[Federal Register Volume 63, Number 83 (Thursday, April 30, 1998)]
[Rules and Regulations]
[Pages 23678-23680]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-11474]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 721
[OPPTS-50622D; FRL-5782-5]
RIN 2070-AB27
Substituted Phenol; 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 substituted phenol, which is the subject of
several premanufacture notices (PMN) P-89-1125, P-91-87, P-92-41, P-92-
511, P-94-1527, and P-94-1755. This rule would require 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 June 1, 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 SNUR would require persons to notify EPA at least 90 days
before commencing the manufacture, import, or processing of substituted
phenol 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) of TSCA.
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) of TSCA 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 TSCA 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
EPA published a direct final SNUR for the chemical substance, which
was the subject of PMNs P-89-1125, P-91-87, P-92-41, P-92-511, P-94-
1527, and P-94-1755 in the Federal Register of August 30, 1995 (60 FR
45072) (FRL-4926-2). EPA received notice of intent to submit adverse
comments following publication for this chemical substance. Therefore,
as required by Sec. 721.160, the final SNUR for P-89-1125 et al. was
withdrawn on June 26, 1997 (62 FR 34414) (FRL-5723-5) and a proposed
rule on the substance was issued on June 26, 1997 (62 FR 34427) (FRL-
5723-6).
The background and reasons for the SNUR are set forth in the
preamble to the proposed rule. EPA received comments concerning the
designated significant new uses in the proposed rule. The commenter
proposed alternative significant new uses that would achieve the same
result of eliminating environmental releases to surface waters. EPA's
response to the comments is discussed in this document and EPA is
issuing a modified final rule.
The commenter stated that the recordkeeping involved to ensure
compliance with the proposed SNUR would hinder the commercial
development of the substance. The commenter proposed several
alternatives. One was a SNUR limiting use to an ingredient in a
photoresist formulation. The second was a SNUR limiting use and
production volume (a 10,000 kilogram (kg) per year production volume
limit was one possibility). The third alternative was a modified PMN
choosing the binding box option for use in part I, section C(2)(a)(3)
of the PMN form with the use designated as ``ingredient in photoresist
formulation.'' The commenter also stated that TSCA section 12(b) export
notification, especially for a formulated product ingredient which will
probably remain confidential, is expected to become a significant
commercial barrier.
EPA rejected the binding box option as the binding box on a PMN
form is not a legally enforceable requirement. While the Agency prefers
to issue performance based regulations that directly address the
potential hazard to human health or the environment such as the release
to surface water designations in the proposed SNUR, EPA can and does
issue SNURs that indirectly limit
[[Page 23679]]
releases based on information in the PMN as well as public comment.
EPA's analysis of uses in photoresist formulations found no
significant releases to surface waters. In addition, the SNUR is
consistent with the existing use of the PMN substance and addresses the
commenter's concerns of customer compliance with the SNUR. Based on
these reasons, EPA is issuing a final SNUR limiting the use of the PMN
substance to an ingredient in a photoresist formulation. Further,
export notification will still apply as TSCA section 12(b) clearly
states that any substance or any formulation containing that substance,
subject to a rule under TSCA section 5 is subject to export
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) of TSCA 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 August 30, 1995, 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
August 30, 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 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
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.
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 this rule. The
Agency's complete economic analysis is available in the public record
for this rule (OPPTS-50622D).
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-50622D (including comments and data submitted
electronically). A public version of the 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 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: April 21, 1998.
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.
2. By adding new Sec. 721.5867 to read as follows:
Sec. 721.5867 Substituted phenol.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance generically
[[Page 23680]]
identified as substituted phenol (PMNs P-89-1125, P-91-87, P-92-41, P-
92-511, P-94-1527, and P-94-1755) 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) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(j) (ingredient in a photoresist
formulation).
(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 (i) 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. 98-11474 Filed 4-29-98; 8:45 am]
BILLING CODE 6560-50-F
