[Federal Register Volume 62, Number 123 (Thursday, June 26, 1997)]
[Proposed Rules]
[Pages 34421-34424]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-16762]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 721
[OPPTS-50623C; FRL-5726-3]
RIN 2070-AB27
Significant New Uses of Certain Chemical Substances; Proposed
Significant New Use Rule
AGENCY: Environmental Protection Agency (EPA).
ACTION: Proposed rule.
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SUMMARY: EPA is proposing a significant new use rule (SNUR) under
section 5(a)(2) of the Toxic Substances Control Act (TSCA) for certain
chemical substances which were the subject of premanufacture notices
(PMNs). This proposal would require certain persons
[[Page 34422]]
who intend to manufacture, import, or process these substances for a
significant new use to notify EPA at least 90 days before commencing
any manufacturing, importing, or processing activities for a use
designated by this SNUR as a significant new use. The required notice
would provide EPA with the opportunity to evaluate the intended use
and, if necessary, to prohibit or limit that activity before it can
occur.
DATES: Written comments must be received by EPA by July 28, 1997.
ADDRESSES: Each comment must bear the docket control number OPPTS-
50623C. All comments should be sent in triplicate to: OPPT Document
Control Officer (7407), Office of Pollution Prevention and Toxics,
Environmental Protection Agency, Rm. ET-G099, 401 M St., SW.,
Washington, DC 20460.
Comments and data may also be submitted electronically by following
the instructions under Unit VIII of this document. No confidential
business information (CBI) should be submitted through e-mail.
All comments which are claimed confidential must be clearly marked
as such. Three additional sanitized copies of any comments containing
CBI must also be submitted. Nonconfidential versions of comments on
this rule will be placed in the rulemaking record and will be available
for public inspection. See Unit VII for further information.
FOR FURTHER INFORMATION CONTACT: Susan Hazen, Director, Environmental
Assistance Division (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;
e-mail: TSCA-Hotline@epamail.epa.gov.
SUPPLEMENTARY INFORMATION: This proposed SNUR would require persons to
notify EPA at least 90 days before commencing the manufacture, import,
or processing of substituted phenol for the significant new uses
designated herein. The required notice would provide EPA with
information with which to evaluate an intended use and associated
activities.
I. Authority
Section 5(a)(2) of TSCA (15 U.S.C. 2604(a)(2)) authorizes EPA to
determine that a use of a chemical substance is a ``significant new
use.'' EPA must make this determination by rule after considering all
relevant factors, including those listed in section 5(a)(2). Once EPA
determines that a use of a chemical substance is a significant new use,
section 5(a)(1)(B) of TSCA requires persons to submit a notice to EPA
at least 90 days before they manufacture, import, or process the
chemical substance for that use. Section 26 of TSCA authorizes EPA to
take action under section 5(a)(2) with respect to a category of
chemical substances.
Persons subject to this SNUR would comply with the same notice
requirements and EPA regulatory procedures as submitters of
premanufacture notices under section 5(a)(1) of TSCA. In particular,
these requirements include the information submission requirements of
section 5(b) and (d)(1), the exemptions authorized by section 5(h)(1),
(h)(2), (h)(3), and (h)(5), and the regulations at 40 CFR part 720.
Once EPA receives a SNUR notice, EPA may take regulatory action under
section 5(e), 5(f), 6, or 7 to control the activities for which it has
received a SNUR notice. If EPA does not take action, section 5(g) of
TSCA requires EPA to explain in the Federal Register its reasons for
not taking action.
Persons who intend to export a substance identified in a proposed
or final SNUR are subject to the export notification provisions of TSCA
section 12(b). The regulations that interpret section 12(b) appear at
40 CFR part 707.
II. Applicability of General Provisions
General regulatory provisions applicable to SNURs are codified at
40 CFR part 721, subpart A. On July 27, 1988 (53 FR 28354) and July 27,
1989 (54 FR 31298), EPA promulgated amendments to the general
provisions which apply to this SNUR. In the Federal Register of August
17, 1988 (53 FR 31252), EPA promulgated a ``User Fee Rule'' (40 CFR
part 700) under the authority of TSCA section 26(b). Provisions
requiring persons submitting SNUR notices to submit certain fees to EPA
are discussed in detail in that Federal Register document. Interested
persons should refer to these documents for further information.
III. Background
EPA published a direct final SNUR for these chemical substances in
the Federal Register of December 2, 1996 (61 FR 63726) (FRL-4964-3).
