[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

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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-H[email protected].

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

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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:
    [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 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