[Federal Register Volume 60, Number 14 (Monday, January 23, 1995)]
[Rules and Regulations]
[Pages 4516-4520]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-1674]
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 799
[OPPTS-42134G; FRL-4924-8]
RIN 2070-2033
Testing Consent Orders for Acetone, n-Amyl Acetate, n-Butyl
Acetate, Ethyl Acetate, Isobutyl Alcohol, Methyl Isobutyl Ketone, and
Tetrahydrofuran
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final Testing Consent Agreements and Orders.
-----------------------------------------------------------------------
SUMMARY: EPA has issued Testing Consent Orders (Orders) that
incorporate Enforceable Consent Agreements (ECAs) pursuant to the Toxic
Substances Control Act (TSCA) with companies who have agreed to perform
certain neurotoxicity tests with the following seven substances:
acetone (CAS No. 67-64-1), 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). This document summarizes the
requirements of the ECAs and amends 40 CFR 799.5000 by adding these
seven substances to the list of chemical substances and mixtures
subject to ECAs. Accordingly, the export notification requirements of
40 CFR part 707 apply to these substances.
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 referred to 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, Environmental Assistance
Division, Office of Pollution Prevention and Toxics, 401 M St., SW.,
(7408), Washington, DC 20460, (202) 554-1404, TDD (202) 554-0551.
SUPPLEMENTARY INFORMATION: Twelve companies that include AlliedSignal,
Inc., Aristech Chemical Corp., BTL Specialty Resins Corp., The Dow
Chemical Co., Eastman Chemical Co., Exxon Chemical Co., General
Electric Co., Georgia Gulf Corp., Goodyear Tire & Rubber Co., Shell Oil
Co., Texaco Refining & Marketing, Inc., and Union Carbide Corp. have
agreed to perform neurotoxicity testing with acetone. The Union Carbide
Corp. has agreed to perform neurotoxicity testing with n-amyl acetate.
Nine companies that include Aristech Chemical Corp., BASF Corp., BP
Chemicals Inc., Eastman Chemical Co., Hoechst Celanese Chemical Group,
Inc., Rhone-Poulenc Inc., Shell Oil Co., Union Carbide Corp., and Vista
Chemical Co. have agreed to perform neurotoxicity testing with butyl
acetate. Six companies that include BP Chemicals Inc., Eastman Chemical
Co., Hoechst Celanese Chemical Group, Inc., Monsanto Co., Rhone-Poulenc
Inc., and Tolson USA, Inc. have agreed to perform neurotoxicity testing
with ethyl acetate. Five companies that include BASF Corp., Eastman
Chemical Co., Hoechst Celanese Chemical Group, Inc., Shell Oil Co., and
Union Carbide Corp. have agreed to perform neurotoxicity testing with
isobutyl alcohol. Six companies that include Eastman Chemical Co.,
Exxon Chemical Co., Hoechst Celanese Chemical Group, Inc., Rhone-
Poulenc Inc., Shell Oil Co., and Union Carbide Corp. have agreed to
perform neurotoxicity testing with methyl isobutyl ketone. Six
companies that include Arco Chemical Co., BASF Corp., E.I. duPont de
Nemours and Co., GE Plastics, ISP Management Company, Inc., and QO
Chemical Inc. have agreed to perform neurotoxicity testing with
tetrahydrofuran.
I. Background
On March 4, 1991 (56 FR 9105), EPA proposed neurotoxicity testing
of 10 substances under section 4 of TSCA. All 10 substances have wide
use as solvents (Refs. 10 and 11). A TSCA section 4(a)(1)(B) finding
for substantial exposure was made for each substance based on
production volume, occupational and consumer exposure,
[[Page 4517]] environmental release, and volatility (Refs. 10-16).
On July 27, 1993, EPA issued a Final Rule (58 FR 40262) requiring
the same neurotoxicity testing of the 10 substances that had been
proposed. These tests consisted of the Functional Observational Battery
(acute and subchronic), Motor Activity (acute and subchronic),
Neuropathology (subchronic), and the Schedule-controlled Operant
Behavior test (subchronic). The rule responded to comments on the
proposed test rule, discussed EPA's TSCA section 4(a) findings, and
specified test standards and reporting requirements.
