Document ID: EPA-HQ-OPPT-2014-0390-0001
Agency: epa
Document Type: Rule
Title: Significant New Use Rules on Certain Chemical Substances
Posted Date: 2014-10-27T04:00Z

[Federal Register Volume 79, Number 207 (Monday, October 27, 2014)]
[Rules and Regulations]
[Pages 63821-63840]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-24916]

=======================================================================
-----------------------------------------------------------------------

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Parts 9 and 721

[EPA-HQ-OPPT-2014-0390; FRL-9914-56]
RIN 2070-AB27

Significant New Use Rules on Certain Chemical Substances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Direct final rule.

-----------------------------------------------------------------------

SUMMARY: EPA is promulgating significant new use rules (SNURs) under 
the Toxic Substances Control Act (TSCA) for 52 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 52 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 26, 2014. For purposes of 
judicial review, this rule shall be promulgated at 1 p.m. (e.s.t.) on 
November 10, 2014.
    Written adverse or critical comments, or notice of intent to submit 
adverse or critical comments, on one or more of these SNURs must be 
received on or before November 26, 2014 (see Unit VI. of the 
SUPPLEMENTARY INFORMATION). If EPA receives written adverse or critical 
comments, or notice of intent to submit adverse or critical comments, 
on one or more of these SNURs before November 26, 2014, EPA will 
withdraw the relevant sections of this direct final rule before its 
effective date.
    For additional information on related reporting requirement dates, 
see Units

[[Page 63822]]

I.A., VI., and VII. of the SUPPLEMENTARY INFORMATION.

ADDRESSES: Submit your comments, identified by docket identification 
(ID) number EPA-HQ-OPPT-2014-0390, by one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the online instructions for submitting comments. Do not submit 
electronically any information you consider to be Confidential Business 
Information (CBI) or other information whose disclosure is restricted 
by statute.
     Mail: Document Control Office (7407M), Office of Pollution 
Prevention and Toxics (OPPT), Environmental Protection Agency, 1200 
Pennsylvania Ave. NW., Washington, DC 20460-0001.
     Hand Delivery: To make special arrangements for hand 
delivery or delivery of boxed information, please follow the 
instructions at http://www.epa.gov/dockets/contacts.html.
    Additional instructions on commenting or visiting the docket, along 
with more information about dockets generally, is available at http://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: 
For technical information contact: Kenneth Moss, Chemical Control 
Division (7405 M), Office of Pollution Prevention and Toxics, 
Environmental Protection Agency, 1200 Pennsylvania Ave. NW., 
Washington, DC 20460-0001; telephone number: (202) 564-9232; email 
address: moss.kenneth@epa.gov.
For general information contact: The TSCA-Hotline, ABVI-Goodwill, 422 
South Clinton Ave., Rochester, NY 14620; telephone number: (202) 554-
1404; email address: TSCA-Hotline@epa.gov.

SUPPLEMENTARY INFORMATION: 

I. General Information

A. Does this action apply to me?

    You may be potentially affected by this action if you manufacture, 
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 submitting comments, 
remember to:
    i. Identify the document by docket ID number and other identifying 
information (subject heading, Federal Register date and page number).
    ii. Follow directions. The Agency may ask you to respond to 
specific questions or organize comments by referencing a Code of 
Federal Regulations (CFR) part or section number.
    iii. Explain why you agree or disagree; suggest alternatives and 
substitute language for your requested changes.
    iv. Describe any assumptions and provide any technical information 
and/or data that you used.
    v. If you estimate potential costs or burdens, explain how you 
arrived at your estimate in sufficient detail to allow for it to be 
reproduced.
    vi. Provide specific examples to illustrate your concerns and 
suggest alternatives.
    vii. Explain your views as clearly as possible, avoiding the use of 
profanity or personal threats.
    viii. Make sure to submit your comments by the comment period 
deadline identified.

II. Background

A. What action is the Agency taking?

    EPA is promulgating these SNURs using direct final procedures. 
These SNURs will require persons to notify EPA at least 90 days before 
commencing the manufacture or processing of a chemical substance for 
any activity designated by these SNURs as a significant new use. 
Receipt of such notices allows EPA to assess risks that may be 
presented by the intended uses and, if appropriate, to regulate the 
proposed use before it occurs. Additional rationale and background to 
these rules are more fully set out in the preamble to EPA's first 
direct final SNUR published in the Federal Register 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

[[Page 63823]]

SNUN requirements and EPA regulatory procedures as submitters of PMNs 
under TSCA section 5(a)(1)(A). In particular, these requirements 
include the information submission requirements of TSCA section 5(b) 
and 5(d)(1), the exemptions authorized by TSCA section 5(h)(1), (h)(2), 
(h)(3), and (h)(5), and the regulations at 40 CFR part 720. Once EPA 
receives a SNUN, EPA may take regulatory action under TSCA sections 
5(e), 5(f), 6, or 7 to control the activities for which it has received 
the SNUN. If EPA does not take action, EPA is required under TSCA 
section 5(g) to explain in the Federal Register its reasons for not 
taking action.

III. Significant New Use Determination

    Section 5(a)(2) of TSCA states that EPA's determination that a use 
of a chemical substance is a significant new use must be made after 
consideration of all relevant factors, including:
     The projected volume of manufacturing and processing of a 
chemical substance.
     The extent to which a use changes the type or form of 
exposure of human 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 52 
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 52 chemical substances in 40 CFR part 721, subpart E. 
In this unit, EPA provides the following information for each chemical 
substance:
     PMN number.
     Chemical name (generic name, if the specific name is 
claimed as CBI).
     Chemical Abstracts Service (CAS) Registry number (if 
assigned for non-confidential chemical identities).
     Basis for the TSCA section 5(e) consent order or, the 
basis for 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 9 PMN substances (P-11-224, P-11-226, P-12-41, 
P-12-404, P-12-405, P-12-406, P-13-175, P-13-176, and P-13-239) 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.  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.
    Where EPA determined that the PMN substance may present an 
unreasonable risk of injury to human health via inhalation exposure, 
the underlying TSCA section 5(e) consent order usually requires, among 
other things, that potentially exposed employees wear specified 
respirators unless actual measurements of the workplace air show that 
air-borne concentrations of the PMN substance are below a New Chemical 
Exposure Limit (NCEL) that is established by EPA to provide adequate 
protection to human health. In addition to the actual NCEL 
concentration, the comprehensive NCELs provisions in TSCA section 5(e) 
consent orders, which are modeled after Occupational Safety and Health 
Administration (OSHA) Permissible Exposure Limits (PELs) provisions, 
include requirements addressing performance criteria for sampling and 
analytical methods, periodic monitoring, respiratory protection, and 
recordkeeping. However, no comparable NCEL provisions currently exist 
in 40 CFR part 721, subpart B, for SNURs. Therefore, for these cases, 
the individual SNURs in 40 CFR part 721, subpart E, will state that 
persons subject to the SNUR who wish to pursue NCELs as an alternative 
to the Sec.  721.63 respirator requirements may request to do so under 
Sec.  721.30. EPA expects that persons whose Sec.  721.30 requests to 
use the NCELs approach for SNURs are approved by EPA will be required 
to comply with NCELs provisions that are comparable to those contained 
in the corresponding TSCA section 5(e) consent order for the same 
chemical substance.
    This rule also includes SNURs on 43 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 Number P-10-235

    Chemical name: Pyridine, 4-decyl-.
    CAS number: 1815-99-2.
    Basis for action: The PMN states that the generic (non-
confidential) use of the substance is as a fragrance component. Based 
on test data on the PMN substance, as well as ecological structure-
activity relationship (SAR) analysis of test data on analogous neutral 
organic compounds, EPA predicts chronic toxicity to aquatic organisms 
may occur at concentrations that exceed 1 part per billion (ppb) of the 
PMN substance in surface waters for greater than 20 days per year. This 
20-day criterion is derived from partial life cycle tests (daphnid 
chronic and fish early-life stage tests) that typically range from 21 
to 28 days in duration. EPA predicts toxicity to aquatic organisms may 
occur if releases of the PMN

[[Page 63824]]

substance to surface water exceed releases from the use described in 
the PMN. For the use described in the PMN, environmental releases did 
not exceed the concentration of concern for more than 20 days per year. 
Therefore, EPA has not determined that the proposed manufacturing, 
processing, or use of the substance may present an unreasonable risk. 
EPA has determined, however, that any use of the substance other than 
as described in the PMN, or any use of the substance resulting in 
surface water concentrations exceeding 1 ppb from manufacturing or 
processing waste stream releases, may result in significant adverse 
environmental effects. Based on this information, the PMN substance 
meets the concern criteria at Sec.  721.170(b)(4)(i) 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 
daphnid chronic toxicity test (OPPTS Test Guideline 850.1300) would 
help characterize the environmental effects of the PMN substance.
    CFR citation: 40 CFR 721.10766.

