[Federal Register Volume 62, Number 125 (Monday, June 30, 1997)]
[Rules and Regulations]
[Pages 35103-35105]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-17175]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Parts 766 and 799
[OPPTS-40030; FRL-5728-5]
Technical Amendments to Test Rules and Enforceable Testing
Consent Agreements/Testing Consent Orders
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: EPA has approved by letter certain modifications to test
standards and schedules for chemical testing programs under section 4
of the Toxic Substances Control Act (TSCA). These modifications,
requested by test sponsors, will be incorporated in the respective test
rules or enforceable testing consent agreements/testing consent orders.
Because these modifications do not significantly alter the scope of a
test or significantly change the schedule for its completion, EPA
approved these requests without seeking public notice and comment. EPA
annually publishes a rule describing all of the modifications granted
by letter for the previous year.
DATES: This rule is effective June 30, 1997.
FOR FURTHER INFORMATION CONTACT:Susan B. Hazen, Director, Environmental
Assistance Office (7408), Office of Pollution Prevention and Toxics,
Environmental Protection Agency, Rm. E-543B, 401 M St., SW.,
Washington, DC 20460. Telephone: (202) 554-1404, TDD: (202) 554-0551,
Internet address: TSCA-Hotline@epamail.epa.gov.
SUPPLEMENTARY INFORMATION: EPA published a rule in the Federal Register
of September 1, 1989 (54 FR 36311) amending procedures in 40 CFR part
790 for modifying test standards and schedules for test rules and
enforceable testing consent agreements/testing consent orders under
section 4 of TSCA.
The amended procedures allow EPA to approve requested modifications
which do not alter the scope of a test or significantly change the
schedule for its completion. These modifications are approved by letter
without public notice and comment. The rule also requires immediate
placement of these letters in the public record and publication of
these modifications in the Federal Register. This rule includes
modifications approved from January 1, 1996, through December 31, 1996.
For a detailed description of the rationale for these modifications and
for the correspondence relating to specific chemical test
modifications, refer to the public record for the appropriate chemical
substance or to the public record for this rulemaking (OPPTS-40030).
I. Discussion of Modifications
Each chemical substance discussed in this rule is identified by a
specific CAS number and docket control number. The following table
lists all chemical-specific modifications approved from January 1,
1996, through December 31, 1996.
[[Page 35104]]
Modifications to Test Standards and Enforceable Testing Consent Agreements/Testing Consent Orders
(January 1, 1996, Through December 31, 1996)
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Chemical name/CAS No. CFR Cite Test Modifications Docket control No.
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Final rules:
Drinking Water Contaminants:
1,1,2,2-Tetrachloroethane/CAS 799.5075 14-day oral subacute 5................... 40030/42111C
No. 79-34-5 testing.
Polyhalogenated Dibenzo-para-
Dioxins/Dibenzofurans
(Dioxins/Furans):
Chloranil (2,3,5,6- Part 766 Analytical testing.. 5................... 40030/40028/83002M
tetrachloro-2,5-
cyclohexadiene-1,4-dione/CAS
No. 118-75-2
Enforceable Testing Agreements/
Orders:
Alkyl Glycidyl Ethers (AGEs):
Alkyl Glycidyl Ether (AGE C12- 799.5000 90-day subchronic 5................... 40030/42185
C13)/CAS No.120547-52-6 dermal toxicity
study.
Neurotoxicity:
Dermal subchronic 5
functional
observational
battery.
Dermal subchronic 5
motor activity.
Dermal subchronic 5
neuropathology.
Dermal subchronic 5
electrophysiology.
Developmental 5
toxicity study.
Genetic toxicity
studies:
Micronucleus assay 5
Gene mutation in 5
stomatic cells in
culture.
Reveise mutation 5
assay.
Change in required 2
purity of test
substance.
Cyclohexane/CAS No. 110-82-7 799.5000 90-day subchronic 5................... 40030/42094C
inhalation toxicity 9
test in rats. 5
Developmental
toxicity test
standard in rats.
Developmental
toxicity studies in
rats and rabbits.
Tertiary Amyl Methyl Ether 799.5000 Pharmacokinetics 5................... 40030/42180
(TAME), CAS No. 994-05-8 study. 5
90-day subchronic 5
study. 5,11
Neurotoxicity screen 5
Reproductive
inhalation study.
Developmental
toxicity study.
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Modifications:
1. Modify sampling schedule.
2. Change test substance (form/purity).
3. Change non-critical test procedure or condition.
4. Add satellite group for further testing.
5. Extend test or protocol deadline, delete test initiation
date.
6. Clarify and/or add specific guideline requirement.
7. Alter specific guideline requirement approved for certain
test(s).
8. Correct CAS No.
9. Amend test standard.
10. Neurotoxicity endpoint rule.
11. Revise protocol.
Note: Only modifications under numbers 2, 5, 9, and 11 in the
above table were approved in 1996.
II. Public Record
EPA has established a public record for this rulemaking under
docket control number OPPTS-40030. The record is available for
inspection from 12 noon to 4 p.m., Monday through Friday, excluding
legal holidays, in the TSCA Nonconfidential Information Center,
Environmental Protection Agency, Rm. NE B-607, 401 M St., SW.,
Washington, DC 20460. Requests for documents should be sent in writing
to: Fax: (202) 260-5069 or e-mail: oppt.ncic@epamail.gov.
