[Federal Register Volume 60, Number 54 (Tuesday, March 21, 1995)]
[Rules and Regulations]
[Pages 14910-14912]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-6766]



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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 799

[OPPTS-42180; FRL 4935-4]
RIN 2070-AB07


Testing Consent Order for Tertiary Amyl Methyl Ether

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final Consent Agreement and Order.

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SUMMARY: EPA has issued a Testing Consent Order that incorporates an 
Enforceable Consent Agreement (ECA) pursuant to the Toxic Substances 
Control Act (TSCA) with members of the TAME Producers Group comprised 
of the following companies: Amerada Hess Corporation, Chevron U.S.A. 
Products Company, Citgo Petroleum, Exxon Company U.S.A., and Texaco 
Refining and Marketing (the Consortium) who have agreed to perform 
certain health effects tests with tertiary-amyl methyl ether (CAS No. 
994-05-8) (TAME). This document summarizes the ECA and adds TAME to the 
list of chemical substances and mixtures subject to ECAs. Accordingly, 
export notification requirements apply to TAME.

 EFFECTIVE DATE: March 21, 1995.

FOR FURTHER INFORMATION CONTACT: Susan B. Hazen, Director, 
Environmental Assistance Division (7408), Office of Pollution 
Prevention and Toxics, Rm. E-543B, 401 M St., SW., Washington, DC 
20460, (202) 554-1404, TDD (202) 554-0551. Technical contact: Gary Timm 
(202) 260-7335.

SUPPLEMENTARY INFORMATION: This document amends 40 CFR 799.5000 by 
adding TAME to the list of chemical substances and mixtures subject to 
ECAs and export notification requirements.

I. Background

    The Clean Air Act (42 U.S.C. 7401-7671q) provides that beginning on 
November 1, 1992, gasoline containing at least 2.7 percent oxygen by 
weight is required to be used in the wintertime in 39 areas of the 
county which failed to comply with the carbon monoxide (CO) National 
Ambient Air Quality Standard. Carbon monoxide pollution is caused by 
incomplete burning of fuels used in internal combustion engines and is 
generally more severe during cold winter temperatures. Tests have shown 
that the use of oxygenates in gasoline can reduce CO emissions by 15 to 
20 percent (Emission Reduction and Cost Effectiveness of Oxygenated 
Gasolines. Environmental Protection Agency. June, 3 1991). Methyl 
tertiary-butyl ether (MTBE) and ethanol are the primary oxygenates used 
in the oxygenated gasoline program.
    MTBE was recommended for health effects testing by the Interagency 
Testing Committee in its 19th report because of its rapidly growing use 
as a fuel additive. EPA negotiated an ECA with the Oxygenated Fuel 
Producers for comprehensive health effects testing in 1988 (53 FR 
10391, March 31, 1988). Despite this extensive testing program and 
experience using MTBE as a gasoline additive, acute health concerns 
were raised in Alaska and Missoula, MT after MTBE's introduction to 
these areas in November, 1992. Additional research was conducted by 
EPA, the American Petroleum Institute (API), and the Oxygenated Fuels 
Association to address the concerns raised by the citizens of Alaska 
and assist policy decision making for the next oxyfuel season. These 
studies, including human exposures, failed to confirm MTBE as the 
source of the human health complaints.
    A meeting between the Federal Government, State of Alaska, and 
industry to plan additional research on the oxyfuels was held in 
December, 1993. This group also recommended that baseline toxicity 
testing information be developed for both ethyl tertiary-butyl ether 
(ETBE) and TAME, widely seen as possible substitutes for MTBE, to 
compare their toxic potential with that of MTBE. The research planning 
workshop recommended the following tests for ETBE and TAME:1st tier 
genotoxicity, 90-day inhalation subchronic, neurotoxicity developmental 
toxicity, reproductive effects pharmacokinetics.
    On March 1, 1994, EPA's Office of Mobile Sources requested that the 
Office of Pollution Prevention and Toxics develop these data under 
section 4 of the Toxic Substances Control Act (TSCA).

II. Enforceable Consent Agreement Negotiations

    EPA sent letters to approximately 50 individuals in the petroleum 
and oxyfuel-related industries announcing the addition of ETBE and TAME 
to EPA's Master Testing List and EPA's interest in pursuing a testing 
program under an ECA. On March 9, 1994, API indicated that the industry 
had agreed to form a testing panel under API auspices to develop and 
present a testing proposal to EPA on ETBE and TAME. On April 18, 1994, 
EPA published a notice in the Federal Register inviting manufacturers 
and processors of ETBE and TAME and other interested persons to 
participate in ECA negotiations on these substances and announced that 
a public meeting would be held on May 9, 1994.
    On behalf of the Consortium, API submitted proposals for testing 
ETBE and TAME in April. At the May 9 meeting, API stated that there was 
support among Consortium members to conduct testing of TAME, but not 
ETBE. The chief difference between the EPA and Consortium positions on 
testing TAME was the design of the reproductive effects and fertility 
study. The Consortium proposed only a one-generation study as opposed 
to the two-generation study recommended by EPA. This issue was resolved 
in a conference call on July 28, 1994, with the Consortium agreeing to 
conduct the two-generation study. Members of the Consortium signed an 
ECA for the testing of TAME in January, 1995; EPA signed the ECA in 
February, 1995.
    Regarding ETBE, after appropriate notification of interested 
persons, EPA held a public meeting on July 14, 1994, to discuss the 
development of an ECA for this substance. At that meeting, ARCO, the 
only current or potential producer in attendance, stated that it had 
conducted screening tests for mutagenicity but that the company had 
decided not to enter into an ECA with EPA to conduct additional 
testing. ETBE thus remains on EPA's Master Testing List in a queue for 
rulemaking under TSCA section 4.

