[Federal Register Volume 63, Number 167 (Friday, August 28, 1998)]
[Rules and Regulations]
[Pages 45954-45956]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-23208]
[[Page 45954]]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 721
[OPPTS-50631A, etc; FRL-6019-2]
RIN 2070-AB27
Modification of Significant New Use Rules for Certain Substances
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: EPA is modifying significant new use rules (SNURs) for five
substances promulgated under section 5(a)(2) of the Toxic Substances
Control Act (TSCA) based on new data. Based on the new data, the Agency
finds that activities not described in the corresponding TSCA section
5(e) consent order or the significant new use notice (SNUN) for these
chemical substances may result in significant changes in human or
environmental exposure.
DATES: This rule is effective September 28, 1998.
FOR FURTHER INFORMATION CONTACT: Susan B. Hazen, Director,
Environmental Assistance Division (7408), Office of Pollution
Prevention and Toxics, Environmental Protection Agency, Rm. E-531, 401
M St., SW., Washington, DC 20460, telephone: (202) 554-1404, TDD: (202)
554-0551; e-mail: TSCA-Hotline@epa.gov.
SUPPLEMENTARY INFORMATION:
Electronic Availability: Electronic copies of this document are
available from the EPA Home Page at the Federal Register-Environmental
Documents entry for this document under ``Laws and Regulations''
(http://www.epa.gov/fedrgstr/).
In the Federal Register referenced for each substance, OPPTS-50591,
April 25, 1991 (56 FR 19235 and 19241); OPPTS-50537A, January 26, 1987
(52 FR 2703); OPPTS-50583, August 9, 1990 (55 FR 32419); and OPPTS-
50582, August 15, 1990 (55 FR 33296), EPA issued a SNUR establishing
significant new uses for the substances. In the Federal Register of
February 24, 1998 (63 FR 9169) (FRL-5767-2), EPA proposed a
modification to the SNURS for five chemical substances based on
additional data received for those substances. For three of these
substances, the Agency is issuing the modification as proposed. For the
remaining two substances, EPA is issuing a modification with revisions
based on public comments received for the proposal.
I. Background
The Agency proposed the modification of the SNURs for these
substances in the Federal Register of February 24, 1998 (63 FR 9169)
(FRL-5767-2). The background and reasons for the modification of the
SNURs are set forth in the preamble to the proposed modifications. For
three of the substances, (40 CFR 721.1790, 40 CFR 721.5740, and 40 CFR
721.9800), the Agency received no public comment concerning the
proposed modification. As a result, EPA is modifying these three SNURs
as proposed. For the other two substances (40 CFR 721.1765 and
721.8450), EPA will issue a final modification based on public comments
as described in this unit.
The commenter agreed with EPA's proposed modification, but also
stated that several labeling and protective equipment requirements in
the SNURs were not consistent with requirements in the corresponding
consent order and requested that EPA also modify the SNUR to reconcile
these differences. Based on these comments and the Agency's review of
the TSCA section 5(e) consent order and proposed SNUR requirements, EPA
is making the following additional modifications to the SNUR.
The SNURs at 40 CFR 721.1765 and 40 CFR 721.8450 designate
Sec. 721.72(g)(2)(iii), which requires notification if the statement
``When using this substance avoid ingestion'' does not appear on the
Material Safety Data Sheet (MSDS). This designation is being eliminated
from these rules as use of this statement is not required in the
corresponding TSCA 5(e) consent order.
The SNURs at 40 CFR 721.1765 and 40 CFR 721.8450 do not designate
Sec. 721.72(g)(2)(v), which requires notification if the statement
``When using this substance use skin protection'' does not appear on
the MSDS. These designations are now being added to these rules as use
of this statement is required in the corresponding TSCA section 5(e)
consent order.