On October 8, 1993, the manufacturers of the 10 substances
petitioned for review of the final rule under TSCA section 19 in the
Fifth Circuit Court of Appeals (Ref. 1). Subsequent to the filing of
this challenge to the rule, EPA, the Chemical Manufacturers Association
(``CMA''), and representatives of the 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. 2), to conduct neurotoxicity
and pharmacokinetics testing of seven of the original 10 substances
under negotiated ECAs, to be implemented by an order issued by EPA
under TSCA section 4. Testing on two of the substances subject to the
final rule, n- butyl acetate and isobutyl alcohol, is already underway.
On June 27, 1994, EPA issued a stay (59 FR 33184) and a proposed
revocation (59 FR 33187) of the final multi-substance rule for the
testing of neurotoxicity. Comments on the proposed revocation of the
final test rule are addressed in the notice to revoke this rule,
published elsewhere in this Federal Register.
II. Enforceable Consent Agreement Negotiations
Pursuant to EPA regulations, 40 CFR 790 subpart B, EPA published a
Federal Register notice (59 FR 33191, June 27, 1994) announcing an
opportunity for interested parties to participate in or monitor
negotiations for the development of consent agreements for the
neurotoxicity testing of the seven substances. It was also announced
that the testing agreed to in the settlement agreement (Ref. 2) would
be the starting point for the negotiations.
EPA met with identified interested parties, on July 28, 1994, to
initiate the negotiation of ECAs (Ref. 17). No new interested parties
identified themselves to EPA during the 30-day comment period or during
the meeting. The testing program outlined in the settlement agreement
was proposed as the basis for the ECAs. Tentative schedules for
completing the negotiation and signing the ECAs were discussed. EPA
announced that it would take comments from the interested parties on
the ECAs. The interested parties submitted comments and raised several
issues that required subsequent discussion. The discussions, which were
completed in early October 1994, addressed the 8(e) reportability of
effects seen above the limit dose and effects seen in the schedule-
controlled operant behavior tests, the description of EPA's lead role
in arranging a workshop on the test results, a request for assurance
from EPA that additional neurotoxicity testing of MIBK would not be
required by the Hazardous Air Pollutants (HAPs) test rules currently
under development, and that EPA's disclosure of test results be
governed by TSCA section 14 instead of limiting disclosures to TSCA
section 14(b). EPA agreed to provide the requested assurance in the ECA
for MIBK concerning neurotoxicity testing of MIBK under the HAPs rule.
EPA also agreed to allow section 14 of TSCA to govern disclosure of
test results.
EPA's request to add a list of specific graphs to the data
reporting requirements in the SCOB guideline (Ref. 18) was rejected,
but the test laboratories were represented by CMA as intending to try
to provide the results in the requested format. Requests to change the
boilerplate language of the consent agreements concerning EPA's right
to assess penalties and to use its professional judgement to determine
the scientific adequacy and validity of the test results were rejected.
EPA agreed to the following modifications to the testing program or
standards outlined in the settlement agreement: (1) renaming of the
``pharmacokinetics/metabolism'' test of butyl acetate to the ``in vivo
hydrolysis'' test of butyl acetate; (2) changing the deadline for the
submission of the in vivo hydrolysis test from 30 months to 24 months;
(3) allowing laboratory safety conditions to influence the setting of
the high dose at 50 percent of the lower explosive limit for all tests;
and (4) not requiring positive control data to be generated once every
year during the course of testing if laboratory conditions do not
change. The modifications were incorporated in the ECAs which EPA
provided to CMA for distribution to the companies for signature.
The companies signed the ECAs in November 1994, and the Assistant
Administrator for EPA'S Office of Prevention, Pesticides, and Toxic
Substances signed the ECAs and accompanying Orders in January 1995
(Refs. 3 through 9). These ECAs and Orders are final actions by EPA on
these seven substances.
III. Testing Program
Table 1 lists the tests, test standards, and reporting requirements
for the seven substances under the ECAs and Orders. This testing
program will allow EPA to further evaluate the potential neurotoxicity
resulting from exposure to these substances.
