[Federal Register Volume 75, Number 181 (Monday, September 20, 2010)]
[Rules and Regulations]
[Pages 57169-57186]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-23415]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Parts 9 and 721
[EPA-HQ-OPPT-2009-922; FRL-8839-7]
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 25
chemical substances which were the subject of premanufacture notices
(PMNs). One of these chemical substances is subject to a TSCA section
5(e) consent order issued by EPA. This action requires persons who
intend to manufacture, import, or process any of these 25 chemical
substances for an activity that is designated as a significant new use
by this rule to notify EPA at least 90 days before commencing that
activity. The required notification will provide EPA with the
opportunity to evaluate the intended use and, if necessary, to prohibit
or limit that activity before it occurs.
DATES: This rule is effective on November 19, 2010. For purposes of
judicial review, this rule shall be promulgated at 1 p.m. (e.s.t.) on
October 4, 2010.
Written adverse or critical comments, or notice of intent to submit
adverse or critical comments, on one or more of these SNURs must be
received on or before October 20, 2010 (see Unit VI. of the
SUPPLEMENTARY INFORMATION).
For additional information on related reporting requirement dates,
see Units I.A., VI., and VII. of the SUPPLEMENTARY INFORMATION.
ADDRESSES: Submit your comments, identified by docket identification
(ID) number EPA-HQ-OPPT-2009-922, 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-2009-922. 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-
2009-922. EPA's policy is that all comments received will be included
in the 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 docket and made available on the
Internet. If you submit an electronic comment, EPA recommends that you
include your name and other contact information in the body of your
comment and with any disk or CD-ROM you submit. If EPA cannot read your
comment due to technical difficulties and cannot contact you for
clarification, EPA may not be able to consider your comment. Electronic
files should avoid the use of special characters, any form of
encryption, and be free of any defects or viruses.
Docket: All documents in the docket are listed in the docket index
available at http://www.regulations.gov. Although listed in the index,
some information is not publicly available, e.g., CBI or other
information whose disclosure is restricted by statute. Certain other
material, such as copyrighted material, will be publicly available only
in hard copy. Publicly available docket materials are available
electronically at http://www.regulations.gov, or, if only available in
hard copy, at the OPPT Docket. The OPPT Docket is located in
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the EPA Docket Center (EPA/DC) at Rm. 3334, EPA West Bldg., 1301
Constitution Ave., NW., Washington, DC. The EPA/DC Public Reading Room
hours of operation are 8:30 a.m. to 4:30 p.m., Monday through Friday,
excluding legal holidays. The telephone number of the EPA/DC Public
Reading Room is (202) 566-1744, and the telephone number for the OPPT
Docket is (202) 566-0280. Docket visitors are required to show
photographic identification, pass through a metal detector, and sign
the EPA visitor log. All visitor bags are processed through an X-ray
machine and subject to search. Visitors will be provided an EPA/DC
badge that must be visible at all times in the building and returned
upon departure.
FOR FURTHER INFORMATION CONTACT: For technical information contact:
Kenneth Moss, Chemical Control Division (7405M), Office of Pollution
Prevention and Toxics, Environmental Protection Agency, 1200
Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone number:
(202) 564-9232; e-mail address: [email protected].
For general information contact: The TSCA-Hotline, ABVI-Goodwill,
422 South Clinton Ave., Rochester, NY 14620; telephone number: (202)
554-1404; 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;
see also 19 CFR 127.28. Chemical importers must certify that the
shipment of the chemical substance complies with all applicable rules
and orders under TSCA. Importers of chemicals subject to these SNURs
must certify their compliance with the SNUR requirements. The EPA
policy in support of import certification appears at 40 CFR part 707,
subpart B. In addition, any persons who export or intend to export a
chemical substance that is the subject of this rule on or after October
20, 2010 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) (see
Unit III.). Once EPA determines that a use of a chemical substance is a
significant new use, TSCA section 5(a)(1)(B) requires persons to submit
a significant new use notice (SNUN) to EPA at least 90 days before they
manufacture, import, or process the chemical substance for that use.
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, exemptions to reporting requirements, and applicability
of the rule to uses occurring before the effective date of the rule.
Provisions relating to user fees
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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.
2612) import certification requirements promulgated at 19 CFR 12.118
through 12.127; see also 19 CFR 127.28. Chemical importers must certify
that the shipment of the chemical substance complies with all
applicable rules and orders under TSCA. Importers of chemicals subject
to these SNURs must certify their compliance with the SNUR
requirements. The EPA policy in support of import certification appears
at 40 CFR part 707, subpart B. In addition, any persons who export or
intend to export a chemical substance identified in a proposed or final
SNUR 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.
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
25 chemical substances that are the subject of these SNURs, EPA
considered relevant information about the toxicity of the chemical
substances, likely human exposures and environmental releases
associated with possible uses, and the four bulleted TSCA section
5(a)(2) factors listed in this unit.
IV. Substances Subject to this Rule
EPA is establishing significant new use and recordkeeping
requirements for 25 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
volume) and other uses designated in this rule, may be claimed as CBI.
Unit IX. discusses a procedure companies may use to ascertain whether a
proposed use constitutes a significant new use.
This rule includes one PMN substance (P-04-269) that is subject to
a ``risk-based'' consent order under TSCA section 5(e)(1)(A)(ii)(I)
where EPA determined that activities associated with the PMN substance
may present unreasonable risk to human health and the environment. The
consent order requires protective measures to limit exposures or
otherwise mitigate the potential unreasonable risk. The so-called
``5(e) SNUR'' on this PMN substance is promulgated pursuant to Sec.
721.160, and is based on and consistent with the provisions in the
underlying consent order. The 5(e) SNUR designates as a ``significant
new use'' the absence of the protective measures required in the
corresponding consent order.
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 24 PMN substances that are not
subject to consent orders under TSCA section 5(e). In these cases, for
a variety of reasons, EPA did not find that the use scenario described
in the PMN triggered the determinations set forth under TSCA section
5(e). However, EPA does believe that certain changes from the use
scenario described in the PMN could result in increased exposures,
thereby constituting a ``significant new use.'' These so-called ``non-
5(e) SNURs'' are promulgated pursuant to Sec. 721.170. EPA has
determined that every activity designated as a ``significant new use''
in all non-5(e) SNURs issued under Sec. 721.170 satisfies the two
requirements stipulated in Sec. 721.170(c)(2), i.e., these significant
new use activities, ``(i) are different from those described in the
premanufacture notice for the substance, including any amendments,
deletions, and additions of activities to the premanufacture notice,
and (ii) may be accompanied by changes in exposure or release levels
that are significant in relation to the health or environmental
[[Page 57172]]
concerns identified'' for the PMN substance.
PMN Number P-04-269
Chemical name: Cobalt lithium manganese nickel oxide.
CAS number: 182442-95-1.
Effective date of TSCA section 5(e) consent order: May 12, 2009.
Basis for TSCA section 5(e) consent order: The PMN states that the
substance will be used as a battery cathode material. The order was
issued under sections 5(e)(1)(A)(i) and 5(e)(1)(A)(ii)(I) of TSCA based
on findings that this substance may present an unreasonable risk of
injury to human health and the environment. To protect against these
risks, the consent order requires use of dermal personal protective
equipment, including gloves demonstrated to be impervious, use of
respiratory personal protective equipment, including a National
Institute of Occupational Safety and Health (NIOSH)-approved respirator
with an assigned protection factor (APF) of at least 150 or compliance
with a NCEL of 0.1 mg/m\3\ as an 8-hour time-weighted average,
establishment of a hazard communication program, and prohibits releases
to water. The SNUR designates as a ``significant new use'' the absence
of these protective measures.
Toxicity concern: Based on test data on nickel, lithium and cobalt, EPA
has concerns for developmental toxicity, mutagenicity, oncogenicity,
pulmonary oncogenicity, and lung overload for workers with inhalation
and dermal exposure to the PMN substance. EPA set the NCEL at 0.1 mg/
m\3\ as an 8-hour time-weighted average. In addition, based on test
data on analogous nickel containing compounds, EPA predicts toxicity to
aquatic organisms may occur at concentrations that exceed 1 part per
billion (ppb) of the PMN substance in surface waters.
