[Federal Register Volume 60, Number 109 (Wednesday, June 7, 1995)]
[Proposed Rules]
[Pages 30050-30052]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-13964]



-----------------------------------------------------------------------


ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 721

[OPPTS-50615B; FRL-4916-4]
RIN 2070-AB27


Organotin Lithium Compound; Proposed Significant New Use Rule

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

-----------------------------------------------------------------------

SUMMARY: EPA is proposing a significant new use rule (SNUR) under 
section 5(a)(2) of the Toxic Substances Control Act (TSCA) for the 
chemical substance described generically as an organotin lithium 
compound which is the subject of premanufacture notice (PMN) P-93-1119. 
This proposal 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: Written comments must be received by EPA by July 7, 1995.

ADDRESSES: Each comment must bear the docket control number OPPTS-
50615B. All comments should be sent in triplicate to: OPPT Document 
Control Officer (7407), Office of Pollution Prevention and Toxics, 
Environmental Protection Agency, Rm. E-G99, 401 M St., SW., Washington, 
DC 20460. All comments which are claimed confidential must be clearly 
marked as such. Three additional sanitized copies of any comments 
containing confidential business information (CBI) must also be 
submitted. Nonconfidential versions of comments on this proposed rule 
will be placed in the rulemaking record and will be available for 
public inspection. See Unit VII. of this document for further 
information.
    Comments and data may also be submitted electronically by sending 
electronic mail (e-mail) to: [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-50615B. No CBI should be submitted through e-
mail. Electronic comments on this proposed rule may be filed online at 
many Federal Depository Libraries. Additional information on electronic 
submissions can be found in Unit VIII. of this document.

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.
SUPPLEMENTARY INFORMATION: This proposed 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 
sections 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 significant new use notice (SNUN), EPA may take 
regulatory action under section 5(e), 5(f), 6, or 7 to control the 
activities for which it has received a SNUN. 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 SNUNs 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 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 adverse comments following publication 
for this chemical substance. Therefore, as required by 40 CFR 721.160, 
the final SNUR for P-93-1119 is being revoked elsewhere in this issue 
of the Federal Register and this proposed rule on the substance is 
being issued.
    The comments were submitted by the PMN submitter's customer for 
this substance. The commenter proposed changing the requirements of the 
SNUR. Based on potential toxicity to the environment, the direct final 
SNUR required notification if the substance was predictably or 
purposefully released to surface waters. The commenter proposed a SNUR 
requiring notification if the substance was predictably or purposefully 
released to surface waters above a concentration of 1 ppb (part per 
billion) according to the formula in 40 CFR 721.90.
    The direct final SNUR was based on the information in the PMN that 
manufacture and use of the PMN substance as a catalyst would not result 
in releases to surface waters. The commenter demonstrated through a 
pilot study and analytical measurements that the substance would be 
released to surface waters. The commenter also demonstrated that 
treatment at that particular plant site would result in surface water 
concentrations below EPA's original 1 ppb concern concentration. 
Because the data demonstrate that releases to water could occur but 
would not exceed the 1 ppb concern level at the intended site of 
[[Page 30051]] manufacture, EPA is proposing this SNUR with a water 
trigger of 1 ppb as a significant new use.
    EPA is not soliciting and will not respond in this proposal to 
comments on any of the other SNURs that were published in the May 27, 
1994 Federal Register because those rules either became final, 
effective July 25, 1994, or EPA is addressing written comments 
concerning those rules in a separate rulemaking. Except for the use of 
the 1 ppb level, the supporting rationale and background to this 
proposal are more fully set out in the preamble to the direct final 
SNUR for this substance and in the preamble to EPA's first direct final 
SNURs published in the Federal Register of April 24, 1990 (55 FR 
17376). Consult those preambles for further information on the 
objectives, rationale, and procedures for the proposal and on the basis 
for significant new use designations including provisions for 
developing test data.

IV. Substance Subject to This Rule

    EPA is proposing significant new use and recordkeeping requirements 
for the following chemical substance under 40 CFR part 721.

PMN Number P-93-1119

Chemical name: (generic) Organotin lithium compound.
CAS number: Not available.
Toxicity concern: The substance will be used as a catalyst. Test data 
on organotin pesticides indicate that the substance may cause toxicity 
to aquatic organisms. Based on these data, EPA expects toxicity to 
aquatic organisms to occur at a concentration of 1 ppb of the substance 
in surface waters. EPA determined that use of the substance as 
described in the PMN did not present an unreasonable risk because the 
substance would not be released to surface waters above a concentration 
of 1 ppb. EPA has determined that manufacture, processing, and use of 
the substance for uses other than as a catalyst could result in 
releases to surface waters above 1 ppb. Based on this information, the 
substance meets the concern criteria at Sec. 721.170(b)(4)(iii).
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 acute toxicity study (40 CFR 797.1050) would 
help characterize the environmental effects of the PMN substance.
CFR citation: 40 CFR 721.9668.

