[Federal Register Volume 77, Number 245 (Thursday, December 20, 2012)]
[Rules and Regulations]
[Pages 75390-75399]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-30695]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Parts 9 and 721
[EPA-HQ-OPPT-2012-0842; FRL-9372-8]
RIN 2070-AB27
Significant New Use Rules on Certain Chemical Substances
AGENCY: Environmental Protection Agency (EPA).
ACTION: Direct final rule.
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SUMMARY: EPA is promulgating significant new use rules (SNURs) under
[[Page 75391]]
the Toxic Substances Control Act (TSCA) for 9 chemical substances which
were the subject of premanufacture notices (PMNs). This action requires
persons who intend to manufacture, import, or process any of these 9
chemical substances for an activity that is designated as a significant
new use by this rule to notify EPA at least 90 days before commencing
that activity. The required notification will provide EPA with the
opportunity to evaluate the intended use and, if necessary, to prohibit
or limit that activity before it occurs.
DATES: This rule is effective on February 19, 2013. For purposes of
judicial review, this rule shall be promulgated at 1 p.m. (e.s.t.) on
January 3, 2013.
Written adverse or critical comments, or notice of intent to submit
adverse or critical comments, on one or more of these SNURs must be
received on or before January 22, 2013 (see Unit VI. of the
SUPPLEMENTARY INFORMATION). If adverse comment is received, EPA will
publish a timely withdrawal of the rule in the Federal Register.
For additional information on related reporting requirement dates,
see Units I.A., VI., and VII. of the SUPPLEMENTARY INFORMATION.
ADDRESSES: Submit your comments, identified by docket identification
(ID) number EPA-HQ-OPPT-2012-0842, by one of the following methods:
Federal eRulemaking Portal: http://www.regulations.gov.
Follow the online instructions for submitting comments.
Mail: Document Control Office (7407M), Office of Pollution
Prevention and Toxics (OPPT), Environmental Protection Agency, 1200
Pennsylvania Ave. NW., Washington, DC 20460-0001.
Hand Delivery: OPPT Document Control Office (DCO), EPA
East Bldg., Rm. 6428, 1201 Constitution Ave. NW., Washington, DC, ATTN:
Docket ID Number EPA-HQ-OPPT-2012-0842. The DCO is open from 8 a.m. to
4 p.m., Monday through Friday, excluding legal holidays. The telephone
number for the DCO is (202) 564-8930. Such deliveries are only accepted
during the DCO's normal hours of operation, and special arrangements
should be made for deliveries of boxed information.
Instructions: Direct your comments to docket ID number EPA-HQ-OPPT-
2012-0842. EPA's policy is that all comments received will be included
in the docket without change and may be made available online at http://www.regulations.gov, including any personal information provided,
unless the comment includes information claimed to be Confidential
Business Information (CBI) or other information whose disclosure is
restricted by statute. Do not submit information that you consider to
be CBI or otherwise protected through regulations.gov or email. The
regulations.gov Web site is an ``anonymous access'' system, which means
EPA will not know your identity or contact information unless you
provide it in the body of your comment. If you send an email comment
directly to EPA without going through regulations.gov, your email
address will be automatically captured and included as part of the
comment that is placed in the docket and made available on the
Internet. If you submit an electronic comment, EPA recommends that you
include your name and other contact information in the body of your
comment and with any disk or CD-ROM you submit. If EPA cannot read your
comment due to technical difficulties and cannot contact you for
clarification, EPA may not be able to consider your comment. Electronic
files should avoid the use of special characters, any form of
encryption, and be free of any defects or viruses.
Docket: All documents in the docket are listed in the docket index
available at http://www.regulations.gov. Although listed in the index,
some information is not publicly available, e.g., CBI or other
information whose disclosure is restricted by statute. Certain other
material, such as copyrighted material, will be publicly available only
in hard copy. Publicly available docket materials are available
electronically at http://www.regulations.gov, or, if only available in
hard copy, at the OPPT Docket. The OPPT Docket is located in the EPA
Docket Center (EPA/DC) at Rm. 3334, EPA West Bldg., 1301 Constitution
Ave. NW., Washington, DC. The EPA/DC Public Reading Room hours of
operation are 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding
legal holidays. The telephone number of the EPA/DC Public Reading Room
is (202) 566-1744, and the telephone number for the OPPT Docket is
(202) 566-0280. Docket visitors are required to show photographic
identification, pass through a metal detector, and sign the EPA visitor
log. All visitor bags are processed through an X-ray machine and
subject to search. Visitors will be provided an EPA/DC badge that must
be visible at all times in the building and returned upon departure.
FOR FURTHER INFORMATION CONTACT:
For technical information contact: Kenneth Moss, Chemical Control
Division (7405M), Office of Pollution Prevention and Toxics,
Environmental Protection Agency, 1200 Pennsylvania Ave. NW.,
Washington, DC 20460-0001; telephone number: (202) 564-9232; email
address: [email protected].
For general information contact: The TSCA-Hotline, ABVI-Goodwill,
422 South Clinton Ave., Rochester, NY 14620; telephone number: (202)
554-1404; email address: [email protected].
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this action apply to me?
You may be potentially affected by this action if you manufacture,
import, process, or use the chemical substances contained in this rule.
The following list of North American Industrial Classification System
(NAICS) codes is not intended to be exhaustive, but rather provides a
guide to help readers determine whether this document applies to them.
Potentially affected entities may include:
Manufacturers, importers, or processors of one or more
subject chemical substances (NAICS codes 325 and 324110), e.g.,
chemical manufacturing and petroleum refineries.
