[Federal Register Volume 60, Number 14 (Monday, January 23, 1995)]
[Rules and Regulations]
[Pages 4514-4516]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-1673]
[[Page 4513]]
_______________________________________________________________________
Part VI
Environmental Protection Agency
_______________________________________________________________________
40 CFR Part 799
Toxic Substances; Testing Regulations: Neurotoxicity and Acetone, etc.;
Final Rule
Federal Register / Vol. 60, No. 14 / Monday, January 23, 1995 / Rules
and Regulations
[[Page 4514]]
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 799
[OPPTS-42134F; FRL-4924-7]
RIN 2070-2033
Revocation of Final Multi-substance Rule for the Testing of
Neurotoxicity
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final Rule Revocation.
-----------------------------------------------------------------------
SUMMARY: This document announces EPA's decision to revoke the Multi-
Substance Rule for the Testing of Neurotoxicity, that required
manufacturers and processors of acetone (CAS No. 67-64-1), technical
grade n-amyl acetate (CAS No. 628-63-7), 1-butanol (CAS No. 71-36-3),
n-butyl acetate (CAS No. 123-86-4), diethyl ether (CAS No. 60-29-7), 2-
ethoxyethanol (CAS No. 110-80-5), ethyl acetate (CAS No. 141-78-6),
isobutyl alcohol (CAS No. 78-83-1), methyl isobutyl ketone (CAS No.
108-10-1), and tetrahydrofuran (CAS No. 109-99-9) to conduct testing
for neurotoxicity. EPA is revoking this rule as part of a settlement
agreement reached with the manufacturers of these chemicals, who have
agreed to perform certain neurotoxicity and in vivo hydrolysis testing
of 7 of the 10 chemicals under enforceable consent agreements
(``ECAs'').
EFFECTIVE DATE: January 23, 1995.
ADDRESSES: A public version of the administrative record supporting
this action, with any confidential business information deleted, is
available for inspection at the TSCA Nonconfidential Information
Center, also known as the TSCA Public Docket Office (7407), Rm. NE
B607, Office of Pollution Prevention and Toxics, Environmental
Protection Agency, 401 M St., SW., Washington, DC 20460 from 12 noon to
4:00 p.m. Monday through Friday, except legal holidays.
FOR FURTHER INFORMATION CONTACT: Susan Hazen, Director, Environmental
Assistance Division, (7408), Office of Pollution Prevention and Toxics,
401 M St., SW., Washington, DC 20460, (202) 554-1404, TDD (202) 554-
0551.
SUPPLEMENTARY INFORMATION: EPA has determined that it is appropriate to
revoke the multi-substance rule for the testing of neurotoxicity
because the manufacturers of 7 of the 10 chemicals subject to the final
test rule have agreed to conduct a modified set of neurotoxicity and in
vivo hydrolysis testing under ECAs that accomplish many of the goals of
the test rule. The following seven chemical substances will be tested
pursuant to ECAs: acetone (CAS No. 67-64-1), technical grade n-amyl
acetate (CAS No. 628-63-7), n-butyl acetate (CAS No. 123-86-4), ethyl
acetate (CAS No. 141-78-6), isobutyl alcohol (CAS No. 78-83-1), methyl
isobutyl ketone (CAS No. 108-10-1), and tetrahydrofuran (CAS No. 109-
99-9). Testing is currently underway for n-butyl acetate and isobutyl
alcohol. In vivo hydrolysis testing will be conducted on butyl acetate
to determine if its test results for neurotoxicity can be used to
assess the neurotoxicity of its metabolite, 1-butanol.
I. Background
On July 27, 1993 (58 FR 40262) EPA issued a test rule under TSCA
section 4 that required manufacturers and processors of 10 substances
to conduct testing for neurotoxicity (Ref. 1). The test rule required
all the testing proposed for the 10 substances on March 4, 1991 (56 FR
9105). The required testing was the same for all 10 substances and
included acute and subchronic functional observational battery and
motor activity, and subchronic neuropathology and schedule-controlled
operant behavior (SCOB). These 10 substances are listed below:
------------------------------------------------------------------------
Chemical name CAS No.
------------------------------------------------------------------------
acetone............................ 67-64-1
n-amyl acetate, technical grade.... 628-63-7
1-butanol.......................... 71-36-3
n-butyl acetate.................... 123-86-4
diethyl ether...................... 60-29-7
2-ethoxyethanol.................... 110-80-5
ethyl acetate...................... 141-78-6
isobutyl alcohol................... 78-83-1
methyl isobutyl ketone............. 108-10-1
tetrahydrofuran.................... 109-99-9
------------------------------------------------------------------------
The manufacturers of these substances petitioned for review of the
final rule under TSCA section 19 in the Fifth Circuit Court of Appeals
(Ref. 2). Subsequent to the filing of this challenge to the rule, EPA,
the Chemical Manufacturers Association (``CMA''), and authorized
representatives of all parties challenging the rule, entered into
settlement negotiations to resolve the lawsuit.
