[Federal Register Volume 74, Number 120 (Wednesday, June 24, 2009)]
[Rules and Regulations]
[Pages 29982-29998]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-14780]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 721
[EPA-HQ-OPPT-2008-0252; FRL-8417-6]
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
section 5(a)(2) of the Toxic Substances Control Act (TSCA) for 23
chemical substances which were the subject of premanufacture notices
(PMNs). Four of these chemical substances are subject to TSCA section
5(e) consent orders issued by EPA. This action requires persons who
intend to manufacture, import, or process any of these 23 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: The effective date of this rule is August 24, 2009 without
further notice, unless EPA receives written adverse or critical
comments, or notice of intent to submit adverse or critical comments
before July 24, 2009. This rule shall be promulgated for purposes of
judicial review at 1 p.m. (e.s.t.) on July 8, 2009.
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 July 24, 2009, 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.
Additionally, significant new use designations for a chemical
substance are legally established as of the date of publication of this
direct final rule June 24, 2009. See the discussion in Unit VII. for
more specific details.
Further, for persons intending to import or export any of the
chemical substances in this rule, they are subject to the TSCA section
13 import certification requirements and the export notification
provisions of TSCA section 12(b) as of July 24, 2009. See the
discussion in Unit I.A. and Unit II.C. for more specific details.
ADDRESSES: Submit your comments, identified by docket identification
(ID) number EPA-HQ-OPPT-2008-0252, by one of the following methods:
Federal eRulemaking Portal: http://www.regulations.gov.
Follow the on-line 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, Rm. 6428, 1201 Constitution Ave., NW., Washington, DC. Attention:
Docket ID Number EPA-HQ-OPPT-2008-0252. 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-
2008-0252. EPA's policy is that all comments received will be included
in the public docket without change and may be made available on-line
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 e-
mail. The regulations.gov website 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 e-
mail comment directly to EPA without going through regulations.gov,
your e-mail address will be automatically captured and included as part
of the comment that is placed in the public 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. For additional
information about EPA's public docket, visit the EPA Docket Center
homepage at http://www.epa.gov/epahome/dockets.htm.
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
[[Page 29983]]
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 Federal 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 general information contact: Colby
Lintner, Regulatory Coordinator, Environmental Assistance Division
(7408M), Office of Pollution Prevention and Toxics, Environmental
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001; telephone number: (202) 554-1404; e-mail address: [email protected].
For technical information contact: Tracey Klosterman, Chemical
Control Division (7405M), Office of Pollution Prevention and Toxics,
Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460-0001; telephone number: (202) 564-2209; e-mail
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.
Potentially affected entities may include, but are not limited to:
Manufacturers, importers, or processors of one or more
subject chemical substances (NAICS codes 325 and 324110), e.g.,
Chemical manufacturing and petroleum refineries.
This listing is not intended to be exhaustive, but rather provides
a guide for readers regarding entities likely to be affected by this
action. Other types of entities not listed in this unit could also be
affected. The North American Industrial Classification System (NAICS)
codes have been provided to assist you and others in determining
whether this action might apply to certain entities. To determine
whether you or your business may be affected by this action, you should
carefully examine the applicability provisions in Sec. 721.5. If you
have any questions regarding the applicability of this action to a
particular entity, consult the technical person listed under FOR
FURTHER INFORMATION CONTACT.
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 (the corresponding EPA policy appears at 40 CFR part
707, subpart B). 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. In addition, any persons
who export or intend to export a chemical substance that is the subject
of this rule on or after July 24, 2009 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 e-mail. 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
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 of April 24, 1990
(55 FR 17376). 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 those listed in TSCA section 5(a)(2). 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. The mechanism
for reporting under this requirement is established under 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,
[[Page 29984]]
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
notice 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.
Chemical importers are subject to the TSCA section 13 (15 U.S.C.
1612) import certification requirements promulgated at 19 CFR 12.118
through 12.127 and 19 CFR 127.28 (the corresponding EPA policy appears
at 40 CFR part 707, subpart B). Chemical importers must certify that
the shipment of the chemical substance complies with all applicable
rules and orders under TSCA. Importers of chemical substances subject
to a proposed or final SNUR must certify their compliance with the SNUR
requirements. In addition, any persons who export or intend to export a
chemical substance identified in a proposed or final SNUR are subject
to the export notification provisions of TSCA section 12(b) (15 U.S.C.
2612 (b)) (see Sec. 721.20), and must comply with the export
notification requirements in 40 CFR part 707, subpart D.
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 23
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 above four factors listed in TSCA section
5(a)(2).
IV. Substances Subject to this Rule
EPA is establishing significant new use and recordkeeping
requirements for 23 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).
CAS number (if assigned for non-confidential chemical
identities).
Basis for the TSCA section 5(e) consent order or, for non-
section 5(e) SNURs, the basis for the SNUR (i.e., SNURs without TSCA
section 5(e) consent orders).
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)
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 4 PMN substances that are subject to ``risk-
based'' consent orders under TSCA section 5(e)(1)(A)(ii)(I) where EPA
determined that activities associated with the PMN substances may
present unreasonable risk to human health or the environment. Those
consent orders require protective measures to limit exposures or
otherwise mitigate the potential unreasonable risk. The so-called
``5(e) SNURs'' on these PMN substances are promulgated pursuant to
Sec. 721.160, and are based on and consistent with the provisions in
the underlying consent orders. The 5(e) SNURs designate as a
``significant new use'' the absence of the protective measures required
in the corresponding consent orders.
Where EPA determined that the PMN substance may present an
unreasonable risk of injury to human health via inhalation exposure,
the underlying TSCA section 5(e) consent order usually requires, among
other things, that potentially exposed employees wear specified
respirators unless actual measurements of the workplace air show that
air-borne concentrations of the PMN substance are below a New Chemical
Exposure Limit (NCEL) that is established by EPA to provide adequate
protection to human health. In addition to the actual NCEL
concentration, the comprehensive NCELs provisions in TSCA section 5(e)
consent orders, which are modeled after Occupational Safety and Health
Administration (OSHA) Permissible Exposure Limits (PELs) provisions,
include requirements addressing performance criteria for sampling and
analytical methods, periodic monitoring, respiratory protection, and
recordkeeping. However, no comparable NCEL provisions currently exist
in 40 CFR part 721, subpart B, for SNURs. Therefore, for these cases,
the individual SNURs in 40 CFR part 721, subpart E, will state that
persons subject to the SNUR who wish to pursue NCELs as an alternative
to the Sec. 721.63 respirator requirements may request to do so under
Sec. 721.30. EPA expects that persons whose Sec. 721.30 requests to
use the NCELs approach for SNURs are approved by EPA will be required
to comply with NCELs provisions that are comparable to those contained
in the corresponding TSCA section 5(e) consent order for the same
chemical substance.
This rule also includes SNURs on 19 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). EPA, however, 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 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
[[Page 29985]]
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-05-1
Chemical name: Formaldehyde, polymer with dialkylphenylamine,
dialkylphenol and trimethylhexanediamine (generic).
CAS number: Not available.
Basis for action: The PMN states that the substance will be used as a
curing agent for epoxy coating systems. Based on test data on analogous
phenols, aliphatic amines, and benzyl amines, EPA predicts toxicity to
aquatic organisms may occur at concentrations that exceed 4 parts per
billion (ppb) of the PMN substance in surface waters. As described in
the PMN, the substance is not released to surface waters. 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 release
to surface waters 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 the results of a ready
biodegradability test (OPPTS 835.3110 test guideline); a fish acute
toxicity test, freshwater and marine (OPPTS 850.1075 test guideline
(public draft)); an aquatic invertebrate acute toxicity test, fresh
water daphnids (OPPTS 850.1010 test guideline (public draft)); and an
algal toxicity test, tiers I and II (OPPTS 850.5400 test guideline
(public draft)) would help characterize the environmental effects of
the PMN substance. All aquatic toxicity testing should be performed
using the static method with nominal concentrations at a pH of 7.
