[Federal Register Volume 79, Number 29 (Wednesday, February 12, 2014)]
[Rules and Regulations]
[Pages 8273-8293]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-03079]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Parts 9 and 721
[EPA-HQ-OPPT-2013-0739; FRL-9903-70]
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
the Toxic Substances Control Act (TSCA) for 35 chemical substances
which were the subject of premanufacture notices (PMNs). Fourteen of
these chemical substances are subject to TSCA section 5(e) consent
orders issued by EPA. This action requires persons who intend to
manufacture (including import) or process any of these 35 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 April 14, 2014. For purposes of
judicial review, this rule shall be promulgated at 1 p.m. (e.s.t.) on
February 26, 2014.
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 March 14, 2014 (see Unit VI. of the
SUPPLEMENTARY INFORMATION). 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 March 14, 2014, EPA will withdraw
the relevant sections of this direct final rule before its effective
date.
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-2013-0739, by one of the following methods:
Federal eRulemaking Portal: http://www.regulations.gov.
Follow the online instructions for submitting comments.
Mail: Document Control Office (7407M), Office of Pollution
Prevention and Toxics (OPPT), Environmental Protection Agency, 1200
Pennsylvania Ave. NW., Washington, DC 20460-0001.
Hand Delivery: OPPT Document Control Office (DCO), EPA
East Bldg., Rm. 6428, 1201 Constitution Ave. NW., Washington, DC. ATTN:
Docket ID Number EPA-HQ-OPPT-2013-0739. 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-
2013-0739. EPA's policy is that all comments received will be included
in the docket without change and may be made available at http://www.regulations.gov, including any personal information provided,
unless the comment includes information claimed to be Confidential
Business Information (CBI) or other information whose disclosure is
restricted by statute. Do not submit information that you consider to
be CBI or otherwise protected through regulations.gov or email. The
regulations.gov Web site is an ``anonymous access'' system, which means
EPA will not know your identity or contact information unless you
provide it in the body of your comment. If you send an email comment
directly to EPA without going through regulations.gov, your email
address will be automatically captured and included as part of the
comment that is placed in the docket and made available on the
Internet. If you submit an electronic comment, EPA recommends that you
include your name and other contact information in the body of your
comment and with any disk or CD-ROM you submit. If EPA cannot read your
comment due to technical difficulties and cannot contact you for
clarification, EPA may not be able to consider your comment. Electronic
files should avoid the use of special characters, any form of
encryption, and be free of any defects or viruses.
Docket: All documents in the docket are listed in the docket index
available at http://www.regulations.gov. Although listed in the index,
some information is not publicly available, e.g., CBI or other
information whose disclosure is restricted by statute. Certain other
material, such as copyrighted material, will be publicly available only
in hard copy. Publicly available docket materials are available
electronically at http://www.regulations.gov, or, if only available in
hard copy, at the OPPT Docket. The OPPT Docket is located in the EPA
Docket Center (EPA/DC) at Rm. 3334, EPA West Bldg., 1301 Constitution
Ave. NW., Washington, DC. The EPA/DC Public Reading Room hours of
operation are 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding
legal holidays. The telephone number of the EPA/DC Public Reading Room
is (202) 566-1744, and the telephone number for the OPPT Docket is
(202) 566-0280. Docket visitors are required to show photographic
identification, pass through a metal detector, and sign the EPA visitor
log. All visitor bags are processed through an X-ray machine and
subject to search. Visitors will be provided an EPA/DC badge that must
be visible at all times in the building and returned upon departure.
FOR FURTHER INFORMATION CONTACT:
For technical information contact: Kenneth Moss, Chemical Control
Division (7405M), Office of Pollution Prevention and Toxics,
Environmental Protection Agency, 1200 Pennsylvania Ave. NW.,
Washington, DC 20460-0001;
[[Page 8274]]
telephone number: (202) 564-9232; email address: [email protected].
For general information contact: The TSCA-Hotline, ABVI-Goodwill,
422 South Clinton Ave., Rochester, NY 14620; telephone number: (202)
554-1404; email address: [email protected].
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this action apply to me?
You may be potentially affected by this action if you manufacture,
process, or use the chemical substances contained in this rule. The
following list of North American Industrial Classification System
(NAICS) codes is not intended to be exhaustive, but rather provides a
guide to help readers determine whether this document applies to them.
Potentially affected entities may include:
Manufacturers (including importers), or processors of one
or more subject chemical substances (NAICS codes 325 and 324110), e.g.,
chemical manufacturing and petroleum refineries.
This action may also affect certain entities through pre-existing
import certification and export notification rules under TSCA. Chemical
importers are subject to the TSCA section 13 (15 U.S.C. 2612) import
certification requirements promulgated at 19 CFR 12.118 through 12.127
and 19 CFR 127.28. Chemical importers must certify that the shipment of
the chemical substance complies with all applicable rules and orders
under TSCA. Importers of chemicals subject to these SNURs must certify
their compliance with the SNUR requirements. The EPA policy in support
of import certification appears at 40 CFR part 707, subpart B. In
addition, any persons who export or intend to export a chemical
substance that is the subject of this rule on or after March 14, 2014
are subject to the export notification provisions of TSCA section 12(b)
(15 U.S.C. 2611(b)) (see Sec. [emsp14]721.20), and must comply with
the export notification requirements in 40 CFR part 707, subpart D.
B. What should I consider as I prepare my comments for EPA?
1. Submitting CBI. Do not submit this information to EPA through
regulations.gov or email. Clearly mark the part or all of the
information that you claim to be CBI. For CBI information in a disk or
CD-ROM that you mail to EPA, mark the outside of the disk or CD-ROM as
CBI and then identify electronically within the disk or CD-ROM the
specific information that is claimed as CBI. In addition to one
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, or processing of a chemical substance for
any activity designated by these SNURs as a significant new use.
Receipt of such notices allows EPA to assess risks that may be
presented by the intended uses and, if appropriate, to regulate the
proposed use before it occurs. Additional rationale and background to
these rules are more fully set out in the preamble to EPA's first
direct final SNUR published in the Federal Register issue of April 24,
1990 (55 FR 17376). Consult that preamble for further information on
the objectives, rationale, and procedures for SNURs and on the basis
for significant new use designations, including provisions for
developing test data.
B. What is the Agency's authority for taking this action?
Section 5(a)(2) of TSCA (15 U.S.C. 2604(a)(2)) authorizes EPA to
determine that a use of a chemical substance is a ``significant new
use.'' EPA must make this determination by rule after considering all
relevant factors, including the four bulleted TSCA section 5(a)(2)
factors listed in Unit III. Once EPA determines that a use of a
chemical substance is a significant new use, TSCA section 5(a)(1)(B)
requires persons to submit a significant new use notice (SNUN) to EPA
at least 90 days before they manufacture or process the chemical
substance for that use. Persons who must report are described in Sec.
721.5.
C. Applicability of General Provisions
General provisions for SNURs appear in 40 CFR part 721, subpart A.
These provisions describe persons subject to the rule, recordkeeping
requirements, exemptions to reporting requirements, and applicability
of the rule to uses occurring before the effective date of the rule.
Provisions relating to user fees appear at 40 CFR part 700. According
to Sec. 721.1(c), persons subject to these SNURs must comply with the
same SNUN requirements and EPA regulatory procedures as submitters of
PMNs under TSCA section 5(a)(1)(A). In particular, these requirements
include the information submission requirements of TSCA section 5(b)
and 5(d)(1), the exemptions authorized by TSCA section 5(h)(1), (h)(2),
(h)(3), and (h)(5), and the regulations at 40 CFR part 720. Once EPA
receives a SNUN, EPA may take regulatory action under TSCA section
5(e), 5(f), 6, or 7 to control the activities for which it has received
the SNUN. If EPA does not take action, EPA is required under TSCA
section 5(g) to explain in the Federal Register its reasons for not
taking action.
III. Significant New Use Determination
Section 5(a)(2) of TSCA states that EPA's determination that a use
of a chemical substance is a significant new use must be made after
consideration of all relevant factors, including:
The projected volume of manufacturing and processing of a
chemical substance.
The extent to which a use changes the type or form of
exposure of human beings or the environment to a chemical substance.
The extent to which a use increases the magnitude and
duration of exposure of human beings or the environment to a chemical
substance.
The reasonably anticipated manner and methods of
manufacturing,
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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 35
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 35 chemical substances in 40 CFR part 721, subpart E.
In this unit, EPA provides the following information for each chemical
substance:
PMN number.
Chemical name (generic name, if the specific name is
claimed as CBI).
Chemical Abstracts Service (CAS) Registry number (if
assigned for non-confidential chemical identities).
Basis for the 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).
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 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 14 PMN substances that are subject to ``risk-
based'' consent orders under TSCA section 5(e)(1)(A)(ii)(I) where EPA
determined that activities associated with the PMN substances may
present unreasonable risk to human health or the environment. Those
consent orders require protective measures to limit exposures or
otherwise mitigate the potential unreasonable risk. The so-called
``section 5(e) SNURs'' on these PMN substances are promulgated pursuant
to Sec. 721.160, and are based on and consistent with the provisions
in the underlying consent orders. The section 5(e) SNURs designate as a
``significant new use'' the absence of the protective measures required
in the corresponding consent orders.
This rule also includes SNURs on 21 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-
section 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-section 5(e) SNURs issued under Sec. [emsp14]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 concerns identified'' for the PMN substance.
PMN Number P-08-179
Chemical name: 1,2,3-Propanetricarboxamide, N1,N2,N3-tris(2-
methylcyclohexyl)-.
CAS number: 160535-46-6.
Basis for action: The PMN states that the generic (non-
confidential) use of the substance is as a nucleator for polymers.
Based on ecological structure activity relationship (EcoSAR) analysis
of test data on analogous amides, EPA predicts toxicity to aquatic
organisms may occur at concentrations that exceed 12 parts per billion
(ppb) of the PMN substance in surface waters. As described in the PMN,
releases of the substance are not expected to result in surface water
concentrations that exceed 12 ppb. Therefore, EPA has not determined
that the proposed manufacturing, processing, or use of the substance
may present an unreasonable risk. EPA has determined, however, that any
use of the substance resulting in surface water concentrations
exceeding 12 ppb may cause significant adverse environmental effects.
Based on this information, the PMN substance meets the concern criteria
at Sec. 721.170(b)(4)(ii).
Recommended testing: EPA has determined that the results of a fish
early-life stage toxicity test (OPPTS Test Guideline 850.1400) and a
daphnid chronic toxicity test (OPPTS Test Guideline 850.1300) would
help characterize the environmental effects of the PMN substance. EPA
also recommends that the guidance document on aquatic toxicity testing
of difficult substances and mixtures (Organisation for Economic Co-
Operation (OECD) Test Guideline 23) be followed.
CFR citation: 40 CFR 721.10695.
PMN Numbers P-11-483, P-11-487, P-11-527, P-11-528, P-11-529, P-11-530,
P-11-532, P-11-533, and P-11-534
Chemical names: Polyfluorinated alkyl thiol (generic) (P-11-483 and
P-11-528); Polyfluorinated alkyl polyamide (generic) (P-11-487);
Polyfluorinated alkyl halide (generic) (P-11-527); Polyfluorinated
alkyl thio acrylamide (generic) (P-11-529); Polyfluorinated alkyl thio
polyacrylamide (generic) (P-11-530 and P-11-533); Polyfluorinated alkyl
amine (generic) (P-11-532); and Polyfluorinated alkyl thio polyacrylic
acid-acrylamide (generic) (P-11-534).
CAS numbers: Not available.
Effective date of TSCA section 5(e) consent order: April 12, 2013.
Basis for TSCA section 5(e) consent order: The PMNs P-11-487, P-11-
530, P-11-533, and P-11-534 state that the generic (non-confidential)
use of these substances is as surfactants. The PMNs P-11-483, P-11-527,
P-11-528, P-11-529, and P-11-532 state that the generic (non-
confidential) use of these substances is as chemical intermediates.
Based on analogy to other perfluorinated chemicals including
perfluorooctanoic acid (PFOA), perfluorooctanesufonate (PFOS), and
perfluorohexane sulfonate (PFHS), EPA has concerns that the PMN
substances and/or degradation products will persist in the environment,
could bioaccumulate or biomagnify, and be toxic (PBT) to people, wild
mammals and birds. Some perfluorinated chemicals, PFOA and PFOS, are
expected to persist for years in the environment. Biodegradation and
photolysis tests of analogous substances to PFOA and PFOS indicate
little or no biodegradation or photolysis of perfluoroalkyl compounds.
