[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]



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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.

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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