[Federal Register Volume 59, Number 122 (Monday, June 27, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-15567]
[[Page Unknown]]
[Federal Register: June 27, 1994]
_______________________________________________________________________
Part V
Environmental Protection Agency
_______________________________________________________________________
40 CFR Part 799
Stay of Multi-substance Rule for the Testing of Neurotoxicity; Rule
Revocation of Multi-substance Rule for the Testing of Neurotoxicity;
Proposal
Opportunity to Participate in Negotiations for Neurotoxicity Testing;
Notice
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 799
[OPPTS-42134D; FRL-4874-4]
Rin 2070-AC27
Stay of Final Multi-substance Rule for the Testing of
Neurotoxicity
AGENCY: Environmental Protection Agency (EPA).
ACTION: Administrative Stay.
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SUMMARY: This document announces EPA's decision to stay the Multi-
Substance Rule for the Testing of Neurotoxicity at 40 CFR 799.5050,
promulgated under section 4 of the Toxic Substances Control Act
(``TSCA''), pending final action on a proposed revocation of the final
test rule, which is published elsewhere in this Federal Register. The
final test rule was published on July 27, 1993 (58 FR 40262), and
requires manufacturers and processors of 10 substances to conduct
testing for neurotoxicity. On October 8, 1993, the Chemical
Manufacturers Association (CMA) and the manufacturers and processors of
these substances filed suit seeking review of the rule in the 5th
Circuit Court of Appeals. EPA is announcing a stay of this rule as part
of a settlement agreement reached with the manufacturers of these
chemicals, who have agreed to perform certain neurotoxicity and
pharmacokinetics testing on 7 of the 10 chemicals subject to the final
test rule, subject to execution of enforceable consent agreements
(``ECA'') containing these studies.
DATES: This stay is effective June 27, 1994.
ADDRESSES: A public version of the administrative record supporting
this action, with any confidential business information deleted, is
available for inspection at 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: Catherine Roman, Chemical Control
Division, (7405), Office of Pollution Prevention and Toxics, 401 M St.,
SW., Washington, DC 20460, (202) 260-8155.
SUPPLEMENTARY INFORMATION: This document announces EPA's decision to
stay the Multi-Substance Rule for the Testing of Neurotoxicity at 40
CFR 799.5050, promulgated under section 4 of the Toxic Substances
Control Act (``TSCA''), pending final action on a proposed revocation
of the final test rule, which is published elsewhere in this Federal
Register. The manufacturers of 7 of the 10 chemicals subject to the
final test rule have agreed, subject to certain conditions set forth in
the settlement agreement (Ref. 3), to conduct a set of neurotoxicity
and pharmacokinetics testing under enforceable consent agreements
(``ECA''). If ECA negotiations are successful, EPA believes that the
previously issued final test rule would no longer be needed. EPA
believes that, under a negotiated ECA, neurotoxicity and
pharmacokinetics testing would be conducted and results made publicly
available more quickly, and EPA resources used more effectively, than
if EPA continued to litigate the merits of the final test rule. It is
anticipated that the following seven substances would 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. EPA does not anticipate entering into an ECA for 1-butanol
(CAS No. 71-36-3), diethyl ether (CAS No. 60-29-7), and 2-ethoxyethanol
(CAS No. 110-80-5), three other substances for which testing is
required under the final test rule.
Elsewhere in this Federal Register, EPA is soliciting interested
parties for participation in or monitoring of ECA negotiations. The
settlement agreement signed by EPA and the parties to the lawsuit in
April 1994 will be the starting point for the ECA negotiations (Ref.
3).
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 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. These 10
substances are listed below:
------------------------------------------------------------------------
Chemical name CAS No.
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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, CMA and the other
parties to the lawsuit have agreed, subject to certain conditions set
forth in the settlement agreement (Ref. 3), to conduct neurotoxicity
and pharmacokinetics testing of seven chemical substances under
negotiated ECAs, to be implemented by an order issued by EPA under TSCA
section 4. Testing on two of the chemicals subject to the final rule,
n-butyl acetate and isobutyl alcohol, is already underway. It is CMA's
stated intent that such testing continue on schedule during the
pendency of this proceeding (Ref. 3).
In turn, EPA has agreed to propose to revoke the final test rule.
The proposed revocation is published elsewhere in this Federal
Register, and contains a more detailed explanation of EPA's decision
with regard to the anticipated testing program. EPA is aware that the
settlement agreement contemplates a reduced set of testing on fewer
chemicals than the testing regimen required by the final rule. However,
EPA believes that the settlement agreement is in the public interest as
it will allow testing to proceed on an expedited basis, without the
uncertainties of protracted litigation. EPA notes that although CMA's
lawsuit has been dismissed without prejudice by the 5th Circuit Court
of Appeals, in response to a joint motion for a stay, it can be
reinstated by either party upon filing of a letter with the court (Ref.
