[Federal Register Volume 80, Number 191 (Friday, October 2, 2015)]
[Rules and Regulations]
[Pages 59593-59610]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-24846]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Parts 9 and 721
[EPA-HQ-OPPT-2015-0388; FRL-9933-30]
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 30 chemical substances
which were the subject of premanufacture notices (PMNs). Nine 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 30 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 December 1, 2015. For purposes of
judicial review, this rule shall be promulgated at 1 p.m. (e.s.t.) on
October 16, 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 November 2, 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 November 2, 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.
ADDRESSES: Submit your comments, identified by docket identification
(ID) number EPA-HQ-OPPT-2015-0388, 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, is available at http://www.epa.gov/dockets.
FOR FURTHER INFORMATION CONTACT: For technical information contact:
Kenneth Moss, Chemical Control Division (7405M), Office of Pollution
Prevention and Toxics, Environmental Protection Agency, 1200
Pennsylvania Ave. NW., Washington, DC 20460-0001; telephone number:
(202) 564-9232; email address: [email protected].
[[Page 59594]]
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. 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) (FRL-3658-5). Consult that preamble for further
information on the objectives, rationale, and procedures for SNURs and
on the basis for significant new use designations, including provisions
for developing test data.
B. What is the agency's authority for taking this action?
Section 5(a)(2) of TSCA (15 U.S.C. 2604(a)(2)) authorizes EPA to
determine that a use of a chemical substance is a ``significant new
use.'' EPA must make this determination by rule after considering all
relevant factors, including the four bulleted TSCA section 5(a)(2)
factors listed in Unit III. Once EPA determines that a use of a
chemical substance is a significant new use, TSCA section 5(a)(1)(B)
requires persons to submit a significant new use notice (SNUN) to EPA
at least 90 days before they manufacture or process the chemical
substance for that use. Persons who must report are described in Sec.
721.5.
C. Applicability of General Provisions
General provisions for SNURs appear in 40 CFR part 721, subpart A.
These provisions describe persons subject to the rule, recordkeeping
requirements, exemptions to reporting requirements, and applicability
of the rule to uses occurring before the effective date of the rule.
Provisions relating to user fees appear at 40 CFR part 700. According
to Sec. 721.1(c), persons subject to these SNURs must comply with the
same SNUN requirements and EPA regulatory procedures as submitters of
PMNs under TSCA section 5(a)(1)(A). In particular, these requirements
include the information submission requirements of TSCA sections 5(b)
and 5(d)(1), the exemptions authorized by TSCA section 5(h)(1), (h)(2),
(h)(3), and (h)(5), and the regulations at 40 CFR part 720. Once EPA
receives a SNUN, EPA may take regulatory action under TSCA section
5(e), 5(f), 6, or 7 to control the activities for which it has received
the SNUN. If EPA does not take action, EPA is required under TSCA
section 5(g) to explain in the Federal Register its reasons for not
taking action.
III. Significant New Use Determination
Section 5(a)(2) of TSCA states that EPA's determination that a use
of a chemical substance is a significant new use must be made after
consideration of all relevant factors, including:
The projected volume of manufacturing and processing of a
chemical substance.
The extent to which a use changes the type or form of
exposure of human beings or the environment to a chemical substance.
The extent to which a use increases the magnitude and
duration of exposure of human beings or the environment to a chemical
substance.
The reasonably anticipated manner and methods of
manufacturing, processing, distribution in commerce, and disposal of a
chemical substance.
In addition to these factors enumerated in TSCA section 5(a)(2),
the statute authorized EPA to consider any other relevant factors.
To determine what would constitute a significant new use for the 30
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 30 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).
[[Page 59595]]
Chemical Abstracts Service (CAS) Registry number (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).
Tests recommended by EPA to provide sufficient information
to evaluate the chemical substance (see Unit VIII. for more
information).
CFR citation assigned in the regulatory text section of
this rule.
The regulatory text section of this rule specifies the activities
designated as significant new uses. Certain new uses, including
production volume limits (i.e., limits on manufacture volume) and other
uses designated in this rule, may be claimed as CBI. Unit IX. discusses
a procedure companies may use to ascertain whether a proposed use
constitutes a significant new use.
This rule includes 8 PMN substances that are subject to ``risk-
based'' consent orders under TSCA section 5(e)(1)(A)(ii)(I) where EPA
determined that activities associated with the PMN substances may
present unreasonable risk to human health or the environment. Those
consent orders require protective measures to limit exposures or
otherwise mitigate the potential unreasonable risk. The so-called
``TSCA 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 TSCA section 5(e)
SNURs designate as a ``significant new use'' the absence of the
protective measures required in the corresponding consent orders.
In addition, this rule includes one SNUR on a PMN substance that is
subject to an ``exposure-based'' consent order under TSCA section
5(e)(1)(A)(ii)(II), wherein EPA determined that the PMN substance is
expected to be produced in substantial quantities, and that there may
either be significant or substantial human exposure and/or the PMN
substance may enter the environment in substantial quantities. The TSCA
section 5(e) consent order requires submission of certain test data to
EPA before the manufacturer may exceed a specified production volume.
These SNURs designate as a ``significant new use'' the absence of the
protective measures or exceedance of the production volume limit
required in the TSCA section 5(e) consent order.
This rule also includes SNURs on 21 PMN substances that are not
subject to consent orders under TSCA section 5(e). In these cases, for
a variety of reasons, EPA did not find that the use scenario described
in the PMN triggered the determinations set forth under TSCA section
5(e). However, EPA does believe that certain changes from the use
scenario described in the PMN could result in increased exposures,
thereby constituting a ``significant new use.'' These so-called ``TSCA
non-section 5(e) SNURs'' are promulgated pursuant to Sec. 721.170. EPA
has determined that every activity designated as a ``significant new
use'' in all TSCA non-section 5(e) SNURs issued under Sec. 721.170
satisfies the two requirements stipulated in Sec. 721.170(c)(2), i.e.,
these significant new use activities 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 Numbers P-12-69, P-12-70, and P-12-520
Chemical name: Fatty acids compound with cyclohexanamine (generic)
(P-12-69 and 70) and Fatty acids amine salt (generic) (P-12-0520).
CAS numbers: Claimed Confidential.
Effective date of TSCA section 5(e) consent order: February 11,
2015.
Basis for TSCA section 5(e) consent order: The PMNs states that the
generic (non-confidential) use of the substances will be as a lubricity
additive (P-12-69 and P-12-70) and a chemical component for fuel
additives (P-12-520). Based on structure-activity relationship (SAR)
analysis of test data on analogous aliphatic amines, EPA predicts
toxicity to aquatic organisms to occur at concentrations that exceed 52
parts per billion (ppb) (P-12-69), 4 ppb (P-12-70) and 180 ppb (P-12-
520) 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 substance to surface water, from
uses other than as described in the PMNs, exceed releases from the use
described in the PMNs. For the uses described in the PMNs,
environmental releases did not exceed 52 ppb, 4 ppb, or 180 ppb,
respectively, for more than 20 days per year. The consent order for
these PMN substances was issued under TSCA sections 5(e)(1)(A)(i) and
5(e)(1)(A)(ii)(I) based on a finding that the uncontrolled manufacture,
processing, distribution in commerce, use and disposal may present an
unreasonable risk to the environment. To protect against these risks,
the consent order requires manufacturing, processing, or use of the
substance for the specific confidential uses stated in the PMNs. The
SNUR designates as a ``significant new use'' the absence of these
protective measures.
Recommended testing: EPA has determined that the results of a fish
early life-stage toxicity test (OPPTS Test Guideline 850.1400) and a
daphnia chronic toxicity test (OPPTS 850.1300) would help characterize
the environmental effects of the PMN substances. Testing should be done
on P-12-69 only. The submitter has agreed not to exceed a confidential
volume limit without performing this testing.
CFR citations: CFR 721.10852 (P-12-69 and P-12-70) and 40 CFR
721.10856 (P-12-520).
PMN Number P-12-169
Chemical name: Fluoro-modified acrylic copolymer (generic).
CAS number: Claimed confidential.
Effective date of TSCA section 5(e) consent order: March 19, 2015.
