[Federal Register Volume 80, Number 21 (Monday, February 2, 2015)]
[Rules and Regulations]
[Pages 5457-5471]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-01721]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Parts 9 and 721
[EPA-HQ-OPPT-2014-0714; FRL-9919-68]
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 27 chemical substances
which were the subject of premanufacture notices (PMNs). Two of these
chemical substances are subject to TSCA section 5(e) consent orders
issued by EPA. This action requires persons who intend to manufacture
(including import) or process any of these 27 chemical substances for
an activity that is designated as a significant new use by this rule to
notify EPA at least 90 days before commencing that activity. The
required notification will provide EPA with the opportunity to evaluate
the intended use and, if necessary, to prohibit or limit that activity
before it occurs.
DATES: This rule is effective on April 3, 2015. For purposes of
judicial review, this rule shall be promulgated at 1 p.m. (e.s.t.) on
February 17, 2015.
Written adverse or critical comments, or notice of intent to submit
adverse or critical comments, on one or more of these SNURs must be
received on or before March 4, 2015 (see Unit VI. of the SUPPLEMENTARY
INFORMATION). If EPA receives written adverse or critical comments, or
notice of intent to submit adverse or critical comments, on one or more
of these SNURs before March 4, 2015, EPA will withdraw the relevant
sections of this direct final rule before its effective date.
For additional information on related reporting requirement dates,
see Units I.A., VI., and VII. of the SUPPLEMENTARY INFORMATION.
[[Page 5458]]
ADDRESSES: Submit your comments, identified by docket identification
(ID) number EPA-HQ-OPPT-2014-0714, by one of the following methods:
Federal eRulemaking Portal: http://www.regulations.gov.
Follow the online instructions for submitting comments. Do not submit
electronically any information you consider to be Confidential Business
Information (CBI) or other information whose disclosure is restricted
by statute.
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: To make special arrangements for hand
delivery or delivery of boxed information, please follow the
instructions at http://www.epa.gov/dockets/contacts.html. Additional
instructions on commenting or visiting the docket, along with more
information about dockets generally, are available at http://www.epa.gov/dockets.
FOR FURTHER INFORMATION CONTACT:
For technical information contact: Kenneth Moss, Chemical Control
Division (7405 M), Office of Pollution Prevention and Toxics,
Environmental Protection Agency, 1200 Pennsylvania Ave. NW.,
Washington, DC 20460-0001; telephone number: (202) 564-9232; email
address: [email protected].
For general information contact: The TSCA-Hotline, ABVI-Goodwill,
422 South Clinton Ave., Rochester, NY 14620; telephone number: (202)
554-1404; email address: [email protected].
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this action apply to me?
You may be potentially affected by this action if you manufacture,
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 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 a proposed or final rule are subject
to the export notification provisions of TSCA section 12(b) (15 U.S.C.
2611(b)) (see Sec. [emsp14]721.20), and must comply with the export
notification requirements in 40 CFR part 707, subpart D.
B. What should I consider as I prepare my comments for EPA?
1. Submitting CBI. Do not submit this information to EPA through
regulations.gov or email. Clearly mark the part or all of the
information that you claim to be CBI. For CBI information in a disk or
CD-ROM that you mail to EPA, mark the outside of the disk or CD-ROM as
CBI and then identify electronically within the disk or CD-ROM the
specific information that is claimed as CBI. In addition to one
complete version of the comment that includes information claimed as
CBI, a copy of the comment that does not contain the information
claimed as CBI must be submitted for inclusion in the public docket.
Information so marked will not be disclosed except in accordance with
procedures set forth in 40 CFR part 2.
2. Tips for preparing your comments. When preparing and submitting
your comments, see the commenting tips at http://www.epa.gov/dockets/comments.html.
II. Background
A. What action is the agency taking?
EPA is promulgating these SNURs using direct final procedures.
These SNURs will require persons to notify EPA at least 90 days before
commencing the manufacture or processing of a chemical substance for
any activity designated by these SNURs as a significant new use.
Receipt of such notices allows EPA to assess risks that may be
presented by the intended uses and, if appropriate, to regulate the
proposed use before it occurs. Additional rationale and background to
these rules are more fully set out in the preamble to EPA's first
direct final SNUR published in the Federal Register issue of April 24,
1990 (55 FR 17376). Consult that preamble for further information on
the objectives, rationale, and procedures for SNURs and on the basis
for significant new use designations, including provisions for
developing test data.
B. What is the agency's authority for taking this action?
Section 5(a)(2) of TSCA (15 U.S.C. 2604(a)(2)) authorizes EPA to
determine that a use of a chemical substance is a ``significant new
use.'' EPA must make this determination by rule after considering all
relevant factors, including the four bulleted TSCA section 5(a)(2)
factors listed in Unit III. Once EPA determines that a use of a
chemical substance is a significant new use, TSCA section 5(a)(1)(B)
requires persons to submit a significant new use notice (SNUN) to EPA
at least 90 days before they manufacture or process the chemical
substance for that use. Persons who must report are described in Sec.
721.5.
C. Applicability of General Provisions
General provisions for SNURs appear in 40 CFR part 721, subpart A.
These provisions describe persons subject to the rule, recordkeeping
requirements, exemptions to reporting requirements, and applicability
of the rule to uses occurring before the effective date of the rule.
Provisions relating to user fees appear at 40 CFR part 700. According
to Sec. [emsp14]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 sections 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
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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 27
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 27 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 the basis
for the TSCA non-section 5(e) SNURs (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 two PMN substances (P-12-17 and P-13-573) that
are subject to ``risk-based'' consent orders under TSCA section
5(e)(1)(A)(ii)(I) where EPA determined that activities associated with
the PMN substances may present unreasonable risk to human health or the
environment. Those consent orders require protective measures to limit
exposures or otherwise mitigate the potential unreasonable risk. The
so-called ``section 5(e) SNURs'' on these PMN substances are
promulgated pursuant to Sec. [emsp14]721.160, and are based on and
consistent with the provisions in the underlying consent orders. The
section 5(e) SNURs designate as a ``significant new use'' the absence
of the protective measures required in the corresponding consent
orders.
Where EPA determined that the PMN substance may present an
unreasonable risk of injury to human health via inhalation exposure,
the underlying TSCA section 5(e) consent order usually requires, among
other things, that potentially exposed employees wear specified
respirators unless actual measurements of the workplace air show that
air-borne concentrations of the PMN substance are below a New Chemical
Exposure Limit (NCEL) that is established by EPA to provide adequate
protection to human health. In addition to the actual NCEL
concentration, the comprehensive NCELs provisions in TSCA section 5(e)
consent orders, which are modeled after Occupational Safety and Health
Administration (OSHA) Permissible Exposure Limits (PELs) provisions,
include requirements addressing performance criteria for sampling and
analytical methods, periodic monitoring, respiratory protection, and
recordkeeping. However, no comparable NCEL provisions currently exist
in 40 CFR part 721, subpart B, for SNURs. Therefore, for these cases,
the individual SNURs in 40 CFR part 721, subpart E, will state that
persons subject to the SNUR who wish to pursue NCELs as an alternative
to the Sec. 721.63 respirator requirements may request to do so under
Sec. [emsp14]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 25 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. [emsp14]721.170.
EPA has determined that every activity designated as a ``significant
new use'' in all non-section 5(e) SNURs issued under Sec.
[emsp14]721.170 satisfies the two requirements stipulated in Sec.
721.170(c)(2), i.e., these significant new use activities 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 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-12-17
Chemical name: Phosphoric acid, iron (2+) lithium salt (1:1:1).
