[Federal Register Volume 60, Number 116 (Friday, June 16, 1995)]
[Rules and Regulations]
[Pages 31643-31646]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-14805]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 372
OPPTS-400086A; FRL-4952-7]
Acetone; Toxic Chemical Release Reporting; Community Right-to-
Know
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: EPA is granting a petition to delete acetone from the list of
toxic chemicals under section 313 of the Emergency Planning and
Community Right-to-Know Act (EPCRA). This deletion is based on a
determination that acetone meets the delisting criteria of EPCRA
section 313(d)(3). By promulgating this rule, EPA is relieving
facilities of their obligation to report releases of acetone that
occurred during the 1994 calendar year and releases that will occur in
the future. This relief applies only to the reporting requirements
under section 313 of EPCRA.
DATES: This rule is effective June 16, 1995.
FOR FURTHER INFORMATION CONTACT: For specific information on this final
rule: Maria J. Doa, Petitions Coordinator, Telephone: 202-260-9592. For
more information on EPCRA section 313: Emergency Planning and Community
Right-to-Know Hotline, Environmental Protection Agency, Mail Code 5101,
401 M St., SW., Washington, DC 20460, Toll free: 1-800-535-0202, In
Virginia and Alaska, 703-412-9877 or Toll free TTD: 1-800-553-7672.
SUPPLEMENTARY INFORMATION:
I. Introduction
A. Statutory Authority
This final 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 (SARA) of 1986 (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 must also report pollution
prevention and recycling data for such chemicals, pursuant to section
6607 of the Pollution Prevention Act (42 U.S.C. 13106). When enacted,
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. Under section 313(e)(1), any
person may petition EPA to add chemicals to or delete chemicals from
the list. EPA has added chemicals to and deleted chemicals from the
original statutory list. 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
petitions. On May 23, 1991 (56 FR 23703), EPA published guidance
regarding the recommended content of petitions to delete individual
members of section 313 metal compound categories. EPA has also
published a statement clarifying its interpretation of the section
313(d)(2) criteria for adding and deleting chemicals from the section
313 toxic chemical list (59 FR 61439, November 30, 1994).
II. Description of Petition and Regulatory History
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.
On September 30, 1994, following a review which consisted of a
toxicity evaluation and an exposure analysis, EPA proposed to grant the
petition to delete acetone from the section 313 list by issuing a
proposed rule in the Federal Register (59 FR 49888). The proposal to
grant the petition was based upon EPA's finding that acetone did not
meet the listing criteria found in section 313(d)(2) of EPCRA. It was
EPA's belief that there was insufficient evidence to demonstrate that
acetone causes or can reasonably be anticipated to cause significant
adverse human health or environmental effects.
Until this time, acetone has been considered to be a Volatile
Organic Compound (VOC). Emissions of VOCs are managed under regulations
(40 CFR parts 51 and 52) that implement Title I of the Clean Air Act
(CAA), as amended, 42 U.S.C. 7401 et seq. 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 finalizing its
addition of acetone to the list of compounds excluded from the
definition of a VOC based on the determination that acetone has a
negligible contribution to tropospheric ozone formation.
III. Final Rule and Rationale for Delisting
A. Comments on the Proposed Deletion of Acetone
The public comment period for the proposed rule closed on November
29, 1994. EPA received 51 comments on the proposed rule to delete
acetone. Of these, 29 comments concurred with the proposal, and 22
comments objected to the proposal.
The Chemical Manufacturers Association objected to the statement in
the proposed rule that all VOCs ``meet the criteria for listing under
EPCRA section 313.''
In the proposed rule, EPA did not state that all VOCs meet the
criteria for listing under EPCRA section 313 solely by virtue of their
being so designated. However, EPA reaffirms its position as stated in
the proposed rule, that chemicals that clearly fit the definition of
VOC under the CAA meet the listing criteria of EPCRA section 313. VOCs
contribute to the formation of tropospheric ozone. Ozone can reasonably
be anticipated to cause significant adverse effects on human health and
the environment, and therefore meets the listing criteria of EPCRA
section 313.
Artco Inc. and National Marine Manufacturers Association comment
that EPA should further research other chemicals which are not
depleting the stratospheric ozone layer and promulgate their removal as
well. EPA does not believe that the removal of chemicals from the EPCRA
section 313 list is warranted solely on the basis of whether they
deplete the stratospheric ozone layer. In making a determination that a
chemical should be deleted from the EPCRA section 313 list, EPA
examines whether the chemical meets any of the criteria set forth in
EPCRA section 313(d)(2). A chemical which is shown not to deplete the
stratospheric ozone layer could still meet one of the other criteria,
and thus, could not be deleted from the list.