Bioaccumulation concerns are based on concerns raised by the measured
presence of certain perfluoroalkyl compounds with longer carbon chain
length, including PFOA, PFOS, and PFHS in wildlife and in human blood
samples. EPA has human health concerns for irritation to skin, eyes,
lungs, mucous membranes, and lung toxicity if inhaled based on
surfactant properties of the PMN substances. Toxicity studies on PFOA
and PFOS indicate liver toxicity, blood toxicity, male reproductive
toxicity, immunosuppression, and oncogenicity. These factors, taken
together, raise
[[Page 8276]]
concerns for potential adverse chronic effects of P-11-483, P-11-487,
P-11-527, P-11-528, P-11-529, P-11-530, P-11-532, P-11-533, P-11-534
and/or degradation products. The consent order was issued under TSCA
section 5(e)(1)(A) based on a finding that these substances may present
an unreasonable risk of injury to human health and the environment,
these substances may be produced in substantial quantities and may
reasonably be anticipated to enter the environment in substantial
quantities, and there may be significant (or substantial) human
exposure to the substances and their potential degradation products. To
protect against these risks, the consent order requires:
1. Risk notification. If as a result of the test data required, the
company becomes aware that the PMN substance may present a risk of
injury to human health or the environment, the company must incorporate
this new information, and any information on methods for protecting
against such risk into a Material Safety Data Sheet (MSDS), within 90
days.
2. Manufacture of the PMN substances: (a) According to the chemical
composition section of the consent order, including analyzing and
reporting certain starting raw material impurities to EPA; and (b)
within the maximum established limits of certain fluorinated impurities
of the PMN substances as stated in the consent order.
3. Use of the substances only as described in the consent order.
4. No use of the PMN substances in consumer products with spray
applications.
5. Submission of certain environmental fate testing prior to
exceeding the confidential production volume limit of the aggregate
amount of the PMN substances, P-11-487, P-11-530, P-11-533, and P-11-
534 specified in the consent order.
6. The individual annual manufacture volume for P-11-487, P-11-530,
P-11-533, and P-11-534 must not reach the confidential annual
production volume specified in the consent order.
7. Incinerate all waste containing any of the PMN substances from
manufacturing and processing in an incinerator with a combustion
temperature of a minimum of 1,000 degrees Celsius (C) and a residence
time of a minimum of 2 seconds.
8. No use of the substances resulting in releases to surface water.
The SNUR designates as a ``significant new use'' the absence of
these protective measures.
Recommended testing: EPA has determined that the test data from
certain human health, environmental fate, and ecotoxicity testing
identified in the consent order would help characterize possible
effects of the substances and their degradation products. The company
has agreed not to exceed the first production limit without performing
a metabolism and pharmacokinetics test (OPPTS Test Guideline 870.7485),
and a combined repeated dose toxicity with the reproduction/development
toxicity screening test (OPPTS Test Guideline 870.3650 modified or OECD
Test Guideline 422 modified) on a species to be determined by the
results of the pharmacokinetics studies with modifications, for the P-
11-483 chemical substance. The PMN submitter has also agreed not to
exceed the second production limit without performing the aerobic and
anaerobic transformation in soil test (OECD Test Guideline 307) for the
P-11-530 chemical substance. The company has agreed not to exceed the
third production limit without performing the fish acute toxicity test,
freshwater and marine test (OPPTS Test Guideline 850.1075), an aquatic
invertebrate acute toxicity test, freshwater daphnids (OPPTS Test
Guideline 850.1010), and an algal toxicity test (Office of Chemical
Safety and Pollution Prevention (OCSPP) Test Guideline 850.4500) for
the P-11-483 chemical substance. The company also has agreed to not to
exceed the fourth production limit without performing the avian
reproduction test (OPPTS Test Guideline 850.2300) for the P-11-483
chemical substance, and hydrolysis as a function of pH and temperature
(OPPTS Test Guideline 835.2130), ultraviolet (UV)/visible absorption
(OPPTS Test Guideline 830.7050), direct photolysis rate in water by
sunlight test (OPPTS Test Guideline 835.2210), if wavelengths greater
than 290 nanometers (nm) are absorbed in the previous test, indirect
photolysis screening test: Sunlight photolysis in waters containing
dissolved humic substances (OPPTS Test Guideline 835.5270), anaerobic
biodegradability of organic compounds in digested sludge: By
measurement of gas production (OPPTS Test Guideline 835.3420), and
modified semi continuous activated sludge (SCAS) test for insoluble and
volatile chemicals (OPPTS Guideline 835.5045), or inherent
biodegradability: Zahn-Wellens/EVPA Test (OECD Test Guideline 302B),
modified with analysis for degradation products for P-11-530 chemical
substance. Further testing details are available in the consent order
located in the docket under docket EPA-HQ-OPPT-2013-0739. EPA has also
determined that the results of certain other human health, ecotoxicity,
and environmental fate testing would help characterize the PMN
substance. The consent order does not require submission of the pended
testing detailed in the consent order at any specified time or
production volume. However, the consent order's restrictions on
manufacture, processing, distribution in commerce, use, and disposal of
the PMNs will remain in effect until the consent order is modified or
revoked by EPA based on submission of that or other relevant
information.
CFR citations: 40 CFR 721.10696 (P-11-483 and P-11-528); 40 CFR
721.10697 (P-11-487); 40 CFR 721.10698 (P-11-527); 40 CFR 721.10699 (P-
11-529); 40 CFR 721.10700 (P-11-530 and P-11-533); 40 CFR 721.10701 (P-
11-532); and 40 CFR 721.10702 (P-11-534).
PMN Numbers P-12-416, P-12-417, P-12-418, and P-12-419
Chemical names: Multi-walled carbon nanotubes (generic).
CAS numbers: Not available.
Effective date of TSCA section 5(e) consent order: December 3,
2012.
Basis for TSCA section 5(e) consent order: The PMNs state that the
use of the substances will be as: An additive for electro-static
discharge (ESD) in semiconductor packaging and electronic devices;
additive for weight-reduction in vehicles and windmill blades; additive
to reinforce building frames and machine components; additive to
improve conductivity in batteries and solar cells; additive in seat-
heaters (heat generating element in heating devices and materials);
electron emitter for lighting and x-ray sources; additive for heat
transfer and thermal emission in electronic devices; additive for
electromagnetic interface (EMI) shielding; catalyst support in chemical
manufacturing; and filter additive to remove nanoscale materials. Based
on test data on analogous respirable, poorly soluble particulates and
other carbon nanotubes (CNTs), EPA identified concerns for pulmonary
toxicity, fibrosis, carcinogenicity, mutagenicity, and immunotoxicity.
Further, available data suggest that pulmonary deposition of some
nanoparticles, including CNTs, may induce cardiovascular toxicity if
inhaled. Although there are no environmental toxicity studies on CNTs
available, EPA expects that some fraction of the CNTs, if released into
the environment, will eventually be suspended in water. There have been
sublethal effects observed for analogue single wall CNTs in rainbow
trout at levels as low as 100 ppb. The order was
[[Page 8277]]
issued under TSCA sections 5(e)(1)(A)(i) and 5(e)(1)(A)(ii)(I) based on
a finding that these substances may present an unreasonable risk of
injury to human health and the environment. To protect against these
risks, the consent order requires:
1. Use of personal protective equipment including gloves and
protective clothing impervious to the substances when there is a
potential dermal exposure and a National Institute of Occupational
Safety and Health (NIOSH)-certified air-purifying, tight-fitting full-
face respirator equipped with N-100, or P-100, or R-100 filters or
power air-purifying particulate respirator with an assigned protection
factor (APF) of at least 50 when there is potential inhalation
exposure.
2. No domestic manufacture.
3. Use of the substances only as described in the consent order.
4. Import of the substances at a cumulative, aggregate volume not
to exceed a confidential volume specified in the consent order unless
the company has submitted the results of certain health studies.
5. No use of the substances resulting in surface water releases.
The SNUR designates as a ``significant new use'' the absence of
these protective measures.
Recommended testing: EPA has determined that the following tests
would help characterize the human health effects of the PMN substances.
The PMN submitter has agreed not to exceed the confidential production
volume stated in the consent order without performing the 90-day
inhalation toxicity test (OPPTS Test Guideline 870.3465) on P-12-416
with a post-exposure observation period of up to 3 months;
bronchoalveolar lavage fluid (BALF) analysis; aggregation/agglomeration
state, shape, particle size distribution and surface properties of
material as-manufactured (dry) and as-administered; aggregation/
agglomeration state, shape, particle size distribution and surface
properties of materials of the delivered materials after
administration; determination of cardiovascular toxicity, heart
histopathology, and data on pulmonary deposition. In addition, in the
consent order, the PMN submitter agreed to provide physical/chemical
properties data within a specified time limit.
CFR citation: 40 CFR 721.10703.
PMN Number P-12-548
Chemical name: Aryl-substituted alkane (generic).
CAS number: Not available.
Effective date of TSCA section 5(e) consent order: April 30, 2013.
Basis for TSCA section 5(e) consent order: The PMN states that the
generic (non-confidential) use of the substance will be as a dielectric
fluid. 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 1,000. Also, based
on submitted test data on the PMN substance, EPA identified concerns
for developmental and liver toxicity to dermally exposed workers. Based
on EcoSAR analysis of test data on neutral organic chemicals, EPA
predicts toxicity to aquatic organisms may occur at concentrations that
exceed 8 ppb of the PMN substance in surface waters. The consent order
was issued under TSCA sections 5(e)(1)(A)(i) and 5(e)(1)(A)(ii)(I)
based on a finding that uncontrolled manufacture, processing,
distribution in commerce, use, and disposal of this substance may
present an unreasonable risk of injury to human health or the
environment. To protect against these risks, the consent order
requires:
1. Use of personal protective equipment including gloves impervious
to the substance when there is a potential dermal exposure.
2. Establishment and use of a hazard communication program.
3. Use of the substance only as described in the consent order.
4. Manufacture of the substance at a cumulative volume not to
exceed a confidential volume specified in the consent order unless the
company has submitted the results of certain health studies.
The SNUR designates as a ``significant new use'' the absence of
these protective measures.
Recommended testing: EPA has determined that the following tests
would help characterize the environmental and human health effects of
the PMN substance. The consent order contains three confidential
production volume limits. The PMN submitter has agreed not to exceed
the first production volume limit without performing a 14-day dermal
toxicity test (OPPTS Test Guideline 870.3200 or OECD Test Guideline
410). The PMN submitter has also agreed not to exceed the second
(higher) production volume limit without performing a bioaccumulation
in sediment-dwelling benthic oligochaetes test (OECD Test Guideline
315). The PMN submitter has also agreed not to exceed the third
(higher) production volume limit without performing a sediment and soil
adsorption/desorption isotherm test (OPPTS Test Guideline 835.1220).
The PMN submitter has also agreed to submit to EPA the results of any
other testing conducted to comply with REACH (Regulation, Evaluation,
Authorization, and Restriction of Chemicals in the European Union) no
later than 90 days after submission of the testing to the European
Union.
CFR citation: 40 CFR 721.10704.
PMN Number P-12-572
Chemical name: Aromatic amine with cyclo amino carbonyls (generic).
CAS number: Not available.
Basis for action: The PMN states that the generic (non-
confidential) use of the substance will be as a reactive amine for
enhancing pigment dispersions. Based on test data on the PMN substance
as well as on analogous aromatic amines, EPA identified human health
concerns regarding oncogenicity and mutagenicity from exposure to the
PMN substance via inhalation, dermal, and drinking water exposures.
Further, based on EcoSAR analysis of test data on analogous anilines,
EPA predicts toxicity to aquatic organisms may occur at concentrations
that exceed 11 ppb of the PMN substance in surface waters. This
concentration is also expected by the Agency to be protective of human
health concerns via drinking water exposure. As described in the PMN,
occupational exposures are expected to be minimal due to the use of
impervious gloves and a NIOSH-certified particulate respirator.
