Tuesday
July 19, 1988
Part IV
Environmental
Protection Agency
40 CFR Parts 260 and 261
Identification and Listing of Hazardous
Waste Treatability Studies Sample
Exemptions; Final Rule
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27290 - Federal Regiater / Vol. 53. No. 138 / Tuesday, July 19. 1988 / Rules and Regulations
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Parts 260 and 261
ISWH-FRL-3350-4]
Identification and Listing of Hazardous
Waste Treatability Studies Sample
Exemption
AGENCY: Environmental Protection
Agency.
ACTION; Final rule.
SUMMARY: On September 18,1987, the
Environmental Protection Agency (EPA)
published a Notice of Data Availability,
which requested comment on whether
the sample exclusion provision should
be expanded to include waste samples
used in small-scale treatability studies.
The sample exclusion provision exempts
from regulation under Subtitle C of the
Resource Conservation and Recovery
Act (RCRA) waste samples collected
solely for the purpose of monitoring or
testing to determine their characteristics
or composition. The Notice also
presented information and requested
comment concerning the appropriate
limitations that couht be hupimed- if the
sample exclusion were expanded.
As a result of comments received.
EPA is today issuing a final rule that
conditionally exempts waste samples
used in small-scale treatability studies
from Subtitle C regulation.
Consequently, generator* of the waste
samples and owners or operators of
laboratories or UBtixgfacilrtEta
conducting such treatability studies wiff
be exempt from the-Subtitle G
hazardous waste regulation*;
the permitting requirements, when.
certain, condition* are net.
DATE: This regulation become* ef&ctw*
on July 19.1988. •
ADDRESSES: The OSW Docket is located
in the sub-basement at the following
address and is open from 9-a.m. to 4
p.m.. Monday through Friday, excluding
Federal holidays: EPA RCRA Docket
(sub-basement). 401M Street, SW..
Washington, DC 20480.
The public must make an appointment
(to review docket materials) by calling
(202) 475-9327. Refer to Docket number
F-88-TSSE-FFFFF when making
appointments to review any background
documentation for this rulemaking.
Copies cost $0.15 per page. Copies of the
background document entitled
"Summary and EPA Responses to Public
Comments on the September 18.1987
Notice of Data Availability and Request
for Comment, and the September 25,
1981 Interim Final Rule" are available
for viewing in the OSW Docket Room.
For Further documentation and
information, see Docket Number
F-87-TSEF-FFFFF.
FOR FURTHER INFORMATION CONTACT:
The RCRA/Superfund Hotline toll free
at (800) 424-9348 in Washington, DC, or
at (202) 382-3000. For technical
information contact Mike Petruskai
Office of Solid Waste (WH-562BJ. U.S,
Environmental Protection Agency, 401 M
Street, SW., Washington, DC 20460.
(202) 475-9888.
SUPPLEMENTARY INFORMATION:
Preamble Outline
Summary
I. Background.
II. Discussion of Major Issues
A. Introduction
1. Need and Rationale for Today's
Rulemaking
2. Determination of de miamis Risk.
B. Scope of'the Exemption
1. Definition of Treatability Study
2. Inclusion of Liner Compatibility and
Other Studies
3. Effects on Exporters of Hazardoas
Waste
C. Limitations
1. Quantity Limits per Waste Stream per
Treatment Process .
2. Transportation Shipment Limit*—
GeB*rater and Facility
3. Treatment Rate Limit
4. Storage Limits
5. Residues and Unused Samples-Time
Limitations
6. Mobile Treatment Units
d Rjcordkeeping
E. EPAJdentificatiein Numbers-
AppfcabMHr«f OSHA Training
F. Incentive* for Safe Transport
III. Today'* Amendment
FV. State Authority
A. AppticabilUy afcRules in Author***
STate*
HBfect omStetaAuthorizationa
V. Effective Date
Vfc TtegtSatary AnoJyse*
A. Executive Order No. 12291
B. Regulatory Flexibility Act
C. Paperwork Reduction Act
VII. Supporting Documentation
VIE. List of Subjects
I. Background
On September 25, 1981 (see 4ft HI
47428). EPA issued an interim final rule-
that conditionally exempted from the
Subtitle C hazardous waste regulation*
any waste samples collected solely far
the purpose of monitoring or testing to
determine their characteristics or
composition. These regulations include
the generator and transporter
requirements of Parts 282 and 263 and
the treatment, storage, and permitting
requirements of Parts 264. 265, and 270.
In particular, the regulations exempt
waste samples from the Subtitle C
requirements when: (1) The sample is
being transported to the laboratory for
testing or is being transported back to
the sample collector after the testing; (2)
.the sample is being stored by the sample
collector or laboratory before testing or
after testing prior to its return to the
generator; (3) the sample is being
analyzed to determine its characteristics
or composition; or (4) the sample is
being stored at the laboratory for a
specific purpose such as a court case or
enforcement action. However, samples
subject to the exemption must still
comply with U.S. Department of
Transportation (DOT), U.S. Postal
Service (USPS), or other applicable
shipping requirements. The sample must
be packaged so that it does not leak,
spill, or vaporize from its packaging.
The Agency granted this exclusion
because of the de minimi's public health
and environmental risks involved. In
particular, the Agency found that certain
incentives already existed that would
assure protection of human health and
the environment without requiring these
samples to be subject to the full set of
Resource Conservation and Recovery
Act (RCRA) hazardous waste
regulations. These incentives include (1)
the costs associated with sample
collection, shipping, analysis, and ,
storage; (2) the generator's need to
obtain results of analyses to determine
if and how they must comply with the
RCRA hazardous waste requirements;
and (3J the considerable likelihood that
a testing? laboratory would return the
sample to the generator as part of a
contractual agreement (partly based on
the generator's desire to protect
proprietary information and partly
based on the testing laboratory's desire
te avoid the costs of disposal), reducing
the concern that the sample would be
indiscriminately disposed. The preamble
stated that the exclusion did not cover
lafge-size samples that are used in
treatability or other testing at pilot scale
or experimental facilities. However, the
preamble did not specify whether the
exclusion applied to small- or bench-
•scalft testability studies at laboratories
. c* other testing facilities. Today's final
rule directly addresses this issue.
The preamble of the 1981 interim final
rota also stated that the Agency had
considered and rejected a quantity limit
for the samples subject to the exclusion.
Ha basis for this was that the available
information indicated that the size of
aaaplea shipped for characterization or
analytical purposes usually did not
exceed 1 gallon. Therefore, the Agency
saw no need to set a specific quantity
limit However, the preamble also stated
that EPA would consider imposing a
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Federal Register / Vol 53. No, 138 / Tuesday, July 19. 1988 / Rutes and Regulations
27291
limit on sample size if comments or
experience indicated that such a limit
was necessary (46 FR 47427).
While the comments received on the
,1981 interim final rule generally
i {supported the exclusion for samples
> shipped forjwaste characterization, a
large percentage of commenters also
recommended that the sample exclusion
provision be expanded to include waste
samples used in treatability studies.
including large-size samples used hi
- pilot-scale units or at experimental
facilities.
Furthermore, on June 2.1987, the
Hazardous Waste Treatment Council
(HWTC) submitted a rulemaking
petition requesting that the Agency
promulgate regulations to provide
limited exemptions from the permitting '.
requirements of RCRA to facilities •
• conducting treatafaility studies. The
petition proposed a three-part solution:
(1) Expand the sample exclusion
provision to. allow treatabifity testa to be
conditionally exempted from regulation;
(2) expand the Comprehensive- , ,
Environmental Response. Compensation
and Liability Act (CERCLA) permits
exclusion at 4O CFR 30O.88(aK3) to
include off-site treatability testing when
performed at the direction of an EPA or
State on-scene coordinator to implement
a response-consistent with CERCLA
section 121; and (3) issue interim
guidance to implement, at least in part,
the suggested changes described in (1)
and (2) above (i.e,, interpret the existing
sample exclusion, in 40 CFR 261.4{d) to
include treatability studies, and issae
interim guidance to on-scene
coordinators regarding off-she
treatability studies). The petition
proposed several limitation* for small-
scale treatability st»die».ThepetirJo»
also recommended regulatory r.hmy»-
that would allow large-scale treatabdtty
studies to be conducted provided that
the facility complies with the
manifesting requirements and ortain
interim status standards. (See section
H.C., Limitations, discussed below.)
The petition asserted that immediate
regulatory relief was needed because
the present RCRA Subtitle C permitting
requirements unnecessarily interfere
with the experimentation and research
necessary to evaluate the various
treatment options for CERCLA cleanup.
activities, HWTC further argued that
these same problems will have a sirailai
effect on RCRA corrective action.