CAS number: 15365-14-7.
Effective date of TSCA section 5(e) consent order: May 27, 2014.
Basis for TSCA section 5(e) consent order: The PMN states that the
generic (non-confidential) use of the PMN will be as electrode
components. Based on test data on analogous respirable, poorly soluble
particulates, EPA identified concerns for lung overload. Further, based
on lithium (about 5 percent of the molecular weight of the PMN), EPA
identified concerns for neurotoxicity, developmental toxicity, and
immunotoxicity. The Order was issued under TSCA sections 5(e)(1)(A)(i)
and 5(e)(1)(A)(ii)(I) based on a finding that the substance may present
an unreasonable risk of injury to human health, the substance may be
produced in substantial quantities and may reasonably be anticipated to
enter the environment in substantial quantities, and there may be
significant (or substantial) human exposure to the substance. To
protect against these risks, the consent order requires:
1. Risk notification. If as a result of the test data required, the
company becomes aware that the PMN substance may present a risk of
injury to human health, the company must incorporate this new
information, and any information on methods for protecting against such
risk into a Material Safety Data Sheet (MSDS), within 90 days.
2. Use of personal protective equipment including a National
Institute of Occupational Safety and Health (NIOSH)-certified
respirator with an assigned protection factor (APF) of at least 10 or
compliance with a NCEL of 2.4 milligram/meter\3\ (mg/m\3\) as an 8-hour
time-weighted average (when there is potential inhalation exposure),
when there is potential inhalation exposure.
3. Submission of certain testing prior to exceeding the
confidential
[[Page 5460]]
production volume limits of the PMN substance specified in the consent
order.
The SNUR designates as a ``significant new use'' the absence of
these protective measures.
Recommended testing: EPA has determined that the test data from
certain human health testing identified in the consent order would help
characterize possible health effects of the substance. The company has
agreed not to exceed the first confidential production limit without
performing a 90-day inhalation toxicity test (OPPTS Test Guideline
870.3465) in rats, with special attention to histopathology as
described in the consent order. If the results of the 90-day inhalation
toxicity test indicates the potential for carcinogenicity, then the
submitter has agreed not to exceed the second confidential production
limit without performing a carcinogenicity test (OPPTS Test Guideline
870.4200) in rats via the inhalation route.
CFR citation: 40 CFR 721.10793.
PMN Numbers P-13-212 and P-13-213
Chemical names: Alkenyl succinate, amine salts (generic).
CAS numbers: Claimed confidential.
Basis for action: The PMNs state that the use of the substances
will be as metalworking fluid additives. Based on test data on
analogous anionic surfactants, EPA predicts toxicity to aquatic
organisms may occur at concentrations that exceed 3 parts per billion
(ppb) in aggregate of the PMN substances 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 substances to
surface water exceed releases from the use described in the PMNs. For
the use described in the PMNs, environmental releases of the substances
did not exceed 3 ppb for more than 20 days per year. 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 result in significant adverse environmental effects. Based on this
information, the PMN substances meet the concern criteria at Sec.
721.170(b)(4)(ii).
Recommended Testing: EPA has determined that 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
Guideline 850.4500), would help characterize the environmental effects
of the PMN substances.
CFR citation: 40 CFR 721.10794.
PMN Number P-13-559
Chemical name: Amine salt of vegetable oil, polymer with
cycloaliphatic glycol, hydroxy substituted carboxylic acid, aliphatic
diisocyanate and tetra hydroxyalkane (generic).
CAS number: Claimed confidential.
Basis for action: The PMN states that the use of the substance will
be as a wood sealer or concrete sealer. Based on ecological structure
activity relationship (SAR) analysis of test data on polyamphoteric
polymers, EPA predicts toxicity to aquatic organisms may occur at
concentrations that exceed 60 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 of
the substances did not exceed 60 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 use of the substance other than
as described in the PMN may result in significant adverse environmental
effects. Based on this information, the PMN substance meets the concern
criteria at Sec. 721.170(b)(4)(ii).
Recommended testing: EPA has determined that the results of a fish
acute toxicity test (OPPTS Test Guideline 850.1075); an aquatic
invertebrate acute toxicity test (OPPTS Test Guideline 850.1010); and
an algal toxicity test (OCSPP Test Guideline 850.4500) would help
characterize the environmental effects of the PMN substance.
CFR citation: 40 CFR 721.10795.
PMN Number P-13-573
Chemical name: Polymer of terephthalic acid and ethyl benzene with
multi-walled carbon nanotube (generic).
CAS number: Claimed confidential.
Effective date of TSCA section 5(e) consent order: April 16, 2014.
Basis for TSCA section 5(e) consent order: The PMN states that the
generic (non-confidential) use of the PMN will be as dispersing agents
for various resin systems, such as thermosets, elastomers,
thermoplastics and solvents and water. Based on test data on analogous
respirable, poorly soluble particulates, EPA identified concerns for
immunotoxicity, oncogenicity, and mutagenicity. Further, based on the
agglomeration potential of carbon nanotubes, EPA identified concerns
for environmental releases to water where the PMN may combine with
dissolved organic matter to form stable aqueous suspensions. The Order
was issued under TSCA sections 5(e)(1)(A)(i) and 5(e)(1)(A)(ii)(I),
based on a finding that the 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. To
protect against these risks, the consent order requires:
1. Use of personal protective equipment involving impervious gloves
and protective clothing (where there is a potential for dermal
exposure) and a NIOSH-certified respirator with N-100, P-100, or R-100
cartridges (where there is a potential for inhalation exposure).
2. Submission of certain physical-chemical data for the PMN
substance within nine months of signing of the consent order.
3. Submission of certain human health testing prior to exceeding
the confidential production volume limit specified in the consent
order.
4. Processing and use of the PMN substance only for the
confidential use specified in the consent order.
5. No use of the substance resulting in releases to surface waters.
The SNUR would designate as a ``significant new use'' the absence
of these protective measures.
Recommended testing: EPA has determined that the development of
data on certain physical-chemical properties, as well as certain human
health and environmental toxicity testing would help characterize
possible effects of the substance. The submitter has agreed to provide
the physical/chemical properties data within the specified time limit.
In addition, the submitter has agreed not to exceed the confidential
production limit without performing a 90-day inhalation toxicity test
(OPPTS Test Guideline 870.3465 or
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Organisation for Economic Co-operation and Development (OECD) Test
Guideline 413) in rats with a post-exposure observation period of up to
3 months (including BALF analysis, a determination of cardiovascular
toxicity (clinically-based blood/plasma protein analyses), and
histopathology of the heart). Although the order does not require the
results of a fish early-life stage toxicity test (OPPTS Test Guideline
850.1400), a chronic daphnid toxicity test (OPPTS Test Guideline
850.1300), and an algal toxicity test (OCSPP Test Guideline 850.4500)
at any specified time or volume, the Order's restrictions on
manufacture, processing, distribution in commerce, and disposal will
remain in effect until the Order is modified or revoked by EPA based on
submission of this or other relevant information.
CFR citation: 40 CFR 721.10796.
PMN Number P-13-674
Chemical name: Polycarbamoylsulfonic acid sodium salt (generic).
CAS number: Claimed confidential.
Basis for action: The PMN states that the use of the substance will
be for leather processing. Based on test data of the PMN substance, EPA
predicts toxicity to aquatic organisms may occur at concentrations that
exceed 11 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 exceeding 11 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 that results in releases to
surface waters exceeding 11 ppb may result in significant adverse
environmental effects. Based on this information, the PMN substance
meets the concern criteria at Sec. 721.170(b)(4)(i).