EPA received notice of intent to submit adverse comments following
publication for these chemical substances. Therefore, as required by
Sec. 721.160, the final SNUR for these substances is being withdrawn
elsewhere in this issue of the Federal Register and this proposed rule
on the substances is being issued.
IV. Substance Subject to This Rule
EPA is proposing significant new use and recordkeeping requirements
for the following chemical substances under 40 CFR part 721, subpart E.
PMN Numbers P-91-1299 and P-95-1667, P-91-1298 and P-91-1297
Chemical name: l-Aspartic acid, homopolymer and ammonium and potassium
salts.
CAS number: 25608-40-6 (P-91-1299 and P-95-1667) and 64723-18-8 (P-91-
1298).
Effective date of section 5(e) consent order: March 29, 1993.
Basis for section 5(e) consent order: The order was issued under
section 5 (e)(1)(A)(i), (e)(1)(A)(ii)(I), and (e)(1)(A)(ii)(II), of
TSCA based on findings that this substance is expected to be produced
in substantial quantities and there may be significant or substantial
human exposure to the substances.
Recommended testing: EPA has determined that a 28-day oral study (OECD
407), an acute oral study (OPPTS 870.1100 test guideline (public
draft)), an ames assay (40 CFR 798.5265), a mouse micronucleus assay by
the intraperitoneal route (40 CFR 798.5395), and a developmental
toxicity study in one species by the oral route (40 CFR 798.4900) would
help characterize possible environmental effects of the substance. The
PMN submitter of P-91-1297, P-91-1298, and P-91-1299 has agreed not to
exceed the production volume limit without performing these tests on
one of the PMN substances.
CFR citation: 40 CFR 721.979.
PMN Numbers P-95-116/96-1250 and P-96-117/96-1251
Chemical name: (generic) Isothiazolinone derivatives.
CAS number: Not available.
Basis for action: The PMN substances will be used as preservatives.
Based on analogy of the substances to isothiazolones, EPA is concerned
that toxicity to aquatic organisms may occur at a concentrations as low
as 10 parts per billion (ppb) of the PMN substances in surface waters.
Based on analogy of the substances to similar substances, EPA is
concerned for acute lethality, corrosion, developmental toxicity, liver
toxicity, sensitization, and cancer to exposed workers. EPA determined
that use of the substances as described in the PMN did not present an
unreasonable risk because the substances would not be released to
surface waters above a concentration of 10 ppb and significant worker
exposure would not occur because the substance was not
[[Page 34423]]
manufactured domestically. EPA has determined that other uses of the
substances may result in releases to surface waters which exceed the
concern concentration and significant worker exposure. Based on this
information the PMN substances meet the concern criteria at
Sec. 721.170 (b)(4)(ii) and (b)(3)(ii).
Recommended testing: EPA has determined that a fish acute toxicity
study (40 CFR 797.1400), a daphnid acute toxicity study (40 CFR
797.1300), and an algal toxicity study (40 CFR 797.1050) would help
characterize the environmental effects of the PMN substances. EPA has
determined that a developmental toxicity study (40 CFR 798.4900) and a
90-day subchronic study (40 CFR 798.2650) would help characterize the
health effects of the PMN substances.
CFR citation: 40 CFR 721.4525.
V. Applicability of SNUR to Uses Occurring Before Effective Date of
the Final SNUR
EPA has decided that the intent of section 5(a)(1)(B) is best
served by designating a use as a significant new use as of the date of
proposal rather than as of the effective date of the rule. Because this
SNUR was first published on December 2, 1996, as a direct final rule,
that date will serve as the date after which uses would be considered
to be new uses. If uses which had commenced between that date and the
effective date of this rulemaking were considered ongoing, rather than
new, any person could defeat the SNUR by initiating a significant new
use before the effective date. This would make it difficult for EPA to
establish SNUR notice requirements. Thus, persons who begin commercial
manufacture, import, or processing of the substances for uses that
would be regulated through this SNUR after December 2, 1996, would have
to cease any such activity before the effective date of this rule. To
resume their activities, such persons would have to comply with all
applicable SNUR notice requirements and wait until the notice review
period, including all extensions, expires. EPA, not wishing to
unnecessarily disrupt the activities of persons who begin commercial
manufacture, import, or processing for a proposed significant new use
before the effective date of the SNUR, has promulgated provisions to
allow such persons to comply with this proposed SNUR before it is
promulgated. If a person were to meet the conditions of advance
compliance as codified at Sec. 721.45(h) (53 FR 28354, July 17, 1988),
the person would be considered to have met the requirements of the
final SNUR for those activities. If persons who begin commercial
manufacture, import, or processing of the substances between proposal
and the effective date of the SNUR do not meet the conditions of
advance compliance, they must cease that activity before the effective
date of the rule. To resume their activities, these persons would have
to comply with all applicable SNUR notice requirements and wait until
the notice review period, including all extensions, expires.