Recommended testing: EPA has determined that the results of the
following tests would help characterize the human health and
environmental effects of the PMN substance: A 90-day inhalation
toxicity test (OPPTS Test Guideline 870.3465); a fish acute toxicity
test, freshwater and marine (OPPTS Test Guideline 850.1075); an aquatic
invertebrate acute toxicity test, freshwater daphnids (OPPTS Test
Guideline 850.1010); and an algal toxicity test, tiers I and II (OPPTS
Test Guideline 850.5400). All aquatic toxicity testing should be
performed using the static method with measured concentrations. Test
reports should include protocols approved by EPA, certificate of
analysis for the test substance, raw data, and results. The order does
not require submission of the aforementioned information at any
specified time or production volume. However, the order's restrictions
on manufacturing, import, processing, distribution in commerce, use,
and disposal of the PMN substance will remain in effect until the order
is modified or revoked by EPA based on submission of that or other
relevant information.
CFR citation: 40 CFR 721.10201.
PMN Number P-08-701
Chemical name: Benzoic acid, 4-chloro-2- [(substituted)azo]-, strontium
salt (1:1) (generic).
CAS number: Not available.
Basis for action: The PMN states that the generic (non-confidential)
use of the substance will be as a pigment for plastics. Based on test
data on analogous substances, EPA has concerns for oncogenicity,
developmental toxicity, and blood and spleen effects from exposure to
the azo reduction products of the PMN substance via inhalation. Since
significant worker exposure is unlikely for the uses described in the
PMN, EPA has not determined that the proposed manufacturing,
processing, or use of the substance may present an unreasonable risk.
EPA has determined, however, that use of the substance other than as
described in the PMN 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 results from the following
tests would help characterize the human health effects of the PMN
substance: A bacterial reverse mutation test (OPPTS Test Guideline
870.5100) with prival modification, and an unscheduled DNA synthesis in
mammalian cells in culture test (OPPTS Test Guideline 870.5550) for the
azo reduction product of the PMN substance. Test reports should include
protocols approved by EPA, certificate of analysis for the test
substance, raw data, and results.
CFR citation: 40 CFR 721.10202.
PMN Number P-08-742
Chemical name: Phosphonium, tetrabutyl-, hydroxide (1:1).
CAS number: 14518-69-5.
Basis for action: The PMN states that the substance will be used as a
chemical intermediate for manufacturing tetrabutylphosphonium salt, as
an export for industrial use, and additional confidential chemical
intermediate uses. Based on test data on the PMN substance, 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, 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)(i).
Recommended testing: EPA has determined that the results of the
following tests would help characterize the environmental effects of
the PMN substance: A fish early-life stage toxicity test (OPPTS Test
Guideline 850.1400); a daphnid chronic toxicity test (OPPTS Test
Guideline 850.1300); and an algal toxicity test, tiers I and II (OPPTS
Test Guideline 850.5400). Fish and daphnid testing should be performed
using the flow-through method with measured concentrations. Algal
testing should be performed using the static method with measured
concentrations. Test reports should include protocols approved by EPA,
certificate of analysis for the test substance, raw data, and results.
CFR citation: 40 CFR 721.10203.
PMN Number P-08-754
Chemical name: Aryloxyacrylate (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 ecological
structural activity relationship (EcoSAR) analysis of test data on
analogous acrylates, EPA predicts toxicity to aquatic organisms may
occur at concentrations that exceed 3 ppb of the PMN substance in
surface waters. As described in the PMN, releases of the PMN substance
are not expected to result in surface water concentrations that exceed
3 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 3 ppb may
cause significant adverse environmental effects. Based on this
information, the PMN substance meets the concern criteria at Sec.
721.170(b)(4)(ii).
Recommended testing: EPA has determined that results of the following
tests would help characterize the environmental effects of the PMN
substance: A fish acute toxicity test, freshwater and marine (OPPTS
Test Guideline 850.1075) using the flow-
[[Page 57173]]
through method with measured concentrations; an aquatic invertebrate
acute toxicity test, freshwater daphnids (OPPTS Test Guideline
850.1010) using the flow-through method with measured concentrations;
and an algal toxicity test, tiers I and II (OPPTS Test Guideline
850.5400) using the static method with measured concentrations. Test
reports should include protocols approved by EPA, certificate of
analysis for the test substance, raw data, and results.
CFR citation: 40 CFR 721.10204.
PMN Number P-09-4
Chemical name: Formaldehyde, polymer with 1,3-benzenediol and 1,1'-
methylenebis[isocyanatobenzene].
CAS number: 1067881-45-1.
Basis for action: The PMN states that the generic (non-confidential)
use of the substance will be as a rubber additive. Based on EcoSAR
analysis of test data on analogous esters and polyphenols, 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,
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 results of the following
tests would help characterize the environmental effects of the PMN
substance: A fish acute toxicity test, freshwater and marine (OPPTS
Test Guideline 850.1075) using the flow-through method with mean
measured concentrations; an aquatic invertebrate acute toxicity test,
freshwater daphnids (OPPTS Test Guideline 850.1010) using the flow-
through method with mean measured concentrations; and an algal toxicity
test, tiers I and II (OPPTS Test Guideline 850.5400) using the static
method with mean measured concentrations. Test reports should include
protocols approved by EPA, certificate of analysis for the test
substance, raw data, and results.
CFR citation: 40 CFR 721.10205.
PMN Number P-09-19
Chemical name: 4-Cyclohexene-1,2-dicarboxylic acid, 1,2-bis(2-
oxiranylmethyl) ester.
CAS number: 21544-03-6.
Basis for action: The PMN states that the substance will be used as an
epoxy resin for filament winding and electrical encapsulation of motors
and generators. Based on test data on analogous esters and epoxides,
EPA identified concerns for lung and dermal sensitization,
mutagenicity, oncogenicity, male reproductive toxicity, liver and
kidney toxicity, and eye corrosion to workers exposed to the PMN
substance. As described in the PMN, worker inhalation exposure is
expected to be negligible and dermal exposure is expected to be minimal
due to the use of 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
dermal protection where there is potential for dermal exposure, or
without the appropriate hazard communication may result in serious
health effects. Based on this information, the PMN substance meets the
concern criteria at Sec. 721.170 (b)(1)(i)(C) and (b)(3)(ii).
Recommended testing: EPA has determined that results of the following
tests would help characterize the human health effects of the PMN
substance: A 90-day dermal toxicity study (OPPTS Test Guideline
870.3250) with attention to the pathology of the reproductive organs
and a carcinogenicity study (OPPTS Test Guideline 870.4200). Test
reports should include protocols approved by EPA, certificate of
analysis for the test substance, raw data, and results.
CFR citation: 40 CFR 721.10206.
PMN Number P-09-38
Chemical name: 1,3-Cyclohexanedimethanamine, N1,N3-bis(2-
methylpropylidene)-.
CAS number: 173904-11-5.
Basis for action: The PMN states that the generic (non-confidential)
use of the substance will be as a curing agent for polyurethane
systems. Based on EcoSAR analysis of test data on analogous Schiff
bases and 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, the substance is not expected
to 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 results of the following
tests would help characterize the environmental effects of the PMN
substance: A water solubility: column elution method; shake flask
method (OPPTS Test Guideline 830.7840); a fish acute toxicity test,
freshwater and marine (OPPTS Test Guideline 850.1075) using the flow-
through method with mean measured concentrations; an aquatic
invertebrate acute toxicity test, freshwater daphnids (OPPTS Test
Guideline 850.1010) using the flow-through method with mean measured
concentrations; and an algal toxicity test, tiers I and II (OPPTS Test
Guideline 850.5400) using the static method and mean measured
concentrations. Test reports should include protocols approved by EPA,
certificate of analysis for the test substance, raw data, and results.
CFR citation: 40 CFR 721.10207.
PMN Number P-09-71
Chemical name: Amines, di-C11-14-isoalkyl, C13-rich.