Recommended testing: EPA has determined that the results of a fish
early-life stage toxicity test (OPPTS Test Guideline 850.1400) and a
daphnid chronic toxicity test (OPPTS Test Guideline 850.1300) would
help characterize the environmental effects of the PMN substance.
CFR citation: 40 CFR 721.10797.
PMN Number P-13-864
Chemical name: Phosphonic acid chloride, diester (generic).
CAS number: Claimed confidential.
Basis for action: The PMN states that the generic use of the
substance will be as a chemical intermediate. Based on ecological SAR
analysis of test data on analogous esters, EPA predicts toxicity to
aquatic organisms may occur at concentrations that exceed 5 ppb of the
PMN substance in surface waters. As described in the PMN, releases of
the substance are not expected to result in surface water
concentrations exceeding 5 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 that results in releases to surface waters exceeding 5
ppb may result in significant adverse environmental effects. Based on
this information, the PMN substance meets the concern criteria at Sec.
721.170(b)(4)(ii).
Recommended testing: EPA has determined that the results of a fish
acute toxicity test (OPPTS Test Guideline 850.1075); an aquatic
invertebrate acute toxicity test (OPPTS Test Guideline 850.1010); and
an algal toxicity test (OCSPP Test Guideline 850.4500) would help
characterize the environmental effects of the PMN substance.
CFR citation: 40 CFR 721.10798.
PMN Numbers P-13-874, P-13-875, P-13-876, and P-13-877
Chemical names: Substituted dimethyl phenols (generic).
CAS numbers: Claimed confidential.
Basis for action: The PMNs state that the generic use of the
substances will be as chemical intermediates. Based on ecological SAR
analysis of test data on analogous phenols, EPA predicts toxicity to
aquatic organisms may occur at concentrations that exceed 10 ppb of the
PMN substances P-13-874 or P-13-875, and 5 ppb of the PMN substances P-
13-876 or P-13-877, in surface waters. As described in the PMNs,
releases of the substances are not expected to result in surface water
concentrations exceeding 10 ppb in aggregate of the PMN P-13-874 and P-
13-875 substances or 5 ppb in aggregate of the PMN P-13-876 and P-13-
877 substances. 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 any use of the
substances that results in releases to surface waters exceeding 10 ppb
in aggregate of the PMN P-13-874 and P-13-875 substances or 5 ppb in
aggregate of the PMN P-13-876 and P-13-877 substances may result in
significant adverse environmental effects. Based on this information,
the PMN substances meet the concern criteria at Sec.
721.170(b)(4)(ii).
Recommended testing: EPA has determined that the results of a fish
acute toxicity test (OPPTS Test Guideline 850.1075); an aquatic
invertebrate acute toxicity test (OPPTS Test Guideline 850.1010); an
algal toxicity test (OCSPP Test Guideline 850.4500); and a ready
biodegradability test (OECD Test Guideline 301) on either P-13-874 or
P-13-875, would help characterize the environmental effects of these
two PMN substances. Further, 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); an algal
toxicity test (OCSPP Test Guideline 850.4500); and a ready
biodegradability test (OECD Test Guideline 301) on P-13-877 would help
characterize the environmental effects of P-13-876 and P-13-877.
CFR citation: 40 CFR 721.10799.
PMN Number P-13-931
Chemical name: 2-propenoic acid, 4-phenoxybutyl ester.
CAS number: 103969-85-3.
Basis for action: The PMN states that the use of the substance will
be a polymerizable component in adhesive formulations. Based on
ecological SAR analysis of test data on analogous acrylates, 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 exceeding 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 that results in releases to
surface waters exceeding 1 ppb may result in significant adverse
environmental effects. Based on this information, the PMN substance
meets the concern criteria at Sec. 721.170(b)(4)(ii).
Recommended testing: EPA has determined that the results of a water
solubility test (OECD Test Guideline 105) and a partition coefficient
(n-octanol/water) test, HPLC Method (OECD Test Guideline 117) would
help to characterize the physical-chemical properties of the PMN
substance. EPA recommends that this testing be performed first as the
results may mitigate the need for further testing or change the testing
recommendations. Depending upon the results of these data, EPA has
determined that the results of a fish acute toxicity test (OPPTS Test
Guideline 850.1075); an aquatic invertebrate acute toxicity test (OPPTS
Test Guideline 850.1010); and
[[Page 5462]]
an algal toxicity test (OCSPP Test Guideline 850.4500) would help
characterize the environmental effects of the PMN substance.
CFR citation: 40 CFR 721.10800.
PMN Number P-13-936
Chemical name: Organic phosphonate salt (generic).
CAS number: Claimed confidential.
Basis for action: The PMN states that the generic use of the
substance will be a contained use in energy production. Based on
ecological SAR analysis of test data on analogous polyanionic monomers,
EPA predicts toxicity to aquatic organisms may occur at concentrations
that exceed 130 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 exceeding 130 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 that results in
releases to surface waters exceeding 130 ppb may result in significant
adverse environmental effects. Based on this information, the PMN
substance meets the concern criteria at Sec. 721.170(b)(4)(ii).
Recommended testing: EPA has determined that the results of an
algal toxicity test (OCSPP Test Guideline 850.4500) and a modified
algal toxicity test with equivalent calcium ion amendments (OCSPP Test
Guideline 850.4500) would help characterize the environmental effects
of the PMN substance.
CFR citation: 40 CFR 721.10801.
PMN Number P-14-39
Chemical name: Quaternized protein/silicone copolymer (generic).
CAS number: Claimed confidential.
Basis for action: The PMN states that the generic use of the
substance will be as a fabric softener additive. Based on test data on
the PMN substance, as well as ecological SAR analysis of test data on
analogous amphoteric surfactants, EPA predicts toxicity to aquatic
organisms may occur at concentrations that exceed 31 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
exceeding 31 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 that results in releases to surface waters exceeding 31 ppb
may result in significant adverse environmental effects. Based on this
information, the PMN substance meets the concern criteria at Sec.
721.170(b)(4)(ii).
Recommended testing: EPA has determined that the results of a fish
acute toxicity test (OPPTS Test Guideline 850.1075); an aquatic
invertebrate acute toxicity test (OPPTS Test Guideline 850.1010); and
an algal toxicity test (OCSPP Test Guideline 850.4500) would help
characterize the environmental effects of the PMN substance.
CFR citation: 40 CFR 721.10802.
PMN Number P-14-70
Chemical name: 1,5-Pentanediamine.
CAS number: 462-94-2.
Basis for action: The PMN states that the uses of the substance
will be as a monomer for polyamides and as an ingredient to produce
metamethylene 1,5 diisocyanate. Based on ecological SAR analysis of
test data on analogous aliphatic amines, EPA predicts toxicity to
aquatic organisms may occur at concentrations that exceed 300 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 exceeding 300 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 that results in releases to surface waters
exceeding 300 ppb may result in significant adverse environmental
effects. Based on this information, the PMN substance meets the concern
criteria at Sec. 721.170(b)(4)(ii).
Recommended testing: EPA has determined that the results of a fish
acute toxicity test (OPPTS Test Guideline 850.1075); an aquatic
invertebrate acute toxicity test (OPPTS Test Guideline 850.1010); and
an algal toxicity test (OCSPP Test Guideline 850.4500) would help
characterize the environmental effects of the PMN substance.
CFR citation: 40 CFR 721.10803.
PMN Number P-14-110
Chemical name: Cashew-nutshell-liquid, polymer with formaldehyde,
reaction products with diethanolamine and diisopropanol amine.
CAS number: 1462343-28-7.