Basis for TSCA section 5(e) consent order: The PMN states that the
use of the substance will be as a substrate wetting and leveling agent
for organic solvent-based paints and inks. EPA has concerns for
potential incineration or other decomposition products of the PMN
substance. These fluorinated decomposition products may be released to
the environment from incomplete incineration of the PMN substance at
low temperatures. EPA has preliminary evidence, including data on some
fluorinated polymers, which suggests that, under some conditions, the
PMN substance could degrade in the environment. EPA has concerns that
these degradation products will persist in the environment, could
bioaccumulate or biomagnify, and could be toxic (PBT) to people, wild
mammals, and birds. These concerns are based on data on analogous
chemical substances, including perfluorooctanoic acid (PFOA) and other
perfluorinated alkyls, including the presumed environmental degradant.
The order was issued under TSCA sections 5(e)(1)(A)(i),
5(e)(1)(A)(ii)(I), and 5(e)(1)(A)(ii)(II), based on a finding that
these substances may present an unreasonable risk of injury to the
environment and human health, the substances may be produced in
substantial quantities and may reasonably be anticipated to enter the
environment in substantial quantities,
[[Page 59596]]
and there may be significant (or substantial) human exposure to the
substances and their potential degradation products. To protect against
these exposures and risks, the consent order requires:
1. Risk notification. If as a result of the test data required, the
company becomes aware that the PMN substance may present a risk of
injury to human health or the environment, the company must incorporate
this new information, and any information on methods for protecting
against such risk into a Material Safety Data Sheet (MSDS), within 90
days.
2. Submission of certain physical/chemical property and
environmental fate testing on a related PMN substance prior to
exceeding the confidential production volume limits as specified in the
consent order of the PMN substance.
3. Recording and reporting of certain fluorinated impurities in the
starting raw material and the initially isolated intermediates; and
manufacture of the PMN substance not to exceed the maximum established
impurity levels of certain fluorinated impurities. The SNUR designates
as a ``significant new use'' the absence of these protective measures.
Recommended testing: EPA has determined that the results of certain
physical/chemical property and environmental fate testing identified in
the TSCA 5(e) consent order would help characterize possible effects of
the substance and its degradation products. The Order prohibits the
Company from exceeding specified confidential production volumes unless
the Company submits the information described in the Testing section of
this Order in accordance with the conditions specified in the Testing
section. Further, EPA has identified certain toxicity and environmental
fate testing described in the Pended Testing section of the Preamble to
the Order that would help characterize the possible effects of the PMN
substance. The Order does not require submission of the pended testing
at any specified time or production volume. However, the Order's
restrictions on manufacture, processing, distribution in commerce, use,
and disposal of the PMN substance will remain in effect until the Order
is modified or revoked by EPA based on submission of that or other
relevant information.
CFR citation: 40 CFR 721.10853.
PMN Number P-12-351
Chemical name: Siloxanes and Silicones, alkyl, alky propoxy ethyl,
methyl octyl, alkyl polyfluorooctyl (generic).
CAS number: Claimed confidential.
Effective date of TSCA section 5(e) consent order: March 19, 2015.
Basis for TSCA section 5(e) consent order: The PMN states that the
generic (non-confidential) use of the substance will be as a coating
additive. EPA has concerns for potential incineration or other
decomposition products of the PMN substance. These fluorinated
decomposition products may be released to the environment from
incomplete incineration of the PMN substance at low temperatures. EPA
has preliminary evidence, including data on some fluorinated polymers,
which suggests that, under some conditions, the PMN substance could
degrade in the environment. EPA has concerns that these degradation
products will persist in the environment, could bioaccumulate or
biomagnify, and could be toxic (PBT) to people, wild mammals, and
birds. These concerns are based on data on analogous chemical
substances, including perfluorooctanoic acid (PFOA) and other
perfluorinated alkyls, including the presumed environmental degradant.
The order was issued under TSCA sections 5(e)(1)(A)(i),
5(e)(1)(A)(ii)(I), and 5(e)(1)(A)(ii)(II), based on a finding that
these substances may present an unreasonable risk of injury to the
environment and human health, the substances may be produced in
substantial quantities and may reasonably be anticipated to enter the
environment in substantial quantities, and there may be significant (or
substantial) human exposure to the substances and their potential
degradation products. To protect against these exposures and risks, the
consent order requires:
1. Risk notification. If as a result of the test data required, the
company becomes aware that the PMN substances may present a risk of
injury to human health or the environment, the company must incorporate
this new information, and any information on methods for protecting
against such risk into a MSDS, within 90 days.
2. Submission of certain physical/chemical property and
environmental fate testing on a related PMN substance prior to
exceeding the confidential production volume limits as specified in the
consent order of the PMN substances.
3. Recording and reporting of certain fluorinated impurities in the
starting raw material and the initially isolated intermediates; and
manufacture of the PMN substances not to exceed the maximum established
impurity levels of certain fluorinated impurities. The SNUR designates
as a ``significant new use'' the absence of these protective measures.
Recommended testing: EPA has determined that the results of certain
physical/chemical property and environmental fate testing identified in
the TSCA 5(e) consent order would help characterize possible effects of
the substances and their degradation products. The Order prohibits the
Company from exceeding specified confidential production volumes unless
the Company submits the information described in the Testing section of
this Order in accordance with the conditions specified in the Testing
section. Further, EPA has identified certain toxicity and environmental
fate testing described in the Pended Testing section of the Preamble to
the Order that would help characterize the effects of the PMN
substances. The Order does not require submission of the pended testing
at any specified time or production volume. However, the Order's
restrictions on manufacture, processing, distribution in commerce, use,
and disposal of the PMN substances will remain in effect until the
Order is modified or revoked by EPA based on submission of that or
other relevant information.
CFR citation: 40 CFR 721.10854.
PMN Number P-12-450 and P-12-451
Chemical name: Partially fluorinated alcohol, reaction products
with phosphorus oxide (P2O5), amine salts
(generic).
CAS number: Claimed confidential.
Effective date of TSCA section 5(e) consent order: March 16, 2015.
Basis for TSCA section 5(e) consent order: The PMNs state that the
generic (non-confidential) use of the substances will be as coating
additives and surface active agents. EPA has concerns for potential
incineration or other decomposition products of the PMN substances.
These perfluorinated decomposition products may be released to the
environment from incomplete incineration of the PMN substances at low
temperatures. EPA has preliminary evidence, including data on some
fluorinated polymers, which suggests that, under some conditions, the
PMN substances could degrade in the environment. EPA has concerns that
these degradation products will persist in the environment, could
bioaccumulate or biomagnify, and could be toxic (PBT) to people, wild
mammals, and birds. These concerns are based on data on analogous
chemical substances, including perfluorooctanoic acid (PFOA) and other
perfluorinated alkyls, including the presumed environmental degradant.
The order was issued under TSCA
[[Page 59597]]
sections 5(e)(1)(A)(i), 5(e)(1)(A)(ii)(I), and 5(e)(1)(A)(ii)(II),
based on a finding that these substances may present an unreasonable
risk of injury to the environment and human health, the substances may
be produced in substantial quantities and may reasonably be anticipated
to enter the environment in substantial quantities, and there may be
significant (or substantial) human exposure to the substances and their
potential degradation products. To protect against these exposures and
risks, the consent order requires:
1. Risk notification. If as a result of the test data required, the
company becomes aware that the PMN substances may present a risk of
injury to human health or the environment, the company must incorporate
this new information, and any information on methods for protecting
against such risk into a MSDS, within 90 days.
2. Submission of certain physical/chemical property and
environmental fate testing on a related PMN substance prior to
exceeding the confidential production volume limits as specified in the
consent order of the PMN substances.
3. Recording and reporting of certain fluorinated impurities in the
starting raw material and the initially isolated intermediates; and
manufacture of the PMN substances not to exceed the maximum established
impurity levels of certain fluorinated impurities. The SNUR designates
as a ``significant new use'' the absence of these protective measures.
Recommended testing: EPA has determined that the results of certain
physical/chemical property and environmental fate testing identified in
the TSCA 5(e) consent order would help characterize possible effects of
the substances and their degradation products. The Order prohibits the
Company from exceeding specified confidential production volumes unless
the Company submits the information described in the Testing section of
this Order in accordance with the conditions specified in the Testing
section. Further, EPA has identified certain toxicity and environmental
fate testing described in the Pended Testing section of the Preamble to
the Order that would help characterize the effects of the PMN
substances. The Order does not require submission of the pended testing
at any specified time or production volume. However, the Order's
restrictions on manufacture, processing, distribution in commerce, use,
and disposal of the PMN substances will remain in effect until the
Order is modified or revoked by EPA based on submission of that or
other relevant information.
