[Federal Register Volume 60, Number 183 (Thursday, September 21, 1995)]
[Proposed Rules]
[Pages 48948-48950]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-23460]



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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 799

[OPPTS-42111H; FRL-4972-3]
RIN 2070-AB94


Office of Water Chemicals Test Rule Proposed Modification

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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SUMMARY: EPA is proposing to withdraw the testing requirements for 
chloroethane, one of the chemical substances listed in the Office of 
Water Chemicals test rule published in the Federal Register of November 
10, 1993. EPA believes that data recently made available provides 
sufficient information to determine or predict the health effects posed 
by short and long-term exposures to chloroethane. Therefore, EPA is 
proposing the withdrawal of the 14-day and 90-day testing requirements 
for chloroethane.

DATES: Written comments must be received by EPA on or before October 
23, 1995.

ADDRESSES: Submit written comments, identified by the docket control 
number (OPPTS-42111H), in triplicate to: Document Control Office 
(7407), Office of Pollution Prevention and Toxics, U.S. Environmental 
Protection Agency, Rm. G-099, 401 M St., SW., Washington, DC 20460. A 
public version of the administrative record supporting this action, 
without Confidential Business Information (CBI), is available for 
inspection in the TSCA Nonconfidential Information Center, Rm. NE-B607, 
401 M St., SW., Washington, DC 20460, from 12 noon to 4 p.m., Monday 
through Friday, except legal holidays.
    Comments and data may be submitted electronically by sending 
electronic mail (e-mail) to: [email protected]. Electronic comments 
must be submitted as an ASCII file avoiding the use of special 
characters and any form of encryption. Comments and data will also be 
accepted in WordPerfect in 5.1 file format or ASCII file format. All 
comments and data in electronic form must be identified by the docket 
number OPPTS-42111H. No CBI should be submitted through e-mail. 
Electronic comments on this proposed rule may be filed online at many 
Federal Depository Libraries. Additional information on electronic 
submissions can be found in Unit IV. of this preamble.

FOR FURTHER INFORMATION CONTACT: Susan B. Hazen, Director, 
Environmental Assistance Division (7408), Office of Pollution 
Prevention and Toxics, 401 M St., SW., Washington, DC 20460, (202) 554-
1404, TDD (202) 554-0551, e-mail: TSCA-H[email protected].

SUPPLEMENTARY INFORMATION: This document proposes to withdraw certain 
testing requirements for one of the chemical substances listed in the 
Office of Water Chemicals test rule referenced above.

I. Summary of Proposed Modification

    Pursuant to section 4 of the Toxic Substances Control Act (TSCA) 
EPA proposed a test rule (FRL-3712-5) in the Federal Register of May 
24, 1990 (55 FR 21393), and finalized the test rule (FRL-4047-2) in the 
Federal Register of November 10, 1993 (58 FR 59667), requiring certain 
testing of chloroethane. The final rule concluded that chloroethane is 
produced in substantial quantities and that there may be substantial 
exposure to it, there are insufficient data to determine or predict the 
health effects from short and long-term exposures to chloroethane in 
drinking water, and that testing is required to determine or predict 
the health effects from short and long-term exposures to chloroethane. 
Based on these conclusions, EPA required a subacute toxicity (oral 14-
day repeated dose toxicity) and a subchronic (oral 90-day subchronic 
toxicity) toxicity test. The data from these studies would be used to 
develop Health Advisories (HAs) for chloroethane in drinking water as 
under section 1445 of the Safe Drinking Water Act (SDWA).
    EPA has recently received information which, in the judgment of 
EPA, provides sufficient information to determine or predict the health 
effects from exposure to chloroethane in drinking water (Ref. 1a). On 
May 1, 1995, the Dow Chemical Company submitted a study entitled 
``Ethyl Chloride Palatability and 14-day 