Basis for action: The PMN states that the generic use of the
substance will be as a polyol to be reacted with polyisocyanates to
create polyurethane foam. Based on ecological SAR analysis of test data
on analogous aliphatic amines, EPA predicts toxicity to aquatic
organisms may occur at concentrations that exceed 1 ppb of the PMN
substance in surface waters. As described in the PMN, releases of the
substance are not expected to result in surface water concentrations
exceeding 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 that results in releases to surface waters exceeding 1 ppb
may result in significant adverse environmental effects. Based on this
information, the PMN substance meets the concern criteria at Sec.
721.170(b)(4)(ii).
Recommended testing: EPA has determined that the results of a water
solubility test (OECD Test Guideline 105) and a partition coefficient
(n-octanol/water) test, high performance liquid chromotography (HPLC)
Method (OECD Test Guideline 117) would help to characterize the
physical-chemical properties of the PMN substance. EPA recommends that
this testing be performed first as the results may mitigate the need
for further testing or change the testing recommendations. Depending on
the results of these tests, EPA has determined that the results of a
fish early-life stage toxicity test (OPPTS Test Guideline 850.1400);
daphnid chronic toxicity test (OPPTS Test Guideline 850.1300); and an
algal toxicity test (OCSPP Test Guideline 850.4500) OR the sediment-
water chironomid life-cycle toxicity test using spiked water or spiked
sediment (OECD Test Guideline 233) and the ready biodegradability test
(OECD Test Guideline 301) would help characterize the environmental
effects of the PMN substance.
CFR citation: 40 CFR 721.10804.
PMN Numbers P-14-202, P-14-203, P-14-204, P-14-205, and P-14-206
Chemical names: Fatty acid imidazolines (generic).
CAS numbers: Claimed confidential.
Basis for action: The PMNs state that the generic use of the
substances will be as emulsifiers. Based on ecological SAR analysis of
test data on analogous aliphatic amines, EPA predicts toxicity to
aquatic organisms may occur at concentrations that exceed 1 ppb in
aggregate of the PMN substances P-14-202 and P-14-203 or 1 ppb in
aggregate of PMNs P-14-204, P-14-205, and P-14-206 in surface waters.
As described in the PMNs, releases of the substances are not expected
to result in surface water concentrations exceeding 1 ppb in aggregate
of P-14-202 and P-14-203 or
[[Page 5463]]
1 ppb in aggregate of PMNs P-14-204, P-14-205, and P-14-206. 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 any use of the substances that results in
releases to surface waters exceeding 1 ppb in aggregate of the PMN
substances P-14-202 and P-14-203 or 1 ppb in aggregate of PMNs P-14-
204, P-14-205, and P-14-206 may result in significant adverse
environmental effects. Based on this information, the PMN substances
meet the concern criteria at Sec. 721.170(b)(4)(ii).
Recommended testing: EPA has determined that a water solubility
test (OECD Test Guideline 105) and a partition coefficient (n-octanol/
water) test, HPLC Method (OECD Test Guideline 117) for P-14-202 and P-
14-204 would help to characterize the physical-chemical properties of
the PMN substances. EPA recommends that this testing be performed first
as the results may mitigate the need for further testing or change the
testing recommendations. Depending on the results of these tests, 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); an algal toxicity test (OCSPP Test
Guideline 850.4500); as well as either the fish acute toxicity
mitigated by humic acid test (OPPTS Test Guideline 850.1085) or the
whole sediment acute toxicity invertebrates, freshwater test (OPPTS
Test Guideline 850.1735) on P-14-202 and P-14-204 may help characterize
the environmental effects of the PMN substances. EPA also recommends
that the guidance document on aquatic toxicity testing of difficult
substances and mixtures (OECD Test Guideline 23) be followed to
facilitate solubility in the test media.
CFR citation: 40 CFR 721.10805.
PMN Number P-14-341
Chemical name: Trimellitic anhydride, polymer with alkanolamine and
tetrahydrophthalic anhydride (generic).
CAS number: Claimed confidential.
Basis for action: The PMN states that the use of the substance will
be as a binder for gluing the individual mineral fibres together to
form a firm product, used industrially in a closed system. Based on
test data on the PMN substance, the EPA identified human health
concerns regarding blood toxicity and uncertain concerns for liver and
kidney toxicity from exposure to the PMN substance via inhalation
exposure. As described in the PMN, exposure is expected to be minimal
for this use. Therefore, EPA has not determined that the proposed
manufacturing, processing, or use of the substance may present an
unreasonable risk. EPA has determined, however, that any use of the
substance other than as listed 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)(3)(i).
Recommended testing: EPA has determined that the results of a
combined repeated dose toxicity study with the reproductive/
developmental toxicity screening test (OECD Test Guideline 422) would
help characterize the human health effects of the PMN substance.
CFR citation: 40 CFR 721.10806.
PMN Number P-14-417
Chemical name: Aliphatic ether ethyl alcohol (generic).
CAS number: Claimed confidential.
Basis for action: The PMN states that the generic (non-
confidential) use of the substance will be as a solvent for ink. Based
on test data on analogous ethylene glycol ethers, EPA identified
concerns for blood, liver, and kidney toxicity, immunotoxicity,
neurotoxicity, and developmental and reproductive toxicity to humans
exposed to the PMN substance. Because of the use described in the PMN,
significant dermal, inhalation and drinking water exposures are not
expected for the worker, the general population, or consumer.
Therefore, EPA has not determined that the proposed manufacturing,
processing, or use of the substance may present an unreasonable risk.
EPA has determined, however, that use of the substance other than as
described in the PMN 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 the
combined repeated dose toxicity study, with the reproduction/
developmental toxicity screening test (OECD Test Guideline 422) would
help characterize the health effects of the PMN substance.
CFR citation: 40 CFR 721.10807.
PMN Number P-14-513
Chemical name: Bisxylenol diglycidyl ether polymer (generic).
CAS number: Claimed confidential.
Basis for action: The PMN states that the generic (non-
confidential) use of the substance will be as a chemical intermediate.
Based on ecological SAR analysis of test data on analogous
polyepoxides, 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 (OCSPP Test Guideline 850.4500) would help
characterize the environmental effects of the PMN substance.
CFR citation: 40 CFR 721.10808.
PMN Number P-14-518
Chemical name: Cyclotetrasiloxane, 2,4,6,8-tetrakis[3-[2-(2-
methoxyethoxy)ethoxy]propyl]-2,4,6,8-tetramethyl-.
CAS number: 17232-95-0.
Basis for action: The PMN states that the substance will be used in
the preparation of a triethyleneoxy-terminated polymer. Based on
ecological SAR analysis of test data on analogous neutral organic
chemicals, EPA predicts toxicity to aquatic organisms may occur at
concentrations that exceed 8 ppb of the PMN substance in surface
waters. As described in the PMN, releases of the substance are not
expected to result in surface water concentrations that exceed 8 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 8 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 (OCSPP Test Guideline 850.4500) would help
characterize the environmental effects of the PMN substance. EPA also
[[Page 5464]]
recommends that the guidance document on aquatic toxicity testing of
difficult substances and mixtures (OECD Test Guideline 23) be followed
to facilitate solubility of the PMN substance in the test media.
CFR citation: 40 CFR 721.10809.
PMN Number P-14-544
Chemical name: Heterocyclic amine potassium salt (generic).
CAS number: Claimed confidential.