Agency experience with the Superfund
Innovative Technology Evaluation
(SITE) program and CERCLA cleanup
actions support the HWTC'a assertion*
Based on these factors (Le.. comments
on the sample exclusion interim final
rule, the HWTC petition, and EPA's own
experience), EPA published a Notice of
Data Availability and Request for
Comment on September 18,1987 (50 FR
35279). The Notice reopened the
comment period on the earlier interim (
fin|al rule and specifi
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27292 Federal Register / Vol. 53. No. 138 / Tuesday. July 19, 1988 / Rules and Regulations
community. The Agency intends to
promote, not defeat research and
development in support of the national
objectives to reduce land disposal of
I hazardous wastes and to increase
;l reliance on; waste minimization and
treatment technologies that reduce'risk
to human health and the environment.
However, the Agency remains pledged
to carry out its primary statutory
obligation to ensure that removing
regulatory barriers does not result in
unwarranted or increased risks to
human health and the environment The
Agency has determined that this
balance can be properly maintained in
promulgating a RCRA exemption for
small scale trealability studies.
2. Determination ofDe Minimi's Risk
Since Congress passed RCRA in 1976,
the Agency has developed and
implemented a "cradle to grave"
program to protect human health and
the environment from the improper .
management of hazardous wastes. A
principal purpose of the RCRA
hazardous waste regulations is to ensure
that hazardous wastes are safely
transported to facilities properly
designed and operated to manage these
wastes in a manner that will minimize
the threat to human health and the
•environment. Hazardous waste
generators, transporters, and owners
and operators of treatment storage, and
disposal facilities (TSDFs) each have
specific responsibilities for properly
managing those wastes defined as
hazardous.
The Agency believes that it can
exempt hazardous waste that is used in
small-scale treatability studies from the
RCRA hazardous waste regulations
because a number of factoi-s will
combine to ensure that the risks to
human health and the environment are
de minimi's. These factors include: (1) A
limitation on the size of the sample that
is exempted; (2) the high cost of
collecting and shipping the sample; (3) a
limitation on the quantity of waste that
can be shipped at any one time; (4) the
applicability of the Department of
Transportation (DOT), U.S. Postal
Service (USPS). or other regulations
governing the transportation of
hazardous materials; (5) a limitation on
the amount of hazardous waste that can
be stored at a laboratory or testing
facility; (6) a limitation on the amount of
hazardous waste that may be processed
(i.e., tested in a treatability unit) in any
one day; (7) the prohibitive costs
involved in conducting legitimate
treatability studies as an alternative to
commercial treatment and disposal; (8) a
limitation on the lime that a waste
sample used in a treatability study or
any residues generated from such
studies may remain at the laboratory or
testing facility without being subject to
the hazardous ;waste regulations; (9) the
RCRA requirement that any unused
sample and residues from d. treatability
study must'still be managed as- a
hazardous waste (if, in fact, it is still
hazardous); and (10) certain reporting
and recordkeeping requirements that
will enable the Agency to conduct
inspections and bring enforcement
actions against persons who abuse this
exemption. In addition, regulations and
requirements administered by other
Federal agencies such as the
Occupational Safety and Health
Administration (OSHA) also ensure
proper management. ' ' ' :
• The Agency believes that all the
above factors contribute to an argument
for de minimis risk. Some factors, such
as the sample size, shipment size,
transportation standards, and storage
limitations, directly relate to the de
minimi's risk in each phase of the
treatability study process. Other factors
such as the recordkeeping and reporting
requirements and the one-time 1000 kg
per waste stream limitation ensure that
treatment and disposal of hazardous
waste do not occur under the guise of
conducting treatability studies.
More specifically, under the
conditional exemption being
promulgated today, die generator or
sample collector may not ship more than
one of the following in any single
shipment: (1) 1000 kg of non-acute
hazardous waste; (2) 1 kg of acute
hazardous waste (see 40 CFR 261.33(e)J;
or (3) 250 kg of acute hazardous waste
that is contained in contaminated soils,
water, or some other contaminated
medium. Since the shipments remain
subject to DOT, USPS, or other
applicable shipping regulations, they
must be packaged and labeled in the
same manner as other shipments of
hazardous materials. One difference is
that these waste samples will not
require a manifest. EPA believes that a
manifest is not required in this situation,
since the generator is spending large
sums of money to obtain the results of a
treatability study. Thus, it is highly
unlikely that the sample would be
indiscriminately disposed. Furthermore,
the generator or sample collector is
likely to have a contractual arrangement
with the laboratory or testing facility
conducting the treatability study either
to have the facility return any unused
sample and/or any residues that are
generated from the treatability study for
subsequent manifesting and shipment to
a designated facility (see 40 CFR 260.10)
or recycling facility or to have the
laboratory or testing facility directly
manifest and ship the wastes to an
appropriate designated facility within
specified time limits. Unless the context
otherwise requires, the use of this term
in today's preamble and rule does not
imply that the facility is required to be
permitted or to have interim status. The
generator must also maintain copies of
the shipping papers and the contract
with the testing facility for a period
ending 3 years from the completion date
of the study.
The operator of a vehicle transporting
waste samples is still required to comply
with the applicable DOT requirements,
including notification of the National
Response Center in the event of a
, hazardous material spill of more than a
reportable quantity and initiation of
cleanup measures in accordance with 49
CFR }71.15.
Owners and operators of a laboratory
or testing facility conducting such
treatability studies must comply with
the limitations regarding shipment,
storage, treatment rate, and disposition
of unused sample and residues after
completion of the studies. The overall
limitations on storage-and treatment
rates, discussed later in today's
preamble, are sufficiently restrictive to
compel a laboratory or testing facility to
carefully coordinate the size and timing
of treatability sample shipments. The
owners and operators of these
laboratories or testing facilities must
also comply with applicable regulations
promulgated by OSHA.
Further business and financial
incentives compelling a laboratory or
testing facility to properly handle these
samples include the cost-intensive
nature of conducting treatability studies,
the need to provide the client with
documented test results, the desire of
the laboratory or testing facility to
maintain its corporate reputation, and
the desire to avoid any liability. After
the treatability study is completed, the
owners or operators of a laboratory or
testing facility must either return the
unused sample and residues to the
generator or manifest and ship them to a
RCRA designated facility (if the material
is a RCRA hazardous waste) within the
time limitations specified. A laboratory
or testing facility not operating within
these limitations must comply with the
appropriate RCRA requirements.
Finally, the Agency is stipulating
recordkeeping and reporting
requirements that will document
compliance with the limitations and will
allow the Agency to take enforcement
action against persons who attempt to
abuse the exemption. The specific
reporting and recordkeeping
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Federal Register / Vol. 53. No. 138 / Tuesday. July 19. 1988 / Rules and Regulation*
27233
requirements are discussed later in
today's preamble.
B. Scope of the Exemptjon^
li Definition'pf Treatat?ili.tj$r Stjudy j
' In the Notice of Data Availability, the
Agency included a definition of
"treatability study" similar to that
proposed by HWTC. According to this
definition, a treatability study is one in
which a relatively small amount of
hazardous waste is subjected to a
known treatment process to determine
the following: (1) Whether the waste is
amenable to a treatment process; (2) .
what pretreatment (if any) is required;
(3) the optimal process conditions
needed to achieve the desired treatment;
1(4) the efficiency of the treatment • :
process; or, (5] the characteristics and .
volume of residuals from a particular
treatment process. [See 52 FR 35280.) '
The commenters generally agreed
with the definition of treatability study.
" However, many commenters expressed ,
concern that the use of the term "known
treatment process" was overly
restrictive and might hinder the
development of innovative technologies.
Thus, these commenters recommended
that the word "known" be deleted from
the'definition in the final rule. HWTCs
proposed regulatory language did not
include a restriction to "known!-*
technologies.
The Agency agrees with these
commenters. As stated earlier, it is
important to promote the development
of treatment technologies that will
reduce the land disposal of hazardous
waste and increase the reliance on
waste minimization and treatment
technologies that reduce risk to human
health and the environment In so doing.
EPA does not want to restrict industry
to the technologies that are already
established or "known"; rather, it wants
to promote the development of
innovative technologies. Therefore, tha
Agency has modified the definition of
"treatability study" accordingly. At the
same time, it is concerned that the
treatability study sample exemption
may be improperly used aa a means to
avoid regulation when regulation is
warranted. To prevent this, EPA has
included specific language in the
definition of treatability study to guard
against such abuse. This language^
makes it clear that the exemption is for
the evaluation of a treatment process
and is not to be used for commercial
treatment or disposal of hazardous
waste. Furthermore, the Agency
emphasizes that the definition of
treatability studies covered under the
exemption does not apply where the
practice could result in a significant
uncontrolled release of hazardous
constituents to the environment. It
would, therefore, include neither open
burning ribr any type 6'f treatment
involving placement of a hazardous
waste on the land (e.g., in situ '
stabilization).
Several commenters also suggested
that the Agency list, in the rule, the
types of treatment studies to be included
in the final definition. Although the
Agency can see some merit in this
suggestion, it has decided not to
incorporate a specific list into the
regulations. EPA believes that such a list
could hinder the development of
innovative technologies. For example, if
it included a list in the rule, the Agency
would be required to go through
mlemaking before new or innovative
treatment technologies would get the
benefit of the treatability exemption. As
previously discussed, the Agency ,
believes that as long as the limitations i
imposed in today's rule are met any
treatabiliry study;will pose a de minania.
risk. Examples of the types of
treatability studies included in the
exemption are physical/chemical/
biological treatment thermal treatment
(incineration, pyrolysis, oxidation.
combustion) solidification, sludge
dewatering. volume reduction, toxicity
reduction, and recycling feasibility.
