[Federal Register Volume 77, Number 213 (Friday, November 2, 2012)]
[Rules and Regulations]
[Pages 66149-66164]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-26658]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Parts 9 and 721
[EPA-HQ-OPPT-2012-0740; FRL-9366-7]
RIN 2070-AB27
Significant New Use Rules on Certain Chemical Substances
AGENCY: Environmental Protection Agency (EPA).
ACTION: Direct final rule.
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SUMMARY: EPA is promulgating significant new use rules (SNURs) under
the Toxic Substances Control Act (TSCA) for 20 chemical substances
which were the subject of premanufacture notices (PMNs). Eight of these
chemical substances are subject to TSCA section 5(e) consent orders
issued by EPA. This action requires persons who intend to manufacture,
import, or process any of these 20 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 January 2, 2013. For purposes of
judicial review, this rule shall be promulgated at 1 p.m. (e.s.t.) on
November 16, 2012.
Written adverse or critical comments, or notice of intent to submit
adverse or
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critical comments, on one or more of these SNURs must be received on or
before December 3, 2012 (see Unit VI. of the SUPPLEMENTARY
INFORMATION).
For additional information on related reporting requirement dates,
see Units I.A., VI., and VII. of the SUPPLEMENTARY INFORMATION.
ADDRESSES: Submit your comments, identified by docket identification
(ID) number EPA-HQ-OPPT-2012-0740, 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, Rm. 6428, 1201 Constitution Ave. NW., Washington, DC. ATTN:
Docket ID Number EPA-HQ-OPPT-2012-0740. The DCO is open from 8 a.m. to
4 p.m., Monday through Friday, excluding legal holidays. The telephone
number for the DCO is (202) 564-8930. Such deliveries are only accepted
during the DCO's normal hours of operation, and special arrangements
should be made for deliveries of boxed information.
Instructions: Direct your comments to docket ID number EPA-HQ-OPPT-
2012-0740. EPA's policy is that all comments received will be included
in the docket without change and may be made available online at http://www.regulations.gov, including any personal information provided,
unless the comment includes information claimed to be Confidential
Business Information (CBI) or other information whose disclosure is
restricted by statute. Do not submit information that you consider to
be CBI or otherwise protected through regulations.gov or email. The
regulations.gov Web site is an ``anonymous access'' system, which means
EPA will not know your identity or contact information unless you
provide it in the body of your comment. If you send an email comment
directly to EPA without going through regulations.gov, your email
address will be automatically captured and included as part of the
comment that is placed in the docket and made available on the
Internet. If you submit an electronic comment, EPA recommends that you
include your name and other contact information in the body of your
comment and with any disk or CD-ROM you submit. If EPA cannot read your
comment due to technical difficulties and cannot contact you for
clarification, EPA may not be able to consider your comment. Electronic
files should avoid the use of special characters, any form of
encryption, and be free of any defects or viruses.
Docket: All documents in the docket are listed in the docket index
available at http://www.regulations.gov. Although listed in the index,
some information is not publicly available, e.g., CBI or other
information whose disclosure is restricted by statute. Certain other
material, such as copyrighted material, will be publicly available only
in hard copy. Publicly available docket materials are available
electronically at http://www.regulations.gov, or, if only available in
hard copy, at the OPPT Docket. The OPPT Docket is located in the EPA
Docket Center (EPA/DC) at Rm. 3334, EPA West Bldg., 1301 Constitution
Ave. NW., Washington, DC. The EPA/DC Public Reading Room hours of
operation are 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding
legal holidays. The telephone number of the EPA/DC Public Reading Room
is (202) 566-1744, and the telephone number for the OPPT Docket is
(202) 566-0280. Docket visitors are required to show photographic
identification, pass through a metal detector, and sign the EPA visitor
log. All visitor bags are processed through an X-ray machine and
subject to search. Visitors will be provided an EPA/DC badge that must
be visible at all times in the building and returned upon departure.
FOR FURTHER INFORMATION CONTACT: For technical information contact:
Kenneth Moss, Chemical Control Division (7405M), Office of Pollution
Prevention and Toxics, Environmental Protection Agency, 1200
Pennsylvania Ave. NW., Washington, DC 20460-0001; telephone number:
(202) 564-9232; email address: moss.kenneth@epa.gov.
For general information contact: The TSCA-Hotline, ABVI-Goodwill,
422 South Clinton Ave., Rochester, NY 14620; telephone number: (202)
554-1404; email address: TSCA-Hotline@epa.gov.
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this action apply to me?
You may be potentially affected by this action if you manufacture,
import, process, or use the chemical substances contained in this rule.
The following list of North American Industrial Classification System
(NAICS) codes is not intended to be exhaustive, but rather provides a
guide to help readers determine whether this document applies to them.
Potentially affected entities may include:
Manufacturers, importers, or processors of one or more
subject chemical substances (NAICS codes 325 and 324110), e.g.,
chemical manufacturing and petroleum refineries.
This action may also affect certain entities through pre-existing
import certification and export notification rules under TSCA. Chemical
importers are subject to the TSCA section 13 (15 U.S.C. 2612) import
certification requirements promulgated at 19 CFR 12.118 through 12.127
and 19 CFR 127.28. Chemical importers must certify that the shipment of
the chemical substance complies with all applicable rules and orders
under TSCA. Importers of chemicals subject to these SNURs must certify
their compliance with the SNUR requirements. The EPA policy in support
of import certification appears at 40 CFR part 707, subpart B. In
addition, any persons who export or intend to export a chemical
substance that is the subject of this rule are subject to the export
notification provisions of TSCA section 12(b) (15 U.S.C. 2611(b)) (see
Sec. 721.20), and must comply with the export notification
requirements in 40 CFR part 707, subpart D.
B. What should I consider as I prepare my comments for EPA?
1. Submitting CBI. Do not submit this information to EPA through
regulations.gov or email. Clearly mark the part or all of the
information that you claim to be CBI. For CBI information in a disk or
CD-ROM that you mail to EPA, mark the outside of the disk or CD-ROM as
CBI and then identify electronically within the disk or CD-ROM the
specific information that is claimed as CBI. In addition to one
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.
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iv. Describe any assumptions and provide any technical information
and/or data that you used.
v. If you estimate potential costs or burdens, explain how you
arrived at your estimate in sufficient detail to allow for it to be
reproduced.
vi. Provide specific examples to illustrate your concerns and
suggest alternatives.
vii. Explain your views as clearly as possible, avoiding the use of
profanity or personal threats.
viii. Make sure to submit your comments by the comment period
deadline identified.
II. Background
A. What action is the agency taking?
EPA is promulgating these SNURs using direct final procedures.
These SNURs will require persons to notify EPA at least 90 days before
commencing the manufacture, import, or processing of a chemical
substance for any activity designated by these SNURs as a significant
new use. Receipt of such notices allows EPA to assess risks that may be
presented by the intended uses and, if appropriate, to regulate the
proposed use before it occurs. Additional rationale and background to
these rules are more fully set out in the preamble to EPA's first
direct final SNUR published in the Federal Register issue of April 24,
1990 (55 FR 17376) (April 24, 1990 SNUR). Consult that preamble for
further information on the objectives, rationale, and procedures for
SNURs and on the basis for significant new use designations, including
provisions for developing test data.
B. What is the agency's authority for taking this action?
Section 5(a)(2) of TSCA (15 U.S.C. 2604(a)(2)) authorizes EPA to
determine that a use of a chemical substance is a ``significant new
use.'' EPA must make this determination by rule after considering all
relevant factors, including the four bulleted TSCA section 5(a)(2)
factors listed in Unit III. Once EPA determines that a use of a
chemical substance is a significant new use, TSCA section 5(a)(1)(B)
requires persons to submit a significant new use notice (SNUN) to EPA
at least 90 days before they manufacture, import, or process the
chemical substance for that use. Persons who must report are described
in Sec. 721.5.
C. Applicability of General Provisions
General provisions for SNURs appear in 40 CFR part 721, subpart A.
These provisions describe persons subject to the rule, recordkeeping
requirements, exemptions to reporting requirements, and applicability
of the rule to uses occurring before the effective date of the rule.
Provisions relating to user fees appear at 40 CFR part 700. According
to Sec. 721.1(c), persons subject to these SNURs must comply with the
same SNUN requirements and EPA regulatory procedures as submitters of
PMNs under TSCA section 5(a)(1)(A). In particular, these requirements
include the information submission requirements of TSCA section 5(b)
and 5(d)(1), the exemptions authorized by TSCA section 5(h)(1), (h)(2),
(h)(3), and (h)(5), and the regulations at 40 CFR part 720. Once EPA
receives a SNUN, EPA may take regulatory action under TSCA section
5(e), 5(f), 6, or 7 to control the activities for which it has received
the SNUN. If EPA does not take action, EPA is required under TSCA
section 5(g) to explain in the Federal Register its reasons for not
taking action.
III. Significant New Use Determination
Section 5(a)(2) of TSCA states that EPA's determination that a use
of a chemical substance is a significant new use must be made after
consideration of all relevant factors, including:
The projected volume of manufacturing and processing of a
chemical substance.
The extent to which a use changes the type or form of
exposure of human beings or the environment to a chemical substance.
The extent to which a use increases the magnitude and
duration of exposure of human beings or the environment to a chemical
substance.
The reasonably anticipated manner and methods of
manufacturing, processing, distribution in commerce, and disposal of a
chemical substance.