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 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 SNUN requirements. Thus, persons who begin commercial 
manufacture, import, or processing of the substance for uses that would 
be regulated through this SNUR after May 27, 1994, would have to cease 
any such activity before the effective date of the rule. To resume 
their activities, such persons would have to comply with all applicable 
SNUN 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), 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 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, these 
persons would have to comply with all applicable SNUN requirements and 
wait until the notice review period, including all extensions, expires.

VI. Economic Analysis

    EPA evaluated the potential costs of establishing SNUN 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 this proposed rule. The Agency's 
complete economic analysis is available in the public record for this 
proposed rule (OPPTS-50615B).

VII. Comments Containing Confidential Business Information

    Any person who submits comments containing information claimed as 
CBI 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

    A record has been established for this rulemaking under docket 
number OPPTS-50615B (including comments and data submitted 
electronically as described below). EPA will accept additional 
materials for inclusion in the record at any time between this proposal 
and designation of the complete record. EPA will identify the complete 
rulemaking record by the date of promulgation. 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 public record is located in the TSCA 
Nonconfidential Information Center, Rm. NE-B607, 401 M St., SW., 
Washington, DC 20460.
    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.
    The official record for this rulemaking, as well as the public 
version, as described above will be kept in paper form. Accordingly, 
EPA will transfer all comments received electronically into printed, 
paper form as they are received and will place the paper copies in the 
official rulemaking record which will also include all comments 
submitted directly in writing. The official rulemaking record is the 
paper record maintained at the address in ``ADDRESSES'' at the 
beginning of this document. [[Page 30052]] 

IX. Regulatory Assessment Requirements

A. Executive Order 12866

    Under Executive Order 12866 (58 FR 51735, October 4, 1993), the 
Agency must determine whether the regulatory action is ``significant'' 
and therefore subject to all the requirements of the Executive Order 
(i.e., Regulatory Impact Analysis, review by the Office of Management 
and Budget (OMB)). Under section 3(f), the order defines a 
``significant regulatory action'' as an action likely to lead to a rule 
(1) Having an annual effect on the economy of $100 million or more, or 
adversely and materially affecting a sector of the economy, 
productivity, competition, jobs, the environment, public health or 
safety, or State, local or tribal governments or communities (also 
referred to as ``economically significant''); (2) creating serious 
inconsistency or otherwise interfering with an action taken or planned 
by another agency; (3) materially altering the budgetary impacts of 
entitlement, grants, user fees, or loan programs or the rights and 
obligations of recipients thereof; or (4) raising novel legal or policy 
issues arising out of legal mandates, the President's priorities, or 
the principles set forth in this Executive Order.
    Pursuant to the terms of this Executive Order, it has been 
determined that this proposed rule would not be ``significant'' and is 
therefore not subject to OMB review.

B. Regulatory Flexibility Act

    Under the Regulatory Flexibility Act (5 U.S.C. 605(b)), EPA has 
determined that this proposed rule would not have a significant impact 
on a substantial number of small businesses. EPA has determined that 
approximately 10 percent of the parties affected by this proposed rule 
could be small businesses. However, EPA expects to receive few SNUNs 
for this substance. Therefore, EPA believes that the number of small 
businesses affected by this proposed rule will not be substantial, even 
if all of the SNUN submitters were small firms.

C. Paperwork Reduction Act.

    OMB has approved the information collection requirements contained 
in this proposed rule under the provisions of the Paperwork Reduction 
Act (44 U.S.C. 3501 et seq.), and has assigned OMB control number 2070-
0012. Public reporting burden for this collection of information is 
estimated to vary from 30 to 170 hours per response, with an average of 
100 hours per response, including time for reviewing instructions, 
searching existing data sources, gathering and maintaining the data 
needed, and completing and reviewing the collection of information.
    Send comments regarding the burden estimate or any other aspect of 
this collection of information, including suggestions for reducing this 
burden, to Chief, Information Policy Branch (2131), Environmental 
Protection Agency, 401 M St., SW., Washington, DC 20460; and to Office 
of Information and Regulatory Affairs, Office of Management and Budget, 
Washington, DC 20503, marked ``Attention: Desk Officer for EPA.'' The 
final rule will respond to any OMB or public comments on the 
information requirements contained in this proposal.

List of Subjects in 40 CFR Part 721

    Environmental protection, Chemicals, Hazardous materials, Reporting 
and recordkeeping requirements, Significant new uses.

    Dated: May 19, 1995.
Charles M. Auer,
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. 721.9668 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 identified generically as 
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 ppb).
    (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. 95-13964 Filed 6-6-95; 8:45 am]
BILLING CODE 6560-50-F