[[Page 31644]]
Eastman Chemical Co. and Hoechst Celanese stated that the deletion
of acetone will ``improve EPA's TRI program as well as conserve EPA and
industry resources.'' Further, Outboard Marine Corp., Hoechst Celanese,
and the Savannah River Pulp and Paper Corp. stated that the removal of
acetone from the list of EPCRA section 313 toxic chemicals will reduce,
in part, the administrative burden on facilities.
As described in the economic analysis, EPA agrees that the deletion
of acetone will result in a resource savings by EPA and industry. In
addition, EPA agrees that, as a result of this action, there will be a
decrease in the administrative burden on facilities who have previously
been required to report for acetone under EPCRA section 313.
A number of the commenters who supported the deletion stated that
acetone is a substitute for more hazardous air pollutants, and that
removing acetone from the list will encourage facilities to use acetone
rather than these more hazardous chemicals. Specifically, Eastman
Chemical Co. and Hoechst Celanese commented that the proposed rule does
not address any of the environmental benefits associated with deleting
acetone from the section 313 list. These two commenters pointed to the
benefits derived from the use of acetone as a substitute for other
regulated chemicals.
Although there might be environmental benefits from using acetone
rather than some other chemicals, this has no impact on whether acetone
meets the listing criteria of EPCRA section 313(d)(2). EPA agrees that,
to the extent that the substances being substituted by acetone are more
hazardous to human health or the environment than acetone, such
substitution would be beneficial.
These two commenters further brought up several technical points,
which they felt should have been included in the proposal.
Specifically, they believe that a description of drinking water studies
which have been conducted with acetone, as well as information on the
recently revised oral reference dose (RfD) for acetone, would be a
useful addition to the preamble to this final rule. EPA acknowledges
that the drinking water studies have been conducted, but does not feel
that a description of them is warranted. These studies support the
decision to delist acetone. EPA also acknowledges that the RfD has
recently been revised. At the time of publication of the proposed rule,
the RfD was 0.1 milligram per kilogram per day (mg/kg/day). EPA has
revised this RfD to 0.9 mg/kg/day. This higher value reflects a
slightly lower toxicity and, as stated above, supports the delisting
decision.
A number of the commenters that oppose the delisting stated that
there are substantial data to support a concern for health effects from
acetone, and that EPA's review of evidence of toxicity for acetone must
address the serious concerns raised by the Agency for Toxic Substances
and Disease Registry (ATSDR) in its Draft Toxicological Profile for
Acetone. In addition, as some commenters have pointed out, there are
insufficient data to assess the toxicity of acetone.
As reviewed by the ATSDR, there has been considerable research on
the health effects of acetone. However, most of this research has
involved acute or subchronic exposure to relatively moderate and high
levels of acetone. There is a lack of information with which to firmly
characterize the critical effects of low-level exposure to acetone.
Under EPCRA section 313, a lack of evidence cannot be used as a basis
for listing a chemical. The known toxicity levels for acetone fall in
the range which can be considered to be moderately low to low, and the
decision must be based on the weight-of-the-evidence available.
EPA has reviewed the ATSDR draft profile as well as other relevant
materials and has concluded that there is not sufficient evidence of
toxicity to retain acetone on the EPCRA section 313 list. According to
the ATSDR, based on a lowest observed adverse effect level (LOAEL) of
1,250 parts per million (ppm) for (transient) neurological effects over
a 6-week period, intermediate and chronic inhalation Minimal Risk
Levels (MRLs) of 13 ppm were calculated. Furthermore, the ATSDR
indicates that levels of acetone which are normally found in outdoor
air are generally significantly lower than this, at less than 8 parts
per billion (ppb), and also generally lower than the air concentrations
of acetone inside homes. At this time, there is insufficient evidence
regarding chronic or subchronic exposure to such low levels of acetone
to warrant listing (Ref. 1).
Several commenters recommended that EPA require industry to fully
test acetone for toxicity under the criteria of section 4 of the Toxic
Substances Control Act (TSCA), stating that testing should be performed
before acetone is removed from the public's right-to-know. Other
commenters, noting that EPA is currently negotiating with industrial
users of acetone for neurotoxicity testing of the chemical, claimed
that the proposal for delisting is ill-timed and inappropriate.
At this time, the Agency has already entered into an Enforceable
Consent Agreement with industry, requiring subchronic testing of
acetone for neurotoxicity. At concentrations to which workers may be
exposed in the workplace, which are much higher than those in outdoor
air, central nervous system (CNS) effects such as narcosis, headache,
and changes in operant behavior do appear to be relevant concerns
indicative of neurotoxicity. However, the criteria for requiring
neurotoxicity testing under TSCA section 4 and the criteria for
inclusion in section 313 of EPCRA are very different. At this point in
time, the weight-of-the-evidence is not sufficient to show that acetone
meets the EPCRA section 313(d)(2) criteria for listing. EPA cannot deny
a petition under EPCRA section 313 based on the fact that testing is
going to be performed to fill data gaps.