CAS number: 1005516-89-1.
Basis for action: The PMN states that the generic (non-confidential)
use of the substance will be as a chemical intermediate. Based on
EcoSAR analysis of test data on analogous aliphatic amines, EPA
predicts that toxicity to aquatic organisms may occur at concentrations
that exceed 2 ppb of the PMN substance in surface waters. As described
in the PMN, releases of the PMN substance are not expected to result in
surface water concentrations that exceed 2 ppb. Therefore, EPA has not
determined that the proposed manufacturing, processing, or use of the
substance may present an unreasonable risk. EPA has determined,
however, that any use of the substance resulting in surface water
concentrations exceeding 2 ppb may cause significant adverse
environmental effects. Based on this information, the PMN substance
meets the concern criteria at Sec. 721.170(b)(4)(ii).
Recommended testing: EPA has determined that results of the following
tests would help characterize the environmental effects of the PMN
substance: A fish acute toxicity test, freshwater and marine (OPPTS
Test Guideline 850.1075) using the flow-through method with mean
measured concentrations or a fish acute toxicity mitigated by humic
acid (OPPTS Test Guideline 850.1085) using the flow-through method with
measured concentrations; an aquatic invertebrate acute toxicity test,
freshwater daphnids (OPPTS Test Guideline 850.1010) using the flow-
through method with mean
[[Page 57174]]
measured concentrations; and an algal toxicity test, tiers I and II
(OPPTS Test Guideline 850.5400) using the static method with mean
measured concentrations. Test reports should include protocols approved
by EPA, certificate of analysis for the test substance, raw data, and
results.
CFR citation: 40 CFR 721.10208.
PMN Number P-09-120
Chemical name: Epoxy terminated, hydrolyzed trialkoxysilane and
glycidyl ether of phenol-formaldehyde resin (generic).
CAS number: Not available.
Basis for action: The PMN states that the substance will be used as a
polymerizable component of adhesive formulations. Based on EcoSAR
analysis of test data on analogous alkoxysilanes and polyepoxides, EPA
predicts toxicity to aquatic organisms may occur at concentrations that
exceed 81 ppb of the PMN substance in surface waters. As described in
the PMN, the substance is not expected to 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 the
following tests would help characterize the environmental effects of
the PMN substance: A fish acute toxicity test, freshwater and marine
(OPPTS Test Guideline 850.1075) using the flow-through method with mean
measured concentrations; an aquatic invertebrate acute toxicity test,
freshwater daphnids (OPPTS Test Guideline 850.1010) using the flow-
through method with mean measured concentrations; and an algal toxicity
test, tiers I and II (OPPTS Test Guideline 850.5400) using the static
method with mean measured concentrations. Test reports should include
protocols approved by EPA, certificate of analysis for the test
substance, raw data, and results.
CFR citation: 40 CFR 721.10209.
PMN Number P-09-130
Chemical name: Soybean oil, epoxidized, reaction products with
diethanolamine.
CAS number: 1002761-12-7.
Basis for action: The PMN states that the generic (non-confidential)
use of the substance will be as a polyol for flexible and rigid
polyurethane foam applications. Based on EcoSAR analysis of test data
on analogous aliphatic amines, EPA predicts toxicity to aquatic
organisms may occur at concentrations that exceed 6 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 the
following tests would help characterize the environmental effects of
the PMN substance: A ready biodegradability test (OPPTS Test Guideline
835.3110); a fish acute toxicity test, freshwater and marine (OPPTS
Test Guideline 850.1075) using the flow-through method with mean
measured concentrations; an aquatic invertebrate acute toxicity test,
freshwater daphnids (OPPTS Test Guideline 850.1010) using the flow-
through method with mean measured concentrations; and an algal toxicity
test, tiers I and II (OPPTS Test Guideline 850.5400) using the static
method with mean measured concentrations. Test reports should include
protocols approved by EPA, certificate of analysis for the test
substance, raw data, and results.
CFR citation: 40 CFR 721.10210.
PMN Number P-09-172
Chemical name: Octadecanoic acid, reaction products with
diethylenetriamine and urea, acetates.
CAS number: 84962-05-0.
Basis for action: The PMN states that the substance will be used as a
softener padded on cotton fabrics. Based on EcoSAR analysis of test
data on analogous aliphatic amines, EPA predicts toxicity to aquatic
organisms may occur at concentrations that exceed 1 ppb of the PMN
substance in surface waters. For the annual manufacture and import
volume described in the PMN, the substance is not expected to be
released to water. 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 exceedance of the
annual maximum manufacture and import limit of 10,000 kilograms, could
result in releases to water, which may cause significant adverse
environmental effects. Based on this information, the PMN substance
meets the concern criteria at Sec. 721.170(b)(4)(ii).
Recommended testing: EPA has determined that the results of the
followings tests would help characterize the environmental effects of
the PMN substance: A fish acute toxicity test, freshwater and marine
(OPPTS Test Guideline 850.1075); an aquatic invertebrate acute toxicity
test, freshwater daphnids (OPPTS Test Guideline 850.1010); and an algal
toxicity test, tiers I and II (OPPTS Test Guideline 850.5400). Fish and
daphnid testing should be performed using the flow-through method with
mean measured concentrations. Algal testing should be formed using the
static method with mean measured concentrations. Test reports should
include protocols approved by EPA, certificate of analysis for the test
substance, raw data, and results.
CFR citation: 40 CFR 721.10211.
PMN Number P-09-241
Chemical name: 1,2-Ethanediol, reaction products with epichlorohydrin.
CAS number: 705265-31-2.
Basis for action: The PMN states that the generic (non-confidential)
use of the substance will be as an industrial reactant. Based on test
data on analogous epoxides, EPA identified the following toxicity
concerns from exposure to the PMN substance: Irritation and
sensitization to eyes, skin, and lungs; mutagenicity; oncogenicity; and
developmental, liver, kidney, and male reproductive toxicity. Based on
this information, the PMN substance meets the concern criteria at Sec.
721.170(b)(3)(ii). At the production volume stated in the PMN, worker
exposure and general population exposure are limited. Therefore, EPA
has not determined that the proposed manufacturing, processing, or use
of the substance may present an unreasonable risk under TSCA section
5(e). However, EPA has determined in accordance with TSCA section
5(a)(2)(A) and (C) and 40 CFR 721.170(a), that exceedance of the annual
maximum manufacture and import limit of 100,000 kilograms may result in
significant human exposures or environmental release.
Recommended testing: EPA has determined that the results of the
following tests would help characterize the human health effects of the
PMN substance: Aerobic mineralization in surface water - simulation
biodegradation test (Organisation for Economic Co-operation and
Development (OECD) 309 test guideline) using the receiving water where
the discharge will occur; an acute oral toxicity test (OPPTS Test
Guideline 870.1100 or OECD 425 test guideline); a bacterial reverse
mutation test (OPPTS
[[Page 57175]]
Test Guideline 870.5100); a mammalian erythrocyte micronucleus test
(OPPTS Test Guideline 870.5395) using the intraperitoneal route; and a
repeated dose 28-day oral toxicity test (OPPTS Test Guideline 870.3050
or OECD 407 test guideline) in rodents. The 28-day oral study should
include, for all test doses, a neurotoxicity functional observational
battery (FOB), as described in neurotoxicity screening battery (OPPTS
Test Guideline 870.6200). Test reports should include protocols
approved by EPA, certificate of analysis for the test substance, raw
data, and results.
CFR citation: 40 CFR 721.10212.
PMN Number P-09-253
Chemical name: Polyether polyester copolymer phosphate (generic).
CAS number: Not available.
Basis for action: The PMN states that the generic (non-confidential)
use of the substance will be as an additive for molding compounds.