Further, a certificate of analysis should be provided for the test
substance.
CFR citation: 40 CFR 721.10134.
PMN Number P-05-11
Chemical name: Phosphinic acid, P,P-diethyl-, zinc salt (2:1).
CAS number: 284685-45-6.
Basis for action: The PMN states that the substance will be used as a
flame retardant for polyamide thermoplastic epoxy resins. Based on test
data on the PMN substance and analogous zinc salts, EPA predicts
toxicity to aquatic organisms may occur at concentrations that exceed
12 ppb of the PMN substance in surface waters. As described in the PMN,
releases of the substance are not expected to result in surface water
concentrations that exceed 12 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 12 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 850.1400 test guideline (public
draft)) with rainbow trout and a daphnid chronic toxicity test (OPPTS
850.1300 test guideline (public draft)) would help characterize the
environmental effects of the PMN substance. Further, a certificate of
analysis should be provided for the test substance.
CFR citation: 40 CFR 721.10135.
PMN Number P-05-177
Chemical name: 2-Propenoic acid, 2-methyl-, 2-hydroxyethyl ester,
reaction products with hexakis(alkoxyalkyl)melamine (generic).
CAS number: Not available.
Basis for action: The PMN states that the substance will be used as a
base resin in UV/EB curable and peroxide curable formulations. Based on
test data on analogous methacrylates and esters, EPA predicts toxicity
to aquatic organisms may occur at concentrations that exceed 100 ppb of
the PMN substance in surface waters. As described in the PMN, the
substance is not released to surface waters. 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 release to surface
waters 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 the results of a Zahn-
Wellens/EMPA test (OPPTS 835.3200 test guideline); a fish acute
toxicity test, freshwater and marine (OPPT 850.1075 test guideline
(public draft)); an aquatic invertebrate acute toxicity test,
freshwater daphnids (OPPTS 850.1010 test guideline (public draft)); and
an algal toxicity test, tiers I and II (OPPTS 850.5400 test guideline
(public draft)) would help characterize the environmental effects of
the PMN substance. Fish and daphnia testing should be performed using
the flow-through method with measured concentrations. Algal testing
should be performed using the static method with measured
concentrations. Further, a certificate of analysis should be provided
for the test substance.
CFR citation: 40 CFR 721.10136.
PMN Number P-05-329
Chemical name: Halogenated phenoxy aromatic (generic).
CAS number: Not available.
Basis for action: The PMN states that the substance will be used as a
fungicide intermediate. EPA identified health and environmental
concerns because the substance may be a persistent, bioaccumulative,
and toxic (PBT) chemical, based on physical/chemical properties of the
PMN substance, as described in the New Chemicals Program's PBT Category
(64 FR 60194; November 4, 1999) (FRL-6097-7). EPA estimates that the
PMN substance will persist in the environment more than two months and
estimates a bioaccumulation factor of greater than or equal to 1,000.
Also, based on test data on analogous neutral organic substances, EPA
predicts toxicity to aquatic organisms. As described in the PMN,
significant worker exposure is unlikely and the substance is not
released to surface waters. 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 predictable
or purposeful release containing the PMN substance into the waters of
the United States may cause serious health effects and significant
environmental effects, since the PMN substance has been characterized
by EPA as a PBT. Based on this information, the PMN substance meets the
concern criteria at Sec. 721.170 (b)(3)(ii), (b)(4)(ii), and
(b)(4)(iii).
Recommended testing: EPA has determined that the results of a subset of
the tiered testing described in the New Chemicals Program's PBT
Category would help characterize the PBT attributes of the PMN
substance. EPA has determined that a ready biodegradability test (OPPTS
835.3110 test guideline); a fish bioconcentration factor test (OPPTS
850.1730 test guideline (public draft)); and a combined repeated dose
study with the reproductive/developmental toxicity screening test
(OPPTS 870.3650 or Organisation for Economic Co-operation and
Development (OECD) 422 test guidelines) would help characterize the
human health and environmental effects of the PMN substance. Further, a
certificate of analysis should be provided for the test substance.
CFR citation: 40 CFR 721.10137.
[[Page 29986]]
PMN Number P-05-336
Chemical name: 3-Isoxazolecarboxylic acid, 4,5-dihydro-5,5-diphenyl-,
ethyl ester.
CAS number: 163520-33-0.
Basis for action: The PMN states that the substance will be used as an
herbicide safener in formulated pesticide products. Based on test data
on the PMN substance submitted under TSCA section 8(e), the substance
may cause liver, kidney, heart and spleen toxicity. Also, based on
information submitted in the PMN Material Safety Data Sheet (MSDS), EPA
has concerns for dermal sensitization. In addition, based on test data
on the PMN substance and analogous aliphatic amines, 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,
significant worker exposure is not expected. Further, general
population exposure is not expected as the substance is not released to
surface waters. Therefore, EPA has not determined that the proposed
manufacturing, processing, and use of the substance may present an
unreasonable risk. EPA has determined, however, that any use of the
substance resulting in release to surface waters may cause serious
health effects and significant adverse environmental effects. Based on
this information, the PMN substance meets the concern criteria at Sec.
721.170 (b)(3)(i), (b)(4)(i), and (b)(4)(ii).
Recommended testing: EPA has determined that the results of a fish
early-life stage toxicity test (OPPTS 850.1400 test guideline (public
draft)) with rainbow trout and a daphnid chronic toxicity test (OPPTS
850.1300 test guideline (public draft)) would help characterize the
environmental effects of the PMN substance. Further, a certificate of
analysis should be provided for the test substance. No human health
testing is recommended at this time.
CFR citation: 40 CFR 721.10138.
PMN Number P-05-776
Chemical name: Ethanone, 1-(1-chlorocyclopropyl)-.
CAS number: 63141-09-3.
Basis for action: The PMN states that the generic (non-confidential)
use of the substance will be as an intermediate. Based on test data on
the PMN substance, EPA has concerns for acute toxicity, strong solvent
(defatting) irritation, and dermal sensitization. Also, based on test
data on analogous chloroalkanes, EPA has concerns for potential
mutagenicity. In addition, based on test data on the PMN substance, EPA
predicts toxicity to aquatic organisms may occur at concentrations that
exceed 500 ppb of the PMN substance in surface waters. As described in
the PMN, significant worker exposure is unlikely due to the use of
adequate personal protective equipment. Significant general population
exposure is not expected to result from the identified environmental
releases from the proposed manufacturing, processing, or use of the
substance. Further, significant environmental exposure is unlikely as
the substance is not released to surface waters resulting in stream
concentrations that exceed 500 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 use
of the substance other than as an intermediate or any use of the
substance resulting in surface water concentrations exceeding 500 ppb
may cause serious health effects and significant adverse environmental
effects. Based on this information, the PMN substance meets the concern
criteria at Sec. 721.170 (b)(3)(i), (b)(3)(ii), and (b)(4)(i).
Recommended testing: EPA has determined that the results of a porous
pot test (OPPTS 835.3220 test guideline); a fish acute toxicity test,
freshwater and marine (OPPTS 850.1075 test guideline (public draft));
an aquatic invertebrate acute toxicity test, freshwater daphnids (OPPTS
850.1010 test guideline (public draft)); an algal toxicity test, tiers
I and II (OPPTS 850.5400 test guideline (public draft)); a mammalian
erythrocyte micronucleus test (OPPTS 870.5395 test guideline) by the
intraperitoneal route; and a repeated dose 28-day oral toxicity study
in rodents (OPPTS 870.3050 test guideline) would help characterize the
human health and environmental effects of the PMN substance. Fish and
daphnia testing should be performed using the flow-through method with
measured concentrations. Algal testing should be performed using the
static method with measured concentrations. Further, a certificate of
analysis should be provided for the test substance.