Releases of the substance are not expected to result in surface water
concentrations that exceed 11 ppb which then effectively limits
drinking water exposures. Therefore, EPA has not determined that the
proposed manufacturing, processing, or use of the substance may present
an unreasonable risk. EPA has determined, however, that any use of the
substance without the use of impervious gloves, where there is a
potential for dermal exposure; use of the substance without a NIOSH-
certified particulate respirator with an APF of at least 10, where
there is a potential for inhalation exposures; use of the substance
other than as an intermediate; or use of the substance resulting in
surface water concentrations exceeding 11 ppb may cause serious health
effects and significant adverse environmental effects. Based on this
information, the PMN substance meets the concern criteria at Sec.
721.170(b)(1)(i)(C), (b)(3)(i), (b)(3)(ii), and (b)(4)(ii).
[[Page 8278]]
Recommended testing: EPA has determined that the results of an
algal toxicity test (OCSPP Test Guideline 850.4500), an aquatic
invertebrate acute toxicity test (OPPTS Test Guideline 850.1010), a
fish acute toxicity test (OPPTS Test Guideline 850.1075), and a
combined repeated dose toxicity with the reproduction/developmental
toxicity test (OPPTS Test Guideline 870.3650) would help characterize
the human health and environmental effects of the PMN substance.
CFR citation: 40 CFR 721.10705.
PMN Number P-12-576
Chemical name: Infused carbon nanostructures (generic).
CAS number: Not available.
Basis for action: The PMN states that the generic (non-
confidential) use of the substance is as an additive to provide
conductive properties to reinforcements used in composites. Based on
available information on analogous carbon structures, EPA identified
concerns for lung effects. No significant inhalation exposures are
expected when the PMN substance is manufactured according to the
process identified in the PMN, to incorporate the PMN substance into
pellets. 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 a manufacturing
process other than as described in the PMN (the manufacturing process
described in the PMN includes incorporation of the PMN substance into
pellets), may cause serious health effects. Based on this information,
the PMN substance meets the concern criteria at Sec.
721.170(b)(3)(ii).
Recommended testing: EPA has determined that the following analysis
of the PMN substance would help characterize the effects of the PMN
substance: The dimensions, the structure, branching characteristics,
presence of the catalyst in the PMN substance, and physical-chemical
properties of the carbon nanostructures. These properties should be
determined and reported to EPA once a year for three consecutive years.
CFR citation: 40 CFR 721.10706.
PMN Number P-13-127
Chemical name: Substituted benzyl acrylate (generic).
CAS number: Not available.
Basis for action: The PMN states that the use of the substance is
as a resin for industrial coatings. 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, 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
releases to surface waters exceeding 1 ppb may result in 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 a
daphnid chronic toxicity test (OPPTS Test Guideline 850.1300) and a
fish early-life stage toxicity test (OPPTS Test Guideline 850.1400)
would help characterize the environmental effects of the PMN substance.
CFR citation: 40 CFR 721.10707.
PMN Number P-13-152
Chemical name: Zirconium substituted heteropolycyclic (generic).
CAS number: Not available.
Basis for action: The PMN states that the generic (non-
confidential) use of the substance is a contained use in electronic
equipment. Based on EcoSAR analysis of test data on analogous zirconium
compounds, EPA predicts toxicity to aquatic organisms may occur at
concentrations that exceed 10 ppb of the PMN substance in surface
waters. As described in the PMN, releases of the PMN substance are not
expected to result in surface water concentrations that exceed 10 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
releases to surface water concentrations exceeding 10 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 an
algal toxicity test (OCSPP Test Guideline 850.4500), a daphnid chronic
toxicity test (OPPTS Test Guideline 850.1300), and a fish early-life
stage toxicity test (OPPTS Test Guideline 850.1400) would help
characterize the environmental effects of the PMN substance. EPA also
recommends that the guidance document on aquatic toxicity testing of
difficult substance and mixtures (OECD Test Guideline 23) be followed.
CFR citation: 40 CFR 721.10708.
PMN Number P-13-168
Chemical name: Alkylphenol (generic).
CAS number: Not available.
Basis for action: The PMN states that the use of the substance is
as a reactant for a lubricant additive. Based on EcoSAR analysis of
test data on analogous phenols, 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 a
daphnid chronic toxicity test (OPPTS Test Guideline 850.1300), a fish
early-life stage toxicity test (OPPTS Test Guideline 850.1400), and an
algal toxicity test (OCSPP Test Guideline 850.4500) would help
characterize the environmental effects of the PMN substance. EPA also
recommends that the guidance document on aquatic toxicity testing of
difficult substances and mixtures (OECD Test Guideline 23) be followed.
CFR citation: 40 CFR 721.10709.
PMN Number P-13-192
Chemical name: 4,7-Methano-1H-indene, 3a,4,7,7a-tetrahydro-,
polymer with 2-methyl-1,3-butadiene and 5-(1-
methylethenyl)bicyclo[2.2.1]hept-2-ene.
CAS number: 1412159-51-3.
Basis for action: The PMN states that the substance is used as a
rubber additive. Based on EcoSAR analysis of test data on analogous
neutral organics, 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 result in significant
adverse
[[Page 8279]]
environmental effects. Based on this information, the PMN substance
meets the concern criteria at Sec. 721.170(b)(4)(ii).
Recommended testing: EPA has determined that the results of a
daphnid chronic toxicity test (OPPTS Test Guideline 850.1300), a fish
early-life stage toxicity test (OPPTS Test Guideline 850.1400), and an
algal toxicity test (OCSPP Test Guideline 850.4500) would help
characterize the environmental effects of the PMN substance. EPA also
recommends that the guidance document on aquatic toxicity testing of
difficult substances and mixtures (OECD Test Guideline 23) be followed.
CFR citation: 40 CFR 721.10710.
PMN Number P-13-197
Chemical name: Alkyl substituted catechol (generic).
CAS number: Not available.
Basis for action: The PMN states that the generic (non-
confidential) use of the substance will be as a raw material for
organic synthesis. Based on test data on an analog, EPA identified
potential human health concerns regarding oncogenicity, skin and eye
irritation and corrosion, dermal sensitization, mutagenicity, and
developmental toxicity from exposure to the PMN substance via
inhalation, dermal, and drinking water exposures. Further, based on
EcoSAR analysis of test data on analogous polyphenols, EPA predicts
toxicity to aquatic organisms may occur at concentrations that exceed
20 ppb of the PMN substance in surface waters. This concentration is
also expected by the Agency to be protective of human health concerns
via drinking water exposures. As described in the PMN, occupational
exposure is expected to be minimal due to the use of impervious gloves
and a NIOSH-certified particulate respirator with an APF of 1,000; and
releases to surface waters are not expected which then effectively
limits drinking water exposures. Therefore, EPA has not determined that
the proposed manufacturing, processing, or use of the substance may
present an unreasonable risk. EPA has determined, however, that any use
of the substance without the use of impervious gloves, where there is a
potential for dermal exposure; use of the substance without a NIOSH-
certified particulate respirator with an APF of 1,000, where there is a
potential for inhalation exposures; use of the substance other than as
an intermediate; or use of the substance resulting in surface water
concentrations exceeding 20 ppb may cause serious health effects and
significant adverse environmental effects. Based on this information,
the PMN substance meets the concern criteria at Sec.
721.170(b)(1)(i)(C), (b)(3)(ii), and (b)(4)(ii).
Recommended testing: EPA has determined that the results of an
algal toxicity test (OCSPP Test Guideline 850.4500); an aquatic
invertebrate acute toxicity test, freshwater daphnids (OPPTS Test
Guideline 850.1010); a fish acute toxicity test, freshwater and marine
(OPPTS Test Guideline 850.1075), as well as either the in vitro skin
corrosion: transcutaneous electrical resistance test (TER) (OECD Test
Guideline 430) or the in vitro skin corrosion: human skin model test
(OECD Test Guideline 431) or the in vitro membrane barrier test method
for skin corrosion (OECD Test Guideline 435) would help characterize
the human health and environmental effects of the PMN substance.
CFR citation: 40 CFR 721.10711.
PMN Number P-13-217
Chemical name: Antimony tris(dialkyldithiocarbamate) (generic).
CAS number: Not available.
Basis for action: The PMN states that the use of the substance is
as an extreme pressure, anti-wear additive for greases and oils. Based
on EcoSAR analysis of test data on analogous dithiocarbamates, EPA
predicts toxicity to aquatic organisms may occur at concentrations that
exceed 4 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 4 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 4 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 a
daphnid chronic toxicity test (OPPTS Test Guideline 850.1300) and a
fish early-life stage toxicity test (OPPTS Test Guideline 850.1400)
would help characterize the environmental effects of the PMN substance.
CFR citation: 40 CFR 721.10712.
PMN Number P-13-259
Chemical name: Antimony tris(dialkyldithiocarbamate) (generic).
CAS number: Not available.
Basis for action: The PMN states that the use of the substance is
as an extreme pressure, anti-wear additive for greases and oils
containing the PMN substance and sulfurized isobutylene. Based on
EcoSAR analysis of test data on analogous organic antimony
dithiocarbamate, EPA predicts toxicity to aquatic organisms may occur
at concentrations that exceed 4 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 4 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 4 ppb may result in significant
adverse environmental effects. Based on this information, the PMN
substance meets the concern criteria at Sec. 721.170(b)(4)(ii).
Recommended testing: EPA has determined that the results of a ready
biodegradability test (OECD Test Guideline 301), a daphnid chronic
toxicity test (OPPTS Test Guideline 850.1300), and a fish early-life
stage toxicity test (OPPTS Test Guideline 850.1400) would help
characterize the environmental effects of the PMN substance. EPA also
recommends that the guidance document on aquatic toxicity testing of
difficult substances and mixtures (OECD Test Guideline 23) be followed.
CFR citation: 40 CFR 721.10713.
PMN Number P-13-260
Chemical name: Zinc bis(dialkyldithiocarbamate) (generic).
CAS number: Not available.
Basis for action: The PMN states that the use of the substance is
as an extreme pressure, anti-wear additive for greases and oils
containing the PMN substance and process oil as well as an extreme
pressure, anti-wear additive for greases and oils containing the PMN
substance and sulfurized isobutylene. Based on EcoSAR analysis of test
data on analogous zinc salts, EPA predicts toxicity to aquatic
organisms may occur at concentrations that exceed 7 ppb of the PMN
substance in surface waters. As described in the PMN, releases of the
substance are not expected to result in surface water concentrations
that exceed 7 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 7 ppb may
result in significant adverse environmental effects. Based on this
information, the PMN substance meets
[[Page 8280]]
the concern criteria at Sec. 721.170(b)(4)(ii).
Recommended testing: EPA has determined that the results of a ready
biodegradability test (OECD Test Guideline 301), a daphnid chronic
toxicity test (OPPTS Test Guideline 850.1300), and a fish early-life
stage toxicity test (OPPTS Test Guideline 850.1400) would help
characterize the environmental effects of the PMN substance. EPA also
recommends that the guidance document on aquatic toxicity testing of
difficult substances and mixtures (OECD Test Guideline 23) be followed.
CFR citation: 40 CFR 721.10714.
PMN Number P-13-346
Chemical name: Carbonic acid, dialkyl ester (generic).
CAS number: Not available.
Basis for action: The PMN states that the generic (non-
confidential) use of the PMN substance will be as an encapsulated part
in a polymer matrix used as part of a fragrance slurry in consumer
fabric care and cleaning products. Based on test data on the PMN
substance and 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 for greater than 20
days per year. This 20-day criterion is derived from partial life cycle
tests (daphnid chronic and fish early-life stage tests) that typically
range from 21 to 28 days in duration. EPA predicts toxicity to aquatic
organisms may occur if releases of the PMN substance to surface water
exceed releases from importing 100,000 kilograms of the PMN substance
per year. For the use described in the PMN and at the importation
volume described in the PMN, environmental releases did not exceed 1
ppb for more than 20 days per year. Therefore, EPA has not determined
that the proposed importing, processing, or use of the substance may
present an unreasonable risk. EPA has determined, however, that any
domestic manufacture of the PMN substance, use of the substance other
than as described in the PMN, or importing the PMN substance at volumes
greater than 100,000 kilograms per year, could result in exposures
which may cause significant adverse environmental effects. Based on
this information, the PMN substance meets the concern criteria at Sec.
721.170(b)(4)(i) and (b)(4)(ii).