This action may also affect certain entities through pre-existing
import certification and export notification rules under TSCA. Chemical
importers are subject to the TSCA section 13 (15 U.S.C. 2612) import
certification requirements promulgated at 19 CFR 12.118 through 12.127
and 19 CFR 127.28. Chemical importers must certify that the shipment of
the chemical substance complies with all applicable rules and orders
under TSCA. Importers of chemicals subject to these SNURs must certify
their compliance with the SNUR requirements. The EPA policy in support
of import certification appears at 40 CFR part 707, subpart B. In
addition, any persons who export or intend to export a chemical
substance that is the subject of this rule on or after January 22, 2013
are subject to the export notification provisions of TSCA section 12(b)
(15 U.S.C. 2611(b)) (see Sec. 721.20), and must comply with the export
notification requirements in 40 CFR part 707, subpart D.
B. What should I consider as I prepare my comments for EPA?
1. Submitting CBI. Do not submit this information to EPA through
regulations.gov or email. Clearly mark the part or all of the
information that you claim to be CBI. For CBI information in a disk or
CD-ROM that you mail to EPA, mark the outside of the disk or CD-ROM as
CBI and then identify electronically within the disk or CD-ROM the
specific information that is claimed as CBI. In addition to one
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complete version of the comment that includes information claimed as
CBI, a copy of the comment that does not contain the information
claimed as CBI must be submitted for inclusion in the public docket.
Information so marked will not be disclosed except in accordance with
procedures set forth in 40 CFR part 2.
2. Tips for preparing your comments. When submitting comments,
remember to:
i. Identify the document by docket ID number and other identifying
information (subject heading, Federal Register date and page number).
ii. Follow directions. The Agency may ask you to respond to
specific questions or organize comments by referencing a Code of
Federal Regulations (CFR) part or section number.
iii. Explain why you agree or disagree; suggest alternatives and
substitute language for your requested changes.
iv. Describe any assumptions and provide any technical information
and/or data that you used.
v. If you estimate potential costs or burdens, explain how you
arrived at your estimate in sufficient detail to allow for it to be
reproduced.
vi. Provide specific examples to illustrate your concerns and
suggest alternatives.
vii. Explain your views as clearly as possible, avoiding the use of
profanity or personal threats.
viii. Make sure to submit your comments by the comment period
deadline identified.
II. Background
A. What action is the agency taking?
EPA is promulgating these SNURs using direct final procedures.
These SNURs will require persons to notify EPA at least 90 days before
commencing the manufacture, import, or processing of a chemical
substance for any activity designated by these SNURs as a significant
new use. Receipt of such notices allows EPA to assess risks that may be
presented by the intended uses and, if appropriate, to regulate the
proposed use before it occurs. Additional rationale and background to
these rules are more fully set out in the preamble to EPA's first
direct final SNUR published in the Federal Register issue of April 24,
1990 (55 FR 17376) (April 24, 1990 SNUR). Consult that preamble for
further information on the objectives, rationale, and procedures for
SNURs and on the basis for significant new use designations, including
provisions for developing test data.
B. What is the agency's authority for taking this action?
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 the four bulleted TSCA section 5(a)(2)
factors listed in Unit III. Once EPA determines that a use of a
chemical substance is a significant new use, TSCA section 5(a)(1)(B)
requires persons to submit a significant new use notice (SNUN) to EPA
at least 90 days before they manufacture, import, or process the
chemical substance for that use. Persons who must report are described
in Sec. 721.5.
C. Applicability of General Provisions
General provisions for SNURs appear in 40 CFR part 721, subpart A.
These provisions describe persons subject to the rule, recordkeeping
requirements, exemptions to reporting requirements, and applicability
of the rule to uses occurring before the effective date of the rule.
Provisions relating to user fees appear at 40 CFR part 700. According
to Sec. 721.1(c), persons subject to these SNURs must comply with the
same SNUN requirements and EPA regulatory procedures as submitters of
PMNs under TSCA section 5(a)(1)(A). In particular, these requirements
include the information submission requirements of TSCA section 5(b)
and 5(d)(1), the exemptions authorized by TSCA section 5(h)(1), (h)(2),
(h)(3), and (h)(5), and the regulations at 40 CFR part 720. Once EPA
receives a SNUN, EPA may take regulatory action under TSCA section
5(e), 5(f), 6, or 7 to control the activities for which it has received
the SNUN. If EPA does not take action, EPA is required under TSCA
section 5(g) to explain in the Federal Register its reasons for not
taking action.
III. Significant New Use Determination
Section 5(a)(2) of TSCA states that EPA's determination that a use
of a chemical substance is a significant new use must be made after
consideration of all relevant factors, including:
The projected volume of manufacturing and processing of a
chemical substance.
The extent to which a use changes the type or form of
exposure of human beings or the environment to a chemical substance.
The extent to which a use increases the magnitude and
duration of exposure of human beings or the environment to a chemical
substance.
The reasonably anticipated manner and methods of
manufacturing, processing, distribution in commerce, and disposal of a
chemical substance.
In addition to these factors enumerated in TSCA section 5(a)(2),
the statute authorized EPA to consider any other relevant factors.
To determine what would constitute a significant new use for the 9
chemical substances that are the subject of these SNURs, EPA considered
relevant information about the toxicity of the chemical substances,
likely human exposures and environmental releases associated with
possible uses, and the four bulleted TSCA section 5(a)(2) factors
listed in this unit.
IV. Substances Subject to This Rule
EPA is establishing significant new use and recordkeeping
requirements for 9 chemical substances in 40 CFR part 721, subpart E.
In this unit, EPA provides the following information for each chemical
substance:
PMN number.
Chemical name (generic name, if the specific name is
claimed as CBI).
Chemical Abstracts Service (CAS) Registry number (if
assigned for non-confidential chemical identities).
Basis for the SNUR.
Toxicity concerns.
Tests recommended by EPA to provide sufficient information
to evaluate the chemical substance (see Unit VIII. for more
information).
CFR citation assigned in the regulatory text section of
this rule.