2. Inclusion of Liner Compatibility and
Other Studies
In the Notice of Data Availability, the
Agency solicited comment as to whether
the exemption shpuld include other
waste testing studies, soch as-oner
compatibility studies. Many commenters
agreed that the exemption should be
expanded to include other types of
studies. The commenters argued that Irt
addftioa to Hner compatibility studies.
the exemption should also include
studies of corrosion, toxteologfca! ana
health effectir, and other material
compatibility studies. \p.g. pomps and
personal protective equipment). White
such studies are not strictly treatabiHty
studies under the proposed definition.
the commenters argued that waste
testing is necessary to develop improved
hazardous waste management
technologies.
The Agency agrees witii tha
commenters mat such studies, ahhougn
not strictly treatability studies, are
necessary for the farther development of
hazardous waste management
technologies. Furthermore, the Agency
believes that such studies can be
conducted using small quantities of
hazardous waste under laboratory
conditions. Also, these types of studies
are subject to the same financial and
business incentives for safe handling as
are treatability studies. Therefore, with
the imposition of the limitations in this
final rule, these studies will involve only
de minimia risk and need not be subject
to RCRA permitting regulations. The
Agehcy is. therefore, allowing the
following types of studies to be
conducted and exempted under the
hazardous waste regulations: liner
compatibility studies, corrosion studies,
toxicological and health effects studies,
and other material compatibility studies
(e.g., relating to leachate collection
systems, geotextile materials, other land
disposal unit requirements, pumps and
personal protective equipment).
3. Effects on Exporters of Hazardous
Waste
EPA. in today's rule, is exempting
samples sent for treatability studies
from Subtitle C requirements. These
include'the requirement to notify EPA
prior to export of hazardous waste (40 ,
CFR 262.50 etseq.}. At the time export
requirements were promulgated. EPA
discussed in the preamble its rationale
for allowing the export, without
notification, of wastes exempt from
manifesting requirements (51 FR 28864,
August 8,1988). m this discussion on
export notification requirements. EPA
specifically focussed on, the sample
exemption in 40 CFR 261.4(d).
The rule promulgated today expands
the scope of this, exemption as
contemplated in 1988. For the same
reasons discussed in the August 8,1986,
rule relating to 5 261.4(d) samples (51 FR
28664 et seq.}, exporters of treatability
study samples who comply with the
limitations of today's rule are also
exempt from the export notification
requirements of Subpart E of Part 262.
While the Agency is exempting these
treatafaiHty study samples from the
export notification requirements at tins
time, me Agency is revisiting die
question as to whether it should exclude
unmanifested waste from the export
notification requirements and may
modify its position in the future.
C. limitations
In the Notice of Data Availability, the
Agency requested specific comment on
what types of limitations should be
placed on the exemption if it were to be
expanded to include treatability studies.
In addition, EPA specifically requested
comment on the limitations, suggested by
the HWTC to its petition. The HWTC
suggested quantity limits for shipping,
storage, and treatment of hazardous
waste samples for the purpose of
conducting a treatability study. In
particular, the Notice suggested the
following limits: (1) No shipment may
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Federal Register / Vol. 53, No. 138 / Tuesday, July 19, 1988 / Rules and Regulations
exceed 250 kg; (2) no mote than 1000 kg
of exempted waste (including residues
derived from the treatability study) may
be present at the laboratory or testing
facility conducting the treatability study
'at any! one time;fand (3) no more than
250 kg of exempted waste may be
introduced into the treatability study in
any one day.
A wide range of opinions concerned
appropriate limitations that would
provide for meaningful treatability
studies. While most commenters
believed that the limitations they
suggested were necessary to conduct
treatability studies, no commenters
provided data indicating that their
suggested limits were protective of
human health and the environment. The
following indicates the range-of quantity'
limits proposed by commenters for
shipment, treatment, and storage:
Shipment: (
mean quantity: 554 kg
standard deviation: 794 kg
range: 250 to 4000 kg
most frequently cited suggestion: 250
kg
Treatment:
mean: 448 kg
standard deviation: 417 kg
range: 250 to 2000 kg
most frequently cited suggestion: 250
„ kg
Storage:
mean: 2000 kg
standard deviation: 2285 kg
range: 250 to 10,000 kg
most frequently cited suggestion: 1000
kg
Many commenters were supportive of
the limitations suggested by HWTC in
its petition. However, some commenters
argued that the limitations suggested in
the notice were not sufficient; although
these commenters provided no data
suggesting that their limits were
protective of human health and the
environment, they maintained that
larger quantities of waste sample were
necessary to conduct treatability
studies. In particular, some commentera
argued that the storage limitations were
unnecessarily restrictive. Additionally,
some commenters urged that a higher
treatability study limit was necessary as
some of the treatability tests required
quantities of waste in excess of 1000 kg.
Finally, some commentera recommended
that the Agency include a mechanism
for approval of case-by-case variances
from the HWTC quantity limitations or
the quantity limitations ultimately
chosen.
Nevertheless, all commenters
generally agreed that suitable
limitations combined with economic
forces would prevent the exemption
from becoming a means to circumvent
the RCRA Subtitle C regulations for
treatment and disposal of hazardous
waste. Additionally, many commenters
noted that it would not be economically
feasible for a person to perform an'
endless series of tests, since treatability
study costs are much higher than
commercial treatment or disposal costs
on a per pound basis. In particular,
Shirco (TSEF-001) stated that most
treatability tests had unit costs greatly
in excess of costs associated with
treatment and disposal options. Shirco
cited an example where treatability
study costs were about $1,000 per pound
versus $0.80 to $1.20 per pound for
disposal at a commercial facility.
Numerous other commenters stated that
the high costs associated with
performing treatability studies would
render invalid any concern the Agency
had that the exemption could [become a ,
"loophole" in the RCRA Subtitle C
regulations.'
The, Agency believes that the
limitations established in this exemption
will ensure that it does not become a
"loophole" and will ensure de minimis
risk so that no significant threat to
human health and the environment will
occur. The following sections discuss
the limits selected by the Agency and
present the rationale for the limitations
adopted.
1. Quantity Limits per Waste Stream per
Treatment Process
In response to the Notice of Data
Availability, several commenters
recommended that limits should be set
for each generated waste stream to
guard against the possibility that
generators and facilities might conduct a
plethora of treatability studies in lieu of.
hazardous waste treatment or disposal.
While data was provided that would
suggest this would not happen, the
Agency has decided that some
limitations should be imposed as an
extra precaution. Thus, to avoid the
potential for such an abuse, the Agency
has first made it clear in the definition of
"treatability study" that the exemption
is for the evaluation of a treatment
process and is not to be utilized as a
commercial treatment option. In
addition, the Agency has placed limits
on the amount of waste that can be
subject to a treatability study evaluation
per generated waste stream. Thus, the
rule provides for an exemption of 1000
kg of non-acute hazardous waste per
waste stream per treatment process; 1
kg of acute hazardous waste per waste
stream per treatment process; or 250 kg
of soils, water, or debris contaminated
by acute hazardous waste per waste
stream per treatment process. The
Agency, in making this decision, realizes
that a generator may need to evaluate
alternative treatment processes for a
particular waste stream. EPA believes
that the limits set will be adequate to
• allow sufficient studies to be conducted.
Furthermore, the quantity limits are
consistent with other limits discussed
elsewhere in today's preamble.
The Agency is broadly defining
"waste stream" such that a waste
stream and the quantity limit are not
based on the EPA waste code alone;
rather, the Agency will interpret and
apply the quantity limit for each medium
or physical form in which the waste
appears. The Agency believes that this
broad interpretation is necessary since
each medium (;'.e., soils, water, or
debris) might require a different
treatability study and may need to be
shipped to a different laboratory or
testing facility for such studies to, be
conducted. The Agency is also broadly
defining "treatment process" to allow a
generator to evaluate various alternative
approaches. For example, a generator •
could send 1000 kg of non-acute
hazardous waste, or 1 kg of acute
hazardous waste, or 250 kg of soils,
water, or debris contaminated with
acute hazardous waste for each
generated waste stream to a number of
different processes: biological treatment,
incineration, fixation, etc. As allowed by
this exemption, the generator or sample
collector would be limited to a total of
1000 kg of nonacute hazardous waste of
a particular waste stream to investigate
alternative fixation processes (or, as
applicable, 250 kg of soils, water, or
debris contaminated with acute
hazardous waste, or 1 kg of acute
hazardous waste). The Agency has
selected the above limits recognizing
that in some instances there may be a
need to evaluate alternative treatment
processes. Finally, the Agency has
decided not to put any limits on the
number of treatability studies that a
laboratory or testing facility can perform
per year. However, if this proves to be a
problem, the Agency may consider
additional regulations.
