[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