental Management Program
A. Significant Environmental
Aspect: Consumption of Toxic
and Hazardous Chemical
B.Document Control Code:
EMP-77-04-SAE-5A-001
C. Date: 11/21/03
1. Objective (s): Reduce life-cycle environmental impacts associated with purchased office furnishings
and equipment.
2. Target(s): Incorporate "green" specifications into market surveys and bid requirements for electronic
equipment purchased post FY2004.
3. Reason for Significance (of aspect):
Electronic equipment contains toxic substances such as lead, mercury, hexavalent chromium, beryllium,
and others.
If plastic from electronic equipment is incinerated dioxins can be emitted.
Indoor air quality
Emission of volatile organic compounds
5. Legal and Other Requirements (Specify):
Comprehensive Procurement Guidelines
E.O. 13101
6. Performance Indicators (measures of achievement):
Compare pre FY 2004 bid specifications with post FY 2004 bid specifications.
7. Program Description:
"Green" specifications established for procurement requests include:
Reduction in toxins:
» Lead—purchase FPD versus CRTs
» mercury
» cadmium
» chromium
Postconsumer recycled content.
Large plastic components are labeled.
No mechanical tools are required to remove batteries.
The use of non-separable connections is minimized.
Plastic components are not painted or varnished.
IT representatives (PC Docs) are trained on EPP and availability of "green" characteristics of electronic
equipment.
55
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Integrating Green Purchasing into your EMS: Final Draft October, 2004
Include in market surveys information that will identify those products that have received certification by
third party eco-label organizations, received a manufacturer's internal self-certification, or have an eco-
declaration.
Green specifications included in requests for bids from vendors.
Quotes received from manufacturers/vendors include products that meet "green" specifications.
Total cost of ownership will be used in the procurement decision.
The Information Resource Management Steering Committee supports and promotes "green" activities for
electronic equipment.
8. Operational Controls:
(see operational controls form, separate page)
9. Budget (resources):
Get information from Information Management Branch.
10. Structure, Authorities, Responsibilities
Tasks
1 . "Green" specifications developed.
2. Work w/ electronic equipment
manufacturers/vendors to determine availability.
1 1 . Records:
12. Document(s):
Person Responsible
1. Information Management Branch creates "green"
specs with assistance from PC Docs.
2. IMB/IRMSC works with manufacturers/vendors.
Person Responsible and Record Location:
Person Responsible and Record Location:
13. Competence of persons responsible on basis of training, education, or experience:
Title
Competence
14. Other Program Elements:
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Integrating Green Purchasing into your EMS: Final Draft October, 2004
EPA Environmental Science Center, Fort Meade, MD
ESC-EP08.01
Environmental Management System Procedure for:
Environmentally Preferable Purchasing (EPP), Communicating with Suppliers and Contractors
April 10, 2004
Issued by:
EMS Coordinator
57
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Integrating Green Purchasing into your EMS: Final Draft October, 2004
April 10, 2004
ESC-EP08.01 Table of Contents
1 Purpose 3
2 Scope 3
3 Definitions 3
4 Procedure 3
4.1 Specific Procedure-FOCUS ON EPA'sEPP GOALS 3
4.2 Specific Procedure - BOILERPLATE LANGUAGE IN CONTRACTS 6
4.3 Specific Procedure - EMS AWARENESS 6
4.4 Specific Procedure - EPP TRAINING 6
4.5 Specific Procedure - REPORTING/MEASUREMENT OF ESC
ENVIRONMENTALLY PREFERABLE PURCHASES 6
4.6 Specific Procedure - ANNUAL PROCEDURAL REVIEW 7
4.7 Responsibilities 7
5 Documentation 7
Attachment 1
Boilerplate Language for All ESC Contracts 8
Attachment 2
Suggested Websites 9
Attachment 3
Fact Sheet for Onsite Contractors (without fixed contracts) 10
58
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ESC-EP08.01 April 10, 2004 Page 59 of
71
1 Purpose
• To help Environmental Science Center staff (ESC) purchase goods and services that
reduce impacts associated with ESC's identified significant environmental aspects.
To communicate information and/or requirements related to the identifiable significant
environmental aspects of goods and services used by the ESC to suppliers and contractors
in accordance with the requirements of the ESC Environmental Management System
(EMS).
2 Scope
The ESC will make available guidance and information on purchasing goods and services that
reduce impacts associated with ESC's identified significant environmental aspects. The ESC will
communicate specific procedures and requirements to those suppliers and contractors that
provide goods and services associated with significant environmental aspects.
3 Definitions
EPP Goals - Environmentally Preferable Purchasing Goals (EPP): Executive Order 13101
mandate to purchase environmentally preferable supplies.
CPG - Comprehensive Procurement Guidelines for buying recycled-content products.
4 Procedure
4.1 Specific Procedure - FOCUS ON EPA's EPP GOALS
The ESC will initially focus on the goods and services targeted through EPA's
Environmentally Preferable Purchasing (EPP) Goals, designed to fulfill the Agency's
responsibilities under Executive Order (E.O.) 13101, "Greening the Government through
Waste Prevention, Recycling, and Federal Acquisition" These goods and services
include building materials and design, janitorial and maintenance services, copy paper
and publications, meetings, office supplies, electronics, fleets, landscaping, and power.
Fleets and power are not addressed in this procedure because these purchases are
coordinated by EPA HQ. (See Attachment 2 for suggested websites where more
information may be found on all of the EPP Goals listed here.)
Building Materials and Design
The ESC already incorporates many environmentally-preferable building
materials and design features, including natural lighting, low-water flush units,
variable air volume fume hoods for lab spaces, energy-efficient bulbs, direct
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ESC-EP08.01 April 10, 2004
Page 60 of 71
digital control of mechanical systems, and recycled-content construction
materials.
For all new construction at ESC, during the planning stages, agency
representatives should investigate environmentally-preferable building materials
and design strategies by gaining a familiarity with the U.S. Green Building
Council's Leadership in Energy and Environmental Design (LEED™) Program's
Green Building Rating System™ for Existing Building Operations (LEED-EB)
(or other applicable LEED standard) and by consulting with the contacts listed for
the "Green Buildings" EPA EPP Goals.
Janitorial Services
The ESC currently purchases janitorial and snow removal services through a
contract. To address ESC's identified significant environmental aspects, the
contract now includes the following:
a clause requiring the use of and acquisition of environmentally-preferable
products and services as required by E.O. 13101 and Title 40 CFR, Part
27.
a clause calling for the incorporation of integrated pest management (IPM)
practices as outlined by the EPA/Army consent decree (December 2000)
and associated MOU.
E.O. 12902 is incorporated into the contract.
In all future contracts for janitorial services, the Facility Manager should
incorporate the above clauses, as appropriate. In addition, agency representatives
should investigate additional environmentally-preferable janitorial practices and
cleaning products to include in the contracts. .
Maintenance Services
Purchases of facility operations and maintenance services for the ESC are made
through contracts.
In future contracts, agency representatives should try to identify environmentally-
preferable maintenance methods that the ESC could use to help EPA meet its EPP
Goals.
Copy Paper and Publications
Facility management staff currently purchase 100-percent postconsumer,
processed chlorine-free, recycled-content copy paper for the ESC.
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ESC-EP08.01 April 10, 2004
Page 61 of 71
When purchasing printing paper, letterhead, envelopes, color paper, and similar
paper products, ESC bank card holders should obtain products that are as close to
100-percent recycled, 50-percent postconsumer content as possible. (See the
Office Supplies section of this document.)
Meetings
When planning any type of meeting at the ESC, staff should consult EPA's Green
Meetings website (see Attachment 2) for ideas and information on conducting an
environmentally-preferable meeting.
Office Supplies
ESC bank card purchases of office supplies are to be made using EPA's agency-
wide Blanket Purchase Agreement (BPA) green online ordering system, which
should be ready in 2004. (See Attachment 2 for the user friendly e-catalog
website.) This site makes available most, "green" office supplies, with a special
emphasis on products that fulfill both the Comprehensive Procurement Guidelines
(CPG) for buying recycled-content products and the Executive Order 13101
mandate to purchase environmentally-preferable supplies.
If office supplies are not available thru the BPA e-catalog, then alternate sources
such as the GSA catalog ("green" supplies, preferably) or commercial vendors
may be used.
Electronics
Currently, ESC ensures that its purchases of copiers, printers, and personal
computers have the Energy Star rating or energy savings sleep mode built in.
ESC will continue to purchase Copiers, printers, and personal computers with the
Energy Star rating or energy savings sleep mode built in and will also use these
criteria when purchasing televisions and monitors, computer peripherals, audio
equipment, VCRs, DVD players, cellular phones, wireless devices, and other
types of electronic equipment.
In addition, an MOA between the ESC and the Computer Support Services group
has been signed that ensures that all printers purchased for the ESC are to be
capable of duplexing, if at all possible. (See Attachment 2 for the ESC EMS
website where a copy of the MOA can be found.)
Landscaping
ESC purchases landscaping services through a contract. To address ESC's
identified significant environmental aspects, the contract includes the following:
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ESC-EP08.01 April 10, 2004
Page 62 of 71
• requirement for IPM.
• requirement for compliance with EC 12856 (1993) Emergency and
Community Right-to-Know Act of 1986 and the Pollution Prevention Act
of 1990 (42 U.S.C. 13101-13109).
incorporates the ESC Spill Prevention Plan, ESC Beneficial Landscaping
Plan (Master Landscaping Plan), and the Fort Meade Landscaping Design
Guidelines (June 1995).
ESC's grounds already include natural landscaping (expanded beyond the original
master plan), bayscaping in the remaining area with native plants, sediment
control ponds, and afforestation areas maintained per MDE requirements for 3
years after initial disturbance.
For future landscaping contracts, agency representatives should investigate
additional environmentally-preferable landscaping methods that ESC could use to
help EPA meet its EPP Goals.
4.2 Specific Procedure - BOILERPLATE LANGUAGE IN CONTRACTS
Where appropriate, the ESC will include boilerplate language in all of its contracts for
goods and services. The boilerplate language will request information on a supplier's
EMS and will note that this information will be used as part of the criteria for ESC's
selection of a supplier (see Attachment 1).
4.3 Specific Procedure - EMS AWARENESS
Before onsite contractors, without fixed contracts, are allowed in the building, Facility
Management will check to see if their work will be associated with any of the ESC's
significant environmental aspects. Once onsite, the contractor is asked to read a fact
sheet on the ESC's EMS policies (see attachment 3).
For vendors who supply products where the ESC has no control over their EMS
operations, staff is encouraged to choose vendors and suppliers which will help the EPA
meet its EPP Goals. One example is the use of the EPA's agency-wide Blanket Purchase
Agreement (BPA) green online ordering system
4.4 Specific Procedure - EPP TRAINING
The ESC will make available guidance and information on purchasing goods and services
that reduce impacts associated with ESC's identified significant environmental aspects.
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ESC-EP08.01 April 10, 2004 Page 63 of
71
4.5 Specific Procedure - REPORTING/MEASUREMENT OF ESC
ENVIRONMENTALLY PREFERABLE PURCHASES
The ESC will follow the agency's requirements for reporting EPP purchases.
4.6 Specific Procedure - ANNUAL PROCEDURAL REVIEW
Annually, the EMS Team will meet to review this procedure and EPA's EPP Goals.
Specifically, the EMS Team will discuss the procedure's effectiveness, whether it should
be modified, and whether tools (e.g., web site or forms) should be developed to facilitate
environmentally-preferable purchasing at ESC. To prepare for the discussion, the EMS
Team should survey purchasers and meeting planners at the ESC to discuss the
effectiveness of the procedure.
Examples of procedural modifications: a) expand the procedure to include additional
products and services purchased at ESC (e.g., products associated with chemicals in
ESC's TRI report); b) add language that specifies ESC staff are allowed to pay extra for
environmentally-preferable products.
Examples of a tools: a) modify the ESC EMS web site to include environmental criteria
that ESC staff could consult before making purchases or developing contracts.
4.7 Responsibilities
Individuals responsible for procurement of goods and services within the categories noted
above and individuals planning meetings are responsible for ensuring their purchases
reduce impacts associated with ESC's identified significant environmental aspects.
Individuals identified by EPA as bank card holders will be responsible for reporting their
environmentally-preferable purchases to the agency. Before onsite contractors, without
fixed contracts, are allowed in the building, Facility Management will check to see if
their work will be associated with any of the ESC's significant environmental aspects.
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5 Documentation
When this procedure is reviewed, records will be maintained on suggested changes, including
procedural changes or tools, and why the changes were or were not included.
Attachment 1
Boilerplate Language for All ESC Contracts
For all contracts, ESC purchasers should include the following boilerplate language:
• Each company offering a cost proposal should provide information on its environmental
management system (EMS) (and whether it is an EPA National Environmental
Performance Track member) to the ESC. The ESC will use this information as part of its
selection criteria.
ESC expects the contractor to understand and comply with ESC's EMS.
For an example, ESC purchasers are encouraged to review ESC's contract for hazardous waste
disposal.
64
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Attachment 2
Suggested Websites
EPP Goals
http://www.epa.gov/greeningepa/p2/eppgoals.httn
EPA's Green Meetings
http://www.epa.gov/oppt/greenmeetings/
Oceans Blue Foundation for Green Meetings
www.bluegreenmeetings. org
EPA's agency-wide Blanket Purchase Agreement (BPA) green online ordering system
http://www.epasupplies.com/
ESC EMS website (includes MO A)
http://www.epa.gov/region03/esc/ems/index.htm
Green Seal's Choose Green Report, "General Purpose Cleaners," March 1998
http://www.doi.gov/oepc/reports/cgr clean.pdf
GSA's Environmental Products and Services Guide: (CPG Compliant and Other Recycled
Content Products)
http://www.gsa.gov/Portal/gsa/ep/channelView.do?pageTypeId=8207&channelPage=/ep/channel
/gsaOverview.jsp&channelId=-12972
EPA's CPG Supplier Database
http://www.ergweb2.com/cpg/user/cpg search.cfm
Database of Environmental Information for Products and Services
http://yosemite.epa.gov/oppt/eppstand2.nsf/
Energy Star web site
www. energy star, gov
Federal Electronics Challenge and Purchasing Guidelines
www.Federalelectronicschallenge.net
US Army Corps of Engineers: EPP Resources Link
http ://www. cecer. army.mil/sustdesign/EPPCleanProd. cfm
65
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Attachment 3
Fact Sheet for Onsite Contractors (without fixed contracts)
The ESC's Environmental Policy
It is the Environmental Science Center's (ESC) policy to integrate environmental stewardship
into all our operations. We manage our organizations and our programs in a manner that protects
the environment, the safety of our employees, and public health through our environmental
management system (EMS). The EMS is designed to manage the environmental impacts that
result from the operations at the facility. All of the operations conducted at this facility are
considered within the scope of the EMS. The activities of all of the occupants of the facility are
subject to the policies and procedures conform to the international standard ISO 14001 (1996),
Environmental Management Systems - Specification With Guidance For Use.
The ESC attempts to prevent pollution before it is produced, reduce the amount of waste at our
facility, re-use and recycle whenever possible, and support pollution prevention by our customers
and suppliers Please consider this policy as you perform your tasks or operations in this
facility and help us support our environmental goals. Thank you!
66
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Objectives and Targets for Elect
Region 10 - Electronics Objectives
Regional commitment to reduce
electricity use by electronic devices
and computers
Reduce by 25% Electricity Used by
Electronic Devices and Computers
Reduce generation of hazardous
waste from batteries in electronic
devices
Reduce generation of solid waste by
50% from electronic devices and
computer
ronics, EPA Region 10
Targets
Policy: Set policy to include energy efficiency as a factor in equipment purchases
Energy Star Equipment
Ensure at least 50% of all electrical equipment purchased is Energy Star efficient.
Include Energy Star requirements in the special terms and conditions in 30% of all
grants and contracts.
Make sure the Energy Star Stand-By Power function is enabled in 50% of eligible
equipment
Battery Management: Switch to rechargeable batteries. Monitor recharger(s) and
batteries. Properly dispose of batteries via contract with disposal facility.
Toner Cartridges: Recycle 100% toner cartridges via contract with recycling
company
End-of-Life Management - Maintain management program to send end-or-life
equipment to proper organizations, and when necessary to an approved recycler,
demanufacturing or disposal facility.
Purchasing: Include environmental factors in determining which electronic
equipment to purchase. Purchase eco-labled products whenever possible
Date
Sept 04
July 04
Aug04
July 04
April 04
Dec 03
Jan 04
Aug04
Metric
policy written &
approved
Energy Star
certification per item
Grant policy updated
Software function
enabled or not
Number of batteries
used. Records of
batteries properly
disposed of.
Number of cartridges
recycled
Records of equipment
surplused or sent for
recycling/disposal
Policy written and
approved. Numbers of
ecolabeled equipment
purchased.
Resources
currently
available for
target
TBD
TBD
ongoing
ongoing
Additional
resource
requirements
estimated for this
task
Data collection
67
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Reduce generation of hazardous
waste from electronic equipment
LCD Replacement: Replace CRTS with LCDs (Liquid Crystal Displays).
Determine/make projections on amount of CRTS that can be replaced annually
Use a recycling contractor that does not send un-processed, non-reuseable, non-
repairable equipment overseas
Conduct annual physical on-site audits of all equipment processing and recycling
facilties used
April 04
Jan 04
Sept 04
Number of CRTs
replaced
Contract
Audit records
IRU
NOTE that this
plan can only be
implemented
contingent on
funding
April 10, 2003 Mike Pagan (Initial)
Revised:
68
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A Guide on
Hazardous Waste Management
for Florida's
Pharmacies
-------
Hazardous Waste (RCRA)
Compliance Assistance Program
With Support from:
David Struhs, FDEP Secretary
Kirby Green, FDEP Deputy Secretary
John Rudell, FDEP Waste Division Director
Bill Hinkley, FDEP Bureau Chief, Solid and
Hazardous Waste Section
U.S. Environmental Protection Agency,
Region IV
Prepared by:
Florida Department of Environmental
Protection Hazardous Waste
Compliance Assistance Program
Satish Kastury, Administrator
Janet Ashwood, Compliance Assistance
Project Manager
Mike Redig, Tallahassee
Glen Perrigan, Tallahassee
John Fusco, Northwest District
Pamela Green, Northeast District
Richard Sykes, Northeast District
Luis Campos, Northeast District
John White, Central District
Lu Burson, Central District
Beth Knauss, Southwest District
Jeff Smith, Southeast District
Charles Emery, South District
Karen Bayly, South District
and
Florida Center for Solid and Hazardous
Waste Management
ACKNOWLEDGEMENTS
Bill Kappler, Florida Department of
Environmental Protection-Central District
Thankyou forthe assistance and expertise
you provided toward the preparation of this
brochure. Your materials were extremely
valuable and helped to produce an "easy to
read" guidance brochure.
Florida Pharmacy Association and Capital
Returns, Inc.
We would like to express our gratitude for your
assistance and enthusiasm in the preparation
of this brochure. We greatly appreciate the
use of your materials as a guideline forthe
production of this brochure and for letting us
use your best management practices within
this publication.
Other RCRA publications produced by the
Center for the Florida Department of
Environmental Protection (DEP) include:
Guides on Hazardous Waste Management
for Florida's
Agricultural Pesticide Users
Automotive Repair Shops
Dry Cleaners
Fiber-Reinforced Plastic Manufacturers
Furniture Finishers
Laboratories
Paint and Body Shops
Photo Shops
Printed Wiring Board Manufacturers
Printers
Managing Mercury: Best Management
Practices for Florida's Medical Facilities
These publications are available from your
County Environmental Protection Department,
the DEP, orthe Center. These publications can
also be downloaded from the Center's web site.
Visit the Center's web site at
http://www.floridaoenter.org
John Schert, Executive Director
Maria Hall, Project Coordinator
Stephen Bissonnette, Research Assistant
GBS Production Graphics, Layout and Design
This document was printed at a cost of $0.47 per copy on
recycled paper. November 1999.
This document was published to assist businesses with hazardous waste management issues and regulatory
compliance. The suggested best management practices (BMPs) may help businesses to operate in an environ-
mentally appropriate manner. Some of the BMPs may go beyond what is required to remain in compliance with
regulations. This information is offered only as guidance. Specific requirements may vary with individual processes
and/or businesses. Business owners are responsible for obtaining complete information about applicable regula-
tions. The Florida Department of Environmental Protection and Florida Center for Solid and Hazardous Waste
Management are not authorized to relieve any person from any requirement of federal regulations or Florida law.
-------
WHY SHOULD I CARE ABOUT HAZARDOUS WASTES?
Some of the materials produced in everyday pharmacy operations may
be harmful to people or the environment.
This booklet suggests a five-step management plan with tips
on how to:
% Comply with federal and state hazardous waste regulations.
9 Avoid penalties by properly managing Pharmaceuticals.
% Save money on disposal costs by reducing pharmaceutical wastes.
Health and the Environment
Hazardous pharmaceutical wastes disposed of improperly may
contaminate soil or seep into the groundwater and contaminate
drinking water supplies.
Hazardous pharmaceutical wastes disposed of improperly may run
off into the nearest body of water where they may poison or kill fish
and other wildlife.
Hazardous pharmaceutical wastes pose a health risk to you,
your employees and your community.
Cost Savings
State and county environmental compliance
inspectors may visit your pharmacy to ensure
that pharmaceutical wastes are being managed
properly. State penalties may involve fines from
$100 to $25,000 per violation per day.
Implementing an effective pharmaceutical waste
control plan can reduce production and disposal costs
and reduce your liability risk.
Public Image
Your customers will appreciate your efforts to prevent pollution.
Your community will recognize your pharmacy as a good neighbor.
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WHAT STEPS SHOULD I FOLLOW TO MANAGE MY
PHARMACEUTICAL WASTES?
Some of the following practices may not be required for your pharmacy to
remain in compliance with regulations. Even if they are not required, they
are good waste management practices. Additional information is available
from the Florida Department of Environmental Protection (DEP).
ft
Step 1
ESTABLISH A PHARMACY
MANAGEMENT PLAN
General Pharmaceutical
Management
% Conduct random expired phar-
maceutical audits and remove
outdated products from inventory.
9 Be sure to inspect all medication
storage areas for outdated
products.
% Remember that Pharmaceuticals
include the samples provided by
pharmaceutical representatives or your suppliers.
9 Designate a clearly marked outdated pharmaceutical quarantine
area to accumulate outdated Pharmaceuticals or pharmaceutical
products that cannot be sold.
% All Pharmaceuticals discarded by the facility must be reviewed for
hazardous waste status and a determination must be made as to
whether or not the discarded Pharmaceuticals are hazardous waste.
9 Never discharge hazardous waste to a drain that is connected
to a publicly owned treatment works facility (POTW) without written
permission from the POTW.
% Never discharge hazardous waste to a septic tank.
9 Never mix hazardous pharmaceutical waste with biomedical
waste for disposal.
% Train all employees according to your outdate management
program and ensure that employees can identify, reduce and
properly handle wastes.
-------
General Pharmaceutical Management (continued)
9 The Pharmacy has two options for managing outdated
Pharmaceuticals for credit through the return process:
1. Use a Reverse Distributor, or
2. Process all returns and waste Internally.
Procedures for Managing Outdated
Pharmaceuticals for Reverse Distribution
% Implement the outdate management procedures provided by your
reverse distributor or create a written outdate management program
and initiate it as standard operating procedure. It is important to
ensure that your reverse distributor is properly permitted and
insured. Check with the Florida Department of Health at (850)
487-1257 for a list of permitted reverse distributors in Florida. For
a list of National Reverse Distributors, check with your Regional
DEA Office or the Returns Industry Association (See page 20 for
contact information).
9 Your outdate management plan should include container, storage,
labeling, shipping, and recordkeeping guidelines.
Procedures for Managing Outdated
Pharmaceuticals Internally
% Separate and store outdated Pharmaceuticals by manufacturer
and by the manufacturer's return policy for possible return to the
manufacturer.
% Using the manufacturer's return policy, distinguish between products
eligible for credit and products that are not returnable for credit.
Store and segregate these products according to the container
and storage guidelines on page 10.
9 Waste management procedures should include container, storage,
labeling, shipping, and recordkeeping guidelines. Follow the
hazardous waste and non-hazardous waste guidelines included
in steps 2-5 of this brochure.
-------
Step 1
ESTABLISH A PHARMACY
MANAGEMENT PLAN (continued)
Management Scenarios:
% Internal Management: A pharmacy separates returnable
from non-returnable Pharmaceuticals and inventories all pharma-
ceuticals. The pharmacy ships only the returnable Pharmaceuticals
to a manufacturer, wholesaler or reverse distributor and retains
the non-returnable Pharmaceuticals for disposal. The pharmacy
is the hazardous waste generator upon determining that the non-
returnable Pharmaceuticals are hazardous waste.
9 Reverse Distribution: A pharmacy does not separate returnable
from non-returnable Pharmaceuticals, inventories a\\ pharma-
ceuticals, and s/7/psthe Pharmaceuticals as a product to a
manufacturer or a reverse distributor. The manufacturer or
reverse distributor is the hazardous waste generator upon
determining that the non-returnable Pharmaceuticals are
hazardous waste.
% Reverse Distribution: A pharmacy contracts with
a reverse distributor to work onsite. The reverse
distributor does not separate returnable
from non-returnable Pharmaceuticals
onsite, but inventories all pharma-
ceuticals, and ships the product
to the reverse distribution
facility. The reverse
distribution facility \s the
hazardous waste generator
upon determining that non-
returnable Pharmaceuticals
are hazardous waste.
-------
ty
Step 2
IDENTIFY YOUR HAZARDOUS AND
NON- HAZARDOUS WASTES
WHEN ARE PHARMACEUTICALS CONSIDERED WASTE?
Be aware of the Federal and State interpretation.
% An outdated product is generally considered waste at the time
and place the decision is made to discard it.
9 According to the EPA, unsorted, outdated Pharmaceuticals may
be shipped as a product (rather than as a waste) if the outdated
Pharmaceuticals are being shipped to a reverse distributor or a
manufacturer with the intent to return the outdated Pharmaceu-
ticals to the manufacturer for credit.
Waste Pharmaceuticals include all Pharmaceuticals that have been
identified as:
% Outdated but not returnable for credit,
9 Used in compounding or IV preparation,
% Spilled or Broken Product no longer useable for intended
purpose, and
9 Any items used in cleaning up a spill (vermiculite, paper
towels, etc.) must be treated as a waste pharmaceutical,
either hazardous or non-hazardous.
WHAT IS A HAZARDOUS WASTE?
A waste is defined as being HAZARDOUS if:
% It has any of the characteristics described on page 8.
9 It is listed as a hazardous waste in the Code of Federal Regulations,
40 CFR Part 261.
-------
IDENTIFY YOUR HAZARDOUS AND
NON-HAZARDOUS WASTES (continued)
Characteristic Wastes
A characteristic hazardous waste is a solid waste that exhibits any
of the properties included in the definitions of ignitability, corrosivity,
reactivity, and toxicity according to the Code of Federal Regulations,
40 CFR Part 261.
Listed Wastes
In addition to characteristic hazardous wastes, a waste is hazardous
if it is identified as a Listed Waste in the Code of Federal Regulations,
40 CFR Part 261. There are numerous listed wastes, a partial list
is provided on page 9. For details on listed wastes and waste
code numbers, contact the DEP (See page 21 for DEP phone
numbers). The Code of Federal Regulations is available online at
http://www.access.gpo.gov/nara/cfr/, or you can obtain information
by calling the U.S. Environmental Protection Agency's RCRA hotline
at (800) 424-9346.
Acutely Hazardous Wastes
Acutely hazardous wastes are extremely dangerous wastes. Small
amounts of these wastes, such as arsenic and cyanide compounds,
are regulated in the same way as large amounts of other wastes. A
pharmacy that generates 2.2 pounds (1 kilogram) or more of these
acutely toxic wastes per month is subject to full regulation under the
hazardous waste rules. Contact the DEP for more information on the
proper management of acutely Hazardous Wastes.
Identifying Your Hazardous Wastes
Once it has been determined that an outdated pharmaceutical cannot
be returned to the manufacturer, that pharmaceutical is classified as
a waste. If this determination has been made at the pharmacy, it is very
important to determine whether the waste is hazardous or non-hazardous.
There are several ways to identify hazardous wastes.
-------
Identifying Your Hazardous Wastes (continued)
% Obtain and read Material Safety Data Sheets (MSDS).
9 Talk to product suppliers and manufacturers.
% Read product labels.
9 Compare product to hazardous waste characteristics and to wastes
listed in federal regulations.
% If product information is not available or is inconclusive, have a
commercial lab sample and test the waste using the Toxicity
Characteristic Leaching Procedure (TCLP).
9 A non-hazardous material or product may become a hazardous
waste due to contaminants added during use. Lab testing may be
necessary to determine whether or not the waste is hazardous.
This is called a "waste determination."
Additional Resources for Identifying Hazardous Wastes
American Hospital Formulary Service (AHFS Drug Information)
Remington's Pharmaceutical Sciences
Merck Manual
The Pill Book-OTC Medications
The Pill Book- Most Prescribed Drugs
Red Book- Pharmacy Fundamental Reference
CRC Handbook of Chemistry and Physics
Drug Facts and Comparisons
Information on the Internet
http://www. RX@RXLIST.COM
-------
CHARACTERISTIC WASTES
Ignitable (A majority of the hazardous wastes that pharmacies handle
are hazardous because they are ignitable. These wastes often pose the
greatest management problems for pharmacies.)
^ Ignitable wastes are easily combustible or flammable. If they
have a flashpoint of 140° F or less or an alcohol content of
f 24% or more, they are hazardous wastes. Examples include:
alcohol (denatured ethyl, ethyl, isopropyl alcohol, and etc.),
_J ammonia inhalants, amyl nitrite, Anbesol®, AquaNet®
aerosol spray, benoxyl peroxide, Benzoin Tincture, Collodion Based
Preparations, Bronchial Dilators (Tornalate), Compound MM®, Cleocin T
Topical Solution®, Erythromycin Topical Solution, Merthiolate Tincture,
mouthwash (alcohol content >24%), Peppermint Spirit, Retin A Gel®, Right
Guard® aerosol spray, Silver Nitrate (oxidi^QrA ^^^r^^;n^fs\ o^^o^i
spray, and some cough medicines (NyquiKS
Corrosive
Corrosive wastes corrode metals or other materials or burn
the skin. These liquids have a pH of 2 or lower or 12.5 or
higher. Examples of acids that exhibit a pH of 2 or lower
include glacial acetic acid and Liquid Phenol (Carbolic Acid).
Examples of bases that exhibit a pH of 12.5 or higher include
Potassium Hydroxide and Sodium Hydroxide.
Reactive
Reactive wastes are unstable and may explode or react
rapidly or violently with water or other materials. Examples
include Clinatest (a test tablet to determine sugar in urine)
and some nitroglycerin formulations.
Toxic
Wastes are toxic if they contain toxic organic chemicals
I or certain heavy metals, such as chromium, lead, mercury,
or cadmium. Examples of potential toxic Pharmaceuticals
include: Arsenic, Barium, Barium Enemas, Cadmium,
Chloroform, Chromium, Fluogen, Fluzone, Insulin with
Cresol, Lindane, Merbromin, Mercury, Mercurochrome, Mixture of Trace
Elements, Selenium, Silver, Silver Nitrate, Thimerosal (contains Mercury),
and vaccines containing mercury as a preservative. Approximately 40
chemicals meet specific leaching concentrations which classify them
as toxic.
8
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LISTED WASTES
There are two types of listed pharmaceutical hazardous wastes. These
are known as acutely hazardous (P-listed) and toxic (U-listed).
P-listed Pharmaceutical Wastes -
These wastes are known as
acutely hazardous.
NAME
Epinephrine (Adrenaline)
Nicotine
Nitroglycerine
Physostigmine
Physostigmine salicylate
Sodium Azide
Strychnine
Warfarin >.3%
P042
P075
P081
P204
P188
P105
P108
P001
U-listed Pharmaceutical
Wastes - These wastes are
known as toxic.
HW# I NAME
HW#
Acetone U002
Chlorambucil U035
Chloroform U044
Cyclophosphamide U058
Daunomycin U059
Dichlorodifluromethane U075
Diethylstilbestrol U089
Formaldehyde U122
Hexachlorophene U132
Lindane U129
Melphalan U150
Mercury U151
MitomycinC U010
Paraldehyde U182
Phenacetin U187
Phenol U188
Reserpine U200
Resorcinol U201
Saccharin U202
Selenium sulfide U205
Streptozotocin U206
Trichloromonofluromethane U121
Uracil mustard U237
Warfarin <.3%, (Coumadin) U248
NOTE: These are not comprehensive lists of "P" and "U" listed chemicals.
Fora complete list, refer to: 40CFR§261.33. The Code of Federal
Regulations is available online at http://www.access.gpo.gov/nara/cfr/,
or you can obtain information by calling the U.S. Environmental
Protection Agency's RCRA hotline at (800) 424-9346.
-------
ty
Step 3
IMPLEMENT BEST MANAGEMENT
PRACTICES (BMPS) FOR:
Container Maintenance
% Maintain containers in good condition.
9 Never place incompatible wastes, such as wastes that react with
each other, in the same container, (e.g. Do not store acids and
bases in the same container.)
% Wastes must be compatible with the container that they are being
stored in (plastic or metal), (e.g. Do not store strong acids or bases
in metal containers.)
Storage
% Separate waste by hazardous waste
classification: P- or U-Listed, Toxicity,
Ignitability, Corrosivity, and Reactivity.
9 Don't combine hazardous waste with
non-hazardous waste.
% Maintain aisle space between
containers to allow for inspection.
9 Inspect medication storage area.
% Be aware of allowable time
limits for storage.
10
-------
Labels
% Label every container with the contents (type of pharmaceutical
or waste).
9 Label every container with whether it is a hazardous waste
or a non-hazardous waste.
% Include any federal waste code numbers that apply.
9 Include the accumulation start date (the date when waste
Pharmaceuticals were first stored in the container).
% Include your pharmacy name and address.
9 Use the following words on labels for hazardous wastes:
HAZARDOUS WASTE
FEDERAL LAW PROHIBITS IMPROPER DISPOSAL
If found, please contact the nearest police or public
safety authority or the U.S. EPA
(Your business's name, address and
manifest document number)
% Use the following words on labels for non-hazardous wastes:
NON-REGULATED WASTE
Optional Information
Shipper
Address
City, State, Zip
Proper DOT Shipping Name
U.N. or N.A. No.
Contents
THIS WASTE IS NOT REGULATED BYTHE U.S. EPA
11
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IMPLEMENT BEST MANAGEMENT
PRACTICES (BMPS) FOR: (continued)
Recordkeeping
% Inspect containers at least once a week and keep a written log
of container inspections.
9 Total weight of P-listed waste generated monthly must be
documented on a monthly basis (Weight of the Container/
Solvent Included).
% Total weights of U-listed and characteristic waste generated
monthly must be documented on a monthly basis.
9 Keep training and inspection records for 3 years.
% Keep manifests and shipping receipts for 3 years.
9 Keep records of completed inventories/audits regarding the
distribution or shipment of prescription drugs for 2 years.
% Keep records of lab tests for 3 years.
9 Keep completed land disposal restriction forms for 3 years.
Spills
% Keep spill cleanup materials readily accessible including: fire
extinguishers; safety equipment such as rubber or latex gloves
and safety glasses; spill cleanup products such as absorbents,
rags, towels, brooms, shovels and dust pans to pick up materials;
and containers to hold spill waste.