As noted above, some commenters
suggested that higher quantity limits are
necessary in order to evaluate certain
treatability study processes or that
additional amounts of waste may be
necessary in instances where
unforeseen circumstances have affected
the results of all or part of a treatability
study evaluation. They suggested that
case-by-case allowances in excess of
the amounts specified above should be
made available if need can be
demonstrated. The Agency agrees that
some flexibility should be made
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Federal Register / Vol. 53, No. 138 / Tuesday. July 19, 1988 / Rules and Regulations 27295
available to allow studies to be
completed properly. However, the
Agency wishes to ensure that adequate
controls are placed on aH such
evaluations to protect human health and
the environment. Accordingly, the '
Agency has included a provision that
allows the Regional Administrator to
grant requests for waste stream quantity
limits in excess of those specified above,
up to an additional 500 kg of non-acute
hazardous waste, 1 kg of acute
hazardous waste, and 250 kg of soils,
water, and debris contaminated with
acute hazardous waste. The Regional
Administrator shall only allow
additional quantities of hazardous
waste when it can be demonstrated that
one of the following circumstances or
situations exist: (1) That there has been
an equipment or mechanical failure and
that additional waste is needed to
conduct a study; (2) that there is a need
to verify the results of a previously
evaluated treatment process; (3) that
there is a need to study and analyze
alternative techniques within a
previously evaluated treatment process;
or (4) that there is a need to do further
evaluation of an ongoing treatability
study to determine final specifications
for treatment. These adjustments may
be authorized only if the 1000 kg (or 250
kg for soils, water, or debris
contaminated with acute hazardous
waste, or 1 kg for acute hazardous
waste) quantity limit per waste stream
per treatment process has been
subjected to a treatability study •
evaluation and insufficient data are
available to properly design a treatment"
process. When authorizing additional .
quantities, the Regional Administrator
will only authorize adjustments for the
minimum quantity necessary to
complete the treatability study
evaluation. The Agency believes that
most treatability studies can be
completed utilizing an extra 250 kg of
sample or less, and only in unusual
circumstances will quantities greater
than 250 kg be required.
Generators and/or sample collectors
seeking such an authorization for
additional quantities must furnish
sufficient information to the Regional
Administrators to verify that they have
met the conditions allowing for quantity
adjustments. Generators and/or sample
collectors will be required to submit, in
writing, the specific reason why an
additional quantity of sample for the
treatability study evaluation is
necessary (i.e., one of the four situations
described above). He or she shall also
provide: (1) Verification of the
additional quantity necessary; (2)
documentation accounting for all
samples of hazardous waste from the
waste stream which have previously
been sent for treatability study
evaluation; (3) a description of the
technical modifications or change in
specifications which will be evaluated
and the expected results; and, (4)'if
further study is being required due to
equipment or mechanical failure, the
generator and/or sample collector must
include information from the laboratory
or testing facility indicating what
handling procedures or equipment
improvements have been made to
protect against further breakdowns.
The Regional Administrator may
perform or require additional analyses
and investigations as are necessary to
determine the minimal amount of
additional waste necessary to conduct
the study and yield the additional data
necessary to properly design and/or
evaluate the performance of the
treatment process.
2. Transportation Shipment Limits—
Generator and Facility
The HWTC, in its petition, suggested
that shipments of waste samples
weighing less than 250 kg
(approximately one standard 55-gallon
drum) should be exempted when such
samples are being shipped for the
purpose of conducting treatability
studies. The petition also recognized
that larger size samples might be
necessary for conducting treatability
studies on contaminated soils or water
hence, the HWTC recommended that a
provision for exempting larger size
samples should be available. A number
of commenters indicated that the 250-kg
shipment limit was too restrictive and
suggested that the limit be increased to
1000 kg. These commenters argued that
the risk associated with shipping a
larger amount (e.g., 1000 kg) is no greater
than that associated with four shipments
of 250 kg each when one considers the
potential for transportation accidents;
After careful consideration of all the
issues, the Agency has decided to set a
single shipment limitation of 1000 kg of
non-acute hazardous waste; 1 kg of
acute hazardous waste; or 250 kg of
soils, water, or debris contaminated
with acute hazardous waste. These
shipment limitations (which, in effect,
govern the exemption from the RCRA
hazardous waste transporter regulations
and manifesting requirements) will
apply to the shipment of waste samples
from the generator or sample collector to
the laboratory or testing facility when
such samples are being sent for the
purpose of conducting a treatability
study. The exemption will also apply
when unused waste samples and
residues generated by the treatability
study are returned to the generator or
sample collector following completion of
the study.
The Agency is setting this limit to be
consistent with the quantity limits set on
generators for the.amount of waste that
can be subject to the treatability study
sample exemption as.discussed in the
previous section. The Agency agrees
with commenters that the risk
associated with shipping the maximum
limit of 1000 kg is no greater than that
associated with four shipments of 250 kg
each. However, it also believes these
levels will pose de minimis risk.
In addition, as already discussed, the
Agency believes other factors exist that .
will ensure safe delivery of the waste
samples to and from the laboratory or
testing facility. For example, the waste
samples will still be subject to the
applicable DOT or USPS regulations
regarding shipment of hazardous
materials. If the shipments do not fall
under DOT or USPS jurisdiction, the
generator or sample collector and the
laboratory or testing facility must follow
the requirements for labeling and
packaging as set forth by EPA in this
amendment. The requirements state that
a sample must be packaged so that it
does not leak, spill, or vaporize from its
packaging. In addition, the following
information must accompany the
sample: (1) The sample collector's name.
address, telephone number, and EPA
identification number (2) the laboratory
or testing facility's name, mailing
address, telephone number, and EPA
identification number; (3) the quantity of
the sample; (4) the date of shipment; and
(5) a description of the sample. Finally,
the Agency believes that most
shipments will be considerably smaller
than the limit,.since other forces, such as
storage limits and treatment rates at the
laboratory or testing facility, will require
careful control of the amount of waste
shipped to the laboratory or testing
facility. The costs to conduct the study
and ta collect, pack, and ship the sample
will tend to limit the sample size to the
smallest amount practicable.
3. Treatment Rate Limit
The HWTC, in its petition, suggested
that the treatment rate limit should be
250 kg per day per laboratory or testing
facility. Many of the commenters agreed:
however, others argued that the limit
should be larger and that it should be
based on either the number of treatment
units or the number of treatment
processes that the laboratory or testing
facility was capable of conducting. For
example, if a facility was capable of
conducting several soil fixation studies
or biological treatment studies at one
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27298 Federal Register / Vol. 53, No. 138 / Tuesday, July 19, 1988 / Rules and Regulations
time, then the limit should be 250 kg per
process. Other commenters argued for
even higher limits, indicating that it
should be 250 kg per unit.
After reviewing the avaUable
Information and considering the .
comments, the Agency has adopted a
treatment rate limit of 250 kg per day of
"as received" waste for the entire
laboratory or testing facility. The term
"as received" has been choaen by the
Agency because some of the treatment
processes involve the addition of non-
waste material to reduce the
environmental mobility of hazardous
constituents. "As received" refers to the
waste shipped by the generator or
sample collector as it arrives at the
laboratory or testing facility. Based on
the information provided by the HWTC,
information submitted by other
commenters in response to the Notice of
Data Availability, and EPA's own
experience, the Agency believes that
most treatability studies can be
conducted at or below the treatment
rate limit of 250 kg per day.
The Agency believes this level will
allow many wastes to be treated and
evaluated as part of a treatability study,
while posing only a de minimis risk to
human health and the environment For
example, if a laboratory or testing
facility were to conduct a treatability
study on a waste using bench-scale
incineration and the study achieved a
99% destruction removal efficiency, only
a small amount of toxic material would
be released into the environment. In
most instances, the amount released is
much lower than any level of concern. In
addition, since in most cases these
studies will be conducted on an
intermittent basis, there is less concern
with repeated exposure.
Laboratories or testing facilities that
are conducting treatability studies and'
that meet the treatment rate limit are
exempted from the requirements to
obtain a Subtitle C treatment permit
The Agency wants to emphasize that the
purpose of the exemption is for
conducting treatability studies, not for
the commercial management of
hazardous waste. The Agency believes
that facilities anticipating the need to
conduct an excessively large number of
studies, or those having numerous
treatment units allowing them to
conduct many studies concurrently, will
probably need to obtain a Research.
Development and Demonstration permit
(40 CFR 270.65}. It should also be noted
that the Agency recently promulgated a
new set of permitting standards under
Subpart X of Part 284 (52 FR 46648, -
December 10,1987) for miscellaneous
hazardous waste management units. The
Agency is also considering developing
regulations under Subpart Y thai would
establish permitting standards for
experimental facilities conducting
research and development on the
storage, treatment or disposal of
hazardous waste.