Table 1.--Required Testing, Test Standards and Reporting Requirements
------------------------------------------------------------------------
Deadline for Interim Reports
Substance Test Final Report\1\ Required\2\
------------------------------------------------------------------------
acetone.......... Scheduled- 30 4
n-amyl acetate... Acute
Neurotoxicity
Functional 24 3
Observational
Battery
Motor Activity 24 3
Subchronic
Neurotoxicity\4\
Functional 36 5
Observational
Battery
Motor Activity 36 5
[[Page 4518]]
Neuropathology 36 5
n-butyl acetate.. Acute
Neurotoxicity\4\
Functional 12 1
Observational
Battery
Motor Activity 12 1
Subchronic
Neurotoxicity\4\
Functional 24 3
Observational
Battery
Motor Activity 24 3
Neuropathology 24 3
Scheduled- 24 3
Controlled
Operant
Behavior,
Subchronic\3\
In Vivo 24 3
hydrolysis\5\
ethyl acetate.... Acute
Neurotoxicity\4\
Functional 18 2
Observational
Battery
Motor Activity 18 2
Subchronic
Neurotoxicity\4\
Functional 30 4
Observational
Battery
Motor Activity 30 4
Neuropathology 30 4
Scheduled- 30 4
Controlled
Operant
Behavior,
Subchronic\3\
isobutyl alcohol. Acute
Neurotoxicity\4\
Functional 12 1
Observational
Battery
Motor Activity 12 1
Subchronic
Neurotoxicity4
Functional 24 3
Observational
Battery
Motor Activity 24 3
Neuropathology 24 3
Scheduled- 24 3
Controlled
Operant
Behavior,
Subchronic\3\
methyl isobutyl Scheduled- 30 4
ketone. Controlled
Operant
Behavior,
Subchronic\3\
tetrahydrofuran.. Acute
Neurotoxicity\6\
Functional 24 3
Observational
Battery
Motor Activity 24 3
Subchronic
Neurotoxicity\4\
Functional 36 5
Observational
Battery
Motor Activity 36 5
Neuropathology 36 5
------------------------------------------------------------------------
\1\Number of months after effective date of the ECA when the final
report will be submitted to EPA.
\2\Number of interim reports to be submitted to EPA. Interim reports
will be due every 6 months from the effective date until the final
report is submitted.
\3\The subchronic schedule-controlled operant behavior (SCOB) test shall
be conducted in accordance with the 1991 EPA Guideline for Schedule-
controlled Operant Behavior (EPA 540/09-01-123, NTIS No.: PB 154617)
as modified.
\4\ Acute and subchronic neurotoxicity studies shall be conducted in
accordance with the 1991 EPA Guidelines in EPA 540/09-01-123, NTIS
No.: PB 154617, pages 13-27 as modified for purposes of these
enforceable consent agreements.
\5\The in vivo hydrolysis test shall be conducted in accordance with the
``Protocol for Determining the In Vivo Hydrolysis of N- Butyl Acetate
in Rats After Intravenous Administration'' (Ref. 5).
\6\ Acute and subchronic neurotoxicity studies shall be conducted in
accordance with the 1991 EPA Guidelines in EPA 540/09-01-123, NTIS
No.: PB 154617, pages 13-27 as modified for purposes of these
enforceable consent agreements.
[[Page 4519]] IV. Test Substances
With the exception of n-amyl acetate, the purity of the test
substances shall be 99 percent or greater. In the case of n-amyl
acetate, the test sponsor will be required to select and test a
technical grade containing a representative percent of n-amyl acetate.
The test sponsor will indicate the percent of n-amyl acetate in the
test substance in the test protocol.
V. Export Notification
The issuance of the ECAs and Orders subjects any persons who export
or intend to export any of the seven chemical substances, of any
purity, to the export notification requirements of section 12(b) of
TSCA. The listing of the chemical substance at 40 CFR 799.5000 serves
as a notification to persons who export or intend to export a chemical
substance or mixture that is the subject of an ECA and Order that 40
CFR part 707 applies.
VI. Public Record
EPA has established a record for these ECAs and Orders under docket
number OPPTS-42134G. This record contains the following information:
A. Supporting Documentation
(1) Federal Register notices pertaining to this document, ECAs, and
Orders 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, 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 summaries.
(c) Meeting summaries (including public meeting on July 28, 1994).
(3) Reports - published and unpublished factual materials.
B. References
(1) Chemical Manufacturers Association (CMA). Petition for
Review. Filed with United States Court of Appeals for the Fifth
Circuit. (October 8, 1993).