The regulatory text section of this rule specifies the activities
designated as significant new uses. Certain new uses, including
production volume limits (i.e., limits on manufacture and importation
volume) and other uses designated in this rule, may be claimed as CBI.
Unit IX. discusses a procedure companies may use to ascertain whether a
proposed use constitutes a significant new use.
This rule includes SNURs on 9 PMN substances that are not subject
to consent orders under TSCA section 5(e). In these cases, for a
variety of reasons, EPA did not find that the use scenario described in
the PMN triggered the determinations set forth under TSCA section 5(e).
However, EPA does believe that certain changes from the use scenario
described in the PMN could result in increased exposures, thereby
constituting a ``significant new use.'' These so-called ``non-5(e)
SNURs'' are promulgated pursuant to Sec. 721.170. EPA has determined
that every activity designated as a ``significant new use'' in all non-
5(e) SNURs issued under Sec. 721.170 satisfies the two requirements
stipulated in Sec. 721.170(c)(2), i.e., these significant new use
activities, ``(i) are
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different from those described in the premanufacture notice for the
substance, including any amendments, deletions, and additions of
activities to the premanufacture notice, and (ii) may be accompanied by
changes in exposure or release levels that are significant in relation
to the health or environmental concerns identified'' for the PMN
substance.
PMN Number P-09-107
Chemical name: Fatty acids, tall-oil, reaction products with
modified fatty acids and polyalkanolamines (generic).
CAS number: Not available.
Basis for action: The PMN states that the generic (non-
confidential) use of the substance is as an asphalt emulsifier. Based
on test data on the PMN substance, and ecological structural activity
relationships (EcoSAR) analysis of test data on analogous aliphatic
amines, EPA predicts toxicity to aquatic organisms may occur at
concentrations that exceed 110 parts per billion (ppb) of the PMN
substance in surface waters. As described in the PMN, releases of the
PMN substance are not expected to result in surface water
concentrations that exceed 110 ppb. Therefore, EPA has not determined
that the proposed manufacturing, processing, or use of the substance
may present an unreasonable risk. EPA has determined, however, that any
use of the substance resulting in surface water concentrations
exceeding 110 ppb may cause significant adverse environmental effects.
Based on this information, the PMN substance meets the concern criteria
at Sec. 721.170(b)(4)(i) and (b)(4)(ii).
Recommended testing: EPA has determined that the results of a fish
early-life stage toxicity test (OPPTS Test Guideline 850.1400) and a
daphnid chronic toxicity test (OPPTS Test Guideline 850.1300) would
help characterize the environmental effects of the PMN substance.
CFR citation: 40 CFR 721.10629.
PMN Numbers P-11-619 and P-11-620
Chemical name: Amino acid, carboxyalkyl, alkylsulfonate, alkali
salts (generic).
CAS number: Not available.
Basis for action: The consolidated PMN states that the generic
(non-confidential) use of the substances will be as an industrial
cleaning solution component. Based on test data on the PMN substances
and EcoSAR analysis of test data on analogous polyanionic monomers, EPA
predicts toxicity to aquatic organisms may occur at concentrations that
exceed 770 ppb for the aggregate of the PMN substances in surface
waters. As described in the PMN, releases to surface waters are not
expected to exceed 770 ppb for the aggregate of the PMN substances.
Therefore, EPA has not determined that the proposed manufacturing or
use of the substances may present an unreasonable risk. EPA has
determined, however, that any use of the substances resulting in
surface water concentrations exceeding 770 ppb for the aggregate of the
PMN substances may cause significant adverse environmental effects.
Based on this information, the PMN substances meet the concern criteria
at Sec. 721.170(b)(4)(ii).
Recommended testing: EPA has determined that the results of an
algal toxicity test (OCSPP Test Guideline 850.4500) would help
characterize the environmental effects of the PMN substances.
CFR citation: 40 CFR 721.10630.
PMN Number P-12-64
Chemical name: Mixed metal borate (generic).
CAS number: Not available.
Basis for action: The PMN states that the generic (non-
confidential) use of the substance will be as an illuminating phosphor.
Based on test data on analogous respirable, poorly soluble
particulates, EPA identified concerns for lung overload and
oncogenicity to workers exposed to the PMN substance. At the production
volume described in the PMN, and because the uses described in the PMN
do not use an application method that generates a vapor, mist, aerosol,
or dust significant worker exposure is minimal. Therefore, EPA has not
determined that the proposed manufacturing, processing, or use of the
substance may present an unreasonable risk. EPA has determined,
however, that any use of the substance exceeding the confidential
annual manufacture and import volume stated in the PMN or any use of
the substance using an application method that generates a vapor, mist,
aerosol, or dust may cause serious health effects. Based on this
information, the PMN substance meets the concern criteria at Sec.
721.170(b)(1)(i)(C) and (b)(3)(ii).
Recommended testing: EPA has determined that the results of a 90-
day inhalation toxicity test (OPPTS Guidelines 870.3465) with a 60-day
holding period; dry particle size distribution/counting by transmission
electron microscope (TEM) or scanning electron microscopy (SEM)
methods; and images of the powder for morphology would help
characterize the human health effects of the PMN substance.
CFR citation: 40 CFR 721.10631.
PMN Number P-12-181
Chemical name: Benzamide, N-[(cyclohexylamino)thioxomethyl]-.
CAS number: 4921-92-0.
Basis for action: The PMN states that the use of the substance is
as a cure initiator in adhesive formulations. Based on analysis of test
data on analogous thioureas, EPA identified concerns for thyroid
toxicity, developmental toxicity, and developmental neurotoxicity to
the general population exposed to the PMN substance. Based on EcoSAR
analysis of test data on analogous imides and thioureas, EPA predicts
toxicity to aquatic organisms may occur at concentrations that exceed 2
ppb of the PMN substance in surface waters. For the uses described in
the PMN, significant general population exposure is unlikely, as use in
consumer product is not expected and releases of the PMN substance are
not expected to result in surface water concentrations that exceed 2
ppb. Therefore, EPA has not determined that the proposed manufacturing,
processing, or use of the substance may present an unreasonable risk.
