[Federal Register Volume 62, Number 123 (Thursday, June 26, 1997)]
[Proposed Rules]
[Pages 34424-34427]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-16757]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 721
[OPPTS-50620B; FRL-5723-4]
RIN 2070-AB27
Butanamide, 2,2'-[3'dichloro[1,1'-biphenyl]-4,4'-diyl) bisazobis
N-2,3-dihydro-2-oxo-1H-benximdazol-5-yl)-3-oxo-; 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 butanamide, 2,2'-[3'dichloro[1,1'-
biphenyl]-4,4'-diyl)bisazobis N-2,3-dihydro-2-oxo-1H-benximdazol-5-yl)-
3-oxo- which is the subject of premanufacture notice (PMN) P-93-1111.
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-
50620B. 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
[[Page 34425]]
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 P-93-1111 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 PMN P-93-1111 in the Federal Register of March 1,
1995 (60 FR 11033) (FRL-4868-4). EPA received comments following
publication for this chemical substance. Therefore, as required by
Sec. 721.160, the final SNUR for P-93-1111 is being withdrawn elsewhere
in this issue of the Federal Register and this proposed rule on the
substance is being issued. The commenter stated that one statement
required on the Material Safety Data Sheet (MSDS) and label in the
section 5(e) consent order was not required in the SNUR while several
statements required in the SNUR were not required in the order. EPA has
changed the proposed SNUR so that its hazard communication requirements
match those of the section 5(e) consent order.
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-93-1111
Chemical name: Butanamide, 2,2'-[3'dichloro[1,1'-biphenyl]-4,4'-
diyl)bisazobis N-2,3-dihydro-2-oxo-1H-benximdazol-5-yl)-3-oxo-.
CAS number: 78245-94-0.
Effective date of section 5(e) consent order: May 27, 1994.
Basis for section 5(e) consent order: The order was issued under
section 5 (e)(1)(A)(i) and (e)(1)(A)(ii)(I) of TSCA based on a finding
that this substance may present an unreasonable risk of injury to human
health and the environment.
Toxicity concern: Structurally similar chemicals have been shown to
cause carcinogenicty and mutagenicity in test animals and toxicity to
aquatic organisms.
Recommended testing: The following data are recommended to help
characterize the PMN substance's potential to cause human health and
environmental effects: Monitoring data to detect the presence of
dichlorobenzidine (DCB) under actual conditions of use; monitoring data
to detect airborne concentrations of DCB; monitoring data on releases
of DCB to surface waters. (See Agency guidelines and information on
performing monitoring studies.) Also recommended to help determine the
PMN substance's potential to cause environmental effects: An anaerobic
biodegradation study (OPPTS 835.3400 test guideline (public draft)).
CFR citation: 40 CFR 721.1907.
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 March 1, 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
[[Page 34426]]
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-50620B).
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-50620B (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:
[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-50620B. Electronic comments on
this proposed rule may be filed online at many Federal Depository
Libraries.
The OPPTS harmonized test guidelines referenced in this document
are available on EPA's World Wide Web site under ``Researchers and
Scientists,'' ``Environmental Test Methods & Guidelines'' (http://
www.epa.gov/epahome/research.htm).
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. 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. 721.1907 to read as follows:
Sec. 721.1907 Butanamide, 2,2'-[3'dichloro[1,1'-biphenyl]-4,4'-
diyl)bisazobis N-2,3-dihydro-2-oxo-1H-benximdazol-5-yl)-3-oxo-.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance generically identified as
butanamide, 2,2'-[3'dichloro[1,1'-biphenyl]-4,4'-diyl)bisazobis N-2,3-
dihydro-2-oxo-1H-benximdazol-5-yl)-3-oxo- (PMN P-93-1111) 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), (e), (concentration set at 0.1
percent), (f), (g)(3)(i), (g)(3)(ii), (g)(4)(iii), and (g)(5). The
following
[[Page 34427]]
additional statements shall appear on each label and Material Safety
Data Sheet (MSDS) as specified by the paragraph: This substance
decomposes in polymers or sheet metal coatings at temperatures greater
than 280 deg.C to give 3',3' DCB a suspect human carcinogen.
(ii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(f) and processing or use at temperatures
above 280 deg.C.
(iii) Release to water. Requirements as specified in Sec. 721.90
(b)(1) and (c)(1). When the substance is processed or used as a
colorant for dyeing plastics, this section does not apply.
(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, 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. 97-16757 Filed 6-25-97; 8:45 am]
BILLING CODE 6560-50-F