The SNUR at 40 CFR 721.1765 designates Sec. 721.63 (a)(2)(i) and
(a)(2)(iii), and the SNUR at 40 CFR 721.8450 designates
Sec. 721.63(a)(2)(i) and (a)(2)(iv), requiring notification unless
impervious gloves and eye protection or protective clothing are used by
potentially exposed workers. These specific designations are eliminated
from these rules as this specific protective equipment is not required
in the corresponding TSCA section 5(e) consent order. However, the TSCA
section 5(e) consent order and SNURs will continue to require
impervious ``personal protective equipment that provides a barrier to
prevent dermal exposure'' for persons reasonable likely to be exposed
to these substances, as per Sec. 721.63(a)(1). The difference between
Sec. 721.63(a)(1) and Sec. 721.63(a)(2) is that Sec. 721.63(a)(1)
allows subject manufacturers and processors to decide which dermal
protective equipment is needed, whereas Sec. 721.63(a)(2) specifies in
greater detail which equipment is required.
The commenter also noted that the respirator requirements
designated in the SNUR, reference numerous National Institute for
Occupational Safety and Health (NIOSH) regulations that will change,
requiring a change in the TSCA section 5(e) consent order and the SNUR.
The Agency is in the process of making these changes for all TSCA
section 5(e) consent orders, SNURs, and the references in 40 CFR
721.63. When completed the changes will also be made to these
substances.
II. Rationale for Modification of the Rules
During review of the chemical substances that are the subject of
these modifications, EPA concluded that regulation was warranted based
on the fact that activities not described in the TSCA section 5(e)
consent order or the PMN may result in significant changes in human or
environmental exposure. In
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the specific case of polybrominated biphenyls, Sec. 721.1790, EPA
concluded that any use may result in significant changes in human or
environmental exposure. The basis for such findings is described in the
rulemaking record referenced in Unit III. of this preamble. Based on
these findings, a TSCA section 5(e) consent order was negotiated with
the PMN submitter and/or a SNUR was promulgated.
In light of the modification to a consent order, toxicity data
submitted for another PMN, or the data submitted in a SNUN or a PMN, as
the case may be, the Agency has determined that modifying these SNURs
will not result in significant changes in human or environmental
exposure. The modification of SNUR provisions for the substances
designated herein is consistent with the provisions of the TSCA section
5(e) consent order or data submitted in the SNUN or PMN.
III. Public Record and Electronic Submissions
The official record for this rulemaking, as well as the public
version, has been established for this rulemaking under docket control
number OPPTS-50631A (including comments and data submitted
electronically). A public version of this record, including printed,
paper versions of electronic comments, which does not include any
information claimed as CBI, is available for inspection from 12 noon to
4 p.m., Monday through Friday, excluding legal holidays. The official
rulemaking record is located in the TSCA Nonconfidential Information
Center, Rm. NE-B607, 401 M St., SW., Washington, DC.
IV. Regulatory Assessment Requirements
Under Executive Order 12866, entitled Regulatory Planning and
Review (58 FR 51735, October 4, 1993), this action is not a
``significant regulatory action'' subject to review by the Office of
Management and Budget (OMB). In addition, this action does not impose
any enforceable duty or contain any unfunded mandate as described in
the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4), or require
prior consultation with State officials as also specified in Executive
Order 12875, entitled Enhancing the Intergovernmental Partnership (58
FR 58093, October 28, 1993). Nor does it involve special considerations
of environmental justice related issues as required by Executive Order
12898, entitled Federal Actions to Address Environmental Justice in
Minority Populations and Low-Income Populations (59 FR 7629, February
16, 1994), or additional OMB review in accordance with Executive Order
13045, entitled Protection of Children from Environmental Health Risks
and Safety Risks (62 FR 19885, April 23, 1997).
According to the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et
seq., an agency may not conduct or sponsor, and a person is not
required to respond to a collection of information that requires OMB
approval under the PRA, unless it has been approved by OMB and displays
a currently valid OMB control number. The OMB control numbers for EPA's
regulations, after initial display in the preamble of the final rules,
are listed in 40 CFR part 9. The information collection requirements
related to this action have already been approved by OMB pursuant to
the PRA under OMB control number 2070-0012 (EPA ICR No. 574). This
action does not impose any burden requiring additional OMB approval.
If an entity were to submit a significant new use notice to the
Agency, the annual burden is estimated to average between 30 and 170
hours per response. This burden estimate includes the time needed to
review instructions, search existing data sources, gather and maintain
the data needed, and complete, review, and submit the required
significant new use notice.
