[Federal Register Volume 61, Number 39 (Tuesday, February 27, 1996)]
[Rules and Regulations]
[Pages 7221-7223]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-4254]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 799
[OPPTS-42111I; FRL-4988-9]
RIN 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 in 40 CFR 799.5075 by rescinding the 90-day and 14-day
testing requirements for chloroethane. 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being rescinded because the Agency has received data adequate to meet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 February 27, 1996. 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 February 27, 1996.
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: 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 chloroethane, and (2) the 14-day
testing requirement for chloroethane.
I. Background
In the Federal Register of September 21, 1995 (60 FR 48948) (FRL-
4972-3), EPA proposed rescinding the 90-day subchronic testing
requirement for chloroethane and the 14-day testing requirement for
chloroethane. EPA promulgated the rule (FRL-4047-2) establishing these
testing requirements pursuant to TSCA section 4(a), and published the
final rule in the Federal
[[Page 7222]]
Register on November 10, 1993 (58 FR 59667).
EPA proposed rescinding the testing requirements for chloroethane
because it received a 14-day single oral dose study from the Dow
Chemical Company on May 1, 1995. This study, entitled ``Ethyl Chloride
Palatability and 14-day Drinking Water Toxicity Study in Fischer 344
Rats'', 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
reviewed the study and concluded that the study was adequate to meet
the data needs for which the test rule was prepared, to establish a
Health Advisory for chloroethane for EPA's Office of Water (Ref. 5).
Therefore, EPA is rescinding the 90-day and 14-day testing requirements
for chloroethane. 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 one public comment from the Dow Chemical Company, the
test sponsor for chloroethane, which 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 14-day and the 90-day subchronic testing
requirement for chloroethane. 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.
V. Rulemaking Record
EPA has established a docket for this rulemaking (docket number
OPPTS-42111I). 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) 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:
Palatability and 14-Day Drinking Water Toxicity Study in Fischer 344
Rats'' (April 28, 1995).
(2) Facsimile note from Roger A. Nelson, USEPA 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:
Palatability 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).
(6) The Dow Chemical Company. Comment on docket number OPPTS-
42111H (FRL-4972-3) (October 16, 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
Street SW., Washington, DC 20460.
VII. Other Regulatory 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 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
one 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
[[Page 7223]]
sector by revoking rules requiring testing.
D. Paperwork Reduction Act
OMB has approved the information collection requirements contained
in this 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
Environmental protection, Chemicals, Chemical export, Hazardous
substances, Health effects, Laboratories, Provisional testing,
Reporting and recordkeeping requirements, Testing, Incorporation by
reference.
Dated: February 11, 1996.
Lynn R. Goldman,
Assistant Administrator for Prevention, Pesticides, and Toxic
Substances.
Therefore, 40 CFR, chapter I, subchapter R, is amended as follows:
PART 799--[AMENDED]
1. The authority citation for part 799 would continue 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), (c)(2)(i)(A), and (d)(1) 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 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
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), (c)(1)(ii)(A),
(c)(1)(ii)(B), (c)(2)(i)(A), and (c)(2)(ii)(A). The effective date for
paragraphs (a)(2), (c)(1)(ii)(A), (c)(1)(ii)(B), and (c)(2)(ii)(A) is
September 29, 1995. Paragraphs (a)(1), (c)(1)(i)(A), and (c)(2)(i)(A)
are effective February 27, 1996.
* * * * *
[FR Doc. 96-4254 Filed 2-26-96; 8:45 am]
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