[Federal Register Volume 62, Number 236 (Tuesday, December 9, 1997)]
[Rules and Regulations]
[Pages 64738-64740]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-32179]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 721
[OPPTS-50608E; FRL-5746-2]
RIN 2070-AB27
Polyalkylene Polyamine; 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 polyalkylene polyamine which is the subject of
premanufacture notice (PMN) P-89-963. This rule would require certain
persons who intend to manufacture, or import this substance for a
significant new use to notify EPA at least 90 days before commencing
any manufacturing or importing 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 January 8, 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-Hotline@epamail.epa.gov.
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 or import 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
[[Page 64739]]
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-89-963 and a TSCA 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 was withdrawn on December 19,
1994 (59 FR 65248) (FRL-4758-2), and a proposed rule on the substance
was issued on December 19, 1994 (59 FR 65289) (FRL-4758-3).
The background and reasons for the SNUR were set forth in the
preamble to the proposed rule. EPA received comments from the current
manufacturer of the PMN substance. EPA's response to the comments and
changes to the proposed rule are discussed in this document.
All but one of the comments can be summarized as follows: Since the
5(e) consent order requires only that manufacturers and importers be
subject to hazard communication requirements concerning environmental
effects, water release restrictions, and recordkeeping requirements,
the SNUR should reflect similar regulation, and processors should not
be subject to these SNUR requirements. EPA agrees with this
clarification. The proposed SNUR would have required that only
manufacturers notify the Agency if the substance was released to water.
In addition, EPA is revising both the hazard communication and
recordkeeping sections to make it clear that only manufacturers and
importers are subject to the requirements of the SNUR.
The other comment was that since the toxicity testing (a 28-day
oral study in rats) required by the 5(e) consent order at a designated
production volume limit had already been completed and submitted to
EPA, the corresponding production volume limit in the proposed SNUR
should not be included in the final SNUR. EPA agrees and accordingly
has eliminated this notification requirement from the final SNUR. In
addition, the hazard communication requirements designated in the
proposed SNUR at Sec. 721.72 (a)(2)(i)(A) and (B) have been eliminated.
These requirements would have compelled manufacturers, importers, or
processors to incorporate into a Material Safety Data Sheet (MSDS) any
risks to human health and methods for protecting against such risk, if
such risks were demonstrated by the results of toxicity testing
required under the section 5(e) consent order. EPA eliminated these
requirements, since the order and the SNUR no longer require toxicity
testing and the test data already submitted did not warrant additional
hazard communication notification.
IV. 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 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 June 8, 1993, 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, 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, and importers
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-50608E).
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-50608E (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
[[Page 64740]]
(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 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 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 substances,
Reporting and recordkeeping requirements.
Dated: November 24, 1997.
Charles M. Auer,
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. 721.6193 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 generically identified as a
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)(4) (users minimize
release to water), and (g)(5) are applicable to manufacturers and
importers.
(ii) 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. Recordkeeping requirements as specified in
Sec. 721.125 (a), (b), (c), (f), (g), (h), (i), and (k) are applicable
to manufacturers and importers of this substance.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
[FR Doc. 97-32179 Filed 12-8-97; 8:45 am]
BILLING CODE 6560-50-F