Based on EcoSAR analysis of test data on analogous organic phosphates,
EPA predicts toxicity to aquatic organisms may occur at concentrations
that exceed 22 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 results of the following
tests would help characterize the environmental effects of the PMN
substance: Ready biodegradability test (OPPTS Test Guideline 835.3110);
a fish acute toxicity test, freshwater and marine (OPPTS Test Guideline
850.1075) using the flow-through method with mean measured
concentrations; an aquatic invertebrate acute toxicity test, freshwater
daphnids (OPPTS Test Guideline 850.1010) using the flow-through method
with mean measured concentrations; and an algal toxicity test, tiers I
and II (OPPTS Test Guideline 850.5400) using the static method with
mean measured concentrations. Test reports should include protocols
approved by EPA, certificate of analysis for the test substance, raw
data, and results.
CFR citation: 40 CFR 721.10213.
PMN Number P-09-286
Chemical name: Poly(oxyalkylenediyl), .alpha.-substituted
carbomonocycle-.omega.-substituted carbomonocycle (generic).
CAS number: Not available.
Basis for action: The PMN states that the generic (non-confidential)
use of the substance will be as a coatings resin. Based on EcoSAR
analysis of test data on analogous esters, 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, 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 the
following tests would help characterize the environmental effects of
the PMN substance: A ready biodegradability - CO2 in sealed
vessels (headspace test) (OECD 310 test guideline); a fish early-life
stage toxicity test (OPPTS Test Guideline 850.1400) using the flow-
through method with measured concentrations; a daphnid chronic toxicity
test (OPPTS Test Guideline 850.1300) using the flow-through method with
measured concentrations; and an algal toxicity test, tiers I and II
(OPPTS Test Guideline 850.5400) using the static method with measured
concentrations. Test reports should include protocols approved by EPA,
certificate of analysis for the test substance, raw data, and results.
CFR citation: 40 CFR 721.10214.
PMN Number P-09-385
Chemical name: Benzenepropanol, .beta.-methyl-.
CAS number: 7384-80-7.
Basis for action: The PMN states that the substance will be used as a
raw material to manufacture another chemical. Based on test data on the
PMN substance, EPA identified possible skin sensitization concerns from
dermal exposure to the PMN substance. Based on test data on analogous
substances, the Agency identified concerns for liver toxicity, kidney
toxicity, neurotoxicity, and possible developmental toxicity to workers
exposed dermally to the PMN substance. For the uses described in the
PMN, worker inhalation exposure is not expected and EPA does not expect
significant dermal exposure due to the use of impervious gloves.
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 other than
as an intermediate, or without the use of impervious gloves where there
is potential for dermal exposure, may cause serious health effects.
Based on this information, the PMN substance meets the concern criteria
at Sec. 721.170 (b)(3)(i) and (b)(3)(ii).
Recommended testing: EPA has determined that the results of a 90-day
oral toxicity test (OPPTS Test Guideline 870.3100) in rodents would
help characterize the human health effects of the PMN substance. Test
reports should include protocols approved by EPA, certificate of
analysis for the test substance, raw data, and results.
CFR citation: 40 CFR 721.10215.
PMN Number P-09-411
Chemical name: 2-Propenoic acid, 3-(5,5,6-trimethylbicyclo[2.2.1]hept-
2-yl)cyclohexyl ester.
CAS number: 903876-45-9.
Basis for action: The PMN states that the generic (non-confidential)
use of the substance will be as a thermoset adhesive component. EPA has
identified health and environmental concerns because the substance may
be a persistent, bio-accumulative, and toxic (PBT) chemical, based on
physical/chemical properties of the PMN substance, as described in the
New Chemical 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 5,000. Also, based on test data on
analogous acrylates, EPA believes exposure to the PMN substance may
cause systemic human health effects and predicts toxicity to aquatic
organisms. As described in the PMN, significant worker exposure is
unlikely, and the substance is neither released to surface waters nor
landfilled. 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 or any disposal of the manufacturing, process, or use
stream of the PMN substance other than by incineration may cause
serious health effects and significant adverse environmental effects,
since the PMN substance has been characterized by EPA as a PBT
substance that can migrate to ground water. Based on this
[[Page 57176]]
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. Test reports
should include protocols approved by EPA, certificate of analysis for
the test substance, raw data, and results.
CFR citation: 40 CFR 721.10216.
PMN Number P-09-426
Chemical name: Branched and linear alcohols (generic).
CAS number: Not available.
Basis for action: The PMN states that the substance will be used as a
site-limited raw material. Based on structure activity relationship
analysis of test data on analogous neutral organic chemicals, EPA
predicts toxicity to aquatic organisms may occur at concentrations that
exceed 1 ppb of the PMN substance in surface waters. As described in
the PMN, releases of the substance are not expected to result in
surface water concentrations that exceed 1 ppb. Therefore, EPA has not
determined that the proposed manufacturing, processing, or use of the
substance may present an unreasonable risk. EPA has determined,
however, that any use of the substance resulting in surface water
concentrations exceeding 1 ppb may cause significant adverse
environmental effects. Based on this information, the PMN substance
meets the concern criteria at Sec. 721.170(b)(4)(ii).
Recommended testing: EPA has determined that the results of the
following tests would help characterize the environmental effects of
the PMN substance: Based on the results of the potential solubility
pretest either a water solubility: column elution method; shake flask
method test (OPPTS Test Guideline 830.7840) or a water solubility:
generator column method test (OPPTS Test Guideline 830.7860) and an
algal toxicity test, tiers I and II (OPPTS Test Guideline 850.5400)
using static method and mean measured concentrations. Based on the
results of these tests, a fish acute toxicity test, freshwater and
marine (OPPTS Test Guideline 850.1075), and an aquatic invertebrate
acute toxicity test, freshwater daphnids (OPPTS Test Guideline
850.1010) may also be recommended. Test reports should include
protocols approved by EPA, certificate of analysis for the test
substance, raw data, and results.
CFR citation: 40 CFR 721.10217.
PMN Number P-09-436
Chemical name: 2-Propenoic acid, 2-methyl-, C12-15-branched and linear
alkyl esters, telomers with alkyl 2-[[(alkylthio)thioxomethyl]thio]-2-
alkanoate, aminoalkyl methacrylate and alkyl methacrylate, tert-Bu 2-
ethylhexanoperoxoate-initiated (generic).
CAS number: Not available.
Basis for action: The PMN states that the generic (non-confidential)
use of the substance will be as a lubricant additive. Based on EcoSAR
analysis of test data on analogous polycationic polymers, EPA predicts
toxicity to aquatic organisms may occur at concentrations that exceed
410 ppb of the PMN substance in surface waters. As described in the
PMN, during manufacturing the substance will not be released to surface
waters. During processing and use, releases of the substance are not
expected to result in surface water concentrations that exceed 410 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 predictable or purposeful release
to surface waters of a manufacturing stream associated with any use of
the substance 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 the
following tests would help characterize the environmental effects of
the PMN substance: A fish acute toxicity test, freshwater and marine
(OPPTS Test Guideline 850.1075); a fish acute toxicity test mitigated
by humic acid (OPPTS Test Guideline 850.1085); an aquatic invertebrate
acute toxicity test, freshwater daphnids (OPPTS Test Guideline
850.1010); and an algal toxicity test, tiers I and II (OPPTS Test
Guideline 850.5400). Fish and daphnid tests should be performed using
the flow-through method with mean measured concentrations. Algal
testing should be performed using the static method with mean measured
concentrations. Test reports should include protocols approved by EPA,
certificate of analysis for the test substance, raw data, and results.
CFR citation: 40 CFR 721.10218.
PMN Number P-09-451
Chemical name: Butanamide,N-[substituted phenyl]-
[(alkoxynitrophenyl)diazenyl]-3-oxo- (generic).
CAS number: Not available.
Basis for action: The PMN states that the generic (non-confidential)
use of the substance will be as a dispersion additive. Based on test
data on the PMN substance, 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, 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)(i).
Recommended testing: EPA has determined that the results of the
following tests would help characterize the environmental effects of
the PMN substance: A fish early-life stage toxicity test (OPPTS Test
Guideline 850.1400) and a daphnid chronic toxicity test (OPPTS Test
Guideline 850.1300). Both tests should be performed using the flow-
through method with mean measured concentrations. Test reports should
include protocols approved by EPA, certificate of analysis for the test
substance, raw data, and results.
CFR citation: 40 CFR 721.10219.