Basis for action: The PMN states that the generic (non-
confidential) use of the substance will be as a dishing reducer. Based
on ecological SAR analysis of test data on structurally similar
substances, EPA predicts toxicity to aquatic organisms may occur at
concentrations that exceed 250 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 either (1)
releases of the PMN substance to surface water, from uses other than as
described in the PMN, exceed releases from the use described in the PMN
or (2) the production volume increases beyond the confidential
production volume described in the PMN. For the use and production
volume described in the PMN, environmental releases did not exceed 250
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
use of the substance other than as described in the PMN, or any
increase in the annual production volume could result in exposures
which may cause significant adverse environmental effects. Based on
this information, the PMN substance meets the concern criteria at Sec.
721.170(b)(4)(ii).
Recommended testing: EPA has determined that the results of a ready
biodegradability test (OECD Test Guideline 301); a fish early-life-
stage toxicity test (OPPTS Test Guideline 850.1400); a daphnid chronic
toxicity test (OPPTS Test Guideline 850.1300); and an algal toxicity
test (OCSPP Test Guideline 850.4500) would help to characterize the
environmental effects of the PMN substance.
CFR citation: 40 CFR 721.10810.
PMN Number P-14-618
Chemical name: Heterocyclic amine substituted acrylamide (generic).
CAS number: Claimed confidential.
Basis for action: The PMN states that the substance will be used as
a monomer for use in the manufacture of a polymer or for export. Based
on ecological SAR analysis of test data on analogous acrylamides, EPA
predicts toxicity to aquatic organisms may occur at concentrations that
exceed 23 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 23 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 23 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); an algal
toxicity test (OCSPP Test Guideline 850.4500); and a ready
biodegradability test (OECD Test Guideline 301) would help characterize
the environmental effects of the PMN substance.
CFR citation: 40 CFR 721.10811.
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 2 of the 27
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 VI.).
In the other 25 cases, where the uses are not regulated under a
TSCA section 5(e) consent order, EPA determined that one or more of the
criteria of concern established at Sec. [emsp14]721.170 were met, as
discussed in Unit IV.
B. Objectives
EPA is issuing these SNURs for specific chemical substances which
have undergone premanufacture review because the Agency wants to
achieve the following objectives with regard to the significant new
uses designated in this rule:
EPA will receive notice of any person's intent to
manufacture or process a listed chemical substance for the described
significant new use before that activity begins.
EPA will have an opportunity to review and evaluate data
submitted in a SNUN before the notice submitter begins manufacturing or
processing a listed chemical substance for the described significant
new use.
EPA will be able to regulate prospective manufacturers or
processors of a listed chemical substance before the described
significant new use of that chemical substance occurs, provided that
regulation is warranted pursuant to TSCA sections 5(e), 5(f), 6, or 7.
EPA will ensure that all manufacturers and processors of
the same chemical substance that is subject to a TSCA section 5(e)
consent order are subject to similar requirements.
Issuance of a SNUR for a chemical substance does not signify that
the chemical substance is listed on the TSCA Chemical Substance
Inventory (TSCA Inventory). Guidance on how to determine if a chemical
substance is on the TSCA Inventory is available on the Internet at
http://www.epa.gov/opptintr/existingchemicals/pubs/tscainventory/index.html.
VI. Direct Final Procedures
EPA is issuing these SNURs as a direct final rule, as described in
Sec. 721.160(c)(3) and Sec. 721.170(d)(4). In accordance with Sec.
[emsp14]721.160(c)(3)(ii) and Sec. 721.170(d)(4)(i)(B), the effective
date of this rule is April 3, 2015 without further notice, unless EPA
receives written adverse or critical comments, or notice of intent to
submit adverse or critical comments before March 4, 2015.
If EPA receives written adverse or critical comments, or notice of
intent to submit adverse or critical comments, on one or more of these
SNURs before March 4, 2015, 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
[[Page 5465]]
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 the Significant New Use Designation
To establish a significant new use, EPA must determine that the use
is not ongoing. The chemical substances subject to this rule have
undergone premanufacture review. In cases where EPA has not received a
notice of commencement (NOC) and the chemical substance has not been
added to the TSCA Inventory, no person may commence such activities
without first submitting a PMN. Therefore, for chemical substances for
which an NOC has not been submitted EPA concludes that the designated
significant new uses are not ongoing.
When chemical substances identified in this rule are added to the
TSCA Inventory, EPA recognizes that, before the rule is effective,
other persons might engage in a use that has been identified as a
significant new use. However, TSCA section 5(e) consent orders have
been issued for 2 of the 27 chemical substances, and the PMN submitters
are prohibited by the TSCA section 5(e) consent orders from undertaking
activities which would be designated as significant new uses. The
identities of 22 of the 27 chemical substances subject to this rule
have been claimed as confidential and EPA has received no post-PMN bona
fide submissions (per Sec. Sec. 720.25 and 721.11). Based on this, the
Agency believes that it is highly unlikely that any of the significant
new uses described in the regulatory text of this rule are ongoing.
Therefore, EPA designates February 2, 2015 as the cutoff date for
determining whether the new use is ongoing. Persons who begin
commercial manufacture or processing of the chemical substances for a
significant new use identified as of that date would have to cease any
such activity upon the effective date of the final rule. To resume
their activities, these persons would have to first comply with all
applicable SNUR notification requirements and wait until the notice
review period, including any extensions, expires. If such a person met
the conditions of advance compliance under Sec. 721.45(h), the person
would be considered exempt from the requirements of the SNUR. Consult
the Federal Register document of April 24, 1990 for a more detailed
discussion of the cutoff date for ongoing uses.
VIII. Test Data and Other Information
EPA recognizes that TSCA section 5 does not require developing any
particular test data before submission of a SNUN. The two exceptions
are:
1. Development of test data is required where the chemical
substance subject to the SNUR is also subject to a test rule under TSCA
section 4 (see TSCA section 5(b)(1)).
2. Development of test data may be necessary where the chemical
substance has been listed under TSCA section 5(b)(4) (see TSCA section
5(b)(2)).
In the absence of a TSCA section 4 test rule or a TSCA section
5(b)(4) listing covering the chemical substance, persons are required
only to submit test data in their possession or control and to describe
any other data known to or reasonably ascertainable by them (see 40 CFR
720.50). However, upon review of PMNs and SNUNs, the Agency has the
authority to require appropriate testing. In cases where EPA issued a
TSCA section 5(e) consent order that requires or recommends certain
testing, Unit IV. lists those tests. Unit IV. also lists recommended
testing for non-5(e) SNURs. Descriptions of tests are provided for
informational purposes. EPA strongly encourages persons, before
performing any testing, to consult with the Agency pertaining to
protocol selection. To access the OCSPP test guidelines referenced in
this document electronically, please go to http://www.epa.gov/ocspp and
select ``Test Methods and Guidelines.'' The Organisation for Economic
Co-operation and Development (OECD) test guidelines are available from
the OECD Bookshop at http://www.oecdbookshop.org or SourceOECD at
http://www.sourceoecd.org.
In the TSCA section 5(e) consent orders for several of the chemical
substances regulated under this rule, EPA has established production
volume limits in view of the lack of data on the potential health and
environmental risks that may be posed by the significant new uses or
increased exposure to the chemical substances. These limits cannot be
exceeded unless the PMN submitter first submits the results of toxicity
tests that would permit a reasoned evaluation of the potential risks
posed by these chemical substances. Under recent TSCA section 5(e)
consent orders, each PMN submitter is required to submit each study
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.
The recommended tests specified in Unit IV. may not be the only
means of addressing the potential risks of the chemical substance.
However, submitting a SNUN without any test data may increase the
likelihood that EPA will take action under TSCA section 5(e),
particularly if satisfactory test results have not been obtained from a
prior PMN or SNUN submitter. EPA recommends that potential SNUN
submitters contact EPA early enough so that they will be able to
conduct the appropriate tests.
