[Federal Register Volume 59, Number 173 (Thursday, September 8, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-21688]
[[Page Unknown]]
[Federal Register: September 8, 1994]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Parts 766 and 799
[OPPTS-40027; FRL-4873-4]
Technical Amendments to Test Rules and 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 and codified in the
respective test regulation or consent order. 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 notice and comment. EPA annually
publishes a notice describing all of the modifications granted by
letter for the previous year.
EFFECTIVE DATE: This rule is effective on September 8, 1994.
FOR FURTHER INFORMATION CONTACT: Susan B. Hazen, Director,
Environmental Assistance Division (7408), Office of Pollution
Prevention and Toxics, Rm. E-543B, 401 M St., SW., Washington, DC
20460, (202) 554-1404, TDD (202) 554-0551.
SUPPLEMENTARY INFORMATION: EPA issued a rule published in the Federal
Register of September 1, 1989 (54 FR 36311), amending procedures for
modifying test standards and schedules for test rules and 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 (40 CFR
790.55 and 790.68). These modifications are approved by letter without
public comment. The rule also requires immediate placement of these
letters in EPA's public files and publication of these modifications in
the Federal Register. This document includes modifications approved
from January 1, 1993, through December 31, 1993. For a detailed
description of the rationale for these modifications, refer to the
submitters' letters and EPA's responses in the public record for this
rulemaking.
I. Discussion of Modifications
Each chemical discussed in this rule is identified by a specific
CAS number. Copies of correspondence relating to specific chemical
modifications may be found in docket number OPPTS-40027 for this rule.
The following table lists all chemical-specific modifications approved
from January 1, 1993, through December 31, 1993:
Modifications to Test Standards and Consent Orders January 1, 1993
Through December 31, 1993
------------------------------------------------------------------------
Chemical/CAS Number Chemical
FR Cite Test Modifications
------------------------------------------------------------------------
Final Rule
Chemicals.
pentabromodipheny 766.35 analytical testing. 5
loxide (32534-81-
9).
octabromodiphenyl 766.35 analytical testing. 5
oxide (32536-52-
0).
1,2- 766.35 analytical testing. 5
bis(tribromophen
oxy)-ethane
(37853-59-1).
tetrabromobisphen 766.35 analytical testing. 5
ol-A-
bisethoxylate
(4162-45-2).
commercial hexane 799.2155 oncogenicity 5
(110-54-3; 96-37- (mouse).
7).
acetone (67-64-1) 799.5050 neurotoxicity 10
testing.
n-amyl acetate, 799.5050 neurotoxicity 10
technical grade testing.
(628-63-7).
1-butanol (71-36- 799.5050 neurotoxicity 10
3). testing.
n-butyl acetate 799.5050 neurotoxicity 10
(123-86-4). testing.
diethyl ether (60- 799.5050 neurotoxicity 10
29-7). testing.
2-ethoxyethanol 799.5050 neurotoxicity 10
(110-80-5). testing.
ethyl acetate 799.5050 neurotoxicity 10
(141-78-6). testing.
isobutyl alcohol 799.5050 neurotoxicity 10
(78-83-1). testing.
methyl isobutyl 799.5050 neurotoxicity 10
ketone (108-10- testing.
1).
tetrahydrofuran 799.5050 neurotoxicity 10
(109-99-9). testing.
Consent Orders.....
acrylic acid (79- 799.5000 bioavailability 5
10-7). study.
4- 799.5000 pharmacokinetics in 3, 5
vinylcyclohexene vitro metabolism
(100-40-3). in rat and mouse
tissues; in vitro
partition
coefficient..
------------------------------------------------------------------------
Modifications
1. Modify sampling schedule.
2. Change to test substance (form/purity).
3. Change in 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. Alternate specific guideline requirement approved for
certain test(s).
8. CAS No. correction.
9. Test standard amendment.
10. By letter to the affected manufacturers, EPA granted certain
modifications to the Multi-substance Rule for the Testing of
Neurotoxicity, 40 CFR 799.5050. Subsequently, however, the rule was
challenged in court. As part of the settlement of that litigation,
EPA agreed to propose to revoke this rule. EPA announced that
pending revocation of the rule (59 FR 33187, June 27, 1994) and
negotiation of enforceable consent agreements under which testing
would be performed, the rule would be stayed (59 FR 33184, June 2,
1994). Copies of the modifications that had been granted are
available in docket number OPPTS-42134B. Anyone who believes they
may be subject to the requirements of this test rule should contact
Catherine Roman at 260-8155 regarding its status before initiating
testing.