CFR citation: 40 CFR 721.10139.
PMN Number P-06-33
Chemical name: Phosphoric acid, tin (2+) salt (2:3).
CAS number: 15578-32-2.
Basis for action: The PMN states that the substance will be used as a
pigment in plastic compounds for laser marking and laser welding. Based
on test data on the PMN substance and on analogous respirable, poorly
soluble particulates, EPA has identified concerns that the PMN
substance may cause lung overload, immunotoxicity, and reproductive
toxicity. Also, based on test data on the PMN substance and analogous
inorganic phosphates, EPA predicts toxicity to aquatic organisms may
occur at concentrations that exceed 10 ppb of the PMN substance in
surface waters. As described in the PMN, significant worker exposure is
unlikely due to the use of adequate personal protective equipment.
Further, environmental exposure is unlikely, as the substance is not
released to surface waters. Therefore, EPA has not determined that the
proposed import, processing, or use of the substance may present an
unreasonable risk. EPA has determined, however, that domestic
manufacture or any use of the substance resulting in release to surface
waters may cause serious health effects and significant adverse
environmental effects. Based on this information, the PMN substance
meets the concern criteria at Sec. 721.170 (b)(3)(i), (b)(3)(ii),
(b)(4)(i), and (b)(4)(ii).
Recommended testing: EPA has determined that the results of a fish
acute toxicity test, freshwater and marine (OPPTS 850.1075 test
guideline (public draft)); an aquatic invertebrate acute toxicity test,
freshwater daphnids (OPPTS 850.1010 test guideline (public draft)); an
algal toxicity test, tiers I and II (OPPTS 850.5400 test guideline
(public draft)); and a reproduction/developmental toxicity screening
test (OPPTS 870.3550 test guideline) would help characterize the human
health and environmental effects of the PMN substance. Further, a
certificate of analysis should be provided for the test substance.
CFR citation: 40 CFR 721.10140.
PMN Number P-06-163
Chemical name: Oils, ginger, zingiber purpureum.
CAS number: 864662-46-4.
Basis for action: The PMN states that the substance will be used in
fragrance compositions in cosmetic products, air fresheners, household
cleaners, dishwashing detergents, and laundry detergents. Based on test
data on analogous methyl eugenol, EPA identified concerns that the PMN
substance may cause cancer. As described in the PMN, significant worker
dermal exposure is unlikely due to the use of adequate dermal
protection. Although there is potential for consumer exposure,
significant dermal and inhalation exposures are not expected.
Therefore, EPA has not determined that the proposed import, processing,
or use of the substance may present an unreasonable risk. EPA has
[[Page 29987]]
determined, however, that domestic manufacture or use of the substance
without the use of impervious gloves, where there is a potential for
potential worker dermal exposure, 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 an in vitro
mammalian erythrocyte micronucleus test (OPPTS 870.5395 test
guideline); a salmonella typhimurium reverse mutation assay
(OPPTS.870.5265 test guideline); and a carcinogenicity test (OPPTS
870.4200 test guideline) would help characterize the human health
effects of the PMN substance.
CFR citation: 40 CFR 721.10141.
PMN Number P-06-199
Chemical name: Oxabicycloalkane carboxylic acid alkanediyl ester
(generic).
CAS number: Not available.
Basis for action: The PMN states that the generic (non-confidential)
use of the substance will be as a monomer. Based on test data on
analogous esters, EPA predicts toxicity to aquatic organisms may occur
at concentrations that exceed 7 ppb of the PMN substance in surface
waters. As described in the PMN, the substance will not be released to
surface waters. 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 release to surface waters 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 the results of a fish
early-life stage toxicity test (OPPTS 850.1400 test guideline (public
draft)) with freshwater fish and a daphnid chronic toxicity test (OPPTS
850.1300 test guideline (public draft)) would help characterize the
environmental effects of the PMN substance. Further, a certificate of
analysis should be provided for the test substance.
CFR citation: 40 CFR 721.10142.
PMN Number P-06-733
Chemical name: Amines, bis (C11-14-branched and linear alkyl).
CAS number: 900169-60-0.
Basis for action: The PMN states that the generic (non-confidential)
use of the substance will be as a chemical intermediate. EPA identified
health and environmental concerns because the substance may be a PBT
chemical, based on physical/chemical properties of the PMN substance,
as described in the New Chemicals Program's PBT Category (64 FR 60194;
November 4, 1999). EPA estimates that the PMN substance will persist in
the environment more than two months and estimates a bioaccumulation
factor of greater than or equal to 1,000. Also, based on test data on
analogous aliphatic amines, EPA predicts toxicity to aquatic organisms.
As described in the PMN, significant worker exposure is unlikely and
the substance is not released to surface waters. 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 predictable or purposeful release of the PMN
substance into the waters of the United States may cause serious health
effects and significant environmental effects, since the PMN substance
has been characterized by EPA as a PBT. Based on this information, the
PMN substance meets the concern criteria at Sec. 721.170 (b)(3)(ii),
(b)(4)(ii), and (b)(4)(iii).
Recommended testing: EPA has determined that the results of the tiered
testing described in the New Chemicals Program's PBT Category would
help characterize the PBT attributes of the PMN substance. The
neutralized substance should be used for all human health testing.
Further, a certificate of analysis should be provided for the test
substance.
CFR citation: 40 CFR 721.10143.
PMN Number P-06-805
Chemical name: Modified thiocarbamate (generic).
CAS number: Not available.
Basis for action: The PMN states that the generic (non-confidential)
use of the substance will be as a mining chemical reagent. Based on
test data on a structurally similar substance, EPA identified human
health concerns for toxicity to liver, thymus, spleen, kidney, and red
blood cells from exposure via drinking water and fish ingestion
resulting from releases to surface and ground water. Further, based on
test data on the PMN substance and analogous imides, EPA predicts
toxicity to aquatic organisms may occur at concentrations that exceed
70 ppb of the PMN substance in surface waters. As described in the PMN,
the substance will not be released to surface and ground waters.
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
release to surface waters may cause significant adverse environmental
effects. Based on this information, the PMN substance meets the concern
criteria at Sec. 721.170 (b)(3)(ii), (b)(4)(i), and (b)(4)(ii).
Recommended testing: EPA has determined that the results of a bacterial
reverse mutation test (OPPTS 870.5100 test guideline); a mammalian
erythrocyte micronucleus test (OPPTS 870.5395 test guideline) by the
intraperitoneal route; a repeated dose 28-day oral toxicity in rodents
(OPPTS 870.3050 test guideline); an acute oral toxicity (OPPTS 870.1100
test guideline); a fish early life-stage toxicity test (OPPTS 850.1400
test guideline (public draft)); a daphnid chronic toxicity test (OPPTS
850.1300 test guideline (public draft)); and either a ready
biodegradability test (OPPTS 835.3110 test guideline) or a sealed
vessel carbon dioxide production test (OPPTS 835.3120 test guideline)
would help characterize the human health and environmental effects of
the PMN substance. Fish and daphnid testing should be performed using
the flow-through method with measured concentrations. Further, a
certificate of analysis should be provided for the test substance.
CFR citation: 40 CFR 721.10144.
PMN Number P-06-816
Chemical name: Modified reaction products of alkyl alcohol, halogenated
alkane, substituted epoxide, and amino compound (generic).
CAS number: Not available.
Effective date of TSCA section 5(e) consent order: May 25, 2007.
