[Federal Register Volume 60, Number 68 (Monday, April 10, 1995)]
[Proposed Rules]
[Pages 18079-18081]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-8734]
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 799
[OPPTS-42111E, FRL-4927-8]
RIN 2070-AB94
Test Rule; Office of Water Chemicals Proposed Withdrawal of
Certain Testing Requirements
AGENCY: Environmental Protection Agency (EPA).
ACTION: Proposed rule.
-----------------------------------------------------------------------
SUMMARY: EPA is proposing to withdraw certain testing requirements for
two of the chemical substances listed in the Office of Water chemicals
test rule published in the Federal Register of November 10, 1993 (58 FR
59667). EPA required specified health effects testing for the two
chemical substances because the substances are produced in substantial
quantities and there may be substantial exposure to these substances,
there are insufficient data to determine or predict the health effects
from exposure to these substances in drinking water, and the testing
required is necessary to determine or predict these health effects. EPA
believes that data recently made available to it are sufficient to
determine or predict the health effects posed by short and long-term
exposures to 1,1-dichloroethane in drinking water and are sufficient to
determine or predict the health effects posed by long-term exposures to
1,1,2,2-tetrachloroethane in drinking water. Therefore, EPA is
proposing the withdrawal of the 90-day subchronic testing requirement
for 1,1,2,2-tetrachloroethane and the 90-day and 14-day testing
requirements for 1,1-dichloroethane.
DATES: Written comments must be received by EPA on or before May 10,
1995.
ADDRESSES: Submit written comments, identified by the document control
number (OPPTS-42111E) in triplicate to: TSCA Document Receipts Office
(Mail stop 7407), Office of Pollution Prevention and Toxics,
Environmental Protection Agency, Rm. ET G-99, 401 M St., SW.,
Washington, DC, 20460. A public version of the administrative record
supporting this action, without confidential business information, is
available for inspection at the above address from 12 p.m. to 4 p.m.,
Monday through Friday, except legal holidays.
FOR FURTHER INFORMATION CONTACT: James G. Willis, Acting 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.
SUPPLEMENTARY INFORMATION: EPA is proposing to withdraw the 90-day
subchronic testing requirement for 1,1,2,2-tetratchloroethane and the
90-day and 14-day testing requirements for 1,1-dichloroethane in the
Office of Water chemicals test rule referenced above.
I. Proposed Modification
Pursuant to section 4 of the Toxic Substances Control Act (TSCA),
EPA proposed a test rule in the Federal Register of May 24, 1990 (55 FR
21393) and finalized the test rule in the Federal Register of November
10, 1993 (58 FR 59667), finding that four chemical substances;
chloroethane (CAS No. 75-00-3); 1,1-dichloroethane (CAS No. 75-34-3);
1,1,2,2-tetrachloroethane (CAS No. 79-34-5); and 1,3,5-trimethylbenzene
(CAS No. 108-67-8) are produced in substantial quantities and that
there may be substantial exposure to these substances, that there are
insufficient data to determine or predict the health effects from short
and long-term exposures to the substances in drinking water, and that
testing is required to determine or predict the health effects from
short and long-term exposures. Thus, EPA required subacute toxicity
(oral 14-day repeated dose) and subchronic (oral 90-day) toxicity
tests. The data from these studies would be used to develop Health
Advisories (HA's) for the four unregulated drinking water contaminants
that are monitored under section 1445 of the Safe Drinking Water Act
(SDWA).
EPA has recently received requests to withdraw all or part of the
testing required for two substances, 1,1-dichloroethane and 1,1,2,2-
tetrachloroethane. On June 28, 1994, the Halogenated Solvents Industry
Alliance (HSIA) requested that EPA revoke the subchronic (oral 90-day)
toxicity test requirements for 1,1,2,2-tetrachloroethane (Ref. 1). This
request was based on the availability of a 90-day subchronic toxicity
drinking water study of 1,1,2,2-tetrachloroethane conducted in rats and
mice by the National Toxicology Program (Ref. 2). EPA reviewed this
study and believes that the study is sufficient to meet the 90-day
subchronic toxicity test required under the test rule and to establish
long-term Health Advisories for the Office of Water (OW) (Ref. 3).
