[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]



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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.

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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