PMN Number P-11-224

    Chemical name: Fluoroether (generic).
    CAS number: Claimed confidential.
    Effective date of TSCA section 5(e) consent order: August 5, 2011.
    Basis for TSCA section 5(e) consent order: The PMN states that the 
PMN will be used as an electrolyte for electrical/electronic equipment. 
Based on test data on the PMN substance, EPA identified concerns for 
subchronic toxicity, systemic toxicity, reproductive effects; as well 
as toxicity to aquatic organisms at concentrations that exceed 9 ppb of 
the PMN substance in surface waters. The Order was issued under TSCA 
section 5(e)(1)(A)(i), 5(e)(1)(A)(ii)(I), and 5(e)(1)(A)(ii)(II) based 
on a finding that the substance may present an unreasonable risk of 
injury to human health and the environment, the substance may be 
produced in substantial quantities and may reasonably be anticipated to 
enter the environment in substantial quantities, and there may be 
significant (or substantial) human exposure to the substance. To 
protect against these risks, the consent order requires:
    1. Submission of certain toxicity and fate testing prior to 
exceeding the confidential production volume limit specified in the 
consent order.
    2. Manufacturing, processing, and use of the substance only as an 
electrolyte for electrical/electronic equipment as described in the 
consent order.
    The SNUR designates as a ``significant new use'' the absence of 
these protective measures.
    Recommended testing: EPA has determined that the test data from 
certain human health, environmental fate, and ecotoxicity testing 
identified in the consent order would help characterize possible 
effects of the substances and their degradation products. The company 
has agreed not to exceed the confidential production limit without 
performing a bacterial reverse mutation test (OPPTS Test Guideline 
870.5100); a mammalian erythrocyte micronucleus test (OPPTS Test 
Guideline 870.5395); a UV/Visible absorption test (Organisation for 
Economic Co-Operation and Development (OECD) Test Guideline 101); and 
an atmospheric half-life test (as referenced in the Consent Order). EPA 
has also determined that the results of a reproduction/development 
toxicity test (OPPTS Test Guideline 870.3550); a fish early-life stage 
toxicity test (OPPTS Test Guideline 850.1400); a daphnid chronic 
toxicity test (OPPTS Test Guideline 850.1300); and information to 
address cardiac sensitization (as described in the Consent Order) would 
help characterize the human health and ecotoxicity effects of the PMN 
substance. The consent order does not require submission of this pended 
testing detailed in the consent order at any specified time or 
production volume. However, the consent order's restrictions on 
manufacture, processing, distribution in commerce, use, and disposal of 
the PMNs will remain in effect until the consent order is modified or 
revoked by EPA based on submission of that or other relevant 
information.
    CFR citation: 40 CFR 721.10767.

PMN Number P-11-226

    Chemical name: N-(2-hydroxyethyl) alkenamide (generic).
    CAS number: Claimed confidential.
    Effective date of TSCA section 5(e) consent order: February 27, 
2014.
    Basis for TSCA section 5(e) consent order: The PMN states that the 
generic (non-confidential) use of the substance will be as a component 
of adhesives and cosmetics. Based on SAR analysis of test data on 
analogous acrylamides, EPA identified concerns for carcinogenicity, 
heritable mutagenicity, reproductive and developmental toxicity, and 
neurotoxicity from dermal and inhalation exposures. Consistent with the 
establishment of a Safe Drinking Water Act maximum contaminant level 
goal (MCLG) of zero for acrylamides, EPA identified concerns for 
nervous system and blood effects from general population drinking water 
exposures to the PMN substance. The consent order was issued under TSCA 
section 5(e)(1)(A)(i) and 5(e)(A)(ii)(I) based on a finding that the 
uncontrolled manufacture, processing, distribution in commerce, use, 
and disposal of the PMN substance may present an unreasonable risk of 
injury to human health and the environment. To protect against these 
risks, the consent order requires:
    1. Risk notification. If as a result of the test data required, the 
company becomes aware that the PMN substance may present a risk of 
injury to human health or the environment, the company must incorporate 
this new information, and any information on methods for protecting 
against such risk into a Material Safety Data Sheet (MSDS), within 90 
days.
    2. Use of personal protective equipment including gloves impervious 
to the substances, when there is a potential dermal exposure; and a 
National Institute of Occupational Safety and Health (NIOSH)-certified 
respirator with an assigned protection factor (APF) of at least 1,000 
or compliance with a NCEL of 0.03 mg/m\3\ as an 8-hour time-weighted 
average (when there is potential inhalation exposure), when there is 
potential inhalation exposure.
    3. Establishment and use of a hazard communication program, 
including human health, environmental hazard precautionary statements 
on each label and the MSDS.
    4. Submission of certain testing prior to exceeding the 
confidential production volume limits of the PMN substance specified in 
the consent order.
    5. Disposal of all waste streams containing the PMN substance 
either by incineration (destruction and removal efficiency of 99.99%) 
or underground injection control (class 1 well, deep well injection for 
hazardous wastes)
    6. No use of the substances resulting in releases to surface water.
    The SNUR designates as a ``significant new use'' the absence of 
these protective measures.
    Recommended testing: EPA has determined that the test data from 
certain human health, testing identified in the consent order would 
help characterize possible effects of the substance. The company has 
agreed not to exceed the first confidential production limit without 
performing a 90-day oral toxicity test (OPPTS Test Guideline 870.3100) 
in rodents, with a functional observational battery for neuropathology 
(OPPTS Test Guideline 870.6300); a rodent oral dominant lethal

[[Page 63825]]

assay (OPPTS Test Guideline 870.5450); and, depending on the results of 
the rodent oral dominant lethal assay, an oral rodent heritable 
translocation test (OPPTS Test Guideline 870.5460) may be required. The 
company has agreed not to exceed the second confidential production 
limit without performing a 2-year oral carcinogenicity test (OPPTS Test 
Guideline 870.4200) in rats and mice.
    CFR citation: 40 CFR 721.10768.

PMN Number P-12-41

    Chemical name: 1-Octadecanaminium, N,N-dimethyl-N-[3-
(triethoxysilyl)propyl]-, chloride (1:1), reaction products with 
ethylene glycol.
    CAS number: 1314035-96-5.
    Effective date of TSCA section 5(e) consent order: March 3, 2014.
    Basis for TSCA section 5(e) consent order: The PMN states that the 
uses of the PMN substance will be for waterproofing inorganic 
substrates, an asphalt binder modifier, and waterproofing of soil. The 
consent order was issued under TSCA section 5(e)(1)(A)(i), 
5(e)(1)(A)(ii)(I), and 5(e)(1)(A)(ii)(II) based on a finding that the 
substance may present an unreasonable risk of injury to human health; 
and the substance may be produced in substantial quantities and there 
may be significant (or substantial) human exposure to the substance. To 
protect against these risks, the consent order requires:
    1. Risk notification. If as a result of the test data required, the 
company becomes aware that the PMN substance may present a risk of 
injury to human health or the environment, the company must incorporate 
this new information, and any information on methods for protecting 
against such risk into an MSDS, within 90 days.
    2. No domestic manufacture of the PMN substance.
    3. Import, processing and use of the PMN substance only for 
waterproofing inorganic substrates, an asphalt binder modifier, and 
waterproofing of soil.
    4. Submission of certain human health testing prior to exceeding an 
aggregate production volume limit of 839,000 kilograms.
    The SNUR designates as a ``significant new use'' the absence of 
these protective measures.
    Recommended testing: EPA has determined that the results of certain 
toxicity testing would help characterize possible health effects of the 
PMN substance. The company has agreed not to exceed the 839,000 
kilogram production limit without performing a 90-day inhalation 
toxicity test (OPPTS Test Guideline 870.3465). EPA has also determined 
that the results of a fish acute toxicity test, freshwater and marine 
(OPPTS Test Guideline 850.1075); a fish acute toxicity mitigated by 
humic acid test (OPPTS Test Guideline 850.1085); an aquatic 
invertebrate acute toxicity test, freshwater daphnids (OPPTS Test 
Guideline 850.1010); and an algal toxicity test (Office of Chemical 
Safety and Pollution Prevention (OCSPP) Test Guideline 850.4500) would 
help characterize the environmental effects of the PMN substance. The 
consent order does not require submission of this aquatic toxicity 
testing at any specified time or production volume. However, the 
consent order's restrictions on manufacture, processing, distribution 
in commerce, use, and disposal of the PMN will remain in effect until 
the consent order is modified or revoked by EPA based on submission of 
that or other relevant information.
    CFR citation: 40 CFR 721.10769.

PMN Numbers P-12-404, P-12-405, P-12-406

    Chemical names: Fluoroalkyl sulfonamide derivatives (generic).
    CAS numbers: Claimed confidential.
    Effective date of TSCA section 5(e) consent order: March 14, 2014.
    Basis for TSCA section 5(e) consent order: The PMNs state that the 
generic (non-confidential) use of the substances are as a chemical 
intermediate (P-12-404) and a surfactant (P-12-405 and P-12-406). Based 
on test data submitted on P-12-405, P-12-406, and closely analogous 
perfluorinated substances, as well as test data on analogous 
perfluorobutane sulfonate (PFBS), EPA identified concerns for liver, 
blood, kidney, developmental, and systemic toxicity. The consent order 
was issued under TSCA section 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 human health and the environment; and 
these substances may be produced in substantial quantities and may 
reasonably be anticipated to enter the environment in substantial 
quantities, and there may be significant (or substantial) human 
exposure to the substances and their potential degradation products. To 
protect against these risks, the consent order requires:
    1. Risk notification. If as a result of the test data required, the 
company becomes aware that the PMN 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 an MSDS, within 90 days.
    2. Use of personal protective equipment including impervious gloves 
(when there is potential dermal exposure) for PMNs P-12-404 and P-12-
406.
    3. Use of personal protective equipment including impervious gloves 
(when there is potential for dermal exposures), and either a NIOSH-
certified respirator with an APF of at least 10 or compliance with a 
NCEL of 0.7 mg/m\3\ as an 8-hour time-weighted average (when there is 
potential inhalation exposure) for the PMN substance P-12-405.
    4. Establishment and use of a hazard communication program.
    5. Submission of certain environmental fate and human health 
testing prior to exceeding the confidential production volume limits of 
the aggregate amount of the PMN substances, P-12-405 and P-12-406, 
specified in the consent order.
    The SNUR designates as a ``significant new use'' the absence of 
these protective measures.
    Recommended testing: EPA has determined that the results of certain 
environmental fate and toxicity testing would help characterize the 
possible effects of the PMN substances. The company has agreed not to 
exceed the first confidential production limit without performing a 
semi-continuous activated sludge (SCAS) test (OPPTS Test Guideline 
835.5045) modified, on PMN substance P-12-406. The PMN submitter has 
also agreed not to exceed the second confidential production limit 
without performing a metabolism and pharmacokinetics test (OPPTS Test 
Guideline 870.7485) and a combined repeated dose toxicity test (OPPTS 
Test Guideline 870.3650) on the predominant degradation product 
identified in the SCAS test. EPA has also determined that the results 
of a combined chronic toxicity/carcinogenicity test (OPPTS Test 
Guideline 870.4300) on PFBS would help characterize the human health 
and environmental effects of the PMN substances. The consent order does 
not require submission of this test on PFBS at any specified time or 
production volume. However, the consent order's restrictions on 
manufacture, processing, distribution in commerce, use, and disposal of 
the PMN substances will remain in effect until the consent order is 
modified or revoked by EPA based on submission of that or other 
relevant information.
    CFR citation: 40 CFR 721.10770.