Recommended testing: EPA has determined that the results of a fish
early-life stage toxicity test (OPPTS Test Guideline 850.1400) would
help characterize the environmental effects of the PMN substance.
CFR citation: 40 CFR 721.10715.
PMN Number P-13-355
Chemical name: Phenol, 2,6-dimethyl-, homopolymer, ether with
2,2',3,3',5,5'-hexamethyl[1,1'-biphenyl]-4,4'-diol
(2:1),bis[(ethenylphenyl)methyl] ether.
CAS number: 558452-77-0.
Basis for action: The PMN states that the use of the substance is
as a polymeric coating. Based on test data on the PMN substance, EPA
predicts 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 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 result in 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 a
chironomid sediment toxicity test (OPPTS Test Guideline 850.1790); a
whole sediment acute toxicity invertebrates, freshwater or marine
(OPPTS Test Guideline 850.1735 or 850.1740); a sediment-water
chironomid toxicity using spiked water test (OECD Test Guideline 219);
a sediment-water chironomid toxicity test using spiked sediment (OECD
Test Guideline 218); a sediment-water lumbriculus toxicity test using
spiked sediment (OECD Test Guideline 225); a sediment-water chironomid
life-cycle toxicity test using spiked water or spiked sediment (OECD
Test Guideline 233); methods for measuring the toxicity and
bioaccumulation of sediment-associated contaminants with freshwater
invertebrates (EPA 600/R-99/064 March 2000; see http://nepis.epa.gov/Exe/ZyPDF.cgi/Docket=30003SBA.PDF), and environmental monitoring of the
PMN substance would help characterize the environmental effects of the
PMN substance. EPA also recommends that the guidance document on
aquatic toxicity testing of difficult substances and mixtures (OECD
Test Guideline 23) be followed.
CFR citation: 40 CFR 721.10716.
PMN Number P-13-365
Chemical name: MDI modified polyalkene glycols (generic).
CAS number: Not available.
Basis for action: The PMN states that the generic (non-
confidential) use of the substance will be as an adhesive component.
Based on test data on analogous diisocyanates, EPA identified concerns
for dermal and respiratory sensitization, and lung and mucous membrane
irritation effects. For the use described in the PMN, EPA does not
expect significant occupational or consumer inhalation exposure due to
the use of adequate personal protective equipment and because the
substance is not applied using a method that generates a vapor, mist,
or aerosol nor is it used in a consumer product. Therefore, EPA has not
determined that the proposed manufacturing, processing, or use of the
substance may present an unreasonable risk. EPA has determined,
however, that any use of the substance without a NIOSH-certified
particulate respirator with an APF of at least 10, where there is a
potential for inhalation exposures; any use of the substance in
consumer products; or any use of the substance involving an application
method that generates a vapor, mist, or aerosol, may cause serious
health effects. Based on this information, the PMN substance meets the
concern criteria at Sec. 721.170(b)(3)(ii).
Recommended testing: EPA has determined that the results of a skin
sensitization test (OPPTS Test Guideline 870.2600) and a 90-day
inhalation toxicity test (OPPTS Test Guideline 870.3465) would help
characterize the human health effects of the PMN substance.
CFR citation: 40 CFR 721.10717.
PMN Number P-13-374
Chemical name: Substituted picolinic acid (generic).
CAS number: Not available.
Basis for action: The PMN states that the specific use of the
substance will be as a pesticide intermediate. Based on test data of
the PMN substance and close analogs, the Agency identified human health
concerns for systemic and developmental toxicities, neurotoxicity, and
oncogenicity from dermal, drinking water, and inhalation exposures.
Further, based on test data on the PMN substance, EPA predicts toxicity
to aquatic organisms may occur at concentrations that exceed 180 ppb of
the PMN substance in surface water. This concentration is also expected
by the Agency to be protective of human health concerns via drinking
water exposure. For the use described in the PMN, EPA does not expect
significant occupational exposures and releases of the PMN substance
are not expected to
[[Page 8281]]
result in surface water concentrations that exceed 180 ppb which then
effectively limits drinking water exposures. 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 a pesticide
intermediate could result in exposures which may cause serious health
or ecological effects. Based on this information, the PMN substance
meets the concern criteria at Sec. 721.170(b)(1)(i)(C), (b)(3)(i), and
(b)(4)(i).
Recommended testing: EPA has determined that the results of
industrial workplace monitoring and environmental release information
would help characterize the health and environmental effects of the PMN
substance.
CFR citation: 40 CFR 721.10718.
PMN Number P-13-392
Chemical name: Acrylic acid esters polymers, reaction products with
polyisocyanate (generic).
CAS number: Not available.
Basis for action: The PMN states that the generic (non-
confidential) use of the substance will be for wood, plastic, and
automotive paint material. Based on test data on analogous
diisocyanates, EPA identified concerns for dermal and respiratory
sensitization, irritation to all moist tissues, and lung effects if
inhaled based on the low molecular weight isocyanates, to workers
exposed to the PMN substance. 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. Therefore,
EPA has not determined that the proposed manufacturing, processing, or
use of the substance may present an unreasonable risk. EPA has
determined, however, that any use of the substance without a NIOSH-
certified respirator with an APF of at least 10, where there is
potential inhalation exposure; or any use of the PMN substance in a
consumer product, may cause serious health effects. Based on this
information, the PMN substance meets the concern criteria at Sec.
721.170(b)(3)(ii).
Recommended testing: EPA has determined that the results of a skin
sensitization test (OPPTS Test Guideline 870.2600) and a 90-day
inhalation toxicity test (OPPTS Test Guideline 870.3465) would help
characterize the human health effects of the PMN substance.
CFR citation: 40 CFR 721.10719.
PMN Number P-13-393
Chemical name: 1,3-Benzenedicarboxylic acid, polymer with 1,4-
benzenedicarboxylic acid, 1,4-dimethyl 1,4-benzenedicarboxylate, 2,2-
dimethyl-1,3-propanediol,dodecanedioic acid, 1,2-ethanediol,
hexanedioic acid, 1,6-hexanediol, alkyldiol ester and aromatic
isocyanate (generic).
CAS number: Not available.
Basis for action: The PMN states that the generic (non-
confidential) use of the substance will be as an industrial adhesive.
Based on test data on analogous diisocyanates, the Agency identified
concerns for dermal and respiratory sensitization, irritation to all
moist tissues, and lung effects if inhaled based on the low molecular
weight isocyanates. For the use described in the PMN, EPA does not
expect significant occupational or consumer inhalation exposure due to
the use of adequate personal protective equipment and because the
substance is not applied using a method that generates a vapor, mist,
or aerosol nor is the substance used in a consumer product. Therefore,
EPA has not determined that the proposed manufacturing, processing, or
use of the substance may present an unreasonable risk. EPA has
determined, however, that any use of the substance without a NIOSH-
certified particulate respirator with an APF of at least 10, where
there is a potential for inhalation exposures; any use of the substance
in consumer products; or any use of the substance involving an
application method that generates a vapor, mist, or aerosol, may cause
serious health effects. Based on this information, the PMN substance
meets the concern criteria at Sec. 721.170(b)(3)(ii).
Recommended testing: EPA has determined that the results of a skin
sensitization test (OPPTS Test Guideline 870.2600) and a 90-day
inhalation toxicity test (OPPTS Test Guideline 870.3465) would help
characterize the human health effects of the PMN substance.
CFR citation: 40 CFR 721.10720.
PMN Number P-13-455
Chemical name: Poly(oxy-1,2-ethanediyl), .alpha.,.alpha.'-[(1-
methylethylidene)di-4,1-phenylene]bis[.omega.-[[6-(2,5-dihydro-2,5-
dioxo-1H-pyrrol-1-yl)-1-oxohexyl]oxy]-.
CAS number: Not available.
Basis for action: The PMN states that the generic (non-
confidential) use of the substance will be as a conductive adhesive in
the electronics industry. Based on EcoSAR analysis of test data on
analogous imides and esters, EPA predicts toxicity to aquatic organisms
may occur at concentrations that exceed 1 ppb of the PMN substance in
surface waters. For the specific use described in the PMN,
environmental releases 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 PMN substance resulting in surface water concentrations
exceeding 1 ppb may cause significant adverse environmental effects.
Based on this information, the PMN substances meet the concern criteria
at Sec. 721.170(b)(4)(ii).
Recommended testing: EPA has determined that the results of a fish
early-life stage toxicity test (OPPTS Test Guideline 850.1400) and a
daphnid chronic toxicity test (OPPTS Test Guideline 850.1300) would
help characterize the environmental effects of the PMN substance.
CFR citation: 40 CFR 721.10721.
PMN Number P-13-468
Chemical name: Oxirane,2-[(1-propen-1-yloxy)methyl]-.
CAS number: 1607-23-4.
Basis for action: The PMN states that the substance will be used as
a site-limited chemical intermediate to make a curable monomer. Based
on test data on analogous epoxides, EPA identified concerns for skin
and lung sensitization, mutagenicity, oncogenicity, developmental
toxicity, male reproductive, liver, and kidney toxicity to workers
exposed to the PMN substance. As described in the PMN, worker
inhalation exposure is not expected and dermal exposure will be minimal
due to the use as an intermediate and 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 any use of the
substance without a NIOSH-certified respirator with an APF of at least
10, where there is potential inhalation exposure; the use of the
substance without impervious gloves, where there is potential for
dermal exposure; or use other than as an intermediate may cause serious
health effects. Based on this information, the PMN substances meet the
concern criteria at Sec. 721.170(b)(1)(i)(C) and (b)(3)(ii).
Recommended testing: EPA has determined that the results of a
carcinogenicity test (OPPTS Test
[[Page 8282]]
Guideline 870.4200) and a 90-day oral toxicity in rodents test (OPPTS
Test Guideline 870.3100) would help characterize the human health
effects of the PMN substance.
CFR citation: 40 CFR 721.10722.
PMN Number P-13-471
Chemical name: Methylene diisocyanate polymer with polypropylene
glycol and diols (generic).
CAS number: Not available.
Basis for action: The PMN states that the generic (non-
confidential) use of the substance will be as an industrial adhesive.
Based on test data on analogous diisocyanates, EPA identified concerns
for oncogenicity, mutagenicity, respiratory and dermal sensitization,
and lung and mucous membrane irritation to workers exposed to the PMN
substance. As described in the PMN, worker inhalation exposure is not
expected and dermal exposure will be minimal due to the use as an
intermediate and 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 any use of the substance without a
NIOSH-certified particulate respirator with an APF of at least 10,
where there is potential inhalation exposure, or the use of the
substance in a consumer product, may cause serious health effects.
Based on this information, the PMN substance meets the concern criteria
at Sec. 721.170(b)(1)(i)(C) and (b)(3)(ii).
Recommended testing: EPA has determined that the results of a skin
sensitization test (OPPTS Test Guideline 870.2600) and a 90-day
inhalation toxicity test (OPPTS Test Guideline 870.3465) would help
characterize the human health effects of the PMN substance.
CFR citation: 40 CFR 721.10723.
PMN Number P-13-472
Chemical name: Oxirane,[[2-(2-ethenyloxy)ethoxy]methyl]-.
CAS number: 16801-19-7.
Basis for action: The PMN states that the substance will be used as
a site-limited intermediate to manufacture a curable monomer. Based on
test data on analogous epoxides, EPA identified concerns for skin and
lung sensitization, mutagenicity, oncogenicity, developmental toxicity,
male reproductive, liver, and kidney toxicity to workers exposed to the
PMN substance. In addition, based on analogous vinyl ethers, there were
concerns for oncogenicity, reproductive toxicity, and blood toxicity.
As described in the PMN, worker inhalation exposure is not expected and
dermal exposure will be minimal due to the use as an intermediate and
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 any use of the substance without a NIOSH-certified
respirator with an APF of at least 10, where there is potential
inhalation exposure; the use of the substance without impervious
gloves, where there is potential for dermal exposure; or use other than
as an intermediate may cause serious health effects. Based on this
information, the PMN substances meet the concern criteria at Sec.
721.170(b)(1)(i)(C) and (b)(3)(ii).
Recommended testing: EPA has determined that the results of a
carcinogenicity test (OPPTS Test Guideline 870.4200) and a 90-day oral
toxicity in rodents test (OPPTS Test Guideline 870.3100) would help
characterize the human health effects of the PMN substance.
