Acetone; Toxic Chemical Release Reporting; Community Right-to- Know

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.

-----------------------------------------------------------------------

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