Basis for TSCA section 5(e) consent order: The PMN states that the
generic (non-confidential) use of the PMN substance will be as a
hydrophobic surface active agent for cellulosic substrates and similar
materials. The order was issued under section 5(e)(1)(A)(i) and
(e)(1)(A)(ii)(I) and (e)(1)(A)(ii)(II) of TSCA based on a finding that
this substance may present an unreasonable risk of injury to the
environment and human health, the substance may be produced in
substantial quantities and may reasonably be anticipated to enter the
environment in substantial quantities, and there may be significant (or
substantial) human exposure to the substance and its potential
degradation products. To protect against this exposure and risk, the
consent order requires that the PMN substance be tested, before a
certain production volume is reached, in various fate and physical/
chemical tests to determine its fate and composition in various media
and conditions in the environment. In addition, for the fluorinated
portion of the polymer, the submitter has agreed to
[[Page 29988]]
analyze, report, and limit specific fluorinated impurities of the PMN
substance where the carbon chain meets or exceeds a specified length,
if these values exceed those reported in the PMN. The SNUR designates
as a ``significant new use'' the absence of these protective measures.
Toxicity concern: EPA has concerns for potential incineration or other
decomposition products of the PMN substance. These perfluorinated
products may be released to the environment from incomplete
incineration of the PMN substance at low temperatures. EPA has
preliminary evidence, including data on some fluorinated polymers that
suggests that, under some conditions, the PMN substance could degrade
in the environment. EPA has concerns that these degradation products
will persist (P) in the environment, could bioaccumulate (B) or
biomagnify, and could be toxic (T) to people, wild mammals, and birds,
based on data on analog chemicals, including perfluorooctanoic acid
(PFOA) and other perfluorinated alkyls, including the presumed
environmental degradation product. There is pharmacokinetic and
toxicological data in animals on PFOA, as well as epidemiological and
blood monitoring data in humans. Toxicity studies on PFOA indicate
developmental, reproductive, and systemic toxicity in various species.
Cancer may also be of concern. These factors, taken together, raise
concerns for potential adverse chronic effects in humans and wildlife.
There is also limited pharmacokinetic data and toxicological data in
animals on other perfluoroalkyls, including the presumed degradation
product and precursors. These data indicate a different and less toxic
profile for the presumed degradation product and precursors. EPA
expects that additional animal data will be developed under various
consent orders that have the expected common degradation product or
analog information.
Recommended testing: EPA has determined that the results of certain
fate and physical/chemical property tests would help characterize
possible effects of the substance. The PMN submitter has agreed not to
exceed the production volume limit without performing these tests. The
consent order contains one production volume limit. The PMN submitter
has agreed not to exceed the production volume limit without performing
the following studies: A modified semi-continuous activated sludge
(SCAS) test for insoluble and volatile chemicals (OPPTS 835.5045 or
OECD 302A test guidelines), with analysis for degradation products; a
UV visible light absorption test (OPPTS 830.7050 or OECD 101 test
guidelines); a direct photolysis rate in water by sunlight test (OPPTS
835.2210 test guideline), if wavelengths greater than 290 nanometers
(nm) are absorbed in the previous test; an indirect photolysis
screening test (OPPTS 835.5270 test guideline); a phototransformation
of chemicals on soil surfaces test (Draft OECD guideline January 2002)
using two soils; an anaerobic biodegradability of organic compounds in
digested sludge test (OECD 311 test guideline); an aerobic and
anaerobic transformation in aquatic sediment systems test (OECD 308
test guideline); and an aerobic sewage treatment simulation test (OECD
303A test guideline).
CFR citation: 40 CFR 721.10145.
PMN Number P-07-87
Chemical name: Partially fluorinated condensation polymer (generic).
CAS number: Not available.
Effective date of TSCA section 5(e) consent order: August 10, 2007.
Basis for TSCA section 5(e) consent order: The PMN states that the
generic (non-confidential) use of the PMN substance will be as an open,
non-dispersive carpet treatment. The order was issued under section
5(e)(1)(A)(i) and (e)(1)(A)(ii)(I) and (e)(1)(A)(ii)(II) of TSCA based
on a finding that this substance may present an unreasonable risk of
injury to the environment and human health, the substance may be
produced in substantial quantities and may reasonably be anticipated to
enter the environment in substantial quantities, and there may be
significant (or substantial) human exposure to the substance and its
potential degradation products. To protect against this exposure and
risk, the consent order requires that the PMN substance be tested,
before certain production volumes are reached, in various fate and
physical/chemical tests to determine its fate and composition in
various media and conditions in the environment. The order also limits
the concentration of the PMN substance in products sold to non-
industrial users or distributors to non-industrial users that could
spray apply the substance (after further dilution). Also, the consent
order forbids the sale of the PMN substance to consumers in a spray
application formulation. In addition, for the fluorinated portion of
the polymer, the submitter has agreed to analyze, report, and limit
specific fluorinated impurities of the PMN substance where the carbon
chain meets or exceeds a specified length. The SNUR designates as a
``significant new use'' the absence of these protective measures.
Toxicity concern: EPA has concerns for potential incineration or other
decomposition products of the PMN substance. These perfluorinated
products may be released to the environment from incomplete
incineration of the PMN substance at low temperatures. EPA has
preliminary evidence, including data on some fluorinated polymers that
suggests that, under some conditions, the PMN substance could degrade
in the environment. EPA has concerns that these degradation products
will persist (P) in the environment, could bioaccumulate (B) or
biomagnify, and could be toxic (T) to people, wild mammals, and birds,
based on data on analog chemicals, including PFOA and other
perfluorinated alkyls, including the presumed environmental degradant.
There is pharmacokinetic and toxicological data in animals on PFOA, as
well as epidemiological and blood monitoring data in humans. Toxicity
studies on PFOA indicate developmental, reproductive, and systemic
toxicity in various species. Cancer may also be of concern. These
factors, taken together, raise concerns for potential adverse chronic
effects in humans and wildlife. There is also limited pharmacokinetic
data and toxicological data in animals on other perfluoroalkyls,
including the presumed degradant and precursors. These data indicate a
different and less toxic profile for the presumed degradant and
precursors. EPA expects that additional animal data will be developed
under various consent orders that have the expected common degradant or
analog information. EPA also has concerns that the PMN substance, under
some conditions of use--particularly non-industrial, commercial, or
consumer use--could cause lung effects, based on limited data on some
perfluorinated compounds and an acute inhalation study on a related
polymer.
Recommended testing: EPA has determined that the results of certain
fate and physical/chemical property tests would help characterize
possible effects of the substance. The PMN submitter has agreed not to
exceed the production volume limits without performing these tests. The
consent order contains three production volume limits. The PMN
submitter has agreed not to exceed the first production volume limit
without performing the following studies: A modified SCAS test for
insoluble and volatile chemicals (OPPTS 835.5045 or OECD 302A test
guidelines), with analysis for degradation products; a UV visible light
[[Page 29989]]
absorption test (OPPTS 830.7050 or OECD 101 test guidelines); a direct
photolysis rate in water by sunlight test (OPPTS 835.2210 test
guideline), if wavelengths greater than 290 nm are absorbed in the
previous test; an indirect photolysis screening test (OPPTS 835.5270
test guideline); a hydrolysis as a function of pH and temperature test
(OPPTS 835.2130 test guideline); an aerobic and anaerobic
transformation in soil test (OECD 307 test guideline); and an anaerobic
biodegradability of organic compounds in digested sludge test (OECD 311
test guideline). The PMN submitter has also agreed not to exceed the
second higher production volume limit without performing the following
tests: A phototransformation of chemicals on soil surfaces test (Draft
OECD guideline January 2002) using two soils; an aerobic sewage
treatment simulation test (OECD 303A test guideline); and an aerobic
and anaerobic transformation in aquatic sediment systems test (OECD 308
test guideline). Finally, the PMN submitter has also agreed not to
exceed the highest production volume limit without performing an
aerobic and anaerobic transformation in soil test (OECD 307 test
guideline).
CFR citation: 40 CFR 721.10146.
PMN Number P-07-198
Chemical name: Acrylate derivative of alkoxysilylalkane ester and mixed
metal oxides (generic).
CAS number: Not available.