In addition to these factors enumerated in TSCA section 5(a)(2),
the statute authorized EPA to consider any other relevant factors.
To determine what would constitute a significant new use for the 20
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 20 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).
Toxicity concerns.
Tests recommended by EPA to provide sufficient information
to evaluate the chemical substance (see Unit VIII. for more
information).
CFR citation assigned in the regulatory text section of
this rule.
The regulatory text section of this rule specifies the activities
designated as significant new uses. Certain new uses, including
production volume limits (i.e., limits on manufacture and importation
volume) and other uses designated in this rule, may be claimed as CBI.
Unit IX. discusses a procedure companies may use to ascertain whether a
proposed use constitutes a significant new use.
This rule includes 8 PMN substances that are subject to ``risk-
based'' consent orders under TSCA section 5(e)(1)(A)(ii)(I) where EPA
determined that activities associated with the PMN substances may
present unreasonable risk to human health or the environment. Those
consent orders require protective measures to limit exposures or
otherwise mitigate the potential unreasonable risk. The so-called
``5(e) SNURs'' on these PMN substances are promulgated pursuant to
Sec. 721.160, and are based on and consistent with the provisions in
the underlying consent orders. The 5(e) SNURs designate as a
``significant new use'' the absence of the protective measures required
in the corresponding consent orders.
Where EPA determined that the PMN substance may present an
unreasonable risk of injury to human health via inhalation exposure,
the underlying TSCA section 5(e) consent order usually requires, among
other things, that potentially exposed employees wear specified
respirators unless actual measurements of the workplace air show that
air-borne concentrations of the PMN substance are below a New Chemical
Exposure Limit (NCEL) that is established by EPA to provide adequate
protection to human health. In addition to the actual NCEL
concentration, the comprehensive NCELs provisions in TSCA section 5(e)
consent orders, which are modeled after Occupational Safety and Health
Administration (OSHA) Permissible Exposure Limits (PELs) provisions,
include requirements
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addressing performance criteria for sampling and analytical methods,
periodic monitoring, respiratory protection, and recordkeeping.
However, no comparable NCEL provisions currently exist in 40 CFR part
721, subpart B, for SNURs. Therefore, for these cases, the individual
SNURs in 40 CFR part 721, subpart E, will state that persons subject to
the SNUR who wish to pursue NCELs as an alternative to the Sec. 721.63
respirator requirements may request to do so under Sec. 721.30. EPA
expects that persons whose Sec. 721.30 requests to use the NCELs
approach for SNURs are approved by EPA will be required to comply with
NCELs provisions that are comparable to those contained in the
corresponding TSCA section 5(e) consent order for the same chemical
substance.
This rule also includes SNURs on 12 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. 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-11-135
Chemical name: Benzoic acid, 4-[(1-oxodecyl)oxy]-.
CAS number: 86960-46-5.
Basis for action: The PMN states that the generic (non-
confidential) use of the substance is as a cleaning enhancer additive
for laundry and automatic dish-washing products. Based on test data on
the PMN substance, and ecological structural activity relationship
(EcoSAR) analysis of test data on analogous esters, EPA predicts
toxicity to aquatic organisms may occur at concentrations that exceed
18 ppb of the PMN substance in surface waters for greater than 20 days
per year. This 20-day criterion is derived from partial life cycle
tests (daphnid chronic and fish early-life stage tests) that typically
range from 21 to 28 days in duration. EPA predicts toxicity to aquatic
organisms may occur if releases of the PMN substance to surface water
exceed releases from the use described in the PMN. For the use
described in the PMN, environmental releases did not exceed 18 ppb for
more than 20 days per year. Therefore, EPA has not determined that the
proposed manufacturing, processing, or use of the substance may present
an unreasonable risk. EPA has determined, however, that any domestic
manufacture or use of the substance other than as described in the PMN
could result in exposures which may cause significant adverse
environmental effects. Based on this information, the PMN substance
meets the concern criteria at Sec. 721.170 (b)(4)(i) and (b)(4)(ii).
Recommended testing: EPA has determined that the results of a fish
early-life stage toxicity test (Office of Pollution Prevention and
Toxic Substances (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. Due to low water
solubility, EPA also recommends that the special considerations for
conducting aquatic laboratory studies (OPPTS Test Guideline 850.1000)
be followed to facilitate solubility in the test media.
CFR citation: 40 CFR 721.10611.
PMN Numbers P-11-327, P-11-328, P-11-329, P-11-330, P-11-331, and P-11-
332
Chemical names: Distillates (lignocellulosic), C5-40 (P11-327);
Paraffin waxes (lignocellulosic) hydrotreated, C5-40-branched, cyclic
and linear (P-11-328); Naphtha (lignocellulosic), hydrotreated, C5-12-
branched, cyclic and linear (P-11-329); Kerosene (lignocellulosic),
hydrotreated, C8-16-branched, cyclic and linear (P-11-330); Distillates
(lignocellulosic), hydrotreated, C8-26-branched, cyclic, and linear (P-
11-331); and Residual oils (lignocellulosic), hydrotreated, C20-40-
branched, cyclic, and linear (P-11-332).
CAS numbers: 1267611-99-3 (P-11-327), 1267611-06-2 (P-11-328),
1267611-35-7 (P-11-329), 1267611-14-2 (P-11-330), 1267611-11-9 (P-11-
331), and 1267611-71-1 (P-11-332).
Effective date of TSCA section 5(e) consent order: July 21, 2012.
Basis for TSCA section 5(e) consent order: The PMN states that the
generic (non-confidential) uses of the PMN substances will be as a
distillation feedstock after hydrotreatment (P-11-327), as a feedstock
(P-11-328), as a blend-stock for conventional fossil fuels (P-11-329,
P-11-330, and P-11-331) and use in a manner comparable to gas oil as it
is currently used in industry (P-11-332). These PMNs are complex
mixtures and have been assessed based on the toxic components within
their mixture. The most important and primary component present is
benzene. Based on this analysis, EPA identified concerns for
oncogenicity, immunosuppression, and skin sensitization (defatting of
the skin tissue) to workers exposed to the PMN substances. The EPA
Maximum Contaminant Level for benzene in drinking water is 5 ppb. The
PMNs' new chemical exposure limit (NCEL) is 0.32 milligram/cubic meter
(mg/m\3\) as an 8-hour time-weighted average. In addition, based on
EcoSAR analysis of test data on analogous neutral organics, EPA
predicts toxicity to aquatic organisms may occur at concentrations that
exceed 82 ppb for P-11-329 and P-11-331, and 180 ppb for P-11-327, P-
11-328, P-11-330, and P-11-332. However, EPA does not expect risk to
aquatic organisms at the expected levels and duration of exposure as
described in the PMNs. 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 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 dermal protection
when there is potential dermal exposure and a National Institute for
Occupational Safety and Health (NIOSH)-certified respirator with an
assigned protection factor (APF) of at least 10,000, or compliance with
a NCEL of 0.32 mg/m\3\ as an 8-hour time-weighted average when there is
potential inhalation exposure.
2. No use of the substances resulting in surface water
concentrations exceeding 5 ppb of the combination of these PMN
substances.
3. Establishment and use of a hazard communication program.
The SNUR designates as a ``significant new use'' the absence of these
protective measures.
Recommended testing: EPA has determined that a combined chronic
toxicity/carcinogenicity test (OPPTS Test Guideline 870.4300); a
daphnid chronic toxicity test (OPPTS Test Guideline 850.1300); and fish
early-life stage toxicity test (OPPTS Test
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Guideline 850.1400) would help characterize the human health and
environmental effects of the PMN substances. The Order does not require
submission of the testing at any specified time or production volume.
However, the order's restrictions on manufacture, import, processing,
distribution in commerce, use, and disposal will remain in effect until
the order is modified or revoked by EPA based on submission of that or
other relevant information.
CFR citations: 40 CFR 721.10612 (P-11-237); 721.10613 (P-11-328);
721.10614 (P-11-329); 721.10615 (P-11-330); 721.10616 (P-11-331); and
721.10617 (P-11-332).
PMN Number P-11-607
Chemical name: Polyaromatic Organophosphorus Compound (generic).
CAS number: Not available.
Effective date of TSCA section 5(e) consent order: July 11, 2012.
Basis for TSCA section 5(e) consent order: The PMN states that the
generic (non-confidential) use of the substance will be as an additive
flame retardant (open, non-dispersive use). Based on test data on the
PMN substance itself, EPA expects the PMN substance to hydrolyze under
neutral and basic conditions. EPA does not expect significant human
health concerns from the intact chemical, but there is uncertainty
regarding the hydrolysis products. Based on test data on structurally
similar phosphinate esters and submitted algae data on the PMN
substance itself, EPA expects toxicity to aquatic organisms to occur at
concentrations that exceed 6 ppb. The consent order was issued under
TSCA sections 5(e)(1)(A)(i), 5(e)(1)(A)(ii)(I), and 5(e)(1)(A)(ii)(II)
based on findings that uncontrolled manufacture, import, processing,
distribution in commerce, use, and disposal of the PMN substance may
present an unreasonable risk of injury to the environment, the
substance may be produced in substantial quantities, may reasonably be
anticipated to enter the environment in substantial quantities, and
there may be significant (or substantial) human exposure to the
substance and its potential degradation products. To protect against
these risks the consent order requires:
1. Use of the substance only as described in the PMN.
2. Establishment and use of a hazard communication program.
3. No use of the substance that results in releases to surface
water.
