Significant New Use Rules on Certain Chemical Substances, 59593-59610 [2015-24846]

Agencies

• ENVIRONMENTAL PROTECTION AGENCY

[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: https://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 https://www.epa.gov/dockets/contacts.html.
    Additional instructions on commenting or visiting the docket, along 
with more information about dockets generally, is available at https://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: moss.kenneth@epa.gov.

[[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: TSCA-Hotline@epa.gov.

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this action apply to me?

    You may be potentially affected by this action if you manufacture, 
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 https://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 https://www.epa.gov/opptintr/existingchemicals/pubs/tscainventory/.

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 https://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 https://www.oecdbookshop.org or SourceOECD at 
https://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 https://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