[Federal Register Volume 60, Number 183 (Thursday, September 21, 1995)]
[Rules and Regulations]
[Pages 48902-48904]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-23461]



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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 799

[OPPTS-42111F, FRL 4927-8]
RIN NO. 2070-AB94

Withdrawal of Certain Testing Requirements for Office of Water 
Chemicals

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: EPA is amending the final test rule for the Office of Water 
Chemicals by rescinding 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. The testing requirements are 
being rescinded because the Agency has received data adequate to meet 
the data needs for which the test rule was promulgated.
DATES: This amendment shall become effective on November 6, 1995. In 
accordance with 40 CFR 23.5, this rule shall be promulgated for 
purposes of judicial review at 1 p.m. eastern (daylight or standard as 
appropriate) time on October 5, 1995.

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, Internet address: TSCA-
H[email protected].

SUPPLEMENTARY INFORMATION: EPA is amending the final test rule for the 
Office of Water Chemicals in 40 CFR 799.5075 by rescinding; (1) the 90-
day subchronic testing requirement for 1,1,2,2-tetrachloroethane, (2) 
the 90-day testing requirements for 1,1-dichloroethane, and (3) the 14-
day testing requirements for 1,1-dichloroethane.

I. Background

    In the Federal Register of April 10, 1995 (60 FR 18079), EPA 
proposed rescinding 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. The rule establishing these 
testing requirements was promulgated pursuant to TSCA section 4(a), and 
published in the Federal Register on November 10, 1993 (58 FR 59667).
    The reasons for the proposal were that data had become available 
for these substances which, after review by EPA, were adjudged to be 
adequate to meet the data needs for which the test rule for these 
substances was promulgated, the establishment of Health Advisories for 
the Office of Water. The final test rule for Drinking Water 
Contaminants Subject to Testing (``the Office of Water Chemicals test 
rule'') which EPA is now amending, is codified in 40 CFR 799.5075.

II. Public Comments

    EPA received only one public comment during the public comment 
period. This comment, from the ODW Chemicals Task Force of Washington, 
D.C., agreed with the Agency proposal.

III. Amended Testing Requirements

    The Office of Water Chemicals test rule at 40 CFR 799.5075 is 
amended to delete the 90-day subchronic testing requirement for 
1,1,2,2-tetrachloroethane and the 14-day and 90-day testing 
requirements for 1,1-dichloroethane. Specifically, parties subject to 
the test rule will no longer have to comply with 40 CFR 799.5075(a)(1), 
(c)(1)(i)(A) and (c)(2)(i)(A).

IV. Economic Analysis

    Eliminating these testing requirements will reduce testing costs. 
Therefore, this amendment should not cause adverse economic impact.

[[Page 48903]]


V. Rulemaking Record

    EPA has established a docket for this rulemaking (docket number 
OPPTS-42111F).This docket contains the basic information considered by 
EPA in developing this rule, appropriate Federal Register notices, and 
the comment received on the proposal. The rulemaking record includes 
the following:
    (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 June 28, 
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).'' November 15, 1994.
    (8) ODW Chemicals Task Force. Letter to TSCA Documents Receipt 
Office, Re: OPPTS-42111E. May 10, 1995.
    (9) USEPA. Office of Water Chemicals; Final Test Rule. 58 FR 59667, 
November 10, 1993.
    (10) USEPA. Test Rule; Office of Water Chemicals Proposed 
Withdrawal of Certain Testing Requirements. 60 FR 18079, April 10, 
1995.

VI. Public Docket

    The docket for this rulemaking is available for inspection from 12 
noon to 4 p.m., Monday through Friday, except legal holidays. The TSCA 
Public Docket Office, is located in Room B-607 Northeast Mall, 401 M 
St., SW., Washington, D.C. 20460.

VII. 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 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 would not have a significant impact on a 
substantial number of small businesses because the amendment would 
relieve a regulatory obligation to conduct certain chemical tests.

C. Unfunded Mandates Reform Act

    Title II of the Unfunded Mandates Reform Act of 1995 (UMRA), Pub.L. 
104-4, establishes requirements for Federal agencies to assess the 
effects of their regulatory actions on State, local, and tribal 
governments and the private sector. Under section 202 of the UMRA, EPA 
generally must prepare a written statement, including a cost-benefit 
analysis, for proposed and final rules with ``Federal mandates'' that 
may result in expenditures to State, local, and tribal governments, in 
the aggregate, or to the private sector, of $100 million or more in any 
1 year. Before promulgating an EPA rule for which a written statement 
is needed, section 205 of the UMRA generally requires EPA to identify 
and consider a reasonable number of regulatory alternatives and adopt 
the least costly, most cost-effective or least burdensome alternative 
that achieves the objectives of the rule. The provisions of section 205 
do not apply when they are inconsistent with applicable law. Moreover, 
section 205 allows EPA to adopt an alternative other than the least 
costly, most cost-effective or least burdensome alternative if the 
Administrator publishes with the final rule an explanation why that 
alternative was not adopted. Before EPA establishes any regulatory 
requirements that may significantly or uniquely affect small 
governments, including tribal governments, it must have developed under 
section 203 of the UMRA a small government agency plan. The plan must 
provide for notifying potentially affected small governments, enabling 
officials of affected small governments to have meaningful and timely 
input in the development of EPA regulatory proposals with significant 
Federal intergovernmental mandates, and informing, educating, and 
advising small governments on compliance with the regulatory 
requirements.
    Today's rule contains no Federal mandates (under the regulatory 
provisions of Title II of the UMRA) for State, local, or tribal 
governments or the private sector. This rule reduces enforceable duties 
on any of these governmental entities or the private sector by revoking 
rules requiring testing.

D. 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 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, November 10, 1993.

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.


[[Page 48904]]

    Dated: September 12, 1995.

Lynn R. Goldman,

Assistant Administrator for Prevention, Pesticides and Toxic 
Substances.

    Therefore, 40 CFR chapter I, subchapter R, 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. 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 Sec. 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 
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) Effective date. (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 on 
November 6, 1995.
*    *    *    *    *

[FR Doc. 95-23461 Filed 9-20-95; 8:45 am]
BILLING CODE 6560-50-F