II. Public Record
EPA has established a public record for this rulemaking (docket
number OPPTS-40027). The record includes the requests for
modifications, information considered by EPA in evaluating the
requested modifications, and EPA's responses to the requests.
The record is available for inspection from 12:00 noon to 4 p.m.,
Monday through Friday, except legal holidays, in Rm. NE-G607, 401 M
St., SW., Washington, DC 20460.
III. Regulatory Assessment Requirements
A. 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 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.
Send comments regarding the information collection requirements of
this rule to Chief, Information Policy Branch, PM-223, U.S.
Environmental Protection Agency, 401 M St., SW., Washington, DC 20460;
and to the Office of Information and Regulatory Affairs, Office of
Management and Budget, Washington, DC 20503.
List of Subjects in 40 CFR Part 799
Chemicals, Chemical export, Environmental protection, Hazardous
substances, Recordkeeping and reporting Requirements, Testing.
Dated: August 24, 1994.
Susan H. Wayland,
Acting Assistant Administrator for Prevention, Pesticides and Toxic
Substances.
Therefore, 40 CFR parts 766 and 799 are amended as follows:
1. In part 766:
PART 766--[AMENDED]
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 revising the following entries in the table
to paragraph (b)(4)(i) and paragraph (f) to read as follows:
Sec. 766.35 Reporting requirements.
* * * * *
(b) * * *
(4) * * *
(i) * * *
------------------------------------------------------------------------
Cas No. Submitter Chemical Due Date
------------------------------------------------------------------------
*******
4162-45-2........ Great Lakes tetrabromobisphe June 2,1993
nol-A-
bisethoxylate
*******
32534-81-9....... Great Lakes pentabromodiphen March 22, 1993
yloxide
32534-81-9....... Ameribrom pentabromodiphen March 22, 1993
yloxide
32536-52-0....... Ameribrom octabromodipheny January 8, 1993
loxide
*******
37853-59-1....... Great Lakes 1,2- January 31, 1993
bis(tribromophe
noxy)-ethane
------------------------------------------------------------------------
* * * * *
(f) Effective date. (1) The effective date of this final rule is
July 6, 1987, except for paragraphs (a)(2)(i)(B), (a)(2)(ii)(A) and
(b)(4)(i) of this section.
(2) The effective date for paragraph (a)(2)(i)(B) is May 21, 1991.
The effective date for paragraph (a)(2)(ii)(A) is June 12, 1992. The
effective date for paragraph (b)(4)(i) is on September 8, 1994.
(3) The guidelines and other test methods cited in this rule are
referenced as they exist on the effective date of the final rule.
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. 799.2155 by revising paragraphs (c)(2)(ii)(A) and (d)
to read as follows:
Sec. 799.2155 Commercial Hexane.
* * * * *
(c) * * *
(2)* * *
(ii) * * *
(A) The oncogenicity test shall be completed and the final report
submitted to EPA within 53 months of the effective date of the final
rule. The mouse portion of the oncogenicity study shall be submitted by
June 5, 1993.
* * * * *
(d) Effective date. (1) The effective date of this final rule is
November 17, 1988, except for the provisions of paragraphs
(c)(2)(ii)(A), (c)(5)(i)(D), (c)(5)(ii)(A)(4), (c)(5)(ii)(C), (c)(8)(i)
and (c)(8)(ii)(A) of this section. The effective date for paragraphs
(c)(5)(i)(D), (c)(5)(ii)(A)(4) and (c)(5)(ii)(C) of this section is May
21, 1990. The effective date for paragraphs (c)(8)(i) and (c)(8)(ii)(A)
of this section is June 12,1992. The effective date of paragraph
(c)(2)(ii)(A) is September 8, 1994.
(2) The guidelines and other test methods cited in this rule are
referenced as they exist on the effective date of the final rule.
[FR Doc. 94-21688 Filed 9-7-94; 8:45 am]
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