Therefore, EPA believes it is appropriate to withdraw the 90-day
subchronic testing requirements for 1,1,2,2-tetrachloroethane.
HSIA also requested that EPA withdraw the 14- and 90-day subchronic
toxicity testing required under the test rule for 1,1-dichloroethane.
This request was based on a study conducted by Muralidhara et al. (Ref.
6) that characterizes the acute (24 hour), subacute (5 and 10 days),
and the subchronic (90 days) toxicity potential of 1,1-dichloroethane.
EPA reviewed the study and believes the study is sufficient to
determine or predict both the short and long-term effects of exposure
to 1,1-dichloroethane (Ref. 7). Therefore, EPA believes it is
appropriate to withdraw both the 14- and 90-day subchronic toxicity
tests required for 1,1-dichloroethane under the test rule for the OW
substances.
EPA is providing 30 days from publication of this proposed
modification for submission of written comments on the elimination of
the subchronic toxicity (oral 90-day) test requirement for 1,1,2,2-
tetrachloroethane and of both the subacute (oral 14-day repeated dose)
and subchronic (oral 90-day) toxicity test requirements for 1,1,2,2-
tetrachloroethane. If the 30 day deadline passes and no public comments
have [[Page 18080]] been received that cause a change in the position
set forth in this Notice, EPA will grant the proposed modification to
delete these tests and publish a notice to the effect in the Federal
Register.
II. Comments Containing Confidential Business Information
Any person who submits comments that certain information claimed as
confidential business information must label the specific information
claimed as confidential by circling, bracketing, or underlining it, and
marking it ``confidential,'' ``trade secret,'' or other appropriate
designation. Comments not claimed as confidential at the time of
submission will be placed in the public file without further notice to
the submitter. 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. Rulemaking Record
EPA has established a docket for this rulemaking (docket number
OPPTS-42111E). Currently, this docket contains the basic information
considered by EPA in developing this proposal.
A public version of the record, from which all information claimed
as CBI has been deleted, is available for inspection in the TSCA
Nonconfidential Information Center, B-607, NE Mall, 401 M St., SW.,
Washington, DC. 20460, from 12 noon to 4 p.m., Monday through Friday,
except legal holidays.
The record includes the following information:
(1) Halogenated Solvents Industry Alliance (HSIA). Letter from
Peter Voytek, Ph.D. to Connie Musgrove, USEPA entitled ``Request for
Modification of Study Requirements''. (June 28, 1994).
(2) National Institute of Environmental Health Sciences (NIEHS).
Letter from William Eastin, Ph.D. to Roger Nelson, USEPA (July 7,
1994) with two attachments:
(a) Pathco. ``Chairperson's Report Structure Activity
Relationship Studies of Halogenated Ethane-Induced Accumulation of
Alpha-2U-Globulin in the Male Rat Kidney: Part A, B, C, -Studies
Conducted in F344 Rats at Microbiological Associates''.
(b) Microbiological Associates, Inc. Final Report Study Nos.
03554.11 - 03554.12, 1,1,2,2-Tetrachloroethane (TCE).
(3) USEPA. Memorandum from Bruce Mintz to Roger Nelson ``Request
for Office of Water Recommendation for Approval/Disapproval of 28
Jun 1994 HSIA Request for Modification of Test Standards for 1,1-
Dichloroethane and 1,1,2,2-Tetrachloroethane (Office of Water Test
Rule)''.
(4) Voytek, P. Note (Fax) to Roger Nelson entitled ``Preliminary
Testing of 1,1-Dichloroethane in Drinking Water''. (Aug. 3, 1994).
(5) Unpublished. Original Draft of Report to EPA HERL,
Cincinnati in 1986. James V. Bruckner, Ph.D. (Undated).
(6) Muralidhara, S., R. Ramanathan, C.E. Dallas and J.V.
Bruckner. ``Acute, Subacute and Subchronic Oral Toxicity Studies of
1,1-Dichloroethane (DCE) in Rats''. Society of Toxicology Abstract.
(1986).
(7) USEPA. Memorandum from Krishan Khanna to Roger Nelson
``Review of 1,1-Dichloroethane (DCE) Data (TSCA Test Rule for Office
of Water Chemicals).'' Nov. 15, 1994.
