[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.     
------------------------------------------------------------------------
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 
------------------------------------------------------------------------
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