As a result of these settlement discussions, the parties to the
lawsuit agreed, subject to certain conditions set forth in the
settlement agreement (Ref. 3), to conduct neurotoxicity and in vivo
hydrolysis testing of 7 chemical substances under ECAs to be negotiated
pursuant to EPA regulations. Testing on two of the chemicals subject to
the final rule, n-butyl acetate and isobutyl alcohol, was already
underway. It was CMA's and the test sponsors stated intent that such
testing continue on schedule during the pendency of this proceeding
(Ref. 3).
In turn, EPA agreed to propose to withdraw the final test rule. EPA
was aware that the settlement agreement contemplated testing fewer
chemicals and a reduced set of testing on some of those chemicals than
the testing regimen required by the final rule. Although EPA believed
that the rulemaking record contained substantial evidence to support
the testing requirements in the final rule, EPA believed that the
settlement agreement was in the public interest as it allowed testing
to proceed on an expedited basis, without the uncertainties of
protracted litigation. CMA's lawsuit was dismissed without prejudice by
the 5th Circuit Court of Appeals on May 13, 1994, in response to a
joint motion for a stay, but it can be reinstated by either party upon
filing of a letter with the court (Ref. 4).
On June 27, 1994, EPA published three notices in the Federal
Register: a Stay of the final test rule (59 FR 33184), a proposal to
revoke the final test rule (59 FR 33187), and an announcement of a
public meeting to initiate negotiation of consent agreement testing (59
FR 33191). The Stay suspended all requirements of the final test rule
until EPA either lifted the Stay or revoked the test rule. Final
revocation of the test rule was conditional on the successful
negotiation of testing to be performed under ECAs. The public meeting
announcement solicited interested parties to participate in the
negotiation and/or observation of negotiations. On July 28, 1994, EPA
held the public meeting to initiate the negotiations. The ECAs which
resulted were signed in November 1994 and January 1995 and required the
neurotoxicity and in vivo hydrolysis testing of the following 7
substances:
[[Page 4515]]
------------------------------------------------------------------------
Substance Tests
------------------------------------------------------------------------
acetone.......................... SCOB (subchronic)
n-amyl acetate, technical grade.. Functional Observational Battery
(acute and subchronic), Motor
Activity (acute and subchronic),
Neuropathology (subchronic)
n-butyl acetate.................. Functional Observational Battery
(acute and subchronic), Motor
Activity (acute and subchronic),
Neuropathology (subchronic), SCOB
(subchronic), In Vivo Hydrolysis
ethyl acetate.................... Functional Observational Battery
(acute and subchronic), Motor
Activity (acute and subchronic),
Neuropathology (subchronic), SCOB
(subchronic)
isobutyl alcohol................. Functional Observational Battery
(acute and subchronic), Motor
Activity (acute and subchronic),
Neuropathology (subchronic), SCOB
(subchronic)
methyl isobutyl ketone........... SCOB (subchronic)
tetrahydrofuran.................. Functional Observational Battery
(acute and subchronic), Motor
Activity (acute and subchronic),
Neuropathology (subchronic)
------------------------------------------------------------------------
The ECA testing program and negotiations are described more fully
in the announcement of the signing of the ECAs, published elsewhere in
this Federal Register. Compared with the final rule, the above testing
program represents a retention of the full set of tests for three
chemicals (n-butyl acetate, ethyl acetate, and isobutyl acetate), a
reduction in tests for four chemicals (acetone, n-amyl acetate, methyl
isobutyl ketone, and tetrahydrofuran), and an elimination of testing
for three chemicals (1-butanol, diethyl ether, and 2-ethoxyethanol). It
is anticipated, however, that the in vivo hydrolysis test of n-butyl
acetate may indicate that the separate testing of 1-butanol may not be
necessary, and because of this, 1-butanol manufacturers have agreed to
share in the cost of n-butyl acetate testing. The evaluation of the
metabolic fate of butyl acetate will be performed in a study of its in
vivo hydrolysis to 1-butanol. If the conversion of butyl acetate to 1-
butanol is sufficiently rapid and complete, EPA may determine that the
neurotoxic effects of 1-butanol can be predicted from the results of
butyl acetate testing. If this is not the case, EPA may consider
reproposing separate testing of 1-butanol.
As mentioned above, a third notice was published on June 27, 1994
(59 FR 33187), which proposed to revoke the final multi-substance rule
for the testing of neurotoxicity. This notice allowed all interested
parties an opportunity to evaluate and comment on EPA's proposed
revocation of the final rule and decision to pursue ECAs as the
mechanism for achieving testing.
II. Public Comments
EPA received one comment on the proposed revocation. This comment
was from CMA and supported EPA's proposal to revoke the test rule and
enter consent agreement negotiations (Ref. 5).
