[Federal Register Volume 59, Number 189 (Friday, September 30, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-24252]
[[Page Unknown]]
[Federal Register: September 30, 1994]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 372
[OPPTS-400086; FRL-4773-6]
Acetone; Toxic Chemical Release Reporting; Community Right-to-
Know
AGENCY: Environmental Protection Agency (EPA).
ACTION: Proposed rule.
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SUMMARY: EPA is proposing to delete acetone from the list of toxic
chemicals subject to section 313 of the Emergency Planning and
Community Right-to-Know Act of 1986 (EPCRA) in response to a petition
filed by Eastman Chemical Company and Hoechst Celanese. Specifically,
EPA is granting this petition by proposing to delist because the Agency
believes that acetone does not meet any of the EPCRA section 313(d)(2)
criteria for remaining on the list. Moreover, as published elsewhere in
this issue of the Federal Register, EPA is proposing to add acetone to
the list of compounds excluded from the definition of A Volatile
Organic Compound (VOC) under the Clean Air Act. VOCs contribute to the
formation of ozone in the lower atmosphere (troposphere), and ozone is
known to cause significant adverse effects on human health and
environment. EPA has previously determined that VOCs meet the criteria
for listing under EPCRA section 313. Therefore, finalization of this
proposed rule is contingent upon the finalization of the proposed rule
to exclude acetone from EPA's definition of a VOC.
DATES: Written comments should be received by November 29, 1994.
ADDRESSES: Written comments should be submitted in triplicate to: OPPT
Docket Clerk, TSCA Nonconfidential Information Center (NCIC), also
known as the TSCA Public Docket Office (7407), Office of Pollution
Prevention and Toxics, Environmental Protection Agency, Rm. NE-B607,
401 M Street SW., Washington, DC 20460. Comments should include the
document control number for this proposal, OPPTS-400086.
FOR FURTHER INFORMATION CONTACT:
Maria J. Doa, Petitions Coordinator, 202-260-9592, for specific
information on this proposed rule, or for more information on EPCRA
section 313, the Emergency Planning and Community Right-to-Know
Hotline, Environmental protection Agency, Mail Code 5101, 401 M Street
SW., Washington, DC 20460, Toll free: 1-800-535-0202, in Virginia and
Alaska: 703-412-9877 or Toll free TDD: 1-800-553-7672.
SUPPLEMENTARY INFORMATION:
I. Introduction
A. Statutory Authority
This proposed rule is issued under sections 313(d) and (e)(1) of
the Emergency Planning and Community Right-to-Know Act of 1986 (EPCRA),
42 U.S.C. 11023. EPCRA is also referred to as Title III of the
Superfund Amendments and Reauthorization Act of 1986 (SARA) (Pub. L.
99-499).
B. Background
Section 313 of EPCRA requires certain facilities manufacturing,
processing, or otherwise using listed toxic chemicals to report their
environmental releases of such chemicals annually. Beginning with the
1991 reporting year, such facilities also must report pollution
prevention and recycling data for such chemicals, pursuant to section
6607 of the Pollution Prevention Act of 1990, 42 U.S.C. 13106. Section
313 established an initial list of toxic chemicals that was comprised
of more than 300 chemicals and 20 chemical categories. Section 313(d)
authorizes EPA to add or delete chemicals from the list, and sets forth
criteria for these actions. EPA has added and deleted chemical from the
original statutory list. Under section 313(e), any person may petition
EPA to add chemicals to or delete chemicals from the list. EPA must
respond to petitions within 180 days either by initiating a rulemaking
or by publishing an explanation of why the petition is denied.
EPA issued a statement of petition policy and guidance in the
Federal Register of February 4, 1987 (52 FR 3479), to provide guidance
regarding the recommended content and format for submitting petitions.
On May 23, 1991 (56 FR 23703), EPA published guidance regarding the
recommended content of petitions to delete individuals members of the
section 313 and metal compound categories.
II. Description of Petition
On September 24, 1991, EPA received a petition from Eastman
Chemical Company and Hoechst Celanese to delete acetone from the EPCRA
section 313 list of toxic chemicals. The petitioners contend that
acetone should be deleted from the EPCRA section 313 list because it
does not meet any of the EPCRA section 313(d)(2) criteria and because
acetone's low photochemical reactivity does not present substantial
concerns for formation of tropospheric ozone or other air pollutants.