EPA has determined, however, that any use of the substance in consumer
products or use of the substance resulting in surface water
concentrations exceeding 2 ppb may cause serious health effects or
significant adverse environmental effects. Based on this information,
the PMN substance meets the concern criteria at Sec.
721.170(b)(1)(i)(C), (b)(3)(ii), and (b)(4)(ii).
Recommended testing: EPA has determined that the results of an
aquatic invertebrate acute toxicity test, freshwater daphnids (OPPTS
Test Guideline 850.1010); fish acute toxicity test, freshwater and
marine (OPPTS Test Guideline 850.1075); algal toxicity test (OCSPP Test
Guideline 850.4500); and a combined repeated dose toxicity with the
reproduction/developmental toxicity screening test (OPPTS Test
Guideline 870.3650) would help characterize the environmental and
health effects of the PMN substance.
CFR citation: 40 CFR 721.10632.
PMN Number P-12-276
Chemical name: Aromatic sulfonic acid amino azo dye salts
(generic).
CAS number: Not available.
Basis for action: The PMN states that the generic use of the PMN
substance will be in exhaust dyeing of cellulosic fabrics. Based on the
alkylation potential of the PMN substance, there are concerns for skin
and lung sensitization; mutagenicity; oncogenicity; and developmental,
liver,
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and kidney toxicities. In addition, there are concerns for mutagenicity
and oncogenicity, based on the beta-aromatic azo reduction product, as
this PMN substance is expected to undergo azo reduction in the GI tract
with good absorption potential of the reduction products. As described
in the PMN, EPA does not expect significant exposure to workers.
Therefore, EPA has not determined that the proposed manufacturing,
processing, or use of the substance may present an unreasonable risk.
EPA has determined, however, that any use of the substance without the
use of a NIOSH-certified M100 respirator with an APF of 10 or any
increase in the annual manufacture and import volume of 10,000
kilograms (kgs) of the substance, could change the potential for
exposure correspondingly, and may result in serious health effects.
Based on this information, the PMN substance meets the concern criteria
at Sec. 721.170(b)(1)(i)(c) and (b)(3)(ii).
Recommended testing: EPA has determined that results of an Ames
test with the Prival modification (OPPTS Test Guideline 870.5100), and
an unscheduled DNA synthesis test in mammalian cells in culture (OPPTS
Test Guideline 870.5550) would help characterize the health effects of
the PMN substance. The test material for the unscheduled DNA synthesis
test must be the specific sulfonated beta-aromatic amine that would
result from the azo reduction of the PMN substance, rather than the
intact PMN compound. It is necessary that the specific sulfonated-
aromatic amine in question be isolated prior to testing. For both
tests, the beta-aromatic amine is to serve as an additional positive
control.
CFR citation: 40 CFR 721.10633.
PMN Number P-12-464
Chemical name: Iodonium, diphenyl-, 4,4'-di-C10-13-alkyl derivs.,
(OC-6-11)-hexafluoroantimonates(1-).
CAS number: 1370442-66-2.
Basis for action: The PMN states that the substance will be used as
a photoinitiator used for ultraviolet release coatings. Based on the
EcoSAR analysis of test data on analogous cationic surfactants, EPA
predicts toxicity to aquatic organisms may occur at concentrations that
exceed 8 ppb of the PMN substance in surface waters for greater than 20
days per year. This 20-day criterion is derived from partial life cycle
tests (daphnid chronic and fish early-life stage tests) that typically
range from 21 to 28 days in duration. EPA predicts toxicity to aquatic
organisms may occur if releases of the PMN substance to surface water
exceed releases from the use described in the PMN. For the use
described in the PMN, environmental releases did not exceed 8 ppb for
more than 20 days per year. Therefore, EPA has not determined that the
proposed manufacturing, processing, or use of the substance may present
an unreasonable risk. EPA has determined, however, that use of the
substance other than as described in the PMN could result in exposures
which may cause significant adverse environmental effects. Based on
this information, the PMN substance meets the concern criteria at Sec.
721.170(b)(4)(ii).
Recommended testing: EPA has determined that a fish early-life
stage toxicity test (OPPTS Test Guideline 850.1400); a daphnid chronic
toxicity test (OPPTS Test Guideline 850.1300); and an algal toxicity
test (OCSPP Test Guideline 850.4500) would help characterize the
environmental effects of the PMN substance. When testing the PMN
substance, if difficulty is encountered in dissolving the chemical in
the test media, the submitter may wish to consult the special
considerations for conducting aquatic laboratory studies (OPPTS Test
Guideline 850.1000).
CFR citation: 40 CFR 721.10634.
PMN Number P-12-480
Chemical name: Alkyl maleimide substituted bicyclic olefin
(generic).
CAS number: Not available.
Basis for action: The PMN states that substance will be used as a
monomer in the manufacture of a specialty polymer. Based on EcoSAR
analysis of test data on analogous imides, EPA predicts toxicity to
aquatic organisms may occur at concentrations that exceed 1 ppb of the
PMN substance in surface waters. As described in the PMN, releases of
the PMN substance are not expected to result in surface water
concentrations that exceed 1 ppb. Therefore, EPA has not determined
that the proposed manufacturing, processing, or use of the substance
may present an unreasonable risk. EPA has determined, however, that any
use of the substance resulting in surface water concentrations
exceeding 1 ppb may cause significant adverse environmental effects.
Based on this information, the PMN substance meets the concern criteria
at Sec. 721.170(b)(4)(ii).