CFR citation: 40 CFR 721.10724.
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 14 of the 35
chemical substances, regulation was warranted under TSCA section 5(e),
pending the development of information sufficient to make reasoned
evaluations of the health or environmental effects of the chemical
substances. The basis for such findings is outlined in Unit IV. Based
on these findings, TSCA section 5(e) consent orders requiring the use
of appropriate exposure controls were negotiated with the PMN
submitters. The SNUR provisions for these chemical substances are
consistent with the provisions of the TSCA section 5(e) consent orders.
These SNURs are promulgated pursuant to Sec. [emsp14]721.160 (see Unit
VI.).
In the other 21 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. [emsp14]721.170 were met, as
discussed in Unit IV.
B. Objectives
EPA is issuing these SNURs for specific chemical substances which
have undergone premanufacture review because the Agency wants to
achieve the following objectives with regard to the significant new
uses designated in this rule:
EPA will receive notice of any person's intent to
manufacture 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 or
processing a listed chemical substance for the described significant
new use.
EPA will be able to regulate prospective manufacturers 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 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 Chemical Substance
Inventory (TSCA Inventory). Guidance on how to determine if a chemical
substance is on the TSCA Inventory is available on the Internet at
http://www.epa.gov/opptintr/existingchemicals/pubs/tscainventory/index.html.
VI. Direct Final Procedures
EPA is issuing these SNURs as a direct final rule, as described in
Sec. [emsp14]721.160(c)(3) and Sec. [emsp14]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 April 14, 2014 without further
notice, unless EPA receives written adverse or critical comments, or
notice of intent to submit adverse or critical comments before March
14, 2014.
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 March 14, 2014, 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
[[Page 8283]]
substance not identified in the comment.
VII. Applicability of the Significant New Use Designation
To establish a significant new use, EPA must determine that the use
is not ongoing. The chemical substances subject to this rule have
undergone premanufacture review. In cases where EPA has not received a
notice of commencement (NOC) and the chemical substance has not been
added to the TSCA Inventory, no person may commence such activities
without first submitting a PMN. Therefore, for chemical substances for
which an NOC has not been submitted EPA concludes that the designated
significant new uses are not ongoing.
When chemical substances identified in this rule are added to the
TSCA Inventory, EPA recognizes that, before the rule is effective,
other persons might engage in a use that has been identified as a
significant new use. However, TSCA section 5(e) consent orders have
been issued for 14 of the 35 chemical substances, and the PMN
submitters are prohibited by the TSCA section 5(e) consent orders from
undertaking activities which would be designated as significant new
uses. The identities of 29 of the 35 chemical substances subject to
this rule have been claimed as confidential and EPA has received no
post-PMN bona fide submissions (per Sec. Sec. 720.25 and 721.11).
Based on this, 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.
Therefore, EPA designates February 12, 2014 as the cutoff date for
determining whether the new use is ongoing. Persons who begin
commercial manufacture or processing of the chemical substances for a
significant new use identified as of that date would have to cease any
such activity upon the effective date of the final rule. To resume
their activities, these persons would have to first comply with all
applicable SNUR notification requirements and wait until the notice
review period, including any extensions, expires. If such a person met
the conditions of advance compliance under Sec. 721.45(h), the person
would be considered exempt from the requirements of the SNUR. Consult
the Federal Register document of April 24, 1990 for a more detailed
discussion of the cutoff date for ongoing uses.
VIII. Test Data and Other Information
EPA recognizes that TSCA section 5 does not require developing any
particular test data before submission of a SNUN. The two exceptions
are:
1. Development of test data is required where the chemical
substance subject to the SNUR is also subject to a test rule under TSCA
section 4 (see TSCA section 5(b)(1)).
2. Development of test data may be necessary where the chemical
substance has been listed under TSCA section 5(b)(4) (see TSCA section
5(b)(2)).
In the absence of a TSCA section 4 test rule or a TSCA section
5(b)(4) listing covering the chemical substance, persons are required
only to submit test data in their possession or control and to describe
any other data known to or reasonably ascertainable by them (see 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-section 5(e) SNURs. Descriptions of tests are provided
for informational purposes. EPA strongly encourages persons, before
performing any testing, to consult with the Agency pertaining to
protocol selection. To access the OCSPP test guidelines referenced in
this document electronically, please go to http://www.epa.gov/ocspp and
select ``Test Methods and Guidelines.'' The 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 orders for several of the chemical
substances regulated under this rule, EPA has established production
volume limits in view of the lack of data on the potential health and
environmental risks that may be posed by the significant new uses or
increased exposure to the chemical substances. These limits cannot be
exceeded unless the PMN submitter first submits the results of toxicity
tests that would permit a reasoned evaluation of the potential risks
posed by these chemical substances. Listings of the tests specified in
the TSCA section 5(e) consent orders are included in Unit IV. The SNURs
contain the same production volume limits as the TSCA section 5(e)
consent orders. Exceeding these production limits is defined as a
significant new use. Persons who intend to exceed the production limit
must notify the Agency by submitting a SNUN at least 90 days in advance
of commencement of non-exempt commercial manufacture or processing.
The recommended tests specified in Unit IV. may not be the only
means of addressing the potential risks of the chemical substance.
However, submitting a SNUN without any test data may increase the
likelihood that EPA will take action under TSCA section 5(e),
particularly if satisfactory test results have not been obtained from a
prior PMN or SNUN submitter. EPA recommends that potential SNUN
submitters contact EPA early enough so that they will be able to
conduct the appropriate tests.
SNUN submitters should be aware that EPA will be better able to
evaluate SNUNs which provide detailed information on the following:
Human exposure and environmental release that may result
from the significant new use of the chemical substances.
Potential benefits of the chemical substances.
Information on risks posed by the chemical substances
compared to risks posed by potential substitutes.
IX. Procedural Determinations
By this rule, EPA is establishing certain significant new uses
which have been claimed as CBI subject to Agency confidentiality
regulations at 40 CFR part 2 and 40 CFR part 720, subpart E. Absent a
final determination or other disposition of the confidentiality claim
under 40 CFR part 2 procedures, EPA is required to keep this
information confidential. EPA promulgated a procedure to deal with the
situation where a specific significant new use is CBI, at 40 CFR
721.1725(b)(1).
Under these procedures a manufacturer or processor may request EPA
to determine whether a proposed use would be a significant new use
under the rule. The manufacturer or processor must show that it has a
bona fide intent to manufacture or process the chemical substance and
must identify the specific use for which it intends to manufacture or
process the chemical substance. If EPA concludes that the person has
shown a bona fide intent to manufacture 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 and processors can
combine the bona fide submission under the procedure in Sec.
721.1725(b)(1) with that under Sec. 721.11 into a single step.
If EPA determines that the use identified in the bona fide
submission would not be a significant new use, i.e.,
[[Page 8284]]
the use does not meet the criteria specified in the rule for a
significant new use, that person can manufacture or process the
chemical substance so long as the significant new use trigger is not
met. In the case of a production volume trigger, this means that the
aggregate annual production volume does not exceed that identified in
the bona fide submission to EPA. Because of confidentiality concerns,
EPA does not typically disclose the actual production volume that
constitutes the use trigger. Thus, if the person later intends to
exceed that volume, a new bona fide submission would be necessary to
determine whether that higher volume would be a significant new use.
X. SNUN Submissions
According to Sec. 721.1(c), persons submitting a SNUN must comply
with the same notification requirements and EPA regulatory procedures
as persons submitting a PMN, including submission of test data on
health and environmental effects as described in 40 CFR 720.50. SNUNs
must be submitted on EPA Form No. 7710-25, generated using e-PMN
software, and submitted to the Agency in accordance with the procedures
set forth in 40 CFR 720.40 and Sec. 721.25. E-PMN software is
available electronically at http://www.epa.gov/opptintr/newchems.
XI. Economic Analysis
EPA has evaluated the potential costs of establishing SNUN
requirements for potential manufacturers and processors of the chemical
substances subject to this rule. EPA's complete economic analysis is
available in the docket under docket ID number EPA-HQ-OPPT-2013-0739.
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 (PRA)
According to PRA (44 U.S.C. 3501 et seq.), an agency may not
conduct or sponsor, and a person is not required to respond to a
collection of information that requires OMB approval under PRA, unless
it has been approved by OMB and displays a currently valid OMB control
number. The OMB control numbers for EPA's regulations in title 40 of
the CFR, after appearing in the Federal Register, are listed in 40 CFR
part 9, and included on the related collection instrument or form, if
applicable. EPA is amending the table in 40 CFR part 9 to list the OMB
approval number for the information collection requirements contained
in this rule. This listing of the OMB control numbers and their
subsequent codification in the CFR satisfies the display requirements
of PRA and OMB's implementing regulations at 5 CFR part 1320. This
Information Collection Request (ICR) was previously subject to public
notice and comment prior to OMB approval, and given the technical
nature of the table, EPA finds that further notice and comment to amend
it is unnecessary. As a result, EPA finds that there is ``good cause''
under section 553(b)(3)(B) of the Administrative Procedure Act (5
U.S.C. 553(b)(3)(B)) to amend this table without further notice and
comment.
The information collection requirements related to this action have
already been approved by OMB pursuant to PRA under OMB control number
2070-0012 (EPA ICR No. 574). This action does not impose any burden
requiring additional OMB approval. If an entity were to submit a SNUN
to the Agency, the annual burden is estimated to average between 30 and
170 hours per response. This burden estimate includes the time needed
to review instructions, search existing data sources, gather and
maintain the data needed, and complete, review, and submit the required
SNUN.
Send any comments about the accuracy of the burden estimate, and
any suggested methods for minimizing respondent burden, including
through the use of automated collection techniques, to the Director,
Collection Strategies Division, Office of Environmental Information
(2822T), Environmental Protection Agency, 1200 Pennsylvania Ave. NW.,
Washington, DC 20460-0001. Please remember to include the OMB control
number in any correspondence, but do not submit any completed forms to
this address.
C. Regulatory Flexibility Act (RFA)
On February 18, 2012, EPA certified pursuant to RFA section 605(b)
(5 U.S.C. 601 et seq.), that promulgation of a SNUR does not have a
significant economic impact on a substantial number of small entities
where the following are true:
1. A significant number of SNUNs would not be submitted by small
entities in response to the SNUR.
2. The SNUR submitted by any small entity would not cost
significantly more than $8,300.
A copy of that certification is available in the docket for this
rule.
This rule is within the scope of the February 18, 2012
certification. Based on the Economic Analysis discussed in Unit XI. and
EPA's experience promulgating SNURs (discussed in the certification),
EPA believes that the following are true:
A significant number of SNUNs would not be submitted by
small entities in response to the SNUR.
Submission of the SNUN would not cost any small entity
significantly more than $8,300.
Therefore, the promulgation of the SNUR would not have a
significant economic impact on a substantial number of small entities.
D. Unfunded Mandates Reform Act (UMRA)
Based on EPA's experience with proposing and finalizing SNURs,
State, local, and Tribal governments have not been impacted by these
rulemakings, and EPA does not have any reasons to believe that any
State, local, or Tribal government will be impacted by this rule. As
such, EPA has determined that this rule does not impose any enforceable
duty, contain any unfunded mandate, or otherwise have any effect on
small governments subject to the requirements of UMRA sections 202,
203, 204, or 205 (2 U.S.C. 1501 et seq.).
E. Executive Order 13132
This action will not have a substantial direct effect on States, on
the relationship between the national government and the States, or on
the distribution of power and responsibilities among the various levels
of government, as specified in Executive Order 13132, entitled
``Federalism'' (64 FR 43255, August 10, 1999).
F. Executive Order 13175
This rule does not have Tribal implications because it is not
expected to have substantial direct effects on Indian Tribes. This rule
does not significantly nor uniquely affect the communities of Indian
Tribal governments, nor does it involve or impose any requirements that
affect Indian Tribes. Accordingly, the requirements of Executive Order
13175, entitled ``Consultation and Coordination with Indian Tribal
Governments'' (65 FR 67249, November 9, 2000), do not apply to this
rule.
G. Executive Order 13045
This action is not subject to Executive Order 13045, entitled
``Protection of Children from Environmental Health
[[Page 8285]]
Risks and Safety Risks'' (62 FR 19885, April 23, 1997), because this is
not an economically significant regulatory action as defined by
Executive Order 12866, and this action does not address environmental
health or safety risks disproportionately affecting children.