Acetone is high volume chemical that is widely used as an
industrial solvent and chemical intermediate, and which is regulated
under several environmental statutes other than EPCRA. Acetone is on
the list of hazardous substances (40 CFR 302.4) under section 102(a) of
the Comprehensive Environmental Response, Compensation, and Liability
Act of 1980 (CERCLA), 42 U.S.C. 9602, with a reportable quantity of
5,000 pounds. Due to its ignitability acetone is regulated under the
Resource Conservation and Recovery Act (RCRA), 42 U.S.C. 6901 et seq.,
as a hazardous waste and its implementing regulations at 40 CFR 261.33.
A. Status of Acetone Under the CAA
Currently, acetone is considered a Volatile Organic Compound (VOC)
and emissions of VOCs are managed under regulations (40 CFR parts 51
and 52) that implement Title I of the Clean Air Act, as amended (CAA),
42 U.S.C. 7401 et. seq. The CAA requires States to submit to EPA for
approval State Implementation Plans (SIPs) that establish a strategy to
reduce the emissions of a regulated pollutant to attain and maintain
the National Ambient Air Quality Standards (NAAQS). Under the SIP
program, the attainment of the NAAQS for ozone are dependent in part on
the control of releases of VOCs. Section 182(a)(3)(B) of the CAA
requires States to adopt regulations requiring sources of VOC (or
oxides of nitrogen (NOX)) emissions to provide the State reports
showing the actual emissions of VOC and NOX. This annual reporting
of VOC emissions by the sources to their State air agencies has been
required as of November 1993. Only facilities located in areas that are
designated non-attainment for ozone or in attainment areas within ozone
transport regions are required to report. EPA's definition of VOCs
excludes certain listed chemicals that have been determined to be
negligibly photochemically reactive (57 FR 3941, February 3, 1992).
Elsewhere in this issue of the Federal Register, EPA is proposing to
add acetone to the list of compounds excluded from the definition of a
VOC, since it has been preliminarily determined that acetone has a
negligible contribution to tropospheric ozone formation.
B. VOC Petitions Under EPCRA Section 313
This is the third petition that EPA has received to delist a VOC
from the EPCRA section 313 list. EPA received on July 13, 1988, a
petition to delist ethylene and propylene from the EPCRA section 313
list and on September 9, 1988, a petition to delist cyclohexane. Both
petitions were denied due to concerns about chemical reactions in the
troposphere that lead to the formation of ozone and other air
pollutants such as formaladehyde (i.e., these chemicals clearly fit the
definition of VOCs). Ozone is known to cause significant adverse
affects on human health and the environment.
III. EPA's Technical Review of Acetone
The technical review of the petition to delete acetone included an
analysis of the toxicological effects of acetone and the production and
release values known for acetone. (Refs. 1, 5 and 6)
A. Toxicological Evaluation of Acetone
1. Acute toxicity. The acute oral LD50 of acetone in rats is
about 6.7 grams/kilogram (g/kg). Lethal concentrations by inhalation
are on the order of 40,000 to 46,000 parts per million (ppm) for 1 hour
for rats, mice, and guinea pigs, and 21,000 ppm for 2 hours for rats.
Acetone produced moderate corneal injury to the eye in rabbits and mild
skin irritation.
In humans, eye, nose, and throat irritations have been observed at
500 and 1,000 ppm. Symptoms of accidental exposure may include slight
intoxication, headache, lassitude, drowsiness, loss of appetite,
nausea, vomiting, respiratory depression, and coma. Central nervous
system depression and narcotic effects are likely to occur at
concentrations in excess of 10,000 ppm. Liver and kidney damage have
also been observed in humans exposed accidentally.
2. Chronic toxicity. Workers exposed chronically to 750 ppm acetone
experienced irritation of mucous tissues of the eye, upper respiratory
system, and gastrointestinal system. In another survey, workers also
experienced respiratory tract irritation, dizziness, and loss of
strength at concentrations of 1,000 ppm, 3 hours per day, over a period
of 7 to 15 years.
3. Subchronic toxicity. A 90-day subchronic toxicity study in rats
produced a no-observed-adverse-effect level (NOAEL) of 100 milligrams/
kilogram/day (mg/kg/day) and a lowest-observed-adverse-effect level
(LOAEL) of 500 mg/kg/day based on increased liver and kidney weights
and nephrotoxicity. Based on these studies, EPA has developed a
Reference Dose (RfD) of 0.1 mg/kg/day.
4. Carcinogenicity. EPA has classified acetone as ``not
classifiable as to carcinogenicity'' (Group D). There is currently no
evidence to suggest a concern for carcinogenicity.
5. Mutagenicity. The weight of evidence indicates that acetone is
not mutagenic in several mutagenicity assay systems.