4. Storage Limits
The HWTC, in its petition,
recommended that a facility be allowed
to store 1000 kg of hazardous waste on
site without a storage permit as long as
such waste is for the purpose of
conducting treatability studies. HWTC
argued that this amount is essentially
equal to the small quantity generator
(SQG) limits and that the 1000 kg of
waste included all waste (both received
waste and treated residue). Many
commenters argued mat the 1000-kg
storage limit would not allow them
sufficient inventory to conduct certain
treatability studies or argued that the
storage limit should be based on the
number of units present at the facility.
After evaluating this issue, the
Agency has decided to adopt a storage
limitation of 1000 kg per laboratory or
testing facility. However, the Agency
has also decided to specify the 1000-kg
storage limitation for "as received
waste. The 1000-kg storage limitation
per laboratory or testing facility can
include 500 kg of soils, water, or debris
contaminated with acute hazardous
waste or 1 kg of acute hazardous waste.
The Agency is making it clear in this
rule that the storage exemption only
applies to laboratories or testing
facilities conducting treatability studies.
The quantity limitations allow sufficient
inventory to conduct small-scale
treatability studies while ensuring de
minimis risk to human health and the
environment Higher storage limits
would not give us this same assurance.
Also the Agency notes, as discussed
previously, financial and business
incentives are present that help to
ensure de minimis risk levels are
maintained.
The Agency limits for soils, water,
and other debris contaminated with
acute hazardous waste were selected to
allow small-scale treatability studies to
be conducted on media contaminated
with dioxin wastes and certain
pesticides such as aldrin and aldicarb.
Although the 500-kg storage limit is
higher than that currently established
for SQGa, the Agency believes that the
500-kg limit will still be protective of .
human health and the environment and
pose de minimis risk, since in moat
instances the sample will-only be stored
for a .short period of time-prior to being
utilized in a study. Furthermore, this.
category is limited to material* in which
the acute hazardous waste involves a
contaminant in a medium such as water
or soil. Therefore, EPA would expect the
concentration of th« acute hazardous
waste to be very low. Furthermore, the .
contaminant may be bound to the
medium itself. For other acute
hazardous wastes (AC., the actual listed
waste), the Agency has adopted a 1-kg
limit consistent with the SQG
regulations.
5. Residues and Unused Samples-Time
Limitations
Although me Notice of Data .
Availability did not propose any time
limitations for completion of a
treatability study, some commenters
strongly recommended that appropriate
time Omits be placed on the storage of
the "as received" waste samples and the
residues generated from the treatability
study. Suggestions on appropriate time
limits varied widely. However, the
commenters generally indicated that 1
year provides ample time to complete
most treatability studies.
The Agency is in agreement with
commenters that specific time limits for
completing treatability studies are
necessary. Time limitations are
necessary to guard against potential
abuses such as use of a laboratory or
testing facility for long-term storage to
avoid treatment and disposal. Any
untreated sample and any residue
generated during die treatability study
must be returned to the generator within
90 days of study completion or within 1
year from the date of shipment by the
generator to the laboratory or testing
facility, whichever is earlier. Otherwise.
these materials must be managed, by the
laboratory or testing facility conducting
the treatability study, as a RCRA
hazardous waste (unless the waste is no
longer hazardous). These time limits
provide the laboratory or testing facility
conducting the treatability study enough
time to do the evaluation, but at me
same time do not allow persons to store
these wastes indefinitely. The 1-year
time limit proved to be noncontroversial
when adopted in other areas. For
example, the 1-year time hmit is
consistent with the speculative
accumulation provision and the closed-
loop tank provision. Under these
provisions, persons or facilities holding
materials have 1 year to accumulate
them before they are potentially subject
to regulation.
Laboratories or testing facilities that
do not return die unused sample or the
residues to the generator or sample
collector within the specified time limits
are subject to appropriate regulation.
Facilities must determine if they meet
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Federal Register / Vol. 53. No. 138 / Tuesday. July 19. 1988 / Rules and Regulations 27297
the SQG requirements of § 261.5 or the
accumulation requirements of § 262.34.
.and they may need to obtain a storage
permit and comply with its conditions.
Once samples and residues are returned
to the generator, they are no longer
'exempt under today's rule. Ultimately,
the unused sample and residues that are
still hazardous must be manifested'and
disposed of in a RCRA-designated
facility by the laboratory or testing
facility, the waste generator, or sample
collector.
6. Mobile Treatment Units
Although the issue of mobile
treatment units (MTUs) was not
addressed in the Notice of Data
Availability and Request for Comment
concern was expressed over how this
exemption applies to MTUs. EPA has
determined that MTUs conducting
treatability studies may qualify for this
exemption. However, each MTU or
group of MTUs operating at the same
location is subject to the treatment rate,
storage, and time limitations and the
notification, recordkeeping, and
reporting requirements that are
applicable to stationary laboratories or
testing facilities conducting treatability
studies. That is. a group of MTUs
operating at one location will be treated
as one MTU facility for purposes of
§ 281.4 (e) and (f)-Furthermore, these
requirements apply to each location
where an MTU will conduct treatability
studies.
D. Reporting and Recordkeeping
Requirements
Although the Notice of Data
Availability did not specifically
recommend that reporting and
recordkeeping provisions be adopted,
some commenters suggested that some
form of reporting and recordkeeping
should be required in the treatability
study exemption. They argued that
without some form of reporting or
recordkeeping requirements, EPA would >
not have a means of determining who i*
violating the exemption or the amount of
waste subjected to treatability studies.
The Agency strongly agrees with the
commenters and believes that reporting
and recordkeeping requirements- are
necessary to facilitate inspector review
and, if necessary, to assist in
enforcement action. In fact, 40 CFR
216.2(f) already requires that persons
who claim that their waste is
conditionally exempt from regulation
must provide appropriate
documentation that they meet the
conditions of the exemption. Therefore,
the Agency is stipulating specific
reporting and recordkeeping
requirements that will document
compliance with the quantity and time
limitations set forth in this rulemaking.
The reporting and recordkeeping
requirements stipulated below are the
minimum requirements necessary to
ensure compliance with the limitations
in the treatability sample exemption.
1. The generator of the sample (who
may also be the shipper or sample
collector) and the laboratory or testing
facility conducting the treatability study
must keep the following records for 3
years after the completion of the study:
a. A copy of the contract (between the
generator and the laboratory or testing
facility) to conduct the treatability
study;
b. Copies of all shipping documents.
(If the waste was shipped to an MTU,
copies of the shipping papers must be
kept with the unit for inspector review.)
2. Generators and sample collectors
must also maintain records indicating
the following: (1) The amount of waste
(per waste stream and treatment
process) shipped under the exemption;
(2) to whom the shipment was sent
(name, address, and EPA identification
number of the laboratory or testing
facility conducting the study); (3) the
date shipment was made; and (4)
whether or not any unused sample or
any residue generated from the
treatability study was returned. In
addition, beginning in 1989, generators
must report this information in their
biennial reports.
3. In addition, laboratories or testing
facilities conducting or intending to
conduct treatability studies must
accomplish the following:
a. Send a letter to the EPA Regional
Administrator or the authorized State
informing the Agency that the
laboratory or testing facility intends to
conduct small-scale treatability studies.
This letter must be received no less than
45 days before the facility begins
conducting treatability studies. The
letter should indicate the address and
EPA identification number of the
laboratory or testing facility conducting
studies and the types of treatability
studies anticipated. Owners and
operators of facilities that do not have
an EPA identification number must
obtain one before conducting any
treatability studies under this
exemption. This reporting requirement
and the requirement to obtain an EPA
identification number apply to owners
and operators of MTUs at every
treatability study location (except at
CERCLA sites where, under CERCLA
section 121(e)(l) and 40 CFR 300.68{a)(3),
RCRA permits are not required).
b. Maintain appropriate records and
documentation for a period of 3 years
following completion of each treatability
study that show compliance with the
appropriate quantity and time
limitations addressed in the final rule.
The records must indicate that the
laboratory oij testing facility is meeting
the requirements for shipment limits,
treatment rate limits, and storage limits.
Specific minimum information, by
treatability study, that must be
maintained include the following:
• The name, address, and EPA
identification number of the generator or
sample collector of the waste samples;
• The date the shipment was
received;
• The quantity of waste accepted;
• The quantity of "as received" waste
in storage each day;
• The date the treatment study was
initiated and the amount of "as
received" waste introduced to treatment
each day;
• The date the treatability study was
concluded; and
• The date the unused sample and
residue were returned to the generator
or, if sent to a designated facility, the
name of the facility and its EPA
identification number. As noted above,
the laboratory or testing facility must
keep copies of all shipping documents
associated with transport of the waste
to and from the facility.
c. By March IS of each year, submit a
report to the authorized State or
Regional Administrator that includes an
estimate of the number of studies and
the amount of waste expected to be
used in treatability studies during the
current year and the following
information for the previous calendar
yean
• The name, address, and EPA
identification number of the generator or
sample collector of each waste sample;
• The date the shipment was
received;
• The quantity of waste accepted;
• The total quantity of "as received"
waste in storage each day;
• The date the treatment study was
initiated and the amount of "as
received" waste introduced to treatment
each day;
• The date the treatability study was
concluded: and
• The date any unused sample and
residues generated from the treatability
study were returned to the generator or
sample collector or, if sent to a
designated facility, the name of the
facility and the EPA identification
number.
d. Notify the Regional Administrator
or authorized State by letter when and if
the laboratory or testing facility is no
longer planning to conduct any
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27298 Federal Register / Vol. 53. No. 138 / Tuesday, July 19, 1988 / Rules and Regulations
treatability studies at the site. (For
example, when an MTU completes a
treatability study at a site, the owners or
operators must submit the required
notice that they will no longer be
conducting treatability studies at that
site.)