PMN Number P-09-478
Chemical name: Phosphoric acid, polymer with cycloaliphatic diglycidyl
ether, alkylethers (generic).
CAS number: Not available.
Basis for action: The PMN states that the generic (non-confidential)
use of the substance will be as a component of a coating. Based on
EcoSAR analysis of test data on analogous polynonionic phosphate
polymers, EPA predicts toxicity to aquatic organisms may occur at
concentrations that exceed 8 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 the
following tests would help characterize the environmental effects of
the PMN substance: A fish acute toxicity test, freshwater and marine
(OPPTS Test Guideline 850.1075) using the flow-through method with mean
measured
[[Page 57177]]
concentrations; an aquatic invertebrate acute toxicity test, freshwater
daphnids (OPPTS Test Guideline 850.1010) using the flow-through method
with mean measured concentrations; and an algal toxicity test, tiers I
and II (OPPTS Test Guideline 850.5400) using the static method with
mean measured concentrations. EPA also recommends that the special
considerations for conducting aquatic laboratory studies (OPPTS Test
Guideline 850.1000) be followed to facilitate solubility in the test
media, because of the PMN's low water solubility. Test reports should
include protocols approved by EPA, certificate of analysis for the test
substance, raw data, and results.
CFR citation: 40 CFR 721.10220.
PMN Number P-09-542
Chemical name: 3-Nonen-1-ol, 1-acetate, (3Z)-.
CAS number: 13049-88-2.
Basis for action: The PMN states that the substance will be used as a
fragrance in the manufacture of scented consumer products. Based on
EcoSAR analysis of test data on analogous esters, EPA predicts toxicity
to aquatic organisms may occur at concentrations that exceed 9 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 9 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 9 ppb may cause significant adverse environmental effects.
Based on this information, the PMN substance meets the concern criteria
at Sec. 721.170(b)(4)(ii).
Recommended testing: EPA has determined that the results of the
following tests would help characterize the environmental effects of
the PMN substance: A fish acute toxicity test, freshwater and marine
(OPPTS Test Guideline 850.1075); an aquatic invertebrate acute toxicity
test, freshwater daphnids (OPPTS Test Guideline 850.1010); and an algal
toxicity test, tiers I and II (OPPTS Test Guideline 850.5400). Fish and
daphnid testing should be performed using the flow-through method with
mean measured concentrations. Algal testing should be performed using
the static method with mean measured concentrations. Test reports
should include protocols approved by EPA, certificate of analysis for
the test substance, raw data, and results.
CFR citation: 40 CFR 721.10221.
PMN Number P-09-581
Chemical name: Styrenyl surface treated manganese ferrite (generic).
CAS number: Not available.
Basis for action: The PMN states that the substance will be used as a
raw material intermediate used in the manufacture of polymerized
pigments. Based on test data on analogous respirable, poorly soluble
particles, subcategory titanium dioxide, EPA identified concerns for
lung toxicity from lung overload if workers inhale the PMN substance.
As described in the PMN, worker inhalation exposure will be minimal due
to the use of 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 serious health effects may result from use of the
substance without a NIOSH-approved respirator with an APF of at least
10 where there is potential inhalation exposure or use of the substance
other than as a raw material intermediate used in the manufacture of
polymerized pigments. Based on this information, the PMN substance
meets the concern criteria at Sec. 721.170(b)(3)(ii).
Recommended testing: EPA has determined that the results of a 90-day
inhalation toxicity test (OPPTS Test Guideline 870.3465) with a 60-day
holding period would help characterize the human health effects of the
PMN substance. A carcinogenicity test (OPPTS Test Guideline 870.4200)
conducted via inhalation may be recommended, if the 90-day inhalation
toxicity test indicates carcinogenic potential. Test reports should
include protocols approved by EPA, certificate of analysis for the test
substance, raw data, and results.
CFR citation: 40 CFR 721.10222.
PMN Number P-09-582
Chemical name: Styrenyl surface treated manganese ferrite with acrylic
ester polymer (generic).
CAS number: Not available.
Basis for action: The PMN states that the substance will be used as a
polymerized pigment used in the manufacture of electronic inks. Based
on test data on analogous respirable, poorly soluble particles,
subcategory titanium dioxide, EPA identified concerns for lung toxicity
from lung overload if workers inhale the PMN substance. As described in
the PMN, worker inhalation exposure will be minimal due to the use of
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 serious health effects may result from use of the
substance without a NIOSH-approved respirator with an APF of at least
10 where there is potential inhalation exposure or use of the substance
other than as a polymerized pigment used in the manufacture of
electronic inks may result in 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 the results of a 90-day
inhalation toxicity test (OPPTS Test Guideline 870.3465) with a 60-day
holding period would help characterize the health effects of the PMN
substance. A carcinogenicity test (OPPTS Test Guideline 870.4200)
conducted via inhalation may be recommended, if the 90-day inhalation
toxicity test indicates carcinogenic potential. Test reports should
include protocols approved by EPA, certificate of analysis for the test
substance, raw data, and results.
CFR citation: 40 CFR 721.10223.
PMN Number P-10-9
Chemical name: Diglycidylaniline (generic).
CAS number: Not available.
Basis for action: The PMN states that the substance will be used as a
reactive epoxide for use in producing reinforced composites (open/non-
dispersive use). Based on test data on the PMN substance, EPA
identified concerns for mutagenicity. Based on test data on analogous
epoxides, EPA identified concerns for oncogenicity, mutagenicity,
developmental toxicity, reproductive toxicity, liver and kidney
toxicity, and skin and lung sensitization. As described in the PMN,
worker inhalation exposure is not expected and dermal exposure will be
minimal due to the use of adequate personal protective equipment.
Additionally, based on test data on the PMN substance, EPA predicts
toxicity to aquatic organisms may occur at concentrations that exceed 5
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 1) any use of the substance without the use of impervious
gloves where there is potential for dermal exposure may cause serious
health effects, 2) manufacture, processing, or use of the substance in
a powder form may cause serious health effects, and 3) any use of the
substance
[[Page 57178]]
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)(1)(i)(C), (b)(3)(i), (b)(3)(ii), and (b)(4)(i).
Recommended testing: EPA has determined that the results of the
following tests would help characterize the human health and
environmental effects of the PMN substance: A carcinogenicity test
(OPPTS Test Guideline 870.4200); a 90-day dermal toxicity test (OPPTS
Test Guideline 870.3250) in rats, with attention to pathology of the
reproductive organs; a fish early-life stage toxicity test (OPPTS Test
Guideline 850.1400); and a daphnid chronic toxicity test (OPPTS Test
Guideline 850.1300). All aquatic toxicity testing should be performed
using the flow-through method with mean measured concentrations. Test
reports should include protocols approved by EPA, certificate of
analysis for the test substance, raw data, and results.
CFR citation: 40 CFR 721.10224.
PMN Number P-10-14
Chemical name: Quino[2,3-b] acridine-7,14-dione, 2,9-dichloro-5,12-
dihydro [4-[[2-(sulfooxy) ethyl] substituted] phenyl]-, sodium salt
(1:1) (generic).
CAS number: Not available.
Basis for action: The PMN states that the generic (non-confidential)
use of the substance will be as a colorant raw material. Based on test
data on analogous respirable, poorly soluble particulates, EPA
identified concerns for lung effects from inhalation exposure to the
PMN substance. Based on physical properties of the PMN substance, EPA
identified concerns for potential systemic effects from dermal exposure
to the PMN substance. For the use described in the PMN, dermal and
inhalation exposures are not expected. Therefore, EPA has not
determined that the proposed manufacturing, processing, or use of the
substance may present an unreasonable risk. EPA has determined,
however, that use of the substance by workers not wearing impervious
gloves and eye protection, use of the substance other than as described
in the PMN, or use of the substance in powder form may cause serious
health effects. Based on this information, the PMN substances meets the
concern criteria at Sec. 721.170(b)(3)(ii).
