[Federal Register Volume 63, Number 37 (Wednesday, February 25, 1998)]
[Rules and Regulations]
[Pages 9449-9450]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-4790]



[[Page 9449]]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 721

[OPPTS-50615C; FRL-5757-2]
RIN 2070-AB27


Organotin Lithium Compound; Final Significant New Use Rule

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: EPA is issuing a significant new use rule (SNUR) under section 
5(a)(2) of the Toxic Substances Control Act (TSCA) for the chemical 
substance described as an organotin lithium compound which is the 
subject of premanufacture notice (PMN) P-93-1119. This rule would 
require certain persons who intend to manufacture, import, or process 
this substance 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: This rule is effective March 27, 1998.
FOR FURTHER INFORMATION CONTACT: Susan B. 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:
    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/).
    This final SNUR would require persons to notify EPA at least 90 
days before commencing the manufacture, import, or processing of P-93-
1119 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(c) 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 and Response to Comments

    EPA published a direct final SNUR for the chemical substance, which 
was the subject of PMN P-93-1119 in the Federal Register of May 27, 
1994 (59 FR 27474). EPA received a notice of intent to submit adverse 
comments for this chemical substance following publication. Therefore, 
as required by Sec. 721.160, the final SNUR for P-93-1119 was withdrawn 
on June 7, 1995 (60 FR 29992) (FRL-4916-3) and a proposed rule on the 
substance was issued on June 7, 1995 (60 FR 30050) (FRL-4916-4).
    The background and reasons for the SNUR are set forth in the 
preamble to the proposed rule including EPA's response to comments to 
the direct final rule and the change to the proposed SNUR based on 
those comments and data submitted. EPA received no additional comments 
to the proposed rule, therefore, EPA is issuing the final rule.

IV. Applicability of SNUR to Uses Occurring Before Effective Date 
of the Final SNUR

    EPA has decided that the intent of TSCA 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 May 27, 1994, 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 substance for uses that would 
be regulated through this SNUR after March 1, 1995, 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 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 SNUR for those 
activities. If persons who begin commercial manufacture, import, or 
processing of the substance 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,

[[Page 9450]]

these persons would have to comply with all applicable SNUR notice 
requirements and wait until the notice review period, including all 
extensions, expires.

V. Economic Analysis

    EPA has evaluated the potential costs of establishing significant 
new use notice requirements for potential manufacturers, importers, and 
processors of the chemical substance at the time of the direct final 
rule. The analysis is unchanged for the substance in the final rule. 
The Agency's complete economic analysis is available in the public 
record for this final rule (OPPTS-50615C).

VI. Public Record

    The official record for this rulemaking, as well as the public 
version, has been established for this rulemaking under docket control 
number OPPTS-50615C (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 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.

VII. 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 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.

VIII. 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 rule 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: February 13, 1998.

Ward Penberthy,

Acting 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. By adding new Sec. 721.9668 to subpart E to read as follows:


Sec. 721.9668   Organotin lithium compound.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance generically identified as an 
organotin lithium compound (PMN P-93-1119) 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) Release to water. Requirements as specified in Sec. 721.90 
(a)(4), (b)(4), and (c)(4) (N = 1).
    (ii) [Reserved]
    (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), and (k) are applicable to manufacturers, 
importers, and processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this section.

[FR Doc. 98-4790 Filed 2-24-98; 8:45 am]
BILLING CODE 6560-50-F