Wednesday
May 2, 1990
Part IV
Hazardous Waste Management System:
Identification and Listing of Hazardous
Waste and CERCLA Hazardous
Substance Designation and Reportable
Quantity Adjustment—1,1-
Dimethylhydrazine Production Wastes;
Final Rule and Proposed Rule
s£_^_s
— —«
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18488 Federal Register / Vol. 55. No. 85 / Wednesday, May 2. 1990 / Rules and Regulations
ENVIRONMENTAL PROTECTION
'AGENCY
40 CFR Parts 261,271, and 302
[SWH-FRL-3719-6]
BIN 2050-AC91
Hazardous Waste Management
System: Identification and Listing of
Hazardous Waste and CERCLA
Hazardous Substance Designation and
Reportable Quantity Adjustment—1,1-
Dlmethylhydrazine Production Wastes
AGENCY: Environmental Protection
Agency.
ACTION; Final rule.
SUMMARY: The Environmental Protection
Agency (EPA) today is amending the
regulations for hazardous waste
management under the Resource
Conservation and Recovery Act (RCRA)
by listing as hazardous four wastes
generated during the production of 1,1-
dimethylhydrazine (UDMH) from
carboxylic acid hydrazides. The effect of
this regulation is that these wastes will
be subject to regulation under 40 CFR
parts 282-266, and parts 270, 271, and
124.
In addition, the Agency also is making
final amendments to regulations
promulgated under the Comprehensive
Environmental Response,
Compensation, and Liability Act
(CERCLA) in 40 CFR part 302 that are
related to today's hazardous waste
listings. In particular, EPA is making
final the designation as CERCLA
hazardous substances all of the wastes
made final in today's rule and the final
reportable quantities that would be
applicable to those wastes.
EFFECTIVE DATE: This regulation
becomes effective on November 2,1990.
ADDRESSES: The official record for this
rulemaking te Identified as Docket
Number F-90-DMHF-FFFFF and is
located in the EPA RCRA Docket, Room
2427,401 wf Street SW., Washington, DC
20460. The public must make an
appointment to review docket materials
by calling (202) 475-9327. Copies of the
non-CBI version of the listing
background document, the Health and
Environmental Effects Profiles (HEEPs).
and not readily available references are
available for viewing and copying only
in the OSW docket. Copies of materials
relevant to the CERCLA portions of this
rulemaking are also located in Room
2427, U.S. EPA. 401 M Street SW.,
Washington, DC 20460. Both dockets are
available for inspection from 9:00 a.m. to
4:00 p.m. Monday through Friday,
excluding Federal holidays. The public
may copy a maximum of 100 pages from
the docket at no charge; additional
copies are available at $0.15 per page.
FOR FURTHER INFORMATION CONTACT:
The RCRA/Superfund Hotline at (800)'
424-9346 or at (202) 382-3000. For
technical information on the RCRA
hazardous waste listings, contact Dr.
Gate Jenkins, Office of Solid Waste
(OS-332), U.S. Environmental Protection
Agency, 401 M Street SW., Washington,
DC 20460, (202) 382-4786. For technical
information on the CERGLA final rule,
contact Ms. Ivette Vega, Response
Standards and Criteria Branch,
Emergency Response Division (OS-210),
U.S. EPA, 401 M St. SW., Washington,
DC 20460, (202) 382-2463.
SUPPLEMENTARY INFORMATION: The
contents of today's preamble are listed
in the following outline:
I. Legal Authority
II. Background
III. Summary of the Final Regulation
IV. Response to Comments
A. Concentration Level Criteria for Listing
Waste as Hazardous
B. Assessment Risk for UDMH in the
Wastes
C. Regulatory Impact Analysis *
*-D. Additional Waste Streams
V. Relation to Other Regulations
VI. Test Methods for Compound Added to
Appendix VII
VII. CERCLA Impacts
VIII. State Authority
A. Applicability of Rules in Authorized
States
B. Effect on State Authorizations
IX. Compliance Dates
A. Notification '
B. Interim Status
X. Regulatory Impact Analysis
XI. Regulatory Flexibility Act
XII. Paperwork Reduction Act
I. Legal Authority
These regulations are being
promulgated under the authority of
sections 2002(a) and 3001 (b) and (e](2)
of the Solid Waste'Disposal Act, as
amended, 42 U.S.C. 6912(a) and 6921 (b)
and (e)(2) (commonly referred to as
RCRA). and section 102(a) of the
comprehensive Environmental
Response, Compensation, and Liability
Act of 1980, 42 U.S.C. 9602(a).
II. Background
Pursuant to section 3001 of subtitle C
of the Resource Conservation and
Recovery Act (RCRA), EPA today
promulgates final rules listing four
wastes generated during the production
of 1,1-dimethylhydrazirie (UDMH) from
carboxylic acid hydrazides. The
following discussion provides a brief
overview of regulatory actions affecting
the wastes being finalized today.
On December 20,1984, EPA proposed
to amend the regulations for hazardous
waste management under RCRA by
listing as hazardous four wastes
generated during the production of 1,1-
dimethylhydrazine (see 49 FR 49556).
These wastes are: (1) Column bottoms
from product separation (EPA
Hazardous Waste No. K107), (2)
condensed column overheads from
product separation and condensed
reactor vent gases.(EPA Hazardous
Waste No. K108), (3) spent filter
cartridges from product purification
(EPA Hazardous Waste No. K109), and
(4) condensed column overheads from
intermediate separation (EPA
Hazardous Waste No. K110).
The basis for this action was a
determination by the Agency that these
wastes contained significant
concentrations of 1,1-dimethylhydrazine
(UDMH). UDMH is carcinogenic,
mutagenic, and teratogenic. UDMH is
typically present in each waste at
significant levels. In addition, UDMH is
mobile and persistent, and can reach
environmental receptors in harmful
concentrations if these wastes are
mismanaged. (See the preamble to the
proposed listing for those wastes (49 FR
49556) and the Listing Background
Document, available from the
ADDRESSES section, for more
information on the hazards of these
wastes.)
On August 17,1989, the Agency made
available for public comment additional
data which supports the conclusion that
. UDMH should be considered a potential
human carcinogen (54 FR 33942). The
Agency requested comments on the use
of this new data as part of the basis for
listing wastes generated from the
manufacture of UDMH. The comments
received on the December 20,1984
proposal to list the four wastes and on
the use of this new data are responded
to in this Federal Register notice. These
comments do not refute the Agency's
conclusion that UDMH is carcinogenic,
mutagenic and teratogenic.
In addition, in a document published
elsewhere in today's Federal Register,
EPA is proposing to list as hazardous
two additional wastes generated during
the production of UDMH from
carboxylic aci'd hydrazides. These
wastes are: (1) Flush water from the
catalyst removal system, and (2) spent
catalyst and filter media. As a result of
comments received from a manufacturer
of UDMH in response to the proposed
listing of four wastes generated during
the manufacture of UDMH (December
20,1984, 49 FR 49556), the Agency
received data that supports a
preliminary determination that these
two additional wastes also should be
listed as hazardous.
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Federal Register / Vol. 55, No. 85 / Wednesday, May 2, 1990 / Rules and Regulations 18497
On November 8,1384, the Hazardous
and Solid Waste Amendments of 1984
(HSWA) were enacted. These
amendments had far reaching
ramifications for EPA's hazardous waste
regulatory program. Section 3001 (e) (2),
which was one of the many provisions
added by HSWA, directed EPA to make
a decision on whether or not to list
certain specified wastes, including
wastes from the manufacture of UDMH,
as hazardous. Today's rule fulfills this
mandate, in part, by promulgating the
final listing for four UDMH production
wastes. EPA also plans to decide, within
the next several years, whether to list as
hazardous wastes generated during a
different UDMH manufacturing process,
namely that used by the O!in
corporation. After EPA has (1) made
that final decision, and (2] taken final
action on today's proposal.to list as
hazardous two additional wastes
generated during the manufacture of
UDMH from carboxylic acid hydrazides,
the Agency will have fulfilled its
mandate under section 3001(e) of RCRA.
III. Summary of the Final Regulation
This regulation designates as RCRA
hazardous wastes the following wastes
generated during the manufacture of
UDMH from carboxylic acid hydrazides:
• K107—Column bottoms from
product, separation from the production
of 1,1-dimethylhydrazine (UDMH) from
carboxylic acid hydrazines
• K108—Condensed cohimn
overheads from product separation and
condensed reactor vent gases from the
production of 1,1-dimethylhydrazine
(UDMH) from carfaoxylic acid
hydrazines
• K109—Spent filter cartridges from
product purification from the production
of 1,1-dimethylhydrazine (UDMH) from
carboxylic acid hydrazines
• KllO—Condensed column
overheads from intermediate separation
from the production of 1,1-
dimethylhydrazine (UDMH) from
carboxylic acid hydrazines.
The hazardous constituent of concern
in these wastes is UDMH. UDMH is
carcinogenic, mutagenic, and
teratogenic. UDMH is typically present
in each waste at significant levels (/.a,
these wastes contain up to 50 percent
UDMH). In addition, UDMH is mobile
and persistent, and can reach
environmental receptors in harmful
concentrations if these wastes are
mismanaged.
In addition to its toxicity, the Rash
point of the condensed column
overheads from product separation and
condensed vent gases from the reactors
(EPA Waste No. K108) has been
measured to be between 11 to 14 "C (52
to 55 °F), which makes this waste
ignitable according to the criteria in 40
CFR 261.21(a)(l). Also, the pH of the
column bottbms from product separation
(EPA Waste No. K107) has been
measured to be between 13 and 14,
which makes this waste corrosive
according to the criteria in 40 CFR
261.22(a)(l).
EPA has evaluated these wastes
against the criteria for listing hazardous
wastes (40 CFR 261.11(a)), and has
determined that they typically contain
high concentrations of the constituent of
concern (UDMH), that this toxicant is
mobile and persistent in the
environment, and that the toxicant in
the wastes is regulated by other EPA
regulations, as well as by regulations of
other government agencies. In addition,
one of the wastes is corrosive, and
another is ignitable, and thus these
wastes are also being listed as
hazardous based on these
characteristics. The Agency, therefore,
believes that these wastes are capable
of posing a substantial present or
potential threat to human health or the
environment when improperly treated,
stored, transported, disposed of, or
otherwise managed, and thus are
hazardous wastes. (Additional
information on the hazards and the toxic
constituents of these wastes may be
found in the listing background '
document and the Health and
Environmental Effects Profiles, available
as described in the "ADDRESSES"
section.)
The Agency received comments on
the proposed listings from the generator
of the wastes (Uniroyal Corporation) as
well as another manufacturer of UDMH
that uses a different process not subject
to these listings. Uniroyal also submitted
comments on the new data on UDMH
made available on August \7L 1989. We
have evaluated these comments
carefully, and have modified the
supporting documentation accordingly.
This notice makes final the regulations
proposed on December 20,1984, and
provides EPA's response to the
comments received.
The manufacturer of UDMH from
carboxylic acid hydrazides, Uniroyal
Corporation, also supplied the Agency
with information on the generation of
two additional wastes from the
manufacture of UDMH as part of their
comments—namely (1) flush water from
the catalyst removal system, and (2)
spent catalyst and filter media. As a
result, the Agency is proposing to add
these two wastes to the list of hazardous
wastes in 40 CFR 261.32 in a document
published elsewhere in today's Federal
Register.
IV. Response to Comments
EPA received comments on several
aspects of the proposed regulations (and
on the use of the data made available •
for public comment on August 17,1989)
from the generator of these wastes,
Uniroyal Corporation; the Agency also
received comments on the proposed
regulations from another manufacturer
of UDMH that uses a different process
not subject to these listings, Olin
Corporation. The Agency has evaluated
these comments carefully, and has
modified the supporting documentation
to this regulation accordingly, as well as
proposing new hazardous waste listings
based on these comments. This section
presents the comments received, as well
as the Agency's response.
A. Concentration Level Criteria for
Listing Waste as Hazardous
One commenter requested that the
Agency's listing of UDMH include a
"delisting threshold" so that industry
would have criteria for determining
whether a waste containing UDMH (or
any other toxicant) is considered
hazardous, and could use this as a basis
for a petition pursuant to 40 CFR 260.22
to exclude a particular UDMH
manufacturing waste from the list of
hazardous waste, the "delisting"
process.
When evaluating delisting petitions,
the Agency considers a number of
factors, including the presence of any
additional toxicants other than those for
which the waste was listed and the
behavior of the toxicants in the
environment. See 40 CFR 260.22(a).
Therefore, the delisting process is more
complex than a simple evaluation of the
concentration of the toxicant(s) for
which the relevant waste was listed.
The Agency has described its general
approach to evaluating delisting
petitions in the Federal Register. See 50
FR 48886, November 27,1985. In that
notice and in many subsequent
proposed and final delisting-
determinations, the Agency described
its evaluation process in detail and
explained how it uses information
provided by the petitioner (e.g., see 54
FR 14101, April 7,1989). For the reasons
described in those notices and above,
the Agency is not including a
concentration level of UDMH in the
wastes below which the wastes would
not be considered hazardous.