Recommended testing: EPA has determined that certain testing would
help characterize the fate, environmental and human health effects of
the PMN substance. The consent order contains two production limits.
The PMN submitter has agreed not to exceed the first production volume
limit without performing: A daphnid chronic toxicity test (OPPTS Test
Guideline 850.1300); fish early-life stage toxicity test (OPPTS Test
Guideline 850.1400); a washing machine study at basic pH based on the
International Organization for Standardization (ISO) color fastness
test to ascertain release rates with analytics to identify hydrolysis
products (ISO 105); an inherent biodegradability test (OPPTS Test
Guideline 835.3215); and a hydrolysis as a function of pH and
temperature test (OPPTS Test Guideline 835.2130). If the results of the
first tier of testing demonstrate that the PMN substance may cause
adverse effects to humans or the environment, the PMN submitter has
agreed to not exceed a production limit before conducting additional
testing to ascertain whether those releases from representative end-use
articles are in sufficient quantities to pose a significant risk.
EPA has also determined that a prenatal developmental toxicity
study (OPPTS Test Guideline 870.3700 or OECD 414) using oral (gavage)
in the rat would help characterize the human health effects of the PMN
substance. The order does not require the submission of the prenatal
developmental toxicity study at any specified time or production
volume. However, the order's restrictions on manufacture, import,
processing, distribution in commerce, use, and disposal of the PMN
substance will remain in effect until the order is modified or revoked
by EPA based on submission of that or other relevant information.
CFR citation: 40 CFR 721.10618.
PMN Number P-11-653
Chemical name: Perfluoroalkylethyl methacrylate copolymer
(generic).
CAS number: Not available.
Effective date of TSCA section 5(e) consent order: July 12, 2012.
Basis for TSCA section 5(e) consent order: The PMN states that the
generic (non-confidential) use of the substance will be as a water and
oil repellant. EPA has concerns for the formation of potential
incineration or other decomposition products from the PMN substance.
These perfluorinated products may be released to the environment from
incomplete incineration of the PMN substance at low temperatures. EPA
has preliminary evidence, including data on some fluorinated polymers,
suggesting that, under some conditions, the PMN substance could degrade
in the environment. EPA has concerns that these degradation products
will persist in the environment, could bioaccumulate or biomagnify, and
could be toxic to people, wild mammals, and birds. These concerns are
based on data on analog chemicals, including perfluorooctanoic acid
(PFOA) and other perfluorinated carboxylates, such as the presumed
environmental degradant of the PMN substance, perfluorohexanoic acid
(PFHxA). There is pharmacokinetic and toxicological data in animals on
PFOA, as well as epidemiological and blood monitoring data in humans.
Toxicity studies on PFOA indicate developmental, reproductive, and
systemic toxicity in various species, as well as cancer. These factors,
taken together, raise concerns for potential adverse chronic effects
from the presumed degradation product in humans and wildlife. The
consent order was issued under TSCA sections 5(e)(1)(A)(i),
5(e)(1)(A)(ii)(I), and 5(e)(1)(A)(ii)(II), based on a finding that this
substance may present an unreasonable risk of injury to human health
and the environment, the substance may be produced in substantial
quantities and may reasonably be anticipated to enter the environment
in substantial quantities, and there may be significant (or
substantial) human exposure to the substance and its potential
degradation products. To protect against these risks, the consent order
requires risk notification. If 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 MSDS,
within 90 days. The SNUR designates as a ``significant new use'' the
absence of this protective measure.
Recommended testing: EPA has determined that the results of certain
fate testing identified in the consent order would help characterize
possible effects of the substance and its degradation products. The PMN
submitter has agreed not to manufacture or import the PMN substance
after September 30, 2014, without performing a modified semi-continuous
activated sludge (SCAS) test (OPPTS Test Guideline 835.5045 or OECD
Test Guideline 302A); a UV/visible absorption test (OPPTS Test
Guideline 830.7050); direct photolysis rate in water by sunlight test
(OPPTS Test Guideline 835.2210); a hydrolysis as a function of pH and
temperature test
[[Page 66154]]
(OPPTS Test Guideline 835.2130 or OECD Test Guideline 111); an indirect
photolysis screening test: sunlight photolysis in waters containing
dissolved humic substances (OPPTS Test Guideline 835.5270); a
photolysis on soils study using the phototransformation of chemicals on
soil surfaces OECD Test Guideline 2005 Draft (located in the docket
under docket ID number EPA-HQ-OPPT-2012-0740); aerobic and anaerobic
transformation in aquatic sediment systems (OECD Test Guideline 308);
and an anaerobic biodegradability of organic compounds in digested
sludge by measurement of gas production test (OECD Test Guideline 311).
These tests are further detailed in the consent order. EPA has
determined if the substance was to be sprayed by commercial or consumer
applicants, that the results of a 90-day inhalation toxicity test
(OPPTS Test Guideline 870.3465) in rats with a 60-day holding period
would help characterize possible effects of the substance and its
degradation products. The consent order does not require submission of
the inhalation testing at any specified time or production volume.
However, the consent order's restrictions on manufacture, import,
processing, distribution in commerce, use, and disposal of the PMN will
remain in effect until the consent order is modified or revoked by EPA
based on submission of that or other relevant information.
CFR citation: 40 CFR 721.10619.
PMN Number P-12-191
Chemical name: Oxirane, 2,2'-(phenylene)bis-.
CAS number: 30424-08-9.
Basis for action: The PMN states that the generic (non-
confidential) use of the substance is as a component of adhesives and
composites. Based on structural activity relationship (SAR) of test
data on analogous epoxides, EPA identified developmental and male
reproductive toxicity and cancer concerns to workers exposed to the PMN
substance via the inhalation route. In addition, based on EcoSAR
analysis of test data on analogous epoxides, EPA predicts toxicity to
aquatic organisms may occur at concentrations that exceed 10 ppb of the
PMN substance in surface waters. As described in the PMN, significant
inhalation exposures are not expected due to low vapor pressure when
the substance is distributed with less than or equal to 5 percent
impurities, and releases of the 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 distribution of the substance with greater than 5
percent impurities, or any use of the substance resulting in surface
water concentrations exceeding 10 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 a ready
biodegradability test (OPPTS Test Guideline 835.3110); a combined
repeated-dose toxicity study with the reproduction/developmental
toxicity screening test (OECD Test Guideline 422) via the inhalation
route in rats; a carcinogenicity study (OECD Test Guideline 451); 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 human health and environmental effects of
the PMN substance.
CFR citation: 40 CFR 721.10620.
PMN Number P-12-196
Chemical name: Distillation bottoms, alkylated benzene by-product
(generic).
CAS number: Not available.
Basis for action: The PMN states that the generic (non
confidential) use of the substance is for bromine recovery. Based on
test data on the PMN substance and 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 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); a
daphnid chronic toxicity test (OPPTS Test Guideline 850.1300); and an
algal toxicity test (Office of Chemical Safety and Pollution Prevention
(OCSPP) Test Guidelines 850.4500) would help characterize the
environmental effects of the PMN substance. EPA also recommends that
the special considerations for conducting aquatic laboratory studies
(OPPTS Test Guideline 850.1000) be followed to facilitate solubility in
the test media, because of the PMN's low water solubility.
CFR citation: 40 CFR 721.10621.
PMN Number P-12-285
Chemical name: Copper(2+), tetraammine-, chloride (1:2).
CAS number: 10534-87-9.
Basis for action: The PMN states that the generic (non
confidential) uses of the substance are as a raw material for
production of copper chemicals and as a raw material for the production
of animal feed micronutrients. Based on test data on the PMN substance
and EcoSAR analysis of test data on analogous inorganic copper
complexes, EPA predicts toxicity to aquatic organisms may occur at
concentrations that exceed 3 ppb of the PMN substance in surface
waters. As described in the PMN, releases of the substance are not
expected to result in surface water concentrations that exceed 3 ppb.
Therefore, EPA has not determined that the proposed manufacturing,
processing, or use of the substance may present an unreasonable risk.
EPA has determined, however, that any use of the substance resulting in
surface water concentrations exceeding 3 ppb may cause significant
adverse environmental effects. Based on this information, the PMN
substance meets the concern criteria at Sec. 721.170 (b)(4)(i) and
(b)(4)(ii).
Recommended testing: EPA has determined that the results of a fish
BCF Test (OPPTS Test Guideline 850.1730) would help characterize the
environmental effects of the PMN substance.
CFR citation: 40 CFR 721.10622.
PMN Numbers P-12-298 and P-12-299
Chemical name: Vinylidene ester (generic).
CAS number: Not available.
Basis for action: The PMN states that the substance will be used as
an adhesive. Based on EcoSAR analysis of test data on analogous esters,
EPA predicts toxicity to aquatic organisms may occur at concentrations
that exceed 7 ppb of the PMN substance in surface waters 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
[[Page 66155]]
exceed releases from the use described in the PMN. For the use
described in the PMN, environmental releases did not exceed 7 ppb for
more than 20 days per year. if releases of the PMN substances to
surface water from uses other than described in the PMN exceed the
releases expected from the use described in the PMN. For the described
use in the PMN, significant environmental releases are not expected.
Therefore, EPA has not determined that the proposed manufacturing,
processing, or use of the substance may present an unreasonable risk.
