[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: ncic@epamail.epa.gov. 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-Hotline@epamail.epa.gov.
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:
ncic@epamail.epa.gov
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