B. Assessment of Risk for UDMH in the
Wastes
Uniroyal challenged the Agency's
evaluation of the carcinogenicity of
UDMH for several reasons. In response
to the December 20,1984 proposed
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18498 Federal Register / Vol. 55, No. 85 / Wednesday, May 2. 1990 / Rules and Regulations
UDMH listings (49 FR 49556), Uniroyal.
contended that a study by Toth,1 which
was used by EPA to conclude that
UDMH should be considered a probable
human carcinogen (a B2 carcinogen
using EPA's weight-of-evidence
classification system), was so flawed as
to be invalid for any risk assessment.
Uniroyal also challenged the validity of
EPA's conclusions on the
carcinogenicity of UDMH based on the
interim results of new studies currently
being conducted by Uniroyal. These
new studies were conducted by
Uniroyal pursuant to requirements
under the Federal Insecticide, Fungicide,
and Rodenticide Act (F1FRA) (U.S.C.
part 136 eL seq.), and were proposed to
be used as a partial basis for the UDMH
listing regulations under RCRA on
August 17,1989 (54 FR 22942).
The response to-challenges by
Uniroyal on the use of either the earlier
Toth study or the new interim results of
the studies conducted by Uniroyal are -
provided below.
1. Use of the Toth Study to Establish
Carcinogenic Risk of UDMH
Uniroyal stated that EPA based its
risk assessment of the carcinogenicity of
UDMH solely on a study by Toth.2
Uniroyal contended that this study
deviated from scientifically valid
protocols, thus invalidating the use of
the study for establishing the .
carcinogenic risk of UDMH to humans.
The specific areas where Uniroyal
claimed that the Toth study was not in
conformance with EPA Guidelines for
oncogenicity studies,3 and the Agency's
specific responses to these comments
are given below. In general, however,
while noting that there are certain
deficiencies in the methodological
conduct of the Toth study, the Agency's
Human Health Assessment Group
(HHAG) (formerly the Carcinogen
Assessment Group (CAG)) made a final
determination in 1988 that the Toth study
may be used as the basis for a
carcinogenicity determination for
UDMH.4 This determination was made
1 Tolh, B. (1973) l.l-Dimelhylhydrazine
(Untymmelrical) Carcinogenesia in Mice. Light
Microscopic and Uttraslructural Studies on
Ncoplastic Blood Vessels./. Natl. CancerInst..
50:181.
« Tolh. B. 11973). ibid.
3 Pesticide Assessment Guidelines, Subdivision F,
1982.
« U.S.EPA. CAG (June. 1988) Evaluation of the
Potential Carcinogenicity of 1.1-Dimethylhydrazine
(57-14-7). in Support of Reporlable Quantity
Adjustments Pursuant to CERCLA section 102
(OHEA-C-073-95. June 1988. Final): W. Pepelko
through Wm. Farlnnd. Director, CAG, to E.
CUuisen. Director. Characterization and
Assessment Division. OSW (January 9,1987)
Evidence for Carcinogenicily of 1.1-
after evaluating the results of an audit
performed on the Toth study by the
Agency in 1985.s The CAG noted that
although the study had certain
deficiencies, the increases in the tumor
incidence was striking and that the
evidence from the Toth study was more
than adequate to. classify UDMH as a
carcinogen in animal test systems, and
as a B2 category carcinogen (a probable
human carcinogen) using EPA's weight-
of-evidence system.
The Agency notes that even if the
Toth study were as flawed as Uniroyal
alleges, subsequent results of new
studies also confirm the Agency's
determination that UDMH is
carcinogenic. These studies, conducted
by Uniroyal as part of the requirements
of the Registration Process under FIFRA,
were noticed for public comment on
August 17,1989 for their potential use to
support these UDMH listing regulations
under RCRA (54 FR 33942). The results
of this new interim study are also
discussed in this Response to Comments
section.
a.'Uniroyal asserted that one
deficiency in the Toth study was that
there were no concurrent controls
(animals maintained under the same test
conditions, but not administered UDMH,
which provide a reference point for
comparison of any statistical increase in
tumors) for any particular animals. The
control group that Dr. Toth described in
his publication actually lived over a
different time span than those animals
which were administered UDMH, and
thus could not be assured to have lived
under the exact same laboratory
conditions as the animals which were
administered UDMH.
Response: As a result of an audit of
the Toth study performed by the
Agency,8 data was located to establish
the existence of as well as records for'
concurrent controls that were
maintained by Dr. Toth's laboratory
during the UDMH bioassay. These
concurrent controls were found to have
essentially the same tumor incidence as
in the non-concurrent control group
reported upon by Dr. Toth in his original
publication of his study. Thus, the
Agency does not believe there are
problems in utilizing the Toth study
because-of Uniroyal's allegations
concerning lack of concurrent control
animals.
b. Uniroyal stated that only one dose
level of UDMH was tested, and this
dose level exceeded the Maximum
Tolerated Dose (MTD).'The MTD is an
administered level of substance that
significantly shortens the life span of
test animals, due to toxicological effects
of the test substance (such as
suppression of the immune system,
endocrine disturbances, and organ
damage). Thus, an exceedance of the
MTD could interfere with any
assessment of the carcinogenic effects of
an administered substance. Uniroyal
contended that any observed
carcinogenicity findings in the Toth
study were therefore likely to have been
caused by metabolic overload and/or
cytotoxicity (exceedance of the MTD),
and not due to a genuine carcinogenic
response to UDMH. Uniroyal pointed
out that after 15 months, there were only
26 percent survivors among the treated
mice instead of the allegedly required 50
percent. The company also stated that
there were no survivors at the end of !§
months, although it alleged that the
Guidelines require a survival rate of 25
percent, thus allegedly providing further
evidence that the dose was in excess of
the MTD.
Response: First, according to the EPA
Guidelines for Carcinogenic Risk
Assessment, only one dose is required
to determine qualitatively the
carcinogenicity of an agent if the results
are positive and if the MTD has not
been exceeded.7 Even if the MTD has
been exceeded, the study is not
necessarily invalidated, but instead
must be evaluated closely to determine
if concomitant pathology and/or
metabolic overload have influenced
results.8 Second, contrary to Uniroyal's
suggestion, there is nothing in the
Guidelines for Carcinogenic Risk
Assessment,9 the uniform procedures
Dimethylhydrazine (DMZ). (Both documents are in
the docket for this final rule, available as indicated
in the ADDRESSES section.)
8 U.S. EPA. OPP (April 22,1985) Report of the
Audits of the Studies on the Carcinogenic Potential
of Succinic Acid 2.2-Dimethylhydrazide
(Daminozide) and 1,1-Dimethylhydrazine in Swiss
Mice. Studies Conducted at the Eppley Institute, the
University of Nebraska Medical Center, Omaha.
Nebraska.
« U.S. EPA. OPP (April 22.198S), ibid.
7 U.S. EPA (September 24.1986) Guidelines for
Carcinogenic Risk Assessment. EPA Publication No.
EPA/600/8-87/045). These guidelines were
published in the Federal Register on September 24,
1986 (51 FR 33992), and were products of a two-year
Agency development and review process, where
drafts were peer-reviewed by experts from
academia. industry, public interest groups, and
other governmental agencies. Proposed guidelines
were published in the Federal Register (49 FR 46294,
November 23,1984), reviewed by special panels of
EPA's Science Advisory Board, and revised to take
into account public and SAB comments, as well as
being reviewed by the Office of Management and
Budget.
8 U.S. EPA (September 24,1986) Guidelines for
Carcinogenic Risk Assessment, ibid.
• U.S. EPA (September 24.1986) Guidelines for
Carcinogenic Risk Assessment, ibid.
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Federal Register / Vol. 55, No. 85 / Wednesday, May 2, 1990 / Rules and Regulations 18499
that EPA uses to evaluate the effects of
toxicants, that require any minimal
survival rate at different stages of a
bioassay. • . .
In addition, .survival rates in the Toth
study did not demonstrate that the MTD
was exceeded. Among male mice,.the-
survival rate was lower than in the
untreated animalsi but only after more
than 50 weeks of exposure. Since -84
percent of the animals in this group
developed vascular.tumors and.78
percent lung tumors, with average
latencies of 42 and 53 weeks,
respectively, it is highly likely that
cancer induction itself was responsible
for mortality after 50 weeks. Among
male hamsters, in which the latency for
tumor development was longer with
fewer incidences, the survival rate was
the same for treated and control
animals. If adjustments are made for
very early mortality in female hamsters,
then the long term survival rate was also
equivalent in treated animals and
controls.
Excessive noncancer liver pathology
was not reported in the Toth study, nor
was it found by the EPA audit*of this
study, as would be expected if the MTD
were exceeded.10 Based upon the
mortality results and lack of reported
pathology, there is little direct evidence
that the MTD was exceeded.
c. Uniroyal challenged the validity of
the Toth study because complete
necropsy records were not maintained,
and portions of the study were
conducted by technicians in the absence
of direct supervision.
Response: The audit performed by
EPA considered in detail this problem
with the Toth study, noting that there
was a large turnover of technicians, and
that none of the observations, •
calculations or other records for the
necropsy histopathology report sheets
were dated, signed, or initialled. Despite
these deficiencies noted by the auditors,
the GAG l J concluded that the Toth
study was still adequate for a risk
assessment, since no evidence was
found to suggest that errors were made
by. the technicians under these
conditions.
d. Uniroyal contended that animal
randomization was inadequate to
prevent in-breeding (a condition that
could lead to heightened sensitivity to"
carcinogens as a result of genetic drift).
Response: According to the EPA
Guidelines,12 humans are assumed to be
10 U.S. EPA (September 24.1988) Guidelines for
Carcinogenic Risk Assessment, ibid.
1' U.S. EPA. CAG (January 7,1987), ibid.
-2 U.S. EPA (September 24.1986), ibid.
as sensitive to the agent as the most
sensitive strains of animal species,
unless there is knowledge otherwise. As
a result, this allegedly possible change
in sensitivity of the colony of mice
maintained by Dr. Toth's laboratory
would not alter the weight-of-evidence .
determination for UDMH.
Furthermore, there is no evidence
from pathological data on the control
animals evaluated in Dr. TotK's
laboratory to suggest that any
genetically enhanced susceptibility to
spontaneous carcinogenesis
(carcinogenesis that occurs without the
intentional administration of a test
substance) has occurred due to genetic
drift. If there was such heightened
sensitivity, then increased spontaneous
carcinogenesis in the control animals
would be expected to accompany any
genetically enhanced susceptibility to
exogenously induced carcinogenesis
(carcinogenesis that occurs as the result
of the administration of a test
substance). The EPA audit of the Toth
study did not reveal any increased rate
of spontaneous carcinogenesis in the
control animals maintained'by Dr.
Toth's laboratory compared to animals
of the same species maintained by other
laboratories and the supplier. This fact
discredits Uniroyal's theory of in-
breeding leading to enhanced
susceptibility to carcinogenesis to
exogenous carcinogens.
In addition, the rate of spontaneous
carcinogenesis was seen to be identical
for the control groups maintained by Dr.
Toth's laboratory two years prior to the
UDMH bioassay as at the same time as
the UDMH bioassay. This further
supports the conclusion that there was
no genetic drift over time due to in-
breeding or other factors in the animals
tested. «*»*
Furthermore, the'Swiss albino strain
of mice used in the Toth study are highly
susceptible to carcinogenesis. This
facilitates the development of tumors
over the short life span of this rodent
species. As a result, any genetic drift
that would occur in these mice is likely
to lead to decreased sensitivity, not the
other way around. Thus, the results of -
the Toth study are hot compromised by
any alleged enhanced sensitivity of the
animals to carcinogens.
e. Uniroyal contended that another
deficiency in the Toth study was a lack
of suitable analytical verification of the
test material during the study.
Response: The EPA auditors
recognized that the overall analytical
verification of the study did not conform
to today's General Laboratory Practice
standards,13 but concluded that despite
the deficiencies, there was no reason to
doubt that the mice received the test
substances (UDMH and Alar®) at the
indicated dosage levels. The EPA
auditors found, however, that the
UDMH purchased from Aldrich
Chemical Company had been analyzed
for chemical composition by Aldrich. In
addition, the auditors found that the
UDMH mixed with water in known
proportions were in fact analyzed for
chemical composition, and that these
were the mixtures that were
administered to the animals in the Toth
study.
The EPA auditors as well as CAG
concluded that despite the uncertainties
with the analytical method, there was
no evidence to suggest that the UDMH/
water solutions did not contain the
concentrations reported in the study.