EPA has determined, however, that combined production volume of the two
PMN substances exceeding 20,000 kilograms per year could result in
exposures which may cause significant adverse environmental effects.
Based on this information, the PMN substances meets the concern
criteria at Sec. 721.170(b)(4)(ii).
Recommended testing: EPA has determined that the results of a fish
acute toxicity test, freshwater and marine (OPPTS Test Guidelines
850.1075); an aquatic invertebrate acute toxicity test, freshwater
daphnids (OPPTS Test Guidelines 850.1010); and an algal toxicity test
(OCSPP Test Guideline 850.4500) would help characterize the
environmental effects of the PMN substances.
CFR citation: 40 CFR 721.10623.
PMN Number P-12-326
Chemical name: Dicyclohexylmethane-4,4'-diisocyanate, polymer with
ethoxylated, propoxylated polyethers (generic).
CAS number: Not available.
Basis for action: The PMN states that the generic (non-
confidential) use of the substance will be as part of 2-component
reactive polyurethane adhesive resin. Based on analogous diisocyanate
substances, EPA identified concerns for potential dermal and
respiratory sensitization from dermal and inhalation exposures, and for
pulmonary toxicity from inhalation exposure to the PMN substance.
Specifically, the Agency expects potential toxicity to workers from
dermal or inhalation exposure to the PMN substance when the molecular
weight is less than 1000 daltons. For the uses described in the PMN and
due to the use of personal protective equipment, significant worker
exposure to the PMN substance where the molecular weight is less than
1000 daltons is unlikely, as dermal and inhalation exposure is not
expected. Therefore, EPA has not determined that the proposed
manufacturing, processing, or use of the substance may present an
unreasonable risk. EPA has determined, however, that the manufacture,
processing, or use of the substance where the molecular weight is less
than 1000 daltons 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 90-
day inhalation toxicity test (OPPTS Test Guideline 870.3465) and a skin
sensitization test (OPPTS Test Guideline 870.2600) would help
characterize the human health effects of the PMN substance.
CFR citation: 40 CFR 721.10624.
PMN Numbers P-12-332 and P-12-333
Chemical name: Distillation bottoms, alkylated benzene by-product,
brominated and bromo diphenyl alkane.
CAS number: Not available.
Basis for action: The PMNs state that the PMN substances will be
used as a feed for a bromine recovery unit. Based on test data on
analogous chemical substances, the Agency identified concerns for liver
toxicity and the potential for other human health risks due to the
possible formation of dioxins and furans. These concerns are for
workers exposed to the PMN substances by the inhalation and dermal
routes. For the uses described in the PMNs and due to the use of
personal protective equipment, significant worker exposure is unlikely,
as dermal and inhalation exposure is not expected. Therefore, EPA has
not determined that the proposed manufacturing, processing, or use of
the substances may present an unreasonable risk. EPA has determined,
however, that use of the substances other than as described in the PMNs
may cause serious health effects. Based on this information, the PMN
substances meet the concern criteria at Sec. 721.170(b)(3)(ii).
Recommended testing: EPA has determined that the results of a 90-
day oral toxicity in rodents test (OPPTS Test Guideline 870.3100) and
either a determination of polychlorinated dibenzo-p-dioxins and
polychlorinated dibenzofurans from stationary sources study (EPA Method
23); or a polychlorinated dibenzo-p-dioxins (PCDDs) and polychlorinated
dibenzofurans (PCDFs) by high resolution gas chromatography/high
resolution mass spectrometry (HRGC/HRMS) study (EPA Method 8290A); or a
same-sample determination of ultratrace levels of
polybromodiphenylethers, polybromodibenzo-p-dioxins/furans, and
polychlorodibenzo-p-dioxins/furans from combustion flue gas study
(Wyrzykowska, B., Tabor, D., and Gullett, B. Anal. Chem., 2009, 81
(11), 4334-4342.) on each of the PMN substances would help characterize
the human health effects of the PMN substances.
CFR citation: 40 CFR 721.10625.
PMN Number P-12-373
Chemical name: 1,4-Butanediol, polymer with substituted alkane and
substituted methylene biscarbomonocycle, 2-hydroxyalkyl acrylate-
blocked (generic).
CAS number: Not available.
Basis for action: The PMN states that the generic (non-
confidential) use of the substance will be as an abrasion resistant,
formable dual-cure lacquer for screen printing. Based on test data on
analogous acrylates and isocyanates, EPA identified concerns for
respiratory and dermal sensitization and irritation to workers from
exposure to the PMN substance. Additionally, the Agency identified low
to moderate concern for mutagenicity, oncogenicity, and developmental
toxicity for the low molecular weight acrylates. For the uses described
in the PMNs significant worker exposure is unlikely because there are
no applications generating a vapor, mist or aerosol, and there are no
consumer exposures. Therefore, EPA has not determined that the proposed
manufacturing, processing, or use of these substances may present an
unreasonable risk. EPA has determined, however, that 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. For the uses described in the PMN and due
to the use of personal protective equipment, significant worker
exposure is unlikely, as dermal and inhalation exposure is not
expected. Therefore, EPA has not determined that the proposed
manufacturing, processing, or use of the substance may present an
unreasonable risk. EPA has determined, however, that use of the
substance in consumer products or in spray applications may cause
serious health effects. Based on this information, the PMN substance
meets the concern criteria at Sec. 721.170 (b)(3)(ii).
Recommended testing: EPA has determined that a 90-day inhalation
toxicity test (OPPTS Test Guideline 870.3465) and a skin sensitization
test (OPPTS Test Guideline 870.2600) would help characterize the human
health effects of the PMN substance.
CFR citation: 40 CFR 721.10626.
[[Page 66156]]
PMN Number P-12-430
Chemical name: Yttrium borate phosphate vanadate with europium and
additional dopants (generic).
CAS number: Not available.
Basis for action: The PMN states that the generic (non-
confidential) use of the PMN substance will be as a coating for the
interior surface of glass lamps. Based on test data on analogous
chemical substances, EPA identified health concerns for lung effects if
the poorly soluble, respirable particles are inhaled. Additionally, due
to the crystalline structure of the PMN substance, the Agency
identified concern for oncogenicity if the PMN substance was inhaled.
These concerns are for workers exposed to the PMN substance by
inhalation. For the use described in the PMN and at the production
volume stated in the PMN, significant worker inhalation exposure is not
expected. Therefore, EPA has not determined that the proposed
manufacturing, processing, or use of the substance may present an
unreasonable risk. EPA has determined, however, that use of the PMN
substance other than as described in the PMN or use exceeding the
annual manufacture or import volume stated in the PMN may result in
serious health effects. Based on this information, the PMN substance
meets the concern criteria at Sec. 721.170 (b)(1)(i)(c) and
(b)(3)(ii).
Recommended testing: EPA has determined that a 90-day inhalation
toxicity test (OPPTS Test Guideline 870.3465) would help characterize
the health effects of the PMN substance.
CFR citation: 40 CFR 721.10627.
PMN Number P-12-432
Chemical name: Mixed metal oxalate (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 intermediate
precipitate used to produce phosphors. Based on test data on analogous
chemical substances, EPA identified health concerns for lung effects if
the poorly soluble, respirable particles are inhaled. Additionally, due
to the crystalline structure of the PMN substance, the Agency
identified concern for oncogenicity if the PMN substance was inhaled.
These concerns are for workers exposed to the PMN substance by
inhalation. For the use described in the PMN and at the production
volume stated in the PMN, significant worker inhalation exposure is not
expected. Therefore, EPA has not determined that the proposed
manufacturing, processing, or use of the substance may present an
unreasonable risk. EPA has determined, however, that use of the PMN
substance other than as described in the PMN or use exceeding the
annual manufacture or import volume stated in the PMN may result in
serious health effects. Based on this information, the PMN substance
meets the concern criteria at Sec. 721.170 (b)(1)(i)(c) and
(b)(3)(ii).
Recommended testing: EPA has determined that a 90-day inhalation
toxicity test (OPPTS Test Guideline 870.3465) would help characterize
the health effects of the PMN substance.
CFR citation: 40 CFR 721.10628.
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 8 of the 20
chemical substances, regulation was warranted under TSCA section 5(e),
pending the development of information sufficient to make reasoned
evaluations of the health or environmental effects of the chemical
substances. The basis for such findings is outlined in Unit IV. Based
on these findings, TSCA section 5(e) consent orders requiring the use
of appropriate exposure controls were negotiated with the PMN
submitters. The SNUR provisions for these chemical substances are
consistent with the provisions of the TSCA section 5(e) consent orders.
These SNURs are promulgated pursuant to Sec. 721.160 (see Unit II.).
In the other 12 cases, where the uses are not regulated under a
TSCA section 5(e) consent order, EPA determined that one or more of the
criteria of concern established at Sec. 721.170 were met, as discussed
in Unit IV.
B. Objectives
EPA is issuing these SNURs for specific chemical substances which
have undergone premanufacture review because the Agency wants to
achieve the following objectives with regard to the significant new
uses designated in this rule:
EPA will receive notice of any person's intent to
manufacture, import, or process a listed chemical substance for the
described significant new use before that activity begins.
EPA will have an opportunity to review and evaluate data
submitted in a SNUN before the notice submitter begins manufacturing,
importing, or processing a listed chemical substance for the described
significant new use.