SNUN submitters should be aware that EPA will be better able to
evaluate SNUNs which provide detailed information on the following:
Human exposure and environmental release that may result
from the significant new use of the chemical substances.
Potential benefits of the chemical substances.
Information on risks posed by the chemical substances
compared to risks posed by potential substitutes.
IX. Procedural Determinations
By this rule, EPA is establishing certain significant new uses
which have been claimed as CBI subject to Agency confidentiality
regulations at 40 CFR part 2 and 40 CFR part 720, subpart E. Absent a
final determination or other disposition of the confidentiality claim
under 40 CFR part 2 procedures, EPA is required to keep this
information confidential. EPA promulgated a procedure to deal with the
situation where a specific significant new use is CBI, at 40 CFR
721.1725(b)(1).
Under these procedures a manufacturer or processor may request EPA
to determine whether a proposed use would be a significant new use
under the rule. The manufacturer or processor must show that it has a
bona fide intent to manufacture or process the chemical substance and
must identify the specific use for which it intends to manufacture or
process the chemical substance. If EPA concludes that the person has
shown a bona fide intent to manufacture or process the chemical
substance, EPA will tell the person whether the use identified in the
bona fide submission would be a significant new use under the rule.
Since most of the chemical identities of the chemical substances
subject to these SNURs are also CBI, manufacturers and processors can
combine the bona fide submission under the procedure in Sec.
[emsp14]721.1725(b)(1) with that under Sec. [emsp14]721.11 into a
single step.
[[Page 5466]]
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 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. [emsp14]721.1(c), persons submitting a SNUN must
comply with the same notification requirements and EPA regulatory
procedures as persons submitting a PMN, including submission of test
data on health and environmental effects as described in 40 CFR 720.50.
SNUNs must be submitted on EPA Form No. 7710-25, generated using e-PMN
software, and submitted to the Agency in accordance with the procedures
set forth in 40 CFR 720.40 and 721.25. E-PMN software is available
electronically at http://www.epa.gov/opptintr/newchems.
XI. Economic Analysis
EPA has evaluated the potential costs of establishing SNUN
requirements for potential manufacturers and processors of the chemical
substances subject to this rule. EPA's complete economic analysis is
available in the docket under docket ID number EPA-HQ-OPPT-2014-0714.
XII. Statutory and Executive Order Reviews
A. Executive Order 12866
This action establishes SNURs for several new chemical substances
that were the subject of PMNs, or TSCA section 5(e) consent orders. The
Office of Management and Budget (OMB) has exempted these types of
actions from review under Executive Order 12866, entitled ``Regulatory
Planning and Review'' (58 FR 51735, October 4, 1993).
B. Paperwork Reduction Act (PRA)
According to PRA (44 U.S.C. 3501 et seq.), an agency may not
conduct or sponsor, and a person is not required to respond to a
collection of information that requires OMB approval under PRA, unless
it has been approved by OMB and displays a currently valid OMB control
number. The OMB control numbers for EPA's regulations in title 40 of
the CFR, after appearing in the Federal Register, are listed in 40 CFR
part 9, and included on the related collection instrument or form, if
applicable. EPA is amending the table in 40 CFR part 9 to list the OMB
approval number for the information collection requirements contained
in this action. This listing of the OMB control numbers and their
subsequent codification in the CFR satisfies the display requirements
of PRA and OMB's implementing regulations at 5 CFR part 1320. This
Information Collection Request (ICR) was previously subject to public
notice and comment prior to OMB approval, and given the technical
nature of the table, EPA finds that further notice and comment to amend
it is unnecessary. As a result, EPA finds that there is ``good cause''
under section 553(b)(3)(B) of the Administrative Procedure Act (5
U.S.C. 553(b)(3)(B)) to amend this table without further notice and
comment.
The information collection requirements related to this action have
already been approved by OMB pursuant to PRA under OMB control number
2070-0012 (EPA ICR No. 574). This action does not impose any burden
requiring additional OMB approval. If an entity were to submit a SNUN
to the Agency, the annual burden is estimated to average between 30 and
170 hours per response. This burden estimate includes the time needed
to review instructions, search existing data sources, gather and
maintain the data needed, and complete, review, and submit the required
SNUN.
Send any comments about the accuracy of the burden estimate, and
any suggested methods for minimizing respondent burden, including
through the use of automated collection techniques, to the Director,
Collection Strategies Division, Office of Environmental Information
(2822T), Environmental Protection Agency, 1200 Pennsylvania Ave. NW.,
Washington, DC 20460-0001. Please remember to include the OMB control
number in any correspondence, but do not submit any completed forms to
this address.
C. Regulatory Flexibility Act (RFA)
On February 18, 2012, EPA certified pursuant to RFA section 605(b)
(5 U.S.C. 601 et seq.), that promulgation of a SNUR does not have a
significant economic impact on a substantial number of small entities
where the following are true:
1. A significant number of SNUNs would not be submitted by small
entities in response to the SNUR.
2. The SNUR submitted by any small entity would not cost
significantly more than $8,300.
A copy of that certification is available in the docket for this
action.
This action 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 action. As
such, EPA has determined that this action does not impose any
enforceable duty, contain any unfunded mandate, or otherwise have any
effect on small governments subject to the requirements of UMRA
sections 202, 203, 204, or 205 (2 U.S.C. 1501 et seq.).
E. Executive Order 13132
This action will not have a substantial direct effect on States, on
the relationship between the national government and the States, or on
the distribution of power and responsibilities among the various levels
of government, as specified in Executive Order 13132, entitled
``Federalism'' (64 FR 43255, August 10, 1999).
F. Executive Order 13175
This action does not have Tribal implications because it is not
expected to have substantial direct effects on Indian Tribes. This
action 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 action.
[[Page 5467]]
G. Executive Order 13045
This action is not subject to Executive Order 13045, entitled
``Protection of Children from Environmental Health Risks and Safety
Risks'' (62 FR 19885, April 23, 1997), because this is not an
economically significant regulatory action as defined by Executive
Order 12866, and this action does not address environmental health or
safety risks disproportionately affecting children.
H. Executive Order 13211
This action is not subject to Executive Order 13211, entitled
``Actions Concerning Regulations That Significantly Affect Energy
Supply, Distribution, or Use'' (66 FR 28355, May 22, 2001), because
this action is not expected to affect energy supply, distribution, or
use and because this action is not a significant regulatory action
under Executive Order 12866.
I. National Technology Transfer and Advancement Act (NTTAA)
In addition, since this action does not involve any technical
standards, NTTAA section 12(d) (15 U.S.C. 272 note), does not apply to
this action.
J. Executive Order 12898
This action does not entail special considerations of environmental
justice related issues as delineated by Executive Order 12898, entitled
``Federal Actions to Address Environmental Justice in Minority
Populations and Low-Income Populations'' (59 FR 7629, February 16,
1994).
XIII. Congressional Review Act
Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.),
EPA will submit a report containing this rule and other required
information to the U.S. Senate, the U.S. House of Representatives, and
the Comptroller General of the United States prior to publication of
the rule in the Federal Register. This action is not a ``major rule''
as defined by 5 U.S.C. 804(2).
List of Subjects
40 CFR Part 9
Environmental protection, Reporting and recordkeeping requirements.
40 CFR Part 721
Environmental protection, Chemicals, Hazardous substances,
Reporting and recordkeeping requirements.
Dated: January 21, 2015.