This is because even in the absence of
analytical verification, laboratory
methods for making solutions of known
Concentrations by the addition of
accurately measured portions of a
substance (UDMH in this instance) have
historically been found to be capable of
great accuracy, in the absence of any
decomposition or other losses of the
substance from the water. Any
deterioration of the UDMH/water
solutions, through hydrolysis or
volatilization of the UDMH, would have
resulted in decreased cancer rates, not
the other way around.
In addition, even if the analysis of the
UDMH obtained from Aldrich Chemical
Company, the supplier, were inaccurate,
as impliedly alleged by Uniroyal, it was
known that Aldrich itself had analyzed
the UDMH for purity. There is no
evidence that the UDMH contained any
toxic contaminants, or that any toxic
contaminants were present in sufficient
concentration or of sufficient potency to
have confounded the observations of the
carcinogenic effects of UDMH.
f. Uniroyal contended that even if the
Toth study were valid, then the
estimated risk from UDMH exposure
was lower than the value derived by
EPA, based on that study. The qi*
(carcinogenic potency) value of 8.66
(mg/kg/day) " • was calculated using an
observed carcinogenic response of 42
out of 50 mice by EPA. Uniroyal
claimed, however, that only 25 of 48
mice were diagnosed as having blood
vessel tumors, basing this contention on
an audit performed for Uniroyal.14
" U.S. EPA. OPP (April 22.1985). ibid.
14 Vesselinovitch. S.D., Report to Uniroyal. Inc.
(1984).
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18500 Federal Register / Vol. 55. No. 85 / Wednesday, May 2. 1990 / Rules and Regulations
Response: EPA's audit1S of the Toth
study confirmed the tumor incidence
found by Dr. Toth. In addition. GAG 16
has concluded that since the control
animals lived longer (not suffering the
acute toxic effects from UDMH that
resulted in premature death, thus
presumably having more time to develop
tumors) the potency of UDMH as a
carcinogen may even be underestimated
using data from the Toth study.
Moreover, even if the incidence of
tumors was the lower rate contended by
UnSroyal, that rate is still highly
significant and would not alter the
determination that UDMH is a category
B2 carcinogenic.
g. Uniroyal expressed the position
that EPA cannot list the UDMH
manufacturing wastes as hazardous
until the scientific validity of the
carcinogenicity study conducted by Toth
was ascertained or repeated. Uniroyal
noted that EPA itself was currently
conducting an audit of the Toth study as
a result of comments on the study
submitted by Uniroyal regarding
proposed regulations under FIFRA, and
suggested that EPA should take the
results of this audit into account
Response: The results of the EPA
auditl7 referred to by Uniroyal became
available after Uniroyal submitted its
comments on the proposed UDMH
listings. As discussed earlier, this audit,
although acknowledging certain
deficiencies hi the Toth study, noted
that the increases hi the tumor
incidences were so striking that even if
the controls had been dropped from the
study, it would not weaken the findings
of the study in any regard. The audit
team found that data obtained from
missing pathology slides that were
subsequently located further
substantiated the tumor incidences
stated in the publication by Dr. Toth.
Thus, this audit does not provide any
support for Uniroyal's position that the
Toth study is invalid for performing a
carcinogenic risk assessment.
2. Use of the Interim Results of Studies
on UDMH Carcinogenicity Currently
Being Conducted by Uniroyal
As part of its review of the.pesticide
manufactured from UDMH, Daminozide
(Alar®), under the Re-registration
Process under FIFRA, EPA required
Uniroyal Corporation to conduct
additional studies on the health effects
of both UDMH AND Daminozide. Based
on the interim results of the data
submitted by Uniroyal, EPA proposed to
cancel certain pesticide product
registrations under FIFRA.18
On August 17,1989. EPA announced
its intent to use this new interim data
developed by Uniroyal as part of the
basis for listing wastes from the
manufacture of UDMH as hazardous
under RCRA,19 since EPA believed that
this data provided strong evidence that
UDMH Is a carcinogen. Uniroyal
responded to the August 17,1989 Notice
of Data Availability with the following
contentions that the data did not
support a dete'rmination that UDMH
was a probable human carcinogen. The
specific challenges to the 'significance of
these data for a carcinogenicity
determination are given below.
a. Uniroyal claimed that the biological
significance of the interim results of the
UDMH and Daminozide study are
questionable. For example, while
positive tumorigenic results were seen in
mice, no significant increases in rumor
incidences were detected in any of the
exposed groups of rats.
Response: The lack of detectable
effects in rats cannot be construed as
evidence for noncarcinogenicity. Only
an extremely potent carcinogen would
be expected to induce an increase in
tumor incidence as early as 12 months
from the start of exposure. In fact the
positive results seen in mice as early as
8 months, suggest that UDMH is not
only a carcinogen, but a rather potent
one. Furthermore, it Is generally
recognized that species may differ in
sensitivity to an applied dose, so the
interim results with rats is not
inconsistent with this expectation.
b. Uniroyal argued'thajt there was no
increase in the number and severity of
liver islands, as would be expected if an
agent was a carcinogen.:
Response: The liver is made up of
liver cells called hepatocytes. In the
liver island assay most of the liver is
removed to stimulate rapid cell division
among the remaining hepatocytes.
Subsequent administration of a
potentially carcinogenic agent may
induce genetic changes resulting in the
gain or loss of specific enzyme systems
in the hepatocytes. Since the cells are
rapidly dividing, one enzymatically
altered cell will reproduce to form an
"island" of similar cells.'These islands
can be made visible by differential
staining techniques. The assay is
regarded as a test for probable
carcinogenicity since the enzymatic
changes are considered by many
investigators to be early steps in the
progression of cellular changes leading
to cancer.
The tumors resulting from exposure to .'
UDMH, however, occur in blood vessels,
a different type of tissue than located in
the liver. Thus, the lack of any increase
or severity of the liver islands does not
negate the carcinogenicity
determination.
c. Uniroyal argued that since positive
results were seen hi mice only at 40 and.
80 ppm, dosages that Uniroyal claims
are clearly in excess of the maximum
tolerated dose (MTD), any conclusions
on the carcinogenicity of UDMH based
on results from tests which exceeded the
MTD are not valid.
Response: According to established
Guidelines 20 using body weight gains,
survival etc., EPA believes that the
MTD was not exceeded. Mortality that
did occur during the first 12 months of
exposure was considered by the EPA
reviewers 21 to more likely be the result
of cancer rather than liver necrosis.
Since tumor increases were detected in
intermediate dosed males as well as in
females, in which the pathological
effects and other toxic signs were
minimal, the results are not considered
to be invalidated by the alleged .
overdosage.
Even if the MTD was exceeded, the .
data can be used in assessing
carcinogenicity according to EPA's risk
assessment Guidelines, if the results are
carefully reviewed to ensure that
responses are not due to factors
operating only at levels above MTD.22
These include effects such as metabolic
activation at high concentrations and
hormonal changes. There is little
information to indicate that UDMH
requires this type of activation,
however, which would call into question
the possibility that the observed effects
were due to an exceedance of the MTD.
In addition, there is also no 'data to
indicate that important hormonal
changes are taking place, another effect
that could be caused if the MTD were
exceeded.
The pathological changes in the liver
would be of serious concern in
evaluating whether the MTD had been
exceeded if the liver itself was the
primary target organ for the
carcinogenic effects of UDMH. The
possible genetic alterations with
increased cell turnover rates resulting
from the pathological changes could
lead to tumor induction in some cases.
'• U.S. EPA. OPP (April 22,1985). ibid.
'« US. EPA. CAC (January 7.1987). ibid.
" U.S. EPA, OPP (April 22.1985), ibid.
18 54 FR 22558. May 24,1989.;
'1J 54 FR 33942. ;
20 U.S. EPA (September 24,1986), ibid.
21 U.S. EPA. OPP (May 15,1989). Second Peer
Review of Daminozide (Alar) and UDMH
(Unsymmetricall.l-dimelhylhydrazine).
22 U.S. EPA (September 24,1986), ibid. pp. 1-5
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Federal Register / Vol. 55, No. 85 / Wednesday, May 2, 1990 / Rules and Regulations 18501
UDMH, however induces tumors in
blood vessels and not in the liver itself.
As a result, the changes in the liver do
not confound the observations of
carcinogenic effects in other organs, the
blood vessels.
Thus, EPA does not believe that the
MTD was exceeded in the recent
Uniroyal studies. Secondly, even if the
MTD has been exceeded, EPA's careful
review of the data has ascertained that
the carcinogenic effects.-ivere
independent of any physiological
changes which could have been caused
by an exceedance of the .MTD. The
results, therefore, still may be used to
determine that UDMH is a carcinogen.
d. Uniroyal claimed that the
carcinogenic effects were accompanied
by a variety of hematological, liver
enzyme and liver pathology changes
that may well have been responsible for
the tumor induction. Thus, the
commenter contended that the tumors
should not be considered to be the result
. of a carcinogenic effect of UDMH.
Response: The hematological, liver
enzyme, and liver pathology changes are
considered by EPA to be a result of
tumor growth, and thus not responsible
for their induction. In other words, these
changes in the liver and blood are
considered to be the result of the
carcinogenic effects of UDMH, and not
due to any direct action of UDMH by a
toxicological mechanism unrelated to
carcinogenesis. In addition, it should be
noted that tumors were induced in
females in which alterations of liver
enzyme activity and hematological
parameters were minimal. Finally,
increased tumor incidences were also
seen in the lungs, an organ showing few
indications of pathological changes.
Thus, the Agency does not agree that the
observation of hematolcgical and liver
changes negates a conclusion that
UDMH should be considered a
causative agent for carcinogenesis.
e. In genp-al. Uniroyal contended that
the weight-of-evidence from the interim
results of the studies on UDMH
carcinogenicity did not support a
determination that UDMH should be
classified as a category "B2" carcinogen,
a "probable human carcinogen."
Response: Given that significant
increases in tumor incidences were seen
at more than one site, in both sexes of
mice, and to occur very early, and
because the responses occurred in the
lungs even at lower, relatively non-toxic
doses, the newer, interim data is
considered by the Agency to be
consistent with the earlier data
regarding the carcinogenicity of UDMH.
According to EPA's Guidelines for
cancer risk assessment, a chemical is
classified into category B2 when there is
sufficient evidence for carcinogenicity in
animals, but insufficient data in humans.
Sufficient evidence for carcinogenicity '
in animals occurs when there is an
increased incidence of malignant or
combined benign and malignant tumors
(a) in multiple strains or species (b) in
multiple experiments (e.g., with different
dose levels) or (c) to an unusual degree
in a single experiment. The interim
results of the studies satisfy both
categories "a" and "c" in that significant
tumor increases occurred in both mice
and hamsters and the response occurred
to an unusual degree, e.g., 84 percent
incidence of hemangiosarcomas in male
mice. Thus, since human data is
inadequate, while animal data is
sufficient, UDMH is still considered to
fit the classification weight-of:evidence
category B2.
f. Uniroyal claimed that the interim
data were also inadequate to establish a
quantitative, or dose-response, risk
estimate for UDMH.
Response: The Agency need not
develop quantitative weight-of-evidence
for a potential carcinogen as a a
necessary basis for a determination that
a toxicant of concern or wastes
containing that toxicant should be
regulated as hazardous under RCRA.
The available study on UDMH does
indicate that it is a potent carcinogen.
The final studies on UDMH
carcinogenicity to be submitted to EPA
in the future are not likely to alter this
evaluation.
g. Uniroyal also claimed that the
results from the interim studies being
conducted by Uniroyal demonstrated
that UDMH was not mutagenic.
Response: A total of 5 mutagenicity
studies were submitted by Uniroyal to
EPA during 1989 as part of the interim
results on UDMH oncogenicity. The
following three tests were considered to
be negative and acceptable: (1] The
Ames Salmonella test, (2) unscheduled
DNA synthesis, and (3) primary rat
hepatocyte and CHO/aberration. The
use of an unusual solvent (0.25 Normal
hydrochloric acid) in these tests,
however, limits the use of the results of
these tests to predict mutagenesis that.
may occur under more usual test
conditions.
Two CHO/hprt gene mutation assays
have also been submitted by Uniroyal;
one using the hydrochloric acid solvent.
In the second, an attempt was made to
buffer the solution. In these latter two
studies there were enough instances of
elevated frequencies to suggest that
there may be mutagenic activity. Taken
as a whole, therefore, the results must
be considered to be equivocal, rather
than negative.
The interim results of the mutagenicity
studies being conducted by Uniroyai
also do not call into question the
validity of the earlier UDMH tests that
were positive for mutagenicity, since the
conditions used by Uniroyal differed
from those in earlier tests. The positive
results of earlier mutagenicity studies
are discussed in the background
documentation for this final rule as well
as in the May, 1988 technical support
document developed by EPA as part of
the FIFRA reregistration review of
Alar.23
In summary, after carefully evaluating
the comments, the Agency believes that
the available evidence supports a
determination that UDMH is
carcinogenic, mutagenic, and
teratogenic.