Recommended testing: EPA has determined that the results of a 90-day
inhalation toxicity test (OPPTS Test Guideline 870.3465) would help
characterize the human health effects of the PMN substance. The test
should be modified to add a post-exposure observation period of up to 3
months. In addition to the standard requirements in the test guideline,
evaluation should include markers of damage, oxidant stress, cell
proliferation, the degree/intensity and duration of pulmonary
inflammation, cytotoxic effects and histopathology of pulmonary
tissues. Test reports should include protocols approved by EPA,
certificate of analysis for the test substance, raw data, and results.
CFR citation: 40 CFR 721.10225.
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 one of the 25
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
substance. The basis for such findings is outlined in Unit IV. Based on
these findings, a TSCA section 5(e) consent order requiring the use of
appropriate exposure controls was negotiated with the PMN submitter.
The SNUR provisions for this chemical substance are consistent with the
provisions of the TSCA section 5(e) consent order. This SNUR is
promulgated pursuant to Sec. 721.160.
In the other 24 cases, where the 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), the effective date of
this rule is November 19, 2010 without further notice, unless EPA
receives written adverse or critical comments, or notice of intent to
submit adverse or critical comments before October 20, 2010.
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 October 20, 2010, EPA will withdraw the relevant sections
of this direct final rule before its effective date. EPA will then
issue a proposed SNUR for the chemical substance(s) on which adverse or
critical comments were received, providing a 30-day period for public
comment.
This rule establishes SNURs for a number of chemical substances.
Any person who submits adverse or critical comments, or notice of
intent to submit adverse or critical comments, must identify the
chemical substance and the new use to which it applies. EPA will not
withdraw a SNUR for a chemical substance not identified in the comment.
VII. Applicability of Rule to Uses Occurring Before Effective Date of
the Rule
Significant new use designations for a chemical substance are
legally established as of the date of publication of this direct final
rule September 20, 2010.
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. A TSCA section 5(e) consent order has
been issued for one chemical substance and the PMN
[[Page 57179]]
submitters are prohibited by the TSCA section 5(e) consent order 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, 13 of the
25 chemical substances contained in this rule have CBI chemical
identities, and since EPA has received a limited number of post-PMN
bona fide submissions (per Sec. Sec. 720.25 and 721.11), the Agency
believes that it is highly unlikely that any of the significant new
uses described in the regulatory text of this rule are ongoing.
As discussed in the 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 the development
of any particular test data before submission of a SNUN. There are two
exceptions: 1) development of test data is required, where the chemical
substance subject to the SNUR is also subject to a test rule under TSCA
section 4 (see TSCA section 5(b)(1)); and 2) development of test data
may be necessary where the chemical substance has been listed under
TSCA section 5(b)(4) (see TSCA section 5(b)(2)). In the absence of a
section 4 test rule or a section 5(b)(4) listing covering the chemical
substance, persons are required only to submit test data in their
possession or control and to describe any other data known to or
reasonably ascertainable by them (see 40 CFR 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. To access the harmonized test guidelines referenced
in this document electronically, please go to http://www.epa.gov/ocspp
and select ``Test Methods and Guidelines.'' The Organisation for
Economic Co-operation and Development (OECD) test guidelines are
available from the OECD Bookshop at http://www.oecdbookshop.org or
SourceOECD at http://www.sourceoecd.org.
In the TSCA section 5(e) consent order for one of the chemical
substances regulated under this rule, EPA has established restrictions
in view of the lack of data on the potential health and environmental
risks that may be posed by the significant new use or increased
exposure to the chemical substance. These restrictions cannot be
removed unless the PMN submitter first submits the results of toxicity
tests that would permit a reasoned evaluation of the potential risks
posed by this chemical substance. A listing of the tests specified in
the TSCA section 5(e) consent order is included in Unit IV. The SNUR
contains the same restrictions as the TSCA section 5(e) consent order.
Persons who intend to begin non-exempt commercial manufacture, import,
or processing for any of the restricted activities must notify the
Agency by submitting a SNUN at least 90 days in advance of commencement
of that activity.
The recommended tests may not be the only means of addressing the
potential risks of the chemical substance. However, SNUN submitting for
significant new use 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 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
[[Page 57180]]
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 Sec.
720.50. SNUNs must be submitted to EPA, on EPA Form No. 7710-25 in
accordance with the procedures set forth in Sec. Sec. 721.25 and
720.40. This form is available from the Environmental Assistance
Division (7408M), 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001. Forms and information are also available electronically at http://www.epa.gov/opptintr/newchems.
XI. Economic Analysis
EPA has evaluated the potential costs of establishing SNUN
requirements for potential manufacturers, importers, and processors of
the chemical substances subject to this rule. EPA's complete economic
analysis is available in the docket.
XII. Statutory and Executive Order Reviews
A. Executive Order 12866
This rule establishes SNURs for several new chemical substances
that were the subject of PMNs, 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. EPA is amending the table
in 40 CFR part 9 to list the OMB approval number for the information
collection requirements contained in this rule. This listing of the OMB
control numbers and their subsequent codification in the CFR satisfies
the display requirements of PRA and OMB's implementing regulations at 5
CFR part 1320. This Information Collection Request (ICR) was previously
subject to public notice and comment prior to OMB approval, and given
the technical nature of the table, EPA finds that further notice and
comment to amend it is unnecessary. As a result, EPA finds that there
is ``good cause'' under section 553(b)(3)(B) of the Administrative
Procedure Act, 5 U.S.C. 553(b)(3)(B), to amend this table without
further notice and comment.
The information collection requirements related to this action have
already been approved by OMB pursuant to PRA under OMB control number
2070-0012 (EPA ICR No. 574). This action does not impose any burden
requiring additional OMB approval. If an entity were to submit a SNUN
to the Agency, the annual burden is estimated to average between 30 and
170 hours per response. This burden estimate includes the time needed
to review instructions, search existing data sources, gather and
maintain the data needed, and complete, review, and submit the required
SNUN.
Send any comments about the accuracy of the burden estimate, and
any suggested methods for minimizing respondent burden, including
through the use of automated collection techniques, to the Director,
Collection Strategies Division, Office of Environmental Information
(2822T), Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460-0001. Please remember to include the OMB control
number in any correspondence, but do not submit any completed forms to
this address.
C. Regulatory Flexibility Act
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 discussed in this unit. 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 1,400 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 XII.) 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 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 57181]]
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
40 CFR Part 9
Environmental protection, Reporting and recordkeeping requirements.
40 CFR Part 721
Environmental protection, Chemicals, Hazardous substances,
Reporting and recordkeeping requirements.
Dated: September 10, 2010.
Wendy C. Hamnett,
Director, Office of Pollution Prevention and Toxics.
0
Therefore, 40 CFR parts 9 and 721 are amended as follows:
PART 9--[AMENDED]
0
1. The authority citation for part 9 continues to read as follows:
Authority: 7 U.S.C. 135 et seq., 136-136y; 15 U.S.C. 2001, 2003,
2005, 2006, 2601-2671; 21 U.S.C. 331j, 346a, 348; 31 U.S.C. 9701; 33
U.S.C. 1251 et seq., 1311, 1313d, 1314, 1318, 1321, 1326, 1330,
1342, 1344, 1345 (d) and (e), 1361; E.O. 11735, 38 FR 21243, 3 CFR,
1971-1975 Comp. p. 973; 42 U.S.C. 241, 242b, 243, 246, 300f, 300g,
300g-1, 300g-2, 300g-3, 300g-4, 300g-5, 300g-6, 300j-1, 300j-2,
300j-3, 300j-4, 300j-9, 1857 et seq., 6901-6992k, 7401-7671q, 7542,
9601-9657, 11023, 11048.
0
2. The table in Sec. 9.1 is amended by adding the following sections
in numerical order under the undesignated center heading ``Significant
New Uses of Chemical Substances'' to read as follows:
Sec. 9.1 OMB approvals under the Paperwork Reduction Act.