H. Executive Order 13211
This action is not subject to Executive Order 13211, entitled
``Actions Concerning Regulations That Significantly Affect Energy
Supply, Distribution, or Use'' (66 FR 28355, May 22, 2001), because
this action is not expected to affect energy supply, distribution, or
use and because this action is not a significant regulatory action
under Executive Order 12866.
I. National Technology Transfer and Advancement Act (NTTAA)
In addition, since this action does not involve any technical
standards, NTTAA section 12(d) (15 U.S.C. 272 note), does not apply to
this action.
J. Executive Order 12898
This action does not entail special considerations of environmental
justice related issues as delineated by Executive Order 12898, entitled
``Federal Actions to Address Environmental Justice in Minority
Populations and Low-Income Populations'' (59 FR 7629, February 16,
1994).
XIII. Congressional Review Act
Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.),
EPA will submit a report containing this rule and other required
information to the U.S. Senate, the U.S. House of Representatives, and
the Comptroller General of the United States prior to publication of
the rule in the Federal Register. This action is not a ``major rule''
as defined by 5 U.S.C. 804(2).
List of Subjects
40 CFR Part 9
Environmental protection, Reporting and recordkeeping requirements.
40 CFR Part 721
Environmental protection, Chemicals, Hazardous substances,
Reporting and recordkeeping requirements.
Dated: February 3, 2014.
Maria J. Doa,
Director, Chemical Control Division, Office of Pollution Prevention and
Toxics.
Therefore, 40 CFR parts 9 and 721 are amended as follows:
PART 9--[AMENDED]
0
1. The authority citation for part 9 continues to read as follows:
Authority: 7 U.S.C. 135 et seq., 136-136y; 15 U.S.C. 2001, 2003,
2005, 2006, 2601-2671; 21 U.S.C. 331j, 346a, 348; 31 U.S.C. 9701; 33
U.S.C. 1251 et seq., 1311, 1313d, 1314, 1318, 1321, 1326, 1330,
1342, 1344, 1345(d) and (e), 1361; E.O. 11735, 38 FR 21243, 3 CFR,
1971-1975 Comp. p. 973; 42 U.S.C. 241, 242b, 243, 246, 300f, 300g,
300g-1, 300g-2, 300g-3, 300g-4, 300g-5, 300g-6, 300j-1, 300j-2,
300j-3, 300j-4, 300j-9, 1857 et seq., 6901-6992k, 7401-7671q, 7542,
9601-9657, 11023, 11048.
0
2. In Sec. 14;9.1, add the following sections in numerical order under
the undesignated center heading ``Significant New Uses of Chemical
Substances'' to read as follows:
Sec. 9.1 OMB approvals under the Paperwork Reduction Act.
------------------------------------------------------------------------
OMB control
40 CFR citation No.
------------------------------------------------------------------------
* * * * *
Significant New Uses of Chemical Substances
* * * * *
721.10695............................................... 2070-0012
721.10696............................................... 2070-0012
721.10697............................................... 2070-0012
721.10698............................................... 2070-0012
721.10699............................................... 2070-0012
721.10700............................................... 2070-0012
721.10701............................................... 2070-0012
721.10702............................................... 2070-0012
721.10703............................................... 2070-0012
721.10704............................................... 2070-0012
721.10705............................................... 2070-0012
721.10706............................................... 2070-0012
721.10707............................................... 2070-0012
721.10708............................................... 2070-0012
721.10709............................................... 2070-0012
721.10710............................................... 2070-0012
721.10711............................................... 2070-0012
721.10712............................................... 2070-0012
721.10713............................................... 2070-0012
721.10714............................................... 2070-0012
721.10715............................................... 2070-0012
721.10716............................................... 2070-0012
721.10717............................................... 2070-0012
721.10718............................................... 2070-0012
721.10719............................................... 2070-0012
721.10720............................................... 2070-0012
721.10721............................................... 2070-0012
721.10722............................................... 2070-0012
721.10723............................................... 2070-0012
721.10724............................................... 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. 721.10695 to subpart E to read as follows:
Sec. 721.10695 1,2,3-Propanetricarboxamide, N1,N2,N3-tris(2-
methylcyclohexyl)-.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as 1,2,3-
Propanetricarboxamide, N1,N2,N3-tris(2-methylcyclohexyl)- (PMN P-08-
179; CAS No. 160535-46-6) is subject to reporting under this section
for the significant new uses described in paragraph (a)(2) of this
section.
(2) The significant new uses are:
(i) Release to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4), and (c)(4) (N = 12).
(ii) [Reserved]
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph.
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a), (b), (c), and (k) are applicable to manufacturers 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. 721.10696 to subpart E to read as follows:
Sec. 721.10696 Polyfluorinated alkyl thiol (generic).
(a) Chemical substances and significant new uses subject to
reporting. (1) The chemical substances identified generically as
polyfluorinated alkyl thiol (PMNs P-11-483 and P-11-528) are subject to
reporting under this section for the significant new uses described in
paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Hazard communication program. A significant new use of the
substances is any manner or method of manufacture or processing
associated with any use of the substances without providing risk
notification as follows:
(A) If as a result of the test data required under the TSCA section
5(e) consent order for the substances, the employer becomes aware that
the substances may present a risk of injury to human health or the
environment, the employer must incorporate this new information, and
any information on methods for protecting against such risk, into a
MSDS as described in Sec. 721.72(c) within 90 days from the time the
employer becomes aware of the new information. If the substance(s) are
not being manufactured, processed, or used in the employer's workplace,
the employer must add the new information to a MSDS before the
substance(s) are reintroduced into the workplace.
[[Page 8286]]
(B) The employer must ensure that persons who will receive the PMN
substance(s) from the employer, or who have received the PMN
substance(s) from the employer within 5 years from the date the
employer becomes aware of the new information described in paragraph
(a)(2)(i)(A) of this section, are provided an MSDS containing the
information required under paragraph (a)(2)(i)(A) of this section
within 90 days from the time the employer becomes aware of the new
information.
(ii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(k) (a significant new use is any use other
than as allowed by the section 5(e) consent order which includes
analysis and reporting and limitations of maximum impurity levels of
certain fluorinated impurities), and (o) (use in a consumer product
that could be spray applied).
(iii) Disposal. Requirements as specified in Sec. 721.85(a)(1) and
(b)(1) (at a temperature of at least 1,000 degrees C with a minimum
residence time of 2 seconds).
(iv) Release to water. Requirements as specified in Sec.
721.90(a)(1), (b)(1), and (c)(1), except for releases allowed by the
section 5(e) the consent order .
(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), (f), (h), (j) and (k) are applicable to
manufacturers and processors of these substances.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
(3) Determining whether a specific use is subject to this section.
The provisions of Sec. 721.1725(b)(1) apply to paragraph (a)(2)(ii) of
this section.
0
6. Add Sec. 721.10697 to subpart E to read as follows:
Sec. 721.10697 Polyfluorinated alkyl polyamide (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
polyfluorinated alkyl polyamide (PMN P-11-487) is subject to reporting
under this section for the significant new uses described in paragraph
(a)(2) of this section.
(2) The significant new uses are:
(i) Hazard communication program. A significant new use of this
substance is any manner or method of manufacture or processing
associated with any use of this substance without providing risk
notification as follows:
(A) If as a result of the test data required under the TSCA section
5(e) consent order for this substance, the employer becomes aware that
this substance may present a risk of injury to human health or the
environment, the employer must incorporate this new information, and
any information on methods for protecting against such risk, into a
MSDS as described in Sec. 721.72(c) within 90 days from the time the
employer becomes aware of the new information. If this substance is not
being manufactured, processed, or used in the employer's workplace, the
employer must add the new information to a MSDS before the substance is
reintroduced into the workplace.
(B) The employer must ensure that persons who will receive the PMN
substance from the employer, or who have received the PMN substance
from the employer within 5 years from the date the employer becomes
aware of the new information described in paragraph (a)(2)(i)(A) of
this section, are provided an MSDS containing the information required
under paragraph (a)(2)(i)(A) of this section within 90 days from the
time the employer becomes aware of the new information.
(ii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(k) (a significant new use is any use other
than as allowed by the section 5(e) consent order which includes
analysis and reporting and limitations of maximum impurity levels of
certain fluorinated impurities), (o) (use in a consumer product that
could be spray applied), (q), and (t).
(iii) Disposal. Requirements as specified in Sec. 721.85(a)(1) and
(b)(1) (at a temperature of at least 1,000 degrees C with a minimum
residence time of 2 seconds).
(iv) Release to water. Requirements as specified in Sec.
721.90(a)(1), (b)(1), and (c)(1), except for releases allowed by the
section 5(e) the consent order.
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph.
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a), (b), (c), (f), (h), (i), (j), and (k) are applicable to
manufacturers 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 paragraph (a)(2)(ii) of
this section.
0
7. Add Sec. [emsp14]721.10698 to subpart E to read as follows:
Sec. 721.10698 Polyfluorinated alkyl halide (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
polyfluorinated alkyl halide (PMN P-11-527) is subject to reporting
under this section for the significant new uses described in paragraph
(a)(2) of this section.
(2) The significant new uses are:
(i) Hazard communication program. A significant new use of this
substance is any manner or method of manufacture or processing
associated with any use of this substance without providing risk
notification as follows:
(A) If as a result of the test data required under the TSCA section
5(e) consent order for this substance, the employer becomes aware that
this substance may present a risk of injury to human health or the
environment, the employer must incorporate this new information, and
any information on methods for protecting against such risk, into a
MSDS as described in Sec. 721.72(c) within 90 days from the time the
employer becomes aware of the new information. If this substance is not
being manufactured, processed, or used in the employer's workplace, the
employer must add the new information to a MSDS before the substance is
reintroduced into the workplace.
(B) The employer must ensure that persons who will receive the PMN
substance from the employer, or who have received the PMN substance
from the employer within 5 years from the date the employer becomes
aware of the new information described in paragraph (a)(2)(i)(A) of
this section, are provided an MSDS containing the information required
under paragraph (a)(2)(i)(A) of this section within 90 days from the
time the employer becomes aware of the new information.
(ii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(k) (a significant new use is any use other
than as allowed by the section 5(e) consent order which includes
analysis and reporting and limitations of maximum impurity levels of
certain fluorinated impurities), and (o) (use in a consumer product
that could be spray applied).
(iii) Disposal. Requirements as specified in Sec. 721.85(a)(1) and
(b)(1) (at a temperature of at least 1,000 degrees C with a minimum
residence time of 2 seconds).
(iv) Release to water. Requirements as specified in Sec.
721.90(a)(1), (b)(1), and
[[Page 8287]]
(c)(1), except for releases allowed by the section 5(e) the consent
order.
(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), (f), (h), (j), and (k) are applicable to
manufacturers 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 paragraph (a)(2)(ii) of
this section.
0
8. Add Sec. 721.10699 to subpart E to read as follows:
Sec. 721.10699 Polyfluorinated alkyl thio acrylamide (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
polyfluorinated alkyl thio acrylamide (PMN P-11-529) is subject to
reporting under this section for the significant new uses described in
paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Hazard communication program. A significant new use of this
substance is any manner or method of manufacture or processing
associated with any use of this substance without providing risk
notification as follows:
(A) If as a result of the test data required under the TSCA section
5(e) consent order for this substance, the employer becomes aware that
this substance may present a risk of injury to human health or the
environment, the employer must incorporate this new information, and
any information on methods for protecting against such risk, into a
MSDS as described in Sec. 721.72(c) within 90 days from the time the
employer becomes aware of the new information. If this substance is not
being manufactured, processed, or used in the employer's workplace, the
employer must add the new information to a MSDS before the substance is
reintroduced into the workplace.
(B) The employer must ensure that persons who will receive the PMN
substance from the employer, or who have received the PMN substance
from the employer within 5 years from the date the employer becomes
aware of the new information described in paragraph (a)(2)(i)(A) of
this section, are provided an MSDS containing the information required
under paragraph (a)(2)(i)(A) of this section within 90 days from the
time the employer becomes aware of the new information.