Recommended testing: EPA has determined that an aquatic
invertebrate acute toxicity test, freshwater daphnids (OPPTS Test
Guideline 850.1010); a fish acute toxicity test, freshwater and marine
(OPPTS Test Guideline 850.1075); and an algal toxicity test (OCSPP Test
Guideline 850.4500) would help characterize the environmental effects
of the PMN substance. When testing the PMN substance, if difficulty is
encountered in dissolving the chemical in the test media, the submitter
may wish to consult the special considerations for conducting aquatic
laboratory studies (OPPTS Test Guideline 850.1000).
CFR citation: 40 CFR 721.10635.
PMN Number P-12-501
Chemical name: Slimes and sludges, automotive coating, wastewater
treatment, solid waste.
CAS number: 1392095-50-9.
Chemical substance definition: The waste solids produced from the
treatment of wastewaters from automotive pretreatment processes,
electro-deposition coating processes, surface coating processes and
topcoat coating processes. It may contain oxides of iron, calcium,
aluminum, zinc, nickel, and magnesium.
Basis for action: The PMN substance will be used as a feedstock
replacement in cement kiln production. Based on analogous crystalline
chemical substances, EPA identified concerns for potential
oncogenicity. These concerns are for effects to workers from inhalation
exposure to the PMN substance in powder form. For the uses described in
the PMN, significant worker exposure is unlikely, as inhalation
exposure is not expected. Therefore, EPA has not determined that the
proposed manufacturing, processing, or use of the substance may present
an unreasonable risk. EPA has determined, however, that the
manufacture, processing, or use of the substance in powder form may
cause serious health effects. Based on this information, the PMN
substance meets the concern criteria at Sec. 721.170(b)(1)(i)(C).
Recommended testing: EPA has determined that the results of a 90-
day inhalation toxicity test (OPPTS Test Guideline 870.3465) would help
characterize the human health effects of the PMN substance. Test should
be conducted with special attention to histopathology (inflammation and
cell proliferation) of the lung tissues and to various parameters of
the bronchoalveolar lavage fluid (BALF), e.g., marker enzyme
activities, total protein content, total cell count, cell differential,
and cell viability. It is not necessary to look at internal organs. A
recovery period of 60 days should be included to assess the progression
or regression of any lesions. If the results of the 90-day inhalation
toxicity test indicate that the PMN particles have carcinogenic
potential, a 2-year
[[Page 75395]]
inhalation bioassay in rats may be warranted.
CFR citation: 40 CFR 721.10636.
V. Rationale and Objectives of the Rule
A. Rationale
In these 9 cases, EPA determined that one or more of the criteria
of concern established at Sec. [emsp14]721.170 were met, as discussed
in Unit IV.
B. Objectives
EPA is issuing these SNURs for specific chemical substances which
have undergone premanufacture review because the Agency wants to
achieve the following objectives with regard to the significant new
uses designated in this rule:
EPA will receive notice of any person's intent to
manufacture, import, or process a listed chemical substance for the
described significant new use before that activity begins.
EPA will have an opportunity to review and evaluate data
submitted in a SNUN before the notice submitter begins manufacturing,
importing, or processing a listed chemical substance for the described
significant new use.
EPA will be able to regulate prospective manufacturers,
importers, or processors of a listed chemical substance before the
described significant new use of that chemical substance occurs,
provided that regulation is warranted pursuant to TSCA sections 5(e),
5(f), 6, or 7.
Issuance of a SNUR for a chemical substance does not signify that
the chemical substance is listed on the TSCA Chemical Substance
Inventory (TSCA Inventory). Guidance on how to determine if a chemical
substance is on the TSCA Inventory is available on the Internet at
http://www.epa.gov/opptintr/existingchemicals/pubs/tscainventory/index.html.
VI. Direct Final Procedures
EPA is issuing these SNURs as a direct final rule, as described in
Sec. 721.160(c)(3) and Sec. 721.170(d)(4). In accordance with Sec.
721.160(c)(3)(ii) and Sec. 721.170(d)(4)(i)(B), the effective date of
this rule is February 19, 2013 without further notice, unless EPA
receives written adverse or critical comments, or notice of intent to
submit adverse or critical comments before January 22, 2013.
If EPA receives written adverse or critical comments, or notice of
intent to submit adverse or critical comments, on one or more of these
SNURs before January 22, 2013, EPA will withdraw the relevant sections
of this direct final rule before its effective date. EPA will then
issue a proposed SNUR for the chemical substance(s) on which adverse or
critical comments were received, providing a 30-day period for public
comment.
This rule establishes SNURs for a number of chemical substances.
Any person who submits adverse or critical comments, or notice of
intent to submit adverse or critical comments, must identify the
chemical substance and the new use to which it applies. EPA will not
withdraw a SNUR for a chemical substance not identified in the comment.
VII. Applicability of Rule to Uses Occurring Before Effective Date of
the Rule
Significant new use designations for a chemical substance are
legally established as of the date of publication of this direct final
rule, December 20, 2012.
To establish a significant ``new'' use, EPA must determine that the
use is not ongoing. The chemical substances subject to this rule have
undergone premanufacture review. In cases where EPA has not received a
notice of commencement (NOC) and the chemical substance has not been
added to the TSCA Inventory, no other person may commence such
activities without first submitting a PMN. For chemical substances for
which an NOC has not been submitted at this time, EPA concludes that
the uses are not ongoing. However, EPA recognizes that prior to the
effective date of the rule, when chemical substances identified in this
SNUR are added to the TSCA Inventory, other persons may engage in a
significant new use as defined in this rule before the effective date
of the rule. However, 6 of the 9 chemical substances contained in this
rule have CBI chemical identities, and since EPA has received a limited
number of post-PMN bona fide submissions (per Sec. Sec. 720.25 and
721.11), the Agency believes that it is highly unlikely that any of the
significant new uses described in the regulatory text of this rule are
ongoing.
