[Federal Register Volume 63, Number 36 (Tuesday, February 24, 1998)]
[Proposed Rules]
[Pages 9169-9171]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-4657]
[[Page 9169]]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 721
[OPPTS-50631, etc; FRL-5767-2]
RIN 2070-AB27
Proposed Modification of Significant New Use Rules for Certain
Substances
AGENCY: Environmental Protection Agency (EPA).
ACTION: Proposed rule.
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SUMMARY: EPA is proposing to modify 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: Written comments must be received by EPA by March 26, 1998.
ADDRESSES: Each comment must bear the docket control number OPPTS-50631
and the name(s) of the chemical substance(s) subject to the comment.
All comments should be sent in triplicate to: OPPT Document Control
Officer (7407), Office of Pollution Prevention and Toxics,
Environmental Protection Agency, 401 M St., SW., Rm. G-099, East Tower,
Washington, DC 20460.
Comments and data may also be submitted electronically to:
[email protected]. Follow the instructions under Unit III. of
this document. No Confidential Business Information (CBI) should be
submitted through e-mail.
All comments which contain information claimed as CBI must be
clearly marked as such. Three sanitized copies of any comments
containing information claimed as CBI must also be submitted and will
be placed in the public record for this rulemaking. Persons submitting
information on any portion of which they believe is entitled to
treatment as CBI by EPA must assert a business confidentiality claim in
accordance with 40 CFR 2.203(b) for each portion. This claim must be
made at the time that the information is submitted to EPA. If a
submitter does not assert a confidentiality claim at the time of
submission, EPA will consider this as a waiver of any confidentiality
claim and the information may be made available to the public by EPA
without further notice to the submitter.
FOR FURTHER INFORMATION CONTACT: Susan B. Hazen, Director,
Environmental Assistance Division (7408), Office of Pollution
Prevention and Toxics, Environmental Protection Agency, Rm. E-543A, 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, EPA issued a
SNUR establishing significant new uses for the substances listed in
Unit I. of this preamble, 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). Because of additional data EPA has received for these
substances, EPA is hereby proposing to modify the SNURs.
I. Proposed Modifications
EPA is proposing to modify the significant new use and
recordkeeping requirements under 40 CFR part 721, subpart E for several
chemical substances. In this unit, EPA provides a description for each
substance, including its premanufacture notice (PMN) number, chemical
name (generic name if the specific name is claimed as CBI), CAS number
(if available), the proposed modification and basis, Federal Register
reference, docket number, and the CFR citation. Further background
information for the substances is contained in the rulemaking record
referenced in Unit III. of this preamble.
PMN Number P-88-436
Chemical name: (generic) Poly(substituted triazinyl) piperazine.
CAS number: Not available.
Federal Register publication date and reference: August 9, 1990 (55 FR
32419).
Docket number: OPPTS-50583.
Basis for modification: The original TSCA section 5(e) consent order
and SNUR contained hazard communication requirements for a label and
Material Safety Data Sheet (MSDS) accompanying the substance in
commerce. The original requirements were intended only for
manufacturers, as processors incorporated the substance within a
polymer (polyolefin) matrix prior to shipping from their processing
site and thus not in a form likely to result in significant exposures.
Based on this lack of significant exposures, the TSCA section 5(e)
consent order was modified so that hazard communication requirements
were not applicable once the substance is encapsulated in a polymeric
matrix. The proposed SNUR modification will extend this exemption to
all manufacturers, importers, and processors.
CFR citation: 40 CFR 721.9800 (Formerly 40 CFR 721.2196).
PMN Numbers P-88-864, P-90-211, and P-94-921
Chemical name: Phenol, 4,4'-methylenebis (2,6-dimethyl-.
CAS number: 5384-21-4.
Federal Register publication date and reference: August 15, 1990 (55 FR
33306).
Docket number: OPPTS-50582.
Basis for modification: EPA received an additional PMN, P-94-921, for
this substance. Based on the most recent toxicity data and potential
exposures, a TSCA section 5(e) consent order was issued for P-94-921.
This TSCA section 5(e) consent order contained additional hazard
communication warnings and water release restrictions not found in
previous consent orders and the SNUR for this substance. The proposed
SNUR modification will extend these requirements to all manufacturers,
importers, and processors.
CFR citation: 40 CFR 721.5740 (Formerly 40 CFR 721.1537).
PMN Number P-90-333
Chemical name: 2-Propenoic acid, 2-methyl-, 2-[3-(2H-benzotriazol-2-
yl)-4-hydroxyphenyl]ethyl ester.
CAS number: 96478-09-0.
Federal Register publication date and reference: April 25, 1991 (56 FR
19241) amended June 9, 1995 (60 FR 30468).
Docket number: OPPTS-50591.