Basis for action: The PMN states that the generic (non-confidential)
use of the substance will be as a film coating additive. Based on test
data on analogous respirable, poorly soluble particulates, EPA has
concerns for lung effects for the PMN substance. Based on physical
properties, EPA has concerns for potential systemic effects from dermal
exposure to the PMN substance. As described in the PMN, worker
inhalation exposure to particulates is not expected and dermal exposure
is minimal due to the use of adequate dermal protection. 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 without the use of impervious gloves
where there is a potential for dermal exposure; use of the substance
other than as described in the PMN; or manufacture, processing, or use
of the substance in a powder form, may cause serious health effects.
Based on this information, the PMN substance meets the concern criteria
at Sec. 721.170(b)(3)(ii).
Recommended testing: EPA has determined that a 90-day inhalation
toxicity test (OPPTS 870.3465 test guideline) would help characterize
the human health effects of the PMN substance.
CFR citation: 40 CFR 721.10147.
PMN Number P-07-330
Chemical name: Acryloxy alkanoic alkane derivative with mixed metal
oxides (generic).
CAS number: Not available.
Basis for action: The PMN states that the generic (non-confidential)
use of the substance will be as a film coating additive. Based on test
data on analogous respirable, poorly soluble particulates, EPA has
concerns for lung effects for the PMN substance. Based on physical
properties, EPA has concerns for potential systemic effects from dermal
exposure to the PMN substance. As described in the PMN, worker
inhalation exposure to particulates is not expected and dermal exposure
is minimal due to the use of adequate dermal protection. 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 without the use of impervious gloves
where there is a potential for dermal exposure; use of the substance
other than as described in the PMN; or manufacture, processing, or use
of the substance in a powder form, may cause serious health effects.
Based on this information, the PMN substance meets the concern criteria
at Sec. 721.170(b)(3)(ii).
Recommended testing: EPA has determined that a 90-day inhalation
toxicity test (OPPTS 870.3465 test guideline) would help characterize
the human health effects of the PMN substance.
CFR citation: 40 CFR 721.10148.
PMN Numbers P-07-0522 and P-07-523
Chemical names: (P-07-522) Carbon black, (3-methylphenyl)-modified,
substituted (generic) and (P-07-523) Carbon black, (4-methylphenyl)-
modified, substituted (generic).
CAS numbers: Not available.
Basis for action: The consolidated PMN states that the generic (non-
confidential) use of the substances will be as colorant process
intermediates. Based on test data on analogous respirable, poorly
soluble particulates, EPA has concerns for lung effects for the PMN
substances. Based on physical properties, EPA has concerns for
potential systemic effects from dermal exposure to the PMN substances.
As described in the PMN, worker inhalation exposure to particulates is
not expected and dermal exposure is minimal due to the use of adequate
dermal protection. Therefore, EPA has not determined that the proposed
manufacturing, processing, or use of the substances may present an
unreasonable risk. EPA has determined, however, that use of the
substances without the use of impervious gloves where there is a
potential for dermal exposure; use of the substances other than as
described in the PMN; or manufacture, processing, or use of the
substances in a powder form, may cause serious health effects. Based on
this information, the PMN substances meet the concern criteria at Sec.
721.170(b)(3)(ii).
Recommended testing: EPA has determined that a 90-day inhalation
toxicity test (OPPTS 870.3465 test guideline) with a post-observation
period of up to 3 months would help characterize the human health
effects of the PMN substances. Evaluations should include markers of
damage, oxidant stress, cell proliferation, the degree/intensity and
duration of pulmonary inflammation, and a cytotoxic effects and
histopathology of pulmonary tissues in addition to the standard
requirements in the test guideline.
CFR citations: 40 CFR 721.10149 (P-07-522) and 40 CFR 721.10150 (P-07-
523).
PMN Number P-07-642
Chemical name: Modified styrene, divinylbenzene polymer (generic).
CAS number: Not available.
Basis for action: The PMN states that the generic (non-confidential)
use of the substance will be as a cleaning and polishing chemical for
semiconductor manufacturing. Based on test data on analogous
respirable, poorly soluble particulates, EPA has concerns for lung
effects for the PMN substance. Based on physical properties, EPA has
concerns for potential systemic effects from dermal exposure to the PMN
substance. As described in the PMN, worker inhalation exposure to
particulates is not expected and dermal exposure is minimal due to the
use of adequate dermal protection. 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 without the use of impervious gloves where there is a
potential for dermal exposure; use of the substance other than as
described in the PMN; or manufacture, processing, or use of the
substance in a powder form, may cause serious health effects. Based on
[[Page 29990]]
this information, the PMN substance meets the concern criteria at Sec.
721.170(b)(3)(ii).
Recommended testing: EPA has determined that a 90-day inhalation
toxicity test (OPPTS 870.3465 test guideline) with a post-observation
period of up to 3 months would help characterize the human health
effects of the PMN substance. Evaluations should include markers of
damage, oxidant stress, cell proliferation, the degree/intensity and
duration of pulmonary inflammation, and a cytotoxic effects and
histopathology of pulmonary tissues, in addition to the standard
requirements in the test guideline.
CFR citation: 40 CFR 721.10151.
PMN Number P-07-674
Chemical name: Oxirane, substituted silylmethyl-, hydrolysis products
with alkanol zirconium(4+) salt and silica, acetates (generic).
CAS number: Not available.
Basis for action: The PMN states that the generic (non-confidential)
use of the substance will be as a protective coating. Based on test
data on analogous respirable, poorly soluble particulates, EPA believes
that the PMN substance may cause lung effects. Based on physical
properties, EPA believes that the PMN substance may cause systemic
effects via dermal exposure. As described in the PMN, significant
worker exposure is unlikely due to use in an enclosed process with
adequate personal protective equipment. 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 without the use of impervious gloves
where there is a potential for dermal exposure; use of the substance in
non-enclosed processes during spray application; use other than as
described in the PMN; or manufacture, processing, or use of the
substance in a powder form, may cause serious health effects. Based on
this information, the PMN substance meets the concern criteria at Sec.
721.170(b)(3)(ii).
Recommended testing: EPA has determined that a 90-day inhalation
toxicity test (OPPTS 870.3465 test guideline) with the addition of a
post-exposure observation period of up to 3 months, and a glove
permeation test (American Society for Testing and Materials (ASTM) F739
and F1194-99 test guidelines) would help characterize the human health
effects of the PMN substance. Evaluations for the inhalation study
should include markers of damage, oxidant stress, cell proliferation,
the degree/intensity and duration of pulmonary inflammation, and a
cytotoxic effects and histopathology of pulmonary tissues, in addition
to the standard requirements in the test guideline.
CFR citation: 40 CFR 721.10152.
PMN Number P-08-6
Chemical name: Modified methyl methacrylate, 2-hydroxyethyl
methacrylate polymer (generic).
CAS number: Not available.
Basis for action: The PMN states that the generic (non-confidential)
use of the substance will be as a resin for coatings. Based on test
data on analogous respirable, poorly soluble particulates, EPA believes
that the PMN substance might cause lung effects. Based on physical
properties, EPA believes that the PMN substance may cause systemic
effects via dermal exposure. As described in the PMN, worker inhalation
exposure to particulates is not expected and dermal exposure is minimal
due to the use of adequate dermal protection. 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 without the use of impervious gloves
where there is a potential for dermal exposure; use of the substance
other than as described in the PMN; or manufacture, processing, or use
of the substance in a powder form, may cause serious health effects.
Based on this information, the PMN substance meets the concern criteria
at Sec. 721.170(b)(3)(ii).
Recommended testing: EPA has determined that a 90-day inhalation
toxicity test (OPPTS 870.3465 test guideline) with the addition of a
post-exposure observation period of up to 3 months, and a glove
permeation test (ASTM F739 and F1194-99 test guidelines) would help
characterize the human health effects of the PMN substance. Evaluations
for the inhalation study should include markers of damage, oxidant
stress, cell proliferation, the degree/intensity and duration of
pulmonary inflammation, and a cytotoxic effects and histopathology of
pulmonary tissues, in addition to the standard requirements in the test
guideline.