9 Observe the safety precautions associated with the material
spilled.
% Stop the source of the spill immediately and cleanup the spill
right away.
9 Recover the spilled substance while observing safety precautions.
% Contain the spilled material.
9 Call your local fire and/or police departments if fire or public
safety hazards are created.
12
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Step 4
DETERMINE YOUR WASTE
GENERATOR STATUS
You must determine how much hazardous waste you generate each
month. The set of rules you must follow depends on how much waste
you generate, how much you store, and how long you store it.
% If you generate less than 220 pounds of hazardous waste
(100 kilograms or about half a drum) per month or you generate
less than 1 kilogram of an acute hazardous waste per month:
you are a "Conditionally Exempt Small Quantity Generator."
% If you generate 220 - 2,200 pounds of hazardous waste
(100 - 1,000 kilograms or about half a drum to 5 drums)
per month: you are a "Small Quantity Generator."
% If you generate more than 2,200 pounds of hazardous
waste (1000 kilograms or more than about 5 drums) per
month or you generate 1 kilogram or more of an acute
hazardous waste per month: you are a "Large Quantity
Generator."
13
-------
ft
StepS
COMPLY WITH GUIDELINES
FOR TRANSPORT AND DISPOSAL
TRANSPORT GUIDELINES FOR MANAGING OUTDATED
PHARMACEUTICALS INTERNALLY
Shipping Guidelines for Waste Transport & Disposal
% Conduct a complete inventory/audit of all Pharmaceuticals or
wastes being shipped offsite. Keep records of completed
inventories/audits for 2 years.
i Make sure your transporter is properly permitted and has an
EPA identification number.
% Make sure that the treatment, storage and disposal facility
receiving your shipment has an EPA identification number and
is properly permitted to dispose of the waste you are shipping.
$ Use manifests for all hazardous wastes shipped offsite.
% Follow container, storage and label guidelines described
on pages 10-11.
Federal Drug Enforcement
Administration (DEA) Regulations
§ If you are shipping Controlled Substances for disposal/destruction,
be sure to follow DEA Regulations. For more information on
shipping controlled substances for disposal/destruction, contact
your Regional DEA office (see page 20).
§ If any of your controlled substances are hazardous waste and are
destined for disposal/destruction, contact the DEP (see page 21).
14
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TRANSPORT GUIDELINES FOR MANAGING OUTDATED
PHARMACEUTICALS FOR REVERSE DISTRIBUTION
Shipping Guidelines for Waste Transport & Disposal
§ Wrap glass/vials/ampules carefully.
% Segregate Controlled Substances in tamper-proof pouches
with no external indication of what is being shipped.
9 Apply DOT Hazardous Materials Label:
• ORM-D Consumer Commodity, and
• Up arrows if over 1 liter.
Federal Drug Enforcement
Administration (DEA) Regulations
(For contact information see page 20.)
% If you are shipping Controlled Substances, be sure that all
DEA regulations are followed.
» Be sure your reverse distributor is registered to accept the
products being shipped. The DEA requires that all transfers
be made between registrants.
% Inventory all Controlled Substances in Schedules III - V:
• Include one copy in the shipment.
• Retain one copy for your records at the pharmacy.
$ If you are shipping Schedule II products, the reverse distribu-
tor must provide you with a Form 222 for the products being
shipped prior to the shipment. Follow the procedures of your
reverse distributor.
% DO NOT indicate that the contents of the shipment contain
controlled substances.
9 DO NOT request or accept a Form 41.
15
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HOW CAN I REDUCE PHARMACEUTICAL
WASTE GENERATION?
Make a commitment to reducing waste in every area of your
pharmacy's operations.
Evaluate your pharmacy's waste and identify areas where changes
can be made.
Facilitate and encourage the participation of all pharmacy personnel
through education, training, and incentives.
Apply Inventory
Management Techniques.
% Dispense older Pharmaceuticals
first.
§ Create an effective inventory
system to reduce outdate
accumulation.
% After inventory is reduced,
prevent the accumulation
of new inventory.
§ Save money by ordering smaller
quantities of Pharmaceuticals
and reducing the need to dispose
of outdated Pharmaceuticals.
% Purchase Pharmaceuticals from suppliers who will accept
returns of unopened Pharmaceuticals.
§ Purchase Pharmaceuticals from vendors who promote
small quantity purchases and who will accept returns of
unopened bottles.
% If a constant stock is required, perform an inventory
review at least once a year to evaluate ordering trends
and pharmacy inventory needs.
-------
Reverse Distribution
% If you inventory and ship all unsorted outdated Pharmaceuticals as
products to a qualified and properly permitted reverse distributor;
OR
§ If you contract a reverse distributor to inventory and ship all
unsorted, outdated Pharmaceuticals as products to the reverse
distribution facility; THEN
\ The reverse distribution facility becomes the Hazardous
Waste Generator upon determining that the non-returnable
Pharmaceuticals are hazardous waste.
§ Your reverse distributor should:
• Inventory and review all items for return eligibility at the
reverse distribution facility, and
• Properly manage all non-returnable items as either
hazardous or non-hazardous waste.
% It is your RESPONSIBILITY to ensure that the reverse distri-
butor is properly handling your outdated Pharmaceuticals.
WHAT ARE THE END RESULTS?
These steps will help to ensure that your pharmacy is able to effectively:
Develop a consistent outdate reduction and management program,
Develop and implement a waste reduction program,
Understand and apply RCRAand State environmental regulations,
and
Assure compliance in all departments to successfully avoid
regulatory fines.
Reducing wastes in your pharmacy makes sense. Benefits include:
Maximizing profits,
Saving money on waste management costs,
Earning a greater return on investments,
Reducing concerns about penalties and liability,
Creating a safer and healthier workplace, and
Promoting positive public relations with clients, customers and
the local community.
17
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CHECKLIST
This checklist will help you to prevent the most common hazardous
waste violations. For more detailed information on hazardous waste
management requirements, contact the DER
O Identify types and quantities of hazardous wastes.
O Notify the Florida DEP of your monthly hazardous waste
generation, and obtain an EPA identification number from the DEP.
QUse proper containers to collect and store wastes.
(^Separate waste by classification: Toxicity, Ignitibility, Corrosivity,
and Reactivity.
O Don't combine hazardous waste with non-hazardous waste.
O Label all containers as hazardous or non-hazardous waste.
O Include the accumulation start dates on labels.
O Maintain aisle space between containers for inspection.
O Inspect containers weekly for rust, leaks or damage and keep
inspection records for three years.
O Total weight of P-Listed waste must be documented monthly.
O Total weights of U-Listed and characteristic waste must be
documented monthly.
ever discharge hazardous wastes to a drain or a septic tank
unless you have an DEP permit that allows you to do so.
rain employees to properly handle hazardous wastes.
QMake sure your transporter and disposal facility have EPA
identification numbers.
QMake sure your reverse distributor is properly licensed
and registered.
QUse Manifests for all waste transported for disposal.
QKeep all records for at least three years.
18
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WHERE CAN I GET MORE INFORMATION?
Additional information on hazardous waste reduction and regulations is
available from many sources.
Florida Department of Environmental Protection
District offices and the Tallahassee office offer technical assistance,
fact sheets and other publications on hazardous waste regulations.
Web site: http://www.dep.state.fl.us/
Hazardous Waste Compliance Assistance Program
Phone: (800)741-4337
(850) 488-0300
Fax: (850)921-8018
Publications available:
Summary of Hazardous Waste Regulations
Requirements for Conditionally Exempt Small Quantity Generators
Requirements for Small Quantity Generators
Handbook for Small Quantity Generators of Hazardous Waste
Florida Board of Pharmacy
Web site: http://www.doh.state.fl.us/mqa/pharmacy/pshome.htm
Address: Board of Pharmacy
2020 Capital Circle SE, Bin #C04
Tallahassee, FL 32399-3254
Phone: (850)414-2969
Email: bobbie_sawner@doh.state.fl.us
Florida Small Business Assistance Program
The Small Business Assistance Program helps businesses with
environmental concerns. Assistance is confidential and staff experts
have business experience.
Phone: (800) 722-7457
U.S. Environmental Protection Agency
The ERA has published a series of industry-specific guidelines and handbooks
on preventing pollution and complying with hazardous waste regulations. The
RCRA Hotline will provide answers to your hazardous waste management
questions. Calls and questions will be kept anonymous at your request.
RCRA Hotline
Phone: (800) 424-9346
19
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DEA CONTACTS IN FLORIDA
MIAMI DIVISION
8400 Northwest 53rd Street
Miami, Florida 33166
(305) 590-4870
ORLANDO DIVISION
300 International Parkway, Suite 424
Heathrow, Florida 32746
(407) 333-7046
TAMPA DIVISION
4950 West Kennedy Boulevard, Suite 400
Tampa, Florida 33609
(813)288-1290
YOUR TRADE & PROFESSIONAL ASSOCIATIONS
Many trade and professional associations have published guides to help
you find solutions to your hazardous waste management problems.
AMERICAN PHARMACEUTICAL
ASSOCIATION
2215 Constitution Avenue,
Northwest
Washington, DC 20037-2985
(202)628-4410
AMERICAN ACADEMY OF
PHARMACEUTICAL
PHYSICIANS
1135 Kildare Farm Road
Suite 200-8
Gary, North Carolina 25711
(919)469-9906
AMERICAN ASSOCIATION
OF PHARMACEUTICAL
SCIENTISTS
1650 King Street, Suite 200
Alexandria, Virginia 22314-2747
(703) 548-3000
FLORIDA PHARMACY
ASSOCIATION
610, North Adams Street
Tallahassee, Florida 32301
(850) 222-2400
RETURNS INDUSTRY
ASSOCIATION
8000 Towers Crescent Drive
Suite 1350
Vienna, VA 22182
(703) 847-3696
Email: riawash@aol.com
20
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OFFICES OF THE FLORIDA DEPARTMENT
OF ENVIRONMENTAL PROTECTION
azardous Waste Regulation Section
Twin Towers Office Building • 2600 Blair Stone Road
Tallahassee, FL 32399-2400
(850) 488-0300
Northwest District
160 Government Center
Pensacola, FL 32501
(850) 695-8360
Northeast District
7825 Baymeadows Way, Suite 200B
Jacksonville, FL 32256
(904) 448-4300
Southwest District
3804 Coconut Palm Dr.
Tampa, FL33619
(813)744-6100
Central District
3319 Maguire Blvd.
Orlando, FL 32803
(407) 894-7555
South District
2295 Victoria Ave., Suite 364
Fort Myers, FL 33901
(941)332-6975
Area
shown
Southeast District
^400 N. Congress Ave.
West Palm Beach, FL 33401
(561)681-6600
The Florida Department of Environmental Protection is an equal opportunity agency and does
not discriminate on the basis of race, creed, color, disability, age, religion, national origin, sex,
marital status, disabled veteran's status, Vietnam Era veteran's status or sexual orientation.
21
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^ —' •*
N OT - =
o
E
& ~
O
CD
-------
United States
Environmental Protection
Agency
Solid Waste and
Emergency Response
(5305W)
EPA530-K-02-010I
October 2001
&EPA
RCRA, Superfund & EPCRA
Call Center Training Module
Introduction to:
Groundwater Monitoring
(40 CFR Parts 264/265, Subpart F)
Updated October 2001
-------
DISCLAIMER
This document was developed by Booz Allen Hamilton Inc. under contract 68-W-01-020 to EPA.
It is intended to be used as a training tool for Call Center specialists and does not represent a
statement of EPA policy.
The information in this document is not by any means a complete representation of EPA s
regulations or policies. This document is used only in the capacity of the Call Center training and
is not used as a reference tool on Call Center calls. The Call Center revises and updates this
document as regulatory program areas change.
The information in this document may not necessarily reflect the current position of the Agency.
This document is not intended and cannot be relied upon to create any rights, substantive or
procedural, enforceable by any party in litigation with the United States.
RCRA, Superfund & EPCRA Call Center Phone Numbers:
National toll-free (outside of DC area) (800) 424-9346
Local number (within DC area) (703) 412-9810
National toll-free for the hearing impaired (TDD) (800) 553-7672
The Call Center is open from 9 am to 5 pm Eastern Time,
Monday through Friday, except for federal holidays.
-------
GROUND WATER MONITORING
CONTENTS
1. Introduction 1
2. Regulatory Summary 2
2.1 Permitted Facility Groundwater Monitoring 6
2.2 Interim Status Groundwater Monitoring 18
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Groundwater Monitoring - 1
1. INTRODUCTION
This module presents the requirements for groundwater monitoring at interim status and
permitted treatment, storage, and disposal facilities (TSDFs) under the Resource Conservation
and Recovery Act (RCRA). The groundwater monitoring regulations are found in 40 CFR Part
264/265, Subpart F. TSDFs managing hazardous waste in certain land-based units are required to
implement a groundwater monitoring program so that releases of hazardous waste from these
units to groundwater are detected and measures are implemented to remediate the contamination
as soon as possible.
The goal of this module is to explain the standards and specific requirements for groundwater
monitoring programs at interim status and permitted facilities. When you have completed this
module you will be able to:
¥ Describe the groundwater monitoring criteria for interim status and permitted facilities
¥ Explain monitoring well placement
¥ Understand the three stages of the groundwater monitoring program for permitted
facilities.
Use this list of objectives to check your knowledge of this topic after you complete the training
session.
The information in this document is not by any means a complete representation of EPA's regulations or policies,
but is an introduction to the topic used for Call Center training purposes.
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2 - Groundwater Monitoring
2. REGULATORY SUMMARY
The groundwater monitoring regulations in Part 264/265, Subpart F, are one part of an overall
strategy to reduce the likelihood of environmental contamination resulting from hazardous waste
treatment, storage, and disposal. This strategy includes restrictions on disposal of untreated
hazardous waste, unit-specific standards for land-based hazardous waste management units, and
monitoring groundwater below these units. The land disposal restrictions program requires the
treatment of hazardous wastes prior to disposal to reduce the mobility or toxicity of hazardous
constituents. The unit-specific standards for land-based hazardous waste management units seek
to prevent the release of hazardous waste to the environment. Groundwater monitoring is the
final link in this strategy to prevent environmental contamination. Owners and operators of all
land-based units must institute a groundwater monitoring program that is able to detect and
characterize any releases of hazardous waste or hazardous constituents to the groundwater
underlying the facility. Should the other elements of the strategy fail, groundwater monitoring
will detect the release so it can be remedied.
The regulations in Subpart F of Part 264/265 are general requirements, establishing performance-
based standards that state what a successful groundwater monitoring program must accomplish;
they do not dictate specific technical standards. Each facility's groundwater monitoring program
is unique because no two TSDFs are exactly the same. Individual groundwater monitoring
programs are based on site-specific conditions, including the underlying geology and hydrology,
as well as the properties of wastes managed on site.
The groundwater monitoring regulations for interim status facilities were promulgated in the May
19, 1980, Federal Register (45 FR 33232) and codified in Part 265, Subpart F. These regulations
were designed to supply background data on facilities before permitting, as well as to act as a
warning system to detect any releases to groundwater prior to permit issuance.
The groundwater monitoring regulations for permitted facilities were promulgated in the July 26,
1982, Federal Register (47 FR 32350) and are found in Part 264, Subpart F. These regulations
pertain to any land-based facility seeking a Part B permit that received waste after July 26, 1982,
or that certified closure after January 26, 1983. Part 264, Subpart F, establishes a three-stage
program designed to detect and remediate any releases from regulated units.
Although the groundwater monitoring programs in Part 264 and Part 265 are different, they do
have some common technical and environmental performance standards. The technical standards
establish an engineering objective and allow a permit applicant to develop a design or set of
practices to achieve certain goals established in the groundwater monitoring requirements under
Subpart F. The
The information in this document is not by any means a complete representation of EPA's regulations or policies,
but is an introduction to the topic used for Hotline training purposes.
-------
Groundwater Monitoring - 3
environmental performance standards specify limits on the levels of contamination that may be
released into the environment before remediation is required.
Groundwater is water found below the land surface in the zone of saturation, meaning that part
of the earth's crust in which all voids are filled with water. An important source of groundwater
is the aquifer, which is a geologic formation, group of formations, or part of a formation capable
of yielding a significant amount of groundwater to wells or springs. There are two types of
aquifers: confined and unconfined. Confined aquifers are under pressure, unconfined aquifers are
not
(Figure 1).
The Subpart F programs protect groundwater that is found in the uppermost aquifer, which is
the water-bearing geologic formation nearest the natural ground surface (X260.10). Also included
in this definition are any and all deeper aquifers that are hydraulically interconnected with the
uppermost aquifer within the facility's property boundary. These interconnected aquifers are
zones of saturation that present a potential pathway for contamination to reach human beings
(Figure 2).
Although the statute does not limit EPA's regulatory authority to only the uppermost aquifer,
the groundwater monitoring regulations only require that the uppermost aquifer be monitored.
The groundwater monitoring regulations of Subpart F do not address other aquifers or any other
groundwater resources which are not in or connected to the uppermost aquifer (/264.90-264.100
and/265.90-265.94). Contamination in such areas can be addressed by other mechanisms such
as authority under RCRA/3004(u) and (v) (for facilities seeking a permit, codified in/264.101);
RCRA/3008(h) (for interim status facilities); RCRA/7003; the Comprehensive Environmental
Remediation, Compensation, and Liability Act (CERCLA); the Safe Drinking Water Act
(SDWA); or state or local enforcement authorities.
The information in this document is not by any means a complete representation of EPA's regulations or policies,
but is an introduction to the topic used for Call Center training purposes.
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4 - Groundwater Monitoring
Figure 1
SCHEMATIC OF CONFINED AND UNCONFINED AQUIFERS
Confined
Aquifer
pressure
raises height
of water
column in well
low permeability
confining layer
permeable
layer
impermeable
>• bedrock
confining layer
Unconfined
Aquifer
permeable
layer
impermeable
bedrock
layer
ater Table
Direction of
Groundwater
The information in this document is not by any means a complete representation of EPA's regulations or policies,
but is an introduction to the topic used for Hotline training purposes.
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Groundwater Monitoring - 5
Figure 2
SCHEMATICS OF AN UPPERMOST AQUIFER
uppermost
aquifer
§
hydraulic 1
along fault line
i
i
i
i
i
i
i
i
i
i
i
i
i
i
i
i
111;
uppermost
aquifer
ater Table
Direction of
Groundwater
The information in this document is not by any means a complete representation of EPA's regulations or policies,
but is an introduction to the topic used for Call Center training purposes.
-------
6 - Groundwater Monitoring
2.1 PERMITTED FACILITY GROUNDWATER MONITORING
EPA has the authority to require the owner and operator of a TSDF to remediate releases of
hazardous waste or hazardous constituents to the environment. All permitted facilities must
comply with Part 264, Subpart F, for releases from solid waste management units (SWMUs).
This module addresses the regulations pertaining to releases to the uppermost aquifer from
regulated units, a subset of SWMUs. See the module entitled RCRA Corrective Action for a
discussion of the regulations that apply to other types of releases from SWMUs. Facilities with
permitted regulated units landfills, surface impoundments, waste piles, or land treatment units
must conduct groundwater monitoring to detect, characterize, and respond to releases of
hazardous waste or hazardous waste constituents into the uppermost aquifer. There are three
stages to the Part 264, Subpart F, groundwater monitoring and follow-up activities:
¥ Detection monitoring - to detect if a release has occurred
¥ Compliance monitoring - to determine if the Groundwater Protection Standard (GWPS)
has been exceeded once a release has occurred
¥ Corrective action - to remediate a release to the uppermost aquifer.
Section 264.97 sets out the basic requirements that apply to all groundwater monitoring
programs under Part 264, Subpart F. The specific requirements that apply to each of the three
phases of groundwater monitoring are found in/264.98, 264.99, and 264.100.
APPLICABILITY, WAIVERS, AND EXEMPTIONS
Owners and operators of TSDFs with regulated units must comply with the groundwater
monitoring requirements of Subpart F during the active life of the regulated unit. There are,
however, limitations to this applicability, expressed in the regulations as waivers and exemptions.
The owner/operator of a regulated unit is not subject to Subpart F monitoring regulations if he or
she can meet any of the conditions for a waiver or exemption (Z264.90(b)). These waivers or
exemptions apply to units for which any of the following apply:
¥ The unit is exempt from Part 264 under^64.1 (/264.90(b)(l))
¥ The unit does not receive free liquids, it is an engineered structure, the unit has inner and
outer containment layers, it has a leak detection system between containment layers, and
the design prevents run-on and run-off (/264.90(b)(2))
¥ The land treatment unit is not releasing hazardous constituents to the environment as
determined by the Regional Administrator (RA) (this exemption applies only during the
post-closure period) (/264.90(b)(3))
¥ The unit has no potential for migration of liquids from the regulated unit(s) as certified by
a qualified geologist or geotechnical engineer (/264.90(b)(4))
The information in this document is not by any means a complete representation of EPA's regulations or policies,
but is an introduction to the topic used for Hotline training purposes.
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Groundwater Monitoring - 7
¥ The waste pile is designed and operated in accordance with/264.250(c) (Z264.90(b)(5)).
Owners/operators of regulated units must also conduct groundwater monitoring in accordance
with Subpart F during the post-closure period. Post-closure is a period of time after the active
life of the facility during which certain maintenance and monitoring activities must be conducted
in order to ensure that no releases will occur from the units and to remediate releases from these
units. Certain units, however, are exempt from the groundwater monitoring requirements after
closure if they are able to demonstrate clean closure, which involves removal or decontamination
of all waste, waste residues, contaminated containment system components, and contaminated
subsoils (/264.90(c)(l)). Subpart F cannot be waived during post-closure care if a detection
monitoring program is being conducted under/264.98, or if the facility is conducting groundwater
monitoring during the compliance period (^264.90(c)(2) and (3)). A summary of the/264.90,
Subpart F, groundwater monitoring applicability requirements is given in Figure 3.
GENERAL GROUNDWATER MONITORING REQUIREMENTS
The general requirements for groundwater monitoring programs at permitted facilities are found in
X264.97. These general requirements apply to all three phases of groundwater monitoring:
detection monitoring, compliance monitoring, and corrective action. A groundwater monitoring
program established pursuant to Part 264, Subpart F, must have a sufficient number of
monitoring wells, installed at appropriate locations and depths, to yield water samples that:
¥ Represent the background conditions of the site (groundwater quality not contaminated
by leakage from an RU)
¥ Represent the quality of groundwater passing the point of compliance
¥ Detect any contamination of the uppermost aquifer at the point of compliance.
The information in this document is not by any means a complete representation of EPA's regulations or policies,
but is an introduction to the topic used for Call Center training purposes.
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8 - Groundwater Monitoring
Figure 3
SUMMARY OF GROUNDWATER MONITORING
APPLICABILITY REQUIREMENTS
Do not have to comply
with Subpart F
NO
Regulated Unit =
Permitted SI, WP, LTU, or LF that
received waste after 7/26/82
§264.90(a)(2)
YES
I
YES
No liquids, engineered structure, inner/outer
containment, leak detection,
AND
no migration? §264.90(b)(2)
Do not have to comply
with Subpart F after
closure
YES
I
NO
LTU Treatment Zone "Clean?"
§264.90(b)(3)
YES
I
NO
No migration?
§264.90(b)(4)
YES
I
NO
Protected WP?
§264.90(b)(5)
NO
YES
Clean Closure?
§264.90(c)
Key
LF - Landfill
LTU - Land Treatment Unit
SI - Surface Impoundment
WP - Waste Pile
NO
Facility MUST comply with
Subpart F requirements
The information in this document is not by any means a complete representation of EPA's regulations or policies,
but is an introduction to the topic used for Hotline training purposes.
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Groundwater Monitoring - 9
If the facility has more than one regulated unit, the owner/operator has the option of installing
one groundwater monitoring system for the entire waste management area. The groundwater
monitoring system for the entire area can be thought of as an imaginary line circumscribing the
group of regulated units, including liners, dikes, or barriers forming the containment area for such
units, rather than for each individual regulated unit within the waste management area, provided
that contamination from any of the regulated units can be detected at the point of compliance
(/264.97(b)). Figure 4 shows examples of groundwater monitoring systems for facilities with
multiple regulated units. Groundwater monitoring system configurations are established on a
site-specific basis and are detailed in the facility permit.
SAMPLING
Groundwater monitoring wells must be properly installed so that samples will yield
representative results. All monitoring wells must be lined, or cased, in a manner that maintains
the integrity of the monitoring well bore hole (/264.97(c)). Poorly installed wells may give false
results.
Consistent sampling and analytical procedures must be implemented to ensure an accurate
representation of the quality of groundwater below the waste management area (/264.97(d)). At
a minimum, there must be procedures and techniques for sample collection, sample preservation
and shipment, analytical procedures, and chain-of-custody control. Sampling and analytical
methods must be appropriate for groundwater sampling and accurately measure the hazardous
constituents being analyzed. Each time that the groundwater is sampled, a determination of the
surface elevation of the uppermost aquifer needs to be made (/264.97(f)). The owner and
operator must develop an appropriate sampling procedure and interval for each hazardous
constituent identified in the facility's permit. This sampling procedure must consist of a
sequence of at least four samples taken at an interval that ensures each is an independent sample.
The owner and operator may use an alternate procedure if approved by the RA. Requirements
and procedures for obtaining and analyzing samples are detailed in the facility permit, usually in a
Sampling and Analysis Plan.
The information in this document is not by any means a complete representation of EPA's regulations or policies,
but is an introduction to the topic used for Call Center training purposes.
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10 - Groundwater Monitoring
Figure 4
EXAMPLES OF GROUNDWATER MONITORING SYSTEMS FOR MULTIPLE
REGULATED UNITS
t
Hazardous Waste
Management Unit A
Hazardous Waste
Management Unit B
' © - © -©-
L _ @. _0_ .0 _ J
V
Hazardous Waste
Management Unit A
©
©
'- © - © -©- -©
-I
Hazardous Waste
Management Unit B
0
----- _0__0_0_0
KEY
Limit of Waste Management Area
Upgradient Well
Downgradient Well
Groundwater Flow
The information in this document is not by any means a complete representation of EPA's regulations or policies,
but is an introduction to the topic used for Hotline training purposes.
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Groundwater Monitoring - 11
STATISTICAL ANALYSIS
The owner/operator has a choice of five different statistical methods for evaluating groundwater
monitoring data. The method selected must be appropriate for the type and distribution of
chemical constituents detected or suspected to be present in the groundwater. The five statistical
method options (which are discussed in detail in/264.97(h)) are:
¥ Parametric analysis of variance
¥ Nonparametric analysis of variance based on ranks
¥ Tolerance or prediction interval procedure
¥ A control chart approach
¥ Another statistical test method approved by the RA.
Any statistical method selected under/264.97(h) must comply with the performance standards
under/264.97(i). These performance standards were established in order to ensure that
evidence of a statistically significant increase (SSI) in a hazardous constituent is a true indication
of a release and is not due to an error in data analysis. All groundwater monitoring data collected
pursuant to/264.97(g) must be maintained in the facility operating record (/264.97(j))- The RA
will specify in the facility's permit when the data must be submitted for review.
STAGE I: DETECTION MONITORING PROGRAM
The goal of a detection monitoring program under/264.98 is to detect and characterize any
release of hazardous constituents from a regulated unit into the uppermost aquifer. The detection
monitoring system must be installed at the point of compliance and adhere to the basic
requirements applicable to all groundwater monitoring systems in/264.97(a)(2), (b), and (c)
(/264.98(b)). The owner and operator must monitor for certain indicator parameters and any
other specific waste constituents or reaction products that would provide a reliable indication of
the presence of hazardous constituents in groundwater at the point of compliance (/264.98(a)).
The RA will designate in the facility's permit what constituents or parameters must be
monitored. These constituents and parameters are monitored to detect potential changes in the
groundwater quality above background levels, which represent the quality of groundwater not
contaminated by hazardous waste management activity at the site. A sequence of at least four
samples from each well (both background and compliance wells) must be collected semiannually
and analyzed using the statistical methods discussed above. The RA will specify the frequency
for collecting samples and for conducting statistical tests. Results from sampling wells at the
point of compliance are then compared to the data on background groundwater quality to
determine if there is any statistical evidence of an increase (increase or decrease in the case of pH)
over background. Statistically significant changes in indicator parameters may suggest that a
release has occurred.
The information in this document is not by any means a complete representation of EPA's regulations or policies,
but is an introduction to the topic used for Call Center training purposes.
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12- Groundwater Monitoring
Using the statistical methods in/264. 97(h), the owner and operator must determine if there has
been an SSI for any chemical or parameter specified in the permit within a reasonable period of
time after completion of sampling. The RA will specify in the permit what is considered a
reasonable period of time. Evidence of a release is probable if an SSI has occurred. An SSI
usually requires that compliance monitoring be initiated, unless the owner and operator can
demonstrate that the SSI was due to an error in sampling or analysis, statistical evaluation, or
natural variations in groundwater chemistry.
If an SSI does occur, the owner and operator must:
¥ Notify the RA within 7 days indicating which parameter(s) or constituent(s) triggered the
SSI
¥ Immediately sample all wells for Part 264, Appendix IX, constituents (Appendix IX is a
list of compounds used to determine the presence of hazardous constituents in
groundwater)
¥ Determine which Appendix IX constituents are present and at what levels
¥ Submit an application for a permit modification within 90 days to establish a compliance
monitoring program meeting the requirements of/264.99
¥ Submit an engineering feasibility plan for a corrective action program within 180 days,
and all data necessary to justify any alternate concentration limit sought under
If the owner and operator can prove, pursuant to/264.98(g)(6), that the contamination did not
result from his or her regulated unit, or that the SSI is due to an error in sample analysis or natural
variations in groundwater geochemistry, the owner and operator will be released from the
requirements to conduct compliance monitoring or to submit a permit modification. The owner
and operator must be able to provide adequate supporting documentation to be released from
these requirements. Figure 5 gives an overview of the detection monitoring program.
STAGE II: COMPLIANCE MONITORING PROGRAM
Once it is established that a release has occurred, the owner and operator must institute a
compliance monitoring program. The goal of the compliance monitoring program is to ensure that
the amount of hazardous constituents released into the uppermost aquifer does not exceed
acceptable levels. Once those levels are exceeded, the owner and operator must initiate corrective
action. The compliance monitoring program establishes routine monitoring (at least
semiannually) to determine if the GWPS has been exceeded.
The information in this document is not by any means a complete representation of EPA's regulations or policies,
but is an introduction to the topic used for Hotline training purposes.
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Groundwater Monitoring - 13
Figure 5
SUMMARY: DETECTION MONITORING PROGRAM (X264.98)
as monitoring revealed
contamination?
O
ompliance Monitoring
ES
264.91(a)(4)
270.14(c)(6)(l)
elected levels >
WPS?
stablish background values for parameters or
onstituents specified by the RA in the permit
o be used in Detection Monitoring
264.97(g)
O
ES
0
mplement a Detection Monitoring Program:
• Indicator parameters and/or constituents are
measured semiannually
• GW Flow Rate and Direction must be
determined annually
§264.98(a),(c),(d),(e)
ES
264.98(g)(6)
rigger SSI?
O
ES
264.98(f)
M
A
W
WPS =
u
SI
Demonstrate SSI not from RU
O
T
mpliance Monitoring
Detected levels >
GWPS?
ES
N
0
*J
0
Groundwater
Groundwater Protection Standards
Regulated Unit
Statistically Significant Increase
The information in this document is not by any means a complete representation of EPA's regulations or policies,
but is an introduction to the topic used for Call Center training purposes.
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14 - Groundwater Monitoring
Groundwater Protection Standard
The GWPS is used to indicate when corrective action is necessary to control plumes of
contamination from regulated units (X264.92). When a facility submits an application for a
permit modification to establish compliance monitoring, the RA specifies the GWPS in the
permit. The GWPS consists of four elements:
¥ A list of hazardous constituents (Z264.93)
¥ The concentration limits for each of the hazardous constituents (X264.94)
¥ The point of compliance (7264.95)
¥ The compliance period during which the GWPS applies (X264.96).
The hazardous constituents identified in the GWPS are those constituents from Part 261,
Appendix VIII, which have been detected in the uppermost aquifer and are reasonably expected
to be in or derived from the waste contained in a regulated unit. Concentration limits are the
levels of hazardous waste or hazardous waste constituents allowed to be present in the
groundwater. The concentration levels can be drawn from one of three sources:
¥ Background levels
¥ Maximum concentration limits (MCLs) identified in Table 1 of/264.94(a)(2) if the
background level of the constituent is below the value given in Table 1
¥ Alternate concentration levels (ACLs) established by the RA under/264.94(b).
The RA will also identify in the permit the compliance period (7264.96) and the point at which
the GWPS applies, known as the point of compliance (7264.95). The point of compliance is the
vertical surface at which the owner and operator must monitor the uppermost aquifer to
determine if the GWPS has been exceeded (Figure 6). A proposed point of compliance is
incorporated into the Part B permit as required by/270.14(c)(3). The compliance period is the
length of time during which the owner and operator must conduct compliance or corrective action
monitoring, equal to the active life of the waste management area, including any waste
management activity prior to permitting and the closure period. This period begins when a
permitted facility begins compliance monitoring. In compliance monitoring, the owner and
operator must determine whether the regulated units are in compliance with the GWPS at the
point of compliance during the compliance period.
The owner and operator must determine whether there is any evidence of increased
contamination for any of the hazardous constituents specified in the permit. This is
accomplished by comparing data on samples collected at the point of compliance to the
concentration limits set in the GWPS. The owner and operator must collect a minimum of four
samples from the background and compliance wells at least semiannually during the compliance
period. The RA will specify the frequency for collecting samples and the statistical method
appropriate to determine if an SSI has
The information in this document is not by any means a complete representation of EPA's regulations or policies,
but is an introduction to the topic used for Hotline training purposes.
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Groundwater Monitoring - 15
Figure 6
SCHEMATIC OF POINT OF COMPLIANCE
LIMIT OF THE WASTE MANAGEMENT AREA
TWO-DIMENSIONAL POINT OF COMPLIANCE |-
UPPERMOST AQUIFER
Direction of Groundwater Flow
occurred. The uppermost aquifer flow rate and direction must also be determined at least
annually (/264.99(d)-(f)).
The owner and operator must analyze samples from compliance wells for all Part 264, Appendix
IX constituents at least annually to determine if any additional constituents are present that are
not specified in the permit. If additional constituents are found, they must be added to the list of
constituents to be monitored.
Appendix IX constituents which are not contained in Appendix VIII of Part 261, may be
included as hazardous constituents into the GWPS of a facility's permit by the Regional
Administrator using the omnibus authority of/270.32(b)(2) and RCRA/3005(c)(3). For further
information on the omnibus authority, see the module entitled Permits and Interim Status.
If the GWPS is exceeded, the owner and operator must notify the RA in writing within seven
days. The owner and operator must indicate which concentration limits have been exceeded,
The information in this document is not by any means a complete representation of EPA's regulations or policies,
but is an introduction to the topic used for Call Center training purposes.
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16 - Groundwater Monitoring
submit a permit modification within 180 days to establish a corrective action program, and
continue to monitor in accordance with the compliance monitoring program (/264.99(h)).