Basis for modification: Based on test data submitted pursuant to the
TSCA section 5(e) consent orders for similar substances EPA no longer
has concerns for potential carcinogenicity of this substance. In
addition, the original SNUR included requirements for statements on the
label and MSDS warning of potential birth defects, when instead it
should have included statements warning of potential immune system
effects. The SNUR modification will remove all references to potential
carcinogenicity (40 CFR 721.72(h)) and will also change the warning
statements by eliminating references to birth defects while including
warnings about immune system effects.
CFR citation: 40 CFR 721.8450 (Formerly 40 CFR 721.1817).
[[Page 9170]]
PMN Number P-90-335
Chemical name: 2-Substituted benzotriazole.
CAS number: Not available.
Federal Register publication date and reference: April 25, 1991 (56 FR
19235) amended June 9, 1995 (60 FR 30468).
Docket number: OPPTS-50591.
Basis for modification: The original SNUR included requirements for
statements on the label and MSDS warning of potential cancer. As EPA
did not make a finding of potential cancer for this substance, the SNUR
modification will remove all references to potential carcinogenicity
(40 CFR 721.72(h)).
CFR citation: 40 CFR 721.1765 (Formerly 40 CFR 721.586).
PMN Number (not available)
Chemical name: Polybrominated biphenyls.
CAS number: 92-66-0.
Federal Register publication date and reference: January 26, 1987 (52
FR 2703).
Docket number: OPPTS-50537A.
Basis for modification: EPA received a SNUN for this substance for a
limited specific use. EPA was unable to make an unreasonable risk
finding based on limited human and environmental exposures. Based on
test data demonstrating carcinogenicity of chlorinated and brominated
biphenyls, EPA has concerns for cancer. Based on structural analogy to
monochloro biphenyl and neutral organic substances, EPA also has a
concern for potential toxicity to aquatic organisms at concentrations
as low as 7 parts per billion (ppb). In addition, based on the
potential high toxicity of the substance, its expected high
bioaccumulation (log fish bioconcentration factor of 3.5) and its
expected persistence in the environment, EPA considers this substance
to be a persisent bioaccumulator. Based on these health and
environmental concerns, EPA will issue a SNUR modification requiring
additional 90-day notification before the SNUN substance, 1,1'-
Biphenyl, 4-bromo, is used for any other uses other than the specific
use described in the SNUN already received by EPA, is manufactured
domestically, is predictably or purposefully released to surface
waters, or exceeds a maximum yearly production volume of 10,000
kilograms (kg). All other brominated biphenyl compounds subject to this
section will still require a SNUN for any use.
CFR citation: 40 CFR 721.1790 (Formerly 40 CFR 721.230).
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 the case of polybrominated biphenyls, EPA
concluded that any use may result in significant changes in human or
environmental exposure. The basis for such findings is 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, the
Agency has determined that modifying these SNURs would not result in
significant changes in human or environmental exposure. The
modification of SNUR provisions for these substances designated herein
is consistent with the provisions of the TSCA section 5(e) consnet
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-50631 (including comments and data submitted
electronically as described below). 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.
Electronic comments can be sent directly to EPA at:
[email protected]
Electronic comments must be submitted as an ASCII file avoiding the
use of special characters and any form of encryption. Comments and data
will also be accepted on disks in WordPerfect 5.1/6.1 or ASCII file
format. All comments and data in electronic form must be identified by
the docket control number OPPTS-50631. Electronic comments on this
proposed rule may be filed online at many Federal Depository Libraries.
IV. Regulatory Assessment Requirements
Under Executive Order 12866 (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 specified by
Executive Order 12875 (58 FR 58093, October 28, 1993), or involve
special considerations of environmental justice related issues as
required by Executive Order 12898 (59 FR 7629, February 16, 1994).
An agency may not conduct or sponsor, and a person is not required
to respond to, an information collection request unless it displays a
currently valid OMB control number. The information collection
requirements related to this action have already been approved by OMB
pursuant to the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et seq.,
under OMB control number 2070-0012 (EPA ICR No. 574). This action does
not impose any burdens requiring additional OMB approval. The public
reporting burden for this collection of information is estimated to
average 100 hours per response. The burden estimate includes the time
needed to review instructions, search existing data sources, gather and
maintain the data needed, and complete and review the collection of
information.
In addition, pursuant to section 605(b) of the Regulatory
Flexibility Act (RFA) (5 U.S.C. 601 et seq.), the Agency has determined
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.
List of Subjects in 40 CFR Part 721
Environmental protection, Chemicals, Hazardous substances,
Reporting and recordkeeping requirements.
Dated: February 13, 1998.
Ward Penberthy,
Acting Director, Chemical Control Division, Office of Pollution
Prevention and Toxics.
Therefore, it is proposed that 40 CFR part 721 be amended as
follows:
[[Page 9171]]
PART 721--[AMENDED]
1. The authority citation for part 721 would continue 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)(2)(i), (a)(2)(iii), (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)(iii), (g)(2)(iv), 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- (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 (p) (10,000 kg).
(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)(2)(i), (a)(2)(iv), (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)(iii), (g)(2)(iv), 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. 98-4657 Filed 2-23-98; 8:45 am]
BILLING CODE 6560-50-F