[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being rescinded because the Agency has received data adequate to meet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-
Hotline@epamail.epa.gov.
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]
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