A number of commenters stated that EPA should consider the
synergistic effects of acetone together with other chemicals and stated
that exposure to acetone is well known to increase the toxicity of many
other chemicals. Commenters stated that the increased toxicity of other
compounds in combination with exposure to acetone, as detailed in the
ATSDR draft profile, justifies maintaining the EPCRA section 313
listing of acetone.
The ATSDR draft profile does provide a detailed review of the
interaction of acetone and other chemicals. This report indicates that
acetone may alter the effect of other chemicals by either increasing,
decreasing, having a mixed effect on or having no effect on their
toxicity. For example, carbon tetrachloride, halogenated alkanes,
ethanol, and some ketones were more toxic when co-administered with
acetone. However, acetone had mixed effects on the toxicity of other
chemicals (dichlorobenzene, chlorinated alkanes, possibly halogenated
alkanes, nitrosoamine, and acetonitrile) either at varying doses or for
different toxicity endpoints. Furthermore, acetone had no reported
effect on styrene or methyl ethyl ketone, and actually reduced the
toxicities of acetaminophen and semicarbazide (Ref. 1).
As with the toxicity of acetone alone, the doses of acetone
required for these interactive effects far exceed the concentrations of
acetone which are found in outdoor air. For example, the lowest doses
for acetone potentiation of toxicity reported by the ATSDR were found
with carbon tetrachloride. Liver toxicity of carbon tetrachloride was
shown to be potentiated by co-administration of acetone. However, non-
effective doses of acetone were as high as 78 milligrams/kilogram (mg/
kg)
[[Page 31645]]
twice a day for 3 days, or 1,000 ppm over 4 hours (Ref. 1).
Again, the weight-of-the-evidence for the synergistic effects of
acetone on the toxicity of other chemicals is not sufficient to show
that acetone meets the EPCRA section 313(d)(2) criteria for listing.
Several commenters state that EPA has not considered the effects of
acetone on susceptible populations such as children, the elderly, or
pregnant women, as detailed in the ATSDR draft profile. EPA disagrees.
The ATSDR draft profile reported no human data on acetone in ``more
susceptible populations.'' Several studies in rats reported possible
sex differences in susceptibility. Other factors which may have
affected susceptibility in rats were age and pregnancy; however, no
doses were reported.
The National Council of the Paper Industry for Air and Stream
Improvement Inc. submitted a review on the Toxicity of Acetone in
support of delisting acetone. This report concludes that acetone does
cause CNS depression and irritation of mucous membranes, but that these
effects become apparent only at high concentrations (above 500 ppm for
irritation and 1,000 ppm for CNS effects).
This review was not as detailed as the ATSDR Draft Toxicological
Profile for Acetone; however, reports of effective dose levels were
similar. This review provides further indication of the relatively high
levels of acetone necessary to induce toxicity or enhance the toxicity
of other chemicals.
The Chesapeake Bay Foundation commented that acetone is toxic to
aquatic life, and that it has a potential to bioaccumulate, and
therefore, it should not be removed from the EPCRA section 313 list of
toxic chemicals. The commenter cites toxicity values of 10 milligrams/
liter (mg/L) to Daphnia magna, and a median lethal concentration
(LC50) for the clawed toad of 25 mg/L.
The toxicity values quoted by the commenter are within the range
which are considered by EPA to be ``moderately low.'' However, the
majority of the available aquatic toxicity (LC50) values for
acetone are greater than 100 mg/L. In fact, several studies reported
LC50 values for Daphnia magna of greater than 100 mg/L. Taken as a
whole, the data indicate that acetone presents a low level of hazard to
aquatic organisms. As to the statement that acetone has the potential
to bioaccumulate, EPA disagrees. As stated in the proposed rule,
acetone is readily biodegradable in aquatic systems. Its octanol/water
coefficient (-0.24) indicates a low potential for bioaccumulation, and
its high water solubility indicates that acetone is not likely to
biomagnify. The commenter did not supply any data which would lead EPA
to change this assessment.
The Maine Greens comment that acetone is a known hazardous
substance based on flammability, and the State and Territorial Air
Pollution Program Administrators/Association of Local Pollution Control
Officials comments that acetone should not be removed from the EPCRA
section 313 list of toxic chemicals because delisting a flammable
solvent will eliminate information needed by emergency response
personnel regarding the true hazard presented by a given facility.