CFR citation: 40 CFR 721.10855.
PMN Number P-13-292
Chemical name: Organophosphorus polymer (generic).
CAS number: Claimed confidential.
Effective date of TSCA section 5(e) consent order: February 13,
2015.
Basis for TSCA section 5(e) consent order: The PMN states that the
generic (non-confidential) use of the substance will be as an additive
for polymers. Using available exposure information from the public
literature (i.e., measured values for similar substances in house dust
in homes), and certain assumptions for mouthing behavior by young
children, EPA identified concerns for potential exposure to the general
population. However, there is uncertainty about the risk from this
scenario due to the absence of hazard data on the PMN substance itself
and information on the ability for the PMN substance to migrate or
leach out of certain consumer products. Consumer exposure is possible
if the PMN migrates from these products or decomposes to form dust
particles that can be inhaled or ingested. Analogous chemicals,
including Tris(2-chloroethyl)phosphate (TCEP) and Tris(1,3-dichloro-2
propyl) phosphate (TDCPP), can be found in household dust, and are
widespread in the environment. Assuming similar use patterns over time,
the PMN substance may be expected to display similar exposure patterns.
The order was issued under TSCA sections 5(e)(1)(A)(i) and
5(e)(1)(A)(ii)(II), based on a finding that this 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 substances and their
potential degradation products. To address potential exposures and
hazards, the consent order requires certain testing by certain
confidential production volume limits.
Recommended testing: EPA has determined that the results of certain
physical/chemical property, toxicity, potential for migration from
products, and dermal and other absorption testing identified in the
TSCA 5(e) consent order would help characterize possible effects of the
substance. The Order prohibits the Company from exceeding specified
confidential production volumes unless the Company submits the
information described in the Testing section of this Order in
accordance with the conditions specified in the Testing section.
CFR citation: 40 CFR 721.10857.
PMN Number P-13-305
Chemical name: Fluorinated acid alkylester (generic).
CAS number: Claimed confidential.
Effective date of TSCA section 5(e) consent order: February 27,
2015.
Basis for TSCA section 5(e) consent order: The PMN states that the
generic (non-confidential) use of the substance will be as an
intermediate. EPA has concerns that the PMN substance will persist in
the environment, could bioaccumulate, and be toxic (``PBT'') to humans,
other mammals, and birds. EPA's concerns are based on data on the PMN
substance, and analogy to perfluorobutanoic acid (PFBA), PFOA,
perfluorooctanol sulfonate (PFOS), and other analogs. The order was
issued under TSCA sections 5(e)(1)(A)(i) and 5(e)(1)(A)(ii)(I), based
on a finding that this substance may present an unreasonable risk of
injury to the environment and human health. To protect against these
exposures and risks, the consent order requires:
1. Risk notification. If the company becomes aware that the PMN
substances may present a risk of injury to human health or the
environment, the company must incorporate this new information, and any
information on methods for protecting against such risk into a Material
Safety Data Sheet (MSDS), within 90 days.
2. Use of personal protective equipment including impervious gloves
and a National Institute of Occupational Safety and Health (NIOSH)-
certified respirator with an assigned protection factor (APF) of at
least 10, when there is potential exposure.
3. Establishment and use of a hazard communication program,
including health hazard precautionary statements on each label and the
MSDS.
4. Use of the PMN substance only as a chemical intermediate. Any
chemical substance manufactured using the PMN substance may contain
residuals of the PMN substance at a certain maximum level.
5. Recover and convert, capture (destroy), recycle, or reuse the
substance at a certain overall efficiency when the PMN substance is
used as an intermediate in accordance with the provisions.
6. Not use the PMN substance in consumer products.
The SNUR designates as a ``significant new use'' the absence of
these protective measures.
Recommended testing: EPA has determined that the results of certain
[[Page 59598]]
toxicity, metabolism and pharmacokinetics testing described in the
Pended Testing section of the Preamble to the Order would help
characterize the human health effects of the PMN substance. The Order
does not require submission of the pended testing at any specified time
or production volume. However, the Order's restrictions on manufacture,
processing, distribution in commerce, use, and disposal of the PMN
substance will remain in effect until the Order is modified or revoked
by EPA based on submission of that or other relevant information.
CFR citation: 40 CFR 721.10858.
PMN Number P-14-563
Chemical name: Quaternary alkyl methyl amine ethoxylate methyl
chloride (generic).
CAS number: Claimed confidential.
Basis for action: The PMN states that the generic (non-
confidential) use of the substance will be as a cleaner/degreaser.
Based on submitted test data on the PMN substance as well as SAR
analysis of test data on analogous cationic surfactants, EPA predicts
toxicity to aquatic organisms may occur at concentrations that exceed
29 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 29 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 water
concentrations exceeding 29 ppb may cause significant adverse
environmental effects. Based on this information, the PMN substance
meets the concern criteria at Sec. 721.170(b)(4)(i) and (ii).
Recommended testing: EPA has determined that the results of a fish
early-life stage toxicity test (OPPTS Test Guideline 850.1400) and a
daphnid chronic toxicity test (OPPTS Test Guideline 850.1300) would
help characterize the environmental effects of the PMN substance.
CFR Citation: 40 CFR 721.10859.
PMN Number P-14-756
Chemical name: Substituted carboxamide (generic).
CAS number: Claimed confidential.
Basis for action: The PMN states that the generic (non-
confidential) use of the substance will be as a material for highly
dispersive use in consumer products and component of a consumer
product. Based on submitted test data on the PMN substance as well as
SAR analysis of test data on analogous amides, EPA predicts toxicity to
aquatic organisms may occur at concentrations that exceed 3 ppb of the
PMN substance in surface waters. As described in the PMN, releases of
the substance are not expected to result in surface water
concentrations exceeding 3 ppb. Therefore, EPA has not determined that
the proposed manufacturing, processing, or use of the substance may
present an unreasonable risk. EPA has determined, however, that any use
of the substance that results in releases to surface water
concentrations exceeding 3 ppb may cause significant adverse
environmental effects. Based on this information, the PMN substance
meets the concern criteria at Sec. 721.170(b)(4)(i) and (ii).
Recommended testing: EPA has determined that the results of a fish
early-life stage toxicity test (OPPTS Test Guideline 850.1400) and a
daphnid chronic toxicity test (OPPTS Test Guideline 850.1300) and would
help characterize the environmental effects of the PMN substance.
CFR Citation: 40 CFR 721.10860.
PMN Number P-14-804
Chemical name: Phosphoric acid, sodium titanium (4+) salt (3:1:2).
CAS number: 22239-24-3.
Basis for action: The PMN states that the substance will be used as
a component in anode material in sealed batteries. Based on SAR
analysis of test data on analogous inorganic phosphates and titanium
compounds, EPA predicts toxicity to aquatic organisms may occur at
concentrations that exceed 4 ppb of the PMN substance in surface
waters. As described in the PMN, releases of the substance are not
expected to result in surface water concentrations exceeding 4 ppb.
Therefore, EPA has not determined that the proposed manufacturing,
processing, or use of the substance may present an unreasonable risk.
EPA has determined, however, that any use of the substance that results
in releases to surface water concentrations exceeding 4 ppb may cause
significant adverse environmental effects. Based on this information,
the PMN substance meets the concern criteria at Sec.
721.170(b)(4)(ii).
Recommended testing: EPA has determined that the results of a fish
acute toxicity test, freshwater and marine (OPPTS Test Guideline
850.1075), an acute invertebrate toxicity test, freshwater daphnids
(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 721.10861.
PMN Numbers P-15-1, P-15-2, P-15-3, P-15-4, P-15-5, and P-15-6
Chemical names: Oxirane, 2-methyl-, polymer with oxirane,
monohexadecyl ether, phosphate (P-15-1); Oxirane, 2-methyl-, polymer
with oxirane, monohexadecyl ether, phosphate, sodium salt (P-15-2);
Oxirane, 2-methyl-, polymer with oxirane, monohexadecyl ether,
phosphate, potassium salt (P-15-3); Oxirane, 2-methyl-, polymer with
oxirane, monohexadecyl ether, phosphate, ammonium salt (P-15-4);
Ethanol, 2-amino-, compd. with 2-methyloxirane polymer with oxirane
monohexadecyl ether phosphate (P-15-5); and Ethanol, 2,2'2'',-
nitrilotris-, compd. with 2-methyloxirane polymer with oxirane
monohexadecyl ether phosphate (P-15-6).