* * * * *
------------------------------------------------------------------------
40 CFR citation OMB control No.
------------------------------------------------------------------------
* * * * *
------------------------------------------------------------------------
Significant New Uses of Chemical Substances
------------------------------------------------------------------------
* * * * *
721.10201............................................ 2070-0012
721.10202............................................ 2070-0012
721.10203............................................ 2070-0012
721.10204............................................ 2070-0012
721.10205............................................ 2070-0012
721.10206............................................ 2070-0012
721.10207............................................ 2070-0012
721.10208............................................ 2070-0012
721.10209............................................ 2070-0012
721.10210............................................ 2070-0012
721.10211............................................ 2070-0012
721.10212............................................ 2070-0012
721.10213............................................ 2070-0012
721.10214............................................ 2070-0012
721.10215............................................ 2070-0012
721.10216............................................ 2070-0012
721.10217............................................ 2070-0012
721.10218............................................ 2070-0012
721.10219............................................ 2070-0012
721.10220............................................ 2070-0012
721.10221............................................ 2070-0012
721.10222............................................ 2070-0012
721.10223............................................ 2070-0012
721.10224............................................ 2070-0012
721.10225............................................ 2070-0012
* * * * *
------------------------------------------------------------------------
* * * * *
PART 721--[AMENDED]
0
3. The authority citation for part 721 continues to read as follows:
Authority: 15 U.S.C. 2604, 2607, and 2625(c).
0
4. Add Sec. 721.10201 to subpart E to read as follows:
Sec. 721.10201 Cobalt lithium manganese nickel oxide.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as cobalt lithium
manganese nickel oxide (PMN P-04-269; CAS No. 182442-95-1) is subject
to reporting under this section for the significant new uses described
in paragraph (a)(2) of this section. The requirements of this section
do not apply to quantities of the PMN substance after it has been
completely reacted (cured).
(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), (a)(4), (a)(5), (a)(6), (b)
(concentration set at 0.1 percent), and (c). Respirators must provide a
National Institute for Occupational Safety and Health (NIOSH) assigned
protection factor (APF) of at least 150. The following NIOSH-approved
respirators meet the requirements of Sec. 721.63(a)(4): Supplied-air
respirator
[[Page 57182]]
operated in pressure demand or other positive pressure mode and
equipped with a tight-fitting full facepiece. As an alternative to the
respirator requirements listed here, a manufacturer, importer, or
processor may choose to follow the New Chemical Exposure Limit (NCEL)
provisions listed in the Toxic Substances Control Act (TSCA) section
5(e) consent order for this substance. The NCEL is 0.1 mg/m\3\ as an 8-
hour time-weighted average. Persons who wish to pursue NCELs as an
alternative to the Sec. 721.63 respirator may request to do so under
Sec. 721.30. Persons whose Sec. 721.30 requests to use the NCELs
approach are approved by EPA will receive NCELs provisions comparable
to those listed in the corresponding section 5(e) consent order.
(ii) Hazard communication program. Requirements as specified in
Sec. 721.72 (a), (b), (c), (d), (e) (concentration set at 0.1
percent), (f), (g)(1)(i), (g)(1)(ii), (g)(1)(vii),(g)(1)(ix), (g)(2),
(g)(3), (g)(4)(iii), and (g)(5).
(iii) Release to water. Requirements as specified in Sec. 721.90
(a)(1), (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), (d), (e), (f), (g), (h), 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
5. Add Sec. 721.10202 to subpart E to read as follows:
Sec. 721.10202 Benzoic acid, 4-chloro-2- [(substituted)azo]-,
strontium salt (1:1) (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as benzoic
acid, 4-chloro-2- [(substituted)azo]-, strontium salt (1:1) (PMN P-08-
701) is subject to reporting under this section for the significant new
uses described in paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(j).
(ii) [Reserved]
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph.
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125 (a), (b), (c), and (i) are applicable to manufacturers,
importers, and processors of this substance.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
(3) Determining whether a specific use is subject to this section.
The provisions of Sec. 721.1725(b)(1) apply to this section.
0
6. Add Sec. 721.10203 to subpart E to read as follows:
Sec. 721.10203 Phosphonium, tetrabutyl-, hydroxide (1:1).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as phosphonium,
tetrabutyl-, hydroxide (1:1) (PMN P-08-742; CAS No. 14518-69-5) 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) 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. Add Sec. 721.10204 to subpart E to read as follows:
Sec. 721.10204 Aryloxyacrylate (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
aryloxyacrylate (PMN P-08-754) 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=3).
(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
8. Add Sec. 721.10205 to subpart E to read as follows:
Sec. 721.10205 Formaldehyde, polymer with 1,3-benzenediol and 1,1'-
methylenebis[isocyanatobenzene].
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as formaldehyde,
polymer with 1,3-benzenediol and 1,1'-methylenebis[isocyanatobenzene]
(PMN P-09-4; CAS No. 1067881-45-1) 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
9. Add Sec. 721.10206 to subpart E to read as follows:
Sec. 721.10206 4-Cyclohexene-1,2-dicarboxylic acid, 1,2-bis(2-
oxiranylmethyl) ester.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as 4-cyclohexene-1,2-
dicarboxylic acid, 1,2-bis(2-oxiranylmethyl) ester (PMN P-09-19; CAS
No. 21544-03-6) 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)(2)(iii), (a)(3), (b) (concentration set
at 0.1 percent), and (c).
(ii) Hazard communication program. Requirements as specified in
Sec. 721.72 (c), (e) (concentration set at 0.1 percent), (g)(1)(i),
(g)(1)(iv), (g)(1)(vi), (g)(1)(vii), (g)(2)(i) and (g)(2)(v).
(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
[[Page 57183]]
(a), (b), (c), (d), (e), (f), and (h) are applicable to manufacturers,
importers, and processors of this substance.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
0
10. Add Sec. 721.10207 to subpart E to read as follows:
Sec. 721.10207 1,3-Cyclohexanedimethanamine, N1,N3-bis(2-
methylpropylidene)-.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as 1,3-
cyclohexanedimethanamine, N1,N3-bis(2-methylpropylidene)- (PMN P-09-38;
CAS No. 173904-11-5) 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) 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
11. Add Sec. 721.10208 to subpart E to read as follows:
Sec. 721.10208 Amines, di-C11-14-isoalkyl, C13-rich.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as amines, di-C11-14-
isoalkyl, C13-rich (PMN P-09-71; CAS No. 1005516-89-1) 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)(4), (b)(4), and (c)(4) (N=2).
(ii) [Reserved]
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph.
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125 (a), (b), (c), and (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
12. Add Sec. 721.10209 to subpart E to read as follows:
Sec. 721.10209 Epoxy terminated, hydrolyzed trialkoxysilane and
glycidyl ether of phenol-formaldehyde resin (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as epoxy
terminated, hydrolyzed trialkoxysilane and glycidyl ether of phenol-
formaldehyde resin (PMN P-09-120) 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
13. Add Sec. 721.10210 to subpart E to read as follows:
Sec. 721.10210 Soybean oil, epoxidized, reaction products with
diethanolamine.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as soybean oil,
epoxidized, reaction products with diethanolamine (PMN P-09-130; CAS
No. 1002761-12-7) 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
14. Add Sec. 721.10211 to subpart E to read as follows:
Sec. 721.10211 Octadecanoic acid, reaction products with
diethylenetriamine and urea, acetates.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as octadecanoic acid,
reaction products with diethylenetriamine and urea, acetates (PMN P-09-
172; CAS No. 84962-05-0) is subject to reporting under this section for
the significant new uses described in paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(s) (10,000 kilograms).
(ii) [Reserved]
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph.
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125 (a), (b), (c), and (i) are applicable to manufacturers,
importers, and processors of this substance.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
0
15. Add Sec. 721.10212 to subpart E to read as follows:
Sec. 721.10212 1,2-Ethanediol, reaction products with
epichlorohydrin.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as 1,2-ethanediol,
reaction products with epichlorohydrin (PMN P-09-241; CAS No. 705265-
31-2) 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(s) (100,000 kilograms).
(ii) [Reserved]
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph.