PMN Numbers P-13-175 and P-13-176

    Chemical names: (P-13-175) Hexane, 1,6-diisocyanato-, homopolymer,

[[Page 63826]]

.alpha.-[1-[[[3-[[3-(dimethylamino)propyl]amino]propyl]amino]carbonyl]-
1,2,2,2-tetrafluoroethyl]-.omega.-(1,1,2,2,3,3,3-
heptafluoropropoxy)poly[oxy[trifluoro(trifluoromethyl)-1,2-
ethanediyl]]-blocked; and (P-13-176) Fluorinated oxirane polymer 
(generic).
    CAS numbers: (P-13-175) 1279108-20-1; and (P-13-176) Claimed 
confidential.
    Effective date of TSCA section 5(e) consent order: December 13, 
2013.
    Basis for TSCA section 5(e) consent order: The PMNs state that the 
substances will be used as a coating additive in paper and paperboard 
to impart grease, alcohol, and solvent resistance (P-13-175) and an 
intermediate for use in the manufacture of a polymer (P-13-176). For 
the PMN substance P-13-176, where the average number molecular width 
<1,000 daltons is less than 0.5%, ecotoxicity concerns were low based 
on ecological SAR analysis of test data on analogous esters. However, 
based on potential concerns for perfluoro ethers, and the uncertainties 
regarding toxicity of the lower molecular weight portions, EPA predicts 
toxicity to aquatic organisms for P-13-176 if the average number 
molecular weight of <1,000 daltons is greater than 0.5%. The consent 
order was issued under TSCA section 5(e)(1)(A)(i) and 5(e)(1)(A)(ii)(I) 
based on a finding that the substances may present an unreasonable risk 
of injury to the environment. To protect against these risks, the 
consent order requires:
    1. Manufacture the PMN substance P-13-175 using the PMN substance 
P-13-176 as the starting raw material.
    2. Manufacture the PMN substance P-13-176: (a) Where the average 
number molecular weight less than 1,000 Daltons is less than or equal 
to 0.5% and (b) for use as a chemical intermediate to manufacture PMN 
substance P-13-175.
    Recommended testing: EPA has determined that the results of either 
a zahn-wellens/EMPA test (OPPTS Test Guideline 835.3200) or a SCAS test 
(OPPTS Test Guideline 835.3210) modified; and a sediment-water 
lumbriculus toxicity test (OECD Test Guideline 225) using spiked 
sediment, on P-13-176, would help characterize the effects of the PMN 
substances. The consent order does not require submission of the 
testing at any specified time or production volume. However, the 
consent order's restrictions on manufacture, processing, distribution 
in commerce, use, and disposal of the PMNs will remain in effect until 
the consent order is modified or revoked by EPA based on submission of 
that or other relevant information.
    CFR citation: 40 CFR 721.10771 (P-13-175) and 40 CFR 721.10772 (P-
13-176).

PMN Number P-13-223

    Chemical name: Methylene bisacetophenone derivative (generic).
    CAS number: Claimed confidential.
    Basis for action: The PMN states that the generic (non-
confidential) use of the substance is as a photoinitiator for coatings 
and inks. Based on test data on the PMN substance, EPA identified 
concerns for reproductive and developmental effects from dermal and 
inhalation exposures. In addition, based on test data on the PMN 
substance, EPA predicts toxicity to aquatic organisms may occur at 
concentrations that exceed 5 ppb of the PMN substance in surface 
waters. As described in the PMN, significant occupational dermal and 
inhalation exposures are not expected due to the use of impervious 
gloves and a NIOSH-certified respirator with an APF of at least 10. 
Further, releases to water are not expected to result in surface water 
concentrations that exceed 5 ppb. Therefore, EPA has not determined 
that the proposed manufacturing, processing, or use will present an 
unreasonable risk. However, EPA has determined that any use of the 
substance without impervious gloves, where there is a potential for 
dermal exposures; any use of the substance without a NIOSH-certified 
respirator with an APF of at least 10, where there is a potential for 
inhalation exposures; or any use of the substance resulting in surface 
water concentrations exceeding 5 ppb may result in serious health 
effects and significant adverse environmental effects. Based on this 
information, the PMN meets the concern criteria at Sec.  721.170 
(b)(3)(i) and (b)(4)(i).
    Recommended testing: EPA has determined that the results of a 90-
day inhalation toxicity test (OPPTS Test Guideline 870.3465); a fish 
early-life stage toxicity test (OPPTS Test Guideline 850.1400); and a 
daphnid chronic toxicity test (OPPTS Test Guideline 850.1300) would 
help characterize the human health and environmental effects of the PMN 
substance. EPA also recommends that the guidance document on aquatic 
toxicity testing of difficult substances and mixtures (OECD Test 
Guideline 23) be followed to facilitate solubility of the PMN substance 
in the test media.
    CFR citation: 40 CFR 721.10773.

PMN Number P-13-239

    Chemical name: Amine adduct (generic).
    CAS number: Claimed confidential.
    Effective date of TSCA section 5(e) consent order: January 15, 
2014.
    Basis for TSCA section 5(e) consent order: The PMN states that the 
generic (non-confidential) use of the PMN substance will be as a 
membrane hardener. Based on test data on the PMN substance, as well as 
ecological SAR analysis of test data on analogous aliphatic amines, EPA 
predicts toxicity to aquatic organisms may occur at concentrations that 
exceed 1 ppb of the PMN substance in surface waters and general 
population exposures from incineration and landfill releases. The 
consent order was issued under TSCA section 5(e)(1)(A)(i), 
5(e)(1)(A)(ii)(I), and 5(e)(1)(A) (ii)(II) based on a finding that the 
substance may present an unreasonable risk of injury to human health 
and the environment, may be produced in substantial quantities and may 
reasonably be anticipated to enter the environment in substantial 
quantities, and there may be significant (or substantial) human 
exposure to the substance. To protect against these risks, the consent 
order requires:
    1. No domestic manufacture of the PMN substance.
    2. Import, processing and use of the PMN substance only as 
described in the consent order.
    3. Submission of certain toxicity and fate testing prior to 
exceeding the confidential production volume limit specified in the 
consent order.
    The SNUR designates as a ``significant new use'' the absence of 
these protective measures.
    Recommended testing: EPA has determined that the results of certain 
toxicity testing would help characterize possible health effects of the 
PMN substance. The company has agreed not to exceed the confidential 
production limit specified in the consent order without performing an 
in vitro mammalian chromosome aberration test (OECD Test Guideline 
473); an in vitro mammalian cell gene mutation test (OECD Test 
Guideline 476) by the hypoxanthine-guanine phosphoribosyl transferase 
(HPRT) path; and a combined repeated dose toxicity study with 
reproduction/developmental toxicity screening (OPPTS Test Guideline 
870.3670 or OECD Test Guideline 422). EPA has also determined that the 
results of a fish acute toxicity test, freshwater and marine (OPPTS 
Test Guideline 850.1075); a fish early-life stage toxicity test (OPPTS 
Test Guideline 850.1400);

[[Page 63827]]

and a daphnid chronic toxicity test (OPPTS Test Guideline 850.1300) 
would help characterize the environmental effects of the PMN substance. 
The consent order does not require submission of this testing at any 
specified time or production volume. However, the consent order's 
restrictions on manufacture, processing, distribution in commerce, use, 
and disposal of the PMN will remain in effect until the consent order 
is modified or revoked by EPA based on submission of that or other 
relevant information.
    CFR citation: 40 CFR 721.10774.

PMN Number P-13-495

    Chemical name: Metal hydroxide, treated with alkenyl alkoxy silane 
(generic).
    CAS number: Claimed confidential.
    Basis for action: The PMN states that the use of the substance will 
be as a filler in fire resistant silicone rubber blends. Based on SAR 
analysis of test data on analogous respirable poorly soluble 
particulates, EPA identified human health concerns for lung toxicity 
and oncogenicity from exposure to the PMN substance via inhalation. As 
described in the PMN, occupational inhalation exposures are not 
expected as the substance is not handled 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 use of the substance in the form 
of a powder may result in serious health effects. Based on this 
information, the PMN substance meets the concern criteria at Sec.  
721.170 (b)(1)(i)(C) and (b)(3)(ii).
    Recommended testing: EPA has determined that the results of a 90-
day inhalation toxicity test (OPPTS Test Guideline 870.3465) with a 60-
day holding period would help characterize the human health effects of 
the PMN substance.
    CFR citation: 40 CFR 721.10775.

PMN Number P-13-793

    Chemical name: Functionalized carbon nanotubes (generic).
    CAS number: Claimed confidential.
    Basis for action: The PMN states that the substance will be used as 
a thin film for electronic device applications. Based on SAR analysis 
of test data on analogous carbon nanotubes and other respirable poorly 
soluble particulates, EPA identified potential lung effects, 
developmental toxicity, and dermal toxicity from exposure to the PMN 
substance via inhalation, dermal, and oral routes. Further, EPA 
predicts toxicity to aquatic organisms via releases of the PMN 
substance to surface water. As described in the PMN, EPA does not 
expect significant occupational exposures due to the use of impervious 
gloves, where there is potential for dermal exposure, and because the 
PMN is used in liquid form and is not spray applied. Further, EPA does 
not expect environmental releases during the use identified in the PMN 
submission. Therefore, EPA has not determined that the proposed 
manufacturing, processing, or use of the substance may present an 
unreasonable risk human health or the environment. EPA has determined, 
however, that any use of the substance without the use of impervious 
gloves, where there is a potential for dermal exposure; manufacturing 
the PMN substance for use other than as a thin film for electronic 
device applications; manufacturing, processing, or using the PMN 
substance in a form other than a liquid; use of the PMN substance 
involving an application method that generates a mist, vapor, or 
aerosol; or any release of the PMN substance into surface waters may 
cause serious health effects or significant adverse environmental 
effects. Based on this information, the PMN substance meets the concern 
criteria in Sec.  721.170 (b)(3)(ii) and (b)(4)(ii).
    Recommended testing: EPA has determined that the results of an oral 
and inhalation pharmacokinetic test (OPPTS Test Guideline 870.7485); a 
90-day inhalation toxicity test (OPPTS Test Guideline 870.3465); a fish 
early-life stage toxicity test (OPPTS Test Guideline 850.1400); a 
daphnid chronic toxicity test (OPPTS Test Guideline 850.1300); an algal 
toxicity test (OCSPP Test Guideline 850.4500); and a surface charge by 
electrophoresis by either the (ASTM Test Guideline E2865-12) or 
measuring the zeta potential of nanoparticles (Nanotechnology 
Characterization Library (NCL) Method PCC-2) (located in the Docket 
under Docket ID number EPA-HQ-OPPT-2014-0390); would help characterize 
the human health and environmental effects of the PMN substance.
    CFR citation: 40 CFR 721.10776.