VI. Economic Analysis
EPA has evaluated the potential costs of establishing significant
new use notice requirements for potential manufacturers, importers, and
processors of the chemical substances at the time of the direct final
rule. The analysis is unchanged for the substances in this proposed
rule. The Agency's complete economic analysis is available in the
public record for this proposed rule (OPPTS-50623C).
VII. Comments Containing Confidential Business Information
Any person who submits comments containing information claimed as
confidential business information must mark the comments as
``confidential,'' ``trade secret,'' or other appropriate designation.
Comments not claimed as confidential at the time of submission will be
placed in the public file without further notice to the submitter. Any
comments marked as confidential will be treated in accordance with the
procedures in 40 CFR part 2. Any party submitting comments claimed to
be confidential must prepare and submit a nonconfidential public
version in triplicate of the comments that EPA can place in the public
file.
VIII. Rulemaking Record
The official record for this rulemaking, as well as the public
version, has been established for this rulemaking under docket number
OPPTS-50623C (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 confidential business information (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:
oppt.ncic@epamail.epa.gov
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 in 5.1 file format or
ASCII file format. All comments and data in electronic form must be
identified by the docket number OPPTS-50623C. Electronic comments on
this proposed rule may be filed online at many Federal Depository
Libraries.
The OPPTS harmonized test guidelines referenced in this document
are available on EPA's World Wide Web site under ``Researchers and
Scientists,'' ``Environmental Test Methods & Guidelines'' (http://
www.epa.gov/epahome/research.htm).
IX. 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
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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.
X. 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, the Agency 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 this rule in
today's 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 materials,
Recordkeeping and reporting requirements.
Dated: June 18, 1997.
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:
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. By adding new Sec. 721.979 to subpart E to read as follows:
Sec. 721.979 l-Aspartic acid, homopolymer and ammonium and potassium
salts.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substances l-Aspartic acid, homopolymer and
ammonium and potassium salts (PMNs P-91-1299 and P-95-1667, P-91-1298
and P-91-1297; CAS nos. 25608-40-6 and 64723-18-8) are 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) Hazard communication program. A significant new use of these
substances is any manner or method of manufacture, import, or
processing associated with any use of these substances without
providing risk notification as follows:
(A) If as a result of the test data required under the section 5(e)
consent order for these substances, the employer becomes aware that
these substances may present a risk of injury to human health or the
environment the employer must incorporate this new information, and any
information on methods for protecting against such risk, into a
Material Safety Data Sheet (MSDS) as described in Sec. 721.72(c) within
90 days from the time the employer becomes aware of the new
information. If these substances are not being manufactured, imported,
processed, or used in the employer's workplace, the employer must add
the new information to an MSDS before the substances are reintroduced
into the workplace.
(B) The employer must ensure that persons who will receive, or who
have received their substances from the employer within 5 years from
the date the employer becomes aware of the new information described in
paragraph (a)(2)(i)(A), are provided an MSDS as described in
Sec. 721.72(c) containing the information required under paragraph
(a)(2)(i)(A) within 90 days from the time the employer becomes aware of
the new information.
(ii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(q).
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph.
(1) Recordkeeping. Recordkeeping requirements as specified in
Sec. 721.125 (a), (h), and (i) are applicable to manufacturers,
importers, and processors of these substances.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
(3) Determining whether a specific use is subject to this section.
The provisions of Sec. 721.1725(b)(1) apply to this section.
3. By adding new Sec. 721.4525 to subpart E to read as follows:
Sec. 721.4525 Isothiazolinone derivatives.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substances identified generically as
isothiazolinone derivatives (PMNs P-95-116/96-1250 and P-95-117/96-
1251) are 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) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(f).
(ii) Release to water. Requirements as specified in Sec. 721.90
(a)(4), (b)(4), and (c)(4) (N = 10).
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph.
(1) Recordkeeping. Recordkeeping requirements as specified in
Sec. 721.125 (a), (b), (c), (i), and (k) are applicable to
manufacturers, importers, and processors of these substances.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
[FR Doc. 97-16762 Filed 6-25-97; 8:45 am]
BILLING CODE 6560-50-F
