[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-H[email protected].

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