(ii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(k) (a significant new use is any use other
than as allowed by the section 5(e) consent order which includes
analysis and reporting and limitations of maximum impurity levels of
certain fluorinated impurities), and (o) (use in a consumer product
that could be spray applied).
(iii) Disposal. Requirements as specified in Sec. 721.85(a)(1) and
(b)(1) (at a temperature of at least 1,000 degrees C with a minimum
residence time of 2 seconds).
(iv) Release to water. Requirements as specified in Sec.
721.90(a)(1), (b)(1), and (c)(1), except for releases allowed by the
section 5(e) the consent order.
(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), (f), (h), (j), and (k) are applicable to
manufacturers 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 paragraph (a)(2)(ii) of
this section.
0
9. Add Sec. 721.10700 to subpart E to read as follows:
Sec. 721.10700 Polyfluorinated alkyl thio polyacrylamide (generic).
(a) Chemical substances and significant new uses subject to
reporting. (1) The chemical substances identified generically as
polyfluorinated alkyl thio polyacrylamide (PMNs P-11-530 and P-11-533)
are subject to reporting under this section for the significant new
uses described in paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Hazard communication program. A significant new use of the
substances is any manner or method of manufacture, or processing
associated with any use of the substances without providing risk
notification as follows:
(A) If as a result of the test data required under the TSCA section
5(e) consent order for the substances, the employer becomes aware that
the substances may present a risk of injury to human health or the
environment, the employer must incorporate this new information, and
any information on methods for protecting against such risk, into a
MSDS as described in Sec. 721.72(c) within 90 days from the time the
employer becomes aware of the new information. If the substance(s) is
not being manufactured, processed, or used in the employer's workplace,
the employer must add the new information to a MSDS before the
substance(s) is reintroduced into the workplace.
(B) The employer must ensure that persons who will receive the PMN
substance(s) from the employer, or who have received the PMN
substance(s) from the employer within 5 years from the date the
employer becomes aware of the new information described in paragraph
(a)(2)(i)(A) of this section, are provided an MSDS containing the
information required under paragraph (a)(2)(i)(A) of this section
within 90 days from the time the employer becomes aware of the new
information.
(ii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(k) (a significant new use is any use other
than as allowed by the section 5(e) consent order which includes
analysis and reporting and limitations of maximum impurity levels of
certain fluorinated impurities), (o) (use in a consumer product that
could be spray applied), (q), and (t).
(iii) Disposal. Requirements as specified in Sec. 721.85(a)(1) and
(b)(1) (at a temperature of at least 1,000 degrees C with a minimum
residence time of 2 seconds).
(iv) Release to water. Requirements as specified in Sec.
721.90(a)(1), (b)(1), and (c)(1), except for releases allowed by the
section 5(e) the consent order.
(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), (f), (h), (j), and (k) are applicable to
manufacturers and processors of this substance.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to paragraph (a)(2)(ii) of 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
10. Add Sec. 721.10701 to subpart E to read as follows:
Sec. 721.10701 Polyfluorinated alkyl amine (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
polyfluorinated alkyl amine (PMN P-11-532) is subject to reporting
under this section for the
[[Page 8288]]
significant new uses described in paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Hazard communication program. A significant new use of this
substance is any manner or method of manufacture or processing
associated with any use of this substance without providing risk
notification as follows:
(A) If as a result of the test data required under the TSCA section
5(e) consent order for this substance, the employer becomes aware that
this substance may present a risk of injury to human health or the
environment, the employer must incorporate this new information, and
any information on methods for protecting against such risk, into a
MSDS as described in Sec. 721.72(c) within 90 days from the time the
employer becomes aware of the new information. If this substance is not
being manufactured, processed, or used in the employer's workplace, the
employer must add the new information to a MSDS before the substance is
reintroduced into the workplace.
(B) The employer must ensure that persons who will receive the PMN
substance from the employer, or who have received the PMN substance
from the employer within 5 years from the date the employer becomes
aware of the new information described in paragraph (a)(2)(i)(A) of
this section, are provided an MSDS containing the information required
under paragraph (a)(2)(i)(A) of this section within 90 days from the
time the employer becomes aware of the new information.
(ii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(k) (a significant new use is any use other
than as allowed by the section 5(e) consent order which includes
analysis and reporting and limitations of maximum impurity levels of
certain fluorinated impurities), and (o) (use in a consumer product
that could be spray applied).
(iii) Disposal. Requirements as specified in Sec. 721.85(a)(1) and
(b)(1) (at a temperature of at least 1,000 degrees C with a minimum
residence time of 2 seconds).
(iv) Release to water. Requirements as specified in Sec.
721.90(a)(1), (b)(1), and (c)(1), except for releases allowed by the
section 5(e) the consent order.
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph.
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a), (b), (c), (f), (h), (i), (j), and (k) are applicable to
manufacturers 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 paragraph (a)(2)(ii) of
this section.
0
11. Add Sec. 721.10702 to subpart E to read as follows:
Sec. 721.10702 Polyfluorinated alkyl thio polyacrylic acid-acrylamide
(generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
polyfluorinated alkyl thio polyacrylic acid-acrylamide (PMN P-11-534)
is subject to reporting under this section for the significant new uses
described in paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Hazard communication program. A significant new use of this
substance is any manner or method of manufacture, or processing
associated with any use of this substance without providing risk
notification as follows:
(A) If as a result of the test data required under the TSCA section
5(e) consent order for this substance, the employer becomes aware that
this substance may present a risk of injury to human health or the
environment, the employer must incorporate this new information, and
any information on methods for protecting against such risk, into a
MSDS as described in Sec. 721.72(c) within 90 days from the time the
employer becomes aware of the new information. If this substance is not
being manufactured, processed, or used in the employer's workplace, the
employer must add the new information to a MSDS before the substance is
reintroduced into the workplace.
(B) The employer must ensure that persons who will receive the PMN
substance from the employer, or who have received the PMN substance
from the employer within 5 years from the date the employer becomes
aware of the new information described in paragraph (a)(2)(i)(A) of
this section, are provided an MSDS containing the information required
under paragraph (a)(2)(i)(A) of this section within 90 days from the
time the employer becomes aware of the new information.
(ii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(k) (a significant new use is any use other
than as allowed by the section 5(e) consent order which includes
analysis and reporting and limitations of maximum impurity levels of
certain fluorinated impurities), (o) (use in a consumer product that
could be spray applied), (q), and (t).
(iii) Disposal. Requirements as specified in Sec. 721.85(a)(1) and
(b)(1) (at a temperature of at least 1,000 degrees C with a minimum
residence time of 2 seconds).
(iv) Release to water. Requirements as specified in Sec.
721.90(a)(1), (b)(1), and (c)(1), except for releases allowed by the
section 5(e) the consent order .
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph.
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a), (b), (c), (f), (h), (i), (j), and (k) are applicable to
manufacturers 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 paragraph (a)(2)(ii) of
this section.
0
12. Add Sec. 721.10703 to subpart E to read as follows:
Sec. 721.10703 Multi-walled carbon nanotubes (generic).
(a) Chemical substances and significant new uses subject to
reporting. (1) The chemical substances identified generically as multi-
walled carbon nanotubes (PMNs P-12-416, P-12-417, P-12-418, and P-12-
419) are 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
substances that have been completely reacted (cured); incorporated or
embedded into a polymer matrix that itself has been completely reacted
(cured); imbedded into a permanent polymer form that is not intended to
undergo further processing; or incorporated into an article as defined
at 40 CFR 721.3(c).
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(1), (a)(2)(i), (a)(2)(ii), (a)(3), (a)(4), (National
Institute of Occupational Safety and Health (NIOSH)-certified air-
purifying, tight-fitting full-face respirator equipped with N-100, or
P-100, or R-100 filters or power air-purifying particulate respirator),
(a)(6)(i), and (c). When determining which persons are reasonably
likely to be exposed as required for Sec. 721.63(a)(1) and (a)(4),
engineering control measures (e.g., enclosure or confinement of the
[[Page 8289]]
operation, general and local ventilation) or administrative control
measures (e.g., workplace policies and procedures) shall be considered
and implemented to prevent exposure, where feasible.
(ii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(f), (k) and (q).
(iii) Release to water. Requirements as specified in Sec.
721.90(b)(1), and (c)(1).
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph.
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a), (b), (c), (d), (e), (i), and (k) are applicable to
manufacturers 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 paragraph (a)(2)(ii) of
this section.
0
13. Add Sec. 721.10704 to subpart E to read as follows:
Sec. 721.10704 Aryl-substituted alkane.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as an
aryl-substituted alkane (PMN P-12-548) 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) Hazard communication program. Requirements as specified in
Sec. 721.72(a), (b), (c), (d), (e) (concentration set at 1.0 percent),
(f), (g)(1)(iv), (g)(1)(ix), (g)(2)(i), (g)(2)(v), and (g)(3)(ii) and
(g)(5).
(iii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(k) and (q). It is a significant new use to
conduct testing on the chemical substance to comply with REACH
(Regulation, Evaluation, Authorization, and Restriction of Chemicals in
the European Union) without submitting all final reports and the
underlying data of the testing to EPA no later than 90 days after
submission of the testing to the European Union.
(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 (i) are applicable
to manufacturers 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 paragraph (a)(2)(iii)
of this section.
0
14. Add Sec. 721.10705 to subpart E to read as follows:
Sec. 721.10705 Aromatic amine with cyclo amino carbonyls (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
aromatic amine with cyclo amino carbonyls (PMN P-12-572) 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), (a)(4), (NIOSH-certified particulate
respirator with an APF of at least 10), (a)(6)(i), (a)(6)(ii), (b)
(concentration set 0.1 percent), and (c). When determining which
persons are reasonably likely to be exposed as required for Sec.
721.63(a)(4), engineering control measures (e.g., enclosure or
confinement of the operation, general and local ventilation) or
administrative control measures (e.g., workplace policies and
procedures) shall be considered and implemented to prevent exposure,
where feasible. The following NIOSH-certified respirators with an APF
of at least 10 meet the requirements of Sec. 721.63(a)(4):
(A) NIOSH-certified power air-purifying respirator with a hood or
helmet and with appropriate gas/vapor (acid gas, organic vapor, or
substance specific) cartridges in combination with high efficiency
particulate absorption (HEPA) filters.
(B) NIOSH-certified continuous flow supplied-air respirator
equipped with a loose fitting face piece, hood, or helmet.
(C) NIOSH-certified negative pressure (demand) supplied-air
respirator with a full face piece.
(ii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(g).
(iii) Release to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4), and (c)(4) (N = 11).
(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 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. 721.10706 to subpart E to read as follows:
Sec. 721.10706 Infused carbon nanostructures (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as infused
carbon nanostructures (PMN P-12-576) 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. A significant new use is any
manufacturing process other than that described in the premanufacture
notice (PMN) which includes the incorporation of the PMN substance into
pellets.
(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 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 paragraph (a)(2)(i) of
this section.
0
16. Add Sec. [emsp14]721.10707 to subpart E to read as follows:
Sec. [emsp14]721.10707 Substituted benzyl acrylate (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as substituted benzyl
acrylate (PMN P-13-127) 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
[[Page 8290]]
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 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. [emsp14]721.10708 to subpart E to read as follows:
Sec. [emsp14]721.10708 Zirconium substituted heteropolycyclic
(generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
zirconium substituted heteropolycyclic (PMN P-13-152) 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=10).
(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 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. [emsp14]721.10709 to subpart E to read as follows:
Sec. [emsp14]721.10709 Alkylphenol (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
alkylphenol (PMN P-13-168) 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 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. [emsp14]721.10710 to subpart E to read as follows:
Sec. [emsp14]721.10710 4, 7-Methano-1H-indene, 3a, 4, 7, 7a-
tetrahydro-, polymer with 2-methyl-1, 3-butadiene and 5-(1-
methylethenyl)bicyclo[2.2.1]hept-2-ene.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as 4, 7-methano-1H-
indene, 3a, 4, 7, 7a-tetrahydro-, polymer with 2-methyl-1, 3-butadiene
and 5-(1-methylethenyl)bicyclo[2.2.1]hept-2-ene (PMN P-13-192; CAS No.
1412159-51-3) is subject to reporting under this section for the
significant new uses described in paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) 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 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. [emsp14]721.10711 to subpart E to read as follows:
Sec. [emsp14]721.10711 Alkyl substituted catechol (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as alkyl
substituted catechol (PMN P-13-197) 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), (a)(4) (NIOSH-certified particulate
respirator with an APF of at least 1,000), and (c). When determining
which persons are reasonably likely to be exposed as required for Sec.
