[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