While EPA believes that the data collected under EPCRA section 313
may be of use to local response authorities in developing emergency
response plans, it is not the primary focus of EPCRA section 313 as it
is with EPCRA sections 302-312. Furthermore, flammability is not one of
the criteria for listing a substance under EPCRA section 313.
B. Rationale for Delisting and Conclusions
EPA is granting the petition by deleting 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.''
EPA believes that acetone does not meet the toxicity criteria of
EPCRA section 313(d)(2)(B) because acetone: (1) Cannot reasonably be
anticipated to cause cancer or neurotoxicity and has not been shown to
be mutagenic, and (2) cannot reasonably be anticipated to cause adverse
developmental effects or other chronic effects except at relatively
high dose levels.
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.
Based upon evaluation of the petition, available toxicity and
exposure information, and public comment, EPA reaffirms its
determination that acetone meets the EPCRA section 313(d)(3) criteria
for deletion. Therefore, EPA is finalizing the deletion of acetone from
the list of chemicals subject to reporting under section 313 of EPCRA.
This petition does not request that any action be taken under any
statutory provision other than EPCRA section 313, and today's rule
should not be inferred as an action under any statutory provision other
than EPCRA section 313. Each statute prescribes different standards for
adding or deleting chemicals or pollutants from its respective list.
Specifically, the deletion of acetone from the EPCRA section 313 list
does not alter its regulatory status under other statutory provisions.
Today's rule is based solely on the criteria in EPCRA section 313.
IV. Effective Date
This action is effective June 16, 1995. Thus the last year in which
facilities had to file a Toxic Release Inventory (TRI) report for
acetone was 1994, covering releases and other activities that occurred
in 1993.
Section 313(d)(4) provides that ``[a]ny revision'' to the section
313 list of toxic chemicals shall take effect on a delayed basis. EPA
interprets this delayed effective date provision to apply only to
actions that add chemicals to the section 313 list. For deletions, EPA
may, in its discretion, make such actions immediately effective. An
immediate effective date, in these circumstances, is also consistent
with 5 U.S.C. section 553(d)(1) because a deletion from the section 313
list relieves a regulatory restriction.
EPA believes that where the Agency has determined, as it has with
acetone, that a chemical does not satisfy any of the criteria of
section 313(d)(2)(A)-(C), no purpose is served by requiring facilities
to collect data or file TRI reports for that chemical, or, therefore,
by leaving that chemical on the section 313 list for any additional
period of time. This construction of section 313(d)(4) is consistent
with previous rules deleting chemicals from the section 313 list. For
further discussion of the rationale for immediate effective dates for
EPCRA section 313 delistings, see 59 FR 33205 June 28, 1994.
V. Rulemaking Record
The record supporting this rule is contained in the docket number
OPPTS-400086A. 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 St., SW.,
Washington, DC 20460.
[[Page 31646]]
VI. References
(1) USEPA, OPPTS, HERD, HEB. Norris, Deborah O., ``Summary of and
Response to Health-Related Public Comments on Proposal to Remove
Acetone from TRI,'' dated March 14, 1995.
(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.
VII. 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 review by 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.
In accord with Executive Order 12866, EPA has prepared an economic
analysis of this final rule. This final rule will reduce the number of
reports submitted under EPCRA section 313 by 2,500 per year. EPA
estimated that this will yield savings of $7 million per year for
industry and EPA. Pursuant to the terms of this Executive Order, EPA
has determined that this final rule is not significant and therefore
not subject to OMB review.
B. Regulatory Flexibility Act
Under the Regulatory Flexibility Act of 1980, EPA must conduct a
small business analysis to determine whether a substantial number of
small entities will be significantly affected. Because this final rule
eliminates an existing requirement, it would result in cost savings to
facilities, including small entities.
C. Paperwork Reduction Act
This final rule relieves facilities from having to collect
information on the use and releases of acetone. Therefore, there were
no information collection requirements for OMB to review under the
provisions of the Paperwork Reduction Act of 1980, 44 U.S.C. 3501 et
seq. This rule will reduce reporting burden by approximately 131,000
hours per year.''
List of Subjects in 40 CFR Part 372
Environmental protection, Chemicals, Community right-to-know,
Reporting and recordkeeping requirements, and Toxic chemicals.
Dated: June 9, 1995.
Lynn R. Goldman,
Assistant Administrator for Prevention, Pesticides and Toxic
Substances.
Therefore, 40 CFR part 372 is amended as follows:
1. The authority citation for part 372 continues to read as
follows:
Authority: 42 U.S.C. 11013 and 11028.
Sec. 372.65 [Amended]
2. Section 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. 95-14805 Filed 6-15-95; 8:45 am]
BILLING CODE 6560-50-F
