[Federal Register Volume 62, Number 123 (Thursday, June 26, 1997)]
[Proposed Rules]
[Pages 34427-34429]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-16760]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 721
[OPPTS-50622C; FRL-5723-6]
RIN 2070-AB27
Substituted Phenol; 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 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 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 28, 1997.
ADDRESSES: Each comment must bear the docket control number OPPTS-
50622C. All comments should be sent in triplicate to: OPPT Document
Control Officer (7407), Office of Pollution Prevention and Toxics,
Environmental Protection Agency, Rm. ET-G099, 401 M St., SW.,
Washington, DC 20460.
Comments and data may also be submitted electronically by following
the instructions under Unit VIII of this document. No confidential
business information (CBI) should be submitted through e-mail.
All comments which are claimed confidential must be clearly marked
as such. Three additional sanitized copies of any comments containing
CBI must also be submitted. Nonconfidential versions of comments on
this rule will be placed in the rulemaking record and will be available
for public inspection. See Unit VII for further information.
FOR FURTHER INFORMATION CONTACT: Susan 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 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). 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 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 this substance is being
withdrawn elsewhere in this issue of the Federal Register and this
proposed rule on the substance is being issued.
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, subpart E.
PMN Numbers P-89-1125, P-91-87, P-92-41, P-92-511, P-94-1527, and P-94-
1755
Chemical name: Substituted phenol.
CAS number: Not available.
Basis of action: The PMN substance has been the subject of six
different PMN notices. Based on test data on the PMN
[[Page 34428]]
substance and by analogy to phenols. EPA is concerned that toxicity to
aquatic organisms may occur at concentrations as low as 1 parts per
billion (ppb) of the PMN substance in surface waters. EPA determined
that use of the substance as described in several of the PMNs did not
present an unreasonable risk because the substance did not exceed a
concentration of 1 ppb when released to surface waters. The only PMN
where releases over 1 ppb were expected has been withdrawn. EPA has
determined that other uses and increased production volume may result
in relases to surface waters above 1 ppb. Based on this information,
the PMN substance meets the concern criteria at Sec. 721.170(b)(4)(i).
Recommended testing: EPA has determined that an algal acute toxicity
study (40 CFR 797.1050), a chronic 60-day fish early life stage
toxicity test in rainbow trout (40 CFR 797.1600), and a 21-day daphnid
chronic toxicity test (40 CFR 797.1330) would help characterize the
environmental effects of the PMN substance.
CFR citation: 40 CFR 721.5867.
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 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 March 1, 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 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) (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.
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-50622C).
VII. Comments Containing Confidential Business Information
Any person who submits comments containing information claimed as
confidential business information 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
The official record for this rulemaking, as well as the public
version, has been established for this rulemaking under docket number
OPPTS-50622C (including comments and data submitted electronically as
described below). 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.
Electronic comments can be sent directly to EPA at:
oppt.ncic@epamail.epa.gov
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-50622C. Electronic comments on
this proposed rule may be filed online at many Federal Depository
Libraries.
IX. 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 determined
that the promulgation of a SNUR does not have a significant adverse
economic impact on a substantial number of small entities.
[[Page 34429]]
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.
X. 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 materials,
Recordkeeping and reporting requirements.
Dated: June 18, 1997.
Ward Penberthy,
Acting 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. 721.5867 to read as follows:
Sec. 721.5867 Substituted phenol.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance generically 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) Release to water. Requirements as specified in Sec. 721.90
(a)(4), (b)(4), and (c)(4)(where n = 1).
(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. 97-16760 Filed 6-25-97; 8:45 am]
BILLING CODE 6560-50-F