The public meeting to initiate negotiation of consent agreement
testing was held on July 28, 1994. No new interested parties identified
themselves to EPA at this meeting or during the 30-day comment period.
During the meeting, the only comment concerning the proposed revocation
came from CMA's legal counsel, and related to procedures for
simultaneous signing of the ECAs and the revocation.
III. Revocation of Final Test Rule
EPA is revoking the final Multi-Substance Rule for the Testing of
Neurotoxicity (40 CFR 799.5050) based upon the reasons stated in the
proposed revocation (59 FR 33187, June 27, 1994, Unit II), the lack of
comments opposing the revocation, and the successful negotiation of
ECAs. EPA believes the decision to allow manufacturers of these
substances to conduct neurotoxicity and in vivo hydrolysis testing
under ECAs will allow for the most timely development and public
availability of data to assess the potential neurotoxicity of these
compounds. While EPA acknowledges that the testing that will be
conducted under ECAs will not be as extensive as that required by the
final test rule, EPA believes that use of the ECA process will result
in the fastest development of data. Testing and data development will
proceed without the potentially lengthy delay of testing pending
resolution of costly litigation on the merits of the final test rule.
IV. Rulemaking Record
EPA has established a record for this revocation under docket
number OPPTS-42134F. This record contains the following information:
A. Supporting Documentation
(1) Federal Register notices pertaining to this rule consisting of:
(a) Notice of proposed multi-substance rule for the testing of
neurotoxcity (56 FR 9105, March 4, 1991).
(b) Notice of final multi-substance rule for the testing of
neurotoxicity (58 FR 40262, July 27, 1993).
(c) Notice announcing administrative stay of final multi-substance
rule for the testing of neurotoxicity (59 FR 33184, June 27, 1994).
(d) Notice of proposed revocation of final multi-substance rule for
the testing of neurotoxicity (59 FR 33187, June 27, 1994).
(e) Notice announcing opportunity to participate in negotiations
for neurotoxicity testing; solicitation for interested parties (59 FR
33191, June 27, 1994).
(2) Communications consisting of:
(a) Written letters.
(b) Contact reports of telephone conversations.
(c) Meeting summaries (including public meeting on July 28, 1994).
B. References
(1) Final multi-substance rule for the testing of neurotoxicity
(58 FR 40262, July 27, 1993).
(2) Chemical Manufacturers Association (CMA). Petition for
Review. Filed with United States Court of Appeals for the Fifth
Circuit. (October 8, 1993).
(3) United States Court of Appeals for the Fifth Circuit.
Settlement Agreement between Environmental Protection Agency (USEPA)
and petitioners. No. 93-5381. (April 28, 1994).
(4) United States Court of Appeals for the Fifth Circuit.
Dismissal of petitioners appeal against EPA. No.93-5381. (May 13,
1994).
(5) Latham & Watkins (legal counsel to CMA), Washington, DC.
Comment on proposed revocation of final multi-substance rule for the
testing of neurotoxicity. Submitted to TSCA Docket Office, USEPA,
Washington, DC.(July 20, 1994). [[Page 4516]]
The public record for this rulemaking is available for inspection
in the TSCA Nonconfidential Information Center (also known as the TSCA
Public Docket Office), Rm. NE B607, 401 M St., SW., Washington, DC from
12 noon to 4:00 p.m., Monday through Friday, except legal holidays.
V. 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 all the requirements of the Executive Order
(i.e., Regulatory Impact Analysis and review by the Office of
Management and Budget (OMB)). Under section 3(f), the order defines
``significant'' as those actions 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 (aka ``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 order, EPA has determined that this rule would not be
``significant''.
B. Regulatory Flexibility Act
Under the Regulatory Flexibility Act, 5 U.S.C. 601 et seq., EPA is
certifying that revocation of this test rule will not have a
significant impact on a substantial number of small businesses because
only the 24 manufacturers who signed the ECAs, which will replace the
revoked test rule, will be responsible for conducting and paying for
the testing. None of these manufacturers are small businesses.
C. Paperwork Reduction Act
There are no information collection requirements associated with
this revocation covered under the provisions of the Paperwork Reduction
Act of 1980, 44 U.S.C. 3501 et seq.
List of Subjects in 40 CFR Part 799
Chemicals, Chemical export, Environmental protection, Hazardous
substances, Health effects, Laboratories, Reporting and recordkeeping
requirements, Testing.
Dated: January 10, 1995.
Lynn R. Goldman,
Assistant Administrator for Prevention, Pesticides and Toxic
Substances.
Therefore, 40 CFR, chapter I, subchapter R, part 799 is amended as
follows:
PART 799--[AMENDED]
1. The authority citation for part 799 continues to read as
follows:
Authority: 15 U.S.C. 2603, 2611, 2625.
Sec. 799.5050--[Removed]
2. By removing Sec. 799.5050.
[FR Doc. 95-1673 Filed 1-20-95; 8:45 am]
BILLING CODE 6560-50-F