PMN Numbers P-13-945 and P-13-946

    Chemical names: (P-13-945) 2,4-Hexadienoic acid, 3-
(trimethoxysilyl)propyl ester; and (P-13-946) 2,4,Hexadienoic acid, 3-
(trimethoxysilyl)propyl ester (2E,4E)-.
    CAS numbers: (P-13-945) 3090-13-9 and (P-13-946) 163802-53-7.
    Basis for action: The PMNs state that the generic (non-
confidential) use of the substances will be as industrial thermoplastic 
additives. Based on test data on the PMN substances, as well as SAR 
analysis of test data on analogous alkoxysilanes, EPA identified 
concerns for respiratory irritation and chronic lung toxicity from 
inhalation exposures. Further, based on test data on the PMN 
substances, EPA predicts toxicity to aquatic organisms may occur at 
concentrations that exceed 58 ppb of the substances in surface waters. 
As described in the PMNs, inhalation exposures are not expected, and 
releases to surface waters are not expected to result in surface water 
concentrations that exceed 58 ppb. Therefore, EPA has not determined 
that the proposed manufacturing, processing, or use of the substances 
may present an unreasonable risk. However, EPA has determined that any 
use of the substances involving an application method that generates a 
vapor, mist, or aerosol; or any use of the substances resulting in 
surface water concentrations exceeding 58 ppb may result in serious 
health effects and significant adverse environmental effects. Based on 
this information, the PMN substances meet the concern criteria at Sec.  
721.170(b)(3)(i), (b)(3)(ii), and (b)(4)(i).
    Recommended testing: EPA has determined that the results of a 90-
day toxicity test in rodents (OPPTS Test Guideline 870.3100) via the 
inhalation route; a hydrolysis test (OPPTS Test Guideline 835.2120); a 
fish early-life stage toxicity test (OPPTS Test Guideline 850.1400); 
and a daphnid chronic toxicity test (OPPTS Test Guideline 850.1300) on 
PMN substance P-13-946 would help characterize the human health and 
environmental effects of the PMN substances.
    CFR citation: 40 CFR 721.10777 (P-13-945) and 40 CFR 721.10778 (P-
13-946).

PMN Number P-14-28

    Chemical name: Substituted alkene, reaction products with 
isophoronediamine (generic).
    CAS number: Claimed confidential.
    Basis for action: The PMN states that the use of the substance will 
be as a site-limited intermediate for coating resin manufacture. Based 
on SAR analysis of test data on analogous organonitriles and cyanides, 
EPA identified human health concerns for acute oral toxicity and 
developmental toxicity from exposure to the PMN substance via 
inhalation. Further, based on ecological SAR analysis of test data on 
analogous aliphatic amines, EPA predicts toxicity to aquatic organisms 
may occur at concentrations that exceed 49 ppb of the PMN substance in 
surface waters. As described in the PMN, occupational

[[Page 63828]]

exposures are expected to be minimal as the substance is used as a 
site-limited intermediate by an application method that does not 
generate a dust, mist, vapor, or aerosol. In addition, releases of the 
substance are not expected to result in surface water concentrations 
that exceed 49 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 other than as a site-limited intermediate; any use of the 
substance involving an application method that generates a dust, vapor, 
mist, or aerosol; or any use of the substance resulting in surface 
water concentrations exceeding 49 ppb 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 
prenatal developmental toxicity test (OPPTS Test Guideline 870.3700) in 
rats; a fish acute toxicity test, freshwater and marine (OPPTS Test 
Guideline 850.1075); a fish acute toxicity mitigated by humic acid 
(OPPTS Test Guideline 850.1085); an aquatic invertebrate acute toxicity 
test, freshwater daphnids (OPPTS Test Guideline 850.1010); 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 721.10779.

PMN Number P-14-72

    Chemical name: Propaneperoxoic acid, 2,2-dimethyl-, 1,1,3,3-
tetramethylbutyl ester.
    CAS number: 22288-41-1.
    Basis for action: The PMN states that the use of the substance will 
be as a polymerization initiator for the production of polyvinyl 
chloride (PVC) and polyethylene resin. Based on test data on the PMN 
substance, as well as ecological SAR analysis of test data on analogous 
peroxy esters, EPA predicts toxicity to aquatic organisms may occur at 
concentrations that exceed 3 ppb of the PMN substance in surface 
waters. As described in the PMN, releases of the substance are not 
expected to result in surface water concentrations that exceed 3 ppb. 
Therefore, EPA has not determined that the proposed manufacturing, 
processing, or use of the substance may present an unreasonable risk. 
EPA has determined, however, that any use of the substance resulting in 
surface waters concentrations exceeding 3 ppb may result in significant 
adverse environmental effects. Based on this information, the PMN 
substance meets the concern criteria at Sec.  721.170(b)(4)(i) and 
(b)(4)(ii).
    Recommended testing: EPA has determined that the results of a ready 
biodegradability test (OECD Test Guideline 301C) with product-specific 
chemical analytics to validate the degradation products (including 
intermediate products) and the rates of degradation (including 
intermediate degradation rates); and a hydrolysis as a function of pH 
and temperature test (OPPTS Test Guideline 835.2130) would help 
characterize the environmental effects of the PMN substance.
    CFR citation: 40 CFR 721.10780.

PMN Numbers P-14-89, P-14-90, P-14-91, and P-14-92

    Chemical names: Fatty acid amide hydrochlorides (generic).
    CAS numbers: Claimed confidential.
    Basis for action: The consolidated PMN states that the substances 
will be used as surfactants for use in asphalt emulsions. Based on 
ecological SAR analysis of test data on analogous aliphatic amines, EPA 
predicts toxicity to aquatic organisms may occur at concentrations that 
exceed the following values of the PMN substances in surface waters:

------------------------------------------------------------------------
                                                       Concentration of
                       PMN No.                          concern  (ppb)
------------------------------------------------------------------------
P-14-89, P-14-92....................................                 110
P-14-90.............................................                 240
P-14-91.............................................                  53
------------------------------------------------------------------------

    For the use described in the PMNs, releases of the substances are 
not expected to result in surface water concentrations that exceed 
these values. 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 
substances resulting in surface water concentrations exceeding the 
aforementioned concentrations of concern 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, freshwater and marine (OPPTS Test Guideline 
850.1075); an aquatic invertebrate acute 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 substances. EPA also recommends that 
the guidance document on aquatic toxicity testing of difficult 
substances and mixtures (OECD Test Guideline 23) be followed.
    CFR citation: 40 CFR 721.10781.

PMN Numbers P-14-158, P-14-159, P-14-161, P-14-162, and P-14-163

    Chemical names: Fatty acid amides (generic).
    CAS numbers: Claimed confidential.
    Basis for action: The consolidated PMN states that the substances 
will be used as chemical intermediates and additives for flotation 
products. Based on ecological SAR analysis of test data on analogous 
amides and aliphatic amines, EPA predicts toxicity to aquatic organisms 
may occur at concentrations that exceed the following values of the PMN 
substances in surface waters:

------------------------------------------------------------------------
                                                       Concentration of
                       PMN No.                          concern  (ppb)
------------------------------------------------------------------------
P-14-158, P-14-159, P-14-161, P-14-163..............                   1
P-14-162............................................                 140
------------------------------------------------------------------------

    For the use described in the PMNs, releases of the substances are 
not expected to result in surface water concentrations that exceed 
these values. 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 
substances resulting in surface water concentrations exceeding the 
aforementioned concentrations of concern 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 (1) a 
water solubility: Column elution method; shake flask method test (OPPTS 
Test Guideline 830.7840) or a water solubility generator column method 
test (OPPTS Test Guideline 830.7860); and (2) a determination of the 
partition coefficient (n-octanol/water) by shake flask method (OPPTS 
Test Guideline 830.7550), or generator column method (OPPTS Test 
Guideline 830.7560), or estimation by liquid chromatography (OPPTS Test 
Guideline 830.7570) would help characterize the physical/chemical 
properties of the PMN substances. Depending upon the results of these 
data, 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

[[Page 63829]]

Guideline 850.4500) may be recommended to help characterize the 
environmental effects of the PMN substances.
    CFR citation: 40 CFR 721.10782.

PMN Numbers P-14-173, P-14-175, P-14-176, P-14-177, P-14-178, P-14-179, 
P-14-180, P-14-181, P-14-182, P-14-183, P-14-184, P-14-185, P-14-186, 
P-14-187, P-14-188, P-14-190, P-14-191, P-14-192 and P-14-193

    Chemical names: Fatty acid amide acetates (generic).
    CAS numbers: Claimed confidential.
    Basis for action: The PMNs state that the substances will be used 
as flotation additives for use in mineral processing. Based on 
ecological SAR analysis of test data on analogous amides and aliphatic 
amines, EPA predicts toxicity to aquatic organisms may occur at 
concentrations that exceed the following values of the PMN substances 
in surface waters:

------------------------------------------------------------------------
                                                          Concentration
                        PMN No.                             of concern
                                                              (ppb)
------------------------------------------------------------------------
P-14-173, P-14-175, P-14-178, P-14-179, P-14-181, P-14-                1
 183, P-14-184, P-14-192, P-14-193.....................
P-14-176, P-14-180, P-14-185, P-14-186, P-14-187, P-14-                2
 190...................................................
P-14-177, P-14-188.....................................                3
P-14-191...............................................                4
P-14-182...............................................              140
------------------------------------------------------------------------

    For the use described in the PMNs, releases of the substances are 
not expected to result in surface water concentrations that exceed 
these values. 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 
substances resulting in surface water concentrations exceeding the 
aforementioned concentrations of concern 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, freshwater and marine (OPPTS Test Guideline 
850.1075); an aquatic invertebrate acute toxicity test, freshwater 
daphnids (OPPTS Test Guideline 850.1010); and an algal toxicity test 
(OCSPP Test Guideline 850.4500) on P-14-184, and any one of the 
remaining PMN substances, would help characterize the environmental 
effects of the PMN substances. Further, EPA determined that the results 
of a fish acute toxicity mitigated by humic acid test (OPPTS Test 
Guideline 850.1085) on PMN P-14-184 would help characterize the 
environmental effects of the PMN substance. EPA also recommends that 
the guidance document on aquatic toxicity testing of difficult 
substances and mixtures (OECD Test Guideline 23) be followed.
    CFR citation: 40 CFR 721.10783.