C. Additional Waste Streams
The commenter, the generator of the
four wastes covered by today's
rulemaking, supplied information on the
generation of two additional
wastestreams, both having the potential
for significant UDMH contamination. As
a result of this new information, the
Agency, in an accompanying action in
today's Federal Register, is proposing to
add two additional waste streams from
the manufacture of UDMH from
carboxylic acid hydrazides to the list of
hazardous wastes.
V. Relation to Other Regulations
A. Toxicity Characteristics (TC)
As one of the mandates of HSWA, the
Agency expanded the toxicity
characteristics (TC) by including
additional toxic organic chemicals.
Under the March 29,1990 final rule (55
FR 11796), hazardous waste listings will ,
not be affected by the toxicity
characteristic—that is, all the listings
will remain in effect, including those
listings that were based on the presence
of TC constituents. It is EPA's intention
that the hazardous waste listings will
continue to complement the TC.
Although the TC currently does not
include UDMH as a toxicity
characteristic contaminant, any future
addition of UDMH to the TC may
capture other wastes contaminated by
UDMH that are not covered by wastes
K107, K108, K109 and KllO. In addition,
the recently promulgated TC may
capture other wastes generated by the
UDMH manufacturing industry that
contain the current toxicity
characteristic contaminants that are not
covered by wastes K107, K108, K109 and
KllO.
23 U.S. EPA, OPP (May. 1989). ibid.
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13502 Federal Register / Vol. 55. No. 85 / Wednesday, May 2, 1990 / Rules and Regulations
B. Land Disposal Restrictions
HSWA mandated that EPA
promulgate under a specific schedule
land disposal restrictions for all wastes
listed or identified as hazardous prior to
the enactment of HSWA (see RCRA
section 3004(g)(4)(C)}. HSWA also
requires the Agency to make a land
disposal prohibition determination for
any hazardous waste that is newly
identified or listed after November 8,
1984, within six months of the date of
identification or listing (RCRA sectipn
3004(g)(4), 42 U.S.C. 6924{g)(4)].
However, the statute does not provide
for an automatic prohibition of the land
disposal of such wastes if EPA fails to
meet this deadline. The Agency is
evaluating treatment standards for
newly listed wastes K107, K108. K109,
and KllO.
VI. Test Methods to Be Added to
Appendix III
Appendix III of 40 CFR part 261 is a
list of test methods that are approved
for use in demonstrating that the .
constituents of concern in listed wastes
are not present at concentrations of
concern. The Agency is designating
Method 8250 for testing for UDMH, and'
is adding this method to Appendix in of
part 261. The proposed regulation
proposed the use of Method 8250 for
testing for UDMH in the wastes (49 FR
49556]; no comments were received
regarding the use of this method for this
purpose. Method 8270 is also believed to
be a suitable method since most
commercial laboratories now prefer to
use the capillary column
chromatography specified in this method
to improve the chromatographic
resolution. The only difference between
these two methods is the use of a
capillary column gas chromatography
technique instead of a packed column
technique.
Persons wishing to submit delisting
petitions must use one of these methods
(or an equivalent ontj to demonstrate
the concentration of UDMH in their
wastes.8* (See 40 CFR 2&U22(d)(l).) As
part of their petitions, EPA requests
submission of quality control data
demonstrating that the methods they
have used yield acceptable recovery
(i.e., >80% recovery at concentrations
above 1 jxg/g) on spiked aliquots of their
waste.
The above methods are in "Test
Methods for Evaluating Solid Waste:
Physical/Chemical Methods," SW-846,
14 Pelilloncra may use other methods to analyze
Tor UDMH if. among other things, they demonstrate
the equivalency of these methods by submitting
their quality control and assurance information
along with their analysis data. (See 40 CFR 260.21.)
3rd Ed., as updated, available from:
Superintendent of Documents,
Government Printing Office,
Washington, DC 20402, .(202] 783-3238,
Document Number: 055-002-81001-2.
VH. CERCLA Impacts
All listed hazardous wastes, as well
as any solid waste that exhibits one or
more of the characteristic? of a
' hazardous waste (as defined in 40 CFR
261.21 through 26124], are hazardous
substances under section 101(14)(C) of
the Comprehensive Environmental
Response, Compensation, and Liability
Act of 1980, as amended (CERCLA].
(CERCLA hazardous substances are
listed in Table 302.4 at 40 CFR 302.4,
along with their reportable quantities
(RQs].) CERCLA section 103(a] requires
that persons in charge of vessels or
facilities from which a hazardous
substance has been released in a
quantity that is equal to or greater than
its RQ immediately notify the National
Response Center of the release [at (800)
424-8802 or in the Washington, DC
metropolitan area at (202] 426-2675]. In
addition, section 304 of the Superfund
Amendments and Reauthqrization Act
of 1986 (SARA] requires the owner or
operator of a facility to report the
release of a hazardous substance to the
appropriate state emergency response
commission (SERC] and to the local
emergency planning committee (LEPC]
when the amount released equals or
exceeds the RQ for the substance.
According to the "mixture rule" used
for notification under CERCLA and
SARA (50 FR 13463, April 4,1985], the
release of mixtures must be reported
when the amount released equals or
exceeds the RQ for the waste, unless the
concentrations of the constituents of the
waste are known. When the
concentrations of the individual
constituents of a hazardous waste are
known, the release of the hazardous
waste would need to be reported to the
NRC and to the appropriate LEPC and
SERC when the RQ of any of the
hazardous constituents is equaled or
exceeded. RQs of different hazardous
substances are not additive under the
mixture rule (except for radionuclides,
see 54 FR 22536, May 24,1989], so that
spilling a mixture containing half an RQ
of one hazardous substance and half an
RQ of another hazardous substance
does not require a report
Under Section 102 of CERCLA, all
hazardous wastes newly designated
under RCRA will have a statutorily-
imposed RQ of one pound unless and
until adjusted by regulation under
CERCLA. In order to coordinate the
RCRA and CERCLA rulemaking with
respect to new waste listings, the
Agency also proposed on December 20,
1984 regulatory amendments under
CERCLA authority in connection with
the proposed listings'to: (1) Designate
wastes K107 to KllO based on the
hazardous substances under section 102
of CERCLA; and (2] adjust the RQs of
wastes K107 to KllO based on the
application of the RQ adjustment
methodology under section 102(a] (49 FR
49556).
The RQs for each waste and for each
of the hazardous constituents are
identified in the table below. The
constituent of concern, UDMH, has an
RQ that has undergone adjustment since
the proposed listing of UDMH
production wastes. On August 14,1939,
EPA adjusted the RQ for UDMH from
one pound to 10 pounds (54 FR 33426).
The adjustment of the RQs of wastes
K107, K108, K109 and KllO from the
statutory one-pound level is based on
the current RQ of the constituent in
these listings. Because the only toxic
constituent of concern in the wastes
(UDMH] has an RQ of 10 pounds, the-
RQs of the four wastes likewise are
being set today as 10 pounds. These RQs
will become effective on the effective
date of today's action, when the wastes
simultaneously become hazardous
substances under CERCLA.
Hazardous substance
Waste No. K107
Waste No. K108
Waste No K109 . . .
Waste No K110
Con-
stituent
UDMH...
UDMH...
UDMH...
UDMH...
'RQ
10 Ibs.
.10 ibs.
10 Ibs.
10 Ibs.
10 Ibs.
10'lbs.
10 Ibs.
10 Ibs.
VIII. State 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. (See 40 CFR
part 271 for the standards and
•requirements for authorization.)
Following authorization, EPA retains
enforcement authority under sections
3007, 3008, 3013, and 7003 of RCRA,
although authorized States have primary
enforcement responsibility.
Prior to the Hazardous and Solid
Waste Amendments of 1984 (HSWA), a
State with final authorization
administered its hazardous waste
program entirely in lieu of EPA
administering the Federal program in
that State. The Federal requirements no
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Federal Register / Vol. 55. No. 85 / Wednesday. May 2. 1990 / Rules and Regulations 13503
However, any person who generates,
transports, treats, stores, or disposes of
these wastes has not previously notified
and received an identification number,
that person must notify EPA or an
authorized State no later than July 31,
1990, of these activities pursuant to
section 3010 of RCRA. Notification .
instructions are set forth in 45 FR 12746,
February 26,1980.
longer .applied in the authorized State,
and EPA could not issue permits for any
facilities in the State that the State was
authorized to permit. When new, more
stringent Federal requirements were
promulgated or enacted, the State was
obliged to enact equivalent authority
withiri specified time frames. New
Federal requirements did not take effect
in an authorized State until the State
adopted the requirements as State law.
In contrast, under section 3006(g) of
RCRA, 42 U.S.C. 6926{g). new
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 hi
authorized States, 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, the HSWA applies in
authorized States in the interim.
Today's rule is promulgated pursuant
to section 3001(e)(2) of RCRA, a
provision added by the HSWA.
Therefore, these wastes have been
added to Table 1 in 40 CFR 271.1(j),
which identifies the Federal program
requirements that are promulgated
pursuant to HSWA, and that take effect
in all States, regardless of their
authorization status. States may apply
for either interim or final authorization
for the HSWA provisions identified hi
Table 1, as discussed in the following
section of this preamble. Because EPA
promulgated rules regarding the timing
for HSWA listings after this rule was
proposed, the existing regulatory time
frames supersede the'discussions hi the
preamble to the proposed rule.
B. Effect on State Authorizations
As noted above, EPA will implement
today's rule in authorized States until
they modify their programs to adopt
these rules, and the modification is
approved by EPA. Because the rule is
promulgated pursuant to HSWA, a State
submitting a program modification may
apply to receive either interim or final
authorization under section 3006(g)(2) or
3006(b), respectively, on the basis of
regulations that are substantially
equivalent or equivalent to EPA's. The
procedures and schedule for State
program modifications under section
3006(b) are described in 40 CFR 271.21.
The same procedures should be
followed for section 3006(g){2).
Section 271.21(e)(2) requires that
States that have final authorization
must modify their programs to reflect
Federal program changes and must
subsequently submit the modifications
to EPA for approval. State program
modifications to1 conform to today's rule
must be made by-July 1.1991. if only
regulatory changes are necessary, or by
July 1,1992, if statutory changes are
necessary. See 40 CFR 271.21(e)(2)(iv)
and 271.21(e)(2)(v). These deadlines can
be extended hi exceptional cases. See 40
CFR 271.21(e)(3).
States with authorized RCRA
programs already may have regulations
• similar to those in today's rule. These
State regulations have not been
assessed against the Federal regulations
being promulgated today"to determine
whether they meet the tests for
authorization. Thus, a State is not
authorized to implement these
regulations in lieu of EPA until the State
program modification is approved. Of
course. States with existing regulations
may continue to administer and enforce
their regulations as a matter of State
law. In implementing the Federal
program,-EPA will work with States
under cooperative agreements to
minimize duplication of efforts. In many
cases, EPA will be able to defer to the
States in their efforts to implement their
programs, rather than take separate
actions under Federal authority.
• States that submit official applications
for final authorization less than 12
months after the effective date of these
regulations are not required to include
standards equivalent to these standards
in their applications. However, a State
must modify its program by the
deadlines set forth in 40 CFR 271.21(e).
States that submit official applications
for final authorization 12 months after
the effective date of these standards
must include standards in their
application. Section 271.3 sets forth the
requirements a State must meet when
submitting its final authorization.'
application.
IX. Compliance Dates
A. Notification
Under section 3010 of RCRA, EPA
may waive the notification requirement
otherwise applicable to persons
managing newly-regulated hazardous
waste. The Agency has decided to
waive the RCRA section 3010
notification requirement for only those
persons who generate, transport, treat,
store, or dispose of hazardous wastes
subject to today's rule that have
previously notified EPA or an authorized
State of hazardous waste activities and
have received an Identification number.
The Agency believes that most, if not
all, persons who manage these wastes
have already notified EPA and received
an EPA identification number and
therefore will not have to re-notify.
B, Permitting
Because HSWA requirements are
applicable hi authorized States at the
same time as in unauthorized States,
EPA will regulate K107-K110 until States
are authorized to regulate these wastes.
Thus, once this regulation becomes
effective, EPA will apply Federal
regulations to these wastes and to their
management in both authorized'and
unauthorized States. Facilities that treat,
store, or dispose of K107-K110, but that
have not received a permit pursuant to
section 3005 of RCRA and are not
operating pursuant to interim status,
might be eligible for interim status under
HSWA (see section 3005(e)(l)(A)(ii) of
RCRA, as amended). In order to operate
pursuant to interim status, the eligible
facilities are required to possess an EPA
ID number pursuant to 40 CFR 270.70{a),
and will be required to submit a Part A
permit application by November 2,1990.
Currently permitted facilities that
manage UDMH wastes must submit
Class 1 permit modifications if they are
to continue managing the newly
regulated wastes in units that require a
permit. The facilities must obtain the
necessary modification by the effective
date of the rule, or they will be
prohibited from accepting additional
UDMH wastes.