[[Page 48949]]
Drinking Water Toxicity Study in Fischer 344 Rats.'' The study 
concluded that there were no toxicological effects from the drinking 
water administration of chloroethane to the treated rats at the level 
of practical saturation. After submission of additional information 
requested by the Agency (Refs. 2, 2a, 3, and 4), EPA conducted a review 
(Ref. 5). The EPA review, dated July 14, 1995, concluded that the 14-
day study provided sufficient information to establish appropriate 
Health Advisories. Therefore, there is no reason to continue to require 
the testing specified for chloroethane in the Office of Water Chemicals 
test rule.
    EPA is providing 30 days from publication of this proposed 
modification for submission of written comments on the elimination of 
both the subacute (oral 14-day repeated dose toxicity) and subchronic 
(oral 90-day subchronic toxicity) toxicity test requirements for 
chloroethane. If the 30-day deadline passes and no adverse public 
comments have been received, EPA will grant the proposed modification 
to delete these tests in a final rule published in the Federal 
Register.

II. Comments Containing Confidential Business Information

    Any person who submits comments claimed as CBI must mark the 
comments as ``confidential,'' ``trade secret,'' or other appropriate 
designation. Comments not claimed as confidential at the time of 
submission will be placed in the public file. Any comments marked as 
confidential will be treated in accordance with the procedures in 40 
CFR part 2. Any party submitting confidential comments must prepare and 
submit a public version of the comments for the EPA public file.

III. Analyses Under Executive Order 12866, the Unfunded Mandates 
Act of 1995, the Regulatory Flexibility Act, and the Paperwork 
Reduction Act

    Because this action reduces certain pending requirements, this 
action is not ``significant'' within the meaning of Executive Order 
12866 (58 FR 51735, October 4, 1993), and does not impose any Federal 
mandate on any State, local, or tribal governments or the private 
sector within the meaning of the Unfunded Mandates Reform Act of 1995 
(Pub. L. 104-4). For the same reasons, pursuant to the Regulatory 
Flexibility Act (5 U.S.C. 605(b)), it has been determined that this 
action will not have a significant economic impact on a significant 
number of small entities. Additionally, the information collection 
requirements associated with TSCA Section 4 Test Rules have been 
approved by OMB under the provisions of the Paperwork Reduction Act, 44 
U.S.C. 3501, and have been assigned OMB control number 2070-0033. EPA 
has determined that this proposed rule eliminates certain pending 
recordkeeping and reporting requirements.

IV. Rulemaking Record

    A record has been established for this proposed rule under docket 
number ``OPPTS-42111H'' (including comments and data submitted 
electronically as described below). A public version of the record, 
including printed, paper versions of electronic comments, which does 
not include any information claimed as CBI, is available for inspection 
from 12 noon to 4 p.m., Monday through Friday, except legal holidays. 
The public record is located in the TSCA Nonconfidential Information 
Center, Rm. NE-B607, 401 M St., SW., Washington, DC 20460.
    Electronic comments can be sent directly to EPA at:

    [email protected]

    Electronic comments must be submitted as an ASCII file avoiding the 
use of special characters and any form of encryption.
    The official record for this proposed rule, as well as the public 
version, as described above will be kept in paper form. Accordingly, 
EPA will transfer all comments received electronically into printed, 
paper form as they are received and will place the paper copies in the 
official record which will also include all comments submitted directly 
in writing. The official record is the paper record maintained at the 
address in ADDRESSES at the beginning of this document.
    The record includes the following information:
    (1) Letter from Annette L. Hayes of Latham Watkins to Amber L. 
Aranda, U.S.E.P.A. transmitting April 28, 1995 Dow Chemical Study 
(May 1, 1995) (with attachment:).

    (a) Dow Chemical Company. Study titled ``Ethyl Chloride: 
Palatibility and 14-Day Drinking Water Toxicity Study in Fischer 344 
Rats'' (April 28, 1995).

    (2) Facsimile note from Roger A. Nelson, U.S.E.P.A. to Dr. Lynn 
Pottenger, The Dow Chemical Company requesting information (June 7, 
1995) (with attachment:).