6. Developmental toxicity. A NOAEL of 2,200 ppm by inhalation has
been reported for developmental toxicity of acetone in rats and mice.
7. Neurotoxicity. There are no data sufficient to support a chronic
concern for significant irreversible neurotoxicity.
8. Environmental effects. Acetone is readily biodegradable in
aquatic systems. Its octanol/water partition coefficient (-0.24)
indicates a low potential for bioaccumulation, and its high water
solubility indicates that acetone is not likely to biomagnify. The most
sensitive aquatic species are probably the water flea (LC50 equals
10 milligrams/liter (mg/L)) and the flagellated protozoa (LC50
equals 28 mg/L). Also, a no-observed-effect concentration (NOEC) of 100
microliters/liter (ul/L) has been reported for higher plants.
B. Production, Use and Release of Acetone
For 1992, the United States (U.S.) production of acetone was 2.4
billion pounds. In addition, 96 million pounds of acetone were
imported. Domestic consumption was 2.2 billion pounds. The majority of
the domestic use of acetone was as an intermediate. Acetone is also
used in the production of drugs, pharmaceuticals, cosmetics and
specialty chemicals. Acetone also has numerous uses as a process
solvent and in direct applications (Ref. 5).
The Toxic Release Inventory (TRI) reports that during 1992 a total
of 138,728,984 pounds of acetone were released into the environment,
the 7th highest amount of releases for EPCRA section 313 chemicals. Of
that total, 133,989,435 pounds were released to air (4th highest on
TRI); 999,584 pounds were released to surface waters (11th highest on
TRI); 559,265 pounds were released to land; and 3,180,700 pounds were
injected underground (15th highest on TRI). In addition, 88,666,077
pounds of acetone were transferred to Publicly Owned Treatment Works
(POTWs) and other off-site locations.
C. Technical Summary
EPA's toxicological evaluation of acetone indicates that it
exhibits acute toxicity only at levels that greatly exceed releases and
resultant exposures. Based on EPA's hazard assessment, the Agency has
determined that acetone: (1) Cannot reasonably be anticipated to cause
cancer or neurotoxicity and is not mutagenic, and (2) cannot reasonably
be anticipated to cause adverse developmental effects or other chronic
effects except at relatively high dose levels. Acetone causes adverse
environmental effects only at relatively high dose levels.
IV. Rationale for Granting
EPA is granting the petition by proposing to delete acetone from
the EPCRA section 313 list. EPA believes that acetone does not meet the
toxicity criteria of EPCRA section 313(d)(2)(A) because acetone
exhibits acute toxicity only at levels that greatly exceed releases and
resultant exposures. Specifically acetone cannot reasonably be
anticipated to cause ``* * * significant adverse acute human health
effects at concentration levels that are reasonably likely to exist
beyond facility site boundaries as a result of continuous, or
frequently recurring releases.''
Based on EPA's hazard assessment of acetone, the Agency has
determined that acetone exhibits low toxicity in chronic studies.
Therefore, EPA believes that acetone does not meet the toxicity
criteria of EPCRA section 313(d)(2)(B).
EPA believes that acetone does not meet the toxicity criteria of
EPCRA section 313(d)(2)(C) because acetone causes adverse environmental
effects only at relatively high dose levels.
Elsewhere in this issue of the Federal Register, EPA is proposing
to add acetone to the list of compounds excluded from the definition of
a VOC since it has been preliminarily determined to have negligible
contribution to tropospheric ozone formation. In addition to the
findings discussed above, based on this proposal, EPA believes that
acetone does not meet the toxicity criteria of EPCRA section
313(d)(2)(B) and (C) because acetone's contribution to the formation of
tropospheric ozone and other air pollutants is negligible. VOCs
contribute to the formation of ozone in the lower atmosphere
(troposphere) and ozone is known to cause significant adverse effects
on human health and the environment. EPA has previously determined that
VOCs meet the criteria for listing under EPCRA section 313. Therefore,
finalization of this proposed rule is contingent upon the issuance of a
final rule to add acetone to the list of compounds excluded from the
definition of a VOC.
Today's action is not intended, and should not be inferred to
affect the status of acetone under any statute or program other than
the Toxic Release Inventory reporting under EPCRA section 313 and the
PPA section 6607. Specifically, the removal of acetone from the EPCRA
section 313 list will not in any way alter its continued status under
the Resource Conservation and Recovery Act or section 102(a) of the
Comprehensive Environmental Response, Compensation, and Liability Act.