CAS numbers: 73361-29-2 (P-15-1); 151688-56-1 (P-15-2); 1456802-88-
2 (P-15-3); 1456802-89-3 (P-15-4); 1456803-12-5 (P-15-5); and 1456803-
14-7 (P-15-6).
Basis for action: The PMNs state that the generic (non-
confidential) use of the substances will be as inert surfactants in
pesticide formulations. Based on SAR analysis of test data on analogous
anionic surfactant compounds, EPA predicts toxicity to aquatic
organisms may occur at concentrations that exceed 18 ppb in aggregate
of the PMN substances in surface waters. As described in the PMNs,
releases of the substances are not expected to result in surface water
concentrations exceeding 18 ppb in aggregate. 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 aggregate
releases to surface waters exceeding 18 ppb 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 acute
invertebrate 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 substances. The
recommended testing may be performed on any one of the 6 PMN chemicals.
CFR Citation: 40 CFR 721.10862.
[[Page 59599]]
PMN Number P-15-25
Chemical name: Nitrile amine (generic).
CAS number: Claimed confidential.
Basis for action: The PMN states that the generic (non-
confidential) use of the substance will be as a site-limited chemical
intermediate. Based on submitted test data on the PMN substance as well
as SAR analysis of test data on analogous neutral organic compounds,
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 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)(i) and
(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 721.10863.
PMN Number P-15-26
Chemical name: 1,3-Propanediamine, N1, N1-alkyl (generic).
CAS number: Claimed confidential.
Basis for action: The PMN states that the generic (non-
confidential) use of the substance will be as a friction modifier.
Based on submitted test data on an analogous substance as well as SAR
analysis of test data on analogous aliphatic amines, EPA predicts
toxicity to aquatic organisms may occur at concentrations that exceed
32 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 32 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 water
concentrations exceeding 32 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
recommends that the guidance document on aquatic toxicity testing of
difficult substance and mixtures (Organisation for Economic Co-
operation and Development (OECD) Test Guideline 23) be consulted to
facilitate solubility in the test media, because of the PMN substance's
low water solubility.
CFR Citation: 40 CFR 721.10864.
PMN Number P-15-36
Chemical name: 2-Pyridinecarboxylic acid, 4,5,6-trichloro-.
CAS number: 496849-77-5.
Basis for action: The PMN states that the generic (non-
confidential) use of the substance will be as a chemical intermediate.
Based on SAR analysis of test data on analogous pyridine-alpha-acids
and neutral organics, EPA predicts toxicity to aquatic organisms may
occur at concentrations that exceed 30 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 30
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 water concentrations exceeding 30 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
acute toxicity test, freshwater and marine (OPPTS Test Guideline
850.1075), an acute invertebrate toxicity test, freshwater daphnids
(OPPTS Test Guideline 850.1010), an algal toxicity test (OCSPP Test
Guideline 850.4500), and the aerobic/anaerobic transformation in soil
test (OECD 307) would help characterize the environmental effects of
the PMN substance.
CFR Citation: 40 CFR 721.10865.
PMN Number P-15-61
Chemical name: Imidazoliurn, polymer with cyclic anhydride and
alkenoic acid, alkali 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 leather chemical. Based
on SAR analysis of test data on analogous polyanionic polymers, EPA
predicts toxicity to aquatic organisms may occur at concentrations that
exceed 200 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 substance to surface
water, from uses other than as described in the PMN, exceed releases
from the use described in the PMN. For the use described in the PMN,
environmental releases did not exceed 200 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 listed 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 ready
biodegradability test (OPPTS Test Guideline 835.3110), 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 721.10866.
PMN Number P-15-98
Chemical name: Hydrochlorofluorocarbon (generic).
CAS number: Claimed confidential.
Basis for action: The PMN states that the generic (non-
confidential) use of the substance will be as an intermediate in the
production of a hydrofluorocarbon (HFC). Based on SAR analysis of test
data on analogous neutral organics, EPA predicts toxicity to aquatic
organisms may occur at concentrations that exceed 99 ppb of the PMN
substance in surface waters. Further, based on test data on analogous
organohalogen compounds, there were health concerns regarding
anesthesia at high inhalation doses from exposure to the PMN substance
via dermal and inhalation exposure. As described in the PMN, exposure
is expected to be minimal due to use of adequate dermal and respiratory
[[Page 59600]]
personal protection equipment and releases of the substance are not
expected to result in surface water concentrations exceeding 99 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 99 ppb, or any use without the
use of NIOSH-certified organic vapor cartridge respirator with an
assigned protection factor of at least 25, or any use other than as a
chemical intermediate may result in serious human health or significant
adverse environmental effects. Based on this information, the PMN
substance meets the concern criteria at Sec. 721.170(b)(3)(ii) and
(b)(4)(ii).
Recommended testing: EPA has determined that the results of a an
acute inhalation toxicity test (OPPTS Test Guideline 870.1300), fish
acute toxicity test (OPPTS Test Guideline 850.1075), an aquatic
invertebrate acute toxicity test (OPPTS Test Guideline 850.1010), and
algal toxicity test (OCSPP Test Guideline 850.4500) would help
characterize the human health and environmental effects of the PMN
substance.
CFR Citation: 40 CFR 721.10867.
PMN Number P-15-136
Chemical name: Alkylalkenoic acid copolymer (generic).
CAS number: Claimed confidential.
Basis for action: The PMN states that the generic (non-
confidential) use of the substance will be as an encapsulating polymer.
Based on test data on analogous high molecular weight polymers, EPA
identified concerns for lung toxicity. As described in the PMN, EPA
does not expect significant worker inhalation exposure due to no
domestic manufacture, and the substance is not manufactured, processed,
or used in the form of a powder. Therefore, EPA has not determined that
the proposed manufacturing, processing, or use of the substance may
present an unreasonable risk. EPA has determined, however, that any
domestic manufacture of the substance or any import, processing, or use
of the substance in the form of a powder may cause serious health
effects. Based on this information, the PMN substance meets the concern
criteria at Sec. 721.170(b)(3)(ii).
Recommended testing: EPA has determined that the results of a 90-
day inhalation toxicity test with a 60-day holding period (OPPTS Test
Guideline 870.3465) would help characterize the human health effects of
the PMN substance.
CFR Citation: 40 CFR 721.10868.
PMN Number P-15-141
Chemical name: D-Glucitol, alkylamino-N-acyl derivs. (generic).
CAS number: Claimed confidential.
Basis for action: The PMN states that the substance will be used as
a surfactant in cleaning products and liquid soaps. Based on test data
on the PMN substance, as well as SAR analysis of test data on analogous
nonionic surfactants, EPA predicts toxicity to aquatic organisms may
occur at concentrations that exceed 14 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 14
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 14 ppb may cause significant
adverse environmental effects. Based on this information, the PMN
substance meets the concern criteria at Sec. 721.170 (b)(4)(i) and
(b)(4)(ii).
Recommended testing: EPA has determined that the results of a fish
early-life stage toxicity test (OPPTS Test Guideline 850.1400) and a
ready biodegradability test (OECD Test Guideline 301) would help
characterize the environmental effects of the PMN substance.
CFR Citation: 40 CFR 721.10869.
PMN Number P-15-150
Chemical name: Cyclohexanedicarboxylic acid, dialkyl ester
(generic).
CAS number: Claimed confidential.
Basis for action: The PMN states that the generic (non-
confidential) use of the substance will be as an adjuvant used in
reaction processes. Based on SAR analysis of test data on analogous
esters, EPA predicts toxicity to aquatic organisms may occur at
concentrations that exceed 10 ppb of the PMN substance in surface
waters. As described in the PMN, releases of the substance are not
expected to result in surface water concentrations that exceed 10 ppb.
Therefore, EPA has not determined that the proposed manufacturing,
processing, or use of the substance may present an unreasonable risk.
EPA has determined, however, that any use of the substance resulting in
surface water concentrations exceeding 10 ppb may cause significant
adverse environmental effects. Based on this information, the PMN
substance meets the concern criteria at Sec. 721.170(b)(4)(ii).