CFR citation: 40 CFR 721.10153.
PMN Number P-08-157
Chemical name: Quaternary ammonium compounds, dicoco alkyldimethyl,
chlorides, reaction products with silica.
CAS number: 956147-76-5.
Basis for action: The PMN states that the generic (non-confidential)
use of the substance will be as raw material for the manufacture of
release coatings. Based on test data on analogous respirable, poorly
soluble particulates, EPA believes that the PMN substance may cause
lung effects. Based on physical properties of the PMN substance, EPA
believes that it may cause systemic effects via dermal exposure. As
described in the PMN, worker inhalation exposure to particulates is not
expected and dermal exposure is minimal due to the use of adequate
dermal protection. 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 without the use of impervious gloves where there is a
potential for dermal exposure; use of the substance other than as
described in the PMN; or manufacture, processing, or use of the
substance in a powder form, may cause serious health effects. Based on
this information, the PMN substance meets the concern criteria at Sec.
721.170(b)(3)(ii).
Recommended testing: EPA has determined that a 90-day inhalation
toxicity test (OPPTS 870.3465 test guideline) with the addition of a
post-exposure observation period of up to 3 months, and a glove
permeation test (ASTM F739 and F1194-99 test guidelines) would help
characterize the human health effects of the PMN substance. Evaluations
for the inhalation toxicity study should include markers of damage,
oxidant stress, cell proliferation, the degree/intensity and duration
of pulmonary inflammation, and a cytotoxic effects and histopathology
of pulmonary tissues, in addition to the standard requirements in the
test guideline. For the glove permeation testing, gloves should be
exposed to the expected conditions of exposure, including the likely
combinations of chemical substances to which the gloves may be exposed
to in the work area. Results should be recorded as a cumulative
permeation rate as a function of time, and shall be documented in
accordance with ASTM F739 using the format specified in ASTM F1194-99
``Guide for Documenting Results of Chemical Permeation Testing on
Protective Clothing Materials'' or its equivalent.
CFR citation: 40 CFR 721.10154.
PMN Number P-08-177
Chemical name: Multi-walled carbon nanotubes (generic).
CAS number: Not available.
Effective date of TSCA section 5(e) consent order: August 11, 2008.
Basis for TSCA section 5(e) consent order: The PMN states that the
generic (non-confidential) use of the substance
[[Page 29991]]
will be as a property modifier in electronic applications and as a
property modifier in polymer composites. The order was issued under
section 5(e)(1)(A)(i) and (e)(1)(A)(ii)(I) of TSCA. Based on test data
on analogous respirable, poorly soluble particulates and on other
carbon nanotubes (CNTs), EPA believes that the PMN substance might
cause lung effects. To protect against this risk, the consent order
requires use of a National Institute for Occupational Safety and Health
(NIOSH)-approved full-face respirator with N-100 cartridges. Based on
physical properties of the PMN substance, EPA believes it may cause
health effects via dermal exposure. To protect against this risk, the
consent order requires that workers wear gloves and protective clothing
impervious to the chemical substance. The SNUR designates as a
``significant new use'' the absence of these protective measures.
Toxicity concern: There is a concern for lung health effects based on
data for poorly soluble particulates and for other CNTs, and for lung
irritation based on particle size.
Recommended testing: EPA has determined that the results of a 90-day
inhalation toxicity study in rats with a post exposure observation
period of up to 3 months, including bronchoalveolar lavage fluid (BALF)
analysis (OPPTS 870.3465 or OECD 413 test guidelines) and certain
material characterization data, would help characterize possible
effects of the PMN substance. In the consent order, the PMN submitter
has agreed not to exceed a specified production volume or production
time limit (whichever comes first) without performing these tests.
CFR citation: 40 CFR 721.10155.
PMN Number P-08-328
Chemical name: Single-walled carbon nanotubes (generic).
CAS number: Not available.
Effective date of TSCA section 5(e) consent order: September 15, 2008.
Basis for TSCA section 5(e) consent order: The PMN states that the
generic (non-confidential) use of the substance will be as a property
modifier in electronic applications and as a property modifier in
polymer composites. The order was issued under section 5(e)(1)(A)(i)
and (e)(1)(A)(ii)(I) of TSCA. Based on test data on analogous
respirable, poorly soluble particulates and on other carbon nanotubes
(CNTs), EPA believes that the PMN substance might cause health effects.
To protect against this risk, the consent order requires use of a
NIOSH-approved full-face respirator with N-100 cartridges. Based on
physical properties of the PMN substance, EPA believes it may cause
health effects via dermal exposure. To protect against this risk, the
consent order requires that workers wear gloves and protective clothing
impervious to the chemical substance. The SNUR designates as a
``significant new use'' the absence of these protective measures.
Toxicity concern: There is a concern for health effects based on data
for poorly soluble particulates and for other CNTs and for lung
irritation based on particle size.
Recommended testing: EPA has determined that the results of a 90-day
inhalation toxicity study in rats with a post exposure observation
period of up to 3 months, including bronchoalveolar lavage fluid (BALF)
analysis (OPPTS 870.3465 or OECD 413 test guidelines) and certain
material characterization data, would help characterize possible
effects of the PMN substance. In the consent order, the PMN submitter
has agreed not to exceed a specified production volume or production
time limit (whichever comes first) without performing these tests.
CFR citation: 40 CFR 721.10156.
V. Rationale and Objectives of the Rule
A. Rationale
During review of the PMNs submitted for the chemical substances
that are subject to these SNURs, EPA concluded that for 4 of the 23
chemical substances, regulation was warranted under TSCA section 5(e),
pending the development of information sufficient to make reasoned
evaluations of the health or environmental effects of the chemical
substances. The basis for such findings is outlined in Unit IV. Based
on these findings, TSCA section 5(e) consent orders requiring the use
of appropriate exposure controls were negotiated with the PMN
submitters. The SNUR provisions for these chemical substances are
consistent with the provisions of the TSCA section 5(e) consent orders.
These SNURs are promulgated pursuant to Sec. 721.160.
In the other 19 cases, where the proposed uses are not regulated
under a TSCA section 5(e) consent order, EPA determined that one or
more of the criteria of concern established at Sec. 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.
EPA will ensure that all manufacturers, importers, and
processors of the same chemical substance that is subject to a TSCA
section 5(e) consent order are subject to similar requirements.
Issuance of a SNUR for a chemical substance does not signify that
the chemical substance is listed on the 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/newchems/pubs/invntory.htm.
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), this rule is effective
August 24, 2009 without further notice, unless EPA receives written
adverse or critical comments, or notice of intent to submit adverse or
critical comments before July 24, 2009.
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 July 24, 2009, 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.
EPA solicits comments on
[[Page 29992]]
whether any of the uses described as significant new uses are ongoing.
VII. Applicability of Rule to Uses Occurring Before Effective Date of
the Rule
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. TSCA section 5(e) consent orders have
been issued for 4 chemical substances and the PMN submitters are
prohibited by the TSCA section 5(e) consent orders from undertaking
activities which EPA is designating as significant new uses. 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, 16 of the 23
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. 720.25 and Sec. 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 Federal Register of April 24, 1990, 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 notice 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 notice requirements and wait until the notice review
period, including all extensions, expires (see Unit III.).
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, except where the
chemical substance subject to the SNUR is also subject to a test rule
under TSCA section 4 (see TSCA section 5(b)). 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. In cases where EPA issued a
TSCA section 5(e) consent order that requires or recommends certain
testing, Unit IV. lists those tests. Unit IV. also 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. Many test guidelines are now available on the
Internet at http://www.epa.gov/opptsfrs/home/guidelin.htm. The OECD
test guidelines are available from the OECD Bookshop at http://www.oecdbookshop.org or SourceOECD at http://www.sourceoecd.org. The
ASTM test guidelines are available at http://www.astm.org/Standard/index.shtml.