If the owner and operator can prove contamination resulted from a source other than the
regulated unit, or that the SSI is due to an error in sample analysis or natural variations in
groundwater geochemistry, he or she must notify the RA in writing within seven days. The
owner and operator must also submit documentation proving the claim to the RA within 90 days
and submit a permit modification within 90 days to make appropriate changes to the compliance
monitoring program. If the contamination is found to have resulted from a regulated unit, the
owner and operator must initiate corrective action. Figure 7 presents an overview of the
compliance monitoring program.
STAGE IH: CORRECTIVE ACTION PROGRAM
The goal of the Subpart F corrective action program is to bring regulated units back into
compliance with the GWPS at the point of compliance (/264.100(a)). The Subpart F corrective
action program seeks to accomplish this goal by requiring that the owner and operator either
remove the hazardous constituents or treat them in place (/264.100(b)). The RA determines the
time period by which the owner and operator must begin corrective action after the GWPS is
exceeded (/264.100(c)). The specific measures undertaken to achieve corrective action are also
specified by the RA and will vary with each facility. Examples of corrective measures include
excavation, stabilization, solidification, and source control. The owner and operator must also
conduct corrective action to remove or treat in place any hazardous constituents that exceed the
GWPS between the point of compliance and the downgradient property boundary, and beyond
the facility boundary where necessary to protect human health and the environment
^264.100(e)(l)and(2)).
Effectiveness of Program
In addition to corrective action, the owner and operator must establish and implement a
groundwater monitoring program to demonstrate the effectiveness of the corrective action
program. This program may be based on the requirements for a compliance monitoring program
under/264.99 (/264.100(d)). A semiannual report on the effectiveness of the corrective action
program is required under/264.100(g).
Duration
Corrective action must commence within a reasonable time period after the GWPS is exceeded.
During the compliance period, corrective action measures must be continued
The information in this document is not by any means a complete representation of EPA's regulations or policies,
but is an introduction to the topic used for Hotline training purposes.
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Groundwater Monitoring - 17
Figure 7
COMPLIANCE MONITORING PROGRAM SUMMARY (X264.99)
• Notify RA
• Monitor and establish concentrations for all
Appendix IX constituents which are detected
• Submit permit modification & engineering
feasibility plan for CA
±
§264.98 (g)
Detection Monitoring
Establish GWPS (§264.92)
.List of HC
. Concentration Limits of HC
. Point of Compliance
. Compliance Period
§264.99(a)
• Implement Compliance Monitoring Program
1. Semiannual monitoring
2. Flow rate and direction annually
3. Appendix IX analysis annually
Exceed GWPS?
YES I §264.99(h)
Demonstrate the release
is NOT from a Regulated
Unit?
O
YES
§§264.99(e)-(g)
§264.99(1)
ey
A - Corrective Action
WPS - Groundwater Protection Standards
C - Hazardous Constituents
NO
The information in this document is not by any means a complete representation of EPA's regulations or policies,
but is an introduction to the topic used for Call Center training purposes.
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18 - Groundwater Monitoring
to the extent necessary to achieve compliance with the GWPS. Once compliance with the GWPS
has been achieved, the owner and operator may reinstitute a compliance monitoring program.
During the compliance period, facilities might move from compliance monitoring to corrective
action, and back again. If the compliance period ends and corrective action is still being
conducted, corrective action must continue as long as necessary to achieve the GWPS. The
owner and operator can only terminate the corrective action program when the GWPS has not
been exceeded for three consecutive years (/264.100(f)). If the regulated unit is still in the post-
closure period, the owner and operator may then reinstate a detection monitoring program.
A facility may move from one phase of groundwater monitoring to another depending on the
status of the groundwater quality. This means a facility may move from:
¥ Detection to compliance monitoring
¥ Detection monitoring to corrective action
¥ Compliance monitoring to corrective action
¥ Corrective action to compliance monitoring
¥ Compliance to detection monitoring (a facility can reinstate a detection monitoring
program if it is still in the post-closure period and the compliance period has ended).
For an overview of the corrective action program and the sequences of the groundwater
monitoring program, refer to Figure 8.
2.2 INTERIM STATUS GROUNDWATER MONITORING
The requirements for groundwater monitoring programs for interim status TSDFs with regulated
units are found in Part 265, Subpart F. This program is designed to determine the facility's
impact on the quality of groundwater in the uppermost aquifer underlying the facility
(/265.90(a)). Part 265, Subpart F, however, does not contain any provisions for corrective
action when a release has occurred. If corrective action is required at an interim status facility, it
will be addressed under RCRA/3008(h), other cleanup authorities such as RCRA/7003, or in
the facility permit when issued. The interim status groundwater monitoring program requires the
owner and operator of a surface impoundment, landfill, or land treatment facility used to manage
hazardous waste to implement a groundwater monitoring program pursuant to Part 265, Subpart
F. These requirements apply to all interim status facilities which have land-based units (except
waste piles), unless the units qualify for an exemption under/265.1. Interim status waste piles
are not subject to Part 265, Subpart F. The owner and operator can also be exempted by
demonstrating that there is a low potential for migration of hazardous waste or hazardous waste
constituents to drinking water supply wells (X265.90(c)). Owners and operators of surface
impoundments that are used only to neutralize corrosive wastes, and contain no other hazardous
waste, may also qualify for an exemption. The owner and operator must demonstrate that there
is no potential for migration of hazardous wastes from the impoundment (Z265.90(e)).
The information in this document is not by any means a complete representation of EPA's regulations or policies,
but is an introduction to the topic used for Hotline training purposes.
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Groundwater Monitoring - 19
Figure 8
OVERVIEW OF THE CORRECTIVE ACTION PROGRAM (264.100)
Notify RA
Submit Permit Modification and
Corrective Action Plan
mplement CA
. Bring RU into compliance
. Prevent HC from exceeding GWPS
. Remove or treat HC in place
264.99(h)
ompliance Monitoring
orrective Action
§264.100(a)and(b)
ES
stablish and implement
rogram to demonstrate
ffectiveness of CA program
T
eport effectiveness to RA
emiannually
T
chieve GWPS?
CA - Corrective Action
CM - Compliance Monitoring
GWPS - Groundwater Protection Standards
HC - Hazardous Constituents
RA - Regional Administrator
RU - Regulated Units
T
0
264.99(d)
264.99(g)
The information in this document is not by any means a complete representation of EPA's regulations or policies,
but is an introduction to the topic used for Call Center training purposes.
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20 - Groundwater Monitoring
To comply with Part 265, Subpart F, the owner/operator must install, operate, and maintain a
groundwater monitoring system capable of representing the background groundwater quality and
detecting any hazardous constituents that have migrated from the waste management area to the
uppermost aquifer. Under Part 265, Subpart F, there are two types of groundwater monitoring
programs: an indicator evaluation program designed to detect the presence of a release, and a
groundwater quality assessment program that evaluates the nature and extent of contamination.
Figure 9 illustrates groundwater monitoring applicability for interim status facilities.
GROUNDWATER MONITORING SYSTEM
To determine existing groundwater conditions at an interim status facility, the owner and
operator must install at least one well hydraulically upgradient from the waste management area.
The well(s) must be able to accurately represent the background quality of groundwater in the
uppermost aquifer. The owner and operator must install at least three wells hydraulically
downgradient at the limit of the waste management area, which are able to immediately detect any
statistically significant evidence of a release.
A separate monitoring system for each management unit is not required as long as the criteria in
/265.91(a) are met and the system is able to detect any release at the edge of the waste
management area.
SAMPLING AND ANALYSIS
Section 265.92 establishes the requirements for the development and implementation of a
groundwater sampling and analysis plan to be followed for all groundwater monitoring activities.
The plan must specify procedures for sample collection, sample preservation, analytical
procedures, and chain-of-custody control (i.e., point of generation to the lab) (/265.92(a)).
The information in this document is not by any means a complete representation of EPA's regulations or policies,
but is an introduction to the topic used for Hotline training purposes.
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Groundwater Monitoring - 21
Figure 9
APPLICABILITY OF GROUNDWATER MONITORING FOR INTERIM STATUS
FACILITIES
Part 265, Subpart F
Not Required
NO
Interim status surface
impoundment,
landfill, or land
treatment unit?
YES
§265.90(a)
YES
Low Migration
Waiver?
Alternative
groundwater
monitoring program
(Assessment)
YES
§265.90(c)
NO
Statistically significant
increase (SSI) of
indicator parameters
assumed?
§265.93(d)
YES
§265.90(d)
NO
Neutralization in
surface impoundment
exemption?
§265.90(e)
NO
Facility must comply with
Part 265, Subpart F
§265.91
The information in this document is not by any means a complete representation of EPA's regulations or policies,
but is an introduction to the topic used for Call Center training purposes.
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22 - Groundwater Monitoring
Owners and operators must establish concentrations for the three sets of parameters listed in
/265.92(b) in both upgradient and downgradient wells. Sampling for these parameters must be
conducted at the following frequencies:
TYPE TESTING FREQUENCY
first year only after first year
Appendix III Constituents* quarterly no further sampling
required
Groundwater Quality Parameters quarterly annually
(Chloride, Iron, Manganese, Phenols, Sodium,
Sulfate)
Groundwater Contamination quarterly semi-annually
Indicator Parameters
(pH, Specific Conductance, Total Organic
Carbon, Total Organic Halogen)
&
Part 265, Appendix III is a list of EPA Interim Primary Drinking Water Standards taken from the Safe Drinking Water Act. Appendix III is
used to determine the suitability of an aquifer as a drinking water supply.
Initial background concentrations are established during the first year by monitoring all wells
(upgradient and downgradient) for the three groups of constituents listed in/265.92(b). After
the first year, the owner and operator must continue to monitor all wells for the groundwater
quality parameters and groundwater contamination indicator parameters. This is known as the
indicator evaluation program. The data on the groundwater contamination parameters collected
from downgradient wells are compared to data on background water quality to determine if any
contamination of the uppermost aquifer has occurred. As discussed earlier, statistically
significant changes in the indicator parameters indicate a potential release. Groundwater elevation
must also be determined each time a sample is taken.
If an owner/operator assumes or already knows that contamination of the uppermost aquifer has
occurred, he or she may initiate an assessment monitoring program as described below in lieu of
an indicator evaluation program (/265.90(d)).
GROUNDWATER ASSESSMENT PROGRAM
In addition to the basic program of at least one upgradient and three downgradient wells under
/265.91, owners and operators must prepare an outline of a more detailed groundwater
monitoring program (265.93). This program must be able to determine whether hazardous
waste or hazardous waste constituents have leached into the uppermost aquifer in a quantity that
would cause a significant change in groundwater quality. This additional program is often
referred to as a groundwater assessment program. The groundwater assessment program must be
implemented when there has been an SSI (increase or decrease for pH) of an indicator parameter
over background levels. The groundwater assessment program is designed to determine whether
hazardous constituents have entered the groundwater. Once the owner and operator make this
determination, they have to establish the rate, extent of migration, and the concentrations of
The information in this document is not by any means a complete representation of EPA's regulations or policies,
but is an introduction to the topic used for Hotline training purposes.
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Groundwater Monitoring - 23
constituents in the plume.
Statistically Significant Increase (SSI)
If variations in groundwater quality are detected by evidence of statistically significant
differences in concentrations of any of the indicator parameters between the downgradient wells
and background data, the regulations require the owner and operator to obtain additional samples
(/265.93(c)(2)). If the assessment monitoring indicates that no hazardous constituents have
entered the groundwater, then the owner and operator may reinstate the basic indicator evaluation
program. If the analyses performed on the second round of samples confirms an SSI, the owner
and operator must notify the RA within seven days. Examples of variations that would require
additional sampling include a significant increase or decrease in pH or a significant increase in any
of the groundwater contamination parameters (e.g., total organic carbon) being monitored. Within
15 days after the initial notification, a written monitoring assessment plan must be developed by
the owner and operator and submitted to the RA. The assessment plan must include the number
of groundwater monitoring wells, the intended sampling, analytical, and evaluation procedures,
and an implementation schedule. The plan must be designed to determine the rate and extent of
migration of hazardous waste constituents and their concentration (/265.93(d)(4)). Information
gathered from assessment monitoring must be submitted within 15 days after it is collected. The
owner and operator must repeat the groundwater assessment at least quarterly until final closure
of the facility £265.93(d)(7)).
An interim status facility's groundwater monitoring program can move from:
¥ Indicator evaluation to assessment monitoring
¥ Assessment to indicator evaluation monitoring
¥ Assessment monitoring through final closure.
To meet the requirements of the groundwater assessment program, the owner and operator may
need to install additional wells at various locations and depths. Additionally, wells are required
to pinpoint the exact location of a contaminated plume. Schematic examples of the placement of
wells for meeting the requirements of the interim status groundwater monitoring assessment
program are given in Figure 10. Notice that wells of various depths are sometimes placed in
"clusters" at a single location, thereby allowing for an assessment of the groundwater at various
depths.
The information in this document is not by any means a complete representation of EPA's regulations or policies,
but is an introduction to the topic used for Call Center training purposes.
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24 - Groundwater Monitoring
Figure 10
SAMPLE OF ASSESSMENT PHASE MONITORING WELL PLACEMENT
Groundwater
Flow
The information in this document is not by any means a complete representation of EPA's regulations or policies,
but is an introduction to the topic used for Hotline training purposes.
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Groundwater Monitoring - 25
Recordkeeping and Reporting Requirements
Owners and operators of interim status TSDFs conducting groundwater monitoring must comply
with the recordkeeping and reporting requirements of/265.94.
At a facility in the indicator evaluation phase (i.e., no release has occurred), the owner and
operator must keep all records of analyses required by/265.92(c), (d), and (e), and/265. 93 (b).
The owner and operator must also report the results of the following to the RA (/265.94(a)(2)).
What When
¥ Background concentrations in all Quarterly for first year
monitoring wells for parameters under
/265.92(b)(l)
¥ Concentrations of parameters under Annually
¥ Groundwater surface evaluation under Annually
/265.93(f)
When a release has occurred and the uppermost aquifer is monitored pursuant to/265.93(d)(4),
the owner and operator must keep all records of analyses and evaluations required under
/265.93(d)(3) on-site and submit an annual report to the RA on the status of the groundwater
quality assessment program.
The information in this document is not by any means a complete representation of EPA's regulations or policies,
but is an introduction to the topic used for Call Center training purposes.
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Managing Pharmaceutical Waste:
A 10-Step Blueprint for Health Care Facilities
In the United States
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April 15, 2006
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Acknowledgements
The Blueprint was written by Eydie Pines, Hospitals for a Healthy Environment and Charlotte
Smith, PharmEcology Associates, LLC.
The U.S. EPA, Office of Solid Waste and Emergency Response, Innovation Initiative, provided
funding for the project and Mary Dever and Peggy Bagnoli, U.S. EPA Region I, were
responsible for it.
The following people were especially helpful in reviewing the Blueprint:
Fawzi Awad, Saint Paul - Ramsey County Department of Public Health
Laura Brannen, Hospitals for a Healthy Environment
Michael Burke, North Memorial Medical Center
Gail Cooper, U.S. EPA, Office of Solid Waste
Janet Bowen, U.S. EPA Region I
Jerry Fink, North Memorial Medical Center
John Gorman, U.S. EPA Region II
Kristin Fitzgerald, U.S. EPA, Office of Solid Waste
Sara Johnson, New Hampshire Department of Environmental Services
Lisa Lauer, U.S. EPA, Office of Solid Waste
John Leigh, Dartmouth-Hitchcock Medical Center
Steven Lucio, Novation
Meg McCarthy, U.S. EPA, Office of Solid Waste
Patricia Mercer, U.S. EPA, Office of Solid Waste
James Michael, U.S. EPA, Office of Solid Waste Virginia Thompson, USEPA Region IE
David Stitzhal, Pharmaceuticals from Households: A Return Mechanism
Alan Woodard, New York State Department of Environmental Conservation
Catherine Zimmer, Minnesota Technical Assistance Program
Special thanks to staff at Dartmouth-Hitchcock Medical Center for their participation in the
project, particularly Lindsey Waterhouse.
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Table of Contents
Introduction 6
Navigating the Blueprint 7
Applying the Precautionary Principle 8
Step One: Getting Started 9
Step Two: Understanding the Regulations 10
1. Defining Hazardous Waste Categories 11
a. P-Listed Wastes (40 CFR Part 261.33(e)) 11
i. Two Necessary Conditions (40 CFR Part 261.33) 12
ii. Empty Containers of P-Listed Wastes (40 CFRPart 261.7(b)(3)) 13
iii. Dilute Concentrations of P-Listed Waste 14
iv. Epinephrine Syringe Interpretation 14
v. Nitroglycerin Exclusion 15
b. U-Listed Wastes (40 CFR Part 261.33(f)) 15
i. Two Necessary Conditions 15
ii. Empty Containers of U-Listed Wastes (40 CFR Part 261.7(b)(l)) 16
c. Characteristic Hazardous Waste (40 CFR Parts 261.21 -261.24) 16
i. Ignitability: D001 (40 CFR261.21) 17
ii. Corrosivity:D002(40CFRPart261.22) 18
iii. Reactivity: D003 (40 CFRPart261.23) 18
iv. Toxicity: Multiple D Codes (40 CFR Part 261.24) 19
v. Empty Containers of Characteristic Wastes (40 CFR 261.7) 19
2. Grappling with Hazardous Waste Combinations 19
a. Contaminated Personal Protective Equipment and Spill Materials 19
i. Listed Waste 19
ii. Characteristic Waste 20
b. Regulated Medical Waste 20
c. Sharps 21
d. Controlled Substances (21 CFRParts 1300 to 1399) 21
3. Distinguishing Between Trace and Hazardous Chemotherapy Waste 22
a. Terminology 22
b. Trace Chemotherapy Waste 23
c. Hazardous Chemotherapy Waste 23
i. Combination Hazardous Chemotherapy and Regulated Medical Wastes 24
ii. Spill and Decontamination Materials 24
4. Understanding Hazardous Waste Management 25
a. Generator Status 25
b. Drain Disposal (40 CFR 403.12 (p)) 26
c. Incineration 27
Step 3: Considering Best Management Practices for Non-Regulated
Pharmaceutical Wastes 28
1. Formulations With a Listed Active Ingredient That is Not the Sole Active Ingredient ....29
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2. All Chemotherapeutic Agents 29
3. Drugs Meeting NIOSH Hazardous Drug Criteria 30
4. Drugs Listed in Appendix VI of OSHA Technical Manual 30
5. Carcinogenic Drugs 31
6. Drugs with LDSOs Less Than or Equal to 50 mg/kg 31
7. Combination Vitamin/Mineral Preparations with Heavy Metals 31
8. Endocrine Disrupters 32
9. All Other Drugs 32
a. Incinerate 32
b. Eliminate Drain Disposal 33
c. Avoid Landfilling 33
Step 4: Performing a Drug Inventory Review 34
1. Gathering Drug Specific Data 34
a. Compounded Items and Re-formulations 35
2. Making RCRA Hazardous Waste Determinations 36
a. Toxicity 36
b. Best Management Practices 37
1. Documenting Your Decisions 37
2. Keeping the Review Current 37
3. Employing Alternative Approaches 38
Step 5: Minimizing Pharmaceutical Waste 39
1. Considering Lifecycle Impacts in the Purchasing Process 39
2. Maximizing the Use of Opened Chemotherapy Vials 39
3. Implementing a Samples Policy 39
4. Labeling Drugs for Home Use 40
5. Priming and Flushing IV Lines with Saline Solution 41
6. Examining the Size of Containers Relative to Use 41
7. Replacing Prepackaged Unit Dose Liquids with Patient-Specific Oral Syringes 42
8. Controlled Substances 42
9. Delivering Chemotherapy Drugs 42
10. Monitoring Dating on Emergency Syringes 42
11. Reviewing Inventory Controls to Minimize Outdates 43
Step 6: Assessing Current Practices. 44
1. Performing Department Reviews 44
2. Conducting aFrequency Analysis 45
3. Confirming Your Generator Status 46
Step 7: Taking On the Communication/Labeling Challenge 47
1. Automating the Labeling Process 47
a. Incorporating Disposition Data in Dispensing Software 47
b. Inserting Disposition Data on Barcodes 47
2. Manually Labeling in the Pharmacy 48
3. Providing Guidance on the Floor 48
4. Selecting a Message for the Label 48
5. Labeling Drugs Further Up the Supply Chain 49
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Step 8: Considering the Management Options 50
1. Option I: Segregating at the Point of Generation 50
2. Option II: Centralizing Segregation 52
3. Option III: Managing All Drug Waste as Hazardous 53
Step 9: Getting Ready for Implementation 54
1. Locating Your Satellite Accumulation Areas 54
a. Corrosive Waste 55
2. Evaluating Your Storage Accumulation Area 55
3. Selecting the Right Vendor(s) 55
a. Reverse Distributors Are Not Waste Management Services 57
4. Conducting a Pilot Program 58
5. Putting It All Together: Pharmaceutical Waste Management Policies and Procedures... 59
6. Preparing for Spills 59
Step 10: Launching the Program 61
1. Educating and Training Staff 61
2. Staging the Roll-Out 61
3. Filling out the Forms 62
a. Hazardous Waste Manifest (40 CFRParts 262.20 - 262.27) 62
b. Land Disposal Restriction Form (40 CFR Part 268.7) 62
4. Tracking, Measuring and Recording Progress 63
Next Steps 64
1. Provide Additional Pharmaceutical Waste Management Assistance to Hospitals 64
2. Clarify, Reconsider and Expand the RCRA Hazardous Waste Regulations 64
3. Eliminate Drain Disposal 65
4. Communicate Hazardous Waste Determinations 65
5. Broaden National Knowledge Base of Pharmaceutical Waste Generation 65
6. Promote Waste Minimization 66
a. Routinely Wasted Drugs 66
b. Lightweighting 66
7. Understand Environmental Impacts of Existing Treatment Technologies and Advance
New Ones 66
8. Summary 67
Appendix A: Tools and Resources 68
Appendix B: Sample Toxicity Characteristic Calculations 72
Appendix C: Sample Pilot Project Training Presentation 76
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Introduction
The discovery of a variety of pharmaceuticals in surface, ground, and drinking waters around the
country is raising concerns about the potentially adverse environmental consequences of these
contaminants. Minute concentrations of chemicals known as endocrine disrupters, some of
which are pharmaceuticals, are having detrimental effects on aquatic species and possibly on
human health and development.1 The consistent increase in the use of potent pharmaceuticals,
driven by both drug development and our aging population, is creating a corresponding increase
in the amount of pharmaceutical waste generated.
Pharmaceutical waste is not one single waste stream, but many distinct waste streams that reflect
the complexity and diversity of the chemicals that comprise pharmaceuticals. Pharmaceutical
waste is potentially generated through a wide variety of activities in a health care facility,
including but not limited to intravenous (IV) preparation, general compounding, spills/breakage,
partially used vials, syringes, and TVs, discontinued, unused preparations, unused unit dose
repacks, patients' personal medications and outdated pharmaceuticals.
In hospitals, pharmaceutical waste is generally discarded down the drain or landfilled, except
chemotherapy agents, which are often sent to a regulated medical waste incinerator. These
practices were developed at a time when knowledge was not available about the potential
adverse effects of introducing waste pharmaceuticals into the environment.
Proper pharmaceutical waste management is a highly complex new frontier in environmental
management for health care facilities. A hospital pharmacy generally stocks between 2,000 and
4,000 different items, each of which must be evaluated against state and federal hazardous waste
regulations. Pharmacists and nurses generally do not receive training on hazardous waste
management during their academic studies, and safety and environmental services managers may
not be familiar with the active ingredients and formulations of pharmaceutical products.
Frequently used pharmaceuticals, such as epinephrine, warfarin, and nine chemotherapeutic
agents, are regulated as hazardous waste under the Resource Conservation and Recovery Act
(RCRA). Failure to comply with hazardous waste regulations by improperly managing and
disposing of such waste can result in potentially seriousviolations and large penalties.
Hospitals for a Healthy Environment (H2E) recommends this 10-step approach to help you
develop and implement a comprehensive pharmaceutical hazardous waste management program
- one that combines regulatory compliance and best management practices with waste
minimization - to safeguard human health and the environment, while minimizing risk in a cost
effective manner.
1 Sumpter, J and Johnson, A. Lessons from Endocrine Disruption and Their Application to Other Issues Concerning
Trace Organics in the Aquatic Environment. Vol. 39, No. 12, 2005, Environmental Science and Technology.
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Navigating the Blueprint
The steps in this Blueprint do not necessarily have to be taken consecutively. Some steps will
occur in parallel and other steps will probably be referenced throughout the development of your
pharmaceutical waste management program.
The following summary of the 10-steps describes how each step can be used to develop and
implement your pharmaceutical waste management program:
Stepl provides action items that you can begin immediately. Step 2 is an overview of how the
federal Resource Conservation and Recovery (RCRA) regulations apply to pharmaceutical waste
management. Step 3 begins where the regulations leave off providing guidance on how to
manage non-regulated hazardous pharmaceutical waste. Step 4 walks you through the steps
necessary to perform a drug inventory review. This step can be very tedious and time
consuming. Step 5 alerts you to waste minimization opportunities. It will be helpful to become
familiar with the waste minimization opportunities before assessing your current practices based
on the guidance provided in Step 6 and to reference them again after you have performed your
department reviews. Taking on the Communication/Labeling Challenge, Step 7 is one of the
most critical aspects of implementing a pharmaceutical waste management program and possibly
the most challenging. How you decide to communicate pharmaceutical disposition information
to the people handling the waste will depend and be dependent upon which of the management
options presented in Step 8 you select and what you learn in Step 9, Getting Ready for
Implementation. When all the preparation from Steps 7-9 comes together you will be ready for
Step 10, Launching the Program. Next Steps follows Step 10 and provides recommendations for
future efforts to facilitate environmentally sound pharmaceutical waste management in health
care facilities.
The following icons have been used to assist you in using the Blueprint:
Indicates additional steps where relevant information can be found
Indicates that a recommendation involving this topic can be found in Next Steps
Indicates that additional resources can be found in the Appendices
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Applying the Precautionary Principle
This Blueprint focuses primarily on three aspects of pharmaceutical waste management:
(1) Management of regulated hazardous pharmaceutical waste;
(2) Management of non-regulated hazardous pharmaceutical waste applying best
management practices; and,
(3) Minimization of pharmaceutical waste
While your first priority has to be the proper management of hazardous pharmaceutical waste,
careful consideration should be given to the management of all pharmaceutical waste. As
research data accumulates on the adverse impacts of waste pharmaceuticals on human health and
the environment, applying the Precautionary Principle becomes increasingly relevant:
"When an activity raises threats of harm to human health or the environment, precautionary
measures should be taken even if some cause and effect relationships are not fully established
scientifically."2
When in doubt, apply the Precautionary Principle.
The Wingspread Consensus Statement on the Precautionary Principle can be accessed at
http://www.sehn.org/wing.html.
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Step One: Getting Started
Designing and implementing a successful pharmaceutical waste management program is a highly
interdisciplinary process. It begins by obtaining support from senior management and
establishing a committee of stakeholders that will meet regularly to develop and implement the
program. This committee may be the current Environmental Health and Safety Committee but
must include at minimum the leaders of Pharmacy, Environmental Services, Safety, Nursing,
Education, and Infection Control. Additional members for consideration are personnel from
Facilities/Engineering, Administration, Laboratory and Purchasing/Materials Management.
Given the complexity of implementation and the potential budgetary impacts (e.g., purchase of
pharmaceutical waste containers and potentially increased disposal costs), the newly formed
committee may find it valuable to arrange a presentation to senior management explaining the
opportunities, challenges and financial implications of proper pharmaceutical waste management
without getting into program specific details.
No single department owns all the responsibility and no single department can
implement a pharmaceutical waste management program alone.
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Step Two: Understanding the Regulations
Pharmaceutical waste management is especially challenging given the complexity of the
regulations that govern this activity and the multiple regulatory agencies that oversee it. Step 2
focuses primarily on how the federal RCRA regulations apply to hazardous pharmaceutical
waste management. It is divided into four major sections to provide a broad overview of the
applicable regulations and an awareness of the overlap between RCRA and other statutes.
> Defining Hazardous Waste Categories
> Grappling with Hazardous Waste Combinations
> Distinguishing Between Trace and Hazardous Chemotherapy Waste
> Understanding Hazardous Waste Management
It is important to note that the RCRA regulations were written with industrial waste
generation in mind, not for finished pharmaceutical dosage forms such as tablets,
capsules, and injectables. Checking with federal and state regulators on areas that
are open to potentially differing interpretations is highly recommended. This
Blueprint offers a conservative interpretation in those situations. A conservative
approach is always acceptable and offers greater environmental protection.
USEPA Region 2 has been very aggressive in inspecting and enforcing hazardous waste
regulations at the 480 hospitals in New York, New Jersey, Puerto Rico and the U.S. Virgin
Islands. Fines have ranged from $40,000 to almost $280,000. USEPA Region 1 has also begun a
health care initiative and has notified 250 hospitals in New England of its intention to enforce
hazardous waste laws in health care facilities.
State regulations may be more stringent than federal regulations and may vary by state. A
number of states, including California, Washington, and Minnesota, have implemented more
stringent hazardous waste regulations that impact pharmaceutical waste management. Check
your state regulations to make sure that you understand your state-specific requirements.
Next Steps contains a recommendation for clarifying, reconsidering and expanding the
RCRA hazardous waste regulations.
There are additional resources in Appendix A: Tools and Resources that will provide you
with a more complete understanding of RCRA and your organization's responsibilities.
10
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Regulatory Bodies that Oversee Pharmaceutical Waste Management
> Environmental Protection Agency (EPA)
> Department of Transportation (DOT)
> Drug Enforcement Administration (DEA)
> Occupational Safety and Health Administration (OSHA)
> State Environmental Agencies,
> State Pharmacy Boards, and
> Local Publicly Owned Treatment Works (POTW)
1. Defining Hazardous Waste Categories
Hazardous wastes are divided into two categories: (1) listed wastes, and (2) characteristic
wastes. Listed wastes appear on one of four lists of hazardous waste (F, K, P and U).
Pharmaceuticals are found on two of these lists, the P and U lists which both contain commercial
chemical products. Characteristic wastes are regulated because they exhibit certain hazardous
properties- ignitability, corrosivity, reactivity andtoxicity.
Wastes that are not listed and do not exhibit a characteristic are considered solid
waste. Solid wastes should be discarded according to state and/or local regulations
including regulated medical waste requirements. There are situations where a solid
waste should be handled as a hazardous waste applying best management practices.
Step 3: Considering Best Management Practices for Non-Regulated
Pharmaceutical Wastes provides recommendations for applying best
management practices.
a. P- Listed Wastes (40 CFR Part 261.33(e))
Pharmaceuticals are chemicals first and therapeutic agents second. P-listed wastes are
commercial chemical products that are categorized as acutely hazardous under RCRA.
One of the primary criteria for including a drug on the P-list as acutely hazardous is an oral lethal
dose of 50 mg/kg (LD50) or less. LD50 is the amount of a material, given all at once, which
causes the death of 50% of a group of test animals. Eight chemicals on the P-list are used as
Pharmaceuticals (see Table 1).
11
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Constituent of Concern
Arsenic trioxide
Epinephrine
Nicotine
Nitroglycerin
fable 1: P-listed Pharmacei
Waste Code
P012
P042
P075
P081
uticals (Chemothet
Constituent of Concern
Phentermine (CIV)
Physostigmine
Physostigmine salicylate
Warfarin >0.3%
•apy agents are noted in itali
Waste Code
P046
P204
P188
P001
cs)
In health care settings, waste epinephrine (Waste Code P042) is by far the most common
hazardous drug waste generated. It is used most often in cardiac care units and during
orthopedic and ophthalmic surgical procedures but may be generated anywhere in the facility to
treat cardiac arrest and allergic reactions.
Identifying Waste Pharmaceuticals
Some drugs have more than one trade name. The underlying chemical name, not the trade
name, is regulated under RCRA. To be sure you do not miss a chemical due to using a trade
name or generic name, use the Chemical Abstracts Service registry numbers that can be
obtained from the Merck Index or other chemical references and compare them to the CAS
numbers in the Code of Federal Regulations.
> Phentermine is a good example of the use of the CAS number, since it is listed in the 40
CFR 261.33 only as Benzeneethanamine, alpha, alpha-dimethyl-. By looking up
phentermine in the Merck Index, its CAS number of 122-09-8 would tie to the chemical
name in 40 CFR 261.33(e) to P046.
> Trisenox® is the trade name for arsenic trioxide which is regulated as P012.
,A
*^ See Healthcare Related P- and U-Listed Wastes in Appendix A: Tools and Resources
for further assistance.
i. Two Necessary Conditions (40 CFR Part 261.33)
When a drug waste containing a P-listed constituent of concern is discarded or intended to be
discarded, it must be managed as hazardous waste if two conditions are satisfied: (1) the
discarded drug waste contains a sole active ingredient (54 FR 31335) that appears on the P list,
and (2) it has not been used for its intended purpose (54 FR 31336).
To satisfy the definition of sole active ingredient, the listed chemical in the discarded drug must
be the only ingredient that performs the intended function of the formulation. Ingredients that
serve ancillary functions such as mobilizing or preserving the active ingredient are not
considered when determining the sole active ingredient.
The phrase "has not been used for its intended purpose" refers to drugs and their associated
containers or dispensing instruments that have not been given to a patient and need to be
discarded. The portion of an IV infusion that was not given to a patient and needs to be
discarded is an example of an item that has not been used for its intended purpose.
12
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How Dermal Patches Work
In order to maintain consistent release rates, transdermal patches contain a
surplus of active molecule. A stable concentration gradient is the mechanism
used to maintain consistent release rates and constant serum drug levels. Most
transdermal patches contain 20 times the amount of drug that will be absorbed
during the time of application. Therefore, after removal, most patches contain
at least 95% of the total amount of drug initially in the patch.
Nicotine is a P-listed constituent of concern (P081). Do worn nicotine patches
need to be managed as RCRA hazardous waste? Nicotine is the sole active
ingredient. So, the answer differs depending on whether you decide to
evaluate the patch or the nicotine remaining in the patch to determine if the
drug has been "used for its intended purpose." EPA has not provided any
specific guidance on how to manage worn dermal patches.
ii. Empty Containers of P-Listed Wastes (40 CFRPart 261.7(b)(3))
A container that has held a P-listed waste is not considered "RCRA empty" unless it has been:
(1) Triple rinsed, and
(2) The rinsate is managed as hazardous waste.
Since triple rinsing is not practical in health care settings, all vials, TVs, and other containers that
have held a P-listed drug must be managed as hazardous waste, regardless of whether or not all
of the contents have been removed.
13
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Tablets and Capsules Containing P-Listed Constituents of Concern
Are you managing the following as hazardous waste?
> The cups used to deliver P-listed pharmaceuticals such as Coumadin, containing
P001 Warfarin
The Minnesota Pollution Control Agency does not consider the "souffle cups"
used to deliver tablets and capsules containing P-listed constituents of concern to
be containers. Therefore, in Minnesota these cups do not have to be managed as
hazardous waste unless they are overtly contaminated with a P-listed residue.