Recommended testing: EPA has determined that the results of a fish
acute toxicity test, freshwater and marine (OPPTS Test Guideline
850.1075); an acute invertebrate toxicity test, freshwater daphnids
(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 721.10870.
PMN Number P-15-221
Chemical name: Isocyanate prepolymer (generic).
CAS number: Claimed confidential.
Basis for action: The PMN states that the generic (non-
confidential) use of the substance will be as ingredient in an
industrial adhesive. Based on SAR analysis of test data on analogous
diisocyanates, EPA identified concerns for irritation and sensitization
to the skin and lungs. As described in the PMN, EPA does not expect
significant occupational dermal or inhalation exposure due to use of
adequate personal protective equipment and consumer exposures are not
expected as the PMN substance is not used in consumer products.
Therefore, EPA has not determined that the proposed manufacture,
processing, or use of the substance may present an unreasonable risk.
EPA has determined, however, that any use of the substance without a
NIOSH-certified particulate respirator with an APF of at least 10 where
there is a potential for inhalation exposure, or any use in consumer
products may cause serious health effects. Based on this information,
the PMN substance meets the concern criteria at Sec.
721.170(b)(3)(ii).
Recommended testing: EPA has determined that the results of a skin
sensitization test (OPPTS Test Guideline 870.2600) and a 90-day
subchronic inhalation toxicity test (OPPTS Test Guideline 870.3465)
would help characterize the human health effects of the PMN substance.
CFR Citation: 40 CFR 721.10871.
PMN Number P-15-242
Chemical name: Heteropolycyclic, polymer with alkanedioic acid, di-
alkenoate (generic).
CAS number: Claimed confidential.
Basis for action: The PMN states that the generic (non-
confidential) use of the substance will be as a coating resin. Based on
test data on analogous acrylates, EPA identified concerns for
oncogenicity, developmental toxicity, liver and kidney toxicity,
sensitization,
[[Page 59601]]
irritation, and acute toxicity. Further, based on SAR analysis of test
data on analogous acrylates, EPA predicts toxicity to aquatic organisms
may occur at concentrations that exceed 120 ppb of the PMN substance in
surface waters. As described in the PMN, occupational exposures are
expected to be minimal due to the use of impervious gloves, goggles,
and NIOSH-certified particulate respirators with an APF of at least 10.
Further, releases of the substance are not expected to result in
surface water concentrations exceeding 120 ppb. Therefore, EPA has not
determined that the proposed manufacturing, processing, or use of the
substance may present an unreasonable risk. EPA has determined,
however, that use of the substance without use of impervious gloves and
goggles, when there is a potential dermal exposure; use of the
substance without a NIOSH-certified particulate respirator with an APF
of at least 10, where there is a potential for inhalation exposures; or
any use of the substance that results in releases to surface waters
exceeding 120 ppb may result in significant adverse health and
environmental effects. Based on this information, the PMN substance
meets the concern criteria at Sec. 721.170 (b)(1)(i)(C), (b)(3)(ii),
and (b)(4)(ii).
Recommended testing: EPA has determined that the results of a
combined repeated dose toxicity with the reproduction/developmental
toxicity screening test (OPPTS 870.3650); 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 human
health and environmental effects of the PMN substance.
CFR Citation: 40 CFR 721.10872.
PMN Number P-15-247
Chemical name: Methylene diisocyanate polymer with diols and triols
(generic).
CAS number: Claimed confidential.
Basis for action: The PMN states that the generic (non-
confidential) use of the substance will be as an industrial adhesive.
Based on SAR analysis of test data on analogous diisocyanates, EPA
identified concerns for respiratory and dermal sensitization and lung
and mucous membrane irritation based on the isocyanate moiety As
described in the PMN, EPA does not expect significant occupational
dermal or inhalation exposure due to use of adequate personal
protective equipment and consumer exposures are not expected as the PMN
substance is not used in consumer products. Therefore, EPA has not
determined that the proposed manufacture, processing, or use of the
substance may present an unreasonable risk. EPA has determined,
however, that any use of the substance without a NIOSH-certified
particulate respirator with an APF of at least 10 where there is a
potential for inhalation exposure, or any use in consumer products, may
cause serious health effects. Based on this information, the PMN
substance meets the concern criteria at Sec. 721.170(b)(3)(ii).
Recommended testing: EPA has determined that the results of a skin
sensitization test (OPPTS Test Guideline 870.2600) and a 90-day
subchronic inhalation toxicity test (OPPTS Test Guideline 870.3465)
would help characterize the human health effects of the PMN substance.
CFR Citation: 40 CFR 721.10873.
PMN Number P-15-278
Chemical name: Polymer of isophorone diisocyanate and amine-
terminated propoxylatedpolyol (generic).
CAS numbers: Claimed confidential.
Basis for action: The PMN states that the generic (non-
confidential) use of the substance will be as a crosslinker. Based on
analogous diisocyanates, EPA identified concerns for potential dermal
and respiratory sensitization from dermal and inhalation exposures, and
for pulmonary toxicity from inhalation exposure, to the PMN substance
when the average molecular weight is below 2500 daltons and any
molecular weight species is below 1000 daltons. EPA does not expect
significant exposures from the form of the PMN substance as described
in the PMN. Therefore, EPA has not determined that the proposed
manufacture of the substance may present an unreasonable risk. EPA has
determined, however, that any manufacture of the PMN substance with an
average molecular weight of below 2500 daltons and any molecular weight
species below 1000 daltons may cause serious health effects. Based on
this information, the PMN substance meets the concern criteria at Sec.
721.170(b)(3)(ii).
Recommended testing: EPA has determined that the results of a skin
sensitization test (OPPTS Test Guideline 870.2600) and a 90-day
subchronic inhalation toxicity test (OPPTS Test Guideline 870.3465)
would help characterize the human health effects of the PMN substance.
CFR Citation: 40 CFR 721.10874.
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 9 of the 30
chemical substances, regulation was warranted under TSCA section 5(e),
pending the development of information sufficient to make reasoned
evaluations of the health or environmental effects of the chemical
substances. The basis for such findings is outlined in Unit IV. Based
on these findings, TSCA section 5(e) consent orders requiring the use
of appropriate exposure controls were negotiated with the PMN
submitters. The SNUR provisions for these chemical substances are
consistent with the provisions of the TSCA section 5(e) consent orders.
These SNURs are promulgated pursuant to Sec. [emsp14]721.160 (see Unit
VI.).
In the other 21 cases, where the uses are not regulated under a
TSCA section 5(e) consent order, EPA determined that one or more of the
criteria of concern established at Sec. [emsp14]721.170 were met, as
discussed in Unit IV.
B. Objectives
EPA is issuing these SNURs for specific chemical substances which
have undergone premanufacture review because the Agency wants to
achieve the following objectives with regard to the significant new
uses designated in this rule:
EPA will receive notice of any person's intent to
manufacture or process a listed chemical substance for the described
significant new use before that activity begins.
EPA will have an opportunity to review and evaluate data
submitted in a SNUN before the notice submitter begins manufacturing or
processing a listed chemical substance for the described significant
new use.
EPA will be able to regulate prospective manufacturers or
processors of a listed chemical substance before the described
significant new use of that chemical substance occurs, provided that
regulation is warranted pursuant to TSCA section 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
[[Page 59602]]
Internet at http://www.epa.gov/opptintr/existingchemicals/pubs/tscainventory/index.html.
VI. Direct Final Procedures
EPA is issuing these SNURs as a direct final rule, as described in
Sec. [emsp14]721.160(c)(3) and Sec. [emsp14]721.170(d)(4). In
accordance with Sec. [emsp14]721.160(c)(3)(ii) and Sec.
[emsp14]721.170(d)(4)(i)(B), the effective date of this rule is
December 1, 2015 without further notice, unless EPA receives written
adverse or critical comments, or notice of intent to submit adverse or
critical comments before November 2, 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 November 2, 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 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 9 of the 30 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 30 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 October 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. Persons who intend to exceed the
production limit must notify the Agency by submitting a SNUN at least
90 days in advance of commencement of non-exempt commercial manufacture
or processing.
The recommended tests specified in Unit IV. may not be the only
means of addressing the potential risks of the chemical substance.