IV. Regulatory Assessment Requirements
A. Executive Order 12866
Under Executive Order 12866 (58 FR 51735, October 4, 1993), the
Agency must determine whether the regulatory action is ``significant''
and therefore subject to review by the Office of Management and Budget
(OMB) and the requirements of the Executive Order. Under section 3(f),
the order defines a ``significant regulatory action'' as an action that
is likely to result in a rule (1) having an annual effect on the
economy of $100 million or more, or adversely and materially affecting
a sector of the economy, productivity, competition, jobs, the
environment, public health or safety, or State, local or tribal
governments or communities (also referred to as ``economically
significant''); (2) creating serious inconsistency or otherwise
interfering with an action taken or planned by another agency; (3)
materially altering the budgetary impacts of entitlement, grants, user
fees, or loan programs or the rights and obligations of recipients
thereof; or (4) raising novel legal or policy issues arising out of
legal mandates, the President's priorities, or the principles set forth
in this Executive Order.
Pursuant to the terms of this Executive Order, it has been
determined that this proposed rule is not ``significant'' and is
therefore not subject to OMB review.
B. Regulatory Flexibility Act
Under the Regulatory Flexibility Act (5 U.S.C. 601 et seq.), I
certify that this test rule, if promulgated, would not have a
significant impact on a substantial number of small businesses because
the proposed amendment would relieve a regulatory obligation to conduct
certain chemical tests.
C. Paperwork Reduction Act
OMB has approved the information collection requirements contained
in this proposed test rule under the provisions of the Paperwork
Reduction Act of 1980, 44 U.S.C. 3501 et seq., and has assigned OMB
Control number 2070-0033.
This proposed rule would reduce the public reporting burden
associated with the testing requirement under the final test rule. A
complete discussion of the reporting burden is contained at 58 FR
59680.
List of Subjects in 40 CFR Part 799
Chemicals, Chemical export, Environmental protection, Hazardous
substances, Health effects, Laboratories, Provisional testing,
Reporting and recordkeeping requirements, Testing, Incorporation by
reference.
Authority: 15 U.S.C. 2603
Dated: March 31, 1995.
Lynn R. Goldman,
Assistant Administrator for Prevention, Pesticides and Toxic
Substances.
Therefore, it is proposed that 40 CFR, chapter I, subchapter R,
part 799 be amended as follows:
PART 799 -- [AMENDED]
a. The authority citation for part 799 would continue to read as
follows:
Authority: 15 U.S.C. 2601, 2603, 2611, 2625.
b. In Sec. 799.5075 by revising paragraphs (a)(1), (c)(1)(i)(A),
(c)(2)(i)(A), and (d)(1) to read as follows:
Sec. 799.5075 Drinking water contaminants subject to testing.
(a) * * *
(1) Chloroethane (CAS No. 75-00-3), 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) * * *
(1) * * *
(i) * * *
(A) An oral 14-day repeated dose toxicity test shall be conducted
with chloroethane, 1,1,2,2-tetrachloroethane, and 1,3,5-
trimethylbenzene in accordance with Sec. 798.2650 of this chapter
except for the provisions in Secs. 798.2650(a); (b)(1); (c); (e)(3),
(4)(i), (5), (6), (7)(i), (iv), (v), (8)(vii), (9)(i)(A), (B), (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
[[Page 18081]] feasible for a given substance, that substance shall be
administered either by oral gavage, in the diet, or in capsules.
* * * * *
(2) * * *
(i) * * *
(A) An oral 90-day subchronic toxicity test shall be conducted with
chloroethane and 1,3,5-trimethylbenzene in accordance with
Sec. 798.2650 of this chapter except for the provisions in
Sec. 798.2650(e)(3), (7)(i), and (11)(v). 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 administered either by oral gavage,
in the diet, or in capsules.
* * * * *
(d) * * * (1) This section is effective on December 27, 1993,
except for paragraphs (a)(1), (c)(1)(i)(A), and (c)(2)(i)(A).
Paragraphs (a)(1), (c)(1)(i)(A), and (c)(2)(i)(A) are effective (insert
date 44 days after publication of the final rule in the Federal
Register).
* * * * *
[FR Doc. 95-8734 Filed 4-7-95; 8:45 am]
BILLING CODE 6560-50-F