    (a) Memorandum from Jennifer Orme-Zavaleta, U.S.E.P.A. to Frank 
Kover, U.S.E.P.A. requesting additional data (June 5, 1995).

    (3) Letter from Lynn Pottenger, The Dow Chemical Company to 
Roger Nelson, U.S.E.P.A., Re: Questions on Chloroethane Study Report 
(June 9, 1995).

    (4) The Dow Chemical Company. ``Report Addendum'' to Ethyl 
Chloride: Palatibility and 14-Day Drinking Water Toxicity Study in 
Fischer 344 Rats (June 9, 1995).

    (5) Memorandum from Jennifer Orme-Zavaleta, U.S.E.P.A. to Frank 
Kover, U.S.E.P.A. Office of Water Review (July 14, 1995).

List of Subjects in 40 CFR Part 799

    Environmental protection, Chemicals, Chemical export, Hazardous 
substances, Health effects, Incorporation by reference, Laboratories, 
Provisional testing, Reporting and recordkeeping requirements, Testing.

    Dated: September 12, 1995.

Lynn R. Goldman,
Assistant Administrator for Prevention, Pesticides and Toxic 
Substances.

    Therefore, it is proposed that 40 CFR part 799 be amended as 
follows:

PART 799--IDENTIFICATION OF SPECIFIC CHEMICAL SUBSTANCE AND MIXTURE 
TESTING REQUIREMENTS

    1. The authority citation for part 799 continues to read as 
follows:

    Authority: 15 U.S.C. 2603, 2611, 2625.

    2. Section 799.5075 is amended by revising paragraphs (a)(1), 
(c)(1)(i)(A), and (c)(2)(i)(A) to read as follows:


Sec. 799.5075  Drinking water contaminants subject to testing.

    (a) Identification of test substance. (1) 1,1,2,2-Tetrachloroethane 
(CAS No. 79-34-5), and 1,3,5-trimethylbenzene (CAS No. 108-67-8) shall 
be tested as appropriate in accordance with this section.
*          *          *          *          *
    (c) Health effects testing--(1) Subacute toxicity--(i) Required 
testing. (A) An oral 14-day repeated dose toxicity test shall be 
conducted with 1,1,2,2-tetrachloroethane, and 1,3,5-trimethylbenzene in 
accordance with Sec. 798.2650 of this chapter except for the provisions 
in Sec. 798.2650 (a), (b)(1), (c), (e)(3), (e)(4)(i), (e)(5), (e)(6), 
(e)(7)(i), (e)(7)(iv), (e)(7)(v), (e)(8)(vii), (e)(9)(i)(A), 
(e)(9)(i)(B), (e)(11)(v), and (f)(2)(i). Each substance shall be tested 
in one mammalian species, preferably a rodent, but a non-rodent may be 
used. The species and strain of animals used in this test should be the 
same as those used in the 90-day subchronic test required in paragraph 
(c)(2)(i) of this section. The tests shall be performed using drinking 
water. However, if, due to poor stability or palatability, a drinking 
water test is not feasible for a given substance, that substance shall 
be 

[[Page 48950]]
administered either by oral gavage, in the diet, or in capsules.
*          *          *          *          *
    (2) Subchronic toxicity--(i) Required testing. (A) An oral 90-day 
subchronic toxicity test shall be conducted with 1,3,5-trimethylbenzene 
in accordance with Sec. 798.2650 of this chapter except for the 
provisions in Sec. 798.2650 (e)(3), (e)(7)(i), and (e)(11)(v). The test 
shall be performed using drinking water. However, if, due to poor 
stability or palatability, a drinking water test is not feasible for a 
given substance, that substance shall be administered either by oral 
gavage, in the diet, or in capsules.
*         *          *          *          *

[FR Doc. 95-23460 Filed 9-20-95; 8:45 am]
BILLING CODE 6560-50-F