The petitioners, Eastman Chemical Company and Hoechst Celanese, do not
request the removal of acetone from any other statute; moreover, the
Agency feels such action at this time would be inappropriate. In
support, the Agency notes that the three lists, and the three statutes
under which they are maintained, serve relevantly different purposes.
Furthermore, each statute prescribes different standards for adding or
deleting chemicals or pollutants from its respective list.
V. Request for Public Comment
EPA requests public comment on this proposal to delete acetone from
the list of chemicals subject to EPCRA section 313. Comments should be
submitted to the address listed under the ADDRESSES unit. All comments
should be received on or before November 29, 1994.
VI. Rulemaking Record
The record supporting this proposed rule is contained in the docket
number OPPTS-400086. All documents, including an index of the docket,
are available in the TSCA Nonconfidential Information Center (NCIC),
also known as the TSCA Public Docket Office, from noon to 4 p.m.,
Monday through Friday, excluding legal holidays. The TSCA Public Docket
Office is located at EPA Headquarters, Rm. NE-B607, 401 M Street SW.,
Washington, DC 20460.
VII. References
(1) IRIS. 1991. Integrated Risk Information System. U.S.
Environmental Protection Agency, Washington, DC.
(2) USEPA, OPPTS, EAB. Cinalli, C., ``Exposure Report for
Acetone,'' dated April 13, 1994.
(3) USEPA, OPPTS, EAB. Nold, A. and Cinalli C., ``Addendum to
Exposure Report for Acetone,'' dated June 15, 1994.
(4) USEPA, OPPTS, ETD. Memorandum and attachment from Brian J.
Evans to Daniel R. Bushman, Economics and Technology Division,
``Section 313 Petition on Acetone Chemistry Report,'' dated November
27, 1991.
(5) USEPA, OPPTS, EETD. Memorandum and attachment from William
Silagi to Tami McNamara, EAD, ``Economic Report for TRI Acetone
Petition,'' dated May 5, 1994.
(6) USEPA, OPPTS, HERD. Memorandum and attachment from Elbert L.
Dage to Dan Bushman, ETD entitled ``HERD Hazard Assessment of
Acetone,'' dated December 19, 1991.
VIII. Regulatory Assessment Requirements
A. Executive Order 12866
Under Executive Order 12866 (58 FR 51735, October 4, 1993), the
Agency must determine whether the regulatory action is ``significant''
and therefore subject to the Office of Management and Budget (OMB) and
the requirements of the Executive Order. Under section 3(f), the order
defines a ``significant regulatory action'' as an action likely to lead
to a rule (1) Having an annual effect on the economy of $100 million or
more, or adversely and materially affecting a sector of the economy,
productivity, competition, jobs, the environment, public health or
safety, or State, local, or tribal governments or communities (also
referred to as ``economically significant''); (2) creating serious
inconsistency or otherwise interfering with an action taken or planned
by another agency; (3) materially altering the budgetary impacts of
entitlements, grants, user fees, or loan programs; or (4) raising novel
legal or policy issues arising out of legal mandates, the President's
priorities, or the principles set forth in this Executive Order.
Pursuant to the terms of this Executive Order, it has been determined
that this proposed rule is not ``significant'' and therefore not
subject to OMB review.
B. Regulatory Flexibility Act
Under the Regulatory Flexibility Act of 1980, the Agency must
conduct a small business analysis to determine whether a substantial
number of small entities will be significantly affected by a proposed
rule. Because this proposed rule eliminates an existing requirement, it
would result in cost savings to facilities, including small entities.
C. Paperwork Reduction Act
This proposed rule does not have any information collection
requirements under the provisions of the Paperwork Reduction Act of
1980, 44 U.S.C. 3501 et seq.
List of Subjects in 40 CFR Part 372
Environmental protection, Chemicals, Community right-to-know,
Reporting and recordkeeping requirements, and Toxic chemicals.
Dated: September 15, 1994.
Lynn R. Goldman,
Assistant Administrator for Prevention, Pesticides and Toxic
Substances.
Therefore it is proposed that 40 CFR part 372 be amended as
follows:
PART 372--[AMENDED]
1. The authority citation for part 372 would continue to read as
follows:
Authority: 42 U.S.C. 11023 and 11048.
Sec. 372.65 [Amended]
2. Sections 372.65 (a) and (b) are amended by removing the entire
entry for acetone under paragraph (a) and removing the entire CAS No.
entry for 67-64-1 under paragraph (b).
[FR Doc. 94-24252 Filed 9-29-94; 8:45 am]
BILLING CODE 6560-50-M