Interim status facilities that manage
UDMH wastes in units that require a
permit must file an amended Part A
permit application under 40 CFR
270.10(g) if they are to continue
managing newly regulated wastes. The
facilities must file the necessary
amendments by the effective date of the
rule, or they will not receive interim
status with respect to the UDMH wastes
(i.e., they will be prohibited from
accepting additional UDMH wastes until
permitted). 4
Newly regulated facilities (i.e.,
facilities at which the only hazardous
wastes that are managed are newly
regulated UDMH wastes) must qualify
for interim status by the compliance
date of the rule in order to continue
managing UDMH wastes prior to
receiving a permit. Under 40 CFR 270.70,
an existing facility may obtain interim
status by getting an EPA identification
number and submitting a Part A permit
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18504 Federal Register / Vol. 55. No. 85 / Wednesday. May 2. 1990 / Rules and Regulations
application by the effective date of this
rule. To retain interim status, a newly-
regulated land disposal facility must
submit a Part B permit application
within one year after the effective date
of the rule and certify that the facility is
in compliance with all applicable ground
water monitoring and financial
responsibility requirements (see RCRA
section 3005(e)(3)).
EPA recently promulgated
amendments to the procedures for
permit modifications for treatment,
storage, and disposal facilities (see 53 '
FR 37934, September 28,1988). The
following discussion assumes *•
implementation in accordance with the
new rule. EPA will implement the
UDMH listing regulations by using the
new permit modification procedures,
consistent with EPA policy (see 53 FR
37933, September 28,1988).
Under the new regulation in 40 CFR
270.42, there are now three classes of
permit modifications with different
submittal and public participation
requirements for each class. In 40 CFR
270.42(g), which concerns newly listed
or identified wastes, a permitted facility
that is "in existence" as.a hazardous
waste facility for the newly listed or
identified waste on the effective date of
the notice must submit a Class 1
modification by that date. Essentially, '
this modification is a notification to the
Agency that the facility is handling the
waste. As part of the procedure, the.
permittee must also notify the public
within 90 days of submittal to the
Agency.
Next, within 180 days of the effective
date, the permittee must submit a Class
2 or 3 modification to the Agency. A
permittee may submit a Class 2
modification if the newly regulated
waste will be disposed in existing TSD
. units and will not require additional or
different management practices from
those authorized in the permit. A Class 1
modification requires public notice by
the facility owner of the modification
request, a 60 day public comment
period, and an informal meeting
between the owner and the public
within the 60 day period. The rule
includes a "default provision," so that
for Class 1 modifications, if the Agency
does not make a decision within 120
days, the modification is automatically
authorized for 180 days. If the Agency
dees not reach a decision by the end of
that period, the modification is
permanently authorized. If the newly
regulated waste requires additional or
different management practices, a Class
3 modification is required. The initial
public notification and public meeting
requirements are the same as for Class
2. However, after the end of the public
comment period, the Agency will
develop a draft permit modification,
open a public comment period of 45
days and hold a public hearing.
X. Regulatory Impact Analysis
Under Executive Order 12291, EPA
must determine whether a regulation is
"major" and, therefore, subject to the
requirement of a Regulatory Impact
Analysis. The generator subject to
today's rule, Uniroyal Corporation, is
not currently manufacturing UDMH. As
a result, none of the wastes covered by
this final regulation are currently being
generated, and therefore no costs from
their management as hazardous would
be incurred at the present time.
However, Uniroyal may resume
production; when this occurs the total
additional incurred cost for disposal of
the wastes as hazardous would be less
than $2,000 (based on previous •
production levels), well under the $100
million constituting a major regulation.
This cost would be insignificant and
would result from minimal"additional
compliance requirements, as these
wastes were already handled as if they
were hazardous.
Since EPA does not expect that the
amendments promulgated here will have
an annual effect on the economy of $100
million-or more, result in a measurable
increase in cost or prices, or have an
adverse impact on the ability of U.S.-
based enterprises to compete in either
domestic or foreign markets, these
amendments are not considered to
constitute a major action. As such, a
Regulatory Impact Analysis is not
required.
The Agency received comments on
the economic impact analysis included
with the December 20,1984 proposed
regulations. Uniroyal criticized the
Agency's economic analysis because it
did not consider the impact of co-
disposal of the aqueous wastes with
other plant wastes by deep well
injection. Uniroyal contended that in the
event that the subject hazardous wastes
are mixed with other solid wastes, the
resulting mixture would be hazardous
wastes by the mixture rule (see 40 CFR
*.WA.wlujl~Sl»**.;j.
Because the commenter ceased
undergr^'m^ injection, of their UDMH
manufacturing wastes in May, 1985
(because of having ceased the
production of UDMH itself), long before
promulgation-of today's rule, the
commenter will not be subject to the
permitting requirements of parts 144 and
148 for Class 1 wells receiving hazardous
wastes (assuming no other hazardous
wastes are being injected). As a result,
no additional management costs would
be incurred by a designation as
hazardous wastes formerly disposed in
this manner. The commenter would still
be required to-comply with the parts 144
and 146 requirements for Class 1 wells
for the disposal of non-hazardous
industrial wastes, however, if the deep
well continues to receive other wastes
from the facility not regulated as
hazardous under RCRA.
XI. Regulatory Flexibility Act
Pursuant to the Regulatory Flexibility
Act, 5 U.S.C. sections 601-612, whenever
an agency is required to publish a
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
organization's, and small governmental
jurisdictions). No regulatory flexibility
analysis is required, however, if the
head of the agency certifies that the rule
will not have a significant economic
impact on a substantial number of small
entities. • .
The hazardous wastes listed here are
not generated by small entities (as
defined by the Regulatory Flexibility
Act), and the Agency received no'
comments that small entities will
dispose of them in significant quantities.
Accordingly, I hereby certify that this
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.
XII. Paperwork Reduction Act
This rule does not contain any
information collection requirements
subject to OMB review under the
Paperwork Reduction Act of 1980, 44
U.S.C. section 3501 et seq.
list of Subjects
40 CFR Part 261
Hazardous waste, Recycling.
40 CFR Part 271
Administrative practice and
procedure. Confidential business
information, Hazardous materials
transportation, Hazardous waste, Indian
lands. Intergovernmental relations.
Penalties, Reporting and recordkeeping
requirements, Water pollution control,
Water supply.
40 CFR Part 302
Air pollution control. Chemicals,
Hazardous materials. Hazardous
materials transportation. Hazardous
substances, Intergovernmental relations,
Natural resources, Nuclear materials.
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Federal Register / Vol. 55, No. 85 / Wednesday, May 2, 1990 / Rules and Regulations ' 18505
Pesticides and pests. Radioactive
materials, Reporting and recordkeeping
requirements, Superfund, Waste
treatment and disposal, Wa,ter pollution
control.
Dated: April 23,1990.
William K. Reffly,
Administrator.--*'
For the reasons set out in the
preamble. Title 40 of the Code of Federal
Regulations is amended as follows:
PART 261—IDENTIFICATION AND
LISTING OF HAZARDOUS WASTE
1. The authority citation for part 261
continues to read as follows:
Authority: 42 U.S.C. 6905, 6912fa), 6921,
6922, and 6938.
2. In § 261.32, add the following waste
streams to the subgroup 'Organic
Chemicals':
§ 261.32 Hazardous wastes from specific sources.
Industry and EPA
hazardous waste No.
Hazardous waste
Hazard
code
Organic chemicals:
• «••»«•
K107 Column bottoms from product separation from the production ol 1,1-dirnethvl-riydrazine (UDMH) from carboxylic acid (C,T)
hydrazines.
K108 _ _. Condensed column overheads from product separation and condensed reactor vent gases from the production of 1,1- (I,T)
dimethylhydrazine (UDMH) from carboxylic acid hydrazides.
K109 ...... Spent filter cartridges from product-purification from the production of 1,1-dimethylhydrazine (UDMH) from carboxylic acid (T)
hydrazides.
K110 _ _ Condensed column overheads from intermediate separation from the production of 1,1-dimethy!hydrazin8 (UDMH) from (T)
carboxylic acid hydrazides.
3. Add the following compound and
analysis methods in alphabetical order
to Table 1 of Appendix III of part 261:
Appendix III—Chemical Analysis Test
Methods .
TABLE 1.—ANALYSIS METHODS FOR OR-
GANIC CHEMICALS CONTAINED IN SW-
846
Compound
Method
No.
4. Add the following entries in
numerical order to Appendix VII of part
261:
Appendix VII—Basis for Listing
Hazardous Waste
EPA
hazardous
waste No.
Hazardous constituents for which listed
K107 1,1-Dimethylhydrazine (UDMH).
K108 1,1-Dimethylhydrazine (UDMH).
K109 1,1-Dimethylhydrazine (UDMH).
K110 1,1-Dimethylhydrazine (UDMH).
PART 271—REQUIREMENTS FOR
AUTHORIZATION OF STATE
HAZARDOUS WASTE PROGRAMS
5. The authority citation for part 271
continues to read as follows:
Authority: 42 U.S.C. 6905, 6912(a), and 6926.
6. Section 271.1(j) is amended by
adding the following entry to Table 1 in
chronological order by date of
publication:
§ 271.1 Purpose and scope.
*****
(]}***
1,1-Dimethyihydrazine (UOMH).
8250
TABLE 1.—REGULATIONS IMPLEMENTING THE HAZARDOUS AND SOLID WASTE AMENDMENTS OF 1984
Promulgation
date
Title of regulation
Federal
Register refer- Effective date
ence
May 1, 1990 Listing Wastes from the Production of UDMH from Carboxylic Acid Hydrazides..
(insert Federal November 2,
Register 1390.
page
numbers].
-------
18506 Federal Register / Vol. 55, No. 85 / Wednesday, May 2. 1990 / Rules and Regulations
PART 302—DESIGNATION,
REPORTABLE QUANTITIES, AND
NOTIFICATION
' 7. The authority oitiation for part 302
continues to read as follows:
Authority: Sees. 101(1)(14) and 102(b) of the 8. Section 302.4 is amended by adding
Comprehensive Environmental Response, the waste streams K107, K108, K109, and
Compensation and Liability Act of 1980, 42 K110 to Table 302.4.
U.S.C. 9601(14) and 9602; sees. 311 and 501(a)
of the Federal Water Pollution Control Act,
33 U.S.C. 1321 and 1361.
§ 302.4 Designation of hazardous
substances.
TABLE 302.4—LIST OF HAZARDOUS SUBSTANCES AND REPORTABLE QUANTITIES
Hazardous substance
* • « •
Column bottoms from product separation from the production of 1,1-dimethylhy-
drazine (UOMH) from carboxylic acid hydraa'nes.
Condensed column overheads from product separation and condensed reactor
vont gases from the production of 1,1-dimethyihydrazine (UDMH) from carbox-
ylic acid hydrazides.
J(1Q9
Spent fitter cartridges from product purification from the production of 1,1-
dmathyihydrazine (UDMH) (ram carboxylic add hydrazides.
Condemsod column overheads from intermediate separation from the production
of l.l-dmettiylhyoVazina (UDMH) from carboxylic acid hydrazides.
• • • •
,
CASRN
Regulatory
synonyms
•
*
RQ
10
10
10
10
Statutory
Code
• •
4
4
4
4
0
RCRA
waste
num-
ber
K107
K108
KI09
K110
Rna
Category
*
X
X
X
X
«
RQ
Pounds
(kg)
10 (4.54)
10 (4.54)
10 (4.54)
10 (4.54)
14—indicates that the statutory source lor designation of this hazardous substance under CERCLA is RCRA section 3001.
[FR Doc. 90-9978 Filed 5-1-90; 8:45 am]
OIUJHQ CODE 85W-50-V
-------
Federal Register /Vol. 55, No. 85 / Wednesday, May 2, 1990 / Proposed Rules 18507
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Parts 261,271, and 302
[SWH-FRL-3719-7]
Hazardous Waste Management
System: Identification and Listing of
Hazardous Waste and CERCLA
Hazardous Substance Designation;
Reportable Quantity Adjustment—1,1-
Dimethylhydrazine Production Wastes
AGENCY: Environmental Protection
Agency.
ACTION: Proposed rule and request for
comments.
SUMMARY: The Environmental Protection
Agency (EPA) today is proposing to
amend the regulations for hazardous
waste management under the Resource
Conservation and Recovery Act (RCRA)
by listing as hazardous two wastes
generated during the production of 1,1-
dimethylhydrazine (UDMH) from
carboxylic acid hydrazides. The effect of
this proposed regulation, if promulgated,
is that these wastes will be subject to
regulation under 40 CFR parts 262r-266,
and parts 270, 271, and 124.