> The residue that is generated when tablets of drugs such as Coumadin are cut to
prepare a smaller dose
> The unit dose packaging from tablets and capsules
Check with your state regulatory agency for guidance on their interpretation or apply
a conservative approach and discard all containers of P-listed waste as hazardous
waste.
iii. Dilute Concentrations of P-Listed Waste
There are no concentration limits or dilution exclusions for P-listed hazardous wastes. If saline or
another solvent is added to a P-listed chemical, additional P-listed hazardous waste is generated.
iv. Epinephrine Syringe Interpretation
Excess and residue epinephrine in a syringe after the proper dose has been administered to a
patient is the single pharmaceutical exception to the definition of the phrase has not been used
for its intended purpose. This exception is based on a December 1994 EPA Hotline
interpretation3 After the proper dose has been injected, EPA considers residues remaining in a
syringe to have been used for their intended purpose. Therefore, the syringe containing residue
epinephrine is not a P042 hazardous waste and can be discarded as Regulated Medical Waste in a
sharps container.
In the interpretative guidance, a reference is made to the syringe as a dispensing instrument. The
question arises regarding the regulatory status of other forms of delivery or dispensing
instruments, such as an IV bag containing excess or residue epinephrine. EPA has not expanded
the definition of a dispensing instrument to include any form of delivery other than a used
syringe. Therefore, only excess or residue epinephrine in a used syringe is excluded from
regulation as a P-listed waste. All excess or residue epinephrine in other types of dispensing
instruments must be managed as a RCRA hazardous waste.
3 RCRA Online #13718
http://yosemite.epa.gov/osw/rcra.nsf/0c994248c239947e85256d090071175f/lcldeb3648a62a868525670f006bccd2!
OpenDocument
14
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v. Nitroglycerin Exclusion
In 2001, a revision to the mixture and derived-from rules (66 FR 27286) excluded all P- and U-
listed wastes listed solely for an ignitability, reactivity and/or corrosivity characteristic (including
mixtures, derived-from and as generated wastes) once they no longer exhibit a characteristic.
Nitroglycerin, P081, is listed solely for its reactivity characteristic. This action effectively
removed medicinal nitroglycerin as a P-listed waste at the federal level since it is a weak, non-
reactive formulation that does not exhibit the reactivity characteristic.
Nitroglycerin formulations must still be evaluated for the other characteristics. Some injectables
such as nitroglycerin 5 mg/ml in some formulations fail the ignitability characteristic, which is
discussed later in this Step.
Status of Exclusion in Your State
All states except Iowa and Alaska must adopt the revised Mixture and Derived-From
Rule before weak non-reactive nitroglycerin is excluded. Hazardous waste regulations
are enforced by USEPA in Iowa and Alaska, therefore this provision was effective
immediately in those states.
Until your state has adopted this provision, nitroglycerin must be managed as a P081
waste and therefore is still subject to Land Disposal Restrictions, which are discussed
later in Step Two.
Some states, such as Michigan, have chosen to be more stringent and not adopt this
revision. Check with your state regulatory agency to determine the status of medicinal
nitroglycerin in your state.
b. U-Listed Wastes (40 CFR Part 261.33(f))
i. Two Necessary Conditions
There are 21 drugs on the U-list (see Table 2: U-Listed Pharmaceuticals). These chemicals are
listed primarily for their toxicity. Similar to a P-listed waste, when a drug waste containing one
of these chemicals is discarded, it must be managed as hazardous waste if two conditions are
satisfied:
(1) The discarded drug waste contains a sole active ingredient that appears on the U list, and
(2) It has not been used for its intended purpose.
As with P-listed wastes, there is no concentration limit or dilution exclusion.
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Constituent of Concern
Chloral hydrate (CIV)
Chlorambucil
Cyclophosphamide
Daunomycin
Dichlorodifluoromethane
Diethylstilbestrol
Hexachlorophene
Lindane
Melphalan
Mercury
Mitomycin C
Waste Code
U034
U035
U058
U059
U075
U089
U132
U129
U150
U151
U010
Constituent of Concern
Paraldehyde (CIV)
Phenol
Reserpine
Resorcinol
Saccharin
Selenium sulfide
Streptozotocin
Trichloromonofluromethane
Uracil mustard
Warfarin <0.3%
Waste Code
U182
U188
U200
U201
U202
U205
U206
U121
U237
U248
Table 2: U-Listed Pharmaceuticals (Chemotherapy agents are noted in italics)
ii. Empty Containers of U-Listed Wastes (40 CFR Part 261.7(b)(D)
A container that has held a U-listed waste is considered "RCRA empty" if two conditions are
met:
(1) All the contents have been removed that can be removed using normal means4, such as
drawing liquid out with a syringe;
AND,
(2) No more than 3% by weight remains.
If both of these criteria are not met, the container must be managed as hazardous waste. Any
residues removed from the empty container must be managed as hazardous waste.
c. Characteristic Hazardous Waste (40 CFR Parts 261.21 - 261.24)
In addition to the P- and U- listed wastes, a waste is considered hazardous under RCRA if it
possesses at least one of four unique and measurable properties or characteristics:
(1) Ignitability,
(2) Corrosivity,
(3) Reactivity, and
(4) Toxicity.
As the generator, you are responsible for determining whether a drug formulation that is intended
for discard exhibits one of the four characteristics through testing or through knowledge of the
4 Normal means are practices commonly employed industry -wide to remove the material from that type of container,
such as pouring, pumping, aspirating, and draining (40 CFR Part 261.7(b)(l)(i))
16
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drug formulation. Once a characteristic waste no longer exhibits any of these properties, it is no
longer considered a hazardous waste. However, RCRA places certain restrictions on the manner
in which a waste can be treated (See What is Treatment? below).
i. Ignitabilitv: D001 (40 CFR 261.21)
The objective of the ignitability characteristic is to identify wastes that either present a fire
hazard under routine storage, disposal, and transportation or are capable of exacerbating a fire
once it has started. There are several ways that a drug formulation can exhibit the ignitability
characteristic.
> Aqueous drug formulations containing 24 percent or more alcohol by volume and having a
flashpoint of less than 140 degrees F or 60 degrees C must be managed as ignitable
hazardous waste. Aqueous refers to a solution containing at least 50 percent water by
weight. Since flashpoint data is somewhat hard to obtain, you should consider managing all
waste formulations containing 24% or more alcohol as ignitable hazardous waste. Many
drugs are relatively insoluble in water and require alcohol to keep them in solution.
> Liquid drug formulations, other than aqueous solutions containing less than 24 percent
alcohol, with a flashpoint of less than 140 degrees F or 60 degrees C must be managed as
ignitable hazardous waste. Being a non-aqueous solution, the flashpoint is used to make the
hazardous waste determination.
> Oxidizers or materials that readily supply oxygen to a reaction in the absence of air as
defined by the DOT5 must be managed as hazardous waste.
> Flammable aerosol propellants meeting the DOT definition of compressed gas must be
managed as hazardous waste.
What is Treatment?
Diluting an ignitable solution containing greater than 24% alcohol during the
normal course of usage, as in the preparation of an IV solution, is not
considered treatment. Any resulting waste would not be ignitable hazardous
waste.
Diluting an ignitable alcoholic solution containing over 24% alcohol for the
purposes of rendering it non-ignitable is considered treatment. As a hazardous
waste generator, you are not permitted to treat hazardous waste. A treatment,
storage and disposal facility permit, which is generally inappropriate for
hospitals, is required.
5 Reference 40 CFR 264 Appendix V Examples of Potentially Incompatible Waste Group 6-A Oxidizers
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Ignitable Properties
Resources
Ignitable Drug Formulations
Aqueous drug formulation
containing 24 % or more
alcohol by volume and having
a flashpoint of less than 140 °
For60°C(261.21(a)(l))
> Material Safety Data Sheet
> Common pharmacy
references such as Facts
and Comparisons or their
on-line database, E-Facts
> Erythromycin Gel 2%
> Texacort Solution 1%
> Taxol Injection
Liquid drug formulations,
other than aqueous solutions
containing less than 24 %
alcohol, with a flashpoint of
less than 140°For60°C
> MSDS
> Standard laboratory test
procedure for measuring
flashpoint
> Flexible collodion used as
a base in wart removers is
not an aqueous solution
and has a flashpoint = 45
degrees C
Oxidizers or materials that
readily supply oxygen to a
reaction in the absence of air
as defined by the DOT
40 CFR 264 Appendix V
Examples of Potentially
Incompatible Waste Group
6-A Oxidizers
Test methods in 49 CFR
173.151
Amyl nitrite inhalers, used
for the rapid relief of
angina pain
Silver nitrate applicators,
used for cauterizing
Bulk chemicals found in
the compounding section
of the pharmacy such as
potassium permanganate
Flammable aerosol propellants
meeting the DOT definition of
compressed gas (261.21(a)(3))
> Test methods in 49 CFR
173.300
> Primatene aerosol
ii. Corrosivity: D002 (40 CFR Part 261.22)
Any waste which has a pH of less than or equal to 2 (highly acidic) or greater than or equal to
12.5 (highly basic) exhibits the characteristic of corrosivity and must be managed as a hazardous
waste. Generation of corrosive pharmaceutical wastes is generally limited to compounding
chemicals in the pharmacy. Compounding chemicals include strong acids, such as glacial acetic
acid and strong bases, such as sodium hydroxide.
Step 9: Locating Your Satellite Accumulation Area includes a discussion on managing
corrosive pharmaceutical waste.
iii. Reactivity: D003 (40 CFR Part 261.23)
Reactive wastes are unstable under "normal" conditions. They can cause explosions, toxic fumes,
gases, or vapors when heated, compressed, or mixed with water. Nitroglycerin is the only drug
that is potentially reactive. Refer to the section above, entitled Nitroglycerin Exclusion, for an
understanding of the regulatory status of medicinal nitroglycerin.
1 Primatene aerosol contains epinephrine. The waste code P042 should also be used when manifesting this waste.
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iv. Toxicity: Multiple D Codes (40 CFR Part 261.24)
Forty chemicals have been included in RCRA as a concern in a solid waste landfill environment
above certain concentrations. Table 3 provides a subset of that list and examples of drug
formulations containing these chemicals and heavy metals. Wastes that exceed these
concentrations must be managed as hazardous waste. The test that determines the ability of
these chemicals and heavy metals to leach in a landfill environment is called the Toxicity
Characteristic Leaching Procedure, or TCLP. If the concentration determined by the TCLP
exceeds the stated limits, the waste must be managed as hazardous waste.
Ingredient
Arsenic
Barium
Cadmium
Chloroform
Chromium
Lindane
M-cresol
Mercury
Selenium
Silver
Waste
Code
D004
D005
D006
D022
D007
D013
D024
D009
D010
D011
Regulatory Level
(mg/1)
5.0
100.0
1.0
6.0
5.0
0.4
200.0
0.2
1.0
5.0
Drugs Formulations Containing
These Ingredients
Arsenic trioxide (also P-listed)
Barium sulfate (used in radiology)
Multiple mineral preparations
No longer commonly used
Multiple mineral preparations
Treatment of lice, scabies
Preservative in human insulins
Vaccines with thimerosal
Dandruff shampoo, multiple mineral
preparations
Silver sulfadiazine cream
Table 3: D-listed Chemicals Used in Drug Formulations
v. Empty Containers of Characteristic Wastes (40 CFR 261.7)
A container that has held a characteristic waste is defined as empty in the same manner as a U-
listed waste if all of the contents have been removed that can be removed through normal
means7 and no more than 3% by weight remains.
2. Grappling with Hazardous Waste Combinations
This section provides guidance on how to manage combinations of hazardous waste and:
> Personal Protective Equipment (PPE) and spill materials,
> Regulated Medical Waste (RMW),
> Sharps, and
> Controlled substances.
a. Contaminated Personal Protective Equipment and Spill Materials
i. Listed Waste
PPE worn to protect employees from exposure to hazardous chemicals, materials used to perform
routine cleaning or decontamination of Biological Safety Cabinets and glove boxes, and spill
clean up materials may become contaminated with hazardous waste.
7 Normal means are practices commonly employed industry -wide to remove the material from that type of container,
such as pouring, pumping, aspirating, and draining (40 CFR Part 261.7(b)(l)(i))
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According to EPA's contained-in policy8, the resulting waste has the same regulatory status as
the original listed component. For example, personal protective equipment such as gloves and
gowns that is known to be or suspected of having been contaminated with P- or U-listed
hazardous waste must be managed as hazardous waste. If PPE is routinely worn but does not
appear to have come into contact with listed waste, it is acceptable for it to be discarded either as
trace chemotherapy waste, if its use involved chemotherapy agents, or in the trash as solid waste.
Any materials used to clean up a hazardous waste spill, such as the contents of an IV bag of
epinephrine, must be managed as hazardous waste and cannot be discarded in a trace
chemotherapy or solid waste container.
Refer to the section below, Distinguishing Between Trace and Hazardous Chemotherapy Waste,
for further discussion of PPE and spill materials contaminated with chemotherapy agents.
ii. Characteristic Waste
The contained-in policy applies differently to characteristic hazardous wastes. PPE and spill
materials contaminated with characteristic wastes are hazardous only if the PPE and spill
material exhibit a characteristic. However, it is best to be conservative and manage PPE that has
been contaminated with a flammable waste or a highly corrosive waste as hazardous waste.
Contaminated Personal Protective Equipment
Indications of contaminated PPE include, but are not limited to:
> Shiny sheen,
> Change in color,
> Change in texture or feel, and/or
> Visual evidence such as seeing the contaminant on the PPE.
b. Regulated Medical Waste
There will be situations where a combination waste that is both infectious Regulated Medical
Waste and hazardous waste must be managed by a limited number of vendors that are permitted
to handle both waste streams. The type of dispensing instrument used and the type of drug being
administered both play an important role in determining how the resulting waste must be
managed.
EPA's contained in policy is explained in the following letters: (1) Marcia Williams to Gary Dietrich (2/9/1987);
(2) Sylvia Lowrance to Timothy Fields, Jr. (1/3/1989; RCRA Online #11387;
http://yosemite.epa.gov/osw/rcra.nsf/0c994248c239947e85256d090071175f/ae8507395dc469558525670f006bdce8!
OpenDocument); and, (3) Devereaux Barnes to Norm Niedergang (2/17/1995; RCRA Online #13732;
http://yosemite.epa.gov/osw/rcra.nsf/0c994248c239947e85256d090071175f/34dd8e7f201f99da8525670f006c23c3!
OpenDocument).
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If, for example, bloody tubing or sharps are not disconnected from an IV bag that contains a
partially used P- or U-listed chemical or from one that no longer contains a P-listed chemical, the
waste must be managed asboth RMW and hazardous waste. Fortunately, in many cases, luer-
lock fittings enable the safe disconnection of the tubing or sharps from the IV bag.
Disconnecting the tubing or sharps from the IV bag avoids the generation of a waste that isboth
RMW and hazardous waste and instead enables the management of the tubing or sharps and IV
bag individually as RMW and hazardous waste, respectively.
Arsenic trioxide and physostigmine are drugs that may be prepared or administered by syringe
and as a result may need to be managed asboth hazardous waste and RMW. Some states, such
as New York may allow a waste that is both RMW and hazardous to be handled as hazardous
waste on the basis that hazardous waste is the more protective category.
c. Sharps
Often partially used syringes, vials or ampules containing P- or U-listed hazardous chemicals or
characteristic hazardous wastes are erroneously discarded in RMW sharps containers. Generally
speaking, most vendors that manage sharps are not legally permitted to manage RCRA
hazardous waste. These vendors are permitted to treat only infectious waste. As the generator, it
is your responsibility to train staff that these distinct types of waste are managed differently and
must be segregated (e.g., not to discard hazardous waste or waste that is both RMW and
hazardous waste in sharps containers unless the containers are specially marked as both
infectious and hazardous waste). If hazardous waste is improperly placed in a sharps container,
the container should be relabeled as RMW and hazardous waste and managed by a vendor that is
permitted to handle both waste streams.
Similarly, it is also possible that during a cardiac arrest code, a vial or ampule of epinephrine
may be used and discarded into the sharps container on the crash cart. In this case, a P-listed drug
container, which remains hazardous unless triple rinsed, is placed into an RMW container. Here
again, the container must be relabeled as an RMW and hazardous waste container and a vendor
that is permitted to handle both waste streams must be utilized.
d. Controlled Substances (21 CFR Parts 1300 to 1399)
Controlled substances are those drugs regulated by the Drug Enforcement Administration. They
are divided into five schedules based on their potential for abuse.
Controlled Substance Schedules
Schedule I includes drugs that have no accepted medical use, such
as heroin.
Schedule II drugs are used medically but have high abuse potential,
such as morphine, and their purchase, storage, and use
requirements are very strictly monitored.
Schedules III through V are drugs with decreasing abuse potential,
including sedatives, tranquilizers, and cough suppressants, such as
codeine.
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Controlled substances must be destroyed so that they are beyond reclamation and two health care
professionals must document the destruction. Since most hospitals no longer have ready access
to incinerators in which to burn the drugs, the next most efficient way to accomplish this is
through drain disposal.
There are three controlled substances that are on Schedule IV due to their moderate abuse
potential that are also RCRA listed constituents of concern: (1) Chloral hydrate (U034), (2)
Paraldehyde (U182), and (3) Phentermine (P046). Other controlled substances may be state
listed hazardous waste, as is the case in Minnesota. Be sure to check with your state regulatory
agency.
These hazardous controlled substance wastes can be transferred to a limited number of hazardous
waste vendors that are also DBA registrants. They also may possibly be sewered. You need to
request written permission from your wastewater treatment plant to sewer small amounts of
hazardous controlled substances. Sewering of controlled substances may be prohibited in your
state or municipality. The hazardous waste regulations pertaining to sewering are described in
more detail below in the section entitled, Drain Disposal.
Step 5: Minimizing Pharmaceutical Waste provides examples of controlled substances
that are routinely wasted and alternatives that will minimize generation of this waste
stream.
Step 9: Selecting the Right Vendor(s) contains requirements for hazardous waste vendors
that are also DBA registrants.
A
9'1 Next Steps contains recommendations for working with DBA to eliminate drain disposal,
understanding the environmental impacts of managing waste pharmaceuticals in sharps
containers and examining the appropriate management of wastes that are both infectious
and hazardous.
Appendix A: Tools and Resources provides additional information on controlled
substances and DBA requirements.
3. Distinguishing Between Trace and Hazardous Chemotherapy Waste
a. Terminology
There is a great deal of confusion among the terms chemotherapeutic, antineoplastic, and
cytotoxic. Technically, chemotherapy is therapeutic chemical treatment. While most commonly
used to describe cancer treatment, it was originally used as an anti-infective term in reference to
the use of mercury and arsenic before the advent of antibiotics. Some journals still refer to
antimicrobial chemotherapy. The term antineoplastic refers specifically to inhibiting or
preventing the growth or development of malignant cells, and is the most specific. The term
cytotoxic is a very general term referring to any chemical that is toxic to cells. It again has taken
on the common meaning of cancer chemotherapy. To confuse matters more, the pharmaceutical
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profession tends to equate the term biohazardous with cytotoxic. Some manufacturers put both
"Cytotoxic" and "Manage as Biohazardous Waste" on the same label. These labels create
confusion as the term "biohazardous" waste should be restricted to the commonly accepted
definition of infectious waste in state blood-borne pathogens regulations, which are typically
items contaminated with pourable, drippable, flakable or squeezable blood, used or unused
sharps, and lancing devices.
Although the term "chemotherapy" technically refers to any type of
drug treatment, it will be used to describe highly toxic cancer therapy
agents in this document.
b. Trace Chemotherapy Waste
The federal RCRA regulations do not address trace chemotherapy waste. There is no recognized
distinction between bulk and trace chemotherapy contamination for P- and U-listed hazardous
wastes since there isn't a lower concentration limit under which these wastes can exit the
regulatory system.
Most state regulated medical waste regulations are either silent or not specific on the definition
of trace chemotherapy waste. The original reference to segregating trace chemotherapy waste is
found in an article written in 1984 by pharmacy personnel at the National Institutes of Health
who pioneered applying the RCRA regulations to antineoplastic wastes9 California's Medical
Waste Management Act and Wisconsin's newly revised Medical Waste Rules identify trace
chemotherapy waste and require incineration at a regulated medical waste facility or other,
approved treatment method.
Refer to Appendix A: Tools and Resources for information on how to access the
California Medical Waste Management Act and the Wisconsin Medical Waste Rules.
All chemotherapy paraphernalia should be managed as trace chemotherapy waste if there has
been the potential for exposure to chemotherapy contamination. Items that are appropriate for
management as trace chemotherapy waste include:
> "RCRA empty" vials, syringes, IV bags, and tubing;
> Gowns, gloves, wipes and other paraphernalia associated with routine handling, preparation,
and administration of chemotherapy; and
> Wipes and other materials used during routine cleaning and decontamination of a Biological
Safety Cabinet or glove box (unless alcohols, phenols or other hazardous materials are used).
c. Hazardous Chemotherapy Waste
One chemotherapy agent is a P-listed constituent of concern and eight chemotherapy agents are
U-listed (See Table 4 below). Trace chemotherapy containers have long been used to discard
Vaccari, P; Tonat, K; DeChristoforo, R; GTallelli, J, Simmerman, P. Disposal of antineoplastic wastes at the
National Institutes of Health, AJHP Vol 41 Jan 1984, pp. 87 - 93.
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listed chemotherapy drug waste that should be managed as hazardous waste. This is not only
illegal but also inappropriate since trace chemotherapy waste is incinerated at an RMW
incinerator, not a hazardous waste incinerator. RMW incinerators have less restrictive emissions
limits and permit requirements. Discarding "bulk" P- or U- listed chemotherapy agents as trace
chemotherapy waste has been the cause of substantial enforcement actions and fines and should
be one of the first changes you implement in your pharmaceutical waste management program.
The term "bulk chemotherapy" is not a regulatory term but is used to
differentiate chemotherapy containers that are not "RCRA empty."
Constituent of Concern
Arsenic Tri oxide
Chlorambucil
Cyclophosphamide
Daunomycin
Diethystilbestrol
Melphalan
Mitomycin C
Streptozotocin
Uracil Mustard
Product Name
Trisenox
Leukeran
Cytoxan, Neosar
Daunorubicin, Cerubidin,
DaunoXome, Rubidomycin
DBS, Stilphostrol
Alkeran, L-PAM
Mitomycin, Mutamycin
Streptozocin, Zanosar
No longer in active use
Waste Code
P012
U035
U058
U059
U089
U150
U010
U206
U237
Table 4: P- and U-Listed Chemotherapy Agents
i. Combination Hazardous Chemotherapy and Regulated Medical Wastes
The Oncology Nursing Society strongly discourages unhooking an IV set unless it has been
designed to protect employees from exposure. When a chemotherapy waste that is both RMW
and hazardous waste is generated, it must be managed by a limited number of vendors that are
permitted to handle both waste streams (See the section above on Regulated Medical Waste for
information on combination wastes).
ii. Spill and Decontamination Materials
Any materials used to clean up a hazardous waste spill, such as the contents of a used
chemotherapy spill kit, must be managed as hazardous waste. This material cannot be discarded
in a trace chemotherapy waste container. If overt contamination of the Biological Safety Cabinet
or glove box surfaces is known or suspected, all cleaning materials should be discarded as
hazardous waste. It is always permissible to manage a waste up to the next hazard class. When
making this decision, you should use good judgment based on how often the Biological Safety
Cabinet or glove box is used and decontaminated. Unless a closed transfer system such as
PhaSeal is being utilized, it is safe to assume that some chemotherapy contamination occurs with
each transfer.
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Minimizing Employee Exposure
> Contamination of Biological Safety Cabinets can be greatly minimized through the use
of a closed transfer system such as PhaSeal at all stages of preparation, transfer, and
administration. The M.D. Anderson Cancer Center in Houston, Texas has done
extensive studies to demonstrate the importance of good work practices in minimizing
employee exposure.
> NIOSH and ASHP studies have shown that trace chemotherapy contamination poses a
threat to exposed workers. It is very important to incinerate rather than autoclave any
material that has the potential of being contaminated with chemotherapy agents.
Step 3: Considering Best Management Practices for Non-Regulated Pharmaceutical Wastes
contains a discussion of best management practices for the over 100 non-regulated
chemotherapy wastes.
Step 6 provides opportunities to minimize chemotherapy waste.
Appendix A: Tools and Resources contains additional resources on managing
chemotherapy wastes and insuring employee safety.
4. Understanding Hazardous Waste Management
a. Generator Status
Organizations that generate RCRA hazardous waste are regulated as one of the following:
> Large Quantity Generators (LQGs), facilities that generate greater than 1,000 kg of
hazardous waste per calendar month (approximately 2,200 Ibs) or greater than 1 kg of acutely
hazardous waste per calendar month (approximately 2.2 Ibs).
> Small Quantity Generators (SQGs), facilities that generate between 100 kg (approximately
220 Ibs) and 1,000 kg of hazardous waste per calendar month and generate no more than 1kg
of acultey hazardous waste per calendar month (approximately 2.2 Ibs.) and accumulate less
than 6,000 kg (approximately 13,200 Ibs) of hazardous waste at any time.
> Conditionally Exempt Small Quantity Generators (CESQGs), facilities that generate less than
100 kg of hazardous waste per calendar month and no more than 1 kg of acutely hazardous
waste per calendar month.
Whether the wastes that you generate are U-listed or P-listed can affect your generator status.
Only 1 kilogram, or 2.2 pounds, of P-listed waste generated in a calendar month will cause your
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facility to become an LQG. These limits are based on how much is generated in a calendar
month and not the amount placed into a container or shipped off site during that month.
When the amount of P-listed pharmaceutical waste that you generate has been accurately taken
into account, it is more than likely that you will become an LQG. To provide some perspective,
1 liter of water weighs 2.2 pounds. Unused epinephrine TVs that are prepared for the ICU or OR
and never used are the primary reason that hospitals are LQGs. In addition, discarding
approximately 20 epinephrine syringes per calendar month makes a facility an LQG.
LQGs have additional requirements related to proper waste management, time and storage limits,
training, prevention and preparedness, contingency plans, and reporting to local, state, and
federal agencies (40 CFR Part 262).
Refer to Appendix A for resources on generator requirements.
Confirm Your Generator Status
Many hospitals currently classify themselves as CESQGs or SQGs. However, the
identification, segregation, documentation and proper disposal of hazardous
pharmaceutical waste has not yet occurred in many of these facilities.
Appropriately managing waste epinephrine as a P-listed hazardous waste is the most
common reason for a facility to move from CESQG or SQG status to LQG status.
It is likely that you will need to re-notify your state regulatory agency of your
corrected generator status once hazardous pharmaceutical waste is managed
properly. Generally speaking, the only facilities that stay beneath the LQG
designation are small, rural, primary care hospitals that do not routinely perform
surgery or manage intensive care units.
Refer to Step 6: Assessing Current Practices for suggestions on how to
confirm your generator status.
b. Drain Disposal (40 CFR 403.12 (p))
According to the Clean Water Act's General Pretreatment Regulations, sewering of 15 kg (33
Ibs) or more of U-listed and characteristic wastes and any amount of P-listed waste in a calendar
month requires notification to the local POTW, the state environmental protection agency, and
the regional EPA waste management division director. Notification of P-listed wastes includes
certification that you have a program in place to reduce the volume and toxicity of hazardous
wastes generated to the degree it has been determined to be economically practical. RCRA
requires verification that the POTW accepts the drugs that you will be sewering. Best
management practices encourage avoiding the drain disposal of any waste pharmaceuticals, with
special emphasis on those that are hazardous.
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Step 3: Considering Best Management Practices for Non-Regulated Pharmaceutical Wastes
contains a discussion of this best management practice.
c. Incinerati on
The Land Disposal Restrictions (LDR) regulations require the treatment of all hazardous
pharmaceutical waste, most commonly by hazardous waste incineration, before it can be
discarded in a hazardous waste landfill. The required technology for each waste category or Best
Demonstrated Available Technology (BOAT) is listed in 40 CFR Parts 268.40 and 268.48. The
resulting ash is tested and eventually disposed in a lined hazardous waste landfill.
Step 9: Getting Ready for Implementation provides a discussion of the paperwork
requirement.
Aerosol Cans: Things to Consider
Non-Hazardous Aerosol Cans
> There are many pharmaceuticals that come in aerosol cans that do not
contain propellants that exhibit the ignitability characteristic. You need to
determine how you are going to manage this waste stream.
Recycling Aerosol Cans
> Some facilities puncture and drain pharmaceutical aerosol cans and recycle
them under the scrap metal exclusion. It minimizes hazardous waste costs
but there are labor costs and the potential for injury.
> Some facilities that puncture and drain aerosol cans indicate that they are not
necessarily empty.
Hazardous Aerosol Cans
> Aerosol cans with flammable propellants may contain the P-listed chemical,
epinephrine, ortheU-listed chemicals dichlorodiflurormethane and
trichlorofluoromethane that are used as freezing agents in Fluori-Methane,
an anesthetic preparation.
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Step 3: Considering Best Management Practices for Non-Regulated
Pharmaceutical Wastes
Many drugs of concern to EPA and the Center for Disease Control and Prevention (CDC),
including hormones, antibiotics, antidepressants, antihypertensives, and other potent drugs, are
not caught by the current hazardous waste regulations. The RCRA hazardous waste regulations
have not been substantially updated since their inception in 1976 and as a result h ave not kept
pace with drug development. In addition, these regulations were not developed with a hospital
setting in mind. As a result, approximately 10% of the drugs that are not technically subject to
the hazardous waste regulations are equally hazardous and many others are suspect. Therefore,
Pharmaceuticals that are not technically RCRA hazardous waste when discarded should be
analyzed for their potential to cause harm to human health and the environment. Best
management practices encourage managing drugs that are equally harmful as hazardous waste
when discarded. Following best management practices is also good risk management.
As our understanding of the impact of waste pharmaceuticals on aquatic species, antibiotic
resistance, and perhaps even directly on human health grows, it is possible we shall see even
more drugs requiring management either as RCRA hazardous waste or through incineration as a
best management practice rather than sewering or landfilling.
The criteria outlined in this step can be used as a guideline in making best management practice
determinations. Drugs that satisfy any of these criteria are sufficiently hazardous to warrant
being treated in the same manner as drugs that are identified as RCRA hazardous waste. It is
always appropriate to manage drug waste at a higher level of care than required by regulation.
A
Q'l Next Steps contains a recommendation for clarifying and expanding the universe of
RCRA hazardous waste.
Appendix A: Tools and Resources contains additional information on the best
management practices described in this step.
Incinerate as Hazardous Waste
Formulations With a Listed Active Ingredient That is Not the Sole Active Ingredient
All Chemotherapeutic Agents
Drugs Meeting NIOSH Hazardous Drug Criteria
Drugs Listed in Appendix VI of OSHA Technical Manual
Drugs with LDSOs Less Than or Equal to 50 mg/kg
Carcinogenic Drugs
Combination Vitamin/Mineral Preparations with Heavy Metals
Endocrine Disrupters
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1. Formulations With a Listed Active Ingredient That is Not the Sole Active Ingredient
From a regulatory perspective, in order for a formulation to meet the scope of a P- or U-listing in
40 CFR 261.33, the formulation must contain only one active ingredient. As a result, there are a
number of drug formulations that do not have to be managed as hazardous waste because they
contain more than one listed constituent of concern or other non-listed active ingredients. There
also are formulations where there are differing regulatory interpretations. To simplify
implementation, assure environmental protection and preclude second-guessing by a regulator
who may not be familiar with the difference between active pharmaceutical ingredients and
inactive excipients, vehicles, and diluents, best management practices encourage managing all
drugs that contain any P- or U-listed constituents as hazardous waste, regardless of whether or
not the listed constituent is the sole active ingredient.
Examples of Formulations with More Than One Listed Ingredient
> Fluori-methane, a drug formulation containing 15% dichlorodifluoromethane (U075)
and 85% trichloromonofluoromethane (U121) does not have to be managed as a
hazardous waste. It contains two listed constituents that both perform the same
intended function so neither one of the listed chemicals is the sole active ingredient.
> When diluent with .05% saccharin (U202) is discarded in the pharmacy in its original
form, it must be managed as a hazardous waste due to the presence of saccharin as the
sole active ingredient. However, saccharin may no longer be the sole active
ingredient and, therefore, no longer a U-listed waste when diluent with .05%
saccharin is used for compounding oral liquid preparations.
> When lidocaine and epinephrine (P042) are used in dental procedures to anesthetize
an area and decrease bleeding, the two drugs perform two different functions. There
are differing regulatory interpretations regarding the management of this solution,
since EACH chemical is the sole active ingredient for its intended function.
2. All Chemotherapeutic Agents
Only 9 chemotherapy drugs are either P- or U- listed chemicals (See Table 4 in Step 2). These
are the drugs that were in use in 1976 or, in the case of arsenic trioxide, were listed as chemicals
before they were used as drugs. Therefore, over 100 equally hazardous chemotherapy drugs
currently in use today are not identified federally as hazardous waste and are not subject to the
RCRA Subtitle C requirements. Examples of these chemotherapy drugs are methotrexate,
vinblastine, vincristine, and 5-fluorouracil.
Best management practice recommends the handling of all chemotherapy agents greater than
trace amounts as hazardous waste even if the waste doesn't meet the definition of a P- or U-
listed chemical or exhibit any of the characteristics of hazardous waste. By managing all bulk
chemotherapy waste as hazardous waste, the potential liability for improper handling of
chemotherapy waste streams is greatly reduced.
EPA Region 2 actively encourages managing all bulk chemotherapeutic agents as hazardous
waste. This management practice is also consistent with (1) the state of Minnesota which
requires all chemotherapy drugs to be managed as hazardous waste, (2) the intent of the National
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Institute of Occupational Safety and Health (NIOSH) Hazardous Drug Alert regarding the proper
handling and management of these materials due to the danger for employee exposure, and (3)
the forthcoming American Society of Health-System Pharmacists (ASHP) Guidelines on
Handling Hazardous Drugs.
The statutory definition of hazardous waste provides sound reasoning for broadening the
universe of chemotherapeutic drugs that should be managed as hazardous waste. The statute
defines the term "hazardous waste" to mean a solid waste, or combination of solid wastes that
because of its quantity, concentration, physical, chemical, or infectious characteristics may: (1)
cause, or significantly contribute to an increase in mortality or an increase in serious irreversible,
or incapacitating reversible, illness; or, (2) pose a substantial present or potential hazard to
human health or the environment when improperly treated, stored, transported, or disposed of, or
otherwise managed. Chemotherapy agents, if managed improperly, meet this definition of
hazardous waste, which is much broader than the regulatory definition. If discarded improperly,
chemotherapy drugs also could be subject to the imminent and substantial endangerment
provisions of RCRA Section 7003, 42 U.S.C. 6973.10
It is important to know and understand the properties of each chemotherapeutic
agent to determine the proper waste management practice. For example, some
chemotherapy agents, such as BCG Intravesical, fit the criteria of a biohazardous or
infectious waste, beins a live attenuated mvcobacterium.
3. Drugs Meeting NIOSH Hazardous Drug Criteria
The criteria for hazardous drugs as listed in the NIOSH Hazardous Drug Alert include:
> Mutagenicity,
> Carcinogenicity,
> Teratogenicity or other developmental toxicity,
> Reproductive toxicity,
> Organ toxicity at low doses,
> Genotoxicity, and
> Structure and toxicity of new drugs that mimic existing drugs determined hazardous by
previous criteria.
OSHA [1999], NIOSH [2004], and the American Society of Health-System Pharmacists (ASHP)
[1990, 2006] recommend that hazardous drug waste be disposed of in a manner similar to that
required for RCRA-listed hazardous waste. This recommendation encourages applying the
RCRA regulations to newer hazardous drugs, addressing the concern that RCRA is outdated with
respect to new drug development.
