[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: 94-15568]


[[Page Unknown]]

[Federal Register: June 27, 1994]


ENVIRONMENTAL PROTECTION AGENCY

[OPPTS-42134C; FRL-4873-9]

 

Notice of Opportunity to Participate in Negotiations for 
Neurotoxicity Testing

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: This notice invites interested parties and manufacturers and 
processors of seven substances subject to the Multi-Substance Rule for 
the Testing of Neurotoxicity at 40 CFR 799.5050 who wish to participate 
in or monitor consent agreement negotiations pursuant to 40 CFR 
790.22(b) to contact the EPA in writing. This notice also announces a 
public meeting to negotiate Enforceable Consent Agreements (ECAs). The 
seven substances for which testing will be negotiated are 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). These seven 
substances along with 1-butanol (CAS No. 71-36-3), diethyl ether (CAS 
No. 60-29-7), and 2-ethoxyethanol (CAS No. 110-80-5) were the subject 
of a final test rule promulgated under section 4 of the Toxic 
Substances Control Act (``TSCA'') on July 27, 1993 (58 FR 40262). The 
final test rule requires manufacturers and processors of the 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. Elsewhere in this Federal Register, 
EPA has issued an administrative stay and proposed to revoke the final 
test rule as part of a settlement agreement reached with the 
manufacturers of these chemicals, who have agreed to perform certain 
neurotoxicity and pharmacokinetics testing of the group of seven 
substances mentioned above, subject to execution of ECAs containing 
these studies. The settlement agreement signed by EPA and industry in 
April 1994 will be the starting point for the ECA negotiations (Ref. 
3). EPA does not anticipate entering into an ECA for 1-butanol, diethyl 
ether, or 2-ethoxyethanol.
DATES: A meeting to negotiate ECAs for neurotoxicity testing of the 
seven substances will be held at the Environmental Protection Agency on 
July 28, 1994. For a person to be designated an ``interested party'' to 
these negotiations, written notice must be received by EPA on or before 
July 27, 1994. EPA will provide an agenda to all ``interested parties'' 
and contact them if the meeting date changes.

ADDRESSES: The public meeting will be held at the Environmental 
Protection Agency, Room 1605, Northeast Mall, 401 M St., SW., 
Washington, DC. Submit written requests to be designated an interested 
party to TSCA Docket Receipts (7407), Rm NE B607, Office of Prevention, 
Pesticides, and Toxics, Environmental Protection Agency, 401 M St., 
SW., Washington, DC 20460. Submission should bear the document control 
number OPPTS-42134C. The public version of the administrative record 
supporting this action, with any confidential business information 
deleted, is available for inspection in Room NE B607 at the above 
address 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: 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. This 
Notice will allow all interested parties an opportunity to indicate 
their interest in participating in the negotiations of ECAs.

I. Background

    On July 27, 1993 (58 FR 40262) EPA issued a test rule under TSCA 
section 4 that required manufacturers and processors of ten 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 7 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. 
4).

II. Testing Program

    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. Solicitation of Interested Parties

    EPA utilizes its procedures at 40 CFR part 790, subpart B, to 
develop enforceable consent agreements (ECA), implemented through 
orders issued under TSCA section 4, to require health and environmental 
effects testing of chemical substances in cooperation with test 
sponsors. EPA believes testing will be achieved more quickly, and EPA 
resources used more effectively, under an ECA, compared with continued 
litigation on the merits of the final Multi-Substance Rule for the 
Testing of Neurotoxicity.
    EPA is soliciting interested parties for participation in or 
monitoring of ECA negotiations to implement the settlement agreement in 
this case. Written notice of interest in being designated an 
``interested party'' to the ECA negotiations must be received by July 
27, 1994. Such notice should be sent to the address listed above in the 
ADDRESSES section of this notice.
    The ECA negotiations will be limited to the seven chemicals 
outlined in the settlement agreement. The testing program described in 
Appendix A of the settlement agreement (Ref. 3) will be offered for 
consideration during the initial session of the ECA negotiations. 
Persons wishing to comment on EPA's decision to revoke all testing 
requirements for 1-butanol (CAS No. 71-36-3), diethyl ether (CAS No. 
60-29-7), and 2-ethoxyethanol (CAS No. 110-80-5), and EPA's intention 
to propose a SNUR for 2-EE, should file these comments with EPA in 
response to EPA's proposed revocation of the final rule, which is 
published elsewhere in this Federal Register. These three chemicals 
will not be considered as part of the ECA negotiations.

IV. Rulemaking Record

    EPA has established a record for this notice under docket no. 
OPPTS-42134C. 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 notice 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).

B. References

    (1) Final multi-substance rule for the testing of neurotoxicity 
(58 FR 40262, July 27, 1994).
    (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.

    Authority: 15 U.S.C. 2603

    Dated: June 10, 1994.

Charles M. Auer,
Director, Chemical Control Division, Office of Pollution Prevention and 
Toxics.

[FR Doc. 94-15568 Filed 6-24-94; 8:45 am]
BILLING CODE 6560-50-F