E. EPA Identification Numbers—•
Applicability of OSHA Training
Requirements
Some commenters suggested that any
laboratory or testing facility conducting
treatability studies should 1)8 required to
have an EPA identification number.
These commenters argued that such a
restriction would ensure that the facility
is in compliance with the requirements
to have a facility contingency plan, has
established emergency procedures, and
is in compliance with OSHA's
hazardous waste workers' training and
medical monitoring requirements. (See
29 CFR 1910.120, 51FR 45654. December
19,1988.)
The Agency partially agrees and is
requiring any laboratory or testing
facility conducting treatability studies to
notify the Agency and obtain an EPA
identification number if the facility does
not already have one. However, as
already explained, the Agency believes
laboratories or testing facilities
conducting treatability studies within
the limits specified present a de minimis
risk. For example, the OSHA hazardous
waste operators and emergency
response requirements (29 CFR 1910.120)
are applicable except for SQGs and
facilities complying with the
accumulation time requirements of 40
CFR 282.34. Other OSHA requirements.
such as the OSHA laboratory standards
and general duty clause (29 USC
654(a](l)), may apply depending on the
type of laboratory or testing facility and
the nature of its activities. Thus, EPA
believes requirements such aa
contingency plans and emergency
procedures are not necessatry for the
protection of human health and the
environment.
F. Incentives for Safe Transport
In the Notice of Data Availability, the
Agency specifically requested comment
on whether the incentives for safe
transport and storage of waste
characterization samples would also
apply to treatability samples. Most
commenters agreed that suitable
incentives exist to ensure proper
handling and shipping of traatabitity
study samples.
The Agency generally agrees. In
particular, a principal purpose of the
generator and transporter requirement*
is to assure that shipments of hazardous
wastes are safely delivered to an
appropriate destination (i.e., a permitted
or interim status hazardous waste
management facility). This is
accomplished through the requirements
for manifesting, recordkeeping, ,
packaging, and labeling of hazardous I
waste. The principal purpose of the
manifest system is to ensure "cradle to
grave" accountability for shipments of
hazardous waste from the generator to a
TSDF.
In the case of treatability study
samples, EPA wants to ensure that the
samples are delivered to the facility
conducting the treatability study, and
that both the unused sample and all
residues generated in the treatability
study are sent back to the generator or
sample collector or, alternatively,
shipped to a designated facility if the
waste remains hazardous.
The Agency believes that sufficient
incentives and requirements are in place
to provide for the safe shipment of
samples to and from laboratories and
testing facilities conducting treatability
studies. In particular, they include:
1. Maintenance of corporate
reputation and public confidence;
2. The high cost of these studies
coupled with the generator's or sample
collector's need for properly
documented results;
3. The need for the generator or
sample collector to verify results of a
treatability study; and
4. Requirements in today's rule for
either returning the unused samples and
residues to the generator or sample
collector, or for manifesting and
shipping these materials to a TSDF for
ultimate disposal.
The Agency believes that the above
incentives and requirements will guard
against any facility not complying with
the limitations or conducting bogus
treatability studies. Furthermore, DOT
or other regulation* «T»TJ guidelines
control the transportation of such
sample* even in the absence of EPA
regulation. The requirements to comply
with DOT shipping regulations regarding
packaging and labeling will be
substantially the same as present
requirement for shipping hazardous
waste. Additionally, the USPS has
stringent guidelines governing the
shipment of hazardous materials,
including samples. (See die "Domestic
Mail Manual,'' Part 124 and Publication
52, "Acceptance of Hazardous or
Perishable Articles.") For the above
reasons, die Agonny believes that die
transport of small quantities of
hazardous waste poses de minimis risk
during shipment to a laboratory or
testing facility or when being returned to
the generator or sample collector.
III. Today's Amendment
The Agency believes that the full
complement of the hazardous waste
regulations found in 40 CFR, Parts 260 ,
through 288 and 270, when applied to j
waste samples used in small-scale
treatability studies, are more
comprehensive than necessary to
adequately protect human health and
the environment. In addition, the
Agency believes that it needs to
promote research and the development
of innovative technologies to manage
hazardous wastes. Therefore, EPA is
amending die regulations to
conditionally exempt waste samples
processed in small-scale treatability
studies from the hazardous waste
regulations under certain conditions.
In particular, EPA is today adding
new paragraphs (e) and (f) to 40 CFR
261.4 which accomplish the following:
First, persons who generate samples are
exempted from the generator and
transporter requirements when samples
are snipped by the generator, or any
other person who collects the sample
(the "sample collector"), to a laboratory
or testing facility for the purpose of
conducting a treatability analysis, or
when shipped from the facility back to
the sample collector, provided that
certain packaging and labeling
requirements are met Second, any
laboratory or testing facility that
conducts treatability studies may store
these waste samples and residues
generated from the treatability study
within the quantity and time limits
specified and not be subject to the
requirements of 40 CFR. Parts 264, 265,
and 270. Thud, the actual testing of the
samples does not require a permit,
provided the laboratory or testing
facility complies with the limitations
specified in today's rule.
Laboratories and testing facilities that
conduct treatability studies must also
keep records and documents regarding
each treatabifity study as enumerated hi
ILD-3.8. above. Additionally, today's
rule requires facilities conducting
treatabifity studies to submit an anrreal
report to ths authorized State or
Administrator of the EPA Region in
which die laboratory or testing facility is
located. The required annual report
must be a distinct document prepared
by the owner and/or operator of the
laboratory or testing facility indicating
the previous calendar year's activities
regarding treatability studies. The report
must be submitted by March 15 of each
year and must identify the laboratory or
testing facility by name, EPA
identification number, and the location
(site address) at which the treatability
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Federal Registet / Vol. 53, No. 138 / Tuesday, July 19. 198fl / Rules and Regulations
27299
studies were conducted. Paragraph
H.D.3.C. above lists specific information
required in the report. The obligation to
submit annual reports continues until
the laboratory or testing facility
discontinues treatability studies, returns
all unused "as received" samples and
any residues generated in the
treatability studies back to the generator
or sample collector, and notifies the
Regional Administrator or State Director
that the laboratory or testing facility no
longer plans to conduct any tseaiabiliijr
studies at the site.
Paragraph (e), Treatability Study
Samples, provides an exemption for
generators of samples of hazardous
waste to be evaluated in treatability
studies, while they are being prepared
for transport or being transported,
provided that these samples and their
residues are returned to the generator
within specified time limita. The
exemption limits the sample collector or
generator from Dipping more than 1000
kg per non-acute hazardous waste
stream per treatment process (or 250 kg
of soils, water, or debris contaminated
with acute hazardous waste, or 1 kg of
acute hazardous waste). Shipments must
comply with the applicable DOT..USPS,
or other applicable regulations for
shipping hazardous materials.
The generator or sample collector
•must also maintain records indicating
the amount of waste shipped under tha
exemption, the name and address of the
laboratory or testing facility, tha facility
EPA identification number, type of
study, and. the expected duration of the
study. Beginning in 1989, the generator
or sample collector must also include
the above information in its biennial
report
Paragraph (f>. Samples Undergoing
Treatability Studies at Laboratories or
Testing Facilities, describes th»
limitations that apply to a facilffy
conducting treatability studies under
this exemption. The facility may subject
no more than 250 kg of "as received"
waste to treatability studies in any one
day. The facility may store a maximum
of 10OO kg of "as received" waste, of
which 500 kg can be soils, water, or
debris contaminated with acute
hazardous waste or 1 kg of acute
hazardous waste. The facility must also
return any unused sample and residues
to the generator within 9O days after
completion of the study or within 1 year
after initial shipment (whichever is
earlier), or otherwise manage the sample
and residue as a RCRA hazardous -
waste, if the residue is still hazardous.
The facility must meet certain
specified reporting requirements. Th«-
facility must provide notification (by
letter) to the Regional Administrator or
authorized State indicating that the
facility intends to conduct treatability
studies under the exemption. It must
obtain an EPA; identification number if it
does not have one. The facility must
also maintain records documenting
compliance with the specified time and
quantity limits for treatment and storage
and must keep records of all shipping
documents for 3 years from the
completion of the treatability study.
The owner or operator of a facility-
conducting treatability studies must als»
submit a report to the Regional
Administrator or authorized State
indicating the type and number of
treatability studies conducted during tha
previous calendar year, for whom each
study was conducted, the quantity of
hazardous waste utilized in each
treatability study, when each study was
conducted, and the final disposition of
residue and any unused sample-. Tha
report must include an estimate of the
number of treatabinty studies to be
conducted and the quantity of
hazardous waste expected to be used in
treatability studies during the coming!
year. The facility must also notify the
Regional Administrator or authorized
State by letter when, and if the facility is
no longer planning to conduct any
treataWity studies at the site.
