[Federal Register Volume 59, Number 242 (Monday, December 19, 1994)]
[Unknown Section]
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From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-30731]
[[Page Unknown]]
[Federal Register: December 19, 1994]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 721
[OPPTS-50608B; FRL-4758-3]
RIN 2070-AB27
Polyalkylene Polyamine; 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 the
chemical substance described generically as polyalkylene polyamine
which is the subject of premanufacture notice (PMN) P-89-963 and which
is subject to a TSCA section 5(e) consent order issued by EPA. 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 January 18, 1995.
ADDRESSES: Each comment must bear the docket control number OPPTS-
50608B. 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.
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-89-963 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 significant new use 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 the chemical substance, which
was the subject of PMN P-89-963 and a TSCA section 5(e) consent order
issued by EPA, in the Federal Register of June 8, 1993 (58 FR 32227).
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-89-963 is being withdrawn elsewhere
in this issue of the Federal Register and this proposed rule on the
substance is being issued.
EPA is not soliciting and will not respond to comments on any of
the other SNURs that were published in the June 8, 1993, Federal
Register because those rules became effective August 7, 1993, or are
being withdrawn and proposed in separate actions. 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 that preamble 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 part 721 subpart E.
PMN Number P-89-963
Chemical name: (generic) Polyalkylene polyamine.
CAS Number: Not available.
Effective date of section 5(e) consent order: June 27, 1992.
Basis for section 5(e) consent order: The order was issued under
section 5(e)(1)(A)(i), (ii)(I), and (ii)(II) of TSCA based on a finding
that this substance may present an unreasonable risk of injury to the
environment, and that this substance is expected to be produced in
substantial quantities and there may be significant or substantial
human exposures.
Toxicity concern: The PMN substance and similar chemicals have been
shown to cause acute toxicity to aquatic organisms at low levels of
exposure. Specifically, based on data submitted on the PMN substance,
the fish acute LC50 value is 780 ppm, the daphnid acute LC50 value is
10 ppm, and the algal acute EC50 value is 2.9 ppm. Applying an
assessment factor of 100 to the daphnid acute value, EPA predicts that
chronic toxicity to aquatic life may occur at concentrations as low as
100 ppb.
Recommended testing: EPA has determined that the results of a 28-day
repeated dose oral study in rats (OECD Guideline No. 407) would help
characterize possible human health effects posed by the substance. The
PMN submitter has agreed not to exceed the production volume limit
without performing this test.
CFR citation: 40 CFR 721.6193.
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 June 8, 1993, as a direct final rule, that
date will serve as the date after which uses will 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 regulated
through this SNUR after June 8, 1993, will 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 SNUR
notice requirements and wait until the notice review period, including
all extensions, expires. EPA, not wishing to 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
unnecessarily, 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 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 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-50608B).
VII. Comments Containing Confidential Business Information
Any person who submits comments 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. 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
EPA has established a record for this rulemaking (docket control
number OPPTS-50608). The record includes basic information considered
by the Agency in developing this proposed rule. EPA will supplement the
record with additional information as it is received.
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 the record without any CBI is
available in the TSCA Nonconfidential Information Center (NCIC) from 12
noon to 4 p.m., Monday through Friday, except legal holidays. The TSCA
NCIC is located in Rm. NE-B607, 401 M St., SW., Washington, DC 20460.
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 review by the Office of Management and Budget
(OMB) and the requirements of the Executive Order. Under section 3(f),
the order defines a ``significant regulatory action'' as an action that
is likely to result in 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 is not ``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 not determined
whether parties affected by this proposed rule would likely be small
businesses. However, EPA expects to receive few SNUR notices for the
substance. Therefore, EPA believes that the number of small businesses
affected by the rule would not be substantial, even if all of the SNUR
notice submitters were small firms.
C. Paperwork Reduction Act
OMB has approved the information collection requirements contained
in this 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), U.S. 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: December 1, 1994.
Joseph A. Carra,
Acting Director, 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. 721.6193 to subpart E to read as follows:
Sec. 721.6193 Polyalkylene polyamine.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
polyalkylene polyamine (PMN P-89-963) 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) Hazard communication program. Requirements as specified in
Sec. 721.72(a), (b), (c), (d), (f), (g)(3)(i), (g)(3)(ii), (g)(4)
(users minimize releases to water), and (g)(5). In addition, a
significant new use of this substance is any manner or method of
manufacture, import, or processing associated with any use of this
substance without providing risk notification as follows:
(A) If as a result of the test data required under the section 5(e)
consent order for this substance, the employer becomes aware that this
substance may present a risk of injury to human health, 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 to an MSDS before the
substance is reintroduced into the workplace.
(B) The employer must ensure that persons who will receive, or who
have received these 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) of this section, are provided an MSDS as
described in Sec. 721.72(c) containing the information required under
paragraph (a)(2)(i)(A) of this section 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).
(iii) Release to water. Requirements as specified in
Sec. 721.90(a)(1).
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph.
(1) Recordkeeping requirements. Requirements as specified in
Sec. 721.125(a), (b), (c), (f) through (i), 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.
(3) Determining whether a specific use is subject to this section.
The provisions of Sec. 721.1725(b)(1) apply to this section.
[FR Doc. 94-30731 Filed 12-16-94; 8:45 am]
BILLING CODE 6560-50-F