4. Drugs Listed in Appendix VI of OSHA Technical Manual
The hazardous drug list in the OSHA Technical Manual Section 6, Chapter 2, Appendix VI: 2-1
was developed in the early 1990's by surveying several prestigious health care organizations and
combining their hazardous drug lists. The NIOSH Hazardous Drug Alert Appendix A list is
more comprehensive. However, the appendix in the OSHA Technical Manual does still serve as
10EPA Region 2 has used the statutory definition of hazardous waste to support their recommendation that all
chemotherapy waste be managed as hazardous waste in a draft document that can be accessed at: http://www.h2e-
onlme.org/pubs/R2_Waste_Chemo_QA_DRAFT.pdf.
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a primary reference for identifying drugs that should be managed as hazardous waste. While the
manual itself is not a regulation, the fact that it is made available by OSHA adds considerable
weight to the recommendations, under the General Duty Clause Section 5(a)l.
5. Carcinogenic Drugs
The U.S. Department of Health and Human Services National Toxicology Program's Report on
Carcinogens (11th Edition) provides information about substances that are known or appear
likely to cause cancer. Section 301(b)(4) of the Public Health Services Act, as amended, requires
that the Secretary of the Department of Health and Human Services (DHHS) publish a biennial
report that contains, among other items, the following information: A) a list of all substances (1)
which either are known to be human carcinogens or may reasonably be anticipated to be human
carcinogens and (2) to which a significant number of persons residing in the United States are
exposed; and B) information concerning the nature of such exposure and the estimated number
of persons exposed to such substances. In addition to chemotherapy agents such as
cyclophosphamide and diethylstilbestrol, which are U-listed constituents of concern, and
tamoxifen, which is on the NIOSH Hazardous Drug Alert list, the drug methoxsalen, used for
skin conditions, is listed in Part A as a known carcinogen and is not caught elsewhere. Drugs
listed in Part B are reasonably anticipated to be human carcinogens.
6. Drugs with LDSOs Less Than or Equal to 50 mg/kg
One of the primary criteria for including a drug on the P-list as acutely hazardous is an oral lethal
dose of 50 mg/kg (LD50) or less. Certain drugs, such as colchicine, meet this criterion but are
not included as constituents of concern on the P-list. You should evaluate the LDSOs of highly
toxic drugs to determine if they should be managed as a hazardous waste. LD50 data is usually
available on the MSDS or on the drug package insert.
7. Combination Vitamin/Mineral Preparations with Heavy Metals
If a pharmaceutical waste contains a heavy metal, such as chromium, cadmium, or selenium, a
TCLP calculation can be performed using a 20 times dilution for a solid dosage form and the
stated concentration for a liquid dosage form. If the concentration of the heavy metal fails the
toxicity characteristic level for that metal, it must be managed as a hazardous waste. There are
vitamin and mineral preparations, however, with inadequate data on the specific concentrations
of chromium, selenium, or cadmium. These preparations may fail the toxicity characteristic. In
the absence of definitive data, it is prudent to manage these preparations as hazardous waste.
Appendix B contains sample Toxicity Characteristic calculations.
PPE and Other Potentially Contaminated Items
Contaminated PPE should also be managed as hazardous waste under best management
practices. This includes items such as gloves and gowns, drip pads, other materials used in the
preparation or administration of chemotherapy drugs, and other hazardous materials that are
known or suspected of having been overtly contaminated with a drug that is being managed as
a best management practice hazardous waste.
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8. Endocrine Disruptors
Endocrine disrupters are chemicals that interfere with an organism's master glands, such as the
thyroid, adrenal, and reproductive glands, and their hormones. These potent chemicals mimic a
hormone, block the hormone, or in some other way enhance or disrupt normal hormone activity.
Endocrine disrupters are active at extremely low concentrations, such as parts per billion or even
parts per trillion, especially in developing embryos, including humans, and in juvenile
amphibians and other aquatic species. Increasing concern is being expressed among
toxicologists and water research experts regarding the impact of endocrine disrupters on aquatic
organisms, particularly those downstream from wastewater treatment plants. Environmental
studies have demonstrated feminization offish populations due to the presence of estrogenic
substances, the female hormone. Laboratory studies have shown interferences with sex
determination and other vital developmental processes when organisms have been exposed to
minute amounts of drugs, both individually and in combinations.
It makes prudent environmental sense to not deliberately introduce these potent chemicals into
water systems. Therefore, consider eliminating the drain disposal of endocrine disrupters and
managing these wastes either as hazardous waste or at least incinerate them at a municipal
incinerator or a regulated medical waste incinerator.
Which Pharmaceuticals Are Endocrine Disruptors?
There is no complete list of endocrine disrupters. Many common endocrine disrupters,
such as estrogens, testosterone, progesterone, androgens, contraceptives, and oxytocics are
listed in the NIOSH Hazardous Drug Alert. Additional endocrine disrupting drugs, such as
the anti-fungal ketoconazole, can be found at www.ourstolenfuture.org.
9. All Other Drugs
a. Incinerate
While your hospital's first priority has to be identifying, segregating and properly managing
hazardous pharmaceutical waste, the precautionary principle should be applied and all other
drugs ought to be collected in a separate container for incineration at either a regulated medical
waste or municipal solid waste incinerator permitted to handle non-hazardous pharmaceutical
waste. Thermal destruction of all discarded drugs would provide the highest level of best
management practice available at this time. Future technologies, such as plasma arc units, may
eventually provide a more environmentally sound option.
California and Washington require non-RCRA drugs to be incinerated either in a regulated
medical waste incinerator or municipal incinerator based on the specifications and permit of the
incinerator. Other states, such as Minnesota, strongly encourage incineration of these "non-
hazardous" drugs.
Next Steps contains a recommendation to better understand the environmental impacts of
existing treatment technologies and advance new ones.
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b. Eliminate Drain Disposal
Many hospitals currently dispose of excess material in syringes and IV bags down drains that
pass into sewer systems. The two largest sources of pharmaceuticals entering the sewer systems
are believed to be from hospitals and households. Wastewater treatment plants are designed to
remove conventional pollutants such as suspended solids and biodegradable organic material, but
they are not designed to remove low concentrations of synthetic pollutants such as
pharmaceuticals. The removal efficiencies of pharmaceuticals appear to be chemical-specific.
Limited testing suggests that certain types of treatment substantially remove some
pharmaceuticals. However, many synthetic compounds are designed to be resistant to biological
degradation and there doesn't appear to b e a single wastewater treatment technology that will
remove all of the pharmaceuticals. Careful consideration should be given to eliminating drain
disposal of unused TVs and other drugs.
States, such as California and Washington, have already prohibited the sewering of virtually any
drugs. You should work with your local wastewater treatment plant to determine what wastes
are appropriate for discharge to the sewer system. Most POTWs (Publicly Owned Treatment
Works) do not have a problem with the sewering of solutions in IV bags that only contain saline,
lactate, nutrients, vitamins, potassium and other electrolytes.
c. Avoid Landfilling
For states where landfilling of non-hazardous drugs is legal, the landfills generally require
MSDSs for each pharmaceutical that is to be landfilled so they can assure themselves it is not a
RCRA hazardous waste and they are permitted to accept it. Landfilling non-hazardous
pharmaceutical waste should be avoided, however, both for environmental and security reasons.
Drugs added to a landfill will eventually leach into groundwater or be deliberately sewered by
the landfill from its leaching beds. Unless immediately rendered non-recoverable in some way,
drugs brought to a landfill are also subject to diversion.
Use Non-PVC IV Sets
Many pharmaceutical products are prepared and dispensed in PVC-containing IV bags and
tubing. Polyvinyl chloride (PVC) manufacture and disposal, when incinerated, contribute
to dioxin formation. Because some dioxins are carcinogens and endocrine disrupting
chemicals, minimizing their production and release to the environment is protective of
public health. The use of non-PVC IV sets for all chemotherapy drugs will reduce the
adverse environmental and public health impacts of treating the waste in a regulated
medical incinerator. Non-PVC bags are a little more expensive but compared to the cost of
the drug the increased expense is insignificant. To the extent possible, all pharmaceutical
waste being incinerated should be administered in PVC-free IV sets.
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Step 4: Performing a Drug Inventory Review
Now that you have gained an understanding of the regulations in Step 2 and determined which
best management practices you will adopt from Step 3, the next step is to perform a drug
inventory review. Depending on your time, background and resources, you may decide to hire a
commercial service to perform this function (see Employing Alternative Approaches below).
Most hospital pharmacies stock 2,000 to 4,000 drugs in their inventory. Approximately 5% or
100 to 200 of the drugs in a typical pharmacy inventory are subject to the RCRA hazardous
waste regulations and an additional 10% should be managed as hazardous waste based on best
management practices. It is important to understand that the percentag e of drugs in the inventory
will not necessarily correlate with the percentage of hazardous drug waste generated at your
facility (See Conducting a Frequency Analysis in Step 5 for a detailed explanation).
RCRA places the burden of proof for making a hazardous waste determination on the generator.
Therefore, as the generator, your next step is to go through all of the individual drugs that are
administered at your facility and determine which ones must be managed as hazardous waste.
As you review every drug product to determine which drugs are RCRA hazardous and which
drugs will be handled as hazardous waste based on best management practices, be sure to
document your research, calculations, and waste stream determinations. Include all of the waste
codes and the reason for managing a non-RCRA drug as hazardous waste. This information will
be invaluable if you are ever audited and asked to support your waste management policies and
procedures.
A
91 Next Steps contains a recommendation to broaden the understanding of pharmaceutical
waste generation.
1. Gathering Drug Specific Data
The vast array of different drugs available within a therapeutic category makes it necessary for
the pharmacy to maintain a formulary to limit the number of drugs stocked, avoiding costly
additions for therapeutic equivalents. The hospital's formulary is a list of drugs approved by the
Pharmacy and Therapeutics Committee that can be prescribed for patients by attending
physicians. Special circumstances may require purchases of drugs not listed in the formulary to
meet a therapeutic need or because of shortages in the industry.
Since drugs not listed in the formulary may be ordered and administered, drug-purchasing
records will provide a more complete list of what the pharmacy has in stock than the approved
formulary. Therefore, an initial review begins by obtaining a 12-month summary of purchasing
records from your drug wholesaler.
To perform the inventory review you will need the following information for all of the drugs
administered at your facility:
> National Drug Code,
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Brand name,
Generic name,
Manufacturer,
Strength,
Dosage form, and
Package size.
It's Preferable to Obtain Purchasing Data from Your Drug Wholesaler
Manufacturers will sometimes modify drug formulations. When a formulation
is modified, the manufacturer assigns a new national drug code (NDC) to the
new formulation. Sometimes the formulation is modified to make it non-
hazardous, as in the case of removing mercury as a preservative in vaccines and
nasal sprays. Therefore, the waste determination for one specific NDC may be
different from another NDC of a drug with the same therapeutic function.
However, your hospital may use one National Drug Code (NDC) to represent
multiple drug manufacturers. If your hospital's NDC list is not current,
modifications of drugs may not be identified, making waste evaluations
inaccurate.
Next you will need to identify all of the ingredients found in each drug formulation, including
preservatives and alcohol, using common pharmaceutical references such as Facts and
Comparisons and Efacts. Drug formulations containing preservatives may require additional
effort to determine the composition of the preservative. Thimerosal and phenylmercuric acetate
are the two preservatives containing mercury. Their presence will cause the item to fail the
TCLP. Some products, such as Fluzone, list the mercury percentage, while others, such as
Haemophilus b Conjugate Vaccine, simply list the preservative thimerosal. M-cresol, D024, is
the other preservative which can cause a formulation to fail the TCLP, but not in all
formulations, depending on concentration.
a. Compounded Items and Re-formulations
It is essential to consider all compounded items as well as re-formulations and IV admixtures to
determine their hazardous waste designation, as the characteristic waste designation for the re-
formulation or IV admixture may not be the same as for the original formulation. In particular, a
pharmaceutical may exhibit the characteristic of ignitability when it is purchased by the
pharmacy but no longer exhibit it after being compounded or prepared for administration in the
pharmacy. The reverse situation also can occur. If a raw chemical is formulated into an
alcoholic preparation, the resulting product may exhibit the characteristic of ignitability.
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Drug Prepared for
Administration
Paclitaxel (Taxol®;
BMS), valrubicin,
etoposide, orteniposide
diluted in an IV
containing less than
24% alcohol
Compounded wart
remover with salicylic
acid and other
ingredients
compounded in a base
of flexible collodion
Waste Designation of
Prepared Drug
> Used IV managed as
trace chemotherapy
waste
> Unused IV managed as
hazardous chemotherapy
waste according to BMP
(See Step 3)
Ignitable Hazardous Waste
Original
Ingredients
Original vials
contain 30 -
50% alcohol
Salicylic acid
and flexible
collodion
Waste Designation
of Original
Ingredients
Ignitable Hazardous
Waste
> Salicylic acid is a
non -hazardous
waste
> Flexible collodion
is an ignitable
hazardous waste
2. Making RCRA Hazardous Waste Determinations
Once you have obtained drug specific information, you are ready to gather the data necessary for
making hazardous waste and best management practices determinations.
You may find that a formulation is both ignitable and contains a P- or U- listed chemical. It is
important to identify all of the applicable waste codes for each drug in your inventory. For
example, epinephrine inhalers exhibit the characteristic of ignitability and contain epinephrine, a
P-listed constituent. This information will be valuable when you are designing your program,
selecting your vendor and eventually when you are manifesting your pharmaceutical wastes.
Selecting the Right Vendor(s) in Step 9 and Hazardous Waste Manifest in Step 10 provide
more information on managing drug formulations with more than one waste code.
a. Toxicity
Determining which drug formulations exhibit the characteristic of toxicity is the most
challenging waste determination. Table 3 contains a list of the D-listed chemicals and the
concentrations at which they become a hazardous waste (See page 16). Identify all formulations
that contain any of these chemicals using Facts and Comparisons®, EFacts, or a similar
reference.
^*~' Appendix A: Tools and Resources has information on accessing Facts and Comparisons®,
and EFacts
^ Appendix B contains sample Toxicity Characteristic calculations for both liquids and solids.
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Alternatively, you can send the formulation to a laboratory for analysis using the TCLP. The
laboratory will determine whether or not the formulation exhibits the toxicity characteristic. The
expense of performing the TCLP may outweigh applying a conservative approach by managing
tablets and capsules, such as vitamin/mineral preparations containing Toxicity Characteristic
chemicals and heavy metals, as hazardous waste.
Step 3: Considering Best Management Practices for Non-Regulated Pharmaceutical Waste
discusses this approach as a best management practice for vitamin/mineral preparations
with heavy metals.
Thimerosal
> All drugs containing thimerosal fail the TCLP for mercury.
> Therefore, manage all drugs containing thimerosal as D009.
> Wherever possible, minimize waste by purchasing alternative products that do not
contain thimerosal.
b. Best Management Practices
While you are reviewing your inventory to determine which drugs should be managed as
hazardous waste, you also will want to apply the criteria for making best management
determinations outlined in Step 3 to the inventory. Drugs that satisfy any of these criteria are
sufficiently hazardous to warrant being treated in the same manner as drugs that are identified as
RCRA hazardous waste.
1. Documenting Your Decisions
As you review every drug product to determine which drugs are RCRA hazardous and which
drugs will be handled as hazardous waste based on best management practices, be sure to
document your research, calculations, and waste stream determinations. Include all of the waste
codes and the reason for managing a non-RCRA drug as hazardous waste. This information will
be invaluable if you are ever audited and asked to support your waste management policies and
procedures.
2. Keeping the Review Current
Once you have performed an initial review of all of the drugs in the inventory, systems must be
established to keep this list updated at least quarterly to capture new drugs that are added to the
formulary and other non-formulary drug purchases, to appropriately manage outdated
physician's samples, and personal medications that are left behind by patients.
Each hospital is responsible for maintaining and updating its OSHA hazardous drug list as new
drugs enter the facility. As you evaluate new drugs proposed for the formulary, you are required
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by OSHA to make a hazardous drug determination with respect to employee exposure. This
would be the time to also evaluate the drug for hazardous waste status. In addition to making
hazardous waste determinations during the inventory/formulary review process, a system must
also be set up to include determinations for off-formulary drugs purchased by pharmacy and
other departments, such as radiology. Either set a trigger within the receiving software that
requires this determination or change printed policies and procedures to inform receiving
personnel of the need to make the waste determination. It is likely that receiving personnel will
need to notify a specific pharmacist or safety person of the presence of those drugs needing
review, as this is a highly technical function.
Summary of Inventory Review Process
a Obtain Drug Specific Data from Drug Wholesaler (e.g., National Drug Code (NDC),
brand name, generic name, manufacturer, strength, dosage form and package size)
a Identify Ingredients using Facts and Comparisons, eFacts, or MSDS
a Determine RCRA Hazardous Waste Code using Code of Federal Regulations, Merck
Index, Periodic Table
a Make Best Management Practice Determinations
a Keep Review Current
3. Employing Alternative Approaches
The number of drugs stocked in a hospital pharmacy and the multiple national drug codes
(NDCs) that may be stocked fora specific drug name make the initial review of all of the drugs
administered at your facility an extremely time -consuming task. If you decide that manually
determining the hazardous waste status of all of these drugs is too time-consuming given the
pressure on current staffing levels, there are commercial services that are available. Subscription
on-line web search engines can be used to look up all of the drugs in the inventory. Using an on-
line web search engine to review your inventory is still a labor-intensive process, but depending
on your familiarity with pharmaceuticals and the hazardous waste regulations and your time
constraints, it may be more efficient than a manual review. Alternatively, you can utilize a
commercial service to perform a review of all drugs purchased within the past 12 months. Once
again depending on your particular circumstances, this may be a cost-effective method for
establishing an initial list of drugs, their NDCs and their hazardous waste status.
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Step 5: Minimizing Pharmaceutical Waste
As you design and implement your pharmaceutical waste management program, it is important
to ask what pharmaceuticals are being "wasted," why they are being wasted and how wasting can
be minimized. There are inherent limitations on the substitution of a less hazardous drug since
the hazardous nature of the chemical often provides the therapeutic effect. However, waste
reduction can minimize compliance hassles, costs and risks. The following section provides a
number of minimization opportunities to consider and explore.
1. Considering Lifecvcle Impacts in the Purchasing Process
Implement a purchasing policy that includes restrictions and preferable purchasing practices.
Examples include but are not limited to:
> Specifying that you will not accept any drugs with less than one year dating unless they are
only available with shorter expiration dates.
> Selecting products with less packaging. This is particularly relevant if the drug contains a P-
listed constituent of concern. Packaging that comes in contact with drugs that contain P-
listed chemicals must be managed as hazardous waste.
> Selecting products without preservatives whenever possible. Drugs such as some multi-dose
vaccines, and eye and ear preparations, may contain the preservatives thimerosal or
phenylmercuric acetate. Manufacturers are moving away from these controversial mercury
based chemicals to less toxic alternatives. Always check your references, such as eFacts,
manufacturers' websites, and your group purchasing organization (GPO) to see if mercury
free alternatives are available.
> Consider single dose containers, which do not need a preservative.
> Communicating your views through your GPO to see if formulation changes can be made in
the future. Human insulin is often preserved with m-cresol, a D-listed chemical that causes
some of these products to exhibit the characteristic of toxicity. At this time there are no
alternatives for this specific product.
2. Maximizing the Use of Opened Chemotherapy Vials
Sometimes opened chemotherapy vials are retained for possible use in oncology pharmacies until
they expire. However, this is not always the case especially in lower volume pharmacies.
Consider possible ways to maximize usage of these partial vials to minimize waste and save
money.
3. Implementing a Samples Policy
Controlling physicians' samples is often an emotionally charged topic. The ability of the
pharmacy to control sampling within the organization is often based on the political realities of
the organization and who controls the medical staff and who owns the associated clinics. The
fact that samples are outdated and need to be discarded indicates that pharmaceutical
representatives are over-supplying samples, physicians' offices are not rotating sample
inventory, physicians are not providing samples to patients, or drug usage patterns have changed
for particular drugs. Whatever the cause, the organization is incurring added costs and liabilities
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managing waste drug samples and should adopt a policy that addresses the acceptance and end-
of-life management of samples.
A good initial step is to document the amount and frequency of outdated sample generation per
outpatient clinic or medical practice area. Determine the cost of handling and disposing of the
samples, being sure to check for hazardous drug waste. Be sure to include staff time to review
sample dating, transport samples, and manage their waste segregation and disposal. At a
minimum, present the estimated costs to the physicians involved in the sample generation as well
as waste minimization opportunities. Ideally, outdated sample management costs should be
transferred to these practices, which goes a long way towards opening up the dialog. Also,
consider asking the manufacturers to cover the disposal costs that they are imposing on the
facility's budget. This should be the manufacturers' cost of doing business and should not be
transferred to the hospital.
Many integrated delivery networks have implemented a variety of controls onphysician
sampling, moving from the least restrictive to the most restrictive, allowing no sampling
whatsoever. Trial medications can still be managed for patients either through introductory
coupons from manufacturers or through small initial trial prescriptions with larger refills.
Patients will need to pay the co-pay, which is a disincentive for the smaller prescription.
Less restrictive strategies include requiring pharmaceutical representatives to package outdated
samples for return to the manufacturer. Under the Food and Drug Administration's Prescription
Drug Marketing Act (PDMA), manufacturers' representatives are not allowed to physically
remove samples from the physicians' offices, but can facilitate their shipment back for disposal.
Another approach is to limit sampling to the top six drugs prescribed in each clinic or practice or
to those drugs listed in the Formulary. If personal use by physicians is an issue, allow physicians
to receive samples but require them to store them personally off-site.
4. Labeling Drugs for Home Use
Many single patient items, such as aerosols, ointments, and sometimes insulin, are only used for
a few days during the hospital stay. These patient-specific medications are returned to the
pharmacy for destruction when the patient is discharged. They cannot be legally dispensed to the
patient without a discharge prescription from the doctor and proper outpatient labeling. In the
current system, these procedures would cause delays in the discharge process that would be
unacceptable to the patient. Consider how the system could be changed to include pre-authorized
discharge orders for maintenance medications and possible label production in the units. This
would reduce waste and save money for both the health care system and the patient. Smaller
hospitals in particular should consider relabeling for home use. This is more difficult logistically
in large facilities, and patients often will not wait for the new orders to be communicated to the
pharmacy and new labels attached. A number of rural hospitals in northern Minnesota have pre-
labeled these items for home use with much success.
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5. Priming and Flushing IV Lines with Saline Solution
Pharmacies should prime all chemotherapy TVs with saline prior to dispensing and nurses should
flush the tubing after administration. These practices not only insure the patient receives the full
dosage but also reduces the opportunity for employee exposure and enables IV tubing and bags
to be managed as trace chemotherapy waste.
6. Examining the Size of Containers Relative to Use
Certain medications are routinely administered in doses that result in waste or in dispensing
devices that could be "lightweighted." Consider conducting a survey of all drugs routinely
wasted in your facility due to the prepared product being too large for complete administration.
Through an on-site review, one hospital found that Lopressor is purchased in 100 mg tablets but
only 50 mg were routinely administered. Therefore, 50 mg of Lopressor were routinely wasted.
Lopressor is available in 50 mg tablets and the generic version, metoprolol, is available in 50 mg
or 25 mg tablets. Changes in your purchasing patterns can save your hospital money by reducing
the amount of pharmaceutical waste that you generate.
If you can't find the product size that meets your needs, share this information with your group
purchasing organization (GPO) so they may provide feedback to the pharmaceutical distributors
and manufacturers to encourage more appropriate packaging sizes. One hospital uses
epinephrine in basic saline solution (BSS) to maintain eye structure during surgery. A 500 cc
solution of BSS and epinephrine is hung but only about 300 cc are used, leaving 200 cc of P-
listed hazardous waste to be discarded. The manufacturer only makes 50 cc, 250 cc and 500 cc
bottles of this solution. This is a situation where working with GPOs and manufacturers to make
appropriate container sizes available will save facilities money. Encourage your GPO to conduct
a broad-based study to determine the total universe of drug formulations that are routinely
wasted due to package size.
There are variations in the weight of dispensing instruments. For example, consider using two -
part polyolefm IV devices to administer antibiotics (e.g. Duplex} that weigh one-third less than
traditional glass vial/PVC IV bag alternatives.
In a small rural hospital, a doctor wanted three 250 cc IVbags of dilute epinephrine
available for shoulder surgeries, but routinely only used one. The pharmacist agreed to
be available to formulate additional IV bags immediately, if needed. After six months,
the system is running smoothly and the amount of waste generated has decreased.
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7. Replacing Prepackaged Unit Dose Liquids with Patient-Specific Oral Syringes
To avoid having to routinely waste the remaining contents of 5 ml and 10 ml prepackaged unit
dose liquids, consider moving to patient-specific oral syringes, especially in the neonatal and
pediatrics units where doses are very customized and patient-specific. This practice is especially
useful for drugs like chloral hydrate, which is also a controlled substance. Eliminating waste also
saves nursing time while preventing the usual drain disposal of a hazardous waste.
Review all Emergency Department multi-dose vials to determine the optimum dosage unit to
stock based on usage frequency and consider moving to single dose syringes when possible to
avoid possible mercury preservatives and to minimize partial use. For example, the single dose
syringe, DeCAVAC (Diphtheria and Tetanus Toxoids, Combined; Aventis-Pasteur) replaces the
5 ml multi-dose vial that contained a mercury preservative, thimerosal. The 5 ml multi-dose
vials often need to be discarded and the level of mercury causes the wasted product to be
managed as a hazardous waste.
If patient-specific insulin vials are used, re-evaluate the necessity of this practice since most are
discarded with significant drug remaining. Multiple patient use of an insulin vial reduces waste
since patient-specific vials are destroyed at the time the patient leaves the hospital regardless of
the remaining volume. Insulin pens are another consideration as they represent a smaller total
volume than a vial (3 ml vs. 10 ml) and can be relabeled when the patient is discharged. Some
insulin contains m-cresol as a preservative, requiring management as a hazardous waste. Each
organization has its own philosophy regarding infection control and medication management.
8. Controlled Substances
Due to the difficulty in disposing of a controlled substance that is also a hazardous waste and the
desire to avoid the drain disposal of all pharmaceutical wastes, it is best to try to eliminate the
generation of these wastes to the degree possible. Minimizing the wastage of controlled
substances will also save the staff time of the two nurses required to witness their destruction.
Chloral Hydrate is an example of a controlled substance that is routinely wasted when it is
administered in a 5 ml unit dose cup to children. If it is purchased as bulk syrup, the exact dose
can be dispensed in an oral syringe, eliminating any routine wastage.
9. Delivering Chemotherapy Drugs
Replace brown paper bags in which chemotherapy is delivered to the floor with hard plastic
buckets. This will not only reduce waste but also provide greater spill and leak protection during
transport.
10. Monitoring Dating on Emergency Syringes
Generally, hospitals replace epinephrine and nitroglycerin syringes and vials on general crash carts
when they are within three months or less of their expiration date. These products can be moved
from general crash carts to the Emergency Department or ICU/CCU three months prior to
outdate to avoid discarding them.
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11. Reviewing Inventory Controls to Minimize Outdates
Create a tighter inventory control program to limit the amount of original manufacturers'
containers and repacks that expire before use. Resources spent on the management of expired
products are resources lost. More and more hospitals are implementing automated pharmacy
shelving and inventory systems and experiencing cost savings through waste reduction.
Next Steps contains a recommendation for moving pharmaceutical waste minimization
forward.
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Step 6: Assessing Current Practices
1. Performing Department Reviews
Gathering current waste generation and disposal practice information, including estimated
volumes and weights, will assist you in designing your program, establishing a baseline to
estimate waste management costs and track progress over time, and identifying ideas for
reducing your pharmaceutical waste stream.
Documenting quantitative volumes of drug waste currently being generated is challenging and
involves either creating a detailed log of all drug waste being discarded within the pharmacy and
nursing units by pharmacy and nursing personnel during a specified timeframe, or manually
sorting and documenting the waste. The first option is time consuming for professional staff. The
second option, a traditional waste audit or assessment, raises safety concerns for those involved.
The most efficient way to gather this information is through an informal but well documented
interview process throughout the organization to determine current medication disposal
practices. Informal interviews should be undertaken in the pharmacy, all nursing units, and
outpatient clinics for which the hospital has waste management responsibilities. If time or
resources are limited, interviews should be conducted in the pharmacy, inpatient and outpatient
oncology areas, cardiac care unit, emergency department, and operating room, including
anesthesia.
Learning what the current practice is will provide valuable guidance as to what practices need to
be modified and what level of consistency is present throughout the organization, especially
where stated policies and procedures have been developed. This exercise will also inform staff
that attention is now being focused on pharmaceutical waste management.
Basic questions should focus on what drugs are being discarded and how pharmacy, nursing, and
medical staff are routinely discarding them: in sharps containers, red bags, down the drain, or
other options. It also is valuable to gain an understanding of how drugs are administered in your
facility to provide a sense of which drugs may need to be managed as both hazardous waste and
RMW. In addition, this is a good time to ask for assistance in identifying waste minimization
opportunities. Care should be taken to emphasize the fact-finding nature of this process and that
there are no right or wrong answers.
The basic interview process can be completed within one or two 8 hour days or longer,
depending on the size and complexity of the organization. All departments that will be visited
should be notified in advance and a schedule set up if at all possible to assure availability of both
the supervisor and designated staff. Do not rely on managers reporting in a meeting setting. As
many staff should be queried as possible to obtain an accurate picture. It is paramount that
nursing management is heavily involved and supportive of this effort.
Data generated from automated drug dispensing cabinet systems can be used to supplement the
information that you collect through your on-site interviews. Automated cabinet systems are
designed to electronically record and track actions related to the disposition of drugs dispensed
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from them. This data can be downloaded onto a spreadsheet and analyzed for the frequency,
location and amount of drug wastage. Pharmacy information systems and medication
management systems may also be a source of data regarding where RCRA drugs are used.
2. Conducting a Frequency Analysis
It is very helpful to perform an analysis on which drugs are dispensed to each unit and in what
quantities over a specific time frame, such as 30 days. If the dispensing software has a function
to sort data by unit and order, this should be a relatively simple task. Billing records might also
be a source of this information. If hard data are not readily available, review with pharmacy staff
their impressions of which units receive the 5% of drugs that are RCRA hazardous waste. These
should already be identified by this time. In addition to the oncology inpatient and outpatient
areas, find out what other units receive chemotherapy drugs for other purposes, such as treatment
of autoimmune diseas es. The data from this analysis can be presented by department or by drug.
This will provide a better understanding of which units within your facility have the potential to
generate significant amounts of hazardous waste. It will also indicate which drugs you can
expect to manage as hazardous waste most frequently.
While there is no documented percentage of drug waste per drug dispensed available at this time,
it is reasonable to assume that areas administering higher volumes of potentially hazardous waste
will generate more hazardous waste. Knowing which units have the potential to generate
significant amounts of hazardous waste will help you identify which departments to visit during
your on-site review and prioritize the roll-out of your program. Knowing the frequency with
which hazardous drugs are administered by department also will help you target the questions
that you ask staff in order to better understand their current waste generation and disposition
practices.
Pharmaceutical Waste Generation
For the following reasons, the percentage of hazardous drugs in your inventory does
not correlate with the percentage of hazardous drug waste that will be generated at
your facility.
> A particular P-listed drug, like epinephrine, may be discarded on a regular
basis, due to the nature of its use, as in an IV bag, while another P-listed drug,
like warfarin, which is a tablet, may be discarded less often.
> The frequency of use will vary among drugs, resulting in fewer opportunities
for waste generation for some compared to others.
> U-listed drugs are not managed as hazardous waste if the containers are
"RCRA empty."
> Contaminated PPE and spill materials will increase the amount of hazardous
waste generated.
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3. Confirming Your Generator Status
Hazardous pharmaceutical waste is generated from numerous activities and events including
preparing IVs, general compounding, cleaning up of spills and breakage, and discarding partially
used vials, syringes, IVs, discontinued medications such as ointments and inhalers, unused unit-
dose repacks, patients' personal medications, outdated pharmaceuticals, and contaminated PPE.
If you are not convinced that you are a LQG, have the pharmacy and nursing staffs document the
weight of all P-listed waste discarded in a calendar month to confirm your generator status.
Alternatively, you can include questions in an on-site review that will help you to qualitatively
determine your generator status.
Logs are particularly helpful in defending your CESQG or SQG status. An inspector will look at
your manifests and then compare them with your logs. The log becomes the record of the P-
listed wastes generated and not the manifest. If you don't log your wastes as you generate them,
you cannot prove the volume generated in a calendar month. If you are a LQG, there is no need
to document how much P-listed waste is generated in a given month.
The weight of the P-listed waste includes the weight of the container regardless of the amount of
the drug remaining.11 In states where nitroglycerin has not been excluded from regulation as a P
waste, the heavy glass bottles will also contribute greatly to large quantity generator status.
If P-listed wastes are combined with other materials, the weight of the entire container does not
have to be included in determining if the facility is a LQG as long as: the exact weight of each
P-listed waste in the container is documented, the P waste remains in its original container, and
the P-listed waste is not mixed with the other waste. Essentially, the original package is
considered primary containment and the outer storage bucket is secondary containment.
Appropriately managing waste epinephrine as a P-listed hazardous waste is the most
common reason for a facility to move from CESQG or SQG status to LQG status.
"RCRA Online #12946,
http://yosemite.epa.gov/osw/rcra.nsf/0c994248c239947e85256d090071175f/a84d28e4c573528e8525670f006clbcc!
OpenDocument
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Step 7: Taking On the Communication/Labeling Challenge
Once the Pharmaceuticals in your inventory have been classified as to their hazardous waste
status, the next challenge is to choose a method for communicating that information to pharmacy
and nursing staff as they generate pharmaceutical waste during the course of their everyday
activities. You may need two systems: one for drugs discarded in the pharmacy and the other for
drugs discarded in the patient care areas. How you choose to communicate this information will
be influenced by variables unique to your organization, such as facility size, pharmacy
complexity, dispensing software, and internal expertise or resources available to procure
expertise. You may decide to adopt one approach to labeling initially while you develop a more
sophisticated approach over time. Regardless of which approach you choose, be sure to include a
process of integrating new drugs into the labeling system.
1. Automating the Labeling Process
a. Incorporating Disposition Data in Dispensing Software
Automated labeling of drugs that are administered to patients involves entering h azardous waste
disposition information for every drug in the inventory into the pharmaceutical dispensing
software. This will enable waste segregation information to be indicated on the patient label. If
your NDC file is continually updated, that is the most desirable level to integrate the hazardous
waste data. If this is not possible, use the pneumonic or generic name of the drug.
Consider all of the possible ways that drugs are labeled in your organization, including unit-dose
items, items prepared for robotic dispensing, items dispensed from automated dispensing
machines, and compounded and reformulated items such as ointments and IVs, to insure that no
segment of drug distribution is missed.
Automated cabinet systems securely store and dispense narcotics and other commonly used
medications. These systems have the automated capability to identify proper pharmaceutical
waste disposition practices and create accountability to better ensure regulatory compliance.
When developing a labeling system for the drugs dispensed through the pharmacy, these "mobile
pharmacies" should not be overlooked. You may decide to apply the same approach that you
select for the drugs that are dispensed from the pharmacy or these systems can be customized to
include appropriate disposition information as a way for the end user to make this determination.