(2) United States Court of Appeals for the Fifth Circuit.
Settlement Agreement between Environmental Protection Agency (USEPA)
and petitioners. No. 93-5381. (April 28, 1994).
(3) United States Environmental Protection Agency. USEPA.
Enforceable Consent Agreement (ECA) and Order for Acetone. (January
1995).
(4) USEPA. ECA and Order for N-Amyl Acetate. (January 1995).
(5) USEPA. ECA and Order for N-Butyl Acetate. (January 1995).
(6) USEPA. ECA and Order for Ethyl Acetate. (January 1995).
(7) USEPA. ECA and Order for Isobutyl Alcohol (January 1995).
(8) USEPA. ECA and Order for Methyl Isobutyl Ketone. (January
1995).
(9) USEPA. ECA and Order for Tetrahydrofuran. (January 1995).
(10) USEPA. ``Economic impact evaluation of proposed multi-
chemical rule for the testing of neurotoxicity .'' Economics and
Technology Division, OTS, USEPA. Washington, DC. (July 25, 1990).
(11) USEPA. ``Multi-substance rule for the testing of
neurotoxicity; proposed rule.'' (56 FR 9105, March 4, 1991).
(12) NIOSH. National Institute for Occupational Safety and
Health. National Occupational Exposure Survey (NOES). Computer
printout. ((March 29, 1989).
(13) USEPA. ``Household Solvent Products. A National Usage
Survey.'' EPA-OTS 560/5-87-005. (July 1987).
(14) Versar, Inc. Springfield, VA. ``Estimates of consumer
exposure to ethyl ether''. Memorandum from Carl D'Ruiz, Versar,
Inc., to Conrad Flessner, Exposure Assessment Branch, OTS, USEPA.
(15) Syracuse Research Corporation, Syracuse, NY. ``Technical
Support for Selection of Solvents for a Neurotoxicity Test Rule.''
Contract No. 68-D8-0117, Task 103. TR 89-218. (January 11, 1990).
(16) USEPA. Toxics-Release Inventory. EPA 560/4-89-006. Office
of Pesticides and Toxic Substances, Washington, DC. (June 1989).
(17) USEPA. Minutes of Neurotoxicity Consent Agreement Public
Meeting. (July 28, 1994).
(18) USEPA. Proposed addition to SCOB guideline. (September 22,
1994).
VII. Regulatory Assessment Requirements
The Office of Management and Budget (OMB) has approved the
information collection requirements contained in the Consent Agreement
under the provisions of the Paperwork Reduction Act of 1980, 44 U.S.C.
3501 et seq., and has assigned OMB control 2070-0033.
Public reporting burden for this collection of information is
estimated to average 586 hours per response. The estimates include time
for reviewing instructions, searching existing data sources, gathering
and maintaining the data needed, and completing and reviewing the
collection of information.
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 part 799 subpart C 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.
2. Section 799.5000 is amended by adding acetone, isobutyl alcohol,
methyl isobutyl ketone, tetrahydrofuran, n-butyl acetate, ethyl
acetate, and n-amyl acetate to the table in CAS Number order, to read
as follows:
Sec. 799.5000 Testing consent agreements for substances and mixtures
with Chemical Abstract Service Registry Numbers.
* * * * * *
------------------------------------------------------------------------
Substance or FR Publication
CAS Number mixture name Testing Date
------------------------------------------------------------------------
* * * *
* * *
67-64-1.......... Acetone Health effects [January 23,
1995]
* * * *
* * *
78-83-1.......... Isobutyl alcohol Health effects [January 23,
1995]
* * * *
* * *
108-10-1......... Methyl isobutyl Health effects [January 23,
ketone 1995]
109-99-9......... Tetrahydrofuran Health effects [January 23,
1995]
[[Page 4520]]
* * * *
* * *
123-86-4......... N-butyl acetate Health effects [January 23,
1995]
* * * *
* * *
141-78-6......... Ethyl acetate Health effects [January 23,
1995]
* * * *
* * *
628-63-7......... N-amyl acetate Health effects [January 23,
1995]
* * * *
* * *
------------------------------------------------------------------------
[FR Doc. 95-1674 Filed 1-20-95; 8:45 am]
BILLING CODE 6560-50-F