In the TSCA section 5(e) consent orders for several of the chemical
substances regulated under this rule, EPA has established production
volume limits in view of the lack of data on the potential health and
environmental risks that may be posed by the significant new uses or
increased exposure to the chemical substances. These limits cannot be
exceeded unless the PMN submitter first submits the results of toxicity
tests that would permit a reasoned evaluation of the potential risks
posed by these chemical substances. Under recent TSCA section 5(e)
consent orders, each PMN submitter is required to submit each study at
least 14 weeks (earlier TSCA section 5(e) consent orders required
submissions at least 12 weeks) before reaching the specified production
limit. Listings of the tests specified in the TSCA section 5(e) consent
orders are included in Unit IV. The SNURs contain the same production
volume limits as the TSCA section 5(e) consent orders. Exceeding these
production limits is defined as a significant new use. Persons who
intend to exceed the production limit must notify the Agency by
submitting a SNUN at least 90 days in advance of commencement of non-
exempt commercial manufacture/import or processing.
The recommended tests may not be the only means of addressing the
potential risks of the chemical substance. However, SNUNs submitted for
significant new uses 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.
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. This rule cross-
references Sec. 721.1725(b)(1) and is similar to that in Sec. 721.11
for situations where the chemical identity of the chemical substance
subject to a SNUR is CBI. This procedure is cross-referenced in each
SNUR that includes specific significant new uses that are CBI.
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
[[Page 29993]]
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
As stated in Unit II.C., according to Sec. 721.1(c), persons
submitting a SNUN must comply with the same notice requirements and EPA
regulatory procedures as persons submitting a PMN, including submission
of test data on health and environmental effects as described in 40 CFR
720.50. SNUNs must be mailed to the Environmental Protection Agency,
OPPT Document Control Office (7407M), 1200 Pennsylvania Ave., NW.,
Washington, DC 20460-0001. Information must be submitted in the form
and manner set forth in EPA Form No. 7710-25. This form is available
from the Environmental Assistance Division (7408M), 1200 Pennsylvania
Ave., NW., Washington, DC 20460-0001 (see Sec. 721.25 and Sec.
720.40). Forms and information are also available electronically at
http://www.epa.gov/opptintr/newchems/pubs/pmnforms.htm.
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 public docket.
XII. Statutory and Executive Order Reviews
A. Executive Order 12866
This final rule establishes SNURs for several new chemical
substances that were the subject of PMNs, or TSCA section 5(e) consent
orders. 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
According to the Paperwork Reduction Act (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 the 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.
The information collection requirements related to this action have
already been approved by OMB pursuant to the 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
Pursuant to section 605(b) of the Regulatory Flexibility Act (RFA)
(5 U.S.C. 601 et seq.), the Agency hereby certifies that promulgation
of these SNURs will not have a significant adverse economic impact on a
substantial number of small entities. The rationale supporting this
conclusion is as follows. The requirement to submit a SNUN applies to
any person (including small or large entities) who intends to engage in
any activity described in the rule as a ``significant new use.''
Because these uses are ``new,'' based on all information currently
available to EPA, it appears that no small or large entities presently
engage in such activities. A SNUR requires that any person who intends
to engage in such activity in the future must first notify EPA by
submitting a SNUN. Although some small entities may decide to pursue a
significant new use in the future, EPA cannot presently determine how
many, if any, there may be. However, EPA's experience to date is that,
in response to the promulgation of over 1,000 SNURs, the Agency
receives on average only 5 notices per year. Of those SNUNs submitted
from 2006-2008, only one appears to be from a small entity. In
addition, the estimated reporting cost for submission of a SNUN (see
Unit XI.) is minimal regardless of the size of the firm. Therefore, EPA
believes that the potential economic impacts of complying with these
SNURs are not expected to be significant or adversely impact a
substantial number of small entities. In a SNUR that published in the
Federal Register of June 2, 1997 (62 FR 29684) (FRL-5597-1), the Agency
presented its general determination that proposed and final SNURs are
not expected to have a significant economic impact on a substantial
number of small entities, which was provided to the Chief Counsel for
Advocacy of the Small Business Administration.
D. Unfunded Mandates Reform Act
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 affect on
small governments subject to the requirements of sections 202, 203,
204, or 205 of the Unfunded Mandates Reform Act of 1995 (UMRA) (Public
Law 104-4).
[[Page 29994]]
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 does
not significantly or 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
In addition, since this action does not involve any technical
standards, section 12(d) of the National Technology Transfer and
Advancement Act of 1995 (NTTAA), Public Law 104-113, 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
The Congressional Review Act, 5 U.S.C. 801 et seq., generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report, which includes a copy of the rule,
to each House of the Congress and to the Comptroller General of the
United States. 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 rule 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: June 11, 2009.
Barbara A. Cunningham,
Acting Director, Office of Pollution Prevention and Toxics.
0
Therefore, 40 CFR part 721 is amended as follows:
PART 721--[AMENDED]
0
1. The authority citation for part 721 continues to read as follows:
Authority: 15 U.S.C. 2604, 2607, and 2625(c).
0
2. By adding new Sec. 721.10134 to subpart E to read as follows:
Sec. 721.10134 Formaldehyde, polymer with dialkylphenylamine,
dialkylphenol and trimethylhexanediamine (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
formaldehyde, polymer with dialkylphenylamine, dialkylphenol and
trimethylhexanediamine (PMN P-05-1) 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)(1), (b)(1), and (c)(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
3. By adding new Sec. 721.10135 to subpart E to read as follows:
Sec. 721.10135 Phosphinic acid, P,P-diethyl-, zinc salt (2:1).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as phosphinic acid,
P,P-diethyl-, zinc salt (2:1) (PMN P-05-11; CAS No. 284685-45-6) 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=12).
(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
4. By adding new Sec. 721.10136 to subpart E to read as follows:
Sec. 721.10136 2-Propenoic acid, 2-methyl-, 2-hydroxyethyl ester,
reaction products with hexakis(alkoxyalkyl)melamine (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as 2-
propenoic acid, 2-methyl-, 2-hydroxyethyl ester, reaction products with
hexakis(alkoxyalkyl)melamine (PMN P-05-177) 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)(1), (b)(1), and (c)(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
[[Page 29995]]
provisions of Sec. 721.185 apply to this section.
0
5. By adding new Sec. 721.10137 to subpart E to read as follows:
Sec. 721.10137 Halogenated phenoxy aromatic (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
halogenated phenoxy aromatic (PMN P-05-329) 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)(1), (b)(1), and (c)(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
6. By adding new Sec. 721.10138 to subpart E to read as follows:
Sec. 721.10138 3-Isoxazolecarboxylic acid, 4,5-dihydro-5,5-diphenyl-,
ethyl ester.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as 3-
isoxazolecarboxylic acid, 4,5-dihydro-5,5-diphenyl-, ethyl ester (PMN
P-05-336; CAS No. 163520-33-0) 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) Release to water. Requirements as specified in Sec. 721.90
(a)(1), (b)(1), and (c)(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
7. By adding new Sec. 721.10139 to subpart E to read as follows:
Sec. 721.10139 Ethanone, 1-(1-chlorocyclopropyl)-.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as ethanone, 1-(1-
chlorocyclopropyl)- (PMN P-05-776; CAS No. 63141-09-3) 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(g).
(ii) Release to water. Requirements as specified in Sec. 721.90
(a)(4), (b)(4), and (c)(4) (N=500).
(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. By adding new Sec. 721.10140 to subpart E to read as follows:
Sec. 721.10140 Phosphoric acid, tin (2+) salt (2:3).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as phosphoric acid,
tin (2+) salt (2:3) (PMN P-06-33, CAS No. 15578-32-2) 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(f).