In addition, the Agency is also
proposing.amendments to regulation
promulgated under the Comprehensive
Environmental Response,
Compensation, and Liability Act
(CERCLA) in 40 CFR part 302 that are
related to today's proposed waste
listings. In particular, EPA is proposing
to designate as CERCLA hazardous
substances the wastes proposed {or
listing under RCRA and would establish
the reportable quantities applicable to
those wastes.
DATES: EPA will accept public
comments on this proposed rule until
June 18,1990. Comments postmarked
after this date will be marked "late" and
may not be considered.
ADDRESSES: The public must send an
original and two copies of their
comments to: EPA RCRA Docket Clerk,
(OS-332), Room 2427, 401 M Street SW,
Washington, DC 20460. Place "Docket
number F-90-UDMP-FFFFF" on your
comments. Copies of materials relevant
fo this proposed rulemaking:are located
in the docket at the address listed
aoove. The public must make an
appointment to review docket materials
by calling (202) 475-9327. Copies of the
non-CBI version of the listing
background document, Health and
Environmental Effects Profiles, and not
readily available references are
available for viewing and copying only
in the OSW docket.
Comments on the CERLA proposal
should be sent in triplicate to:
Emergency Response Division, Docket
Clerk, Attn: Docket No. RQ, Room 2427,
U.S. EPA, 401 M Street SW.,
Washington, DC 20460.
• Copies of materials relevant to the
CERCLA portions of this rulemaking are
located in Room 2427 at the above
address. Both dockets are available for
inspection from 9:00'a.m. to 4:00 p.m.,
Monday through Friday. The public may.
copy 100 pages from either docket at no
charge; additional copies are $0.15 per
page.
FOR FURTHER INFORMATION CONTACT:
The RCRA/Superfund Hotline, toll-free
at (800) 424-9346 or at (202) 382-3000.
For technical information on the RCRA
hazardous waste listing, contact Dr.
Gate Jenkins, Office of Solid Waste
(OS-333), Environmental Protection
Agency, 401M Street SW., Washington,
DC 20460, (202) 382-4786. For technical
information on the CERCLA proposed
rule, contact: Ms. Ivette Vega, Response
Standards and Criteria Branch,
Emergency Response Division (OS-210),
U.S. EPA, 401 M Street SW.,
Washington, DC 20460.
SUPPLEMENTARY INFORMATION: The
contents of today's preamble are listed
in the following outline:
I. Legal Authority
II. Background
III. Summary of the Proposed Regulation
IV. Relation to Other Regulations
A. Proposed Toxicity Characteristic
B. Land Disposal Restrictions
C. Regulation of UDMH under FIFRA
V. Test Methods for Compounds Added to
Appendix VII
VI. CERCLA Designation and Adjustment
VII. State Authority
A. Applicability of Rules in Authorized
States
B. Effect on State Authorizations
VIII. Compliance Dates
A. Notification
B. Permitting
IX. Regulatory Impact Analysis
X. Regulatory Flexibility Act
XI. Paperwork Reduction Act
I. Legal Authority
These proposed regulations would be
promulgated under the authority of
sections 2002(a) and 3001 (b) and (e)(2)
of the Solid Waste Disposal Act, as
amended, 42 U.S.C. 6912(a) and 6921(b)
and (e)(2) (commonly referred to as
RCRA), and section 102(a) of the
Comprehensive Environmental
Response, Compensation, and Liability
Act of 1980, 42 U.S.C. 9602(a).
II. Background
As part of its regulations
implementing section 3001 of RCRA,
EPA publishes a list of hazardous
wastes which includes hazardous
wastes generated from specific sources.
This list has been amended several
times, and is published in 40 CFR 261.32.
In today's action, EPA is proposing to
amend this section to add two wastes
generated during the manufacture of 1,1-
dimethyl hydrazine (also known as
unsymmetrical dimethylhydrazine, or
UDMH) from carboxylic acid
hydrazides. These wastes are (1) spent
catalyst and filter media, and (2) flush
water from the catalyst Temoval system.
On December 20,1984, the Agency
proposed to list as hazardous four
UDMH process wastes (see 49 FR
49556). These four listings are being
promulgated as final rules in an
accompanying document published
elsewhere in today's Federal Register.
As a result of public comments on those
listings, EPA obtained additional data
that would support the listing of two
. additional waste streams from the
manufacture of UDMH; as a result, these
two wastes are today being proposed to
be added to the list of hazardous wastes
under 40 CFR 261.32.
The basis for this proposed regulation
is'a determination by the Agency that
these wastes contain significant
concentrations of 1,1-dimethylhydrazine
(UDMH). UDMH is carcinogenic,1
mutagenic, and teratogenic. UDMH is
typically present in each waste at
significant levels. In addition, UDMH is
mobile and persistent, and can reach
environmental receptors in harmful
concentrations if these wastes are
mismanaged.
November 8,1984, the Hazardous and
Solid Waste Amendments of 19S4
(HSWA) were enacted. These
amendments had far reaching
ramifications for EPA's hazardous waste
regulatory program. Section 3001(e)(2),
which was one of the many provisions
added by HSWA, directed EPA to make
a decision on whether or not to list
certain specified wastes, including
wastes from the manufacture of UDMH,
as hazardous. Today's proposed rule
would fulfill this mandate, in part, by
listing two additional UDMH production
wastes.
1 On August 17,1989, the Agency made available
for public comment additional data regarding the
carcinogenicity of UDMH (see 54 FR 33942). The
Agency requested comments on the use of this new
data to support the determination that UDMH is a
potential human carcinogen. The comments
received on the use of this data are responded to in
the accompanying Federal Register notice which
finalizes the hazardous waste listing of four other
UDMH manufacturing wastes. EPA determined that
these comments on the additional data did not
refute the Agency's conclusion that UDMH is
carcinogenic.
-------
HI. Summary of the Proposed Regulation
This proposed regulation would
designate as hazardous the following
wastes generated during the
manufacture of UDMH from carboxylic
add hydrazides:
» K137—Flush water from catalyst'
removal system from the production of -
1,1-dimethylhydrazine (UDMH) from
carboxylic acid hydrazides
» K138—Spent catalyst and filter
media from.the production of 1.1-
dimethylhydrazine (UDMH) from
carboxylic acid hydrazides.
Currently, only one manufacturer*
Uniroyal Corporation, uses this
proprietary process to produce UDMH.
At the present time, the generator of
these wastes is not manufacturing
UDMH. and thus is not generating .the
wastes. Production of UDMH may
resume in the future, however, since
UDMH has a number of different uses.
(See the Listing Background Document,
available in the ADDRESSES section of
this Notice.) Available information in
the Section 3007 RCRA Industry Studies
data base indicates that approximately
443 kkg (metric tons) per year of total
wastes would be covered by this
proposed regulation, assuming previous
production levels.
The hazardous constituent of. onnnfirn
in these wastes is UDMH. UDMH is
carcinogenic, mutagenic, and
teratogenic. UDMH is typically present
in each waste at significant levels, as
high as 0.01 percent. In addition, UDMH
is mobile and persistent, and can reach
environmental receptors in harmful
concentrations If these wastes are
mismanaged.
The Agency's determination that
UDMH is carcinogenic is discussed in
greater detail in the accompanying
Federal Register document which
finalizes the listing of four other UDMH
manufacturing wastes. This
determination was based on the Health.
and Environmental Effects Profile
(HEEP) for UDMH,2 the final
determination by the Agency's
Carcinogen Assessment Group (GAG,
now the Human Health Assessment
Group) that UDMH is carcinogenic,3 and
a May 15,1909 peer reviewed assessment
by the Agency of new data that also
supports the determination that UDMH
is carcinogenic.4 These assessments are
available from the RCRA Docket for this
proposed rule (see "ADDRESSES" section
of this proposal).
The first proposed listed waste (K137)
is the flush water from the catalyst
removal system from the manufacture of
UDMH using carboxylic acid
hydrazides. Uniroyal Corporation has
supplied information to the Agency
indicating that this waste contains up to
0.01% UDMH (trace to 100 parts per
million). (More definitive concentration
information would need to be submitted
by Uniroyal if there is any reason to.
believe that this waste may not contain
environmentally significant UDMH
concentrations.) Approximately 437 kkg
of this waste are generated annually.
The second proposed listed waste
(K138) is the spent catalyst and filter
media from the manufacture of UDMH
using carboxylic acid hydrazides.
Uniroyal Corporation has supplied
information indicating that this waste
also contains up to 0.01% UDMH (trace
to 100 parts per million). (More
definitive concentration information
would need to be submitted by Uniroyal
if there is any reason to believe that this
waste may not contain environmentally
significant UDMH concentrations.)
• -Approximately 6 kkg of this waste are
generated annually; this waste is sent
off-site to a catalyst manufacturer to be
reclaimed for reuse as catalyst material.
The Agency has made a preliminary
estimate that persons face a one per
million increased risk of cancer as a
result of a lifetime daily dose of 1.15 X
10"7 milligrams UDMH per kilogram
body weight, or 8.05 X 10~6 milligrams
for a seventy kilogram man (U.S. EPA,
1980-1984). The basis for this estimate is
exnlained further in the Listing
Background Document. The
corresponding concentration in drinking
water ingested over a lifetime resulting
in a one-per-million increased risk of
cancer is 4.03 X 10~3 milligrams per liter
(parts per million), or 4.03 X lO'10
percent. Interim risk levels based on
new data submitted to EPA by Uniroyal
indicate a similar carcinogenic potency
of UDMH.5 i
' U.S. EPA (1984) Health and Environmental
Effects Profile (brl.l-Dimelhylhydrazine. Prepared
by Environmental Criteria and Assessment Office,
Cincinnati. OH, Document No. ECAO-CIN-026.
3 U.S. EPA. CAG dune. 1988) Evaluation of the
Potontinl GuclnoRcnicity of 1,1-Dimelhylhydrazine
(57-14-7). in Support of Reportable Quantity
Adjustments Pursunnt to CERCLA section 102
|OI IEA-C-073-95. |unu.1S88. Final).
4 U.S. EPA. Office of Pesticides and Toxic
Substances (May IS. 1989) Second Peer Review of
Daminozide (Alar) and UDMH'tUnsymmetrical 1.1-
dimethylhydrazine).
5 U.S. EPA. Office of Pesticide Programs (May
1SB9) Daminozide Special Review Technical
Support Document—Preliminary Determination to
Cancel the Food Uses of Daminozide. Available
from the OPP Docket in support of the May 24.1989
proposal cancellation of Daminozide (54 FR 22558)
as well as the Docket for this proposed rule.
Thus, the concentrations of UDMH in •
these wastes are many orders of
magnitude greater than the levels
related to this human health risk. For
example, if the wastes were
contaminated with even one part per
million of UDMH, then the
concentration would approach one
million times the level related to human
health risks in drinking water.
UDMH is soluble in water in all .
proportions (miscible) (U.S. EPA, 1980-
1984). In addition, UDMH's low octanol-
water partition coefficient and complete
miscibility with water indicate that
UDMH in any'waste contacting soil may
migrate and contaminate ground water
without being absorbed onto the soil
matrix. UDMH also has been shown to
leach and migrate in experimental soil
columns (Braun, 1983). The UDMH in the
wastes thus has a high mobility and
migratory potential. In addition, under
conditions typical of waste
mismanagement, UDMH is persistent
enough to cause harmful exposures.
Only a fraction of the toxicant present in
these wastes need migrate and reach
environmental receptors to pose the
potential for substantial harm.
The primary degradation mechanisms
of UDMH in the unsaturated soil zone or
aerated surface waters is expected to be
oxidation, presumably with dissolved
oxygen and free radicals. In the absence
of microbial degradation the half-life of
UDMH was reported to be 10 to 14 days
in ponds and seawaters (Zirrolli, 1983).
In anaerobic conditions, such as in
ground water, however, UDMH has the
potential for persisting for much longer
periods. UDMH was found to be
extremely stable in distilled water
(Braun, 1983).
The potential for aerobic
biodegradation of UDMH in water has
not been explored thoroughly, but may
be minor relative to oxidation under
neutral to basic conditions. UDMH-
oxidation was found to proceed at the
same rate in sterile or non-sterile lake
water as well as in pure distilled water
(Baneriee; 1977,1981). Under anaerobic
conditions, the loss of UDMH with
anaerobic bacteria was 26 percent after
a six-day bioassay. Biodegradation of
UDMH may also be limited by its
toxicity; aerobic bacterial degradation
was inhibited when UDMH
concentrations were as low as 20 parts
per million (Kane, 1983).
UDMH could also be released to the
atmosphere by evaporation from spills,
leaks, and venting during loading,
transfer, storage, or treatment.
Evaporation of UDMH from water
solutions are expected to be significant
(MacNaughton, 1975: Stauffer, 1977).
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Federal Register / Vol, 55, No. 85 / Wednesday, May 2, 1990 / Proposed Rules
18S09
Once volatilized, UDMH may degrade
by reaction with hydroxyl radicals
(Pitts, 1981), NO2 or ozone (Tuazon,
1982).