Within the pharmacy, shelf stickers can provide pharmacy staff with information on how to
dispose of drugs pulled directly from inventory for IV preparation or other compounding
activities as well as provide information on spill clean up. Check with your drug wholesaler to
determine if waste disposition data can be integrated into your ordering and receiving software,
enabling shelf stickers to be electronically generated.
b. Inserting Disposition Data on Barcodes
Using bar codes also eliminates the need to label items individually. If the hospital has
implemented bedside bar coding for ensuring patient safety, messages can also be inserted into
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the administration software, notifying nurses of disposition requirements. A hospital must be
totally bar-coded at the bedside to implement this system. Only about 5% of hospitals are
currently at that level, but adoption of bedside bar coding is expected to escalate in the next few
years.
An automated waste-sorting machine, similar to a reverse dispensing device, is in development.
This device will enable nursing personnel to scan the bar code at the bedside and a door will
open for the appropriate waste stream. A waste determination can be made once and then
transferred to data systems that then provide a failsafe segregation system, facilitating
compliance.
2. Manually Labeling in the Pharmacy
If your current dispensing software does not enable an additional field to be accessed or printed,
you can use the hazardous waste designations in the inventory review to manually label drugs
that will be administered to patients. A sticker can be placed on the drugs upon their arrival in
the pharmacy or on all orders that are prepared for patient administration. The pharmacist either
can consult a list to determine the appropriate sticker or reference shelf stickers, which is
preferable to save time and avoid errors. Shelf stickers cue the pharmacy personnel to dispose of
these drugs appropriately in the pharmacy preparation areas as well as to apply appropriate labels
to each drug as it is dispensed to the nursing unit. Check with your drug wholesaler to determine
if the information for the shelf sticker can be integrated into your receiving software to automate
the labeling of the shelf stickers. Another approach is to physically organize the pharmacy
according to the waste designation. Regardless of the approach you select, a sticker must be
placed on all orders that are prepared for the nursing units. This requires strict attention to detail
and continuous quality assurance. While this is a manual process that requires constant vigilance,
virtually any pharmacy can implement it regardless of their software or technology level.
Migrate to an automated system as soon as possible.
3. Providing Guidance on the Floor
Place stickers on hazardous waste containers on the floor and/or display guidance posters near
the containers. This approach is often used to educate users of solid waste recycling programs.
4. Selecting a Message for the Label
A code name or word should be chosen which is easy for staff to remember but that does not
alarm the patient. There are two pieces of information that should be conveyed through this
message, the dis card location and how the container is managed. The message can be a color-
coding, text or a combination of color-coding and text. The table below provides some
suggested abbreviations for text messages. For P-listed drugs, such as epinephrine, the cue
should include the terms "empty or full," since the container is also considered to be hazardous
waste. In addition, simply a color-coded strip or Blue Bin 1 or 2 can be used. There is no
regulatory requirement so pick acronyms or color-coding that make sense to your organization.
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Sample Text Label Message
HW-I
HW-T, empty = trace
HW-T, empty or full
HW-T unless empty
HW-P, empty or full
Type of Waste
Ignitable Hazardous Waste (if you decide
ignitable hazardous waste separately)
to manage
Hazardous Chemotherapy Waste
P-Listed Hazardous W aste
U-Listed Hazardous Waste
P-Listed Hazardous Waste (if you wish to
listed drugs for documentation purposes)
segregate P-
5. Labeling Drugs Further Up the Supply Chain
The most significant challenge to achieving compliance with RCRA is the difficulty of making
hazardous waste determinations for all of the drugs in the inventory and implementing a system
to label Pharmaceuticals based on those determinations. For an individual hospital, overcoming
these challenges is a resource intensive endeavor. On the national level, however, there are more
efficient solutions to bridging this critical gap that adversely impacts the ability of the health care
sector to comply with RCRA regulations. By educating and engaging the supply chain,
innovative entrepreneurial solutions can be developed to provide easy to understand segregation
guidance on drug labels. A nationally implemented approach to hazardous waste identification
and communication would reduce the need to devote scarce resources to reviewing your
inventory, implementing a labeling system and devising systems to keep both of these efforts
current. Use your purchasing power to advocate for supply chain labeling.
Next Steps contains a recommendation to apply a national approach to overcome the
labeling challenge.
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Step 8: Considering the Management Options
Your program goals (e.g., ensuring compliance and simplicity) and facility constraints (e.g.,
space, technology and resources) will drive the design of your pharmaceutical management
program. Three options for managing pharmaceutical wastes are presented: 1) segregating
waste at the point of generation, in the pharmacy and on the hospital floor; 2) segregating waste
at the central storage accumulation area; and 3) managing all drug waste as hazardous waste. All
three options involve satellite accumulation (described in Step 9) and two of the three options
require drug segregation within the facility. Selecting an option should p roceed in parallel with
Step 9: Getting Ready for Implementation since some approaches involve more vendor
participation than others, and cost estimates from vendors may also impact the approach.
1. Option I: Segregating at the Point of Generation
Ideally, pharmaceutical hazardous waste will be segregated at the point of generation and
discarded in hazardous pharmaceutical waste containers that are located as conveniently as
practical to the point of generation. Personnel that are trained to handle hazardous waste transfer
the containers from the satellite accumulation areas at the point of generation to the central
storage accumulation area (described in Step 9) where they are picked up by a permitted
hazardous waste vendor.
You will need to consider purchasing containers. The container market for hazardous
pharmaceutical waste is still evolving, but to date the containers are available in black or blue
with the choice of "Hazardous Waste- Toxic", or "Hazardous Waste- Ignitable" labels.
Different container sizes are available ranging from 2 to 18 gallons.
The most common waste streams used for point of generation pharmaceutical waste segregation
are included below in Table 4.
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Type of Waste
Hazardous Toxic
and BMP Toxic
Hazardous
Igni table
Hazardous and
Infectious
Trace
Chemotherapy
Drain Disposal
BMP Non-
Regulated
Description of Waste
P, U and toxic D wastes
All bulk non -listed
chemotherapy drugs
Non-listed toxic drugs
PPE with visible contamination
D001 wastes
Hazardous toxic wastes and
BMP toxic wastes combined
withRMW
Entire contents of sharps
containers if P-listed hazardous
waste was properly or
improperly discarded in
container
"RCRA empty" vials of
chemotherapy agents,
syringes/needles, TVs,
PPE used to prepare or
administer chemotherapy
without visible contamination
Controlled substances,
NaCl, dextrose, vitamins,
electrolytes
All other drugs
Description of
Container
Black or dark blue
Black or dark blue
Sharps container
(e.g., white/blue)
with a Hazardous
Waste and RMW
label applied
Yellow or white
Sewer
White with blue top
(most common)
Type of Treatment
Incineration at RCRA
hazardous waste facility
Incineration at RCRA
hazardous waste facility
Incineration at a facility
permitted to handle RCRA
hazardous waste and RMW
Incineration at RMW facility
Local POTW (permission
required)
Incineration at RMW or MSW
facility
Table 4. Pharmaceutical waste streams
Should Ignitable Wastes Be Managed Separately?
Consider the following:
> Waste compatibility
> Vendor's requirements
> Quantity of ignitable waste generated
> Potential cost savings from managing ignitable waste separately
> Feasibility of combining pharmaceutical ignitable waste with other ignitable waste
> Local and national fire code requirements
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2. Option II: Centralizing Segregation
In centralized segregation, all drug waste is discarded in hazardous waste containers that are
located at the point of generation. The nursing and pharmacy staffs are not required to make
decisions regarding the final destination of the drug waste. However, bulk chemotherapy and
trace chemotherapy waste are an exception, as these wastes should be segregated in the patient
care areas to avoid employee exposure. Overall, this option minimizes the number of containers
that must be maintained at the point of generation. Ultimately, the containers are moved to a
central storage accumulation area and either hospital personnel that have received hazardous
waste training or a hazardous waste vendor manually sort the waste into appropriate containers.
Hospitals that are implementing this approach experience inappropriate waste segregation of
regulated medical waste and trace chemotherapy. In other words, nursing and pharmacy staffs
are discarding wastes that are not pharmaceutical waste in hazardous pharmaceutical waste
containers. Therefore, containers for all types of waste gen erated at the facility should be
available in the manual sorting area. The requirements for a hazardous waste storage
accumulation area apply to the sorting location.
It is still necessary to determine which drugs become hazardous waste when discarded (Step 7:
Taking On the Labeling Challenge). Pre-labeling may be more time efficient for segregation
personnel as lists are difficult to maintain and use in this environment. However, generally
speaking, hospitals that are currently implementing this approach are using an easily accessible
list identifying the appropriate bin for all of the drugs and drug containers generated by the
facility. This list must be updated on a regular basis to reflect changes that are made to the
inventory.
Centralized segregation may be easier to implement initially but it is harder and often more
costly to operate. There are also several drawbacks to this system. If any hazardous waste leaks
in the container, it could potentially contaminate other items and render all of the contents
hazardous. Infectious waste can render the entire contents a combination hazardous waste and
RMW waste that must be managed by a limited number of vendors that are permitted to manage
both waste streams. There also is a real risk of encountering sharps and infectious waste.
If hospital employees are sorting the waste, they need to receive extensive training in hazardous
material and waste handling and management requirements and must be provided with
appropriate personal protective equipment. Given the employee exposure risks involved, it is
strongly suggested that external hazardous waste vendor personnel be used to accomplish the
sort. These technicians usually have extensive hazardous materials and hazardous waste training,
including Hazardous Waste Operations and Emergency Response (HAZWOPER).
If a hazardous waste vendor is utilized, labor costs should be carefully evaluated and compared
with the upfront costs of developing automated hazardous waste identification systems and the
labor costs associated with manual hazardous waste identification. Experience will provide the
best data for an accurate cost analysis.
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Step 9: Getting Ready for Implementation describes the requirement for a hazardous waste
storage accumulation area in more detail.
Appendix A: Tools and Resources provides references for additional information on the
Hazardous Waste Operations and Emergency Response Standard under OSHA.
3. Option III: Managing All Drug Waste as Hazardous
In small facilities with fewer than 50 beds, this may be the simplest and most economical
solution in the long run. For large facilities, pilot programs have documented this approach could
result in added hazardous waste costs of in excess of $1,000,000 annually. Analysis should
provide the best answer as to whether this approach is a viable alternative. Careful cost
modeling or a pilot program may be the only way to make this determination.
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Step 9: Getting Ready for Implementation
1. Locating Your Satellite Accumulation Areas
Collecting hazardous waste in the immediate area in which it is generated is called "satellite
accumulation." Specific federal regulations apply to this activity and state requirements may be
more stringent. For example, clearly labeling the door to the satellite accumulation area may be
required.
All of the program design options presented in Step 8 involve satellite accumulation. It is not
realistic for nursing and pharmacy staff to go to a central storage accumulation area each and
every time hazardous waste is generated. Therefore, you will need to evaluate where waste
containers will be placed, consulting with pharmacy and nursing staff in the process.
To maximize compliance, satellite accumulation sites should be as conveniently located to where
drug waste is generated as possible. Consider locating hazardous waste containers in the sterile
products clean room and in the main pharmacy and in the soiled utility rooms or near medication
carts in a secure area in the nursing units. Containers cannot be stored near a working sink or
open floor drain without secondary containment. A locked wall unit that could be placed in the
patient's room is under development.
Each container must be spill-proof, leak-proof, compatible with the waste to be contained, and
labeled as hazardous waste with the appropriate waste stream noted (toxic or ignitable). The
containers must be kept closed when active addition is not occurring. This can be a challenging
requirement but one that needs to be taken seriously. During the administration of chemotherapy
drugs, for example, the containers may be open, as active addition will be occurring. However,
these containers must not be left open when they will not be added to for a period of time (e.g.,
lunch breaks, over night, when the satellite operator/nurse is not present). Violations of this
requirement are often cited during compliance inspections. The simplest way to insure timely
and consistent container closure is the use of wire frame trolleys or hard plastic carriers that are
opened with a foot pedal, leaving the hands free and closing automatically.
While there is no time limit on the length of satellite accumulation federally, some states do have
limits, usually one year. There is, however, a quantity limit. No more than 55 gallons of
combined U and characteristic waste can be accumulated and not more than 1 quart of P-listed
waste. Once a quart of P-listed waste has been stored, the container must be sealed and moved to
the storage accumulation area within 3 days. Some states do not allow the three days, so check
your state regulations and design monitoring systems accordingly.
The 1-quart limit is a major concern regarding the generation of waste IV epinephrine in the
pharmacy, ICU and Surgical Suites, especially if orthopedic surgery is routinely performed.
Another surgical area to check for epinephrine is ophthalmic surgery, as it is often used as flush
with partial IV bags remaining after the procedure. To insure compliance with the 1-quart rule,
you should consider locating hazardous waste containers in each surgical suite. In addition,
these high generation areas should be visited at least daily and the containers moved at that time
to the storage accumulation area to stay within the volume limit.
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It is important to remember that wastes should be kept in their original closed containers when
discarded, not squirted or drained into the waste container. If there is any free liquid designated
as P waste within the container then all of the content that is contaminated with the free liquid is
a hazardous waste mixture and therefore the P-listing applies to the entire contents within the
container.
Next Steps contains a recommendation to review the appropriateness and practicality of
the RCRA hazardous waste regulations.
a. Corrosive Waste
It is not necessary to set up a separate container for corrosive hazardous waste in the pharmacy,
since it will not be generated on a day -to-day basis. All compounding chemicals should be
reviewed annually and disposed of as lab packs by your hazardous waste vendor if no longer in
use. Under the requirements of the United States Pharmacopeia Chapter 191 (USP 197\ all
chemicals used in sterile compounding must also be dated upon receipt and discarded after one
year unless the manufacturer has included an expiration date.
2. Evaluating Your Storage Accumulation Area
When hazardous drug waste containers are removed from satellite accumulation areas in the
pharmacy, nursing units, and clinics, they must be transferred to and stored in an area known as a
hazardous waste storage accumulation area. You will need to review the requirements of a
hazardous waste storage accumulation area to insure compliance with RCRA regulations for
your generator size, especially if management of pharmaceutical waste moves you from SQGto
LQG status. There are very specific requirements for setting up and maintaining a hazardous
waste storage accumulation area that can be found in 40 CFR Part 262.34.
It is likely that your organization already has established a central storage accumulation area for
other hazardous wastes such as xylene. However, it is possible the area may need to be enlarged,
a second storage accumulation area established, or your hazardous waste vendor will
need to schedule more frequent pick-ups to handle the new pharmaceutical hazardous waste
stream. A pilot program can provide valuable data concerning the volume and frequency of
hazardous waste containers being generated and any logistical challenges associated with the
location of the existing storage area.
A discussion on how to conduct a pilot program is provided in Step 10: Launching the
Program.
3. Selecting the Right Vendor(s)
First and foremost, you are looking for a vendor that is licensed by EPA to transport hazardous
waste to a permitted treatment, storage, and disposal facility (TSDF). Your organization may
already have a contract with a hazardous waste vendor or may utilize their services on an as
needed basis. It is very important to insure that your current vendor is permitted to handle P, U
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and toxic D waste. For example, some vendors are fuel blenders and can handle ignitable wastes
but are not permitted to manage the pharmaceutical wastes that you will be generating. You also
may need a vendor that can provide specialty services such as being able to handle combinations
of hazardous and infectious wastes or being registered with DBA to take possession of waste
controlled substances.
Hazardous Controlled Substances
A vendor that can handle controlled substances that are also hazardous waste will
have a registration with the DEA. You are required by DEA regulations to have a
copy of this registration for your files. It will indicate which schedules, 1 through 5,
the vendor is registered to handle. Schedules 2 through 5 are applicable to health care
facilities. When the vendor picks up the controlled substances, you are transferring
these items to them in a very formal manner which must include either a Form 222,
(issued from the vendor to you) if they are Schedule II drugs such as morphine, or a
detailed inventory list (from you to the vendor) if the drugs are in Schedules III
through V. The pharmacy department should be actively involved in this process
since they work with this same procedure when controlled substances are sent through
reverse distribution. The vendor is taking on two areas of liability: accountability to
the DEA for security and documentation and to the EPA for proper disposal and
documentation. The persons responsible for this transaction should be completely
familiar with DEA regulations as they pertain to a transfer between registrants.
Some vendors that operate RCRA permitted hazardous waste incinerators also provide on-site
pick up services. Availability depends on your geographical location. You will want to evaluate
regional brokers as well as final disposers. Regional brokers are usually permitted as 10-day
transfer stations and often take all forms of hazardous waste, including universal waste such as
fluorescent bulbs and batteries. It is important to know all of the vendors that the broker uses for
actual disposal or recycling and require them to alert you to all changes.
To determine your best service options, have all available vendors in your area submit detailed
price quotes with line items that can be compared across vendors as well as documentation on
permits, violations over the past three years, and recommendations from other hospital
customers. As the generator, your facility is liable for improper management of your waste.
Before you finalize your vendor selection, check with your local regulator and EPA for their
compliance status. Be sure you have a solid contract with your vendor including indemnification
against such liability.
Vendor selection can proceed in parallel with Step 8: Considering the Management Option
since some approaches involve more vendor participation than others.
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a. Reverse Distributors Are Not Waste Management Services
Reverse distribution of pharmaceuticals primarily involves the return of unused, outdated
Pharmaceuticals to the manufacturer for credit. The reverse distribution industry emerged in the
early 1990's to maintain an ever-changing database of manufacturers' return policies and to
provide hospitals with the labor-intensive service of inventorying all of their unused, outdated
items and comparing them to this database.
Two interpretative letters from EPA (RCRA Online #11606 Returned Pharmaceutical Products
and RCRA Online #11012 Applicability of 261.33 to Discarded Products) indicate that given the
underlying assumption that returned items might potentially be recycled, EPA would not
consider these items a waste until they reach the destination where the decision to discard them is
made. This decision allows these items to be sent through interstate commerce as products, rather
than as wastes, and does not require the pharmacy to make a hazardous waste determination.
If the drugs are not returnable to the manufacturer as determined by the reverse distributor, the
reverse distributor becomes the generator and must make a hazardous waste determination and
manage the waste accordingly.
EPA did not intend for you to use reverse distribution to relieve you of your responsibility as a
generator for making hazardous waste determinations. Reverse distributors cannot be used as
waste management services.
The following items should never be returned to a reverse distributor since they are never
creditable:
> Unused compounded TVs,
> Partial or empty vials,
> Used ointments,
> Bulk chemicals or materials,
> Outdated samples,
> Outdated Pharmacy re-packs,
> Waste controlled substances unless the reverse distributor has a solid waste permit and the
10
technical ability to report the transaction to ARCOS.
12 Automation of Reports and Consolidated Orders System (ARCOS) is a reporting system managed by DBA. All
manufacturers, distributors, and reverse distributors are required to report all schedule II and narcotic schedule III
transactions to ARCOS on a monthly or quarterly basis.
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Stay Abreast of Reverse Distribution Developments
In some EPA regions and in an increasing number of states, regulators are prohibiting
the reverse distribution of outdated drugs that have become hazardous waste if they
have a history of notbeing recycled or reused. These prohibitions may apply even if
the drug is eligible for credit from the manufacturer.
It is important for you to be aware of how the drugs that you send to your reverse
distributor are being managed and to modify your reverse distribution program
accordingly. For example, epinephrine syringes often are not returnable to the
manufacturer for credit and end up being managed as hazardous waste by the reverse
distributor on a regular basis. Therefore, it is your responsibility as the generator to
discontinue sending these syringes to your reverse distributor and manage them as
hazardous waste.
You should monitor your state environmental protection agency and EPA region and
adjust your return policies periodically. Selecting a competent and reliable reverse
distributor that knows and abides by state and federal hazardous waste regulations
will assist you in this effort.
4. Conducting a Pilot Program
The three highest profile areas, the pharmacy, any oncology units or outpatient clinics and the
ICU, should be considered for an initial pilot program. Not only are they easier to control than
some units, these are the areas regulatory agents will be sure to examine. There is no more
certain way to generate a notice of violation than by the absence of a hazardous waste container
in an area where bulk chemotherapy waste or epinephrine may be generated.
During the pilot program, you should be evaluating how you label the drugs for pharmacy and
nursing personnel. You will need to perform training, and can therefore estimate the time and
costs involved in training three shifts of personnel. Feedback from pharmacy, nursing,
environmental services and safety will be extremely important. The logistics of number and size
of container, frequency of change out, volume to be stored in storage accumulation, and costs of
disposal are all areas that can be clarified by the pilot. Perhaps most importantly, if you have
made decisions that just don't work for your organization, you can back away from them citing
the experimental nature of pilot programs. You should have all the "bugs" worked out before you
set up your full house rollout schedule.
Appendix C: Sample Pilot Project Training Presentation provides a starting point for a
staff training presentation.
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5. Putting It All Together: Pharmaceutical Waste Management Policies and Procedures
After conducting a pilot and before rolling out the program to the entire facility, new policies and
procedures for hazardous drug segregation need to be drafted. Involve safety, nursing,
pharmacy, and environmental services management in the drafting of these new policies and
procedures. All aspects of your pharmaceutical waste management and minimization program
should be incorporated into existing policies and procedures or if necessary new ones should be
created. In addition, it is helpful to set up a specific manual of pharmaceutical waste
management and minimization policies and procedures to have all of the steps documented in
one location. This overarching operating manual can reference other appropriate policies and
procedures, such as chemotherapy preparation, administration, and disposal or general hazardous
waste management.
Policies and Procedures
At a minimum pharmaceutical waste management policies and procedures should be
developed to detail the organization's approach to:
o Identifying drugs that must be managed as hazardous waste;
o Determining which non-regulated drugs will be managed as hazardous waste
o Maintaining a system to add new drugs;
o Labeling drugs to facilitate segregation of hazardous waste;
o Segregating waste streams;
o Training staff (e.g., which staff, what information and how often);
o Managing spills;
o Contacting emergency coordinators;
o Setting up and managing satellite accumulation and storage accumulation areas;
o Preparing and maintaining hazardous waste manifests;
o Determining their hazardous waste generation status;
o What criteria are used for hazardous waste selection;
o Scheduling regular program reviews;
o Keeping management informed; and,
o Using pharmaceutical waste management as a stepping-stone to a facility-wide
Environmental Management System (EMS).
6. Preparing for Spills
Your organization may already have a well-developed spill management plan. Oncology nurses
receive chemotherapy spill clean up training during their annual re-certification process.
Pharmacists and pharmacy technicians involved with chemotherapy preparation also usually
have spill clean up awareness and experience. Since you are now identifying other
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Pharmaceuticals that will be discarded as hazardous waste, it is important to re-evaluate general
spill management procedures and be certain that all employees, particularly nursing, pharmacy,
and environmental services personnel, are trained upon hire and annually on proper spill clean up
procedures.
Determine a maximum amount of material that can be safely cleaned up by immediate personnel.
Once you have made that determination, photograph a spill of that amount. It is often hard for
people to visualize what 5 mis, 15 mis, or 30 mis looks like when spilled. Be sure the appropriate
spill kits are available to handle that maximum amount. Personnel must either be trained to
determine if the spill is a hazardous waste or must call the hazardous materials team to make that
determination.
If not already in place, develop a hazardous materials team for the second level of emergency
spill response comprised of managers from safety, environmental services, nursing and
pharmacy. These individuals should receive additional HAZWOPER training and a more
complete spill cart should be kept in a central location for quick access. At least one HAZMAT
team member should be on duty at all times. HAZMAT team members must be trained to
determine if the spilled material is a hazardous waste and how to properly dispose of it and the
spill clean up materials. Again, determine the maximum spill to be handled by this team before
the Fire Department hazardous materials unit is called.
There are several different acronyms hospitals have used to describe the process. You might
already have one in place that serves your organization well. Putting a laminated summary on a
card that is attached to the employees ID badge is a good way to insure they have the reference
with them at all times.
Spill Acronyms
EAR
Evacuate the immediate area
Alert the spill response team, dial the emergency #
Remain by the phone outside affected area, keep people from going into area, and
communicate with spill team.
CLEAN
Contain the spill
Leave the area
Emergency medical treatment (seek)
Access the MSDS
Notify
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Step 10: Launching the Program
1. Educating and Training Staff
Once all policies and procedures are drafted, and the knowledge gained from the pilot program
has been applied to refining the approach, conduct just-in-time training session for all pharmacy
personnel and nursing personnel in the selected units on all shifts. Having a PowerPoint
presentation with an accompanying waste sorting exercise is an effective method, which can then
be used to orient new employees.
A successful waste pharmaceutical management program depends on the participation of all
employees. Active promotion is the best way to help employees understand the program and
encourage their participation. Take advantage of any Safety Fairs, Nursing Education Expos, or
other hospital-wide events to do a general introduction to the topic of pharmaceutical waste
management. Involve nurse educators heavily in your efforts. Consider including information in
an orientation for new employees, on signs and posters and in newsletters and email updates.
If environmental services personnel are to be involved in transporting hazardous waste
containers, they must receive appropriate hazard training based on their responsibilities and the
hazardous waste generator status of the organization.
^ Appendix C: Sample Pilot Project Training Presentation provides a starting point for
developing a training presentation.
2. Staging the Roll-Out
The most successful implementation programs have involved carefully staged roll-outs,
developed with the input of all parties involved, especially nursing. Just-in-time training of all
three shifts should be held the week prior to the roll-out for a particular unit. All containers, spill
response items, and appropriate signage should be in place prior to the start date. Pharmacy must
be ready to identify those items that will be managed as hazardous waste if the labeling approach
requires their participation. In the newer automated dispensing machines, messages can be
"turned on" by unit, as the rollout proceeds around the hospital.
Most of the research is done prior to launch. You do not want to have to re-visit policies and
procedures or re-train anymore than is absolutely necessary. While some tweaks will be
inevitable, most major hurdles should be overcome during the planning and pilot stages. A
successful implementation will insure greater compliance and enthusiasm for the program.
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3. Filling out the Forms
a. Hazardous Waste Manifest (40 CFR Parts 262.20- 262.27)
The hazardous waste manifest is a form, which has both EPA and DOT components. It is
designed to provide documentation for cradle to grave tracking of hazardous waste from the
generator through the transporter to the final disposer and to provide emergency response
information should there be a spill in transit. Completing a hazardous waste manifest properly
requires knowledge of the contents of each container of waste and specific DOT training to
insure proper shipping names.
There are two approaches to manifesting hazardous waste: profiling and lab -packing. In most
states, hospitals can provide their vendor with a list of all P, U, and D waste codes being
generated and the vendor can pre-certify the list and create a waste profile. All possible waste
codes will be listed on the manifest for a particular waste stream. This is the simpler, more time
efficient approach. Otherwise, the nursing and pharmacy staffs need to document what is
discarded in each container to be able to include all the appropriate waste codes on the manifest.
This is considered lab packing. Please note that hazard classes such as ignitable and toxic may be
mixed when waste profiling is done, but they cannot be mixed in lab packs. Mixing of hazard
classes is dependent on the capabilities of your vendor.
Hazardous waste vendors can provide assistance in this area, but you shouldn't depend solely on
the vendor's expertise. Ultimately, you as the generator and not the hauler/vendor are legally
responsible for proper waste management including manifesting. If your vendor provides
services in multiple states with differing requirements, you need to ensure that the appropriate
state requirements are followed.
If a compliance audit is conducted by EPA or by your state regulatory
agency, the lack of waste epinephrine on your hazardous waste manifests is
clear evidence that you are not disposing of hazardous waste appropriately
and, probably have not accurately determined your generator status.
Appendix A: Tools and Resources provides more information on hazardous waste
manifests, waste profiling, and lab packs.
b. Land Disposal Restriction Form (40 CFR Part 268.7)
A Land Disposal Restrictions form must accompany your manifest. This document indicates
what wastes you are disposing and how they will be treated prior to application on the land to
assure compliance with RCRA. Your hazardous waste vendor can prepare this for you.
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Step 2: Understanding the Regulations provides additional information on Land Disposal
Restrictions
Appendix A: Tools and Resources provides references for further information on Land
Disposal Restrictions.
4. Tracking. Measuring and Recording Progress
As you implement your pharmaceutical waste management program, it is important to establish a
process to track and measure your progress. This can be done at each step of the process.
Identification: Maintain complete records on how waste categorization was done initially and
how new drugs are being evaluated when they enter the system. Some facilities have conducted
before and after surveys to determine baseline practices and degree of implementation.
Labeling: Document how consistent your labeling efforts are, especially if you are relying on
manual stickers being placed on labels going to the nursing units. As other medication
management procedures evolve, re-evaluate these procedures at least annually to determine if a
more sophisticated, less labor-intensive model can be adopted, such as electronic labeling (a
function of pharmacy software), or the use of a sorting device (a function of bedside bar coding
capabilities).
Compliance: Perform periodic surveys of pharmacy and nursing staff to determine if the
procedures are understood and followed. Perform periodic checks of the waste containers
themselves to determine if the appropriate drugs are being discarded in them. Be sure to wear
appropriate personal protective equipment to perform this function.
Quantity: Track the number, size, and weight of hazardous waste containers being generated.
Adjust sizes and pick up times to maximize efficiency and minimize costs. This information is
also needed for state and federal reporting purposes.
Costs: Track all costs involved with the development and setup of the program. Once fully
operational, track all hard costs involved with containment, storage and disposal. Once a base
line is established, consider all waste minimization opportunities to begin reducing costs.
JCAHO Performance Improvement Initiative: Document the entire process to be used in your
next JCAHO Survey as a Performance Improvement Initiative.
H2E Award Opportunity: Identify goals and action plans detailing how your facility will achieve
your goals. Submit your efforts for annual recognition as an H2E Partner for Change Award
winner.
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Next Steps
Overcoming the challenges unique to pharmaceutical waste management that assure compliance
with RCRA and implementation of best management and waste minimization practices will
require the combined and innovative efforts of the regulators, the regulated community and the
supply chain. Following are recommendations for next steps to facilitate environmentally sound
pharmaceutical waste management in health care facilities.
1. Provide Additional Pharmaceutical Waste Management Assistance to Hospitals
Given the number of hospitals that are currently out of RCRA compliance and the difficulty of
implementing a pharmaceutical waste management program, it would be valuable to provide
training based on this Blueprint to a broad audience, especially pharmacists.
There are a number of existing pharmaceutical waste management tools that should be shared
(e.g., training presentations, guidance posters for segregating pharmaceutical waste) and new
tools that need to be developed (e.g., spreadsheet for performing a manual inventory review, on-
site review checklist, purchasing policy) that would facilitate the development and
implementation of a pharmaceutical waste management program.
An executive summary of this Blueprint, modeled after a typical H2E 10-step guide, would be
valuable in enticing busy hospital personnel to fully utilize this more extensive resource.
2. Clarify. Reconsider and Expand the RCRA Hazardous Waste Regulations
The RCRA regulations have not been updated significantly since their inception in 1976 and as a
result have not kept up with drug development. There are toxic chemotherapeutic agents,
endocrine disrupters, anti-hypertensives, anti-depressants, anti-cholesteremics, and antibiotics
that can legally be sewered or landfilled under the current regulations. Based on an increasing
body of research, it is apparent that continuous introduction of these agents into aquatic
environments may have negative consequences on fish and other aquatic species.
Step 3 of this Blueprint outlines criteria for identifying drugs that should be managed as
hazardous waste when discarded. These criteria can be used as a starting point to assist EPA in
increasing the number of hazardous drugs that are regulated as hazardous waste. For example
EPA could add the drugs listed in Appendix A of the NIOSH Hazardous Drug Alert. In addition,
Minnesota has developed a scheme for evaluating drugs based on risk that could be evaluated.
At the same time that EPA is adding additional P- and U-listed drugs, it would be prudent to
review the appropriateness of the existing listed constituents of concern.
In the meantime, there is sufficient confusion on several regulatory issues to warrant uniform
clarification from EPA HQ on aspects of the existing regulations. For example, what is the
definition of dispensing device, how should worn nicotine patches be managed, and does the
December 1994 interpretation apply to syringes used in compounding IVs where epinephrine is
transferred?
It is also important to review the appropriateness and practicality of the regulations to
pharmaceutical waste management. For example, the 1-quart satellite accumulation limit is a
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major concern for waste IV epinephrine generated in the pharmacy, ICU and Surgical Suites,
especially if orthopedic and/or ophthalmic surgery is routinely performed. To insure compliance
with the 1-quart rule, these high generation areas must be visited at least daily and the containers
moved at that time to the storage accumulation area to stay within the volume limit.
In the long term, EPA should consider adapting the regulations to take a practical and holistic
approach to pharmaceutical waste management that achieves a more favorable environmental
outcome for this significant source contamination.
3. Eliminate Drain Disposal
Wastewater treatment plants are designed to remove conventional pollutants such as suspended
solids and biodegradable organic material, not other pollutants such as pharmaceuticals. It is
important to work with DBA to allow alternative methods to drain disposal to render controlled
substances non-recoverable.
4. Communicate Hazardous Waste Determinations
Making hazardous waste determinations and communicating the hazardous waste disposition
information to the nursing and pharmacy staffs are very complex and resource intensive aspects
of implementing a pharmaceutical waste management program. A hospital's ability to make
these determinations accurately and to communicate them effectively impacts their ability to
comply with RCRA.
There are several ways that hazardous waste determinations can be made and that disposition
information can be conveyed. Hazardous waste determinations can be performed manually or
there are commercial services available to provide hospitals with assistance. Performing
hazardous waste determinations manually is an arduous process as there are as many as 4,000
drugs that must be initially reviewed. Each determination requires research, calculations or
knowledge of the drug. Generally, the MSDS does not provide sufficient disposition information
to make a hazardous waste determination.
Once the hazardous waste determination has been made, the information must be communicated
to the pharmacy and nursing staffs. It can be integrated into the pharmacy dispensing software,
included on the barcodes that FDA has recently required be placed on pharmaceuticals by
manufacturers, and/or added as an additional field in wholesaler invoicing software.
Overcoming these challenges on a hospital-by-hospital basis is extremely resource intensive.
There is a need for a national stakeholder forum to bring these issues to the attention of the
supply chain, encouraging them to come up with innovative win-win solutions that economically
and environmentally benefit pharmaceutical waste management. The results of such a forum
will also benefit the advancement of proper pharmaceutical management at the consumer level.
5. Broaden National Knowledge Base of Pharmaceutical Waste Generation
There is no documented percentage of drug waste per drug dispensed or per hospital bed
available at this time. The percentage of hazardous drugs in the inventory does not correlate
with the percentage of hazardous drug waste generated at a hospital for several reasons: (1) P-
listed drugs such as epinephrine may be discarded on a regular basis, due to the nature of its use,
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as in an IV bag, while another P-listed drug such as warfarin, which is a tablet, may be discarded
less often; (2) frequency of use varies among drugs, resulting in fewer opportunities for waste
generation for some compared to others; (3) U-listed drugs are not managed as hazardous waste
if the containers are "RCRA empty"; and, (4) contaminated PPE and spill materials will increase
the amount of hazardous waste generated. It is reasonable to assume that areas administering
higher volumes of potentially hazardous waste will generate more waste. Determining the actual
percentages of specific hazardous waste generated provides an excellent research opportunity.
6. Promote Waste Minimization
In Step 5, various waste minimization opportunities are identified. Additional research and work
involving multiple stakeholders is necessary to efficiently implement some of the practices
identified. The following are examples of national projects to move these waste minimization
practices forward.
a. Routinely Wasted Drugs
Work with hospitals, GPOs, pharmaceutical distributors, and pharmaceutical manufacturers to
conduct a broad based study to determine the universe of drug formulations that are routinely
wasted due to package size and to facilitate change.