However, submitting a SNUN without any test data may increase the
likelihood that EPA will take action under TSCA section 5(e),
particularly if satisfactory test results have not been obtained from a
prior PMN or SNUN submitter. EPA recommends that potential SNUN
submitters contact EPA early enough so that they will be able to
conduct the appropriate tests.
SNUN submitters should be aware that EPA will be better able to
evaluate SNUNs which provide detailed information on the following:
Human exposure and environmental release that may result
from the significant new use of the chemical substances.
Potential benefits of the chemical substances.
Information on risks posed by the chemical substances
compared to risks posed by potential substitutes.
IX. Procedural Determinations
By this rule, EPA is establishing certain significant new uses
which have
[[Page 59603]]
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.
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 Sec. 721.25. E-PMN software is
available electronically at http://www.epa.gov/opptintr/newchems.
XI. Economic Analysis
EPA has evaluated the potential costs of establishing SNUN
requirements for potential manufacturers and processors of the chemical
substances subject to this rule. EPA's complete economic analysis is
available in the docket under docket ID number EPA-HQ-OPPT-2015-0388.
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
[[Page 59604]]
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.
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: September 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. 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
------------------------------------------------------------------------
* * * * *
721.10852............................................... 2070-0012
721.10853............................................... 2070-0012
721.10854............................................... 2070-0012
721.10855............................................... 2070-0012
721.10856............................................... 2070-0012
721.10857............................................... 2070-0012
721.10858............................................... 2070-0012
721.10859............................................... 2070-0012
721.10860............................................... 2070-0012
721.10861............................................... 2070-0012
721.10862............................................... 2070-0012
721.10863............................................... 2070-0012
721.10864............................................... 2070-0012
721.10865............................................... 2070-0012
721.10866............................................... 2070-0012
721.10867............................................... 2070-0012
721.10868............................................... 2070-0012
721.10869............................................... 2070-0012
721.10870............................................... 2070-0012
721.10871............................................... 2070-0012
721.10872............................................... 2070-0012
721.10873............................................... 2070-0012
721.10874............................................... 2070-0012
------------------------------------------------------------------------
* * * * *
------------------------------------------------------------------------
* * * * *
PART 721--[AMENDED]
0
3. The authority citation for part 721 continues to read as follows:
Authority: 15 U.S.C. 2604, 2607, and 2625(c).
0
4. Add Sec. 721.10852 to subpart E to read as follows:
Sec. 721.10852 Fatty acids compound with cyclohexanamine (generic).
(a) Chemical substances and significant new uses subject to
reporting. (1) The chemical substances identified generically as fatty
acids compound with cyclohexanamine (PMNs P-12-69 and P-12-70) 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(k) and (q).
(ii) [Reserved]
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph.
(1) Recordkeeping. Recordkeeping requirements as specified in
[[Page 59605]]
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 this section.
0
5. Add Sec. 721.10853 to subpart E to read as follows:
Sec. 721.10853 Fluoro-modified acrylic copolymer (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as fluoro-
modified acrylic copolymer (PMN P-12-169) is subject to reporting under
this section for the significant new uses described in paragraph (a)(2)
of this section.
(2) The significant new uses are:
(i) Hazard communication program. A significant new use of the
substance is any manner or method of manufacture or processing
associated with any use of the substance without providing risk
notification as follows:
(A) If as a result of the test data required under the TSCA section
5(e) consent order for the substance, the employer becomes aware that
the substances may present a risk of injury to human health or the
environment, the employer must incorporate this new information, and
any information on methods for protecting against such risk, into a
MSDS as described in Sec. 721.72(c) within 90 days from the time the
employer becomes aware of the new information. If the substance is not
being manufactured, processed, or used in the employer's workplace, the
employer must add the new information to a MSDS before the substance is
reintroduced into the workplace.
(B) The employer must ensure that persons who will receive the PMN
substance from the employer, or who have received the PMN substance
from the employer within 5 years from the date the employer becomes
aware of the new information described in paragraph (a)(2)(i)(A) of
this section, are provided an MSDS containing the information required
under paragraph (a)(2)(i)(A) of this section within 90 days from the
time the employer becomes aware of the new information.
(ii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(k) (a significant new use is any use other
than as allowed by the section 5(e) consent order, which includes
analysis and reporting and limitations of maximum impurity levels of
certain fluorinated impurities), and (q).
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph.
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125 (a), (b), (c), (f), 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.
(3) Determining whether a specific use is subject to this section.
The provisions of Sec. 721.1725(b)(1) apply to this section.
0
6. Add Sec. 721.10854 to subpart E to read as follows:
Sec. 721.10854 Siloxanes and Silicones, alkyl, alky propoxy ethyl,
methyl octyl, alkyl polyfluorooctyl (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
siloxanes and silicones, alkyl, alky propoxy ethyl, methyl octyl, alkyl
polyfluorooctyl (PMN P-12-351) is subject to reporting under this
section for the significant new uses described in paragraph (a)(2) of
this section.
(2) The significant new uses are:
(i) Hazard communication program. A significant new use of the
substance is any manner or method of manufacture or processing
associated with any use of the substance without providing risk
notification as follows:
(A) If as a result of the test data required under the TSCA section
5(e) consent order for the substance, the employer becomes aware that
the substances may present a risk of injury to human health or the
environment, the employer must incorporate this new information, and
any information on methods for protecting against such risk, into a
MSDS as described in Sec. 721.72(c) within 90 days from the time the
employer becomes aware of the new information. If the substance is not
being manufactured, processed, or used in the employer's workplace, the
employer must add the new information to a MSDS before the substance is
reintroduced into the workplace.
(B) The employer must ensure that persons who will receive the PMN
substance from the employer, or who have received the PMN substance
from the employer within 5 years from the date the employer becomes
aware of the new information described in paragraph (a)(2)(i)(A) of
this section, are provided an MSDS containing the information required
under paragraph (a)(2)(i)(A) of this section within 90 days from the
time the employer becomes aware of the new information.
(ii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(k) (a significant new use is any use other
than as allowed by the section 5(e) consent order, which includes
analysis and reporting and limitations of maximum impurity levels of
certain fluorinated impurities), and (q).
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph.
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125 (a), (b), (c), (f), 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.
(3) Determining whether a specific use is subject to this section.
The provisions of Sec. 721.1725(b)(1) apply to this section.
0
7. Add Sec. 721.10855 to subpart E to read as follows:
Sec. 721.10855 Partially fluorinated alcohol, reaction products with
phosphorus oxide (P[bdi2]O[bdi5]) amine salts (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substances identified generically as
partially fluorinated alcohol, reaction products with phosphorus oxide
(P2O5), amine salts (PMNs P-12-450 and P-12-451)
are subject to reporting under this section for the significant new
uses described in paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Hazard communication program. A significant new use of the
substances is any manner or method of manufacture or processing
associated with any use of the substances without providing risk
notification as follows:
(A) If as a result of the test data required under the TSCA section
5(e) consent order for the substances, the employer becomes aware that
the substances may present a risk of injury to human health or the
environment, the employer must incorporate this new information, and
any information on methods for protecting against such risk, into a
MSDS as described in Sec. 721.72(c) within 90 days from the time the
employer becomes aware of the new information. If the substance(s) are
not being manufactured, processed, or used in the employer's workplace,
the employer must add the new information to a MSDS before the
substance(s) are reintroduced into the workplace.
[[Page 59606]]
(B) The employer must ensure that persons who will receive the PMN
substance(s) from the employer, or who have received the PMN
substance(s) from the employer within 5 years from the date the
employer becomes aware of the new information described in paragraph
(a)(2)(i)(A) of this section, are provided an MSDS containing the
information required under paragraph (a)(2)(i)(A) of this section
within 90 days from the time the employer becomes aware of the new
information.
(ii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(k) (a significant new use is any use other
than as allowed by the section 5(e) consent order, which includes
analysis and reporting and limitations of maximum impurity levels of
certain fluorinated impurities), and (q).
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph.
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125 (a), (b), (c), (f), 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.
(3) Determining whether a specific use is subject to this section.
The provisions of Sec. 721.1725(b) (1) apply to paragraph (a)(2)(ii)
of this section.
0
8. Add Sec. 721.10856 to subpart E to read as follows:
Sec. 721.10856 Fatty acids amine salt (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as fatty
acids amine salt (PMN P-12-520) is subject to reporting under this
section for the significant new uses described in paragraph (a)(2) of
this section.