As discussed in the April 24, 1990 SNUR, EPA has decided that the
intent of TSCA section 5(a)(1)(B) is best served by designating a use
as a significant new use as of the date of publication of this direct
final rule rather than as of the effective date of the rule. If uses
begun after publication were considered ongoing rather than new, it
would be difficult for EPA to establish SNUR notification requirements
because a person could defeat the SNUR by initiating the significant
new use before the rule became effective, and then argue that the use
was ongoing before the effective date of the rule. Thus, persons who
begin commercial manufacture, import, or processing of the chemical
substances regulated through this SNUR will have to cease any such
activity before the effective date of this rule. To resume their
activities, these persons would have to comply with all applicable SNUR
notification requirements and wait until the notice review period,
including any extensions expires.
EPA has promulgated provisions to allow persons to comply with this
SNUR before the effective date. If a person meets the conditions of
advance compliance under Sec. 721.45(h), the person is considered
exempt from the requirements of the SNUR.
VIII. Test Data and Other Information
EPA recognizes that TSCA section 5 does not require developing any
particular test data before submission of a SNUN. The two exceptions
are:
1. Development of test data is required where the chemical
substance subject to the SNUR is also subject to a test rule under TSCA
section 4 (see TSCA section 5(b)(1)).
2. Development of test data may be necessary where the chemical
substance has been listed under TSCA section 5(b)(4) (see TSCA section
5(b)(2)).
In the absence of a TSCA section 4 test rule or a TSCA section
5(b)(4) listing covering the chemical substance, persons are required
only to submit test data in their possession or control and to describe
any other data known to or reasonably ascertainable by them (see Sec.
720.50). However, upon review of PMNs and SNUNs, the Agency has the
authority to require appropriate testing. Unit IV. lists recommended
testing for non-5(e) SNURs. Descriptions of tests are provided for
informational purposes. EPA strongly encourages persons, before
performing any testing, to consult with the Agency pertaining to
protocol selection. To access the OCSPP test guidelines referenced in
this document electronically, please go to http://www.epa.gov/ocspp and
select ``Test Methods and Guidelines.''
The recommended tests specified in Unit IV. may not be the only
means of addressing the potential risks of the chemical substance.
However, submitting a SNUN without any test data may increase the
likelihood that EPA will take action under TSCA section 5(e),
particularly if satisfactory test results have not been obtained from a
prior PMN or SNUN submitter. EPA recommends that potential SNUN
submitters contact EPA early enough so that they will be able to
conduct the appropriate tests.
[[Page 75396]]
SNUN submitters should be aware that EPA will be better able to
evaluate SNUNs which provide detailed information on the following:
Human exposure and environmental release that may result
from the significant new use of the chemical substances.
Potential benefits of the chemical substances.
Information on risks posed by the chemical substances
compared to risks posed by potential substitutes.
IX. Procedural Determinations
By this rule, EPA is establishing certain significant new uses
which have been claimed as CBI subject to Agency confidentiality
regulations at 40 CFR part 2 and 40 CFR part 720, subpart E. Absent a
final determination or other disposition of the confidentiality claim
under 40 CFR part 2 procedures, EPA is required to keep this
information confidential. EPA promulgated a procedure to deal with the
situation where a specific significant new use is CBI, at 40 CFR
721.1725(b)(1).
Under these procedures a manufacturer, importer, or processor may
request EPA to determine whether a proposed use would be a significant
new use under the rule. The manufacturer, importer, or processor must
show that it has a bona fide intent to manufacture, import, or process
the chemical substance and must identify the specific use for which it
intends to manufacture, import, or process the chemical substance. If
EPA concludes that the person has shown a bona fide intent to
manufacture, import, or process the chemical substance, EPA will tell
the person whether the use identified in the bona fide submission would
be a significant new use under the rule. Since most of the chemical
identities of the chemical substances subject to these SNURs are also
CBI, manufacturers, importers, and processors can combine the bona fide
submission under the procedure in Sec. 721.1725(b)(1) with that under
Sec. 721.11 into a single step.
If EPA determines that the use identified in the bona fide
submission would not be a significant new use, i.e., the use does not
meet the criteria specified in the rule for a significant new use, that
person can manufacture, import, or process the chemical substance so
long as the significant new use trigger is not met. In the case of a
production volume trigger, this means that the aggregate annual
production volume does not exceed that identified in the bona fide
submission to EPA. Because of confidentiality concerns, EPA does not
typically disclose the actual production volume that constitutes the
use trigger. Thus, if the person later intends to exceed that volume, a
new bona fide submission would be necessary to determine whether that
higher volume would be a significant new use.
X. SNUN Submissions
According to Sec. 721.1(c), persons submitting a SNUN must comply
with the same notification requirements and EPA regulatory procedures
as persons submitting a PMN, including submission of test data on
health and environmental effects as described in Sec. 720.50. SNUNs
must be submitted on EPA Form No. 7710-25, generated using e-PMN
software, and submitted to the Agency in accordance with the procedures
set forth in Sec. Sec. 721.25 and 720.40. E-PMN software is available
electronically at http://www.epa.gov/opptintr/newchems.
XI. Economic Analysis
EPA has evaluated the potential costs of establishing SNUN
requirements for potential manufacturers, importers, and processors of
the chemical substances subject to this rule. EPA's complete economic
analysis is available in the docket under docket ID number EPA-HQ-OPPT-
2012-0842.
XII. Statutory and Executive Order Reviews
A. Executive Order 12866
This rule establishes SNURs for several new chemical substances
that were the subject of PMNs. The Office of Management and Budget
(OMB) has exempted these types of actions from review under Executive
Order 12866, entitled ``Regulatory Planning and Review'' (58 FR 51735,
October 4, 1993).