Send any comments about the accuracy of the burden estimate, and
any suggested methods for minimizing respondent burden, including
through the use of automated collection techniques, to the Director,
OPPE Regulatory Information Division, U.S. Environmental Protection
Agency (Mail Code 2137), 401 M St., SW., Washington, DC 20460, with a
copy to the Office of Information and Regulatory Affairs, Office of
Management and Budget, 725 17th St., NW., Washington, DC 20503, marked
Attention: Desk Officer for EPA. Please remember to include the OMB
control number in any correspondence, but do not submit any completed
forms to these addresses.
In addition, pursuant to section 605(b) of the Regulatory
Flexibility Act (RFA) (5 U.S.C. 601 et seq.), the Agency has previously
certified, as a generic matter, that the promulgation of a SNUR does
not have a significant adverse economic impact on a substantial number
of small entities. The Agency's generic certification for promulgation
of new SNURs appears on June 2, 1997 (62 FR 29684) (FRL-5597-1) and was
provided to the Chief Counsel for Advocacy of the Small Business
Administration.
V. Submission to Congress and the Comptroller General
The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the
Small Business Regulatory Enforcement Fairness Act of 1996, generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report, which includes a copy of the rule,
to each House of the Congress and to the Comptroller General of the
United States. EPA will submit 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 United States prior
to publication of the rule in the Federal Register. This is not a
``major rule'' as defined by 5 U.S.C. 804(2).
List of Subjects in 40 CFR Part 721
Environmental protection, Chemicals, Hazardous substances,
Reporting and recordkeeping requirements.
Dated: August 17, 1998.
Charles M. Auer,
Director, Chemical Control Division, Office of Pollution Prevention and
Toxics.
Therefore, 40 CFR part 721 is amended as follows:
PART 721--[AMENDED]
1. The authority citation for part 721 continues to read as
follows:
Authority: 15 U.S.C. 2604, 2607, and 2625(c).
2. Section 721.1765 is amended by revising paragraphs (a)(2)(i) and
(a)(2)(ii) to read as follows:
Sec. 721.1765 2-Substituted benzotriazole.
(a) * * *
(2) * * *
(i) Protection in the workplace. Requirements as specified in
Sec. 721.63 (a)(1), (a)(3), (a)(4), (a)(5)(ii), (a)(5)(iv), (a)(5)(v),
(a)(6)(i), (a)(6)(ii), (a)(6)(iv), (b) (concentration set at 1.0
percent), and (c).
(ii) Hazard communication program. Requirements as specified in
Sec. 721.72 (a), (b), (c), (d), (e) (concentration set at 1.0 percent),
(f), (g)(1)(i), (g)(1)(ii), (g)(1)(iv), (g)(1)(vi), (g)(1)(viii),
(g)(2)(i), (g)(2)(ii), (g)(2)(iv), (g)(2)(v), and (g)(5).
* * * * *
3. Section 721.1790 is revised to read as follows:
Sec. 721.1790 Polybrominated biphenyls.
(a) Chemical substances and significant new uses subject to
reporting. (1) The chemical substances identified as 1,1'-(Biphenyl,
4,4'-dibromo- (CAS No. 92-86-4); 1,1'-(Biphenyl, 2-bromo-
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(CAS No. 2052-07-5); 1,1'-(Biphenyl, 3-bromo- (CAS No. 2113-57-7);
1,1'-(Biphenyl, 2,2', 3,3', 4,4', 5,5', 6,6'-decabromo- (CAS No. 13654-
09-6); Nonabromobiphenyl (CAS No. 27753-52-2); Octabromobiphenyl (CAS
No. 27858-07-7); and Hexabromobiphenyl (CAS No. 36355-01-8) are subject
to reporting under this section for the significant new uses described
in paragraph (a)(1)(i) of this section.
(i) The significant new use is: Any use.
(ii) Specific requirements. The provisions of subpart A of this
part apply to this section except as modified by this paragraph.
(A) Persons who must report. Section 721.5 applies to this section
except for Sec. 721.5(a)(2). A person who intends to manufacture,
import, or process for commercial purposes a substance identified in
paragraph (a)(1) of this section and intends to distribute the
substance in commerce must submit a significant new use notice.