In some instances, a drug's expiration date may be an arbitrary date rather than the true activity
life. Work with GPOs and pharmaceutical manufacturers to ensure that the expiration dates are
accurate.
Generally, hospitals replace epinephrine syringes and nitroglycerin bottles and vials on general
crash carts when they are within three months or less of their expiration date. Work with several
hospitals to pilot moving these products from general crash carts to the Emergency Department
or ICC/CCU three months prior to outdate to avoid discarding them.
b. Lightweighting
There are variations in the weight of dispensing instruments. Work with the pharmaceutical
supply chain to identify lightweighting opportunities. For example, a two -part polyolefm IV
device used to administer antibiotics (e.g. Duplex) weighs one-third less than traditional glass
vial/PVC IV bag alternatives.
7. Understand Environmental Impacts of Existing Treatment Technologies and Advance
New Ones
There are unanswered questions surrounding the proper treatment of pharmaceutical waste that
need to be examined. RCRA dictates the incineration of hazardous pharmaceutical waste. But,
how should non-hazardous pharmaceutical waste be managed? Current research findings
support the elimination of drain disposal. Is it really problematic to discard all non-regulated
waste Pharmaceuticals in solid waste landfills? Should these wastes be managed in a hazardous
waste landfill? Does treatment of non-hazardous pharmaceutical waste in regulated medical or
municipal solid waste incinerators create adverse environmental impacts? What are the
environmental impacts of discarding non-hazardous waste pharmaceuticals in sharps containers?
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By complying with the hazardous waste regulations and adopting best management practices,
hospitals play an important role in creating the market-based incentives necessary to make
alternativ e treatment technologies such plasma arc and ultrasound commercially available.
8. Summary
Pharmaceutical waste continues to be a new frontier in environmental management for health
care facilities. The compliant, cost-effective management of waste pharmaceuticals is a complex
challenge. It is interdisciplinary in nature, involving pharmacy, nursing, environment services,
safety, infection control, quality assurance, risk management, education, administration, and
purchasing, requiring the implementation of new systems to insure proper waste management.
Aware of the need to develop new systems, professionals within state and federal environmental
protection agencies are beginning to assist the regulated community in developing practical
compliance models. It will take the involvement of the entire supply chain, from manufacturers
through distributors to hospitals, to develop more user-friendly systems to insure protection of
human health and the environment. This Blueprint is intended to provide detailed guidance to
hospitals today while stimulating the broader research and solutions needed for tomorrow.
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Appendix A: Tools and Resources
Step One: Getting Started
a EPA Pharmaceutical Industry Sector Notebook
http://www.epa.gov/compliance/resources/publications/assistance/sectors/notebooks/pharmac
eutical.html
a Cradle-to-Cradle Stewardship of Drugs for Minimizing Their Environmental Disposition
While Promoting Human Health Parts 1 and 2 can be accessed at:
http://www.epa.gov/nerlesdl/chemistry/ppcp/images/greenl .pdf and
http://epa.gov/nerlesdl/chemistry/ppcp/images/green2.pdf
a Minnesota Pollution Control Agency Healthcare Waste Fact Sheets can be accessed at:
http://www.pca.state.mn.us/industry/healthcare.html
a USEPA Region 2 Guidance on Healthcare Hazardous Wastes, including pharmaceuticals can
be accessed at: http://www.epa.gov/region2/healthcare
a Health Facilities Management Magazine, March 2006, Waste Watch: A Model for
Managing Discarded Pharmaceuticals can be accessed at:
http://www.hfmmagazine.com/hfmmagazine/hospitalconnect/search/arti cle.jsp?dcrpath=HF
MMAGAZINE/PubsNewsArticleGen/data/2006March/0603HFM_DEPT_EnvirSer&domain
=HFMMAGAZINE
Step Two: Understanding and Applying the Regulations
General
a The RCRA Orientation Manual can be accessed at:
http://www.epa.gov/epaoswer/general/orientat/
a RCRA hazardous waste regulations can be accessed on e-CFR at: http://ecfr.gpoaccess.gov
Hazardous Waste Identification
a RCRA Online #13718: Epinephrine Residue In A Syringe Is Not P042 (December 1994)
can be accessed at:
http://yosemite.epa.gov/osw/rcra.nsf/0c994248c239947e85256d090071175f/lcldeb3648a62
a868525670f006bccd2!OpenDocument
a Nitroglycerin Exclusion 66 FR 27286 Hazardous Waste Identification Rule (HWIR):
Revisions to the Mixture and Derived-From Rules can be accessed at:
http://www.epa.gov/EPA-WASTE/2001/May/Day-16/fll411.htm
a Healthcare-Related P -and U-Listed Wastes can be accessed at: http://www.h2e-
online. org/pub s/Healthcare_P_U_Wastes .pdf
a Wilkosz, M and Bogner, R. (2003) Transdermal Drug Delivery can be accessed at:
http://www.uspharmacist.com/index.asp?show=article&page=8_1061.htm
a Flynn GL. (1996) Cutaneous and transdermal delivery: Processes and systems of delivery. In:
Banker GS, Rhodes CT, eds. Modern Pharmaceutics. New York, NY: Marcel Dekker; p.239-
299.
Chemotherapy Waste
a H2E March 11, 2005 Teleconference Presentation- Managing Waste Chemotherapeutic
Agents: What to Know and What to Find Out can be accessed at: http://www.h2e-
online.org/pubs/Rev_%20H2E_Chemo_Teleconference_Presentation.ppt
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a H2E September 12, 2003 Teleconference Presentation- Identifying and Managing
Hazardous Waste, http://www.h2e-online.org/events/teleconf/moly desc.cfm?Date=2003-09-
12
a California Medical Waste Management Act can be accessed at:
http://www.dhs.ca.gov/ps/ddwem/environmental/Med_Waste/LawRegs/default.htm
a Recommendations for Chemotherapy Spill Response detailed in the OSHA Technical
Manual C.5 can be accessed at: http://www.osha.gov/dts/osta/otm/otm_vi/otm_vi_2.html#5
a Recommendations for Respirator Protection detailed in the OSHA Technical Manual B.6.c
can be accessed at: http://www.osha.gov/dts/osta/otm/otm_vi/otm_vi_2.html#5
a Chemotherapy spills on carpet can be accessed at:
http://www.des.nh.gov/nhppp/Healthcare_P2/default.asp?link=faq6
a Wisconsin's Medical Waste Rules NR 526.03 (3) and 526.055 can be accessed at:
http://www.legis.state.wi.us/rsb/code/nr/nr526.pdf
a Draft Questions and Answers Regarding the Management of Waste Chemotherapy
(Antineoplastic) Drugs can be accessed at: http://www.h2e-
online.org/pubs/R2_Waste_Chemo_Q A_DRAFT.pdf
a The American Society of Health-System Pharmacists (ASHP) Guidelines on Handling
Hazardous Drugs can be accessed at: http://www.ashp.org/bestpractices/new/HD-Prepub-
fmal.pdf.
a The NIOSH Hazardous Drug Alert can be accessed at: http://www.cdc.gov/niosh/docs/2004-
165/
a Spivey S. and Connor T.H. (2003) Determining sources of workplace contamination with
antineoplastic drugs and comparing conventional IV drug preparation with a closed system.
Hospital Pharmacy. 38: 135-139
a Information on Phaseal can be accessed at: http://www.phaseal.com/siteUS/default.asp
Controlled Substances
a Controlled substance schedules can be accessed at:
http://www.deadiversion.usdoj.gov/schedules/index.html
a The DEA's Diversion website can be accessed at:
http://www.deadiversion.usdoj.gov/new.htm
a The regulations applying to controlled substances, 21 CFR 1300 to 1399, can be accessed at:
http ://www. deadiversion.usdoj .gov/21 cfr/cfr/index.html
a The Pharmacist's Manual, a summary of the DEA disposal requirements can be accessed at:
http://www.deadiversion.usdoj.gov/pubs/manuals/pharm2/index.htm/
Generator Status
a Minnesota Pollution Control Agency's Evaluate Waste - Determine Generator Size can be
accessed at: http://www.pca.state.mn.us/publications/w-hwl-01.pdf
a Small and large quantity generators must register with EPA for an Identification Number.
Registration forms and instructions for small and large quantity generator identification
numbers can be accessed at:
http://www.epa.gov/epaoswer/hazwaste/data/form8700/forms.htm#waste
Drain Disposal
a Tri-TAC Memo to POTW Pretreatment Coordinators and Managers, September 23, 2003,
http://www.ciwmb.ca.gov/WPIE/HealthCare/TriTACMemAtt.pdf
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Aerosol Cans
a RCRA Online #11782: Regulatory Status Of Used Residential And Commercial/Industrial
Aerosol Cans (October 1993) can be accessed at:
http://yosemite.epa.gov/osw/rcra.nsf/ea6e50dc6214725285256bf00063269d/0c95b3d30e33c
db68525670f006bece7!OpenDocument
a State of North Carolina "Management of Aerosol Cans for Businesses and Industries" can be
accessed at: http://www.p2pays.org/ref/01/00007.htm
a Minnesota Pollution Control Agency's fact sheet, Managing Waste Aerosols, can be
accessed at: www.pca.state.mn.us/waste/pubs/4_00.pdf
a Steel Recycling Institute promotes the recycling of aerosol cans at: http://www.recycle-
steel.org/ 800-876-7274
Step Three: Considering Best Management Practices for Non-Regulated
Wastes
a The NIOSH Hazardous Drug Alert can be accessed at: http://www.cdc.gov/niosh/docs/2004-
1657
a Environmentally Classified Pharmaceuticals, a brochure with a list of 159 active substances
classified on their PBT potential, can be accessed at:
http://www.noharm.org/details.cfm?ID=1027&type=document
a The Occupational Safety and Health Administration (OSHA) Technical Manual Section 6,
Chapter 2, Appendix VI: 2 http://www.osha-slc.gov/dts/osta/otm/otm_vi/otm_vi_2.html
a Minnesota Pollution Control Agency's fact sheet, Alternative Method to Evaluate
Pharmaceutical Waste for the Lethality Characteristic, can be accessed at:
http://www.pca.state.mn.us/publications/w-hw4-45b.pdf
a The Toxicology Program's Report on Carcinogens (11th Edition) can be accessed at:
http://ntp.niehs.nih.gov/ntp/roc/tocl 1 .html
a The full Precautionary Principle statement can be accessed at http://www.gdrc.org/u-
gov/precaution-3 .html.
a Health Care Without Harm's Alternatives to PVC and DEHP can be accessed at:
http ://www. noharm. org/detail s. cfm?type=document&id=5 91
Step Four: Performing a Review of Your Drug Inventory
a Sample Toxicity Characteristic Calculations can be found in Appendix B
a Information on purchasing Facts and Comparisons and Efacts can be accessed at
http://www.factsandcomparisons.com/
Step Eight: Considering the Management Options
a The OSHA Hazardous Waste Operations and Emergency Response Standard can be accessed
at: http://www.osha.gov/html/faq-hazwoper.html.
Step Nine: Getting Ready for Implementation
Locating Your Satellite Accumulation Areas
a USEPA's Frequently Asked Questions about Satellite Accumulation Areas, March 17, 2004,
can be accessed at: http://www.epa.gov/osw/specials/labwaste/memo-saa.htm
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Selecting the Right Vendor(s)
a Licensed hazardous waste transport, storage, and disposal facilities nationwide can be
accessed at: http://www.epa.gov/enviro/html/rcris/rcris_queryJava.html
Reverse Distribution
a RCRA Online # 11012 Applicability of 261.33 to Discarded Products
http://yosemite.epa.gov/osw/rcra.nsf/0c994248c239947e85256d090071175f/b630cd51dc85e
dc58525670f006bce84!OpenDocument
a RCRA Online # 11606 Returned Pharmaceutical Products
http://yosemite.epa.gov/osw/rcra.nsf/ea6e50dc6214725285256bf00063269d/a3a7a7a8f29743
8b8525670f006be5d8! OpenDocument
Pharmaceutical Waste Management Pol icies and Procedures
a Healthcare Guidance to Pollution Prevention Implementation through Environmental
Management Systems can be accessed at: http://www.epa.gov/region2/ems
Step 10: Launching the Program
Filling out the Forms
a Information about hazardous waste manifests can be accessed at
http ://www. epa.gov/epaoswer/hazwaste/gener/manifest/.
a 40 CFR 173.24 contains general requirements for packaging and packages
a 40 CFR 173.24(a) for additional requirements for non-bulk packaging and packages.
a 49 CFR 173.12 (b)(2)(iii) has exceptions for shipments of waste materials
a Information on the 40 CFR Part 268 Land Disposal Restrictions can be accessed at
http://www.epa.gov/epaoswer/general/orientat/rom36.pdf.
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Appendix B: Sample Toxicity Characteristic Calculations
For Liquids and Solids
Liquids
Evaluation of Thimerosal Toxicity
per Merck Index, Twelfth Edition:
Thimerosal (C9H9HgNaO2S) molecular weight = 404.82
C 26.70%
H2.24%
Hg 49.55%
Na5.68%
O 7.90%
87.92%
1:1000 Solution
Thimerosal may be used as a preservative in a concentration of 1:1000, which means, by
definition, 1 gram in 1000ml of solution.
Since thimerosal is 49.55% mercury:
Ig thimerosal x 49.55% = 0.4955 g mercury.
lgthimerosal/1000ml = 0.4955 g Hg/lOOOml = 495.5 mg Hg/1000 ml = 495.5 mg Hg/liter
The regulatory limit for mercury is 0.2mg per liter
1:10,000 Solution
Thimerosal may also be used as a preservative in a concentration of 1:10,000, which means, by
definition, 1 gram in 10,000ml of solution.
1 g/10,000 ml_= 0.1 g/lOOOml
Since thimerosal is 49.55% mercury:
O.lg thimerosal x 49.55% = 0.04955g mercury.
0.1 g thimerosal/1000ml = 0.04955 g Hg/lOOOml = 49.55 mg Hg/1000 ml = 49.55 mg Hg/liter
The regulatory limit for mercury is 0.2mg/liter.
Therefore, products containing thimerosal as a preservative at either 1:1,000 or 1:10,000 exceed
the regulatory limit for mercury and exhibit the toxicity characteristic.
Evaluation of Phenylmercuric Acetate Toxicity
per Merck Index, Twelfth Edition:
Phenylmercuric Acetate (CgHgHgC^) molecular weight = 336.74
C 28.53%
H2.39%
Hg 59.57%
O 9.50%
Most nasal sprays contain phenylmercuric acetate 0.002% (of total solution) as preservative.
0.002% = 0.002 g/lOOml =0.02 g/1000 ml
Since phenylmercuric acetate is 59.57% mercury:
0.02g phenylmercuric acetate x 59.57% = 0.0119g mercury
72
-------
0.02g phenylmercuric acetate = 0.0119g Hg/1000 ml = 11.9 mg Hg/1000ml = 11.9mgHg/liter
The regulatory limit for mercury is 0.2mg/liter.
Therefore, products containing phenylmercuric acetate as a preservative exceed the regulatory
limit for mercury and exhibit the toxicity characteristic of a RCRA hazardous waste.
Evaluation of m-Cresol Toxicity
Some insulins use m-cresol as a preservative. For example, Humalog 75/25 contains 1.76 mg/ml
of m-cresol:
1.76 mg/ml = 1760 mg/1000 ml = 1760 mg/liter
The Toxicity Characteristic limit for m-cresol is 200mg/liter.
Therefore, the Humalog 75/25 would meet the criteria for the toxicity characteristic when
discarded.
Evaluation of Barium Sulfate in Barium Enemas and Suspensions
The following calculations document why barium sulfate used in barium enemas and
suspensions may exhibit the Toxicity Characteristic.
Barium Sulfate
Per Merck Index, Twelfth Edition:
Barium sulfate (BaSO/t) molecular weight 233.39:
Ba 58.84%
813.74%
O 27.42%
Preparations of barium sulfate for radiographic examination of the GI tract come in varying
concentrations, one of the lowest being 1.2% (Readi-CAT Suspension by E-Z-EM):
1.2% =1.2gm/100ml =12gm/1000ml
Since barium is 58.84% of barium sulfate, 12 gm x .5884 = 7.06 gm of barium
7.06 gm/1000 ml = 7060 mg/liter
The Toxicity Characteristic for barium is 100mg/l, therefore even dilute solutions of barium
sulfate exceed the toxicity characteristic for barium.
Some hospitals have sent their specific solutions to laboratories and the results have passed the
TCLP. During an inspection, EPA has indicated it may conduct its own TCLP to verify these
results. If a TCLP is not performed, manage waste barium sulfate as a hazardous waste under the
toxicity characteristic.
73
-------
Solids
For solid dosage forms such as creams, tablets or capsules, a dilution ratio of 20 times can be
used, which is an accepted standard for determining the theoretical leaching concentration for
solids. You will need to weigh the tablet or capsule to determine the starting percentage of the
listed chemical in the dosage form. For creams, you can use the percentage of original drug in
the base as given by the manufacturer. If the chemical itself is not listed in the Merck Index,
determine the percentage of the element or chemical by taking the molecular weight, looking up
the atomic weight of each element in the Periodic Table of the Elements, and determining the
appropriate percentage. This can then be applied to the formulation. When you have determined
the mg/Kg concentration, divide by 20 to simulate dilution in a leach bed and convert to mg/L.
The following is an example of a solid calculation for silver sulfadiazine cream:
Evaluation of Silver Sulfadiazine Cream (SSD, Silvadene, Thermazene)
Molecular formula: QoHgAgN^ S
Element
Carbon (C)
Hydrogen
(H)
Silver (Ag)
Sodium (Na)
Oxygen (O)
Sulfur
Totals
Atomic
Weight
12
1
108
23
16
32
Number of
Molecules
10
9
1
4
2
1
Atomic Weight in
Compound
120
9
108
92
32
32
393
Percentage
30.5
2.3
27.5
23
8
8.1
99.4%
The commercial products containing silver sulfadiazine list the concentration as 10 mg/gm. The
concentration of silver in silver sulfadiazine is approximately 27.5%.
lOmg/gm x .275 = 2.75mg/Gm. This must be converted to kg to be comparable to liters, the unit
given in the concentration limits in the regulations.
2.75mg/gm x 1000 = 2750mg/kg. To simulate a 20x dilution, which is assumed in landfill
operations, divide by 20.
2750mg/kg divided by 20 = 173.5 mg/kg which would convert to 173.5mg/l in liquid measure.
The regulatory limit for silver as D011 hazardous waste is 5.0mg/l. Therefore, silver sulfadazine
cream fails the Toxicity Characteristic Leaching Procedure (TCLP) and must be managed as
hazardous waste.
74
-------
Using a Total Constituent Analysis Instead of a TCLP Analysis
Section 1.2 of the TCLP Method 1311 allows for a total constituent analysis in
lieu of the TCLP extraction. If a waste is 100% solid, as defined by the TCLP
method, then the results of the total constituent analysis may be divided by 20 to
convert the total results into the maximum teachable concentration. This factor
is derived from the 20:1 liquid-to-solid ratio employed in the TCLP. If a waste
has filterable liquid, then the concentration of the analyte in each phase (liquid
and solid) must be determined. The following equation may be used to calculate
this value:
[A x B] + [C x D]
= E
B + [20 (I/kg) x D]
Where:
A = Concentration of the analyte in liquid portion of the sample (mg/1)
B = Volume of the liquid portion of the sample (1).
C = Concentration of the analyte in solid portion of the sample (mg/kg)
D = Weight of the solid portion of the sample (kg)
E = Maximum theoretical concentration in leachate (mg/1)
The value obtained (E) can be used to show that the maximum theoretical
concentration in a leachate from the waste could not exceed the concentration
specified in the toxicity characteristic (TC) (40 CFR 261.24). In addition, if the
total constituent analysis results themselves are below the TC limits without
dividing by 20, then the same argument holds true, i.e., the maximum theoretical
concentration in the leachate could not exceed the TC limits.
The full Test Method 1311 TCLP can be accessed at http://www.epa.gov/sw-
846/pdfs/131 l.pdf and Test Methods, TCLP Questions can be accessed at: See
http://www.epa.gov/sw-846/faqs_tclp.htm#Total
75
-------
Appendix C: Sample Pilot Project Training Presentation
Presentation attached - pages 77 - 108 of this document
76
-------
harmaceutical Waste
Pilot Project
orth Memorial Medical Center
Robbinsdale. Minnesota
-------
Overview
Laws governing hospital waste have existed
for years
• The Resource Conservation and Recovery Act
(RCRA) of 1976
• Environmental Protection Agency's Audit
Policy of 12/1995; updated 4/2000
Clean Air Act
Clean Water Act
Community Right to Know Act (EPCRA)
Hospital/Medical/Infectious Waste
Incinerators Rule
-------
Overview
Goal of regs is to prevent harm to
human health and environment
through proper management of
hazardous waste
Recent focus is o
ply to al
healthcare facilities across U.S.
-------
Overview
Regulations enforced by
JCAHO
U.S. Environmental Protection
Agency (EPA^
Minnesota Pollution Control Agency
Hennemn Count
-------
Overview
Healthcare institutes generate 2 million tons
the U.S.
1999-2000 study found pharm & other
organic wastewater contaminates in 139
streams across the US
Concerns about effects of very small amt of
some pharmaceuticals on fetus development
and newborns, causing genital abnormalities
and hormone-related cancers later in life
-------
Overview
Managing pharmaceutical waste is
not new
Focus has been
on mercu
chemotherapy drugs, and waste
reduction
Recent focus is on other hazardous
pharmaceutical waste
-------
Overview
uly 2005
Compliance affects all departments
-------
Why is NM concerned about
azardous Pharmaceutical Was
ast
To protect humans from harm (You an
/* • •« N.
To protect/promote cleaner environment
(ground water, air)
To be a good citizen/steward
To comply with our Code of Conduct re:
complying with applicable regulations
To avoid fines and imprisonment
• $27,000/violation/day
-------
What is Hazardous
Pharmaceutical Waste?
Waste generated in healthcare facilities that include:
Creams/Pastes/
Ointments
Eye drops
Inhalers
IV Bags and tubing
Lotions
Nebulizer containers
PPEs and absorbents used to
cleanup pharmaceutical
spills
Powders
Tablets/Pills
Test strips
Sprays (e.g., throat, nasal)
Syringes
Vials
-------
What is Not Hazardous
Pharmaceutical Waste?
Examples:
• Outside baggies
Unit dose packaging
• Caps from vial
IV and IV tubing not a
drug
• Normal Saline
• Dextrose
• Dextrose with Saline
• Electrolytes
• Lactate Ringers
Put remaining fluid down
the drain if needed then
put bag/tubing into
regular waste
-------
What does it mean to me?
ate
wast
Change where drug waste is disposed
Will have additional waste
streams/containers
-------
Process: Hazardous
Pharmaceutical Waste
Pharmacy will identify these
items for you
• When possible, a BLACK label S
will be put on item/bag QDP^IAI
IAL DISPOSAL
REQUIRED
Pyxis
• Floor will need to add labels if
adding drugs
When not possible, message will
appear in Pyxis to alert you of the
special disposal requirement (like
other pop up messages )
Special Disposal Required
-------
Process: Hazardous
Pharmaceutical Waste
2 Kinds/Locations
i Haz Pharmaceutical Waste w/o
Sharps
• By Pyxis
i Haz Pharmaceutical Waste w/
Sharps [Dual Waste]
• One by Pyxis
• One on Crash Carts (ICUs)
^^^^
/
-------
Process: Hazardous
Pharmaceutical Waste
Container for Hazardous
Pharmaceutical Waste without Sharps
by Pyxis
RCRA HAZARDOUS|
WASTE
Accumulation Start Date:
-------
Process: Hazardous
Pharmaceutical Waste
Labeling
Container for Hazardous
Pharmaceutical Waste with
Sharps
• By Pyxis
i On Crash Cart
BIOHAZARD
BIOHAZARDOUS
AND
RCRA HAZARDOUS
WASTE
Accumulation Start
Date:
-------
Process: Hazardous
Pharmaceutical Waste
Record on log what is put into container
• Write date placing into container
• Check type of drug (or write in if not on log)
• Check type of container/form (e.g., tablet,
paste)
• Write in estimated amount (e.g., # of pills, # of
-------
NM
Hazardous
Pharmaceutical
Waste Log
A
a I T ; T j
rbjrnucmiicMT Wulc lH>tnh>n
OMtCilUllMrllldMHli
I
3. rhY i fhfrt | Vjinlhnnljiin irittfipilniriirrillrilTinTrrn»nrT Miur MimJ^nvvcf !«|
' E9IBHB SMIIFj Trnwn«E
-------
>ur III MI.-HWM l«l
Pharmaceutical VtuHt latemtnry Lo§
ian CwUtlHM p III, '"I
«1 fc ml nun
remuiulM n ci
lkil Hunlrtar "VBtit.! [Mm Mil"
Uri ir.ol i»nj
fel«rt|>« ir hiirl ,1 r,;lijlnJ
t^irn / C«nlMl«fr far
-------
Pharmaceutical Waste Containers
BLACK Hazardous Pharmaceutical Waste
Container
• Will be picked up and replaced by Special
Will pick up log at same time
Need more containers before scheduled pick
up, call Environmental Services (ext. 5653)
Container and log must be removed together.
-------
Process: Non-Hazardous
Pharmaceutical Waste
Go in WHITE container with
WHITE label
Containers Location
One in each patient1 s
bathroom
One in each ICU patient's
room
Labeled as "Non-Hazardous
Pharmaceutical Waste Only"
CAUTION:
NON-HAZARDOUS
PHARMACEUTICAL WASTE
-------
Process: Handling of Non-
Hazardous Pharmaceutical Waste
ntamers
WHITE Non-Hazardous Waste
• Will be picked up by
Environmental Services staff
• Will be put into WHITE Bin in
Soiled Utility Room
NM Sanitation
sta
-------
North Memorial Pilot Study Pharmaceutical Waste Streams
Hazardous Pharm Waste
BLACK Label or Pyxis Disposal Instructions
"Special Disposal Required"
Labeled
Hazardous Rx
Waste
Pyxis Labeled
Hazardous Rx
Waste
BLACK Hazardous
Pharm Waste
Container
Labeled
Hazardous
Pharm Waste
with Sharps
Complete
Waste Log
BLACK.
Hazardous
Pharm
Waste W/
Sharps
Non-Hazardous
Pharm Waste
No BLACK
Label or Pyxis
Special Disposal
Required
Message
WHITE
Non-
Hazardous
Pharm
Container w/
WHITE bag
Regular Waste
No BLACK
Label or Pyxis
Special Disposal
Required
Message
Examples:
•Outside baggy
• Unit Dose Packaging
• IV and tubing
- Saline
- Dextrose
- Dextrose w/ Saline
- Electrolytes
- Lactate Ringer
Regular
Trash
Container w/
Clear Bag
Procedures NOT
Changing
•Safe pharmaceutical
handling and admini-
stration practices &
policies
•Handling of Narcotics
•Handling of Chemo-
therapy Drugs/Waste
•Removing patient in-
formation before
disposal of items
•Use of pill crusher
•Draining of non-
drug TV's before
disposal (Saline,
Dextrose, Dextrose
with Saline, Electro-
lytes, Lactate Ringer)
then in regular clear
bag waste
-------
What to do in case of a Spill or
Wipe up with paper towe
Put absorbent material and PPE's used
to cleamm soill into orooer waste
CO
Write on Hazardous Pharmaceutical
Waste Log as appropriate
-------
What's Next
Your area is part of pilot
• 5th floor, Float Unit
Pilot starts 0700 o
Februa
-------
Goals of Pilot
-I!!!!
Test/im
Before further rollout
Evaluate containers
• Size
Location
Ease of Use
Number
-------
Goals of Pilot
nd hazardous pharmaceutical wast
we generate
&
Determine costs
Determine best practices
Identify additional applicable
-------
Resources
Each area has Waste Master
Area Resource Educator and Clinica
Nurse Specialist
members
Job aids/posters
-------
Resources
erry rm
Questions ext. 1395
• Emergency pager: 612-530-1203
• DoorNotes (Chart on back door of
Conference Room)
• De-brief sessions
List of applicable drugs for pilot
-------
After Pilot
Education Expo
Will rollout floor-by-floor
Must be in compliance by July 2005
-------
-------
-------
Pilot Project Task Team Members
Paul Anderson, Psihos & Assoc.
Melody Boll, Resource Educators
Emily Clarkin, TNICU
Carol Droegemueller, CNS
Jerry Fink, Regulated Waste
Coordinator
Ken Graner, Manager, Float Team
Bill Kelsey, Psihos & Assoc.
Carol Kilian, Resource Educator
John Kuzma, Security Officer
Nora Lehti, Nurse Manager, Ortho
Deb McConnell, Nurse Manager,
MSICUl
Cindy Schuvieller, CNS
John Simpson, SWDI, Inc.
Lola Stapel, Education Coord.
Dennis Thelen, Manager, Pharm
Jane VanDeusen-Morrison, CNS
Lori Wildman, Nurse Manage?
TNICU
Mary Winger, RN, Ortho
Judy Zak, Manager, Neuro
-------
STATE
REQUIREMENTS
You may be regulated
both by your state
hazardous waste agency
and EPA. RCRA allows
states to receive legal per-
mission, known as author-
ization, to implement the
RCRA hazardous waste
program. "Vbu must always
contact your state authori-
ty to determine which
state requirements apply to
your business.
To operate a hazardous
\vaste program, a state's
regulations must be con-
sistent with, and at least as
stringent as, the federal
program. Some states
adopt more stringent
requirements for facilities
handling hazardous waste,
which are considered part
of the authorized program.
FREQUENTLY ASKED
QUESTIONS ABOUT RCRA
What Is RCRA?
The Resource Conservation and Recovery Act (RCRA) is a federal law that encourages
environmentally sound methods for managing commercial and industrial waste as well as
household and municipal waste. It regulates facilities that generate, transport, treat, store, or
dispose of hazardous waste. Most healthcare facilities are considered hazardous waste generators.
The term "RCRA" is often used interchangeably to refer to the law, the regulations, and EPA
policy and guidance. The law describes the waste management program mandated by Congress that
gave EPA authority to develop the RCRA program. EPA regulations carry out the Congressional
intent by providing explicit, legally enforceable requirements for waste management. EPAguidance
documents and policy directives clarify issues related to the implementation of the regulations.
All of the RCRA hazardous waste regulations can be found in the Code of Federal Regulations
(CFR), Title 40, Parts 260 to 280. The CFR can be purchased through the U.S. Government
Printing Office (GPO) or is available online at http://\vww.access.gpo.gov/nara/cfr/
cfr-table-search.html.
Who Is Regulated?
Any healthcare facility that generates solid waste is potentially subject to RCRA. ^Cou must
conduct tests required by the regulations or use your knowledge of and familiarity with the
waste you generate to determine whether it is hazardous waste (as opposed to other types of
waste). "Vbu might be subject to substantial civil and criminal penalties if you fail to properly
or completely identify hazardous waste generated by your business.
What Is Hazardous Waste?
To be considered hazardous waste, a material first must be classified as a solid waste. EPA
defines solid waste as garbage, refuse, sludge, or other discarded material (including solids,
semisolids, liquids, and contained gaseous materials). If your waste is considered solid waste, you
must then determine if it is hazardous waste. Wastes are defined as hazardous by EPA if they are
specifically named on one of four lists of hazardous wastes (listed wastes) or if they exhibit one of
four characteristics (characteristic wastes). Each type of RCRA hazardous waste is given a unique
hazardous waste code using the letters D, F, K, P, or U and three digits (e.g., D001, F005, P039).
Listed Wastes. Wastes are listed as hazardous because they are known to be harmful to human
health and the environment when not managed properly, regardless of their concentrations. The
lists include the following three types of waste:
• Non-Specific Source Wastes. These are material-specific wastes, such as solvents, generated
by several different industries. Waste codes range from F001 to F039. Examples of healthcare
facility wastes that fit this category are solvents often used in research laboratories, pharmacies,
and morgues, such as methanol, acetone, and methylene chloride.
• Specific Source Wastes. These are wastes from specifically identified industries. Waste codes
range from K001 to K161. Healthcare facilities typically do not produce specific source wastes.
• Discarded Commercial Chemical Products. Off-specification products, container residuals,
spill residue runoff, or active ingredients that have spilled or are unused and that have been,
or are intended to be, discarded. Waste codes range from P001 to P205 and U001 to U411.
Examples of healthcare facility wastes that fit into this category are epinephrine (P042), ethylene
oxide (U115), certain expired pharmaceuticals, etc.
-------
Characteristic Wastes. Even if your waste does not appear on one of the hazardous waste lists, it
still might be regulated as hazardous waste if it exhibits one or more of the following characteristics:
• Ignitability. Ignitable wastes create fires under certain conditions or are spontaneously
combustible, and have a flash point less than 60 °C (140 °F) or are oxidizers. Two examples are
rubbing alcohol and paregoric. The waste code for these materials is D001.
• Corrosivity. Corrosive wastes are acids or bases that are capable of corroding metal containers,
such as storage tanks, drums, and barrels. One example is compounding with glacial acetic acid
or sodium hydroxide (with pH <2 or >12.5). The waste code for these materials is D002.
• Reactivity. Reactive wastes are unstable under "normal" conditions. They can cause
explosions, toxic fumes, gases, or vapors when mixed with water. Examples include picric
acid, lithium-sulfur batteries, and explosives. The waste code for these materials is D003.
• Toxicity. Toxic wastes are harmful or fatal when ingested or absorbed. When toxic wastes are
disposed of on land, contaminated liquid may drain (leach) from the waste and pollute ground
water. Toxicity is defined through a laboratory procedure called the Toxicity Characteristic
Leaching Procedure (TCLP). Toxic healthcare wastes include chloroform, lindane, m-cresol,
mercury and mercury compounds (thimerosal), and certain metals (such as arsenic and
barium). The waste codes for these materials range from D004 to D043.
What Is Universal Waste?
There are four types of universal waste: hazardous waste batteries, hazardous waste pesticides
that are recalled or sent to a collection program, mercury-containing thermostats, and spent
fluorescent lamps and other hazardous lamps (e.g., with mercury or lead). EPA created the
Universal Waste Rule (40 CFR §273) in May 1995 to encourage and streamline recycling. Labeling
and storage requirements are less stringent than for hazardous waste. This allows hospitals to more
easily recycle batteries, thermostats, and fluorescent lamps. The universal waste rule does not apply
if state requirements are more stringent, or if waste crosses into more stringent states. For New
"Vbrk, Puerto Rico, and the U.S. Virgin Islands, federal rules apply. New Jersey has state universal
\vaste laws that include recycling of computer monitors.
How Are Generators Regulated?
If your healthcare facility generates hazardous waste, you must manage it according to
regulations for your specific generator type. Hazardous waste generators are divided into three
categories, according to how much they generate in a calendar month:
• Large Quantity Generators (LQGs). LQGs generate greater than or equal to 1,000 kg
(approximately 2,200 Ibs) of hazardous waste per month, or greater than 1 kg (approximately
2.2 Ibs) of acutely hazardous waste per month.
• Small Quantity Generators (SQGs). SQGs generate greater than 100 kg (approximately
220 Ibs) but less than 1,000 kg of hazardous waste, and/or 1kg (approximately. 2.2 Ibs) of
acutely hazardous waste per month.
• Conditionally Exempt Small Quantity Generators (CESQGs). CESQGs generate less
than or equal to 100 kg of hazardous waste per month, and less than or equal to 1 kg of acutely
hazardous waste per month.