IV. Stet» Authority
A. Applicability of Rules in Authorized
States' • .
Under section 3006 of RCRA, EPA
may authorize qualified States to
administer and enforce the RCRA
program within, the State. (Sec 40 CFR
Part271 forth* standards and
requirements foe authorization.)
Following authorization, EPAretains.
enforcement authority «nd«-»eetion*
300a 7003. and 3013 of RCHA.altfctwglr
authorized Staten haw primaiy
enforcement responsibility;
Prior to tha Hazardous and Solid
Waste Amendments of 1984 (IriSW A), *
State with final authorization
administered its hazardous waste
program entirely in lies of EPA
administering the Federal proyam in
that Slat*. The Federal reooaemerrt* no
longer applied in &a authorized States
and EPA could not iasuepenaMs for any
facilities in the State that the Stafe w«s
authorized to permit. When new, more
stringent Federal requireiaenta were
promulgated or enacted, the State was
obliged to enact equivalent authority-
within specified tia» frame*N«w
Federal requirements did not take effect
in an authorised StatoMfflttl fee Stat*
adopted the requirements as-State law.
In contrast, under secttoa 3008fgt«^
RCRA, 42 U .S.C. MZefg). iw*r
requirements and prohibitions imposed
by the HSWA take effect in authorized
States at the same time that they take
effect in nonauthorized States. EPA is
directed to implement those
requirements and prohibitions in an
authorized State, including the issuance
of permits, until the State is granted
authorization to do so. While States
must still adopt HSWA-related
provisions as State law to retain final
authorization, HSWA applies in
authorized States in the interim.
B. Effect of State Authorizations
•Today's announcement promulgates
regulations that awmrf effective under
HSWA in authorized States, since this
rulemaking does not impose
requirements or prohibitions contained
in HSWA. Thus, the regulations will be
applicable only in those States that do
not have final authorization. In an
authorized State, the regulations will not "
be applicable until the State revises its
program to adopt equivalent regulations
under State law.
40 CFR 271^1(e)(2) requires that
States having final authorization.must
modify their programs to include
equivalent regulations within a year of
promulgation of these regulations if only
regulatory changes are necessary, or
within 2 years of promulgation if
statutory changes are necessary. These
deadlines can be extended in
exceptional cases (40 CFR ZTL21(e)(3}i.
Once EPA approves the modification,
the State requirements become Subtitle
C RCRA requirements.
States- with authorized RCRA
programs may already have regulations-
similar to those in today's rule. These
State regulations have not been
compared with the Federal regulation*;
being promulgated today to detennin*.
whether they meet tha testa for
authorizationi Thus, a State is not
authorized to implement these
regulations hi lieu of EPA until the State.
program modification is submitted to
EPA and approved. Of course. States
with existing regulation! may continue
to administer and enforce their
regulations ss a matter of State law.
Authorized States are only required to-
modify their programs when EPA
promulgates Federal regulations that are
more stringent or broader in scope than
the authorised State regulations. For
those changes that are less stringent or
reduce the scope of the Federal program.-
States are not required to modify their
programs. This is a result of section 3009
of RCRA. which allows States to impose
more stringent or broader regulations
than the Federal program. The
regulations promulgated today at
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27300 Federal Register / Vol. 53. No. 138 / Tuesday. July 19. 1988 / Rulea and Regulation
§§ 281.4 (e) and (f) are considered to be
less stringent than or reduce the scope
of the existing Federal regulations
because today's rule exempts certain
activities now within the purview of
RGRA. Therefore, authorized States are
not required to modify their programs to
adopt regulations consistent with and
equivalent to this rulemaking.
Even though States are not required to
adopt today's rulemaking, EPA strongly
encourages States to do so as quickly as
possible. As already explained in this
preamble, today's rule isi needed to
facilitate evaluating remediation
alternatives for CERCLA clean-ups and
the RCRA Corrective Action Program,
and to speed research and development
for treatment alternatives to land
disposal and waste minimization,
recycling, and reuse. States are.
therefore, urged to consider the adoption
of today's rule; EPA will expedite
review of authorized State program
revision applications.
States are also encouraged to use
existing authorities to provide for
comparable treatability exemptions
prior to adopting and receiving
authorization for today's rule. Some
States may have authority comparable
to RCRA Section 7003, which allows
EPA to order response action in the case
of imminent and substantial
endangerment to health or the
environment "notwithstanding any other
provision of this Act" An authorized
State may use comparable section 7003-
type authority to authorize treatability
studies and may waive the generator,
transporter, notification, and permit
requirements consistent with today's
rulemaking.
In addition to, or in Hew of, a section
7003-type authority, a State may have
general waiver, permit waiver, or
emergency permit authority. Consistent
with this rule, states are encouraged to
use any such authority to grant
treatability exemptions in a manner
consistent with today's rule.
V. Effective Date
Section 3010{b) of RCRA provides that
EPA's hazardous waste regulations and
revisions to those regulations take effect
6 months after promulgation. The
purpose of this requirement is to allow
facilities that handle hazardous wastes
sufficient lead time to prepare for and to
comply with major new regulatory
requirements. Given the potential of this
rule to increase the timeliness of
CERCLA remedial clean-up activities,
RCRA corrective actions, and
compliance with the land disposal
restrictions, the Agency believes that an
effective date of 8 months after
promulgation would unnecessarily
disrupt implementation of the
regulations and would not be in the
public interest. Since this amendment
reduces, rather than increases, the
existing requirements for facilities that
handle waste samples, there is no basis
for allowing a lengthy time period to
prepare for compliance. The same
reasons provide good cause to make this
rule effective immediately upon
publication notwithstanding section 4(d)
of the Administrative Procedure Act, 5
U.S.C. 553(d). Therefore, this
amendment takes effect immediately
upon publication in the Federal Register.
The application of this final rule is
prospective only. Any treatability
studies covered by this final rule that
were conducted before the effective
date of this regulation are subject to the
Subtitle C hazardous waste regulations,
including permitting requirements.
VI. Regulatory Analyses
A. Executive Order No. 12291
Under Executive Order No. 12291,
EPA must judge whether a regulation is
"major" and therefore subject to the
requirement of a Regulatory Impact
Analysis. This final regulation is not
major because it will not result in an
effect on the economy of $100 million or
more, and it will not increase costs or
prices to industry. Rather, this regulation
will reduce the overall costs and
economic impact of EPA's hazardous
waste management regulations by
eliminating permitting requirements for
laboratories and testing facilities
intending to conduct treatability studies.
The Agency estimates that perhaps 400
facilities and laboratories nationwide
will be affected by promulgation of this
rule. Facilities and laboratories will be
spared the time (as much as 2 years) and
the costs (estimated to be between
$100,000 and $200,000) otherwise
necessary to obtain a RCRA permit In
addition, there will be no adverse effect
on the ability of U.S.-based enterprises
to compete with the non-U.S.-based
enterprises in domestic or export
markets. Because this amendment is not
a major regulation, no Regulatory
Impact Analysis has been conducted.
This amendment was submitted to the
Office of Management and Budget
(OMB) for review as required by
Executive Order No. 12291. <
B. Regulatory Flexibility Act
Pursuant to the Regulatory Flexibility
Act. 5 U.S.C. 601 et seq., whenever an
Agency is required to publish general
notice of rulemaking for any proposed or
final rule, it must prepare and make
available for public comment a
regulatory flexibility analysis that
describes the impact of the rule on small
entities (i.e., small businesses, small
organizations, and small governmental
jurisdictions). The Administrator may
certify, however, that the rule will not
have a significant economic impact on a
substantial number of small entities. As
noted previously in this preamble, the
universe of facilities affected is
estimated to total about 400; of these,
perhaps 200 are small business entities.
By eliminating time-consuming and
costly permitting requirements, the
Agency anticipates that promulgation of
this rule will have a positive effect on
small entities.
This amendment will have no adverse
economic impact on small entities. In
fact, it should reduce the burden
imposed on small entities that conduct
treatability studies and comply with the
provisions of this rulemaking.
Accordingly, I hereby certify that this, '
final regulation will not have a
significant economic impact on a !
substantial number of small entities.
This regulation therefore does not
require a regulatory flexibility analysis.
C. Paperwork Redaction Act
The information collection.
requirements contained in this rule have
been approved by the Office of
Management and Budget (OMB) under
the Paperwork Reduction Act of 1980, 44
U.S.C. 3501 et. seq., and have been
assigned the OMB control number 2050-
0088tTreatability Studies Notification
and Recordkeeping).
Public reporting burden for this
collection of information is estimated to
vary from 90 to 250 hours per response,
with an average of 155 hours per
response, including time for reviewing
instructions, searching existing data
sources, gathering and maintaining the
data needed, and completing and
reviewing the collection of information.