PMN Numbers P-14-216, P-14-217, P-14-218, and P-14-231

    Chemical names: (P-14-216, P-14-217, and P-14-218) Mixed butyltin 
mercaptoester sulfides (generic) and (P-14-231) Mixed methyltin 
mercaptoester sulfides (generic).
    CAS numbers: Claimed confidential.
    Basis for action: The PMNs state that the substances will be used 
as stabilizers in polyvinyl chloride. Based on the physical-chemical 
properties of the PMN substances and their anticipated degradation 
products, as well as SAR analysis of test data on analogous organotin 
compounds, EPA identified concerns for immunotoxicity, neurotoxicity, 
developmental and reproductive toxicity, asthma and skin sensitization 
from dermal and inhalation exposures to the PMN substances, and 
toxicity to aquatic organisms at concentrations that exceed 0.5 ppb of 
the PMN substances in surface waters. For the use described in the PMNs 
(including waste handling and hazard communication), EPA does not 
expect significant occupational or general population exposures, nor 
significant releases to the aquatic environment due to
    1. Use of impervious gloves, where there is a potential for dermal 
exposures.
    2. Maintaining workplace airborne concentrations of the PMN 
substances not to exceed the OSHA PEL for organotins of 0.1 micrograms/
m\3\ by percent tin (% Sn).
    3. Labeling transport containers and providing hazard 
communication.
    4. Use of the substance only as described in the PMN. and
    5. Releases of any waste stream into the waters of the United 
States not to exceed 0.5 ppb.
    Therefore, EPA has not determined that the proposed manufacturing, 
processing, or use of the substance may present an unreasonable risk. 
EPA has determined, however, that any use of the substance without 
dermal protection, where there is a potential for dermal exposures; any 
use of the PMN substances without maintaining workplace airborne 
concentrations exceeding the OSHA PEL of 0.1 micrograms/m\3\ by percent 
tin; use of the substance without container labeling and appropriate 
hazard communication; or any use of the substances other than as 
stabilizers in polyvinyl chloride at concentrations not to exceed 2%, 
or any use of the substance resulting in releases to surface waters 
exceeding concentrations of 0.5 ppb of the PMN substances may result in 
serious health effects and significant adverse environmental effects. 
Based on this information, the PMN substances meet the concern criteria 
at Sec.  721.170(b)(3)(ii), (b)(3)(iii), (b)(4)(ii), and (b)(4)(iv).
    Recommended testing: EPA has determined that the results of the 
following testing on either P-14-216, P-14-217, or P-14-218; and P-14-
231 would help characterize the human health and environmental effects 
of the PMN substances: A 90-day toxicity test (OPPTS Test Guideline 
870.3100) in rats, by the oral route, with special attention to 
lymphoid organs (thymus, spleen, peripheral lymph nodes) and bone 
marrow; a neurotoxicity test (OPPTS Test Guideline 870.6200) to include 
motor activity, functional observational battery, and neuropathology 
with special attention to lesions in the hippocampus; 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); an aerobic ready biodegradability test (OECD Test Guideline 
301); a fish early life stage toxicity test (OPPTS Test Guideline 
850.1400); and a daphnid chronic toxicity test (OPPTS Test Guideline 
850.1300). In addition, Further, EPA had determined that a leaching 
from PVC pipe study on PMN substances P-14-216, P-14-217, or P-14-218 
(or model dibutyltin mercaptoester sulfide); and a leaching from PVC 
pipe study on PMN substance P-14-231 (or model dimethyltin 
mercaptoester sulfide) would be helpful in characterizing the PMN 
substances.
    CFR citation: 40 CFR 721.10784 (P-14-216, P-14-217, and P-14-218) 
and 40 CFR 721.10785 (P-14-231).

PMN Number P-14-234

    Chemical name: Trisubsituted ethoxylated carbomonocycle (generic).
    CAS number: Claimed confidential.
    Basis for action: The PMN states that the generic (non-
confidential) use of the substance is as a dispersant. Based on test 
data on the PMN substance, as well as ecological SAR analysis of test 
data on analogous nonionic surfactants, EPA predicts toxicity to 
aquatic organisms

[[Page 63830]]

may occur at concentrations that exceed 24 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 24 
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 24 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 an 
aquatic invertebrate acute 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 721.10786.

PMN Number P-14-270

    Chemical name: Multi-functional novolac type epoxy resin (generic).
    CAS number: Claimed confidential.
    Basis for action: The PMN states that the substance will be used as 
a monomer for polyamides and as an ingredient to produce metamethylene 
1,5 diisocyanate. Based on ecological SAR analysis of test data on 
analogous polyepoxides, EPA predicts toxicity to aquatic organisms may 
occur at concentrations that exceed 1 ppb of the PMN substance in 
surface waters. As described in the PMN, releases of the substance are 
not expected to result in surface water concentrations that exceed 1 
ppb. Therefore, EPA has not determined that the proposed manufacturing, 
processing, or use of the substance may present an unreasonable risk. 
EPA has determined, however, that any use of the substance resulting in 
surface water concentrations exceeding 1 ppb may cause significant 
adverse environmental effects. Based on this information, the PMN 
substance meets the concern criteria at Sec.  721.170(b)(4)(ii).
    Recommended testing: EPA has determined that the results of a fish 
early-life stage toxicity test (OPPTS Test Guideline 850.1400); a 
daphnid chronic toxicity test (OPPTS Test Guideline 850.1300); and an 
algal toxicity test (OCSPP Test Guideline 850.4500) would help 
characterize the environmental effects of the PMN substance.
    CFR citation: 40 CFR 721.10787.

PMN Number P-14-357

    Chemical name: Alkanedioic acids, polymer with substituted 
propanediol, alkanediols, polyethylene glycol and MDI (generic).
    CAS number: Claimed confidential.
    Basis for action: The PMN states that the use of the substance will 
be with lamination of plastic sheets and textiles. Based on SAR 
analysis of test data on analogous diisocyanates, EPA identified 
concerns for irritation to the eye, skin, and mucous membranes; and 
dermal and respiratory sensitization. As described in the PMN, EPA does 
not expect significant occupational exposures due to the use of a 
NIOSH-certified respirator with an APF of at least 10, where there is a 
potential for inhalation exposures; and the substance is applied by a 
method that does not generate a vapor, mist, or aerosol. Further, 
consumer inhalation exposures are not expected as the PMN is not being 
used in consumer products. Therefore, EPA has not determined that the 
proposed manufacturing, processing, or use of the substance may present 
an unreasonable risk. EPA has determined, however, that any use of the 
substance without a NIOSH-certified organic vapor respirator with an 
APF of at least 10, where there is a potential for inhalation exposure; 
any use in consumer products; or any use of the substance involving an 
application method that generates a vapor, mist, or aerosol may cause 
serious health effects. Based on this information, the PMN substances 
meet the concern criteria at Sec.  721.170(b)(3)(ii).
    Recommended testing: EPA has determined that the results of a skin 
sensitization test (OPPTS Test Guideline 870.2600) and a 90-day 
inhalation toxicity test (OPPTS Test Guideline 870.3465) would help 
characterize the human health effects of the PMN substance.
    CFR citation: 40 CFR 721.10788.

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 52 
chemical substances, regulation was warranted under TSCA section 5(e), 
pending the development of information sufficient to make reasoned 
evaluations of the health or environmental effects of the chemical 
substances. The basis for such findings is outlined in Unit IV. Based 
on these findings, TSCA section 5(e) consent orders requiring the use 
of appropriate exposure controls were negotiated with the PMN 
submitters. The SNUR provisions for these chemical substances are 
consistent with the provisions of the TSCA section 5(e) consent orders. 
These SNURs are promulgated pursuant to Sec.  721.160 (see Unit VI.).
    In the other 43 cases, where the uses are not regulated under a 
TSCA section 5(e) consent order, EPA determined that one or more of the 
criteria of concern established at Sec.  721.170 were met, as discussed 
in Unit IV.

B. Objectives

    EPA is issuing these SNURs for specific chemical substances which 
have undergone premanufacture review because the Agency wants to 
achieve the following objectives with regard to the significant new 
uses designated in this rule:
     EPA will receive notice of any person's intent to 
manufacture or process a listed chemical substance for the described 
significant new use before that activity begins.
     EPA will have an opportunity to review and evaluate data 
submitted in a SNUN before the notice submitter begins manufacturing or 
processing a listed chemical substance for the described significant 
new use.
     EPA will be able to regulate prospective manufacturers or 
processors of a listed chemical substance before the described 
significant new use of that chemical substance occurs, provided that 
regulation is warranted pursuant to TSCA sections 5(e), 5(f), 6, or 7.
     EPA will ensure that all manufacturers and processors of 
the same chemical substance that is subject to a TSCA section 5(e) 
consent order are subject to similar requirements.
    Issuance of a SNUR for a chemical substance does not signify that 
the chemical substance is listed on the TSCA Chemical Substance 
Inventory (TSCA Inventory). Guidance on how to determine if a chemical 
substance is on the TSCA Inventory is available on the Internet at 
http://www.epa.gov/opptintr/existingchemicals/pubs/tscainventory/index.html.