(B) [Reserved]
(2) The chemical substance identified as 1,1'-(Biphenyl, 4-bromo-
(CAS No. 92-66-0) is subject to reporting under this section for the
significant new uses described in paragraph (a)(2)(i) of this section.
(i) The significant new uses are:
(A) Industrial, commercial, and consumer activites. Requirements as
specified in Sec. 721.80 (f), (j), and (s) (10,000 kilograms).
(B) Release to water. Requirements as specified in Sec. 721.90
(a)(1), (b)(1), and (c)(1).
(ii) Specific requirements. The provisions of subpart A of this
part apply to this section except as modified by this paragraph.
(A) Recordkeeping. Recordkeeping requirements as specified in
Sec. 721.125 (a), (b), (c), (i), and (k) are applicable to
manufacturers, importers, and processors of this substance.
(B) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
(C) Determining whether a specific use is subject to this section.
The provisions of Sec. 721.1725(b)(1) apply to this section.
(b) [Reserved]
4. Section 721.5740 is amended by revising paragraphs (a) and
(b)(1) as follows:
Sec. 721.5740 Phenol, 4,4'-methylenebis (2,6-dimethyl-.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as Phenol, 4,4'-
methylenebis (2,6-dimethyl- (PMNs P-88-864, P-90-211, and P-94-921; CAS
No. 5384-21-4) is subject to reporting under this section for the
significant new uses described in paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in
Sec. 721.63 (a)(1), (a)(3), (a)(4), (a)(5)(ii), (a)(5)(iv), (a)(5)(v),
(a)(6)(i), (b) (concentration set at 1 percent), and (c).
(ii) Hazard communication program. Requirements as specified in
Sec. 721.72 (a), (b), (c), (d), (e) (concentration set at 1 percent),
(f), (g)(1)(iv), (g)(2)(iv), (g)(2)(v), (g)(3)(ii), (g)(4)(iii), and
(g)(5). The label and MSDS as required by this paragraph shall also
include the following statements: This substance may cause blood
effects. This substance may cause chronic effects.
(iii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80 (g), (l), and (q).
(iv) Release to water. Requirements as specified in Sec. 721.90
(a)(1), (b)(1), and (c)(1).
(b) * * *
(1) Recordkeeping. Recordkeeping requirements as specified in
Sec. 721.125 (a), (b), (c), (d), (e), (f), (g), (h), (i), and (k) are
applicable to manufacturers, importers, and processors of this
substance.
* * * * *
5. Section 721.8450 is amended by revising paragraphs (a)(2)(i) and
(a)(2)(ii) to read as follows:
Sec. 721.8450 2-Propenoic acid, 2-methyl-, 2-[3-(2H-benzotriazol-2-
yl)-4-hydroxyphenyl]ethyl ester.
(a) * * *
(2) * * *
(i) Protection in the workplace. Requirements as specified in
Sec. 721.63 (a)(1), (a)(3), (a)(4), (a)(5)(ii), (a)(5)(iv), (a)(5)(v),
(a)(6)(i), (a)(6)(ii), (a)(6)(iv), (b) (concentration set at 1.0
percent), and (c).
(ii) Hazard communication program. Requirements as specified in
Sec. 721.72 (a), (b), (c), (d), (e) (concentration set at 1.0 percent),
(f), (g)(1)(i), (g)(1)(ii), (g)(1)(iv), (g)(1)(vi), (g)(1)(viii),
(g)(2)(i), (g)(2)(ii), (g)(2)(iv), (g)(2)(v), and (g)(5).
* * * * *
6. Section 721.9800 is amended by revising paragraph (a)(2)(i) to
read as follows:
Sec. 721.9800 Poly(substituted triazinyl) piperazine (generic name).
(a) * * *
(2) * * *
(i) Hazard communication program. Requirements as specified in
Sec. 721.72 (b)(2), (c), (e) (concentration set at 1.0 percent), (f),
(g)(1) (statement-health effects not fully determined), (g)(2)(i),
(g)(2)(ii), (g)(2)(iii), and (g)(5). The requirements of this paragraph
shall not apply when the PMN substance is encapsulated in a polymeric
matrix.
* * * * *
[FR Doc. 98-23208 Filed 8-27-98; 8:45 am]
BILLING CODE 6560-50-F