Send comments regarding the burden
estimate or any other aspect of this
collection of information including
suggestions for reducing this burden, to
Chief, Information Policy Branch, PM-
223, U.S. Environmental Protection
Agency, 401- M Street, SW,, Washington,
DC 20480; and to the Office of
Information and Regulatory Affairs,
Office of Management and Budget,
Washington, DC 20503.
VII. Supporting Documentation
A background document in which
EPA responds to any comments not
addressed in this preamble, entitled
"Summary and EPA Responses to Public
Comments on the September 18,1987
Notice of Data Availability and Request
for Comment, and the September 25,
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Federal Register / Vol. 53, No. 138 / Tuesday, July 19,, 1988 / Rules and Regulations
27381
1981 Interim Final Rule," dated June
1988. is available in the RCRA docket at
EPA (LG-100), 401 M St., SW.,
Washington, DC 20480. The docket
number for this rulemaking is F-88-
TSSE-FFFFFF. The docket is open from
9 a.m. to 4 p.m., Monday through Friday,
excluding Federal holidays. The public
must make an appointment to review
docket materials by calling (202) 475-
9327. Copies cost $0.15 per page.
VIII. List of Subjects
40CFR Part 260
Administrative practice and
procedure, Confidential business
information. Hazardous waste.
40 CFR Part 261
Hazardous waste. Recycling.
Date: July 11.1989.
Lea M. Thomas,
Administrator.
For the reasons set out in the
preamble. Title 40 of the Code of Federal
Regulations is amended as follows:
PART 260—HAZARDOUS WASTE
MANAGEMENT SYSTEM: GENERAL
1. The Authority Citation for Part 260
continues to read as follows:
Authority: 42 U.S.C. 6905.6912(a),. 6921
through 6927,693O, 6934. 6935, 6937, 6938, 8839
and 6974.
2. Section 260.10 is amended by
adding the following definition in
alphabetical order:
§ 260.10 Definition*.
*****
"Treatability Study" means a study In
which a hazardous waste is subjected to
a treatment process to determiner fl>
Whether the waste is amenable to the
treatment process, (2) what pretreatment
(if any) is required, (3) the optima}
process conditions needed to achieve
the desired treatment (4) the efficiency
of a treatment process for a specific
waste or wastes, or (5) the
characteristics and volumes of residual*
from a particular treatment process.
• Also included in this definition for the
purpose of the § 261.4 (e) and (f)
exemptions are liner compatibility,
corrosion, and other material
compatibility studies and lexicological
and health effects studies. A.
"treatability study" is not a means to
commercially treat or dispose of
hazardous waste.
PART 261—IDENTIFICATION AND
LISTING OF HAZARDOUS WASTE
3. The Authority Citation for Part 261
is revised to read as follows:
Authority: 42 U.S.C. 6905. 6912fa). 6921,
6922. and 6938.
4. Section 281.4 is amended by adding
two new paragraphs (e) and (f) to read
as follows: .-;
§ 261.4 Exclusions.
*****
(e) Treatability Study Samples. (i)
Except as provided in paragraph (e)(2)
of this section, persons who generate or
collect samples for the purpose of
conducting 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
requirements 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 .
generator 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 treatability
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 1000 kg of any non-acute hazardous
waste. 1 kg of acute hazardous waste, or
25O kg of soils, water, or debris
contaminated with acute hazardous
waste for each process being evaluated
foresee generated waste stream; and
(ii) The mass of each sample- shipment
does not exceed 1000 kg of non-acute
hazardous waste, 1 kg of acute
hazardoos waste, or 250 kg of soils.
water, or debris-contaminated with:
acute hazardous waste; and
(iii} The sample mast be packaged so
that it will not leak, spill, or vaporiz»
from its packaging during shipment and
the requirements of paragraph A or B of
this subparagraph are met.
(A) The transportation of each sample
shipment complies with U.S. Department
of Transportation (DOT), U.S. Postal
Service (USPS), or any other applicable
shipping requirements; or
(B) If the DOT, USPS. or other
shipping requirements do not apply to
the shipment of the sample, the
following information must accompany
the sample:
(1) The name, mailing address, and
telephone number of the originator of
the sample:
(2) The name, address, and telephone
number of the facility that will perform
the treatability study;
(3} The quantity of the sample;
(4) The date of shipment; and I
(5) A description of the sample!,
including its EPA Hazardous Wa'stei
Number.
(iv) The sample is shipped to a
laboratory or testing facility which is
exempt under 5 281.4(f) or has an
appropriate 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 theifcreatability study;
(C) Documentation showing:
(1) The .amount of waste shipped
under this exemption;
(2} The name, address, and EP. A •
identification 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
generator. •
(vi) The generator reports the
information required under paragraph
(e)(v)(C) of this section in its biennial
report.
(3) The Regional Administrator, or
State Director (if located in an
authorized State), may grant requests*
on a case-by-case basis, for quantity
limits in excess of those specified in
paragraph (e)(2Ki} of this section, for. up
to an addStieaal 580 kg of non-aarte
hazardous waste, 1 kg of acnte-
hazardous waste, and 250 kg of soils,
water, or debris contaminated with
acute hazardous waste, to conduct
further treatability study evaluation
when: Thera has been an equipment or
mechanical failure daring the conduct of
a treatability study; there is a need to
verify the results of a previously
conducted treatability study; there is a
need to study and analyze alternative
techniques withm a: previously
evaluated treatment process: or there is
a need to do further evaluation of an
ongoing treaiafaility study to determine
final specifications for treatment. The
additional quantities allowed are
subject to all the provisions in
paragraphs (e)(l) and (e)(2)(ii)(vi) of this
section. The generator or sample
collector must apply to the Regional
Administrator in the Region where the
sample is collected and provide in
writing the following information:
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27302 Federal Register / Vol. 53. No. 138 / Tuesday. July 19, 1988 / Rules and Regulations
(ij The reason why the generator or
sample collector requires additional
quantity of sample for the treatability
study evaluation and the additional
quantity needed;
(ii) Documentation accounting for all
samples of hazardous waste from the
waste stream which have been sent for
or undergone treatability studies
including the data 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 of each treatability study;
(iii) A description of the technical
modifications or change in
specifications which will be evaluated
and the expected results;
(iv) If such further study is being
required due to equipment or
mechanical failure, the applicant must
include information regarding the reason
for the failure or breakdown and also
include what procedures or equipment
improvements have been made to
protect against further breakdowns; and
(v) Such other information that the
Regional Administrator considers
necessary.
(f) Samples Undergoing Treatability
Studies at Laboratories and Testing
Facilities. Samples undergoing
treatability studies and the laboratory or
testing facility conducting such
treatability studies (to the extent such
facilities are not otherwise subject to
RCRA requirements) are not subject to
any requirement of this Part, Part 124,
Parts 282-266,268, and 270, or to the
notification 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 facility
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 dayn before
conducting treatability studies, the
facility notifies the Regional
Administrator, or State Director (if
located in an authorized State), in
writing that it intends to conduct *
trea lability 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 250 kg of
"as received" hazardous waste is
subjected to initiation of treatment in all
treatability studies in any single day.
"As received" waste refers to the waste
as received in the shipment from the
generator or sample collector.
(4) The quantity of "as received"
hazardous waste stored at the facility
for the purpose of evaluation in ,
treatability studies does not exceed 1000
kg, the total of which can include 500 kg
of soils, water, or debris contaminated
with acute hazardous waste or 1 kg of
acute hazardous waste. This quantity
limitation does not include:
(i) Treatability study residues; and
(ii) Treatment materials (including ,
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 has elapsed since the
generator or sample collector shipped
the sample to the laboratory or testing
facility, whichever date first occurs.
(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 and the storage
time and quantity limits. The following
specific information must be included
for each treatability study conducted:
(i) The name, address, and EPA .
identification number of the generator or
sample collector of each waste sample;
(ii) The date the shipment was
received;
(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
received" 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 treatability
study were returned to the generator or
sample collector or, if sent to a
designated facility, the name of the
facility and the EPA identification
number. ,
I (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
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 Administrator, 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
• expected to be used in treatability
studies during the current year, and i
includes; the following information for
the previous calendar year:
(i) The name, address, and EPA
identification number of the facility
conducting the treatability studies;
(ii) The types (by process) of
treatability studies conducted;
(iii) The names and addresses of
persons for whom studies have been
conducted (including their EPA
identification 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 oach
treatability study.
(10) The facility determines whether
any unused sample or residues
generated by the treatability study are
hazardous waste under § 261.3 and, if
so, are subject to Parts 281 through 268,
and Part 270 of this Chapter, unless the
residues and unused samples are
returned to the sample originator under
the S 261.4(e> exemption.
(11) The facility notifies the Regional
Administrator, or State Director (if
located in an authorized State), by letter
when the facility is no longer planning
to conduct any treatability studies at the
site.
(Approved by the Office of Management and
Budget under control mimber 2050-0088)
[FR Doc. 88-16188 Filed 7-18-88; 8:45 am]
BtLUNOCOCC MCO-M-M
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