VI. Direct Final Procedures

    EPA is issuing these SNURs as a direct final rule, as described in 
Sec.  721.160(c)(3) and Sec.  721.170(d)(4). In accordance with Sec.  
721.160(c)(3)(ii) and Sec.  721.170(d)(4)(i)(B), the effective date of 
this rule is December 26, 2014 without further notice, unless EPA 
receives written adverse or critical comments, or notice of intent to 
submit adverse or critical comments before November 26, 2014.
    If EPA receives written adverse or critical comments, or notice of 
intent to

[[Page 63831]]

submit adverse or critical comments, on one or more of these SNURs 
before November 26, 2014, EPA will withdraw the relevant sections of 
this direct final rule before its effective date. EPA will then issue a 
proposed SNUR for the chemical substance(s) on which adverse or 
critical comments were received, providing a 30-day period for public 
comment.
    This rule establishes SNURs for a number of chemical substances. 
Any person who submits adverse or critical comments, or notice of 
intent to submit adverse or critical comments, must identify the 
chemical substance and the new use to which it applies. EPA will not 
withdraw a SNUR for a chemical 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 52 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 46 of the 52 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 27, 2014 as the cutoff date for 
determining whether the new use is ongoing. Persons who begin 
commercial manufacture or processing of the chemical substances for a 
significant new use identified as of that date would have to cease any 
such activity upon the effective date of the final rule. To resume 
their activities, these persons would have to first comply with all 
applicable SNUR notification requirements and wait until the notice 
review period, including any extensions, expires. If such a person met 
the conditions of advance compliance under Sec.  721.45(h), the person 
would be considered exempt from the requirements of the SNUR. Consult 
the Federal Register document of April 24, 1990 for a more detailed 
discussion of the cutoff date for ongoing uses.

VIII. Test Data and Other Information

    EPA recognizes that TSCA section 5 does not require developing any 
particular test data before submission of a SNUN. The two exceptions 
are:
    1. Development of test data is required where the chemical 
substance subject to the SNUR is also subject to a test rule under TSCA 
section 4 (see TSCA section 5(b)(1)).
    2. Development of test data may be necessary where the chemical 
substance has been listed under TSCA section 5(b)(4) (see TSCA section 
5(b)(2)).
    In the absence of a TSCA section 4 test rule or a TSCA section 
5(b)(4) listing covering the chemical substance, persons are required 
only to submit test data in their possession or control and to describe 
any other data known to or reasonably ascertainable by them (see 40 CFR 
720.50). However, upon review of PMNs and SNUNs, the Agency has the 
authority to require appropriate testing. In cases where EPA issued a 
TSCA section 5(e) consent order that requires or recommends certain 
testing, Unit IV. lists those tests. Unit IV. also lists recommended 
testing for TSCA non-section 5(e) SNURs. Descriptions of tests are 
provided for informational purposes. EPA strongly encourages persons, 
before performing any testing, to consult with the Agency pertaining to 
protocol selection. To access the OCSPP test guidelines referenced in 
this document electronically, please go to http://www.epa.gov/ocspp and 
select ``Test Methods and Guidelines.'' The Organisation for Economic 
Co-operation and Development (OECD) test guidelines are available from 
the OECD Bookshop at http://www.oecdbookshop.org or SourceOECD at 
http://www.sourceoecd.org. ASTM International standards are available 
at http://www.astm.org/Standard/index.shtml.
    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 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

[[Page 63832]]

under the rule. The manufacturer or processor must show that it has a 
bona fide intent to manufacture or process the chemical substance and 
must identify the specific use for which it intends to manufacture or 
process the chemical substance. If EPA concludes that the person has 
shown a bona fide intent to manufacture or process the chemical 
substance, EPA will tell the person whether the use identified in the 
bona fide submission would be a significant new use under the rule. 
Since most of the chemical identities of the chemical substances 
subject to these SNURs are also CBI, manufacturers and processors can 
combine the bona fide submission under the procedure in Sec.  
721.1725(b)(1) with that under Sec.  721.11 into a single step.
    If EPA determines that the use identified in the bona fide 
submission would not be a significant new use, i.e., the use does not 
meet the criteria specified in the rule for a significant new use, that 
person can manufacture or process the chemical substance so long as the 
significant new use trigger is not met. In the case of a production 
volume trigger, this means that the aggregate annual production volume 
does not exceed that identified in the bona fide submission to EPA. 
Because of confidentiality concerns, EPA does not typically disclose 
the actual production volume that constitutes the use trigger. Thus, if 
the person later intends to exceed that volume, a new bona fide 
submission would be necessary to determine whether that higher volume 
would be a significant new use.

X. SNUN Submissions

    According to Sec.  721.1(c), persons submitting a SNUN must comply 
with the same notification requirements and EPA regulatory procedures 
as persons submitting a PMN, including submission of test data on 
health and environmental effects as described in 40 CFR 720.50. SNUNs 
must be submitted on EPA Form No. 7710-25, generated using e-PMN 
software, and submitted to the Agency in accordance with the procedures 
set forth in 40 CFR 720.40 and 721.25. E-PMN software is available 
electronically at http://www.epa.gov/opptintr/newchems.

XI. Economic Analysis

    EPA has evaluated the potential costs of establishing SNUN 
requirements for potential manufacturers and processors of the chemical 
substances subject to this rule. EPA's complete economic analysis is 
available in the docket under docket ID number EPA-HQ-OPPT-2014-0390.

XII. Statutory and Executive Order Reviews

A. Executive Order 12866

    This rule establishes SNURs for several new chemical substances 
that were the subject of PMNs, or TSCA section 5(e) consent orders. The 
Office of Management and Budget (OMB) has exempted these types of 
actions from review under Executive Order 12866, entitled ``Regulatory 
Planning and Review'' (58 FR 51735, October 4, 1993).

B. Paperwork Reduction Act (PRA)

    According to PRA (44 U.S.C. 3501 et seq.), an agency may not 
conduct or sponsor, and a person is not required to respond to a 
collection of information that requires OMB approval under PRA, unless 
it has been approved by OMB and displays a currently valid OMB control 
number. The OMB control numbers for EPA's regulations in title 40 of 
the CFR, after appearing in the Federal Register, are listed in 40 CFR 
part 9, and included on the related collection instrument or form, if 
applicable. EPA is amending the table in 40 CFR part 9 to list the OMB 
approval number for the information collection requirements contained 
in this rule. This listing of the OMB control numbers and their 
subsequent codification in the CFR satisfies the display requirements 
of PRA and OMB's implementing regulations at 5 CFR part 1320. This 
Information Collection Request (ICR) was previously subject to public 
notice and comment prior to OMB approval, and given the technical 
nature of the table, EPA finds that further notice and comment to amend 
it is unnecessary. As a result, EPA finds that there is ``good cause'' 
under section 553(b)(3)(B) of the Administrative Procedure Act (5 
U.S.C. 553(b)(3)(B)) to amend this table without further notice and 
comment.
    The information collection requirements related to this action have 
already been approved by OMB pursuant to PRA under OMB control number 
2070-0012 (EPA ICR No. 574). This action does not impose any burden 
requiring additional OMB approval. If an entity were to submit a SNUN 
to the Agency, the annual burden is estimated to average between 30 and 
170 hours per response. This burden estimate includes the time needed 
to review instructions, search existing data sources, gather and 
maintain the data needed, and complete, review, and submit the required 
SNUN.
    Send any comments about the accuracy of the burden estimate, and 
any suggested methods for minimizing respondent burden, including 
through the use of automated collection techniques, to the Director, 
Collection Strategies Division, Office of Environmental Information 
(2822T), Environmental Protection Agency, 1200 Pennsylvania Ave. NW., 
Washington, DC 20460-0001. Please remember to include the OMB control 
number in any correspondence, but do not submit any completed forms to 
this address.

C. Regulatory Flexibility Act (RFA)

    On February 18, 2012, EPA certified pursuant to RFA section 605(b) 
(5 U.S.C. 601 et seq.), that promulgation of a SNUR does not have a 
significant economic impact on a substantial number of small entities 
where the following are true:
    1. A significant number of SNUNs would not be submitted by small 
entities in response to the SNUR.
    2. The SNUR submitted by any small entity would not cost 
significantly more than $8,300.

A copy of that certification is available in the docket for this rule.
    This rule is within the scope of the February 18, 2012 
certification. Based on the Economic Analysis discussed in Unit XI. and 
EPA's experience promulgating SNURs (discussed in the certification), 
EPA believes that the following are true:
     A significant number of SNUNs would not be submitted by 
small entities in response to the SNUR.
     Submission of the SNUN would not cost any small entity 
significantly more than $8,300.

Therefore, the promulgation of the SNUR would not have a significant 
economic impact on a substantial number of small entities.

D. Unfunded Mandates Reform Act (UMRA)

    Based on EPA's experience with proposing and finalizing SNURs, 
State, local, and Tribal governments have not been impacted by these 
rulemakings, and EPA does not have any reasons to believe that any 
State, local, or Tribal government will be impacted by this rule. As 
such, EPA has determined that this rule does not impose any enforceable 
duty, contain any unfunded mandate, or otherwise have any effect on 
small governments subject to the requirements of UMRA sections 202, 
203, 204, or 205 (2 U.S.C. 1501 et seq.).

E. Executive Order 13132

    This action will not have a substantial direct effect on States, on 
the relationship between the national government and the States, or on 
the distribution of power and responsibilities among the various levels 
of government, as specified in

[[Page 63833]]

Executive Order 13132, entitled ``Federalism'' (64 FR 43255, August 10, 
1999).

F. Executive Order 13175

    This rule does not have Tribal implications because it is not 
expected to have substantial direct effects on Indian Tribes. This rule 
does not significantly nor uniquely affect the communities of Indian 
Tribal governments, nor does it involve or impose any requirements that 
affect Indian Tribes. Accordingly, the requirements of Executive Order 
13175, entitled ``Consultation and Coordination with Indian Tribal 
Governments'' (65 FR 67249, November 9, 2000), do not apply to this 
rule.