EPA will be able to regulate prospective manufacturers,
importers, or processors of a listed chemical substance before the
described significant new use of that chemical substance occurs,
provided that regulation is warranted pursuant to TSCA sections 5(e),
5(f), 6, or 7.
EPA will ensure that all manufacturers, importers, and
processors of the same chemical substance that is subject to a TSCA
section 5(e) consent order are subject to similar requirements.
Issuance of a SNUR for a chemical substance does not signify that
the chemical substance is listed on the TSCA Chemical Substance
Inventory (TSCA Inventory). Guidance on how to determine if a chemical
substance is on the TSCA Inventory is available on the Internet at
http://www.epa.gov/opptintr/existingchemicals/pubs/tscainventory/index.html.
VI. Direct Final Procedures
EPA is issuing these SNURs as a direct final rule, as described in
Sec. 721.160(c)(3) and Sec. 721.170(d)(4). In accordance with Sec.
721.160(c)(3)(ii) and Sec. 721.170(d)(4)(i)(B), the effective date of
this rule is January 2, 2013 without further notice, unless EPA
receives written adverse or critical comments, or notice of intent to
submit adverse or critical comments before December 3, 2012.
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 December 3, 2012, EPA will withdraw the relevant sections
of this direct final rule before its effective date. EPA will then
issue a proposed SNUR for the chemical substance(s) on which adverse or
critical comments were received, providing a 30-day period for public
comment.
This rule establishes SNURs for a number of chemical substances.
Any person who submits adverse or critical comments, or notice of
intent to submit adverse or critical comments, must identify the
chemical substance and the new use to which it applies. EPA will not
withdraw a SNUR for a chemical substance not identified in the comment.
VII. Applicability of Rule to Uses Occurring Before Effective Date of
the Rule
Significant new use designations for a chemical substance are
legally established as of the date of publication of this direct final
rule, November 2, 2012.
To establish a significant ``new'' use, EPA must determine that the
use is not ongoing. The chemical substances
[[Page 66157]]
subject to this rule have undergone premanufacture review. TSCA section
5(e) consent orders have been issued for 8 chemical substances and the
PMN submitters are prohibited by the TSCA section 5(e) consent orders
from undertaking activities which EPA is designating as significant new
uses. In cases where EPA has not received a notice of commencement
(NOC) and the chemical substance has not been added to the TSCA
Inventory, no other person may commence such activities without first
submitting a PMN. For chemical substances for which an NOC has not been
submitted at this time, EPA concludes that the uses are not ongoing.
However, EPA recognizes that prior to the effective date of the rule,
when chemical substances identified in this SNUR are added to the TSCA
Inventory, other persons may engage in a significant new use as defined
in this rule before the effective date of the rule. However, 11 of the
20 chemical substances contained in this rule have CBI chemical
identities, and since EPA has received a limited number of post-PMN
bona fide submissions (per Sec. Sec. 720.25 and 721.11), the Agency
believes that it is highly unlikely that any of the significant new
uses described in the regulatory text of this rule are ongoing.
As discussed in the April 24, 1990 SNUR, EPA has decided that the
intent of TSCA section 5(a)(1)(B) is best served by designating a use
as a significant new use as of the date of publication of this direct
final rule rather than as of the effective date of the rule. If uses
begun after publication were considered ongoing rather than new, it
would be difficult for EPA to establish SNUR notification requirements
because a person could defeat the SNUR by initiating the significant
new use before the rule became effective, and then argue that the use
was ongoing before the effective date of the rule. Thus, persons who
begin commercial manufacture, import, or processing of the chemical
substances regulated through this SNUR will have to cease any such
activity before the effective date of this rule. To resume their
activities, these persons would have to comply with all applicable SNUR
notification requirements and wait until the notice review period,
including any extensions, expires.
EPA has promulgated provisions to allow persons to comply with this
SNUR before the effective date. If a person meets the conditions of
advance compliance under Sec. 721.45(h), the person is considered
exempt from the requirements of the SNUR.
VIII. Test Data and Other Information
EPA recognizes that TSCA section 5 does not require developing any
particular test data before submission of a SNUN. The two exceptions
are:
1. Development of test data is required where the chemical
substance subject to the SNUR is also subject to a test rule under TSCA
section 4 (see TSCA section 5(b)(1)).
2. Development of test data may be necessary where the chemical
substance has been listed under TSCA section 5(b)(4) (see TSCA section
5(b)(2)).
In the absence of a TSCA section 4 test rule or a TSCA section
5(b)(4) listing covering the chemical substance, persons are required
only to submit test data in their possession or control and to describe
any other data known to or reasonably ascertainable by them (see Sec.
720.50). However, upon review of PMNs and SNUNs, the Agency has the
authority to require appropriate testing. In cases where EPA issued a
TSCA section 5(e) consent order that requires or recommends certain
testing, Unit IV. lists those tests. Unit IV. also lists recommended
testing for non-5(e) SNURs. Descriptions of tests are provided for
informational purposes. EPA strongly encourages persons, before
performing any testing, to consult with the Agency pertaining to
protocol selection. To access the OCSPP and OPPTS test guidelines
referenced in this document electronically, please go to http://www.epa.gov/ocspp and select ``Test Methods and Guidelines'' or for
guidelines not currently available on the Web site, EPA has placed a
copy of that guideline in the public docket. The Organization 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. To access EPA Method 23 and
Method 8290A, please go to http://www.epa.gov/ttn/emc/methods/method23.html and http://www.epa.gov/osw/hazard/testmethods/sw846/pdfs/8290a.pdf. To access the International Organization for Standardization
(ISO) standard, ISO 105, please go to http://www.ihs.com/products/industry-standards/org/iso/list/page9.aspx.
In the TSCA section 5(e) consent orders for several of the chemical
substances regulated under this rule, EPA has established production
volume limits in view of the lack of data on the potential health and
environmental risks that may be posed by the significant new uses or
increased exposure to the chemical substances. These limits cannot be
exceeded unless the PMN submitter first submits the results of toxicity
tests that would permit a reasoned evaluation of the potential risks
posed by these chemical substances. Under recent TSCA section 5(e)
consent orders, each PMN submitter is required to submit each study at
least 14 weeks (earlier TSCA section 5(e) consent orders required
submissions at least 12 weeks) before reaching the specified production
limit. Listings of the tests specified in the TSCA section 5(e) consent
orders are included in Unit IV. The SNURs contain the same production
volume limits as the TSCA section 5(e) consent orders. Exceeding these
production limits is defined as a significant new use. Persons who
intend to exceed the production limit must notify the Agency by
submitting a SNUN at least 90 days in advance of commencement of non-
exempt commercial manufacture, import, or processing.
The recommended tests 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, importer, or processor may
request EPA to determine whether
[[Page 66158]]
a proposed use would be a significant new use under the rule. The
manufacturer, importer, or processor must show that it has a bona fide
intent to manufacture, import, or process the chemical substance and
must identify the specific use for which it intends to manufacture,
import, or process the chemical substance. If EPA concludes that the
person has shown a bona fide intent to manufacture, import, or process
the chemical substance, EPA will tell the person whether the use
identified in the bona fide submission would be a significant new use
under the rule. Since most of the chemical identities of the chemical
substances subject to these SNURs are also CBI, manufacturers,
importers, and processors can combine the bona fide submission under
the procedure in Sec. 721.1725(b)(1) with that under Sec. 721.11 into
a single step.
If EPA determines that the use identified in the bona fide
submission would not be a significant new use, i.e., the use does not
meet the criteria specified in the rule for a significant new use, that
person can manufacture, import, or process the chemical substance so
long as the significant new use trigger is not met. In the case of a
production volume trigger, this means that the aggregate annual
production volume does not exceed that identified in the bona fide
submission to EPA. Because of confidentiality concerns, EPA does not
typically disclose the actual production volume that constitutes the
use trigger. Thus, if the person later intends to exceed that volume, a
new bona fide submission would be necessary to determine whether that
higher volume would be a significant new use.
X. SNUN Submissions
According to Sec. 721.1(c), persons submitting a SNUN must comply
with the same notification requirements and EPA regulatory procedures
as persons submitting a PMN, including submission of test data on
health and environmental effects as described in Sec. 720.50. SNUNs
must be submitted on EPA Form No. 7710-25, generated using e-PMN
software, and submitted to the Agency in accordance with the procedures
set forth in Sec. Sec. 721.25 and 720.40. E-PMN software is available
electronically at http://www.epa.gov/opptintr/newchems.
XI. Economic Analysis
EPA has evaluated the potential costs of establishing SNUN
requirements for potential manufacturers, importers, and processors of
the chemical substances subject to this rule. EPA's complete economic
analysis is available in the docket under docket ID number EPA-HQ-OPPT-
2012-0740.
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 and, in some cases, 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 (RAF)
On February 18, 2012, EPA certified pursuant to RFA section 605(b)
(5 U.S.C. 601 et seq.), that promulgation of a SNUR does not have a
significant economic impact on a substantial number of small entities
where the following are true:
1. A significant number of SNUNs would not be submitted by small
entities in response to the SNUR.
2. The SNUR submitted by any small entity would not cost
significantly more than $8,300.
A copy of that certification is available in the docket for this
rule.
This rule is within the scope of the February 18, 2012,
certification. Based on the Economic Analysis discussed in Unit XI. and
EPA's experience promulgating SNURs (discussed in the certification),
EPA believes that the following are true:
A significant number of SNUNs would not be submitted by
small entities in response to the SNUR.