III. TAME Testing Program

    Table I describes the tests, the test standards and reporting 
requirements For TAME under the ECA. This testing program will allow 
EPA to better characterize the potential health hazards resulting from 
exposure to TAME.

                                                                        
[[Page 14911]]                                                          
 Table I.-- Required Testing, Test Standards and Reporting Requirements 
                                for TAME                                
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  Description of                        Deadline for     Interim Reports
      Tests         Test Standard\1\   Final Report\2\     Required\3\  
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Pharmacokinetics   795.230 (Appendix  20                3               
 (Inhalation,       I)                                                  
 rats and mice).                                                        
                                                                        
90-Day Subchronic  798.2450 Amended   18                2               
 (Inhalation,       to include                                          
 rats and mice).    mitogenesis,spec                                    
                    ial staining and                                    
                    immunochemistry                                     
                    (Appendix II)                                       
                                                                        
Neurotoxicity      795.247 (Appendix  20                3               
 Screen.            III)                                                
                                                                        
Mutagenicity: CHO  798.5300           15                2               
 HGPRT.             (Appendix)                                          
                                                                        
Mutagenicity:      798.5375           15                2               
 Chromosomal        (Appendix)                                          
 aberrations.                                                           
                                                                        
Reproduction and   OPPTS 870.3800     30                5               
 Fertility                                                              
 (Inhalation,                                                           
 rats).                                                                 
                                                                        
Developmental      OPPTS 870.3700     15                2               
 toxicity                                                               
 (Inhalation,                                                           
 rats and mice).                                                        
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\1\Citation is to 40 CFR unless otherwise noted. The OPPTS 870 series   
  guidelines are available from EPA but have not been published.        
\2\ Number of months after the effective date of the consent order.     
\3\ Interim reports are required every 6 months from the effective date 
  until the final report is submitted. This column shows the number of  
  interim reports required for each test.                               

IV. Export Notification

    The issuance of the ECA and Order subjects any persons who export 
or intend to export the chemical substance TAME (CAS No. 994-05-8), of 
any purity, to the export notification requirements of section 12(b) of 
TSCA and the regulations promulgated pursuant to it at 40 CFR part 707. 
The listing of the chemical substance or mixture at 40 CFR 799.5000 
serves as a notification to persons who intend to export such a 
chemical substance or mixture that the substance or mixture is the 
subject of an ECA and Order and 40 CFR part 707 applies.

V. Rulemaking Record

    EPA has established a record for this ECA and Order under docket 
number OPPTS-52098, which is available for inspection Monday through 
Friday, excluding legal holidays, in Rm. NE B607, 401 M St.,SW., 
Washington, DC., 20460 from 1 p.m. to 4 p.m. Confidential Business 
Information (CBI), while part of the record, is not available for 
public review. This record contains the basic information considered in 
developing this ECA and Order, and includes the following information:
    (1) Testing Consent Order for TAME with incorporated Enforceable 
Consent Agreement and associated testing protocols attached as 
appendices.
    (2) Federal Register notice announcing the opportunity to initiate 
Negotiations for a TSCA Section 4 Testing ECA (April 18, 1994; 59 FR 
18399).
    (3) Communications consisting of:
    (a) Written Letters.
    (b) Contact reports of telephone summaries.
    (c) Meeting summaries.
    (4) Reports -published and unpublished factual materials.

List of Subjects in 40 CFR Part 799

    Chemicals, Chemical export, Environmental protection, Hazardous 
substances, Health effects, Laboratories, Reporting and recordkeeping 
requirements, Testing.

    Dated: March 7, 1995.
Lynn R. Goldman,
Assistant Administrator for Prevention, Pesticides and Toxic 
Substances.

    Therefore, 40 CFR part 799 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 tertiary-amyl methyl ether 
(TAME) 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      
------------------------------------------------------------------------
                                                                        
       *                  *                  *                  *       
                  *                  *                  *               
994-05-8.........  Tertiary-amyl      Health effects..  March 21, 1995. 
                    methyl ether.                                       
                                                                        
       *                  *                  *                  *       
                  *                  *                  *               
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[[Page 14912]] [FR Doc. 95-6766 Filed 3-20-95; 8:45 am]
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