(ii) Release to water. Requirements as specified in Sec. 721.90
(b)(1) and (c)(1).
(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
9. By adding new Sec. 721.10141 to subpart E to read as follows:
Sec. 721.10141 Oils, ginger, zingiber purpureum.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as oils, ginger,
zingiber purpureum (PMN P-06-163; CAS No. 864662-46-4) 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)(1), (a)(2)(i), (a)(3), (b), and (c).
(ii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(f).
(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), (e), 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.
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10. By adding new Sec. 721.10142 to subpart E to read as follows:
Sec. 721.10142 Oxabicycloalkane carboxylic acid alkanediyl ester
(generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
oxabicycloalkane carboxylic acid alkanediyl ester (PMN P-06-199) 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)(1), (b)(1), and (c)(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.
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11. By adding new Sec. 721.10143 to subpart E to read as follows:
Sec. 721.10143 Amines, bis (C11-14-branched and linear alkyl).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as amines, bis (C11-
14-branched and linear alkyl) (PMN P-06-733; CAS No. 900169-60-0) is
subject to reporting
[[Page 29996]]
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)(1), (b)(1), and (c)(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.
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12. By adding new Sec. 721.10144 to subpart E to read as follows:
Sec. 721.10144 Modified thiocarbamate (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
modified thiocarbamate (PMN P-06-805) 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)(1), (b)(1), and (c)(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.
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13. By adding new Sec. 721.10145 to subpart E to read as follows:
Sec. 721.10145 Modified reaction products of alkyl alcohol,
halogenated alkane, substituted epoxide, and amino compound (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
modified reaction products of alkyl alcohol, halogenated alkane,
substituted epoxide, and amino compound (PMN P-06-816) 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(k) (analysis and reporting and limitations
of maximum impurity levels of certain fluorinated impurities) and (q).
(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.
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14. By adding new Sec. 721.10146 to subpart E to read as follows:
Sec. 721.10146 Partially fluorinated condensation polymer (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
partially fluorinated condensation polymer (PMN P-07-87) 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(k) (analysis and reporting and limitations
of maximum impurity levels of certain fluorinated impurities), (l)
(maximum percentage of the PMN substance in a non-industrial product or
distributed for use as a non-industrial product), (o) (use in a
consumer product that could be spray applied), and (q).
(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.
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15. By adding new Sec. 721.10147 to subpart E to read as follows:
Sec. 721.10147 Acrylate derivative of alkoxysilylalkane ester and
mixed metal oxides (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
acrylate derivative of alkoxysilylalkane ester and mixed metal oxides
(PMN P-07-198) 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)(1), (a)(2)(i), (a)(3), (b) (concentration set at 1 percent),
and (c).
(ii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80 (j), (v)(1), (w)(1), and (x)(1).
(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), (e), 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.
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16. By adding new Sec. 721.10148 to subpart E to read as follows:
Sec. 721.10148 Acryloxy alkanoic alkane derivative with mixed metal
oxides (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
acryloxy alkanoic alkane derivative with mixed metal oxides (PMN P-07-
330) 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)(1), (a)(2)(i), (a)(3), (b) (concentration set at 1 percent),
and (c).
(ii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80 (j), (v)(1), (w)(1), and (x)(1).
(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), (e), and (i) are applicable to
manufacturers, importers, and processors of this substance.
[[Page 29997]]
(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.
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17. By adding new Sec. 721.10149 to subpart E to read as follows:
Sec. 721.10149 Carbon black, (3-methylphenyl)-modified, substituted
(generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as carbon
black, (3-methylphenyl)-modified, substituted (PMN P-07-522) 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)(1), (a)(2)(i), (a)(3), (b) (concentration set at 1 percent),
and (c).
(ii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80 (j), (v)(1), (w)(1), and (x)(1).
(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), (e), and (i) are applicable to
manufacturers, importers, and processors of these substances.
(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.
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18. By adding new Sec. 721.10150 to subpart E to read as follows:
Sec. 721.10150 Carbon black, (4-methylphenyl)-modified, substituted
(generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as carbon
black, (4-methylphenyl)-modified, substituted (PMN P-07-523) 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)(1), (a)(2)(i), (a)(3), (b) (concentration set at 1 percent),
and (c).
(ii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80 (j), (v)(1), (w)(1), and (x)(1).
(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), (e), and (i) are applicable to
manufacturers, importers, and processors of these substances.
(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.
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19. By adding new Sec. 721.10151 to subpart E to read as follows:
Sec. 721.10151 Modified styrene, divinylbenzene polymer (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
modified styrene, divinylbenzene polymer (PMN P-07-642) 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)(1), (a)(2)(i), (a)(3), (b) (concentration set at 1 percent),
and (c).
(ii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80 (j), (v)(1), (w)(1), and (x)(1).
(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), (e), and (i) are applicable to
manufacturers, importers, and processors of these substances.
(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.
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20. By adding new Sec. 721.10152 to subpart E to read as follows:
Sec. 721.10152 Oxirane, substituted silylmethyl-, hydrolysis products
with alkanol zirconium(4+) salt and silica, acetates (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
oxirane, substituted silylmethyl-, hydrolysis products with alkanol
zirconium(4+) salt and silica, acetates (PMN P-07-674) 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)(1), (a)(2)(i), (a)(3), (b) (concentration set at 1 percent),
and (c).
(ii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80 (a), (j), (v)(1), (w)(1), and (x)(1).
(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), (e), and (i) are applicable to
manufacturers, importers, and processors of these substances.
(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.
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21. By adding new Sec. 721.10153 to subpart E to read as follows:
Sec. 721.10153 Modified methyl methacrylate, 2-hydroxyethyl
methacrylate polymer (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
modified methyl methacrylate, 2-hydroxyethyl methacrylate polymer (PMN
P-08-6) 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)(1), (a)(2)(i), (a)(3), (b) (concentration set at 1 percent),
and (c).
(ii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80 (j), (v)(1), (w)(1), and (x)(1).
(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), (e), and (i) are applicable to
manufacturers, importers, and processors of these substances.
(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.
[[Page 29998]]
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22. By adding new Sec. 721.10154 to subpart E to read as follows:
Sec. 721.10154 Quaternary ammonium compounds, dicoco alkyldimethyl,
chlorides, reaction products with silica.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as quaternary ammonium
compounds, dicoco alkyldimethyl, chlorides, reaction products with
silica (PMN P-08-157; CAS No. 956147-76-5) 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)(1), (a)(2)(i), (a)(3), (b) (concentration set at 1 percent),
and (c).
(ii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80 (j), (v)(1), (w)(1), and (x)(1).
(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), (e), and (i) are applicable to
manufacturers, importers, and processors of these substances.
(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.
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23. By adding new Sec. 721.10155 to subpart E to read as follows:
Sec. 721.10155 Multi-walled carbon nanotubes (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as multi-
walled carbon nanotubes (PMN P-08-177) 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)(1), (a)(2)(i), (a)(2)(ii), (a)(3), (a)(4), (a)(5) (National
Institute for Occupational Safety and Health (NIOSH)-approved air-
purifying, tight-fitting full-face respirator equipped with N100
filters), (a)(6)(i), and (c).
(ii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80 (j) and (q).
(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), (e), 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.
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24. By adding new Sec. 721.10156 to subpart E to read as follows:
Sec. 721.10156 Single-walled carbon nanotubes (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as single-
walled carbon nanotubes (PMN P-08-328) 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)(1), (a)(2)(i), (a)(2)(ii), (a)(3), (a)(4), (a)(5) (National
Institute for Occupational Safety and Health (NIOSH)-approved air-
purifying, tight-fitting full-face respirator equipped with N100
filters), (a)(6)(i), and (c).
(ii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80 (j) and (q).
(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), (e), 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.
[FR Doc. E9-14780 Filed 6-23-09; 8:45 am]
BILLING CODE 6560-50-S