B. Paperwork Reduction Act (PRA)
According to PRA (44 U.S.C. 3501 et seq.), an agency may not
conduct or sponsor, and a person is not required to respond to a
collection of information that requires OMB approval under PRA, unless
it has been approved by OMB and displays a currently valid OMB control
number. The OMB control numbers for EPA's regulations in title 40 of
the CFR, after appearing in the Federal Register, are listed in 40 CFR
part 9, and included on the related collection instrument or form, if
applicable. EPA is amending the table in 40 CFR part 9 to list the OMB
approval number for the information collection requirements contained
in this rule. This listing of the OMB control numbers and their
subsequent codification in the CFR satisfies the display requirements
of PRA and OMB's implementing regulations at 5 CFR part 1320. This
Information Collection Request (ICR) was previously subject to public
notice and comment prior to OMB approval, and given the technical
nature of the table, EPA finds that further notice and comment to amend
it is unnecessary. As a result, EPA finds that there is ``good cause''
under section 553(b)(3)(B) of the Administrative Procedure Act (5
U.S.C. 553(b)(3)(B)) to amend this table without further notice and
comment.
The information collection requirements related to this action have
already been approved by OMB pursuant to PRA under OMB control number
2070-0012 (EPA ICR No. 574). This action does not impose any burden
requiring additional OMB approval. If an entity were to submit a SNUN
to the Agency, the annual burden is estimated to average between 30 and
170 hours per response. This burden estimate includes the time needed
to review instructions, search existing data sources, gather and
maintain the data needed, and complete, review, and submit the required
SNUN.
Send any comments about the accuracy of the burden estimate, and
any suggested methods for minimizing respondent burden, including
through the use of automated collection techniques, to the Director,
Collection Strategies Division, Office of Environmental Information
(2822T), Environmental Protection Agency, 1200 Pennsylvania Ave. NW.,
Washington, DC 20460-0001. Please remember to include the OMB control
number in any correspondence, but do not submit any completed forms to
this address.
C. Regulatory Flexibility Act (RAF)
On February 18, 2012, EPA certified pursuant to RFA section 605(b)
(5 U.S.C. 601 et seq.), that promulgation of a SNUR does not have a
significant economic impact on a substantial number of small entities
where the following are true:
1. A significant number of SNUNs would not be submitted by small
entities in response to the SNUR.
2. The SNUR submitted by any small entity would not cost
significantly more than $8,300.
A copy of that certification is available in the docket for this rule.
This rule is within the scope of the February 18, 2012
certification. Based on the Economic Analysis discussed in Unit XI. and
EPA's experience promulgating SNURs (discussed in the certification),
EPA believes that the following are true:
A significant number of SNUNs would not be submitted by
small entities in response to the SNUR.
[[Page 75397]]
Submission of the SNUN would not cost any small entity
significantly more than $8,300.
Therefore, the promulgation of the SNUR would not have a significant
economic impact on a substantial number of small entities.
D. Unfunded Mandates Reform Act (UMRA)
Based on EPA's experience with proposing and finalizing SNURs,
State, local, and Tribal governments have not been impacted by these
rulemakings, and EPA does not have any reasons to believe that any
State, local, or Tribal government will be impacted by this rule. As
such, EPA has determined that this rule does not impose any enforceable
duty, contain any unfunded mandate, or otherwise have any effect on
small governments subject to the requirements of UMRA sections 202,
203, 204, or 205 (2 U.S.C. 1501 et seq.).
E. Executive Order 13132
This action will not have a substantial direct effect on States, on
the relationship between the national government and the States, or on
the distribution of power and responsibilities among the various levels
of government, as specified in Executive Order 13132, entitled
``Federalism'' (64 FR 43255, August 10, 1999).
F. Executive Order 13175
This rule does not have Tribal implications because it is not
expected to have substantial direct effects on Indian Tribes. This rule
does not significantly nor uniquely affect the communities of Indian
Tribal governments, nor does it involve or impose any requirements that
affect Indian Tribes. Accordingly, the requirements of Executive Order
13175, entitled ``Consultation and Coordination with Indian Tribal
Governments'' (65 FR 67249, November 9, 2000), do not apply to this
rule.
G. Executive Order 13045
This action is not subject to Executive Order 13045, entitled
``Protection of Children from Environmental Health Risks and Safety
Risks'' (62 FR 19885, April 23, 1997), because this is not an
economically significant regulatory action as defined by Executive
Order 12866, and this action does not address environmental health or
safety risks disproportionately affecting children.
H. Executive Order 13211
This action is not subject to Executive Order 13211, entitled
``Actions Concerning Regulations That Significantly Affect Energy
Supply, Distribution, or Use'' (66 FR 28355, May 22, 2001), because
this action is not expected to affect energy supply, distribution, or
use and because this action is not a significant regulatory action
under Executive Order 12866.
I. National Technology Transfer and Advancement Act (NTTAA)
In addition, since this action does not involve any technical
standards, NTTAA section 12(d) (15 U.S.C. 272 note), does not apply to
this action.
J. Executive Order 12898
This action does not entail special considerations of environmental
justice related issues as delineated by Executive Order 12898, entitled
``Federal Actions to Address Environmental Justice in Minority
Populations and Low-Income Populations'' (59 FR 7629, February 16,
1994).
XIII. Congressional Review Act
Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.),
EPA will submit 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 United States prior to publication of
the rule in the Federal Register. This action is not a ``major rule''
as defined by 5 U.S.C. 804(2).
List of Subjects
40 CFR Part 9
Environmental protection, Reporting and recordkeeping requirements.
40 CFR Part 721
Environmental protection, Chemicals, Hazardous substances,
Reporting and recordkeeping requirements.
Dated: December 13, 2012.
Maria J. Doa,
Director, Chemical Control Division, Office of Pollution Prevention and
Toxics.