21).
II. Testing Program
The testing program required for all 10 substances by the final
test rule includes the following tests conducted according to the
designated TSCA test guidelines:
------------------------------------------------------------------------
TSCA
Test guideline
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Functional observational battery, acute and subchronic Sec.
798.6050
Motor activity, acute and subchronic Sec.
798.6200
Neuropathology, subchronic Sec.
798.6400
Schedule-controlled operant behavior (SCOB), subchronic Sec.
798.6500
------------------------------------------------------------------------
The test rule requires the submission of interim status reports
every 6 months until the completion of testing, as well as final
reports and data once testing is complete.
The settlement agreement contemplates a testing program which would
retain the full set of tests for three chemicals (n-butyl acetate,
ethyl acetate, and isobutyl acetate), reduce the number of tests for
four chemicals (acetone, n-amyl acetate, methyl isobutyl ketone, and
tetrahydrofuran), and eliminate testing of three chemicals (1-butanol,
diethyl ether, and 2-ethoxyethanol). It is anticipated, however, that
the pharmacokinetics/metabolism 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 pharmacokinetics
and 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. EPA believes that this
testing would represent a reasonable compromise which could avoid
protracted litigation while still developing relevant data necessary to
determine the neurotoxicity of these chemical substances.
III. Stay of Final Test Rule
EPA is issuing this administrative stay of the final test rule
pursuant to 5 U.S.C. 705, which authorizes an agency to postpone the
effective date or any deadlines imposed by administrative action taken
by the agency when ``justice so requires,'' pending judicial review.
See also Rule 18 of the Federal Rules of Appellate Procedure
authorizing issuance of administrative stays pending review. (The need
for and proper scope of neurotoxicity testing of the 10 chemical
substances subject to the final test rule is at issue in litigation
challenging the final rule. Although the suit has been dismissed, it
can be reinstated by either party upon filing of a letter with the
Fifth Circuit Court of Appeals (Ref. 21).) EPA believes that issuance
of a stay of the deadlines for submission of interim and final reports,
and final submissions of test data, is necessary pending resolution of
all outstanding issues. In particular, EPA believes that should ECAs be
concluded, and testing conducted under orders incorporating such ECAs,
the final rule itself would be moot. Consequently, EPA finds issuance
of this stay is in the interests of justice.
Although EPA does not regard this administrative stay as a rule,
were it to be viewed as a rule, to the extent good cause (pursuant to 5
U.S.C. 553(b)) is needed to justify EPA's immediately effective stay of
all deadlines in the final rule, EPA believes that there is good cause
for issuing it without prior notice and opportunity for comment and for
making it immediately effective. EPA believes that the impending
deadlines for submission of interim status reports under a rule that,
pending public comment, may be rescinded, the ongoing testing that is
being conducted even pending the final outcome of negotiations for
ECAs, EPA's solicitation of interested parties to monitor or
participate in ECA negotiations, and EPA's solicitation of comment on
all other aspects of today's action, provide such good cause.
IV. Rulemaking Record
EPA has established a record for this stay under docket no. OPPTS-
42134D. This record contains the information EPA considered in reaching
the settlement agreement and the following information:
A. Supporting Documentation
(1) Federal Register notices pertaining to this stay consisting of:
(a) Notice of proposed multi-substance rule for the testing of
neurotoxicity (56 FR 9105, March 4, 1991).
(b) Notice of final multi-substance rule for the testing of
neurotoxicity (58 FR 40262, July 27, 1994).
(2) Communications consisting of:
(a) Written letters.
(b) Contact reports of telephone conversations.
(c) Meeting summaries.
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).
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 (also known 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 order, EPA has determined that this stay
would not be ``significant''.
B. Regulatory Flexibility Act
Under the Regulatory Flexibility Act, 5 U.S.C. 601 et seq., EPA is
certifying that a stay of this test rule would not have a significant
impact on a substantial number of small businesses.
C. Paperwork Reduction Act
There are no information collection requirements associated with
this administrative stay 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: June 18, 1994.
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 would continue to read as
follows:
Authority: 15 U.S.C. 2603, 2611, 2625.
Sec. 799.5050 [Stayed]
2. By staying Sec. 799.5050 until further notice.
[FR Doc. 94-15567 Filed 6-24-94; 8:45 am]
BILLING CODE 6560-50-F