III. Regulatory Assessment Requirements
A. Waiver of Notice of Proposed Rulemaking and Delay of Effective Date
Because the test rule schedule modifications codified in this rule
have no substantive effect on any person, EPA finds that public notice
and comment are unnecessary. Thus, this rule may be promulgated without
prior opportunity for public notice and comment pursuant to the
Administrative Procedure Act (5 U.S.C. 553(b)(3)(B)), and may be made
effective upon publication in the Federal Register, without a 30-day
delay, pursuant to 5 U.S.C. 553(d)(3).
B. Executive Order 12866
Under Executive Order 12866 (58 FR 51735, October 4, 1993), it has
been determined that this action is not ``significant'' pursuant to the
terms of this Executive Order because the modifications to the subject
testing actions do not impose any additional requirements on the
public. This action is therefore not subject to review by the Office of
Management and Budget (OMB).
C. Regulatory Flexibility Act
Under the Regulatory Flexibility Act (5 U.S.C. 601 et seq.), I
hereby certify that this action will not have a significant economic
impact on a substantial number of small entities because the
modifications referenced in this rule do not alter the scope of any
test required under a test rule or significantly change the reporting
schedule for any test rule.
D. 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 certain regulatory actions on State, local, and tribal
governments and the private sector, and to seek input from State,
local, and tribal governments on certain regulatory actions. EPA has
determined that this action does not contain a Federal mandate that may
[[Page 35105]]
result in expenditures of $100 million or more for State, local, and
tribal governments, in the aggregate, or the private sector in any 1
year. No costs are imposed by this rulemaking since these test rule
modifications only make non-significant changes to the reporting
schedules for test rules. Therefore, this action is not subject to the
requirements of section 202 and 205 of UMRA. The requirements of
sections 203 and 204 of UMRA which relate to regulatory requirements
that might significantly or uniquely affect small governments and to
regulatory proposals that contain a significant Federal
intergovernmental mandate, respectively, also do not apply to this rule
because the rule affects only the private sector, i.e., those companies
that test chemicals.
E. Paperwork Reduction Act
The information collection requirements associated with this rule
have been approved by OMB under the provisions of the Paperwork
Reduction Act, 44 U.S.C. 350l et seq., and have been assigned OMB
control number 2070-0033 (EPA ICR No. 1139). EPA has determined that
this rule does not change existing recordkeeping or reporting
requirements nor does it impose any additional recordkeeping or
reporting requirements on the public.
F. Submission to Congress and the General Accounting Office
Under 5 U.S.C. 801 (a)(1)(A), as added by the Small Business
Regulatory Enforcement Fairness Act of 1996, EPA has submitted a report
containing this rule and other required information to the U.S. Senate,
the U.S. House of Representatives, and the Comptroller General of the
General Accounting Office prior to publication of the rule in this
Federal Register. This rule is not a ``major rule'' as defined by 5
U.S.C. 804(2).
List of Subjects in 40 CFR Parts 766 and 799
Environmental protection, Chemicals, Exports, Hazardous substances,
Reporting and recordkeeping requirements.
Dated: June 25, 1997.
Susan H. Wayland,
Acting Assistant Administrator for Prevention, Pesticides and Toxic
Substances.
Therefore, 40 CFR chapter I is amended as follows:
PART 766--[AMENDED]
1. In part 766:
a. The authority citation for part 766 continues to read as
follows:
Authority: 15 U.S.C. 2603 and 2607.
b. In Sec. 766.35, by adding an entry in numerical order by ``CAS
No.'' to the table in paragraph (b)(4)(i) to read as follows:
Sec. 766.35 Reporting requirements.
* * * * *
(b) * * *
(4) * * *
(i) * * *
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CAS No. Submitter Chemical name Due date Effective Date
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* * * * * * *
118-75-2....................... Rhone-Poulenc Inc. 2,3,5,6-tetrachloro- July 5, 1996..... June 30, 1997
2,5-cyclohexadiene-
1,4-dione.
* * * * * * *
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* * * * *
PART 799--[AMENDED]
2. In part 799:
a. The authority citation for part 799 continues to read as
follows:
Authority: 15 U.S.C. 2603, 2611, 2625.
b. In Sec. 799.5075, by revising paragraphs (c)(1)(ii)(A) and (d)
to read as follows:
* * * * *
Sec. 799.5075 Drinking water contaminants subject to testing.
* * * * *
(c) * * *
(1) * * *
(ii) * * *
(A) Each subacute test shall be completed and the final report
submitted to EPA within 12 months of the date specified in paragraph
(d)(1) of this section, except for 1,1,2,2-tetrachloroethane. The
subacute testing for 1,1,2,2-tetrachloroethane shall be completed and
the final report submitted to EPA by February 15, 1996.
* * * * *
(d) Effective date. (1) This section is effective on December 27,
1993, except for paragraphs (a)(1), (a)(2), (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)(B), and (c)(2)(ii)(A)
is September 29, 1995. The effective date for paragraphs (a)(1),
(c)(1)(i)(A), and (c)(2)(i)(A) is February 27, 1996. The effective date
for paragraph (c)(1)(ii)(A) is June 30, 1997.
(2) The guidelines and other test methods cited in this section are
referenced as they exist on the effective date of the final rule.
[FR Doc. 97-17175 Filed 6-27-97; 8:45 am]
BILLING CODE 6560-50-F