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
[[Page 66159]]
relationship between the national government and the States, or on the
distribution of power and responsibilities among the various levels of
government, as specified in Executive Order 13132, entitled
``Federalism'' (64 FR 43255, August 10, 1999).
F. Executive Order 13175
This rule does not have Tribal implications because it is not
expected to have substantial direct effects on Indian Tribes. This rule
does not significantly nor uniquely affect the communities of Indian
Tribal governments, nor does it involve or impose any requirements that
affect Indian Tribes. Accordingly, the requirements of Executive Order
13175, entitled ``Consultation and Coordination with Indian Tribal
Governments'' (65 FR 67249, November 9, 2000), do not apply to this
rule.
G. Executive Order 13045
This action is not subject to Executive Order 13045, entitled
``Protection of Children from Environmental Health Risks and Safety
Risks'' (62 FR 19885, April 23, 1997), because this is not an
economically significant regulatory action as defined by Executive
Order 12866, and this action does not address environmental health or
safety risks disproportionately affecting children.
H. Executive Order 13211
This action is not subject to Executive Order 13211, entitled
``Actions Concerning Regulations That Significantly Affect Energy
Supply, Distribution, or Use'' (66 FR 28355, May 22, 2001), because
this action is not expected to affect energy supply, distribution, or
use and because this action is not a significant regulatory action
under Executive Order 12866.
I. National Technology Transfer and Advancement Act (NTTAA)
This action does not involve any technical standards, so 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).
XIV. 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: October 22, 2012.
Maria J. Doa,
Director, Chemical Control Division, Office of Pollution Prevention and
Toxics.
Therefore, 40 CFR parts 9 and 721 are amended as follows:
PART 9--[AMENDED]
0
1. The authority citation for part 9 continues to read as follows:
Authority: 7 U.S.C. 135 et seq., 136-136y; 15 U.S.C. 2001,
2003, 2005, 2006, 2601-2671; 21 U.S.C. 331j, 346a, 348; 31 U.S.C.
9701; 33 U.S.C. 1251 et seq., 1311, 1313d, 1314, 1318, 1321, 1326,
1330, 1342, 1344, 1345 (d) and (e), 1361; E.O. 11735, 38 FR 21243, 3
CFR, 1971-1975 Comp. p. 973; 42 U.S.C. 241, 242b, 243, 246, 300f,
300g, 300g-1, 300g-2, 300g-3, 300g-4, 300g-5, 300g-6, 300j-1, 300j-
2, 300j-3, 300j-4, 300j-9, 1857 et seq., 6901-6992k, 7401-7671q,
7542, 9601-9657, 11023, 11048.
0
2. In Sec. 9.1, add the following sections in numerical order under
the undesignated center heading ``Significant New Uses of Chemical
Substances'' to read as follows:
Sec. 9.1 OMB approvals under the Paperwork Reduction Act.
* * * * *
------------------------------------------------------------------------
40 CFR citation OMB control No.
------------------------------------------------------------------------
* * * * *
Significant New Uses of Chemical Substances
* * * * *
721.10611........................................... 2070-0012
721.10612........................................... 2070-0012
721.10613........................................... 2070-0012
721.10614........................................... 2070-0012
721.10615........................................... 2070-0012
721.10616........................................... 2070-0012
721.10617........................................... 2070-0012
721.10618........................................... 2070-0012
721.10619........................................... 2070-0012
721.10620........................................... 2070-0012
721.10621........................................... 2070-0012
721.10622........................................... 2070-0012
721.10623........................................... 2070-0012
721.10624........................................... 2070-0012
721.10625........................................... 2070-0012
721.10626........................................... 2070-0012
721.10627........................................... 2070-0012
721.10628........................................... 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. 721.10611 to subpart E to read as follows:
Sec. 721.10611 Benzoic acid, 4-[(1-oxodecyl)oxy]-.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as benzoic acid, 4-
[(1-oxodecyl)oxy]- (PMN P-11-135, CAS No. 86960-46-5) is subject to
reporting under this section for the significant new uses described in
paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Industrial, commercial and consumer activities. Requirements as
specified in Sec. 721.80(f) and (j)
(ii) [Reserved]
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph.
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125 (a), (b), (c), and (i) are applicable to manufacturers,
importers, and processors of this substance.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
(3) Determining whether a specific use is subject to this section.
The provisions of Sec. 721.1725(b)(1) apply to paragraph (a)(2)(i) of
this section.
0
5. Add Sec. 721.10612 to subpart E to read as follows:
Sec. 721.10612 Distillates (lignocellulosic), C5-40.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as distillates
(lignocellulosic), C5-40 (PMN P-11-327, CAS No. 1267611-99-3) is
subject to reporting under this section for the significant new uses
described in paragraph (a)(2) of this section.
[[Page 66160]]
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(1), (a)(3), (a)(4), (a)(6), (b)(concentration set at 0.1
percent), and (c). The following NIOSH-approved respirators with an APF
of 10,000 meet the minimum requirements for Sec. 721.63(a)(4): Any
NIOSH-certified pressure-demand or other positive pressure mode (e.g.,
open/closed circuit) self-contained breathing apparatus (SCBA) equipped
with a hood or helmet or a full facepiece.
(A) As an alternative to the respiratory requirements listed in
paragraph (a)(2)(i), a manufacturer, importer, or processor may choose
to follow the new chemical exposure limit (NCEL) provisions listed in
the TSCA section 5(e) consent order for this substance. The NCEL is
0.32 milligram/cubic meter (mg/m\3\) as an 8-hour time-weighted
average. Persons who wish to pursue NCELs as an alternative to the
Sec. 721.63 respirator requirements may request to do so under Sec.
721.30. Persons whose Sec. 721.30 requests to use the NCELs approach
are approved by EPA will receive NCELs provisions comparable to those
contained in the corresponding section 5(e) consent order.
(B) [Reserved]
(ii) Hazard communication program. Requirements as specified in
Sec. 721.72(a), (b), (c), (d), (e)(concentration set at 0.1 percent),
(f), and (g).
(iii) Release to water. Requirements as specified in Sec. 721.90
(a)(4), (b)(4), and (c)(4) (Where N=5, and 5 is an aggregate of
releases for the following substances: distillates (lignocellulosic),
C5-40 (PMN P-11-327, CAS No. 1267611-99-3); paraffin waxes
(lignocellulosic) hydrotreated, C5-40--branched, cyclic and linear (PMN
P-11-328, CAS No. 1267611-06-2); naphtha (lignocellulosic),
hydrotreated, C5-12-branched, cyclic and linear (PMN P-11-329, CAS No.
1267611-35-7); kerosene (lignocellulosic), hydrotreated, C8-16-
branched, cyclic and linear (PMN P-11-330, CAS No. 1267611-14-2);
distillates (lignocellulosic), hydrotreated, C8-26--branched, cyclic,
and linear (PMN P-11-331, CAS No. 1267611-11-9); and residual oils
(lignocellulosic), hydrotreated, C20-40- branched, cyclic, and linear
(PMN P-11-332, CAS No. 1267611-71-1)).
(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) through (h) and (k) are applicable to manufacturers,
importers, and processors of this substance.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
0
6. Add Sec. 721.10613 to subpart E to read as follows:
Sec. 721.10613 Paraffin waxes (lignocellulosic) hydrotreated, C5-40--
branched, cyclic and linear.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as paraffin waxes
(lignocellulosic) hydrotreated, C5-40--branched, cyclic and linear (PMN
P-11-328, CAS No. 1267611-06-2) is subject to reporting under this
section for the significant new uses described in paragraph (a)(2) of
this section.
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in Sec.
721.63 (a)(1), (a)(3), (a)(4), (a)(6), (b) (concentration set at 0.1
percent), and (c). The following NIOSH-approved respirators with an APF
of 10,000 meet the minimum requirements for Sec. 721.63(a)(4): Any
NIOSH-certified pressure-demand or other positive pressure mode (e.g.,
open/closed circuit) self-contained breathing apparatus (SCBA) equipped
with a hood or helmet or a full facepiece.
(A) As an alternative to the respiratory requirements listed in
paragraph (a)(2)(i), a manufacturer, importer, or processor may choose
to follow the new chemical exposure limit (NCEL) provisions listed in
the TSCA section 5(e) consent order for this substance. The NCEL is
0.32 milligram/cubic meter (mg/m\3\) as an 8-hour time-weighted
average. Persons who wish to pursue NCELs as an alternative to the
Sec. 721.63 respirator requirements may request to do so under Sec.
721.30. Persons whose Sec. 721.30 requests to use the NCELs approach
are approved by EPA will receive NCELs provisions comparable to those
contained in the corresponding section 5(e) consent order.
(B) [Reserved]
(ii) Hazard communication program. Requirements as specified in
Sec. 721.72(a), (b), (c), (d), (e)(concentration set at 0.1 percent),
(f), and (g).
(iii) Release to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4), and (c)(4) (Where N=5, and 5 is an aggregate of
releases for the following substances: distillates (lignocellulosic),
C5-40 (PMN P-11-327, CAS No. 1267611-99-3); paraffin waxes
(lignocellulosic) hydrotreated, C5-40--branched, cyclic and linear (PMN
P-11-328, CAS No. 1267611-06-2); naphtha (lignocellulosic),
hydrotreated, C5-12-branched, cyclic and linear (PMN P-11-329, CAS No.