EPA has evaluated these wastes
against the criteria for listing hazardous
wastes (40 CFR 261.11(a)), and believes
that they typically contain high
concentrations or have the potential for
containing high concentrations of
UDMH (the hazardous constituent of
concern) and this toxicant is mobile and
persistent in the environment in
situations similar to waste
mismanagement, and may reach
environmental receptors in harmful
concentrations. The Agency believes,
therefore, that these wastes are capable
of posing a substantial present or
potential threat to human health or the
environment when improperly treated,
stored, transported, disposed of, or
otherwise managed, and thus should be
regulated as hazardous wastes.
Additional information on the hazards
of these wastes and the toxic
constituents of these wastes may be
found in the listing background
document and other supporting
documentation available as described in
the "ADDRESSES" section.
IV. Relation to Other Regulations
A. Toxicity Characteristics
As one of the mandates of HSWA, the
Agency expanded the toxicity
characteristics (TC) by including
additional toxic organic chemicals.
Under the March 29,1990 final rule (55
FR11796), hazardous waste listings will
not be affected by the toxicity
characteristic—that is, all the listings
will remain in effect, including those
listings .that were based on the presence
of TC constituents. It is EPA's intention
that the hazardous waste listings will
continue to'complement the TC.
Although the TC currently does not
include UDMH as a toxicity
characteristic contaminant, any future
addition of UDMH to the TC may
capture other wastes contaminated by
UDMH that are not covered by wastes
K107, K108, K109 and KllO. In addition,
the recently promulgated TC may •
capture other wastes generated by the
UDMH manufacturing industry that
contain the current toxicity
characteristic contaminants that are not
covered by wastes K137 and K138, as
well as K107, K108, K109, and KllO.
B. Land Disposal Restrictions
HSWA mandated that EPA
promulgate under a specific schedule
land disposal restrictions for all wastes
listed or identified as hazardous prior to
the enactment of HSWA (see RCRA
3004(g)(4)(C)). HSWA also requires the
•Agency to make a land disposal
prohibition determination for any
hazardous waste that is newly identified
or listed after November 8,1984, within
six months of the date of identification
or listing (RCRA section 3004(g)(4), 42
U.S.C. 6924(g)(4)). However, the statute
does not provide for an automatic
prohibition of the land disposal of such
wastes if EPA fails to meet this
deadline.
V. Test Methods To Be Added to
Appendix III
Appendix" III of 40 CFR part 261 is a
list of test methods that are approved
for use in demonstrating that the
constituents of concern in listed wastes
are not present at concentrations of
concern. In an accompanying document
published in today's Federal Register,
the Agency added Method 8250 to
Appendix III of part 261 for testing of
UDMH in the final rule which listed
K107-K110 UDMH manufacturing
wastes. The Agency believes that
Methods 8250 as well as 8270 would also
be appropriate for testing UDMH hi the
proposed hazardous wastes—K137 and
K138—and solicits comments in this
regard. The only difference between
Method 8270 and 8250 is the fact that
Method 8270 uses a capillary column gas
chromatography technique-instead- of-
the packed column technique specified
in Method 8250. Most commercial
laboratories now prefer to use capillary
column chromatography to improve •
chromatographic resolution. The Agency
is also proposing to add Method 8270 to
Appendix III for the four other UDMH.
manufacturing wastes subject to the
final regulation, K107-K110.
Persons wishing to submit delisting
petitions would be required to use one
of these methods (or an equivalent one)
to demonstrate the concentration of
UDMH in their wastes.8 (See 40 CFR
260.22(d)(l).J As part of their petitions,
EPA requests submission of quality
control data demonstrating that the
mediods they have used yield
acceptable recovery (i.e., >80%
recovery at concentrations above 1 ng/g)
on spiked aliquots of their waste.
The above methods are in "Test
Methods for Evaluating Solid Waste:
Physical/Chemical Methods," SW-846,
3rd Ed., as updated, available from:
Superintendent of Documents,
Government Printing Office,
' Petitioners may use other methods to analyze
for UDMH if. among other things, they demonstrate
the equivalency of these methods by submitting
their quality control and assurance information
along with their analysis data. (See 40 CFR 260.21.)
Washington, DC 20402, (202) 783-3238,
Document Number: 055-002-81001-2.
VI. CERCLA Designation and
Adjustment
All listed wastes, as well as any solid
waste that exhibits one or more of the
characteristics of a hazardous waste (as
defined in 40 CFR 261.21 through 261.24),
become hazardous substances under
section 101(14)(C) of the Comprehensive
Environmental Response,
Compensation, and Liability Act of 1980
(CERCLA). (CERCLA hazardous
substances are listed in Table 302.4 at 40
CFR 302.4, along with their reportable
quantities (RQs).) CERCLA section
103(a) requires that persons in charge of
vessels or facilities from which a
hazardous substance has been released
in a quantity that is equal to or greater
than its RQ immediately notify the
National Response Center of the release
[at (800) 424-8802 or in the Washington,
DC, metropolitan area at (202) 426-2675].
In addition, section 304 of the Superfund
Amendments and Reauthorization Act •
of 1986 (SARA) requires the owners or
operator of a facility to report the
release of a hazardous substance to the
appropriate state emergency response
commission (SERC) and to the local
emergency planning committee (LEPC)
when the amount released equals or
exceeds the RQ for the substance.
According to the "mixture rule" used
for notification under CERCLA and
SARA (50 FR 13463, April 4, 1985), the
release of mixtures must be reported
when the amount released equals or
exceeds the RQ for the waste, unless the
concentrations of the constituents of the
waste are known. When the
concentrations of the individual
constituents of a hazardous waste are
known, the release of the hazardous
waste would need to be reported to the
NRC and to the appropriate LEPC and
SERC when the RQ of any of the
hazardous constituents is equaled or
exceeded. RQs of different hazardous
substances are not additive under the
mixture rule (except for radionuclides,
see 54 FR 22536, May 24,1989), so that
spilling a mixture containing half an RQ
of one hazardous substance and half an
RQ of another hazardous substance
does not require a report.
Under section 102 of CERCLA, all
hazardous wastes newly designated
under RCRA will have a statutorily-
imposed RQ of one pound unless and
until adjusted by regulation under
CERCLA. In order to coordinate the
RCRA and CERCLA rulemaking with
respect to new waste listings, the
Agency today is proposing regulatory
amendments under CERCLA authority
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18510
Federal Register / Vol. 55. No. 85 / Wednesday, May 2. 1990 / Proposed Rules
in connection with the proposed listing
of wastes K137 and K138 to: '(1)
Designate wastes K137 and K138 as
hazardous substances under section 102
of CERCLA: and (2) adjust the RQs of
wastes K137 and K138 to 10 pounds,
based on the application of the RQ
adjustment methodology under section
102(a).
The RQs for each waste and for each
of the hazardous constituents are
Identified in the table below. Because
the only constituent of concern, UDMH,
has an RQ of 10 pounds (see 54 FR
33428, August 14.1989). the proposed RQ
of both wastes—K137 and K138—is 10
pounds.-This RQ will become effective
on the effective date of the final rule,
when the wastes simultaneously
become hazardous substances under
CERCLA.
Hazardous substance
Waata No. K137-.
Wasta No K138
Constitu-
ent
UOMH —
UDMH....
RQ
(pounds)
10
10
10
10
VII. State Authority
A. Applicability of Rules in Authorized
Slates
Under section 3006 of RCRA, EPA
may authorize qualified States to
administer and enforce the RCRA
program within the State. [See 40 CFR
part 271 for the standards and
requirements for authorization.)
Following authorization, EPA retains
enforcement authority under sections
3007,3008.3013, and 7003 of RCRA.
although authorized States have primary
enforcement responsibility.
Prior to the Hazardous and Solid
Waste Amendments of 1984 (HSWA), a
State with final authorization
administered its hazardous waste
program entirely in lieu of EPA
administering the Federal program in
that State. The Federal requirements no
longer applied in the authorized State,
and EPA could not issue permits for any
facilities in the State that the State was
authorized to permit When new. more
stringent Federal requirements were
promulgated or enacted, the State was ,
obliged to enact equivalent authority
within specified time frames. New
Federal requirements did not take effect
in an authorized State until the State
adopted requirements as State law.
In contrast, under section 3006(g) of
RCRA. 42 U.S.C. 6926(g). new
requirements and prohibitions imposed
by (he HSWA take effect in authorized
Slates at the same time that they take
effect in nonauthorized States. EPA is
directed to implement those
requirements and prohibitions in
authorized States, including the issuance
of permits, until the State is granted
authorization to do so. While States still
must adopt HSWA-related provisions as
State law to retain final authorization,
the HSWA applies in authorized States
in the interim.
Today's rule will be promulgated
pursuant to section 3001(e)(2) of RCRA,.
a provision added by the HSWA.
Therefore,, the Agency is proposing to
add these wastes to Table 1 in 40 CFR
271.1(j), which identifies the Federal
program requirements that are
promulgated pursuant to the HSWA,
and that take effect in all States,
regardless of their authorization status.
States may apply for either interim or
final authorization for the HSWA
provisions identified in Table 1. as
discussed in the following section of this
preamble.
B. Effect on State Authorizations
As noted above, EPA would
implement today's proposed rule in
authorized States until they modify their
programs to adopt these rules, and the
modification is approved by EPA.
Because the proposed rule would be
promulgated pursuant to HSWA, a State
submitting a program modification
would be able to apply to receive either
interim or final authorization under
section 3006(g)(2) or 30C6(b),
respectively, on the basis of
requirements that are substantially
equivalent or equivalent to EPA's. The
procedures and schedule for State
program modifications under section
3006(b) are described in 40 CFR 271.21.
The same procedures -should be
followed for section 3006(g)(2)-
. Section 271.21(e)(2) requires that
States that have final authorization to
m& JIfy their programs to reflect Federal
program changes, and must
subsequently submit the modification to
liPA for approval. The deadline by
which States must modify their
programs to adopt this proposed
regulation will be determined by the
date of promulgation of the final rule in
accordance with 40 CFR 271.21(e)(2).
States with authorized RCRA
programs already may have regulations
similar to those in today's proposed rule.
These State regulations have not been
assessed against the Federal regulations
being proposed today to determine
whether they meet the tests for
authorization. Thus, a State would not
be authorized to implement these
proposed regulations in lieu of EPA until
the State program modification is
approved. Of course, States with
existing regulations may continue to
administer and enforce their regulations
as a matter of State law. In
implementing the Federal program, EPA
will work with States under cooperative
agreements to minimize duplication of
efforts. In many cases, EPA will be able
to defer to the States in their efforts to
implement their programs, rather than
take separate actions under Federal
authority.
States that submit official applications
for final authorization less than 12
months after promulgation of EPA's
regulations are not required to include
standards equivalent to those
promulgated in their applications.
However, the State must modify its
program by the deadlines set forth in 40
CFR 271.21[e). States that submit official
applications for final authorization 12
months after the effective date of these
standards, when promulgated, must
include standards in their applications.
Section 271.3 sets forth the requirements
a State must meet when submitting its
final authorization application.
VIII. Compliance Dates
A. Notification
Under the Solid Waste Disposal
Amendments of 1980 (Pub. L. 96-452),
EPA was given the option of waiving the
notification requirement under section
3010 of RCRA following revision of the
Section 3001 regulations at the
discretion of the Administrator. The
Agency is proposing to waive the RCRA
section 3010 notification requirement for
only those persons who generate,
transport, treat, store, or dispose of
these hazardous wastes that have
previously notified EPA or an authorized
State of hazardous waste activities and
have received an identification number.
The Agency believes that most, if not
all, persons who manage these wastes
have already notified EPA and received
an EPA identification number and
therefore will not have to re-notify.
However,, any person who generates,
transports, treats, stores, or disposes of
these wastes has not previously notified
and received an identification number,
that person would be required to notify
EPA or an authorized State no later than
90 days after publication of the final rule
listing these wastes as hazardous,
pursuant to section 3010 of RCRA.
Notification instructions are set forth in
45 FR 12746, February 26,1980.
B. Permitting
Because HSWA requirements are
applicable in authorized States at the
same time as in unauthorized States,
EPA will regulate K137 and K138 until
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Federal Register / Vol. 55, No. 85 / Wednesday, May 2, 1990 / Proposed Rules
18511
States are authorized to regulate these
wastes. Thus, once this regulation
becomes effective in a final Agency rule,
EPA will apply Federal regulations to
these wastes and to their management
in both authorized and unauthorized
States. Facilities that treat, store, or
dispose of K137 and K138, but that have
not received a permit pursuant to
section 3005 of RCRA and are not
operating pursuant to interim status,
might be eligible for interim status under
HSWA (see section 3005(e)(l)(A](ii] of
RCRA, as amended). In order to operate
pursuant to interim status, the eligible
facilities are required to possess an EPA
ID number pursuant to 40 CFR 270.70{a),
and will be required to submit a part A
permit application within 6 months of
such publication.