(2) The significant new uses are:
(i) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(k) and (q).
(ii) [Reserved]
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph.
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a), (b), (c), and (i) are applicable to manufacturers and
processors of this substance.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
(3) Determining whether a specific use is subject to this section.
The provisions of Sec. 721.1725(b)(1) apply to this section.
0
9. Add Sec. 721.10857 to subpart E to read as follows:
Sec. 721.10857 Organophosphorus polymer (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
organophosphorus polymer (PMN P-13-292) 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(q).
(ii) [Reserved]
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph.
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a), (b), (c), and (i) are applicable to manufacturers and
processors of this substance.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
(3) Determining whether a specific use is subject to this section.
The provisions of Sec. 721.1725(b)(1) apply to this section.
0
10. Add Sec. [emsp14]721.10858 to subpart E to read as follows:
Sec. [emsp14]721.10858 Fluorinated acid alkylester (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
fluorinated acid alkylester (PMN P-13-305) is subject to reporting
under this section for the significant new uses described in paragraph
(a)(2) of this section.
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in Sec.
721.63 (a)(1), (a)(2)(i), (a)(3), (a)(4), (a)(6)(i), (a)(6)(ii), (b)
(concentration set at 1.0 percent), and (c). When determining which
persons are reasonably likely to be exposed as required for Sec.
721.63(a)(4), engineering control measures (e.g., enclosure or
confinement of the operation, general and local ventilation) or
administrative control measures (e.g., workplace policies and
procedures) shall be considered and implemented to prevent exposure,
where feasible. The following 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): Any NIOSH-certified air-purifying full facepiece
respirator equipped with N100 (if oil aerosols absent), R100, or P100
filters.
(ii) Hazard communication program. Requirements as specified in
Sec. 721.72(a), (b), (c), (d), (e), (f)(concentration set at 1.0
percent), (g)(1)(The PMN substance may cause central nervous system
depression, liver effects, endocrine effects), (g)(2), and (g)(5). In
addition a significant new use of the substances is any manner or
method of manufacture or processing associated with any use of the
substances without providing risk notification as follows:
(A) If as a result of the test data required under the TSCA section
5(e) consent order for the substances, the employer becomes aware that
the substances may present a risk of injury to human health or the
environment, the employer must incorporate this new information, and
any information on methods for protecting against such risk, into a
MSDS as described in Sec. 721.72(c) within 90 days from the time the
employer becomes aware of the new information. If the substance(s) are
not being manufactured, processed, or used in the employer's workplace,
the employer must add the new information to a MSDS before the
substance(s) are reintroduced into the workplace.
(B) The employer must ensure that persons who will receive the PMN
substance(s) from the employer, or who have received the PMN
substance(s) from the employer within 5 years from the date the
employer becomes aware of the new information described in paragraph
(a)(2)(i)(A) of this section, are provided an MSDS containing the
information required under paragraph (a)(2)(i)(A) of this section
within 90 days from the time the employer becomes aware of the new
information.
(iii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80 (g) and (o). It is a significant new use
for any chemical substance manufactured using the PMN substance to
contain residuals of the PMN substance above the level specified in the
consent order. It is a significant new use to recover and convert,
capture (destroy), recycle, or reuse the PMN substance below the
overall efficiency specified in the consent order, when the PMN
substance is used as an intermediate.
(b) Specific requirements. The provisions of subpart A of this part
[[Page 59607]]
apply to this section except as modified by this paragraph.
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a), (b), (c), and (i) are applicable to manufacturers and
processors of this substance.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
(3) Determining whether a specific use is subject to this section.
The provisions of Sec. 721.1725(b)(1) apply to this section.
0
11. Add Sec. [emsp14]721.10859 to subpart E to read as follows:
Sec. 721.10859 Quaternary alkyl methyl amine ethoxylate methyl
chloride (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
quaternary alkyl methyl amine ethoxylate methyl chloride (PMN P-14-563)
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=29).
(ii) [Reserved]
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph.
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125 (a), (b), (c), and (k) are applicable to manufacturers and
processors of this substance.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
0
12. Add Sec. 721.10860 to subpart E to read as follows:
Sec. 721.10860 Substituted carboxamide (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
substituted carboxamide (PMN P-14-756) is subject to reporting under
this section for the significant new uses described in paragraph (a)(2)
of this section.
(2) The significant new uses are:
(i) Release to water. Requirements as specified in Sec. 721.90
(a)(4), (b)(4), and (c)(4) (N=3).
(ii) [Reserved]
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph.
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125 (a), (b), (c), and (k) are applicable to manufacturers and
processors of this substance.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
0
13. Add Sec. 721.10861 to subpart E to read as follows:
Sec. 721.10861 Phosphoric acid, sodium titanium (4+) salt (3:1:2).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as phosphoric acid,
sodium titanium (4+) salt (3:1:2) (PMN P-14-804; CAS No. 22239-24-3) 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=4).
(ii) [Reserved]
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph.
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125 (a), (b), (c), and (k) are applicable to manufacturers and
processors of this substance.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
0
14. Add Sec. 721.10862 to subpart E to read as follows:
Sec. 721.10862 Oxirane, 2-methyl-, polymer with oxirane,
monohexadecyl ether, phosphate; Oxirane, 2-methyl-, polymer with
oxirane, monohexadecyl ether, phosphate, sodium salt; Oxirane, 2-
methyl-, polymer with oxirane, monohexadecyl ether, phosphate,
potassium salt; Oxirane, 2-methyl-, polymer with oxirane, monohexadecyl
ether, phosphate, ammonium salt; Ethanol, 2-amino-, compd. with 2-
methyloxirane polymer with oxirane monohexadecyl ether phosphate; and
Ethanol, 2,2'2'',-nitrilotris-, compd. with 2-methyloxirane polymer
with oxirane monohexadecyl ether phosphate.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substances identified as oxirane, 2-methyl-
, polymer with oxirane, monohexadecyl ether, phosphate (P-15-1; CAS No.
73361-29-2); oxirane, 2-methyl-, polymer with oxirane, monohexadecyl
ether, phosphate, sodium salt (P-15-2; CAS No. 151688-56-1); oxirane,
2-methyl-, polymer with oxirane, monohexadecyl ether, phosphate,
potassium salt (P-15-3; CAS No. 1456802-88-2); oxirane, 2-methyl-,
polymer with oxirane, monohexadecyl ether, phosphate, ammonium salt (P-
15-4; CAS No. 1456802-89-3); ethanol, 2-amino-, compd. with 2-
methyloxirane polymer with oxirane monohexadecyl ether phosphate (P-15-
5; CAS No, 1456803-12-5); and ethanol, 2,2''2'',-nitrilotris-, compd.
with 2-methyloxirane polymer with oxirane monohexadecyl ether phosphate
(PMN P-15-6; CAS No. 1456803-14-7) 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=18 in aggregate).
(ii) [Reserved]
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph.
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125 (a), (b), (c), and (k) are applicable to manufacturers and
processors of this substance.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
0
15. Add Sec. 721.10863 to subpart E to read as follows:
Sec. 721.10863 Nitrile amine (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as nitrile
amine (PMN P-15-25) is subject to reporting under this section for the
significant new uses described in paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Release to water. Requirements as specified in Sec. 721.90
(a)(4), (b)(4), and (c)(4) (N=1).
(ii) [Reserved]
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph.
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125 (a), (b), (c), and (k) are applicable to manufacturers and
processors of this substance.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
0
16. Add Sec. 721.10864 to subpart E to read as follows:
[[Page 59608]]
Sec. 721.10864 1,3-propanediamine, N1, N1-alkyl (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as 1,3-
propanediamine, N1, N1-alkyl (PMN P-15-26) 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=32).
(ii) [Reserved]
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph.
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125 (a), (b), (c), and (k) are applicable to manufacturers and
processors of this substance.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
0
17. Add Sec. 721.10865 to subpart E to read as follows:
Sec. 721.10865 2-Pyridinecarboxylic acid, 4,5,6-trichloro-.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as 2-
pyridinecarboxylic acid, 4,5,6-trichloro- (PMN P-15-36; CAS No. 496849-
77-5) is subject to reporting under this section for the significant
new uses described in paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Release to water. Requirements as specified in Sec. 721.90
(a)(4), (b)(4), and (c)(4) (N=30).