1267611-35-7); kerosene (lignocellulosic), hydrotreated, C8-16-
branched, cyclic and linear (PMN P-11-330, CAS No. 1267611-14-2);
distillates (lignocellulosic), hydrotreated, C8-26--branched, cyclic,
and linear (PMN P-11-331, CAS No. 1267611-11-9); and residual oils
(lignocellulosic), hydrotreated, C20-40- branched, cyclic, and linear
(PMN P-11-332, CAS No. 1267611-71-1)).
(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) through (h) and (k) are applicable to manufacturers,
importers, and processors of this substance.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
0
7. Add Sec. 721.10614 to subpart E to read as follows:
Sec. 721.10614 Naphtha (lignocellulosic), hydrotreated, C5-12-
branched, cyclic and linear.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as naphtha
(lignocellulosic), hydrotreated, C5-12-branched, cyclic and linear (PMN
P-11-329, CAS No. 1267611-35-7) 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)(3), (a)(4), (a)(6), (b) (concentration set at 0.1
percent), and (c). The following NIOSH-approved respirators with an APF
of 10,000 meet the minimum requirements for Sec. 721.63(a)(4): Any
NIOSH-certified pressure-demand or other positive pressure mode (e.g.,
open/closed circuit) self-contained breathing apparatus (SCBA) equipped
with a hood or helmet or a full facepiece.
(A) As an alternative to the respiratory requirements listed in
paragraph (a)(2)(i), a manufacturer, importer, or processor may choose
to follow the new chemical exposure limit (NCEL) provisions listed in
the TSCA section 5(e) consent order for this substance. The NCEL is
0.32 milligram/cubic meter (mg/m\3\) as an 8-hour time-weighted
average. Persons who wish to pursue NCELs as an alternative to the
Sec. 721.63 respirator requirements may request to do so under Sec.
721.30. Persons whose Sec. 721.30 requests to use the NCELs approach
are approved by EPA will receive NCELs provisions comparable to
[[Page 66161]]
those contained in the corresponding section 5(e) consent order.
(B) [Reserved]
(ii) Hazard communication program. Requirements as specified in
Sec. 721.72(a), (b), (c), (d), (e)(concentration set at 0.1 percent),
(f), and (g).
(iii) Release to water. Requirements as specified in Sec. 721.90
(a)(4), (b)(4), and (c)(4) (Where N=5, and 5 is an aggregate of
releases for the following substances: distillates (lignocellulosic),
C5-40 (PMN P-11-327, CAS No. 1267611-99-3); paraffin waxes
(lignocellulosic) hydrotreated, C5-40--branched, cyclic and linear (PMN
P-11-328, CAS No. 1267611-06-2); naphtha (lignocellulosic),
hydrotreated, C5-12-branched, cyclic and linear (PMN P-11-329, CAS No.
1267611-35-7); kerosene (lignocellulosic), hydrotreated, C8-16-
branched, cyclic and linear (PMN P-11-330, CAS No. 1267611-14-2);
distillates (lignocellulosic), hydrotreated, C8-26--branched, cyclic,
and linear (PMN P-11-331, CAS No. 1267611-11-9); and residual oils
(lignocellulosic), hydrotreated, C20-40- branched, cyclic, and linear
(PMN P-11-332, CAS No. 1267611-71-1)).
(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) through (h) and (k) are applicable to manufacturers,
importers, and processors of this substance.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
0
8. Add Sec. 721.10615 to subpart E to read as follows:
Sec. 721.10615 Kerosene (lignocellulosic), hydrotreated, C8-16-
branched, cyclic and linear.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as kerosene
(lignocellulosic), hydrotreated, C8-16-branched, cyclic and linear (PMN
P-11-330, CAS No. 1267611-14-2) is subject to reporting under this
section for the significant new uses described in paragraph (a)(2) of
this section.
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(1), (a)(3), (a)(4), (a)(6), (b) (concentration set at 0.1
percent), and (c). The following NIOSH-approved respirators with an APF
of 10,000 meet the minimum requirements for Sec. 721.63(a)(4): Any
NIOSH-certified pressure-demand or other positive pressure mode (e.g.,
open/closed circuit) self-contained breathing apparatus (SCBA) equipped
with a hood or helmet or a full facepiece.
(A) As an alternative to the respiratory requirements listed in
paragraph (a)(2)(i), a manufacturer, importer, or processor may choose
to follow the new chemical exposure limit (NCEL) provisions listed in
the TSCA section 5(e) consent order for this substance. The NCEL is
0.32 milligram/cubic meter (mg/m\3\) as an 8-hour time-weighted
average. Persons who wish to pursue NCELs as an alternative to the
Sec. 721.63 respirator requirements may request to do so under Sec.
721.30. Persons whose Sec. 721.30 requests to use the NCELs approach
are approved by EPA will receive NCELs provisions comparable to those
contained in the corresponding section 5(e) consent order.
(B) [Reserved]
(ii) Hazard communication program. Requirements as specified in
Sec. 721.72(a), (b), (c), (d), (e)(concentration set at 0.1 percent),
(f), and (g).
(iii) Release to water. Requirements as specified in Sec. 721.90
(a)(4), (b)(4), and (c)(4) (Where N=5, and 5 is an aggregate of
releases for the following substances: distillates (lignocellulosic),
C5-40 (PMN P-11-327, CAS No. 1267611-99-3); paraffin waxes
(lignocellulosic) hydrotreated, C5-40--branched, cyclic and linear (PMN
P-11-328, CAS No. 1267611-06-2); naphtha (lignocellulosic),
hydrotreated, C5-12-branched, cyclic and linear (PMN P-11-329, CAS No.
1267611-35-7); kerosene (lignocellulosic), hydrotreated, C8-16-
branched, cyclic and linear (PMN P-11-330, CAS No. 1267611-14-2);
distillates (lignocellulosic), hydrotreated, C8-26--branched, cyclic,
and linear (PMN P-11-331, CAS No. 1267611-11-9); and residual oils
(lignocellulosic), hydrotreated, C20-40- branched, cyclic, and linear
(PMN P-11-332, CAS No. 1267611-71-1)).
(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) through (h) and (k) are applicable to manufacturers,
importers, and processors of this substance.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
0
9. Add Sec. 721.10616 to subpart E to read as follows:
Sec. 721.10616 Distillates (lignocellulosic), hydrotreated, C8-26--
branched, cyclic, and linear.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as distillates
(lignocellulosic), hydrotreated, C8-26--branched, cyclic, and linear
(PMN P-11-331, CAS No. 1267611-11-9) is subject to reporting under this
section for the significant new uses described in paragraph (a)(2) of
this section.
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(1), (a)(3), (a)(4), (a)(6), (b) (concentration set at 0.1
percent), and (c). The following NIOSH-approved respirators with an APF
of 10,000 meet the minimum requirements for Sec. 721.63(a)(4): Any
NIOSH-certified pressure-demand or other positive pressure mode (e.g.,
open/closed circuit) self-contained breathing apparatus (SCBA) equipped
with a hood or helmet or a full facepiece.
(A) As an alternative to the respiratory requirements listed in
paragraph (a)(2)(i), a manufacturer, importer, or processor may choose
to follow the new chemical exposure limit (NCEL) provisions listed in
the TSCA section 5(e) consent order for this substance. The NCEL is
0.32 milligram/cubic meter (mg/m\3\) as an 8-hour time-weighted
average. Persons who wish to pursue NCELs as an alternative to the
Sec. 721.63 respirator requirements may request to do so under Sec.
721.30. Persons whose Sec. 721.30 requests to use the NCELs approach
are approved by EPA will receive NCELs provisions comparable to those
contained in the corresponding section 5(e) consent order.
(B) [Reserved]
(ii) Hazard communication program. Requirements as specified in
Sec. 721.72(a), (b), (c), (d), (e)(concentration set at 0.1 percent),
(f), and (g).
(iii) Release to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4), and (c)(4) (Where N=5, and 5 is an aggregate of
releases for the following substances: distillates (lignocellulosic),
C5-40 (PMN P-11-327, CAS No. 1267611-99-3); paraffin waxes
(lignocellulosic) hydrotreated, C5-40--branched, cyclic and linear (PMN
P-11-328, CAS No. 1267611-06-2); naphtha (lignocellulosic),
hydrotreated, C5-12-branched, cyclic and linear (PMN P-11-329, CAS No.
1267611-35-7); kerosene (lignocellulosic), hydrotreated, C8-16-
branched, cyclic and linear (PMN P-11-330, CAS No. 1267611-14-2);
distillates (lignocellulosic), hydrotreated, C8-26--branched, cyclic,
and linear (PMN P-11-331, CAS No. 1267611-11-9); and
[[Page 66162]]
residual oils (lignocellulosic), hydrotreated, C20-40- branched,
cyclic, and linear (PMN P-11-332, CAS No. 1267611-71-1)).
(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) through (h) and (k) are applicable to manufacturers,
importers, and processors of this substance.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
0
10. Add Sec. 721.10617 to subpart E to read as follows:
Sec. 721.10617 Residual oils (lignocellulosic), hydrotreated, C20-40-
branched, cyclic, and linear.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as residual oils
(lignocellulosic), hydrotreated, C20-40- branched, cyclic, and linear
(PMN P-11-332, CAS No. 1267611-71-1) is subject to reporting under this
section for the significant new uses described in paragraph (a)(2) of
this section.