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. [emsp14]9.1, add the following sections in numerical order
under the undesignated center heading ``Significant New Uses of
Chemical Substances'' to read as follows:
Sec. [emsp14]9.1 OMB approvals under the Paperwork Reduction Act.
* * * * *
------------------------------------------------------------------------
OMB Control
40 CFR Citation No.
------------------------------------------------------------------------
* * * * *
------------------------------------------------------------------------
Significant New Uses of Chemical Substances
------------------------------------------------------------------------
* * * * *
721.10793............................................... 2070-0012
721.10794............................................... 2070-0012
721.10795............................................... 2070-0012
721.10796............................................... 2070-0012
721.10797............................................... 2070-0012
721.10798............................................... 2070-0012
721.10799............................................... 2070-0012
721.10800............................................... 2070-0012
721.10801............................................... 2070-0012
721.10802............................................... 2070-0012
721.10803............................................... 2070-0012
721.10804............................................... 2070-0012
721.10805............................................... 2070-0012
721.10806............................................... 2070-0012
721.10807............................................... 2070-0012
721.10808............................................... 2070-0012
721.10809............................................... 2070-0012
721.10810............................................... 2070-0012
721.10811............................................... 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. [emsp14]721.10793 to subpart E to read as follows:
Sec. [emsp14]721.10793 Phosphoric acid, iron (2+) lithium salt
(1:1:1).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as phosphoric acid,
iron (2+) lithium salt (1:1:1) (PMN P-12-17; CAS No. 15365-14-7) is
subject to reporting under this section for the significant new uses
described in paragraph (a)(2) of this section. The SNUR does not apply
to the PMN substance when it is manufactured, pursuant to any of the
exemptions in 40 CFR 720.30(h) with no commercial purpose separate from
the substance, mixture, or article of which it is a part.
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in Sec.
721.63 (a)(3), (a)(4), (a)(6)(ii), (a)(6)(v), (a)(6)(vi), (b), and (c).
When determining which persons are reasonably likely to be exposed as
required for Sec. 721.63 (a)(4), engineering control measures (e.g.,
enclosure or confinement of the operation, general and local
ventilation) or administrative control measures (e.g., workplace
policies and procedures) shall be considered and implemented to prevent
exposure, where feasible. The following National Institute for
Occupational Safety and Health (NIOSH)-certified respirators with an
Assigned Protection Factor (APF) of at least 10 meet the requirements
of Sec. 721.63(a)(4):
(A) NIOSH-certified power air-purifying respirator with a hood or
helmet and with appropriate gas/vapor (acid gas, organic vapor, or
substance specific) cartridges in combination with HEPA filters.
(B) NIOSH-certified continuous flow supplied-air respirator
equipped with a loose fitting face piece, hood, or helmet.
(C) NIOSH-certified negative pressure (demand) supplied-air
respirator with a full face piece.
(1) As an alternative to the respiratory requirements listed here,
a manufacturer 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 2.4 mg/m\3\ as an 8-hour
time weighted average verified by actual monitoring data.
(2) [Reserved]
(ii) Hazard communication program. Requirements as specified in
Sec. 721.72.
(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
[[Page 5468]]
methods for protecting against such risk, into a MSDS as described in
Sec. 721.72(c) within 90 days from the time the employer becomes aware
of the new information. If this substance is not being manufactured,
processed, or used in the employer's workplace, the employer must add
the new information to a MSDS before the substance is reintroduced into
the workplace.
(B) The employer must ensure that persons who will receive the PMN
substance from the employer, or who have received the PMN substance
from the employer within 5 years from the date the employer becomes
aware of the new information described in paragraph (a)(2)(i)(A) of
this section, are provided an MSDS containing the information required
under paragraph (a)(2)(i)(A) of this section within 90 days from the
time the employer becomes aware of the new information.
(iii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80 (k) and (q).
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125 (a) through (f) and (i) are applicable to manufacturers and
processors of this substance.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
(3) Determining whether a specific use is subject to this section.
The provisions of Sec. 721.1725(b)(1) apply to paragraph (a)(2)(iii)
of this section.
0
5. Add Sec. 721.10794 to subpart E to read as follows:
Sec. 721.10794 Alkenyl succinate, amine salts (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substances identified generically as
alkenyl succinate, amine salts (PMNs P-13-212 and P-13-213) 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. The significant new use is any use other
than as a metalworking fluid additive.
(ii) [Reserved]
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125 (a), (b), (c), and (i) are applicable to manufacturers and
processors of these substances.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
0
6. Add Sec. 721.10795 to subpart E to read as follows:
Sec. 721.10705 Amine salt of vegetable oil, polymer with
cycloaliphatic glycol, hydroxy substituted carboxylic acid, aliphatic
diisocyanate and tetra hydroxy alkane (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as amine
salt of vegetable oil, polymer with cycloaliphatic glycol, hydroxy
substituted carboxylic acid, aliphatic diisocyanate and tetra hydroxy
alkane (PMN P-13-559) 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. The significant new use is any use other
than as a wood sealer or concrete sealer.
(ii) [Reserved]
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125 (a), (b), (c), and (i) are applicable to manufacturers and
processors of this substance.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
0
7. Add Sec. 721.10796 to subpart E to read as follows:
Sec. [emsp14]721.10796 Polymer of terephthalic acid and ethyl benzene
with multi-walled carbon nanotube (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as polymer
of terephthalic acid and ethyl benzene with multi-walled carbon
nanotube (PMN P-13-573) is subject to reporting under this section for
the significant new uses described in paragraph (a)(2) of this section.
The SNUR does not apply to the PMN substance when it is manufactured,
pursuant to any of the exemptions in 40 CFR 720.30(h) with no
commercial purpose separate from the substance, mixture, or article of
which it is a part.
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in Sec.
721.63 (a)(1), (a)(2)(i), (a)(2)(ii), (a)(3), (a)(4),
(a)(6)(particulate), (b), and (c). When determining which persons are
reasonably likely to be exposed as required for Sec. 721.63 (a)(1) and
(a)(4), engineering control measures (e.g., enclosure or confinement of
the operation, general and local ventilation) or administrative control
measures (e.g., workplace policies and procedures) shall be considered
and implemented to prevent exposure, where feasible. A National
Institute for Occupational Safety and Health (NIOSH)-certified
respirators with an N-100, P-100, or R-100 cartridge meet the
requirements of Sec. 721.63(a)(4).
(ii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80 (k)(a significant new use is any
processing or use other than described in the consent order) 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 (b).
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125 (a) through (e), (i), and (k) are applicable to manufacturers
and processors of this substance.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
(3) Determining whether a specific use is subject to this section.
The provisions of Sec. 721.1725(b)(1) apply to paragraph (a)(2)(iii)
of this section.
0
8. Add Sec. [emsp14]721.10797 to subpart E to read as follows:
Sec. 721.10797 Polycarbamoylsulfonic acid sodium salt (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
polycarbamoylsulfonic acid sodium salt (PMN P-13-674) is subject to
reporting under this section for the significant new uses described in
paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Release to water. Requirements as specified in Sec. 721.90
(a)(4), (b)(4), and (c)(4) (N=11).
(ii) [Reserved]
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
[[Page 5469]]
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125 (a), (b), (c), and (k) are applicable to manufacturers and
processors of this substance.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
0
9. Add Sec. [emsp14]721.10798 to subpart E to read as follows:
Sec. 721.10798 Phosphonic acid chloride, diester (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
phosphonic acid chloride, diester (PMN P-13-864) 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=5).