G. Executive Order 13045

    This action is not subject to Executive Order 13045, entitled 
``Protection of Children from Environmental Health Risks and Safety 
Risks'' (62 FR 19885, April 23, 1997), because this is not an 
economically significant regulatory action as defined by Executive 
Order 12866, and this action does not address environmental health or 
safety risks disproportionately affecting children.

H. Executive Order 13211

    This action is not subject to Executive Order 13211, entitled 
``Actions Concerning Regulations That Significantly Affect Energy 
Supply, Distribution, or Use'' (66 FR 28355, May 22, 2001), because 
this action is not expected to affect energy supply, distribution, or 
use and because this action is not a significant regulatory action 
under Executive Order 12866.

I. National Technology Transfer and Advancement Act (NTTAA)

    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).

XIV. Congressional Review Act

    Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.), 
EPA will submit a report containing this rule and other required 
information to the U.S. Senate, the U.S. House of Representatives, and 
the Comptroller General of the United States prior to publication of 
the rule in the Federal Register. This action is not a ``major rule'' 
as defined by 5 U.S.C. 804(2).

List of Subjects

40 CFR Part 9

    Environmental protection, Reporting and recordkeeping requirements.

40 CFR Part 721

    Environmental protection, Chemicals, Hazardous substances, 
Reporting and recordkeeping requirements.

    Dated: October 9, 2014.
Maria J. Doa,
Director, Chemical Control Division, Office of Pollution Prevention and 
Toxics.

    Therefore, 40 CFR parts 9 and 721 are amended as follows:

PART 9--[AMENDED]

0
1. The authority citation for part 9 continues to read as follows:

    Authority:  7 U.S.C. 135 et seq., 136-136y; 15 U.S.C. 2001, 
2003, 2005, 2006, 2601-2671; 21 U.S.C. 331j, 346a, 348; 31 U.S.C. 
9701; 33 U.S.C. 1251 et seq., 1311, 1313d, 1314, 1318, 1321, 1326, 
1330, 1342, 1344, 1345 (d) and (e), 1361; E.O. 11735, 38 FR 21243, 3 
CFR, 1971-1975 Comp. p. 973; 42 U.S.C. 241, 242b, 243, 246, 300f, 
300g, 300g-1, 300g-2, 300g-3, 300g-4, 300g-5, 300g-6, 300j-1, 300j-
2, 300j-3, 300j-4, 300j-9, 1857 et seq., 6901-6992k, 7401-7671q, 
7542, 9601-9657, 11023, 11048.

0
2. In Sec.  9.1, add the following sections in numerical order under 
the undesignated center heading ``Significant New Uses of Chemical 
Substances'' to read as follows:

Sec.  9.1  OMB approvals under the Paperwork Reduction Act.

* * * * *

 
------------------------------------------------------------------------
                                                            OMB control
                     40 CFR citation                            No.
------------------------------------------------------------------------
 
                                * * * * *
               Significant New Uses of Chemical Substances
------------------------------------------------------------------------
 
                                * * * * *
721.10766...............................................       2070-0012
721.10767...............................................       2070-0012
721.10768...............................................       2070-0012
721.10769...............................................       2070-0012
721.10770...............................................       2070-0012
721.10771...............................................       2070-0012
721.10772...............................................       2070-0012
721.10773...............................................       2070-0012
721.10774...............................................       2070-0012
721.10775...............................................       2070-0012
721.10776...............................................       2070-0012
721.10777...............................................       2070-0012
721.10778...............................................       2070-0012
721.10779...............................................       2070-0012
721.10780...............................................       2070-0012
721.10781...............................................       2070-0012
721.10782...............................................       2070-0012
721.10783...............................................       2070-0012
721.10784...............................................       2070-0012
721.10785...............................................       2070-0012
721.10786...............................................       2070-0012
721.10787...............................................       2070-0012
721.10788...............................................       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.  721.10766 to subpart E to read as follows:

Sec.  721.10766  Pyridine, 4-decyl-.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified as pyridine, 4-decyl- 
(PMN P-10-235; CAS No. 1815-99-2) is subject to reporting under this 
section for the significant new uses described in paragraph (a)(2) of 
this section.
    (2) The significant new uses are:
    (i) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80(j).
    (ii) Release to water. Requirements as specified in Sec.  
721.90(a)(4) and (b)(4) (N=1).
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph (b).
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125(a), (b), (c), (i), and (k) are applicable to manufacturers and 
processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.
    (3) Determining whether a specific use is subject to this section. 
The provisions of Sec.  721.1725(b)(1) apply to paragraph (a)(2)(i) of 
this section.

0
5. Add Sec.  721.10767 to subpart E to read as follows:

Sec.  721.10767  Fluoroether (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified

[[Page 63834]]

generically as fluoroether (PMN P-11-224) is subject to reporting under 
this section for the significant new uses described in paragraph (a)(2) 
of this section. The requirements of this section do not apply to 
quantities of the PMN substance after they have been completely reacted 
(cured).
    (2) The significant new uses are:
    (i) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80(k) (a significant new use is any 
manufacturing, processing, or use other than as an electrolyte for 
electrical/electronic equipment) 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 (b).
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125(a), (b), (c), and (i) are applicable to manufacturers and 
processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.
    (3) Determining whether a specific use is subject to this section. 
The provisions of Sec.  721.1725(b)(1) apply to paragraph (a)(2)(i) of 
this section.

0
6. Add Sec.  721.10768 to subpart E to read as follows:

Sec.  721.10768  N-(2-hydroxyethyl) alkenamide (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as N-(2-
hydroxyethyl) alkenamide (PMN P-11-226) is subject to reporting under 
this section for the significant new uses described in paragraph (a)(2) 
of this section. The requirements of this section do not apply to 
quantities of the PMN substance after they have been completely reacted 
(cured).
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in Sec.  
721.63(a)(1), (a)(2)(i), (a)(3), (a)(4), (a)(6)(ii), (a)(6)(vi), (b), 
and (c). When determining which persons are reasonably likely to be 
exposed as required for Sec.  721.63(a)(1) and (4), engineering control 
measures (e.g., enclosure or confinement of the operation, general and 
local ventilation) or administrative control measures (e.g., workplace 
policies and procedures) shall be considered and implemented to prevent 
exposure, where feasible.
    (A) The following gloves have been demonstrated to meet the 
requirements of Sec.  721.63(a)(3): North Silver Shield Gloves, Ansell 
Barrier Gloves, North Butyl Gloves, Ansell Chemi Pro Gloves, Ansell 
Neoprene Gloves, Ansell So-Vex, and Ansell Canners.
    (B) The following National Institute for Occupational Safety and 
Health (NIOSH)-certified respirators with an Assigned Protection Factor 
(APF) of at least 1,000 meet the requirements of Sec.  721.63(a)(4):
    (1) 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.
    (2) NIOSH-certified continuous flow supplied-air respirator 
equipped with a loose fitting face piece, hood, or helmet.
    (3) NIOSH-certified negative pressure (demand) supplied-air 
respirator with a full face piece.
    (C) As an alternative to the respiratory requirements listed here, 
a manufacturer or processor may choose to follow the New Chemical 
Exposure Limit (NCEL) provisions listed in the section TSCA 5(e) 
consent order for this substance. The NCEL is 0.03 mg/m\3\ as an 8-hour 
time weighted average verified by actual monitoring data.
    (ii) Hazard communication program. Requirements as specified in 
Sec.  721.72(a), (b), (c), (d), (e), (f), (g)(1)(i), (g)(1)(iii), 
(g)(1)(iv), (g)(1)(vi), (g)(1)(vii), (g)(1)(viii), (g)(1)(ix), 
(g)(2)(i), (g)(2)(ii), and (g)(2)(iv) (use respiratory protection, or 
maintain workplace airborne concentrations at or below an 8-hour time-
weighted average of 0.03 mg/m\3\), (g)(2)(v), (g)(3), and (g)(4). A 
significant new use of this substance is any manner or method of 
manufacture or processing associated with any use of this substance 
without providing risk notification as follows under Sec.  721.72(c):
    (A) If as a result of the test data required under the TSCA section 
5(e) consent order for this substance, the employer becomes aware that 
this substance may present a risk of injury to human health or the 
environment, the employer must incorporate this new information, and 
any information on methods for protecting against such risk, into a 
MSDS as described in Sec.  721.72(c) within 90 days from the time the 
employer becomes aware of the new information. If this substance is not 
being manufactured, processed, or used in the employer's workplace, the 
employer must add the new information to a MSDS before the substance is 
reintroduced into the workplace.
    (B) The employer must ensure that persons who will receive the PMN 
substance from the employer, or who have received the PMN substance 
from the employer within 5 years from the date the employer becomes 
aware of the new information described in paragraph (a)(2)(i)(A) of 
this section, are provided an MSDS containing the information required 
under paragraph (a)(2)(i)(A) of this section within 90 days from the 
time the employer becomes aware of the new information.
    (iii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80(k) and (q).
    (iv) Disposal. Requirements as specified in Sec.  721.85(a)(1) 
(destruction and removal efficiency of 99.99%), (a)(3) (underground 
injection control (class 1 well, deep well injection hazardous waste)), 
(b)(1) (destruction and removal efficiency of 99.99%), (b)(3) 
(underground injection control (class 1 well, deep well injection 
hazardous waste)), (c)(1) (destruction and removal efficiency of 
99.99%), (c)(3) (underground injection control (class 1 well, deep well 
injection hazardous waste)).
    (v) Release to water. Requirements as specified in Sec.  
721.90(a)(1), (b)(1), and (c)(1).
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph (b).
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125(a) through (k) are applicable to manufacturers and processors 
of these substances.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.
    (3) Determining whether a specific use is subject to this section. 
The provisions of Sec.  721.1725(b)(1) apply to paragraph (a)(2)(iii) 
of this section.