Therefore, 40 CFR parts 9 and 721 are amended as follows:
PART 9--[AMENDED]
0
1. The authority citation for part 9 continues to read as follows:
Authority: 7 U.S.C. 135 et seq., 136-136y; 15 U.S.C. 2001, 2003,
2005, 2006, 2601-2671; 21 U.S.C. 331j, 346a, 348; 31 U.S.C. 9701; 33
U.S.C. 1251 et seq., 1311, 1313d, 1314, 1318, 1321, 1326, 1330,
1342, 1344, 1345 (d) and (e), 1361; E.O. 11735, 38 FR 21243, 3 CFR,
1971-1975 Comp. p. 973; 42 U.S.C. 241, 242b, 243, 246, 300f, 300g,
300g-1, 300g-2, 300g-3, 300g-4, 300g-5, 300g-6, 300j-1, 300j-2,
300j-3, 300j-4, 300j-9, 1857 et seq., 6901-6992k, 7401-7671q, 7542,
9601-9657, 11023, 11048.
0
2. In Sec. 9.1, add the following sections in numerical order under
the undesignated center heading ``Significant New Uses of Chemical
Substances'' to read as follows:
Sec. [emsp14]9.1 OMB approvals under the Paperwork Reduction Act.
* * * * *
------------------------------------------------------------------------
OMB
40 CFR citation control No.
------------------------------------------------------------------------
* * * * *
------------------------------------------------------------------------
Significant New Uses of Chemical Substances
------------------------------------------------------------------------
* * * * *
721.10629.................................................. 2070-0012
721.10630.................................................. 2070-0012
721.10631.................................................. 2070-0012
721.10632.................................................. 2070-0012
721.10633.................................................. 2070-0012
721.10634.................................................. 2070-0012
721.10635.................................................. 2070-0012
721.10636.................................................. 2070-0012
* * * * *
------------------------------------------------------------------------
* * * * *
PART 721--[AMENDED]
0
3. The authority citation for part 721 continues to read as follows:
Authority: 15 U.S.C. 2604, 2607, and 2625(c).
0
4. Add Sec. 721.10629 to subpart E to read as follows:
Sec. 721.10629 Fatty acids, tall-oil, reaction products with modified
fatty acids and polyalkanolamines (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as fatty
acids, tall-oil, reaction products with modified fatty acids and
polyalkanolamines (PMN P-09-107) 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) (N=110).
(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.
[[Page 75398]]
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
0
5. Add Sec. 721.10630 to subpart E to read as follows:
Sec. 721.10630 Amino acid, carboxyalkyl, alkylsulfonate, alkali salt
(generic).
(a) Chemical substances and significant new uses subject to
reporting. (1) The chemical substances identified generically as amino
acid, carboxyalkyl, alkylsulfonate, alkali salts (PMNs P-11-619 and P-
11-620) are 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 = 770 parts per billion (ppb)
for the aggregate of the PMN substances, P-11-619 and P-11-620). When
calculating the surface water concentrations according to the
instructions in Sec. 721.90(a)(4), (b)(4), and (c)(4), the statement
that the amount of the substances that will be released will be
calculated before the substances enter control technology does not
apply. Instead, if the waste stream containing the substances will be
treated before release, then the amount of the substances reasonably
likely to be removed from the waste stream by such treatment may be
subtracted in calculating the number of kilograms released. No more
than 90 percent removal efficiency may be attributed to such treatment.
(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.
0
6. Add Sec. 721.10631 to subpart E to read as follows:
Sec. 721.10631 Mixed metal borate (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as mixed
metal borate (PMN P-12-64) 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(s), (y)(1), and (y)(2).
(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.
(3) Determining whether a specific use is subject to this section.
The provisions of Sec. 721.1725(b)(1) apply to this section.
0
7. Add Sec. 721.10632 to subpart E to read as follows:
Sec. 721.10632 Benzamide, N-[(cyclohexylamino)thioxomethyl]-.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as benzamide, N-
[(cyclohexylamino)thioxomethyl]- (PMN P-12-181; CAS No. 4921-92-0) 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(o).
(ii) Release to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4), and (c)(4) (N= 2).
(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), (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.
0
8. Add Sec. 721.10633 to subpart E to read as follows:
Sec. 721.10633 Aromatic sulfonic acid amino azo dye salts (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
aromatic sulfonic acid amino azo dye salts (PMN P-12-276) 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) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(4) (National Institute for Occupational Safety and Health
(NIOSH)-certified M100 respirator with an assigned protection factor of
at least 10), (a)(6), (b) (concentration set at 0.1 percent), and (c).
(ii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(s) (10,000 kilograms).
(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), (d), 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.
0
9. Add Sec. 721.10634 to subpart E to read as follows:
Sec. 721.10634 Iodonium, diphenyl-, 4,4'-di-C10-13-alkyl derivs.,
(OC-6-11)-hexafluoroantimonates(1-).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as iodonium, diphenyl-
, 4,4'-di-C10-13-alkyl derivs., (OC-6-11)-hexafluoroantimonates(1-)
(PMN P-12-464; CAS No. 1370442-66-2) 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) (photoinitiator used for ultraviolet
release coatings).
(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.
0
10. Add Sec. 721.10635 to subpart E to read as follows:
Sec. 721.10635 Alkyl maleimide substituted bicyclic olefin (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as alkyl
maleimide
[[Page 75399]]
substituted bicyclic olefin (PMN P-12-480) 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) (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.
0
11. Add Sec. 721.10636 to subpart E to read as follows:
Sec. 721.10636 Slimes and sludges, automotive coating, wastewater
treatment, solid waste.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as slimes and sludges,
automotive coating, wastewater treatment, solid waste (PMN P-12-501;
CAS No. 1392095-50-9) 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(v)(1), (w)(1), and (x)(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 (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. 2012-30695 Filed 12-19-12; 8:45 am]
BILLING CODE 6560-50-P