Currently permitted facilities that
manage UDMH wastes would be
required to submit Class 1 permit
modifications if they are to continue
managing the newly regulated wastes in
'units that require a permit at the time
these proposed regulations are
published as final rules. The facilities
would be required to obtain the
necessary modification by the effective
date of the rule, or they would be
prohibited from accepting additional
UDMH wastes.
Interim status facilities that manage
UDMH wastes in units that require a
permit would be required to file an
amended part A permit application
under 40 CFR 270.10(g) if they are to
continue managing newly regulated
wastes. The facilities would be required
to file the necessary amendments by the
effective date of the rule, or they would
not receive interim status with respect
to the UDMH wastes (i.e., they would be
prohibited from accepting additional
UDMH wastes until permitted).
Newly regulated facilities (i.e.,
facilities at which the only hazardous
wastes that are managed are newly
regulated UDMH wastes) would be
required to qualify for interim status by
the compliance date of the rule in order
to continue managing UDMH wastes
prior to receiving a permit. Under 40
CFR 270.70, an existing facility may
obtain interim status by getting an EPA
identification number and submitting a
part A permit application by the
effective date of this rule. To retain
interim status, a newly-regulated land
disposal facility must submit a part B
permit application within one year after
the effective date of the rule and certify
that the facility is in compliance with all
applicable ground water monitoring and
financial responsibility requirements
(see RCRA section 3005(e)(3)).
EPA recently promulgated
amendments to the procedures for
permit modifications for treatment,
storage, and disposal facilities (see 53
FR 37934, September 28,1988). The
following discussion assumes
implementation in accordance with the
new rule. EPA would implement the
UDMH listing regulations by using the
new permit modification procedures,
consistent with EPA policy (see 53 FR
37933. September 28,1988).
Under the new regulation in 40 CFR
270.42, there are now three classes of
permit modifications with different
submittal and public participation
requirements for each class. In
§ 270.42(g), which concerns newly listed
or identified wastes, a permitted facility
that is "in existence" as a hazardous
waste facility for the newly listed or
identified waste on the effective date of
the notice must submit a Class 1
modification by that date. Essentially,
this modification is a notification to the
Agency that the facility is handling the
waste. As part of the procedure, the
permittee must also notify the public
within 90 days of submittal to the
Agency. Next, within 180 days of the
effective date, the permittee must submit
a Class 2 or 3 modification to the
Agency. A permittee may submit a Class
2 modification if the newly regulated
waste will be disposed in existing TSD
units and will not require additional or
different management practices from
those authorized in the permit. A Class 2
modification requires public notice by
the facility owner of the modification
request, a 60 day public comment
period, and an informal meeting
between the owner and the public
within the 60 day period. The proposed
rule includes a "default provision," so
that for Class 2 modifications, if the
Agency does not make a decision within
120 days, the modification is
automatically authorized for 180 days. If
the Agency does not reach a decision by
the end of that period, the modification
is permanently authorized. If the newly
regulated waste requires additional or ,
different management practices, a Class
3 modification is required. The initial
public notification and public meeting -•„
requirements are the same as for Class
2. However, after the end of the public
comment period, the Agency will
develop a draft permit modification,
open a public comment period of 45
days and hold a public hearing.
IX. Regulatory Impact Analysis
Under Executive Order 12291, EPA
must determine whether a regulation is
"major" and, therefore, subject to the
requirement of a Regulatory Impact
Analysis. As already indicated, no costs
are projected to be incurred by the
generator of these wastes at the present
time, since they ceased the production
of UDMH itself, and thus do not
currently generate the wastes.
However, the generator may resume
production; when this occurs, the total
additional incurred cost for disposal of
the wastes as hazardous would be less
than $2,000 (based on previous
production levels), well under the $100
million constituting a major regulation.
This cost would be insignificant and
results from minimal additional
compliance requirements, as these
wastes were already handled as if they
were hazardous.
Since EPA does not expect that the
amendments proposed here will have an
annual effect on the economy of $100
million or more, result in a measurable
increase in cost or prices, or have an
adverse impact on the ability of U.S.-
based enterprises to compete in either
domestic or foreign markets, these
amendments are not considered to
constitute a major action. As such, a
Regulatory Impact Analysis is not
required.
X. Regulatory Flexibility Act
Pursuant to the Regulatory Flexibility
Act, 5 U.S.C. 601-612, whenever an
agency is required to publish a 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). No regulatory flexibility
analysis is required, however, if the
head of the agency certifies that the rule
will not have a significant economic
impact on a substantial number of small
entities.
The hazardous wastes proposed to be
listed here are not generated by small
entities (as defined by the Regulatory
Flexibility Act). Accordingly, I hereby
certify that this proposed amendment
would not have a significant economic
impact on a substantial number of small
entities. This regulation, therefore, does
not require a regulatory flexibility
analysis.
XL Paperwork Reduction Act
This proposed rule does not contain
any information collection requirements
subject to OMB review under the
Paperwork Reduction Act of 1980, 44
U.S.C. Section 3501 et sag.
List of Subjects
40 CFR Part 261
Hazardous waste. Recycling.
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18512
Federal Register / Vol. 55, No. 85 / Wednesday, May 2. 1990 / Proposed Rules
40 CFR Part 271
Administrative practice and
procedure, Confidential business
information, Hazardous materials
transportation, Hazardous waste, Indian
lands, Intergovernmental relations,
Penalties, Reporting and recordk'eeping
requirements, Water pollution control,
Water supply.
40 CFR Part 302
Air pollution control, Chemicals,
Hazardous materials, Hazardous
materials transportation. Hazardous
substances, Intergovernmental relations,
Natural resources, Nuclear materials,
Pesticides and pests, Radioactive
materials. Reporting and recordkeeping
requirements, Superfund, Waste
treatment and disposal, Water pollution
control.
Dated: April 23.1990.
William K. Reilly,
Administrator.
References
Banerjee, S., H.C. Sikka and R. Gray. 1977.
Environmental degradation of 1,1-
dimethylhydrazine. Proc. Conf. Environ.
Chem. Hydrazine Fuels. Tyndall AFB, FL.
NTIS AD-AGS4194.
Banerjee, S., E.J. Pack, H. Sikka and CM.
Kelly. 1981. Kinetics of oxidation of
mothylhydrazinea in water. Factors
controlling the formation of 1,1-
dimethylnitrosamine from the
corresponding hydrazine. Unpublished
study. Syracuse Research Corporation,
Syracuse, NY.
Braun, BJV. and J.A. Zirrolli. 1983.
Environmental fate of hydrazine fuels in
aqueous and soil environments. Eng.
Serv. Lab.. Air Force Eng. Serv. Center,
Tyndall AFB, FL. Rep. No. ESL-TR-82-
45. NTIS AD-A125813. 23pp.
Callahan. M.A.. M.YV. Slimak. N.W. Gabel. et
al. 1979. Water related environmental
fate of 129 priority pollutants. Vol. II.
Dimethylnitrosamine. EPA-440/4-79-
0290.
Hanst, P.L., J.W. Spence and M. Miller. 1977.
Atmospheric chemistry of N-nitroso
dimethylamine. Environ. Sci. Technol.
11:403-405.
Kane. D.A. and K.J. Williamson. 1983.
Bacterial toxicity and metabolism of
hydrazine fuels. Arch. Environ. Contam.
Toxicol. 12:447-453.
MacNaughton. M.G., J. Zirrolli, T.B. Stauffer
and D.A. Stone/1979. Environmental
chemistry of hydrazine fuels. Proc. 9th
Conf. Environ. Toxicol., March. Aerosp.
Med. Res. Lab., Aerosp. Med. Div., Air
Force Systems Command, Wright-
Patterson AFB, Dayton. OH. AMRL-
TR79-68. pp. 121-128.
Mallik. M.A.B. and K. Tesfai. 1981.
Transformation of nitrosamines in soil
and in vitro by soil microorganisms. Bull.
Environ. Contam. Toxicol. 27:115-121.
Oliver, J.E., P.C. Kearney and A. Kontson.
1979. Degradation of herbicide related
nitrosamines in aerobic soils; J. Agric.
Food Chem. 27:887-891. \
Stauffer, T.B. 1977. Hydrazine Evaporation.
Proc. Con£ Environ. Chem. Hydrazine
Fuels, Tyndall AFB. NTIS AD-A054194.
pp. 25r-38.
Tate. R.L. and M. Alexander. 1975. Stability
of nitrosoamines in samples of lake
water, soil and sewage. J. Natl. Cancer
Inst. 54:327-330.
Tuazon, E.G., W.P.L. Carter, A.M. Winer and
J.N. Pitts, Jr. 1981. Reactions of
hydrazines with ozone under simulated
atmospheric conditions. Environ. Sci.
Technol. 15:823-828.
For the reasons set out in the
preamble, it is proposed to amend title
40 of the Code of Federal Regulations as
follows:
PART 261—IDENTIFICATION AND
LISTING OF HAZARDOUS WASTE
1. The authority citation for part 251
continues to read as follows:
Authority: 42 U.S.C. 6905, 6912(a), 6921,
6922, and 6938.
2. In § 261.32, add the following waste
streams to the subgroup 'Organic
Chemicals'.:
§ 261.32 Hazardous wastes from specific
sources.
Industry and EPA
hazardous waste
No.
Hazardous waste
Hazard
code
Organic chemicals ....
K137...
K138.—
Rush water (ram
catalyst removal
system from the
production of 1,1-
dimethyihydrazme
(UDMH) from
carboxylic acid
hydrazides.
Spent catalyst and
filter media from
the production of
1,1-
dimethylhydrazine
(UDMH) from
carboxylic acid
hydrazides.
m
(T)
3. Add the following compound and
analysis methods in alphabetical order
to Table 1 of Appendix III of part 261:
Appendix III—Chemical Analysis Test
Methods
TABLE 1.—ANALYSIS METHODS FOR OR-
GANIC CHEMICALS CONTAINED iNSW-
846
Compound
Method
Nos.
1,1-Dimethylhydrazine 8250, 8270
4. Add the following entries in
numerical order to Appendix VII of part
261:
Appendix VII—Basis for Listing
Hazardous Waste
EPA hazardous
waste No.
Hazardous constituents for
which listed
K137 1,1-Dimethylhydrazine (UDMH).
K138 1,1-Dimethylhydrazine (UDMH).
PART 271—REQUIREMENTS FOR
AUTHORIZATION OF STATE
HAZARDOUS WASTE PROGRAMS
5. The authority citation for Part 271
continues to read as follows:
Authority: 42 U.S.C. 6905, 6912(a), and 6926.
6. Section 271.1(j) is amended by
adding the following entry to Table I in
chronological order by date of
publication:
§ 271.1 Purpose and scope.
* * * - * *
m * * *
TABLE I.—REGULATIONS IMPLEMENTING
THE HAZARDOUS AND SOLID WASTE
AMENDMENTS OF 1984
Promulga-
tion date
•
[Insert
date of
publica-
tion].
•
Title of
regulation
• *
Listing Wastes
from the
Production
of UDMH
from
Carboxylic
Acid
Hydrazides.
• •
reference
,
[Insert
FEDER-
AL
REGIS-
TER
page
num-
bers].
•
Effective
date
.
[Insert
Effec-
tive
date]
•
PART 302—DESIGNATION,
REPORTABLE QUANTITIES, AND
NOTIFICATION
7. The authority citation for part 302
continues to read as follows:
Authority: Sections 101(1)(14) and 102(b) of
the Comprehensive Environmental Response,
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- Federal Register / Vol. 55, No. 85 / Wednesday, May 2. 1990 / Proposed Rules 18513
Compensation and Liability Act of 1980, 42 8. Section 302.4 is amended by adding § 302.4 Designation of hazardous
U.S.C. 9601(14) and 9602; Sections 311 and the waste streams K137 and K138 to substances.
501(a) of the Federal Water Pollution Control Table 302.4: ' * * * * * '
Act. 33 U.S.C. 1321 and 1361.
TABLE 302.4.—LIST OF HAZARDOUS SUBSTANCES AND REPORTABLE QUANTITIES
Statutory
Final RQ
Hazardous substance
CASRN
. Regulatory synonyms
RCRA
RQ Code 4 waste Category Pounds (kg)
No.
K137
Flush water from catalyst removal system
from the production of 1,1-dimethylhydra-
zine (UDMH) from carboxylic acid hydra-
zides.
K138
Spent catalyst and filter media from the
production of 1,1-dimethylhydrazine
(UDMH) from carboxylic acid hydrazides.
10
10
4 K107 X
4 K108 X,
10 (4.54)
10 (4.54)
4—indicates that the statutory source for designation of this hazardous substance under CERCLA is RCRA Section 3001.
[FR Doc. 90-9979-Filed 5-1-90; 8:45 am]
BILLING CODE 6560-50-M
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