(ii) [Reserved]
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph.
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125 (a), (b), (c), and (k) are applicable to manufacturers and
processors of this substance.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
0
18. Add Sec. 721.10866 to subpart E to read as follows:
Sec. 721.10866 Imidazoliurn, polymer with cyclic anhydride and
alkenoic acid, alkali salt (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
imidazoliurn, polymer with cyclic anhydride and alkenoic acid, alkali
salt (PMN P-15-61) is subject to reporting under this section for the
significant new uses described in paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Industrial commercial, and consumer activities. Requirements as
specified in Sec. 721.80 (j).
(ii) [Reserved]
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph.
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125 (a), (b), (c), and (i) are applicable to manufacturers and
processors of this substance.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
(3) Determining whether a specific use is subject to this section.
The provisions of Sec. 721.1725(b)(1) apply to paragraph (a)(2)(i) of
this section.
0
19. Add Sec. 721.10867 to subpart E to read as follows:
Sec. 721.10867 Hydrochlorofluorocarbon (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
hydrochlorofluorocarbon. (PMN P-15-98) is subject to reporting under
this section for the significant new uses described in paragraph (a)(2)
of this section.
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in Sec.
40 CFR 721.63 (a)(4), (a)(6)(i), (a)(6)(ii), (b)(concentration set at
1.0 percent), and (c). When determining which persons are reasonably
likely to be exposed as required for Sec. 721.63(a)(4), engineering
control measures (e.g., enclosure or confinement of the operation,
general and local ventilation) or administrative control measures
(e.g., workplace policies and procedures) shall be considered and
implemented to prevent exposure, where feasible. The following National
Institute for Occupational Safety and Health (NIOSH)-certified
respirators with an assigned protection factor (APF) of at least 25
meet the requirements of Sec. 721.63(a)(4):
(A) NIOSH-certified power air-purifying respirator with a hood or
helmet and with appropriate gas/vapor (acid gas, organic vapor, or
substance specific) cartridges in combination with HEPA filters.
(B) NIOSH-certified continuous flow supplied-air respirator
equipped with a loose fitting facepiece, hood, or helmet.
(ii) Industrial commercial, and consumer activities. Requirements
as specified in Sec. 721.80 (g).
(iii) Release to water. Requirements as specified in Sec. 721.90
(a)(4), (b)(4), and (c)(4) (N=99).
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph.
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125 (a), (b), (c), (d), (i), and (k) are applicable to
manufacturers and processors of this substance.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
0
20. Add Sec. 721.10868 to subpart E to read as follows:
Sec. 721.10868 Alkylalkenoic acid copolymer (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
alkylalkenoic acid copolymer (PMN P-15-136) is subject to reporting
under this section for the significant new uses described in paragraph
(a)(2) of this section.
(2) The significant new uses are:
(i) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80 (f), (v)(1), (w)(1), and (x)(1).
(ii) [Reserved]
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph.
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125 (a), (b), (c) and (i) are applicable to manufacturers and
processors of this substance.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
0
21. Add Sec. 721.10869 to subpart E to read as follows:
Sec. 721.10869 D-Glucitol, alkylamino-N-acyl derivs. (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as D-
glucitol, alkylamino-N-acyl derivs. (PMN P-15-141) 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:
[[Page 59609]]
(i) Release to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4), and (c)(4) (N=14).
(ii) [Reserved]
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph.
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125 (a), (b), (c), and (k) are applicable to manufacturers and
processors of this substance.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
0
22. Add Sec. 721.10870 to subpart E to read as follows:
Sec. 721.10870 Cyclohexanedicarboxylic acid, dialkyl ester (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
cyclohexanedicarboxylic acid, dialkyl ester (PMN P-15-150) is subject
to reporting under this section for the significant new uses described
in paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Release to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4), and (c)(4) (N=10).
(ii) [Reserved]
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph.
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125 (a), (b), (c), and (k) are applicable to manufacturers and
processors of this substance.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
0
23. Add Sec. 721.10871 to subpart E to read as follows:
Sec. 721.10871 Isocyanate prepolymer (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
isocyanate prepolymer (PMN P-15-221) is subject to reporting under this
section for the significant new uses described in paragraph (a)(2) of
this section.
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(4), (a)(6)(ii), and (c). When determining which persons are
reasonably likely to be exposed as required for Sec. 721.63(a)(4),
engineering control measures (e.g., enclosure or confinement of the
operation, general and local ventilation) or administrative control
measures (e.g., workplace policies and procedures) shall be considered
and implemented to prevent exposure, where feasible. The following
National Institute for Occupational Safety and Health (NIOSH)-certified
respirators with an assigned protection factor (APF) of at least 10
meet the requirements of Sec. 721.63(a)(4):
(A) NIOSH-certified power air-purifying respirator with a hood or
helmet and with appropriate gas/vapor (acid gas, organic vapor, or
substance specific) cartridges in combination with HEPA filters.
(B) NIOSH-certified continuous flow supplied-air respirator
equipped with a loose fitting facepiece, hood, or helmet.
(C) NIOSH-certified negative pressure (demand) supplied-air
respirator with a full facepiece.
(ii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(o).
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph.
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125 (a), (b), (c), (d) and (i) are applicable to manufacturers,
importers, and processors of this substance.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
0
24. Add Sec. 721.10872 to subpart E to read as follows:
Sec. 721.10872 Heteropolycyclic, polymer with alkanedioic acid, di-
alkenoate (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
heteropolycyclic, polymer with alkanedioic acid, di-alkenoate (PMN P-
15-242) is subject to reporting under this section for the significant
new uses described in paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(1), (a)(2)(i), (a)(2)(iii), (a)(3), (a)(4), (a)(6)(ii),
(a)(6)(v), and (c). When determining which persons are reasonably
likely to be exposed as required for Sec. 721.63(a)(1) and (a)(4),
engineering control measures (e.g., enclosure or confinement of the
operation, general and local ventilation) or administrative control
measures (e.g., workplace policies and procedures) shall be considered
and implemented to prevent exposure, where feasible. The following
National Institute for Occupational Safety and Health (NIOSH)-certified
respirators with an assigned protection factor (APF) of at least 10
meet the requirements of Sec. 721.63(a)(4):
(A) NIOSH-certified power air-purifying respirator with a hood or
helmet and with appropriate gas/vapor (acid gas, organic vapor, or
substance specific) cartridges in combination with HEPA filters.
(B) NIOSH-certified continuous flow supplied-air respirator
equipped with a loose fitting facepiece, hood, or helmet.
(ii) Release to water. Requirements as specified 721.90 (a)(4),
(b)(4), and (c)(4) (N=120).
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph.
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125 (a), (b), (c), (d), (e) and (k) are applicable to
manufacturers, importers, and processors of this substance.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
0
25. Add Sec. 721.10873 to subpart E to read as follows:
Sec. 721.10873 Methylene diisocyanate polymer with diols and triols
(generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
methylene diisocyanate polymer with diols and triols (PMN P-15-247) is
subject to reporting under this section for the significant new uses
described in paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(4), (a)(6)(ii), and (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
[[Page 59610]]
specific) cartridges in combination with HEPA filters.
(B) NIOSH-certified continuous flow supplied-air respirator
equipped with a loose fitting facepiece, hood, or helmet.
(C) NIOSH-certified negative pressure (demand) supplied-air
respirator with a full facepiece.
(ii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(o).
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph.
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125 (a), (b), (c), (d) and (i) are applicable to manufacturers,
importers, and processors of this substance.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
0
26. Add Sec. 721.10874 to subpart E to read as follows:
Sec. 721.10874 Polymer of isophorone diisocyanate and amine-
terminated propoxylatedpolyol (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as polymer
of isophorone diisocyanate and amine-terminated propoxylatedpolyol (PMN
P-15-278) 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 manufacture of
the substance where the average molecular weight is below 2500 daltons
and where any molecular weight species is below 1000 daltons.
(ii) [Reserved]
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph.
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125 (a), (b), (c) and (i) are applicable to manufacturers,
importers, and processors of this substance.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
[FR Doc. 2015-24846 Filed 10-1-15; 8:45 am]
BILLING CODE 6560-50-P