[Federal Register Volume 63, Number 23 (Wednesday, February 4, 1998)]
[Rules and Regulations]
[Pages 5740-5742]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-2715]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 721
[OPPTS-50620D; FRL-5757-3]
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-; 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 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
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 March 6, 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, 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 and Response to Comments
EPA published a direct final SNUR for the chemical substance, which
was the subject of PMN P-93-1111 and a TSCA section 5(e) consent order
issued by EPA in the Federal Register of March 1, 1995 (60 FR 11033)
(FRL-4868-4). 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-93-1111 was withdrawn
on June 26, 1997 (62 FR 34413) (FRL-5723-3) and a proposed rule on the
substance was issued on June 26, 1997 (62 FR 34424) (FRL-5723-4).
The background and reasons for the SNUR are set forth in the
preamble to the proposed rule. EPA received one comment concerning the
category of substances which is the basis of this rule but not on the
issuance of this specific rule. EPA's response to the comment is
discussed in this document and EPA is issuing the final rule.
The commenter agreed with hazard and risk concerns for release of
3,3'-dichlorobenzidine (DCB) from processing or use of DCB pigments at
high temperatures (greater than 200 degrees centigrade) as described in
the category statement for ``Dichlorobenzidine-based Pigments,'' found
in the document ``TSCA New Chemicals Program (NCP) Chemical
Categories'' (http://www.epa.gov/opptintr/chemcat). The commenter
disagreed with EPA's category statement that pigments containing DCB
may biodegrade in the environment over a period of months. The
commenter stated that diarylide pigments containing DCB have been
extensively tested for breakdown in living organisms and found to
remain intact, that diarylide pigments do not bioaccumulate or
bioconcentrate in organisms, and that there is no evidence for the
biodegradation of diarylide pigments over a period of months. However,
the commenter submitted no data to support the contention concerning
the biodegradation of diaryl pigments.
EPA is neither disputing that DCB pigments are relatively stable
nor
[[Page 5741]]
contending that these pigments bioaccumulate or bioconcentrate in
living organisms. EPA's concern for substances that fall within this
category are based solely on the potential release, toxicity, and
bioaccumulation of DCB. As stated in the category statement and the
section 5(e) consent order for P-93-1111, EPA is concerned for the
potential anaerobic biodegradation of these types of pigments if they
reach sediments. EPA does not have data that indicate these substances
do not biodegrade in the environment over a period of months. If any
currently ongoing or unpublished anaerobic or natural sediment
biodegradation studies can address this issue, EPA encourages the
commenter to submit these data. While EPA does not expect any
significant anaerobic biodegradation of DCB pigments under typical
conditions of processing, use, and disposal (as permitted under the
terms of the TSCA section 5(e) consent order and SNUR), it is
appropriate and reasonable to identify testing that would address
potential risks to human health and the environment in the event of
more widespread use and greater production volume, and consequently
greater potential for release of and exposure to this (or other) DCB
based pigments. This is especially prudent when considering the
significant cancer potency of 3,3'-dichlorobenzidine. Although the
existence of a category for DCB-based pigments does not represent a
policy of regulation for such substances per se, EPA will continue to
evaluate the potential risk for these types of PMN substances based on
all relevant use, exposure, and environmental release information
available at the time of the PMN submission.
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 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 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, importers, and
processors 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-50620D).
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-50620D (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 Non Confidential Information Center, Rm. NE-B607, 401 M St.,
SW., Washington, DC 20460.
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.
[[Page 5742]]
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: January 23, 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(c).
2. By adding new Sec. 721.1907 to subpart E 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
additional statements shall appear on each label and Material Safety
Data Sheet (MSDS) as specified by this 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. 98-2715 Filed 2-3-98; 8:45 am]
BILLING CODE 6560-50-F