721.63(a)(4), engineering control measures (e.g., enclosure or
confinement of the operation, general and local ventilation) or
administrative control measures (e.g., place policies and procedures)
shall be considered and implemented to prevent exposure, where
feasible. The following NIOSH-certified respirators with an APF of at
least 1,000 meet the requirements of Sec. 721.63(a)(4);
(A) NIOSH-certified continuous flow supplied-air respirator
equipped with a full face piece.
(B) NIOSH-certified pressure-demand supplied-air respirator
equipped with a full face piece.
(ii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(g).
(iii) Release to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4), and (c)(4) (N=20).
(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 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. [emsp14]721.10712 to subpart E to read as follows:
Sec. [emsp14]721.10712 Antimony tris(dialkyldithiocarbamate)
(generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
antimony tris(dialkyldithiocarbamate) (PMN P-13-217) 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=4).
(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 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. [emsp14]721.10713 to subpart E to read as follows:
Sec. [emsp14]721.10713 Antimony tris(dialkyldithiocarbamate)
(generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
antimony tris(dialkyldithiocarbamate) (PMN P-
[[Page 8291]]
13-259) 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=4).
(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 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. [emsp14]721.10714 to subpart E to read as follows:
Sec. [emsp14]721.10714 Zinc bis(dialkyldithiocarbamate) (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as zinc
bis(dialkyldithiocarbamate) (PMN P-13-260) 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=7).
(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 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. [emsp14]721.10715 to subpart E to read as follows:
Sec. [emsp14]721.10715 Carbonic acid, dialkyl ester (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
carbonic acid, dialkyl ester (PMN P-13-346) is subject to reporting
under this section for the significant new uses described in paragraph
(a)(2) of this section.
(2) The significant new uses are:
(i) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(f), (j), and (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 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. [emsp14]721.10716 to subpart E to read as follows:
Sec. [emsp14]721.10716 Phenol, 2,6-dimethyl-, homopolymer, ether with
2,2',3,3',5,5'-hexamethyl[1,1'-biphenyl]-4,4'-diol
(2:1),bis[(ethenylphenyl)methyl] ether.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as phenol, 2,6-
dimethyl-, homopolymer, ether with 2,2',3,3',5,5'-hexamethyl[1,1'-
biphenyl]-4,4'-diol (2:1),bis[(ethenylphenyl)methyl] ether (PMN P-13-
355, CAS No. 558452-77-0) is subject to reporting under this section
for the significant new uses described in paragraph (a)(2) of this
section.
(2) The significant new uses are:
(i) Release to water. Requirements as specified in Sec.
721.90(a)(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 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. [emsp14]721.10717 to subpart E to read as follows:
Sec. [emsp14]721.10717 MDI modified polyalkene glycols (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as MDI
modified polyalkene glycols (PMN P-13-365) 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)(6)(ii) and (a)(6)(v), and (c). When determining which
persons are reasonably likely to be exposed as required for Sec.
721.63(a)(4), engineering control measures (e.g., enclosure or
confinement of the operation, general and local ventilation) or
administrative control measures (e.g., workplace policies and
procedures) shall be considered and implemented to prevent exposure,
where feasible. The following National Institute for Occupational
Safety and Health (NIOSH)-certified respirators with an assigned
protection factor (APF) of at least 10 meet the requirements of Sec.
721.63(a)(4):
(A) NIOSH-certified power air-purifying respirator with a hood or
helmet and with appropriate gas/vapor (acid gas, organic vapor, or
substance specific) cartridges in combination with HEPA filters.
(B) NIOSH-certified continuous flow supplied-air respirator
equipped with a loose fitting facepiece, hood, or helmet.
(C) NIOSH-certified negative pressure (demand) supplied-air
respirator with a full facepiece.
(ii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(o) and (y)(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), and (i) are applicable to manufacturers and
processors of this substance.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
0
27. Add Sec. [emsp14]721.10718 to subpart E to read as follows:
Sec. [emsp14]721.10718 Substituted picolinic acid (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
substituted picolinic acid (PMN P-13-374) 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. A significant new use is any use other
than as a pesticide intermediate.
(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
[[Page 8292]]
Sec. 721.125(a), (b), (c), and (i) are applicable to manufacturers 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. [emsp14]721.10719 to subpart E to read as follows:
Sec. [emsp14]721.10719 Acrylic acid esters polymers, reaction
products with polyisocyanate (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as acrylic
acid esters polymers, reaction products with polyisocyanate (PMN P-13-
392) 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)(6)(ii), (a)(6)(v), and (c). When determining which
persons are reasonably likely to be exposed as required for Sec.
721.63(a)(4), engineering control measures (e.g., enclosure or
confinement of the operation, general and local ventilation) or
administrative control measures (e.g., workplace policies and
procedures) shall be considered and implemented to prevent exposure,
where feasible. The following NIOSH-certified respirators with an APF
of at least 10 meet the requirements of Sec. 721.63(a)(4):
(A) NIOSH-certified power air-purifying respirator with a hood or
helmet and with appropriate gas/vapor (acid gas, organic vapor, or
substance specific) cartridges in combination with HEPA filters.
(B) NIOSH-certified continuous flow supplied-air respirator
equipped with a loose fitting face piece, hood, or helmet.
(C) NIOSH-certified negative pressure (demand) supplied-air
respirator with a full face piece.
(ii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(o).
(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 and
processors of this substance.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
0
29. Add Sec. [emsp14]721.10720 to subpart E to read as follows:
Sec. [emsp14]721.10720 1,3-Benzenedicarboxylic acid, polymer with
1,4-benzenedicarboxylic acid, 1,4-dimethyl 1,4-benzenedicarboxylate,
2,2-dimethyl-1,3-propanediol,dodecanedioic acid, 1,2-ethanediol,
hexanedioic acid, 1,6-hexanediol, alkyldiol ester and aromatic
isocyanate (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as 1,3-
Benzenedicarboxylic acid, polymer with 1,4-benzenedicarboxylic acid,
1,4-dimethyl 1,4-benzenedicarboxylate, 2,2-dimethyl-1,3-
propanediol,dodecanedioic acid, 1,2-ethanediol, hexanedioic acid, 1,6-
hexanediol, alkyldiol ester and aromatic isocyanate (PMN P-13-393) 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)(6)(ii) and (a)(6)(v), and (c). When determining which
persons are reasonably likely to be exposed as required for Sec.
721.63(a)(4), engineering control measures (e.g., enclosure or
confinement of the operation, general and local ventilation) or
administrative control measures (e.g., workplace policies and
procedures) shall be considered and implemented to prevent exposure,
where feasible. The following National Institute for Occupational
Safety and Health (NIOSH)-certified respirators with an assigned
protection factor (APF) of at least 10 meet the requirements of Sec.
721.63(a)(4):
(A) NIOSH-certified power air-purifying respirator with a hood or
helmet and with appropriate gas/vapor (acid gas, organic vapor, or
substance specific) cartridges in combination with HEPA filters.
(B) NIOSH-certified continuous flow supplied-air respirator
equipped with a loose fitting facepiece, hood, or helmet.
(C) NIOSH-certified negative pressure (demand) supplied-air
respirator with a full facepiece.
(ii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(o) and (y)(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), and (i) are applicable to manufacturers and
processors of this substance.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
0
30. Add Sec. [emsp14]721.10721 to subpart E to read as follows:
Sec. [emsp14]721.10721 Poly(oxy-1,2-ethanediyl), .alpha.,.alpha.'-
[(1-methylethylidene)di-4,1-phenylene]bis[.omega.-[[6-(2,5-dihydro-2,5-
dioxo-1H-pyrrol-1-yl)-1-oxohexyl]oxy]-.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as poly(oxy-1,2-
ethanediyl), .alpha.,.alpha.'-[(1-methylethylidene)di-4,1-
phenylene]bis[.omega.-[[6-(2,5-dihydro-2,5-dioxo-1H-pyrrol-1-yl)-1-
oxohexyl]oxy]- (PMN P-13-455) 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 and
processors of this substance.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
0
31. Add Sec. [emsp14]721.10722 to subpart E to read as follows:
Sec. [emsp14]721.10722 Oxirane,2-[(1-propen-1-yloxy)methyl]-.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as oxirane,2-[(1-
propen-1-yloxy)methyl]- (PMN P-13-468; CAS No. 1607-23-4) is subject to
reporting under this section for the significant new uses described in
paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(1), (a)(2)(i), (a)(3), (a)(4), (a)(6)(ii), (a)(6)(v), (b)(1)
(concentration set at 0.1 percent), and (c). When determining which
persons are reasonably likely to be exposed as required for Sec.
721.63(a)(1) and (a)(4), engineering control measures (e.g., enclosure
or confinement of the operation, general and local ventilation) or
administrative control measures (e.g., workplace policies and
procedures) shall be considered and implemented to prevent exposure,
where feasible. The following NIOSH-certified respirators with an APF
of at least 10 meet the requirements of Sec. 721.63(a)(4):
(A) NIOSH-certified power air-purifying respirator with a hood or
[[Page 8293]]
helmet and with appropriate gas/vapor (acid gas, organic vapor, or
substance specific) cartridges in combination with HEPA filters.
(B) NIOSH-certified continuous flow supplied-air respirator
equipped with a loose fitting face piece, hood, or helmet.
(C) NIOSH-certified negative pressure (demand) supplied-air
respirator with a full face piece.
(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) through (e) and (i) are applicable to manufacturers and
processors of this substance.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
0
32. Add Sec. [emsp14]721.10723 to subpart E to read as follows:
Sec. [emsp14]721.10723 Methylene diisocyanate polymer with
polypropylene glycol and diols (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
methylene diisocyanate polymer with polypropylene glycol and diols (PMN
P-13-471) 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)(6)(i), (a)(6)(ii), (a)(6)(v), and (c). When
determining which persons are reasonably likely to be exposed as
required for Sec. 721.63(a)(4), engineering control measures (e.g.,
enclosure or confinement of the operation, general and local
ventilation) or administrative control measures (e.g., workplace
policies and procedures) shall be considered and implemented to prevent
exposure, where feasible. The following NIOSH-certified respirators
with an APF of at least 10 meet the requirements of Sec. 721.63(a)(4):
(A) NIOSH-certified power air-purifying respirator with a hood or
helmet and with appropriate gas/vapor (acid gas, organic vapor, or
substance specific) cartridges in combination with HEPA filters.
(B) NIOSH-certified continuous flow supplied-air respirator
equipped with a loose fitting face piece, hood, or helmet.
(C) NIOSH-certified negative pressure (demand) supplied-air
respirator with a full face piece.
(ii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(o).
(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 and
processors of this substance.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
0
33. Add Sec. [emsp14]721.10724 to subpart E to read as follows:
Sec. [emsp14]721.10724 Oxirane, [[2-(2-ethenyloxy)ethoxy]methyl]-.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as oxirane, [[2-(2-
ethenyloxy)ethoxy]methyl]- (PMN P-13-472; CAS No. 16801-19-7) 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), (a)(4), (a)(6)(ii), (a)(6)(v),
(b)(concentration set at 0.1 percent), and (c). When determining which
persons are reasonably likely to be exposed as required for Sec.
721.63(a)(1) and (a)(4), engineering control measures (e.g., enclosure
or confinement of the operation, general and local ventilation) or
administrative control measures (e.g., workplace policies and
procedures) shall be considered and implemented to prevent exposure,
where feasible. The following NIOSH-certified respirators with an APF
of at least 10 meet the requirements of Sec. 721.63(a)(4):
(A) NIOSH-certified power air-purifying respirator with a hood or
helmet and with appropriate gas/vapor (acid gas, organic vapor, or
substance specific) cartridges in combination with HEPA filters.
(B) NIOSH-certified continuous flow supplied-air respirator
equipped with a loose fitting face piece, hood, or helmet.
(C) NIOSH-certified negative pressure (demand) supplied-air
respirator with a full face piece.
(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) through (e) and (i) are applicable to manufacturers and
processors of this substance.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
[FR Doc. 2014-03079 Filed 2-11-14; 8:45 am]
BILLING CODE 6560-50-P