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125 (a), (b), (c), and (i) are applicable to manufacturers,
importers, and processors of this substance.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
0
16. Add Sec. 721.10213 to subpart E to read as follows:
[[Page 57184]]
Sec. 721.10213 Polyether polyester copolymer phosphate (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
polyether polyester copolymer phosphate (PMN P-09-253) 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
17. Add Sec. 721.10214 to subpart E to read as follows:
Sec. 721.10214 Poly(oxyalkylenediyl),.alpha.-substituted
carbomonocycle-.omega.-substituted carbomonocycle (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
poly(oxyalkylenediyl),.alpha.-substituted carbomonocycle-.omega.-
substituted carbomonocycle (PMN P-09-286) 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
18. Add Sec. 721.10215 to subpart E to read as follows:
Sec. 721.10215 Benzenepropanol, .beta.-methyl-.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as benzenepropanol,
.beta.-methyl- (PMN P-09-385; CAS No.7384-80-7) 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 1.0
percent), and (c).
(ii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(g).
(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.
0
19. Add Sec. 721.10216 to subpart E to read as follows:
Sec. 721.10216 2-Propenoic acid, 3-(5,5,6-
trimethylbicyclo[2.2.1]hept-2-yl)cyclohexyl ester].
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as 2-propenoic acid,
3-(5,5,6-trimethylbicyclo[2.2.1]hept-2-yl)cyclohexyl ester (PMN P-09-
411; CAS No. 903876-45-9) is subject to reporting under this section
for the significant new uses described in paragraph (a)(2) of this
section.
(2) The significant new uses are:
(i) Disposal. Requirements as specified in Sec. 721.85 (a)(1),
(b)(1), and (c)(1).
(ii) Release to water. Requirements as specified in Sec. 721.90
(a)(1), (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), (j), 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
20. Add Sec. 721.10217 to subpart E to read as follows:
Sec. 721.10217 Branched and linear alcohols (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
branched and linear alcohols (PMN P-09-426) is subject to reporting
under this section for the significant new uses described in paragraph
(a)(2) of this section.
(2) The significant new uses are:
(i) Release to water. Requirements as specified in Sec. 721.90
(a)(4), (b)(4), and (c)(4) (N=1).
(ii) [Reserved]
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph.
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125 (a), (b), (c), and (k) are applicable to manufacturers,
importers, and processors of this substance.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
0
21. Add Sec. 721.10218 to subpart E to read as follows:
Sec. 721.10218 2-Propenoic acid, 2-mehtyl-, C12-15-branched and
linear alkyl esters, telomers with alkyl 2-
[[(alkylthio)thioxomethyl]thio]-2-alkanoate, aminoalkyl methacrylate
and alkyl methacrylate, tert-Bu 2-ethylhexanoperoxoate-initiated
(generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as 2-
propenoic acid, 2-methyl-, C12-15-branched and linear alkyl esters,
telomers with alkyl 2-[[(alkylthio)thioxomethyl]thio]-2-alkanoate,
aminoalkyl methacrylate and alkyl methacrylate, tert-Bu 2-
ethylhexanoperoxoate-initiated (PMN P-09-436) 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).
(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
22. Add Sec. 721.10219 to subpart E to read as follows:
[[Page 57185]]
Sec. 721.10219 Butanamide,N-[substituted phenyl]-
[(alkoxynitrophenyl)diazenyl]-3-oxo- (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
butanamide,N-[substituted phenyl]-(alkoxynitrophenyl)diazenyl]-3-oxo-
(PMN P-09-451) 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
23. Add Sec. 721.10220 to subpart E to read as follows:
Sec. 721.10220 Phosphoric acid, polymer with cycloaliphatic
diglycidyl ether, alkylethers (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
phosphoric acid, polymer with cycloaliphatic diglycidyl ether,
alkylethers (PMN P-09-478) 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
24. Add Sec. 721.10221 to subpart E to read as follows:
Sec. 721.10221 3-Nonen-1-ol, 1-acetate, (3Z)-.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as 3-nonen-1-ol, 1-
acetate, (3Z)- (PMN P-09-542; CAS No. 13049-88-2) 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) Release to water. Requirements as specified in Sec. 721.90
(a)(4), (b)(4), and (c)(4) (N=9).
(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
25. Add Sec. 721.10222 to subpart E to read as follows:
Sec. 721.10222 Styrenyl surface treated manganese ferrite (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
styrenyl surface treated manganese ferrite (PMN P-09-581) is subject to
reporting under this section for the significant new uses described in
paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in Sec.
721.63 (a)(4), (a)(5), (a)(6), (b) (concentration set at 1.0 percent),
and (c). Respirators must provide a National Institute for Occupational
Safety and Health (NIOSH) assigned protection factor (APF) of at least
10. The following NIOSH-approved respirators with an APF of 10-25 meet
the minimum requirements for Sec. 721.63(a)(4): Air-purifying, tight-
fitting respirator equipped with N100 (if oil aerosols absent), R100,
or P100 filters (either half- or full-face); powered air-purifying
respirator equipped with a loose-fitting hood or helmet and High
Efficiency Particulate Air (HEPA) filters; powered air-purifying
respirator equipped with a tight-fitting facepiece (either half- or
full-face) and HEPA filters; supplied-air respirator operated in
pressure demand or continuous flow mode and equipped with a hood or
helmet, or tight-fitting facepiece (either half- or full-face).
(ii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(j) (raw material intermediate used in the
manufacture of polymerized pigments).
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph.
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125 (a), (b), (c), (d), and (i) are applicable to manufacturers,
importers, and processors of this substance.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
0
26. Add Sec. 721.10223 to subpart E to read as follows:
Sec. 721.10223 Styrenyl surface treated manganese ferrite with
acrylic ester polymer (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
styrenyl surface treated manganese ferrite with acrylic ester polymer
(PMN P-09-582) is subject to reporting under this section for the
significant new uses described in paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in Sec.
721.63 (a)(4), (a)(5), (a)(6), (b) (concentration set at 1.0 percent),
and (c). Respirators must provide a National Institute for Occupational
Safety and Health (NIOSH) assigned protection factor (APF) of at least
10. The following NIOSH-approved respirators with an APF of 10-25 meet
the minimum requirements for Sec. 721.63(a)(4): Air-purifying, tight-
fitting respirator equipped with N100 (if oil aerosols absent), R100,
or P100 filters (either half- or full-face); powered air-purifying
respirator equipped with a loose-fitting hood or helmet and High
Efficiency Particulate Air (HEPA) filters; powered air-purifying
respirator equipped with a tight-fitting facepiece (either half- or
full-face) and HEPA filters; supplied-air respirator operated in
pressure demand or continuous flow mode and equipped with a hood or
helmet, or tight-fitting facepiece (either half- or full-face).
(ii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(j) (polymerized pigment used in the
manufacture of electronic inks).
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph.
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125 (a), (b), (c), (d), and (i) are applicable to manufacturers,
importers, and processors of this substance.
[[Page 57186]]
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
0
27. Add Sec. 721.10224 to subpart E to read as follows:
Sec. 721.10224 Diglycidylaniline (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
diglycidylaniline (PMN P-10-9) is subject to reporting under this
section for the significant new uses described in paragraph (a)(2) of
this section.
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in Sec.
721.63 (a)(1), (a)(2)(i), (a)(3), (b) (concentration set at 0.1
percent), and (c).
(ii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80 (v)(1), (w)(1), and (x)(1).
(iii) Release to water. Requirements as specified in Sec. 721.90
(a)(1), (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), (d), (e), (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
28. Add Sec. 721.10225 to subpart E to read as follows:
Sec. 721.10225 Quino[2,3-b] acridine-7,14-dione, 2,9-dichloro-5,12-
dihydro [4-[[2-(sulfooxy) ethyl] substituted] phenyl]-, sodium salt
(1:1) (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
quino[2,3-b] acridine-7,14-dione, 2,9-dichloro-5,12-dihydro [4-[[2-
(sulfooxy) ethyl] substituted] phenyl]-, sodium salt (1:1) (PMN P-10-
14) 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)(iii), (a)(3), (b) (concentration set
at 1.0 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.
[FR Doc. 2010-23415 Filed 9-17-10; 8:45 am]
BILLING CODE 6560-50-S