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(1), (a)(3), (a)(4), (a)(6), (b) (concentration set at 0.1
percent), and (c). The following NIOSH-approved respirators with an APF
of 10,000 meet the minimum requirements for Sec. 721.63(a)(4): Any
NIOSH-certified pressure-demand or other positive pressure mode (e.g.,
open/closed circuit) self-contained breathing apparatus (SCBA) equipped
with a hood or helmet or a full facepiece.
(A) As an alternative to the respiratory requirements listed in
paragraph (a)(2)(i), a manufacturer, importer, or processor may choose
to follow the new chemical exposure limit (NCEL) provisions listed in
the TSCA section 5(e) consent order for this substance. The NCEL is
0.32 milligram/cubic meter (mg/m\3\) as an 8-hour time-weighted
average. Persons who wish to pursue NCELs as an alternative to the
Sec. 721.63 respirator requirements may request to do so under Sec.
721.30. Persons whose Sec. 721.30 requests to use the NCELs approach
are approved by EPA will receive NCELs provisions comparable to those
contained in the corresponding section 5(e) consent order.
(B) [Reserved]
(ii) Hazard communication program. Requirements as specified in
Sec. 721.72(a), (b), (c), (d), (e)(concentration set at 0.1 percent),
(f), and (g).
(iii) Release to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4), and (c)(4) (Where N=5, and 5 is an aggregate of
releases for the following substances: distillates (lignocellulosic),
C5-40 (PMN P-11-327, CAS No. 1267611-99-3); paraffin waxes
(lignocellulosic) hydrotreated, C5-40--branched, cyclic and linear (PMN
P-11-328, CAS No. 1267611-06-2); naphtha (lignocellulosic),
hydrotreated, C5-12-branched, cyclic and linear (PMN P-11-329, CAS No.
1267611-35-7); kerosene (lignocellulosic), hydrotreated, C8-16-
branched, cyclic and linear (PMN P-11-330, CAS No. 1267611-14-2);
distillates (lignocellulosic), hydrotreated, C8-26--branched, cyclic,
and linear (PMN P-11-331, CAS No. 1267611-11-9); and residual oils
(lignocellulosic), hydrotreated, C20-40- branched, cyclic, and linear
(PMN P-11-332, CAS No. 1267611-71-1)).
(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) through (h) and (k) are applicable to manufacturers,
importers, and processors of this substance.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
0
11. Add Sec. 721.10618 to subpart E to read as follows:
Sec. 721.10618 Polyaromatic organophosphorus compound (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
polyaromatic organophosphorus compound (PMN P-11-607) is subject to
reporting under this section for the significant new uses described in
paragraph (a)(2) of this section. The requirements of this rule do not
apply to quantities of the PMN substance after it has been embedded in
a solid polymer matrix.
(2) The significant new uses are:
(i) Hazard communication program. Requirements as specified in
Sec. 721.72(a), (b), (c). (d), (e), (f), (g)(3)(i), (g)(3)(ii), and
(g)(4)(iii).
(ii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(j) and (q).
(iii) Release to water. Requirements as specified in Sec.
721.90(a)(1), (b)(1), and (c)(1).
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph.
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a), (b), (c), (f), (g), (h), (i) and (k) are applicable to
manufacturers, importers, and processors of this substance.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
(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. 721.10619 to subpart E to read as follows:
Sec. 721.10619 Perfluoroalkylethyl methacrylate copolymer (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
perfluoroalkylethyl methacrylate copolymer (PMN P-11-653) 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, import, 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
Material Safety Data Sheet (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, imported,
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) within 90 days from the time the
[[Page 66163]]
employer becomes aware of the new information.
(ii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(p)(any amount after September 30, 2014).
(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), and (i) are applicable to
manufacturers, importers, and processors of this substance.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
0
13. Add Sec. 721.10620 to subpart E to read as follows:
Sec. 721.10620 Oxirane, 2,2'-(phenylene)bis-.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as oxirane, 2,2'-
(phenylene)bis- (PMN P-12-191, CAS No. 30424-08-9) is subject to
reporting under this section for the significant new uses described in
paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(j)(distribution of chemical substance with
less than or equal to 5 percent impurities).
(ii) Release to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4), and (c)(4) (N= 10).
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph.
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a), (b), (c), (i), and (k) are applicable to manufacturers,
importers, and processors of this substance,
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this significant new use rule.
0
14. Add Sec. 721.10621 to subpart E to read as follows:
Sec. 721.10621 Distillation bottoms, alkylated benzene by-product
(generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
distillation bottoms, alkylated benzene by-product (PMN P-12-196) is
subject to reporting under this section for the significant new uses
described in paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Release to Water. Requirements as specified in Sec.
721.90(a)(4), (b)(4), and (c)(4) (N= 1).
(ii) [Reserved]
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph.
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a), (b), (c), and (k) are applicable to manufacturers,
importers, and processors of this substance.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
0
15. Add Sec. 721.10622 to subpart E to read as follows:
Sec. 721.10622 Copper(2+), tetraammine-, chloride (1:2).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as copper(2+),
tetraammine-, chloride (1:2) (PMN P-12-285, CAS No. 10534-87-9) is
subject to reporting under this section for the significant new uses
described in paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Release to Water. Requirements as specified in Sec.
721.90(a)(4), (b)(4), and (c)(4) (N= 3).
(ii) [Reserved]
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph.
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a), (b), (c), and (k) are applicable to manufacturers,
importers, and processors of this substance.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
0
16. Add Sec. 721.10623 to subpart E to read as follows:
Sec. 721.10623 Vinylidene ester (generic).
(a) Chemical substances and significant new uses subject to
reporting. (1) The chemical substances identified generically as
vinylidene ester (PMNs P-12-298 and P-12-299) 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) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(s)(20,000 kilograms of the aggregate of
the two chemical substances).
(ii) [Reserved]
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph.
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a), (b), (c), and (i) are applicable to manufacturers,
importers, and processors of this substance.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
0
17. Add Sec. 721.10624 to subpart E to read as follows:
Sec. 721.10624 Dicyclohexylmethane-4,4'-diisocyanate, polymer with
ethoxylated, propoxylated polyethers (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
dicyclohexylmethane-4,4'-diisocyanate, polymer with ethoxylated,
propoxylated polyethers (PMN P-12-326) is subject to reporting under
this section for the significant new uses described in paragraph (a)(2)
of this section.
(2) The significant new uses are:
(i) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(j) (manufacture, processing, or use where
the molecular weight is 1000 daltons or more).
(ii) [Reserved]
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph.
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a), (b), (c), and (i) are applicable to manufacturers,
importers, and processors of this substance.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
0
18. Add Sec. 721.10625 to subpart E to read as follows:
Sec. 721.10625 Distillation bottoms, alkylated benzene by-product,
brominated and bromo diphenyl alkane (generic).
(a) Chemical substances and significant new uses subject to
reporting. (1) The chemical substances identified generically as
distillation bottoms, alkylated benzene by-product, brominated and
bromo diphenyl alkane (PMNs P-12-332 and P-12-333) 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) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(j)(feed for a bromine recovery unit).
(ii) [Reserved]
[[Page 66164]]
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph.
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a), (b), (c), and (i) are applicable to manufacturers,
importers, and processors of this substance.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
(3) Determining whether a specific use is subject to this section.
The provisions of Sec. 721.1725(b)(1) apply to paragraph (a)(2)(i) of
this section.
0
19. Add Sec. 721.10626 to subpart E to read as follows:
Sec. 721.10626 1,4-Butanediol, polymer with substituted alkane and
substituted methylene biscarbomonocycle, 2-hydroxyalkyl acrylate-
blocked (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as 1,4-
butanediol, polymer with substituted alkane and substituted methylene
biscarbomonocycle, 2-hydroxyalkyl acrylate-blocked (PMN P-12-373) is
subject to reporting under this section for the significant new uses
described in paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(o) and (y)(1).
(ii) [Reserved]
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph.
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a), (b), (c), and (i) are applicable to manufacturers,
importers, and processors of this substance.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
0
20. Add Sec. 721.10627 to subpart E to read as follows:
Sec. 721.10627 Yttrium borate phosphate vanadate with europium and
additional dopants (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as yttrium
borate phosphate vanadate with europium and additional dopants (PMN P-
12-430) is subject to reporting under this section for the significant
new uses described in paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(j) and (s).
(ii) [Reserved]
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph.
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a), (b), (c), and (i) are applicable to manufacturers,
importers, and processors of this substance.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
(3) Determining whether a specific use is subject to this section.
The provisions of Sec. 721.1725(b)(1) apply to paragraph (a)(2)(i) of
this section.
0
21. Add Sec. 721.10628 to subpart E to read as follows:
Sec. 721.10628 Mixed metal oxalate (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as mixed
metal oxalate (PMN P-12-432) is subject to reporting under this section
for the significant new uses described in paragraph (a)(2) of this
section.
(2) The significant new uses are:
(i) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(j) and (s).
(ii) [Reserved]
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph.
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a), (b), (c), and (i) are applicable to manufacturers,
importers, and processors of this substance.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
(3) Determining whether a specific use is subject to this section.
The provisions of Sec. 721.1725(b)(1) apply to paragraph (a)(2)(i) of
this section.
[FR Doc. 2012-26658 Filed 11-1-12; 8:45 am]
BILLING CODE 6560-50-P