[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-H[email protected].

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