(ii) [Reserved]
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125 (a), (b), (c), and (k) are applicable to manufacturers and
processors of this substance.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
0
10. Add Sec. [emsp14]721.10799 to subpart E to read as follows:
Sec. 721.10799 Substituted dimethyl phenols (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substances identified generically as
substituted dimethyl phenols (PMNs P-13-874, P-13-875, P-13-876, and P-
13-877) are subject to reporting under this section for the significant
new uses described in paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Release to water. Requirements as specified in Sec. 721.90
(a)(4), (b)(4), and (c)(4) (N=10 in aggregate for PMN substances P-13-
874 and P-13-875, and N=5 in aggregate for the PMN substances P-13-876
and P-13-877).
(ii) [Reserved]
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125 (a), (b), (c), and (k) are applicable to manufacturers and
processors of these substances.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
0
11. Add Sec. [emsp14]721.10800 to subpart E to read as follows:
Sec. 721.10800 2-Propenoic acid, 4-phenoxybutyl ester.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as 2-propenoic acid,
4-phenoxybutyl ester (PMN P-13-931; CAS No. 103969-85-3) is subject to
reporting under this section for the significant new uses described in
paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Release to water. Requirements as specified in Sec. 721.90
(a)(4), (b)(4), and (c)(4) (N=1).
(ii) [Reserved]
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125 (a), (b), (c), and (k) are applicable to manufacturers and
processors of this substance.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
0
12. Add Sec. [emsp14]721.10801 to subpart E to read as follows:
Sec. 721.10801 Organic phosphonate salt (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as organic
phosphonate salt (PMN P-13-936) 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=130).
(ii) [Reserved]
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125 (a), (b), (c), and (k) are applicable to manufacturers and
processors of this substance.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
0
13. Add Sec. [emsp14]721.10802 to subpart E to read as follows:
Sec. 721.10802 Quaternized protein/silicone copolymer (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
quaternized protein/silicone copolymer (PMN P-14-39) 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=31).
(ii) [Reserved]
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125 (a), (b), (c), and (k) are applicable to manufacturers and
processors of this substance.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
0
14. Add Sec. [emsp14]721.10803 to subpart E to read as follows:
Sec. 721.10803 1,5-Pentanediamine.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as 1,5-pentanediamine
(PMN P-14-70; CAS No. 462-94-2) is subject to reporting under this
section for the significant new uses described in paragraph (a)(2) of
this section.
(2) The significant new uses are:
(i) Release to water. Requirements as specified in Sec. 721.90
(a)(4), (b)(4), and (c)(4) (N=300).
(ii) [Reserved]
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125 (a), (b), (c), and (k) are applicable to manufacturers and
processors of this substance.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
0
15. Add Sec. [emsp14]721.10804 to subpart E to read as follows:
Sec. 721.10804 Cashew-nutshell-liquid, polymer with formaldehyde,
reaction products with diethanolamine and diisopropanol amine.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as cashew-nutshell-
liquid, polymer with
[[Page 5470]]
formaldehyde, reaction products with diethanolamine and diisopropanol
amine (PMN P-14-110; CAS No. 1462343-28-7) is subject to reporting
under this section for the significant new uses described in paragraph
(a)(2) of this section.
(2) The significant new uses are:
(i) Release to water. Requirements as specified in Sec. 721.90
(a)(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 (b).
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125 (a), (b), (c), and (k) are applicable to manufacturers and
processors of this substance.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
0
16. Add Sec. [emsp14]721.10805 to subpart E to read as follows:
Sec. 721.10805 Fatty acid imidazolines (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substances identified generically as fatty
acid imidazolines. (PMNs P-14-202, P-14-203, P-14-204, P-14-205, and P-
14-206) are subject to reporting under this section for the significant
new uses described in paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Release to water. Requirements as specified in Sec. 721.90
(a)(4), (b)(4), and (c)(4) (where N=1 in aggregate for PMNs P-14-203
and P-14-204; N=1 in aggregate for PMNs P-14-204, P-14-205, P-14-206).
(ii) [Reserved]
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125 (a), (b), (c), and (k) are applicable to manufacturers and
processors of these substances.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
0
17. Add Sec. [emsp14]721.10806 to subpart E to read as follows:
Sec. 721.10806 Trimellitic anhydride, polymer with alkanolamine and
tetrahydrophthalic anhydride (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
trimellitic anhydride, polymer with alkanolamine and tetrahydrophthalic
anhydride (PMN P-14-341) is subject to reporting under this section for
the significant new uses described in paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Industrial commercial, and consumer activities. Requirements as
specified in Sec. 721.80. A significant new use is any use of the PMN
substance other than as a binder for gluing the individual mineral
fibers together to form a firm product, used industrially in a closed
system.
(ii) [Reserved]
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125 (a), (b), (c), and (i) are applicable to manufacturers and
processors of this substance.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
0
18. Add Sec. [emsp14]721.10807 to subpart E to read as follows:
Sec. 721.10807 Aliphatic ether ethyl alcohol (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
aliphatic ether ethyl alcohol (PMN P-14-417) is subject to reporting
under this section for the significant new uses described in paragraph
(a)(2) of this section.
(2) The significant new uses are:
(i) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80. A significant new use is any use other
than the confidential use as stated in the PMN.
(ii) [Reserved]
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125 (a), (b), (c), and (i) are applicable to manufacturers and
processors of this substance.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
(3) Determining whether a specific use is subject to this section.
The provisions of Sec. 721.1725(b)(1) apply to paragraph (a)(2)(i) of
this section.
0
19. Add Sec. [emsp14]721.10808 to subpart E to read as follows:
Sec. 721.10808 Bisxylenol diglycidyl ether polymer (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
bisxylenol diglycidyl ether polymer (PMN P-14-513) 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 (b).
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125 (a), (b), (c), and (k) are applicable to manufacturers and
processors of this substance.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
0
20. Add Sec. [emsp14]721.10809 to subpart E to read as follows:
Sec. 721.10809 Cyclotetrasiloxane, 2,4,6,8-tetrakis[3-[2-(2-
methoxyethoxy)ethoxy]propyl]-2,4,6,8-tetramethyl-.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as cyclotetrasiloxane,
2,4,6,8-tetrakis[3-[2-(2-methoxyethoxy)ethoxy]propyl]-2,4,6,8-
tetramethyl- (PMN P-14-518; CAS No. 17232-95-0) is subject to reporting
under this section for the significant new uses described in paragraph
(a)(2) of this section.
(2) The significant new uses are:
(i) Release to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4), and (c)(4) (N=8).
(ii) [Reserved]
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125 (a), (b), (c), and (k) are applicable to manufacturers and
processors of this substance.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
0
21. Add Sec. [emsp14]721.10810 to subpart E to read as follows:
Sec. 721.10810 Heterocyclic amine potassium salt (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The
[[Page 5471]]
chemical substance identified generically as heterocyclic amine
potassium salt (PMN P-14-544) 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)(a significant new use is any use other
than the confidential use stated in the PMN) 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 (b).
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125 (a), (b), (c), and (i) are applicable to manufacturers and
processors of this substance.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
(3) Determining whether a specific use is subject to this section.
The provisions of Sec. 721.1725(b)(1) apply to paragraph (a)(2)(i) of
this section.
0
22. Add Sec. [emsp14]721.10811 to subpart E to read as follows:
Sec. 721.10811 Heterocyclic amine substituted acrylamide (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
heterocyclic amine substituted acrylamide (PMN P-14-618) 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=23).
(ii) [Reserved]
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125 (a), (b), (c), and (k) are applicable to manufacturers and
processors of this substance.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
[FR Doc. 2015-01721 Filed 1-30-15; 8:45 am]
BILLING CODE 6560-50-P