RCRA defines acute waste as P-listed wastes. Some states do not recognize the CESQG class.
Contact your state environmental agency to find out if the CESQG status is recognized. To find
your appropriate state contact, call the RCRA Hotline at 800 424-9346. In Region 2, New
Jersey, Newark, Puerto Rico, and the U.S. Virgin Islands all recognize the CESQG class.
MORE
QUESTIONS?
Call the RCRA
Hotline at
800 424-9346 or TDD 800
553-7672 for additional
information about RCRA
rules and regulations. In
the Washington, DC, area,
call 703 412-9810 or TDD
703 412-3323.
AM I
REGULATED BY
RCRA OR
SUPERFUND?
[CRA regulates the
treatment, storage,
and disposal of hazardous
waste being generated
now and in the future.
Superfund was created to
pay for the identification,
inspection, investigation,
ranking, and cleanup
of abandoned or uncon-
trolled hazardous waste
sites that people responsi-
ble for
contamination are unable
or unwilling to clean up.
Call the RCRA Hotline
for more information.
-------
More on Generator Status
Under the federal RCRA requirements, your generator status might change from one month
to the next as the quantity of waste you generate changes. State requirements vary widely. "Vbu
must comply with whichever standard is applicable for a given month. In many cases, small
businesses that fall into different generator categories at different times choose to always satisfy the
more stringent requirements (usually state requirements) to simplify compliance. Generators must
"count" the amount of waste generated, which involves adding up the total weight of all quantities
of characteristic and listed waste generated at a particular facility. Certain wastes, such as those that
are reclaimed or recycled continuously on site, are not counted under the federal regulations but
might be counted under some state regulations.
Do Exclusions Exist?
The RCRA regulations contain many exclusions for wastes and waste management practices
that are not considered to be hazardous. Several exclusions and exemptions pertain specifically to
healthcare facilities. Some states, however, do not recognize the federal exclusions.
Exclusions and Exemptions Description
Nitroglycerine Formulation
Reverse Distribution of
Pharmaceuticals
(see page 11)
Domestic Sewage Exclusion
As of August 14, 2001, federal policy exempted
nitroglycerine formulations for hospital use.
Waste and expired pharmaceuticals shipped to reverse
distributors may be exempt from hazardous •waste regulations.
The materials may be shipped as product instead of •waste.
Point Source
Discharge Exclusion
Wastewater Treatment Unit
Exemption
Elementary Neutralization Unit
Exemption
Mixtures of domestic sewage and other •wastes that pass
through a sewer system to a publicly owned treatment
•works (POTW) for treatment are excluded from the defini-
tion of solid •waste. Generators are encouraged to contact
their local POTW for prior approval.
Point source discharges of industrial •waste •waters that are
subject to regulation under §402 of the Clean Water Act are
excluded from the definition of solid •waste.
Any hazardous •waste tank system used to store or treat the
wastewater that is managed at an onsite wastewater treat-
ment facility •with a National Pollutant Discharge
Elimination System (NPDES) permit or that discharges to a
POTW is exempt from the RCRA regulations.
Tanks used for neutralizing •waste that is hazardous solely
because of its corrosive characteristic are excluded from the
permitting requirements. Waste treated in these units is not
considered hazardous •while in the units.
De Minimis Exclusion
Small quantities of some solvents and other chemicals are
exempt from the regulations •when they are mixed •with
•wastewater in a wastewater treatment system discharging
according to the Clean Water Act.
Epinephrine Syringes
Federal policy exempted epinephrine syringes for hospital use.
-------
EXAMPLES OF HEALTHCARE
WASTE GENERATION
WASTE
GENERATED
PHARMACY
RADIOLOGY
ONCOLOGY
DIALYSIS
DENTAL
CLINIC
GASTRO-
ENTEROLOGY
MORGUE
MATERIALS
MANAGEMENT
PRINTING
BIOMEDICAL
ENGINEERING
Examples of Healthcare Solid Waste Generation
Paper
Non-returnable drums
Normal palettes
Construction and demolition debris (which can also be hazardous)
Examples of Healthcare Hazardous Waste Generation
Solvents and acids: thimerosals, methiolate, other mercury compounds, cumedin, methanol
(U154), picric acid (D003). Expired Pharmaceuticals (if not returned to the manufacturer
under "reverse distribution"): see the sidebars on pages 9 and 10.
Silver, lead aprons
Lead pigs and aprons.
Chemotherapy drugs: Chlorambucil (Leukeran), Cyclophosphamide, Daunomycin,
Melphalan, Mitomycin C, Streptozotocin, Uracil Mustard, and Arsenic Trioxide (P012).
See also the sidebars on pages 9 and 10
Formaldehyde (U122)
Bitewings (contain lead)
Cresol
Amalgam (contains mercury)
Other mercury-containing items (fillings)
Lead aprons
Lead shielding removed during renovation
Gl tubes (used to expand esophagus, contain mercury)
Formaldehyde (U122), picric acid (D003)
Bouin's solution (contains picric acid mixed with methanol (U154) and formaldehyde)
Ethyleneoxide(ETO)(U115)
Acrylonitrile (U009)
More chemicals are listed on the sidebars on pages 9 and 10.
Inks for forms and menus
Defibrillators (mercury)
Pacemakers (mercury)
Aerosol cleaners
Scintillation counters (lead and mixed waste)
Lead shields
Other components or equipment which must be dismantled and analyzed before disposal
may contain additional hazardous waste. Note: Batteries may be covered by the Universal
Waste Rule.
-------
Healthcare Hazardous Waste Generation (continued)
MEDICAL
MONITORING/
COMPUTER
SERVICES
LABORATORIES
OPERATING
ROOMS
FACILITY
ENGINEERING
HOUSEKEEPING/
CLEANING
WASTE
GENERATED
HAZARDOUS
WASTE ROOM
SATELLITE
ACCUMULATION
Thermometers (mercury)
Sphygmomanometers (mercury)
Computers, computer monitors, batteries, and other electrical equipment
Note: Batteries may be covered by the Universal Waste Rule.
Solvents and acids (see sidebars page 9 and 10).
Scintillation counters (lead and mixed waste)
Electronics
Lead shields
Disinfectants (see sidebars on pages 9 and 10)
Anesthetic for humans or animals (fluoroethanes, haloethanes)
Osmium tetroxide (P087)
Picric acid (D003)
Mercury fixatives
Cacodylic acid (U136)
See also the sidebars on pages 9 and 10.
Paint
Mercury and mercury compounds
Lamps (may contain mercury)
Chlorofluorocarbons (CFCs)
Paint thinners (contain solvents)
Solvent-based glues
Asbestos
Note: Lamps may be covered by the Universal Waste Rule
Phenolic cleaners
Bleaches
Caustics
Example of Healthcare "Red Bag" Waste Generation
Human/animal pathological waste
"Sharps"
Blood and blood products
Isolation wastes
Example of Healthcare Hazardous Waste Management Practices
Proper engineering controls (berm, secondary containment)
Chemical storage by compatibility
Weekly inspections
Communications system
Accumulation dates
Gas cylinders (like oxygen) stored correctly with compatible materials
Satellite collection: transfer materials within required time period.
-------
OTHER ENVIRONMENTAL LAWS
AFFECTING HEALTHCARE
FACILITIES
OCCUPATIONAL SAFETY AND HEALTH ACT
The Occupational Safety and Health Act (OSHA) was enacted by Congress to require employers
to provide workplaces free from serious recognized hazards and compliance with occupational safety
and health standards. OSHA protects healthcare workers from diseases such as the hepatitis B virus
and the human immunodeficiency virus (HIV) through regulation of bloodborne pathogens. OSHA
also requires healthcare workers to wear proper personal protective equipment and to use safe han-
dling procedures. Many additional chemicals used by healthcare facilities may be considered haz-
ardous chemicals as defined by OSHA. Contact your local OSHA office if you have questions about
whether the chemicals used in your healthcare facility are considered hazardous under OSHA.
OSHA Resources:
• Internet access: www.osha.gov and www.osha.gov/SLTC/etools/hospitaVmainpage.html
THE FORMER MEDICAL WASTE TRACKING ACT
The Medical Waste Tracking Act of 1988, which has since been rescinded but revived through
Title 40 CFR Part 60, was part of a demonstration project to regulate national medical and infectious
waste (also known as "red bag" waste) and provided standards for separating, packaging, and labeling
red bag waste. This ruling also regulates air quality and emissions from incinerators of medical/infec-
tious waste incinerators or "HMIWIs" (see Clean Air Act). Since red bag waste is mainly regulated on
a state-level, healthcare facilities can find further information from their state environmental agencies.
Medical Waste Tracking Act Resources:
• State environmental agencies: www.h2e-online.org/tools/map.htm
NUCLEAR WASTE POLICY ACT
As a result of the Nuclear Regulatory Waste Policy Act, EPA and the Nuclear Regulatory
Commission (NRC), among other agencies, oversee the storage and disposal of all commercially
generated radioactive medical and infectious waste. Many healthcare facilities generate low-level
radioactive waste as a by-product of administrating radiopharmaceuticals, radioimmunology and
nuclear medicine procedures.
NRC Resources:
• Internet access: www.nrc.gov/waste.html
THE EMERGENCY PLANNING AND COMMUNITY RIGHT-TO-KNOW ACT
The Superfund Amendments and Reauthorization Act (SARA) of 1986 created the Emergency
Planning and Community Right-to-Know Act (EPCRA). This law was designed to improve com-
munity access to information about potential chemical hazards and to facilitate the development
of chemical emergency response plans by state and local governments. The EPCRA regulations
establish several types of reporting obligations for facilities that store or manage specified chemicals.
Hospital facilities are exempt from EPCRA Section 313 (the Toxic Release Inventory) unless they
are federal facilities, but they are subject to all other EPCRA requirements. Certain notification
requirements apply to healthcare facilities that use or store extremely hazardous substances, such
as chemotherapy agents and ethylene oxide (ETO).
CFR GUIDE TO
HAZARDOUS
WASTE
REGULATIONS
To review the RCRA
regulations referred
to in this document, con-
sult the following citations
in 40 CFR:
Part 260—Hazardous
waste management sys-
tem: general.
Part 261—Identification
and listing of hazardous
waste.
Part 262—Standards
applicable to generators of
hazardous waste.
Part 263—Standards
applicable to transporters
of hazardous waste.
Part 264—Standards for
owners and operators of
hazardous waste and spe-
cific types of hazardous
waste management facili-
ties.
Part 265—Interim status
standards for owners and
operators of TSDFs.
Part 266—Standards for
the management of
specific hazardous wastes
and specific types of haz-
ardous waste management
facilities.
-------
CFR GUIDE
continued
Part 268—Land disposal
restrictions.
Part 270—EPA adminis-
tered permit programs:
the Hazardous Waste
Permit Program.
Part 272—Approved state
hazardous waste manage-
ment programs.
Part 273—Standards
for universal waste
management.
Part 279—Standards
for the management of
used oil.
Part 280—Standards
for the management of
Underground Storage
Tanks (USTs)
EPA'S LIST OF
LISTS
This consolidated
compilation of
chemicals lists those that
are regulated under
EPCRA and Section
112(r)oftheCAA. It
also has a list of the
"Unlisted Hazardous
Wastes" of RCRA: the
D- and F-type wastes.
See http://www.epa.gov/
ceppo/pubs/title3 .pdf.
EPCRA Resources:
• 40 CFR Parts 350 to 372
• The State Emergency Response Commission (contact available from RCRA Hotline)
• Internet access: www.epa.gov/tri and www.epa.gov/oswer/hotline/epara.htm
THE CLEAN AIR ACT
The Clean Air Act (CAA) regulates air pollution. It includes national emission standards for
new stationary sources within particular industrial categories. It also includes national emission
standards, which are designed to control the emissions of particular hazardous air pollutants
(HAPs). The CAA seeks to prevent the accidental release of certain hazardous chemicals and to
minimize the consequences of such releases. At hospitals, air emissions come from four primary
areas: air conditioning and refrigeration, boilers, medical waste incinerators, and asbestos. Internet
links with more information on these four areas are listed below.
CAA Resources:
• 40 CFR Parts 50 to 99
• Control Technology Center, Office of Air Quality, Planning and Standards, EPA, general
information: 919 541-0800, publications: 919 541-2777
• Internet access: www.epa.gov/ttn/catc
• Region 2's Air Conditioning and Refrigeration Web Site: http://www.epa.gov/region02/cfc/
• EPA's Asbestos Web Site: http://www.epa.gov/asbestos/
• EPA's AirToxics Website (Rule/Implementation Info for Hospital/Medical/Infectious Waste
Incinerators): http://www.epa.gov/ttn/atw/129/hmiwi/rihmiwi.html
• EPA's AirToxics Website (Rule/Implementation Info for Industrial/ Commercial/Institutional
Boilers and Process Heaters): http://www.epa.gov/ttn/atw/boiler/boilerpg.html
THE CLEAN WATER ACT
The Water Pollution Control Act, commonly known as the Clean Water Act (CWA), is the
federal program designed to restore and maintain the integrity of the nation's surface waters.
CWA controls direct discharges to surface waters (e.g., through a pipe) from industrial processes
or stormwater systems associated with an industrial activity. It also regulates indirect discharges,
or discharges to POTWs, through a public sewer system. EPA established effluent limitations for
hospitals with greater than 1,000 beds that discharge directly (for biochemical oxygen demand,
total suspended solids, and pH). Hospitals that discharge to POTWs are subject to general
standards that prohibit discharges that interfere with proper POTW operation. Hospitals should
coordinate with their local POTW to ensure that what they pour down the drain does not inter-
fere with POTW operation. Private hospitals are not required to have permits for storm water
discharges unless they are operating a construction site covering greater than 1 acre. Public hospi-
tals in urbanized areas must apply for a Phase II storm water permit or otherwise comply with
Phase II storm water requirements, because they are considered municipal separate storm sewer
systems (MS 4s).
CWA Resources:
• 40 CFR Part 460 (direct discharges with > 1,000 beds)
• 40 CFR Part 403 (all indirect discharges)
• 40 CFR Part 122 and 123 (stormwater discharges)
• Internet access: http://www.epa.gov/npdes
• EPA Office of Water: 202 564-5700
• "Vbur state water authority, regional EPA office, and local POTW
• http://cfpub.epa.gov/npdes/stormwater/swfinal.cfm
8
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Oil Pollution Prevention Under the CWA
The Oil Pollution Prevention regulations were promulgated under the authority of the CWA.
These regulations establish requirements for facilities to prevent oil spills from reaching the navigable
•waters of the United States or adjoining shorelines. The regulations apply to non-transportation-relat-
ed facilities with a specific aboveground or underground oil storage capacity that, because of their
location, can reasonably be expected to discharge oil into the navigable waters of the United States.
Under Oil Pollution Prevention regulations, hospitals with an oil storage capacity of greater than
1,320 gallons, or total completely buried oil storage capacity greater than 42,000 gallons must prepare
and implement a Spill Prevention, Control, and Countermeasure Plan (SPCCP). Facilities with
underground storage tanks (USTs) already regulated by federal UST guidelines and storage contain-
ers less than or equal to 55 gallons are exempt from storage capacity determination for SPCCPs.
Oil Pollution Prevention Regulation Resources:
• 40 CFR Part 112
• Internet access: www.epa.gov/oilspill
COMPREHENSIVE ENVIRONMENTAL RESPONSE, COMPENSATION,
AND LIABILITY ACT (CERCLA OR SUPERFUND)
The Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA) of
1980, commonly known as Superfund, authorizes EPA to respond to releases, or threatened releases,
of hazardous substances that might endanger public health, welfare, or the environment, that might
come from any source. Superfund also grants EPA the authority to force parties responsible for envi-
ronmental contamination to clean it up or to reimburse response costs incurred by EPA. The most
important part of this act applicable to healthcare facilities is the hazardous substance release report-
ing requirement. The person in charge at your business must report to the National Response
Center (phone: 800 424-8802) any release of a hazardous substance that exceeds a designated
"reportable quantity" for that substance within a 24-hour period.
Superfund Resource:
• Internet access: www.epa.gov/superfund
SAFE DRINKING WATER ACT
The Safe Drinking Water Act (SDWA) mandates that EPA establish regulations to protect
human health from contaminants present in drinking water. Under the authority of SDWA, EPA
developed national drinking water standards and created a joint federal-state system to ensure
compliance with these standards. EPA also regulates underground injection of liquid wastes under
the SDWA to protect underground sources of drinking water, including any hospital discharges to
a septic system, drywell, or other type of Class V Shallow Well. Hospitals and doctors' offices must
make sure that what they pour down a drain goes to a sewer, not a drywell or septic system. These
devices are regulated by the underground injection control (UIC) program of the SDWA.
SDWA Resources:
• 40 CFR Parts 141 to 148
• SDWA Hotline: 800 426-4791
• Internet access: www.epa.gov/ogwdw
• Internet access: www.epa.gov/safewater/dwa/electronic/uic.html
COMMON
U-LISTED
HOSPITAL
WASTE
(Note: This list is not
exhaustive, but lists wastes
commonly seen in hospitals,
especially pharmacies.)
2-Chloroethyl Vinyl Ether
(U042)
3-Methylchloranthrene
(U157)
Acetone (U002)
Acetyl Chloride (U006)
Acrylonitrile (U009)
Aniline (U012)
Azaserine (U015)
Bromoform (U225)
Cacodylic Acid (U136)
Carbon Tetrachloride
(U211)
Chloral Hydrate (U034)
Chlorambucil (U035)
Chlornaphazin (U026)
Chloroform (U044)
Creosote (U051)
Cresols (U052)
Cyclophosphamide (U058)
Daunomycin (U059)
Dichlorobenzenes (U070,
U071, U072)
Diethylstilbesterol (U089)
Ethyl Acetate (Ul 12)
Ethyl Carbamate (U238)
Ethyl Ether (Ul 17)
Ethylene Oxide (Ul 15)
Formaldehyde (U122)
Formic acid (U123)
Hexachloroethane (U131)
Hexachlorophene (U132)
Lindane (U129)
Maleic Anhydride (U147)
Melphalan (U150)
Mercury (U151)
Methanol/Methyl alcohol
(U154)
Methylpyrilene (U155)
Methylthiouracil (U164)
Mitomycin C (U010)
Naphthalene (U165)
N-butyl alcohol (U031)
Paraldehyde (U182)
p-Chloro-m-Cresol
(U039)
Phenacetin (U187)
Phenol (U188)
Reserpine (U200)
Resorcinol (U201)
-------
COMMON
U-LISTED
HOSPITAL
WASTE
(CONTINUED)
Saccharin (U202)
Selenium sulfide (U205)
Streptozotocin (U206)
Tetrachloroethylene
(U210)
Thiram (U244)
Trichloroethylene (U228)
Uracil mustard (U237)
Warfarin < 0.3% (U248)
COMMON
P-LISTED
HOSPITAL
WASTE
(Note: This list is not
exhaustive, but lists
P-wastes commonly seen in
hospitals, especially
pharmacies.)
3-Benzyl Chloride (P028)
Arsenic (P012)
Arsenic Trioxide (P012)
Chloropropionitrile (P027)
Cyanide Salts (P030)
Epinephrine (P042)
Nicotine (P075)
Nitroglycerin (P081)*
Osmium Tetroxide (P087)
Phentermine (P046)
Phenylmercuric Acetate
(P092)
Physotigmine (P204)
Physotigmine salicylate
(P188)
Potassium Silver Cyanide
(P099)
Sodium Azide(P 105)
Strychnine (P108)
Warfarin > 0.3% (P001)
^Unless the state adopted
the 2001 federal
exemption for nitroglycer-
ine formulations.
TOXIC SUBSTANCES CONTROL ACT
The Toxic Substances Control Act (TSCA) allows EPA to collect data on chemicals to evaluate,
assess, mitigate, and control risks that might be posed by their manufacture, processing, and use.
Healthcare facilities may be affected by some of the TSCA requirements.
TSCA Resources:
• 40 CFR Parts 702 to 799
• TSCA Hotline: 202 554-1404
• Internet access: www.epa.gov/oppts/
LEAD-BASED PAINT DISCLOSURE
Under the Residential Lead-Based Paint Hazard Reduction Act of 1992, sellers, landlords, and
agents must provide purchasers and tenants with an EPA-approved lead hazard information pamphlet
for housing built before 1978. If a hospital has housing on grounds (such as for attending physicians)
that was built before 1978, they must provide lead-based paint disclosure pamphlets to all residents.
Any contract to rent housing that was built before 1978 must also include or have attached to it a lead
warning statement that describes the landlord or agent's responsibilities and the renters' rights.
Lead-Based Paint Resources:
• http://www.hud.gov/officesAead/disclosurerule/index.cfm
• http://www.epa.gov/Region2Aiealth/leadpoisoning.htm
FEDERAL INSECTICIDE, FUNGICIDE, AND RODENTICIDE ACT
The Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) provides federal control
of pesticide distribution, sale, and use. EPA has authority under FIFRA not only to study the
consequences of pesticide usage but also to require users (healthcare facilities, farmers, utility
companies, and others) to register when purchasing pesticides.
FIFRA Resources:
• Internet access: www.epa.gov/pesticides/regulating/index.htm
MOST COMMON HOSPITAL
HAZARDOUS WASTE
VIOLATIONS
• Labeling of FEW not done or incorrect
• Not conducting proper weekly inspections of FEW storage
• Improper disposal of chemotherapy drugs
• FEW determination not done or incorrect
• No or inadequate FEW manifest
• Throwing FEW down the drain
• Improper management of expired pharmaceutical, paints, etc.
• Lack of contingency plan
• Lack of or inadequate training for employees in FEW management
• Failure to ensure that FEW meets Land Disposal Restrictions
• Failure to upgrade or close USTs by 12/22/1998
• Improper consolidation of wastes from nearby facilities
10
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BEST MANAGEMENT
PRACTICES
CHEMOTHERAPY DRUGS
Although only 8 chemotherapy drugs are currently listed as specific RCRA hazardous waste,
it is best to handle all chemotherapy drugs the same way. It simplifies training staff to handle
chemotherapy waste properly and ensures that personnel properly protect themselves. See
www.h2e-online.org.
EXPIRED PHARMACEUTICALS
One way to simplify handling outdated pharmaceuticals is by using reverse distribution. There
are close to 40 organizations that will take outdated pharmaceuticals, reprocess them when possible,
and properly discard them if they cannot be used. The reverse distribution process minimizes the
amount of pharmaceuticals that are needlessly discarded and maximizes the proper disposal of non-
hazardous and hazardous waste. Reverse distribution may enable facilities to ship expired pharma-
ceutical as product, instead of waste. More information is available at the Returns Industry
Association web page (http://www.returnsindustry.com).
TOP DOWN POLICY MAKING
The hospitals with the best environmental compliance records and minimized hazardous waste
have top management commitment and support. If management commitment is seen as lacking,
environmental concerns will not receive the priority they deserve. Top management should clearly
communicate (both internally and externally) their commitment to a cleaner environment by:
• establishing a written environmental policy that includes a commitment to compliance with
applicable federal, state, and local environmental regulations, continuous improvement in envi-
ronmental performance, pollution prevention, and public outreach/community involvement:
• providing adequate resources to meet the above commitments, including skilled personnel,
technology, and financial resources:
• designating a "Green Team" that consists of staff throughout the hospital (e.g., nurses, doctors,
housekeeping, purchasing, laboratory managers, infection control staff, etc.) that will always be
on the look out for ways to reduce packaging; provide safer materials for patients, staff, and the
environment; reduce the amount of toxic materials used; purchase recycled goods; and reuse
items rather than using disposable products; and
• reviewing and evaluating (at least annually) the hospital's progress toward environmental
excellence and making any necessary changes to procedures/ policies.
REGULAR SELF-AUDITS
Hospitals should have a comprehensive compliance audit performed at their facility by an
independent auditor at least every three years to ensure that they have adequate systems in place to
maintain compliance. If violations are found, hospitals should consider taking advantage of EPA's
audit policy to reduce or eliminate accompanying violations. Information on our policy can be
obtained from EPA Region 2's compliance incentives website at www.epa.gov/region02/capp/cip.
GOOD EMPLOYEE TRAINING
Training employees about environmental management is important for two reasons
• Every employee can impact the environment. They need to know how their actions
can affect the hospital's environmental performance and how to perform their work to
prevent or mitigate the occurrence of environmental incidences
• Trained staff are more likely to offer suggestions on how the hospital can improve its
environmental management program.
POLLUTION
PREVENTION
TIPS
Only buy what you
need. "Vbu will store
less waste and have less
expired pharmaceuticals.
BEST
MANAGEMENT
PRACTICES
For more information
on these and other best
management practices for
healthcare facilities, call the
EPA Region 2 Compliance
Assistance Hotline at
(212) 637-4050 or visit
www.epa.gov/region02/
healthcare. Additional
resources are on Page 14.
11
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WHAT IS ENVI-
RONMENTALLY
PREFERABLE
PURCHASING
(EPP)?
Environmentally
Preferable
Purchasing (EPP) means
you buy products that
don't contain hazardous
waste and minimize envi-
ronmental impact, includ-
ing products that are:
• Mercury free and
non-toxic (or less toxic)
• Recyclable or made of
recycled material
• Packaged with less
packing
• Energy Efficient
• Reusable
• Durable
• Safer for patients, work-
ers, and the environment
c
Jertain cleaners,
copiers, and other
electronic equipment are
easier on the environment
than others. For more
information on EPP
in general, visit
http ://www.epa.gov/oppt/
epp. For hospital-specific
EPP information, see
http ://www.h2e-
online.org/tools/
grnpurch/epp .htm.
Remember to train employees on a continuous basis to keep them abreast of new regulations,
procedures, technological developments, new and emerging environmental and health concerns,
etc. Explain why a certain environmental procedure is in place, not just what the procedure is.
OPERATING ROOM KITS: SMART USE
To minimize waste from operating rooms, hospitals should evaluate surgical and procedure kits to
determine if all products are used in the standard kit and that kits don't expire before use due to one
or two products. The hospital should adjust the contents of the kits to minimize excess, and have
additional on hand if needed for a particular procedure. Ideally, the hospital should track their surgical
materials by doctor and procedure to ensure that only needed tools are opened, used, and discarded.
ENVIRONMENTALLY PREFERABLE PURCHASING:
PVC AND MERCURY FREE
To reduce harmful dioxin and mercury emissions from medical waste incinerators and reduce the
incidence of mercury spills, hospitals should establish purchasing policies that prohibit the purchase
of polyvinyl chloride (PVC) and mercury containing products where alternatives exist. They should
also encourage manufacturers, vendors, and group purchasing organizations to identify and label
products made from PVCs and mercury and to offer products and packaging materials that are mer-
cury and PVC-free. Information on alternatives can be obtained from the Sustainable Hospitals
Project http://www.sustainablehospitals.org/ and http://www.epa.gov/region2/p2/health.htm.
MINIMIZE PESTICIDES
Hospitals should minimize the use of pesticides and practice Integrated Pest Management
(IPM) to minimize the exposure of these toxic substances to patients, staff, and the general public.
More information on IPM can be obtained from the New "Vbrk Coalition for Alternatives to
Pesticides at www.altpest.org. Hospitals must also follow label directions and use pesticides,
sterilants, and disinfectants for approved uses only (and at approved concentrations only).
MINIMIZE RED BAG WASTE
One of the best ways to reduce the amount of waste that needs to be sent to incinerators,
autoclaves, or other medical waste treatment facilities is to keep non-infectious wastes out of the
infectious waste stream. The best way to do this is to educate hospital employees on what the defi-
nition of "infectious waste" really is. Then, strategically place "red bag" garbage cans to discourage
employees and visitors from putting regular trash in the infectious waste stream. The hospital
should also label all containers clearly and consistently, make sure they have the right size contain-
er for the job (if clear bag bins fill too quickly, it's likely waste will get dumped in a red bag
instead), have walk throughs to check up on the system on a regular basis, and where red bags are
needed, keep red bag and clear bag containers next to one another to offer a choice.
KNOW WHERE YOUR WASTE IS: COMPUTER TRACKING
Hospitals should consider establishing a computer tracking system for monitoring chemical inven-
tories and wastes (preferably by department) to ensure that excess chemicals are not purchased, that
purchased materials are used in a first-in, first out order to avoid expiration of their shelf-life, that the
most environmentally-friendly products are purchased, and that wastes are minimized to the maxi-
mum extent possible. It will also help you comply with the reporting requirements of the Emergency
Planning and Community Right to Know Act and determine your hazardous waste generator status.
GREEN HOSPITALS
For remodeled or new hospital facilities, incorporate green design and construction goals and strate-
gies. Using healthier building materials can improve public health and preserve the global environ-
ment. Use good energy design to cut utility costs, daylighting to improve productivity, good indoor air
quality to improve recovery times and reduced staff absenteeism, and careful interior finish material
selection to cut cleaning and maintenance cost. See http://www.epa.gov/region2/p2/health.htm.
12
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PARTNERSHIPS AND RESOURCES
HOSPITALS FOR A HEALTHY ENVIRONMENT
Hospitals for a Healthy Environment (H2E, www.h2e-online.org) is a voluntary program with
goals of safer work places, reduced waste and disposal costs, and greener, more environmentally
friendly hospitals. H2E educates health care professionals about pollution prevention opportunities
through best managment practices, model plans for total waste management, resource directories,
and case studies. H2E aims to provide tools to minimize waste and lessen the use of persistent,
bioaccumulative, and toxic chemicals. Such practices should benefit the environment and reduce
\vaste disposal costs.
The American Hospital Association, EPA, Health Care Without Harm, and the American
Nurses Association all sponsor H2E. In addition, various state and local resources have also joined
the effort to help health care facilities achieve the goals outlined in H2E.
SUSTAINABLE HOSPITALS
The Sustainable Hospitals Project (SHP, www.sustainablehospitals.org) supports the healthcare
industry by providing technical resources for selecting products and work practices that eliminate
or reduce occupational and environmental hazards, maintain quality patient care, and contain
costs. The Lowell Center for Sustainable Production created SHP.
THE RESOURCE CONSERVATION CHALLENGE
EPA's Resource Conservation Challenge (RCC, www.epa.gov/rcc) is a voluntary, joint effort
between EPA, businesses, and communities. RCC aims to find flexible, yet more protective ways
of improving waste reduction, public health, and the environment. As part of the Resource
Conservation Challenge, the EPA is asking the hospital industry to develop projects for the reuse
and recycling of potentially harmful hospital items and the reduction of waste. See
http://www.epa.gov/epaoswer/osw/conserve/clusters/hospital.htm.
Lead needed to protect a doctor from CatScan radiation, mercury in ultraviolet lamps, and
residual or expired pharmaceuticals are just a few examples of the hospital waste that can harm the
environment if disposed of improperly. EPA's RCC is committed to supporting projects that:
• Reduce the volume of non-hazardous solid waste (including paper) from health care industry:
• Eliminate all mercury waste from the health care industry waste stream; and
• Improve the management of pharmaceutical waste by reducing the amount of expired/unused
pharmaceuticals that are disposed of in landfills.
PERFORMANCE TRACK
Performance Track (www.epa.gov/performancetrack) is a public/private partnership recognizing
top environmental performance among participating U.S. facilities of all types, sizes, and complex-
ity, public and private. Program partners are providing leadership in many areas, including pre-
venting pollution at its source. Currently, the program has approximately 300 members and
welcomes all qualifying facilities. Applications are accepted twice a year: February 1-April 30 and
August 1-October 31.
HEALTHCARE WITHOUT HARM
Healthcare Without Harm (www.noharm.org) aims to eliminate the harm to human health and
environment from the medical field. Over 400 organizations in 52 countries participate. Healthcare
Without Harm offers information on mercury, polyvinyl chlorides (PVCs) and di-ethylhexyl phthalate
(DEHP), medical waste, healthy building, pesticides and cleaners, and green purchasing.
PARTNERSHIPS
AND RESOURCES
For more information on
these and other related
resources, call the EPA
Region 2 Compliance
Assistance Hotline at
202-637-4050 or visit
www.epa.gov/region2/
healthcare.
SELF AUDITING
EPA offers incentives to
encourage self auditing.
When businesses perform
self-policing, discovery, dis-
closure, correction and pre-
vention, EPA can at least
partially lessen the gravity of
any penalty for violation.
Moreover, companies that
self audit tend to have the
best compliance records.
Learn more at
http ://www.epa.gov/region02
/capp/cip/policyhtm.
13
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CONTACTS AND RESOURCES
HOTLINES AND
INFORMATION CENTERS
RCRA Hotline/
Information Center
U.S. Environmental Protection Agency
RCRA Information Center (5305W)
1200 Pennsylvania Avenue, NW.
Washington, DC 20460
Phone: 800 424-9346
or TDD 800 553-7672
In the Washington, DC, area:
703 412-9810, or TDD 703 412-3323
E-mail: rcra-docket@epa.gov
Home page:
Answers questions and provides information
on matters related to RCRA solid waste, haz-
ardous waste, and underground storage tanks,
EPCRA, and CERCLA.
HEALTHCARE INTERNET
ADDRESSES
Hospitals for a Healthy Environment
EPA Region 2 Compliance Healthcare
Sustainable Hospitals
Pollution Prevention Resource Exchange
Healthcare Without Harm
EnviRN
EPA Environmentally Preferable Purchasing
(EPP)
Health Care EPP Network Information
Exchange Bulletin
Purchasing for a Healthy Environment
EPA Region 5 Mercury in Medical Waste
Factsheet
PROACT Factsheet, Management of
Medical/Infectious Waste
US Army Center for Health Promotion and
Preventive Medicine Hazardous Waste
Management Program
Occupational Health and
Safety Administration (OSHA)
U.S. Department of Labor
OSHA
200 Constitution Avenue
Washington, DC 20210
Phone: 800 321-OSHA
Home page:
Provides information on workplace safety and
health issues.
U.S. Government Printing
Office
Superintendent of Documents
P.O. Box 371954
Pittsburgh, PA 15250-7954
Phone: 202 512-1800
Fax: 202 512-2250
Home page:
Prints and distributes the Code of Federal
Regulations. Title 40, Parts 260 to 299, contains
most of the RCRA requirements.
National Response Center
(NRC)
Phone: 800 424-8802
Home page:
In the event of a fire, explosion, or other
release of hazardous waste that could threaten
human health outside the facility, call the
NRC to report the emergency. The NRC
will evaluate the situation and help you
make appropriate emergency decisions.
ADDITIONAL INTERNET
ADDRESSES
Small Business Ombudsman
Clearinghouse/Hotline
U.S. Environmental Protection Agency
Small Business Ombudsman (1808T)
1200 Pennsylvania Avenue, NW.
Washington, DC 20460
Phone: 800 368-5888
Fax: 202 566-2848
Home page:
Helps private citizens, small businesses, and
smaller communities with questions on all
program aspects within EPA.
Pollution Prevention Information
Clearinghouse (PPIC)
U. S. Environmental Protection Agency
Pollution Prevention Clearinghouse (PPIC)
1200 Pennsylvania Avenue, NW. (7407-T)
Washington, DC 20460
Phone: 202 566-0799
Fax: 202 566-0794
E-mail: ppic@epa.gov
Provides information on reducing and
eliminating industrial pollutants.
EPA Home Page
EPA RCRA Hazardous Waste Resources
Code of Federal Regulations
Envirosense
(contains technical, policy, and general
information on pollution prevention topics)
EPA Library Resources
U.S. Nuclear Regulatory Commission
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