0
7. Add Sec.  721.10769 to subpart E to read as follows:

Sec.  721.10769  1-Octadecanaminium, N,N-dimethyl-N-[3-
(triethoxysilyl)propyl]-, chloride (1:1), reaction products with 
ethylene glycol.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified as 1-octadecanaminium, 
N,N-dimethyl-N-[3-(triethoxysilyl)propyl]-, chloride (1:1), reaction 
products with ethylene glycol (PMN P-12-41; CAS No. 1314035-96-5) is 
subject to reporting under this section for the significant new uses 
described in paragraph (a)(2) of this section. The requirements of this 
section do not apply to quantities of the PMN substance after they have 
been completely reacted (cured).
    (2) The significant new uses are:

[[Page 63835]]

    (i) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80(f), (k) (a significant new use is import, 
processing and use of the PMN substance other than for waterproofing 
inorganic substrates, an asphalt binder modifier, and waterproofing of 
soil), and (q) (839,000 kilograms).
    (ii) [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph (b).
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125(a), (b), (c), and (i) are applicable to manufacturers and 
processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.

0
8. Add Sec.  721.10770 to subpart E to read as follows:

Sec.  721.10770  Fluoroalkyl sulfonamide derivatives (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substances identified generically as 
fluoroalkyl sulfonamide derivatives (PMN P-12-404, P-12-405, and P-12-
406) 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 for P-12-404 and P-12-406 are:
    (i) Protection in the workplace. Requirements as specified in Sec.  
721.63(a)(1), (a)(2)(i), (a)(3), (b), and (c). When determining which 
persons are reasonably likely to be exposed as required for Sec.  
721.63(a)(1), 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.
    (ii) Hazard communication program. Requirements as specified in 
Sec.  721.72(a), (b), (c), (e), (f), (g)(1) (The PMN substances may: 
Cause serious eye damage; and suspected of damaging fertility or the 
unborn child), and (g)(2) (When using these substances: Wear eye/face 
protection; avoid breathing dust/fume/gas/mist/vapors/spray; and wear 
protective gloves). A significant new use of these substances is any 
manner or method of manufacture or processing associated with any use 
of these substances without providing risk notification as follows 
under Sec.  721.72(c):
    (A) If as a result of the test data required under the TSCA section 
5(e) consent order for these substances, the employer becomes aware 
that this substance may present a risk of injury to human health or the 
environment, the employer must incorporate this new information, and 
any information on methods for protecting against such risk, into a 
MSDS as described in Sec.  721.72(c) within 90 days from the time the 
employer becomes aware of the new information. If these substances are 
not being manufactured, processed, or used in the employer's workplace, 
the employer must add the new information to a MSDS before the 
substances are reintroduced into the workplace.
    (B) The employer must ensure that persons who will receive the PMN 
substances from the employer, or who have received the PMN substances 
from the employer within 5 years from the date the employer becomes 
aware of the new information described in paragraph (a)(2)(i)(A) of 
this section, are provided an MSDS containing the information required 
under paragraph (a)(2)(i)(A) of this section within 90 days from the 
time the employer becomes aware of the new information.
    (iii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80(k) and (q).
    (3) The significant new uses for P-12-405 are:
    (i) Protection in the workplace. (A) Requirements as specified in 
Sec.  721.63(a)(1), (a)(2)(i), (a)(3), (a)(4), (a)(6)(v), (a)(6)(vi), 
(b), and (c). When determining which persons are reasonably likely to 
be exposed as required for Sec.  721.63(a)(1) and (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):
    (1) 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.
    (2) NIOSH-certified continuous flow supplied-air respirator 
equipped with a loose fitting face piece, hood, or helmet.
    (3) NIOSH-certified negative pressure (demand) supplied-air 
respirator with a full face piece.
    (B) As an alternative to the respiratory requirements listed here, 
a manufacturer or processor may choose to follow the New Chemical 
Exposure Limit (NCEL) provisions listed in the section TSCA 5(e) 
consent order for these substances. The NCEL is 0.7 mg/m\3\ as an 8-
hour time weighted average verified by actual monitoring data.
    (ii) Hazard communication program. Requirements as specified in 
Sec.  721.72(a), (b), (c), (e), (f), (g)(1) (The PMN substance may: 
Cause serious eye damage; and suspected of damaging fertility or the 
unborn child), and (g)(2) (When using this substance: Wear eye/face 
protection; avoid breathing dust/fume/gas/mist/vapors/spray; use 
respiratory protection, or maintain workplace airborne concentrations 
at or below an 8-hour time-weighted average of 0.70 mg/m\3\; and wear 
protective gloves). A significant new use of this substance is any 
manner or method of manufacture or processing associated with any use 
of this substance without providing risk notification as follows under 
Sec.  721.72(c):
    (A) If as a result of the test data required under the TSCA section 
5(e) consent order for this substance, the employer becomes aware that 
this substance may present a risk of injury to human health or the 
environment, the employer must incorporate this new information, and 
any information on methods for protecting against such risk, into a 
MSDS as described in Sec.  721.72(c) within 90 days from the time the 
employer becomes aware of the new information. If this substance is not 
being manufactured, processed, or used in the employer's workplace, the 
employer must add the new information to a MSDS before the substance is 
reintroduced into the workplace.
    (B) The employer must ensure that persons who will receive the PMN 
substance from the employer, or who have received the PMN substance 
from the employer within 5 years from the date the employer becomes 
aware of the new information described in paragraph (a)(2)(i)(A) of 
this section, are provided an MSDS containing the information required 
under paragraph (a)(2)(i)(A) of this section within 90 days from the 
time the employer becomes aware of the new information.
    (iii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80(k) and (q).
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph (b).
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125 (a) through (i) are applicable to

[[Page 63836]]

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)(iii) 
and (a)(3)(iii) of this section.

0
9. Add Sec.  721.10771 to subpart E to read as follows:

Sec.  721.10771  Hexane, 1,6-diisocyanato-, homopolymer, .alpha.-[1-
[[[3-[[3-(dimethylamino)propyl]amino]propyl]amino]carbonyl]-1,2,2,2-
tetrafluoroethyl]-.omega.-(1,1,2,2,3,3,3-
heptafluoropropoxy)poly[oxy[trifluoro(trifluoromethyl)-1,2-
ethanediyl]]-blocked.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified as hexane, 1,6-
diisocyanato-, homopolymer, .alpha.-[1-[[[3-[[3-
(dimethylamino)propyl]amino]propyl]amino]carbonyl]-1,2,2,2-
tetrafluoroethyl]-.omega.-(1,1,2,2,3,3,3-
heptafluoropropoxy)poly[oxy[trifluoro(trifluoromethyl)-1,2-
ethanediyl]]-blocked (PMN P-13-175; CAS No. 1279108-20-1) is subject to 
reporting under this section for the significant new uses described in 
paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Hazard communication program. A significant new use of this 
substance is any manner or method of manufacture or processing 
associated with any use of this substance without providing risk 
notification as follows:
    (A) If as a result of the test data required under the TSCA section 
5(e) consent order for this substance, the employer becomes aware that 
this substance may present a risk of injury to human health or the 
environment, the employer must incorporate this new information, and 
any information on methods for protecting against such risk, into a 
MSDS as described in Sec.  721.72(c) within 90 days from the time the 
employer becomes aware of the new information. If this substance is not 
being manufactured, processed, or used in the employer's workplace, the 
employer must add the new information to a MSDS before the substance is 
reintroduced into the workplace.
    (B) The employer must ensure that persons who will receive the PMN 
substance from the employer, or who have received the PMN substance 
from the employer within 5 years from the date the employer becomes 
aware of the new information described in paragraph (a)(2)(i)(A) of 
this section, are provided an MSDS containing the information required 
under paragraph (a)(2)(i)(A) of this section within 90 days from the 
time the employer becomes aware of the new information.
    (ii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80(k) and (q).
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph (b).
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125(a), (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)(ii) of 
this section.

0
10. Add Sec.  721.10772 to subpart E to read as follows:

Sec.  721.10772  Fluorinated oxirane polymer (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 
fluorinated oxirane polymer (PMN P-13-176) is subject to reporting 
under this section for the significant new uses described in paragraph 
(a)(2) of this section. The requirements of this section do not apply 
to quantities of the PMN substance after they have been completely 
reacted (cured).
    (2) The significant new uses are:
    (i) Hazard communication program. A significant new use of this 
substance is any manner or method of manufacture or processing 
associated with any use of this substance without providing risk 
notification as follows:
    (A) If as a result of the test data required under the TSCA section 
5(e) consent order for this substance, the employer becomes aware that 
this substance may present a risk of injury to human health or the 
environment, the employer must incorporate this new information, and 
any information on methods for protecting against such risk, into a 
MSDS as described in Sec.  721.72(c) within 90 days from the time the 
employer becomes aware of the new information. If this substance is not 
being manufactured, processed, or used in the employer's workplace, the 
employer must add the new information to a MSDS before the substance is 
reintroduced into the workplace.
    (B) The employer must ensure that persons who will receive the PMN 
substance from the employer, or who have received the PMN substance 
from the employer within 5 years from the date the employer becomes 
aware of the new information described in paragraph (a)(2)(i)(A) of 
this section, are provided an MSDS containing the information required 
under paragraph (a)(2)(i)(A) of this section within 90 days from the 
time the employer becomes aware of the new information.
    (ii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80(k) and (q).
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph (b).
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125(a), (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)(ii) of 
this section.

0
11. Add Sec.  721.10773 to subpart E to read as follows:

Sec.  721.10773  Methylene bisacetophenone derivative (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 
methylene bisacetophenone derivative (PMN P-13-223) 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), and (a)(4). When determining which 
persons are reasonably likely to be exposed as required for Sec.  
721.63(a)(1) and (4), engineering control measures (e.g., enclosure or 
confinement of the operation, general and local ventilation) or 
administrative control measures (e.g., workplace policies and 
procedures) shall be considered and implemented to prevent exposure, 
where feasible.
    (A) 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):
    (1) NIOSH-certified power air-purifying respirator with a hood or 
helmet and with appropriate gas/vapor (acid gas, organic vapor, or 
substance

[[Page 63837]]

specific) cartridges in combination with HEPA filters.
    (2) NIOSH-certified continuous flow supplied-air respirator 
equipped with a loose fitting face piece, hood, or helmet.
    (3) NIOSH-certified negative pressure (demand) supplied-air 
respirator with a full face piece.
    (B) [Reserved]
    (ii) Release to water. Requirements as specified in Sec.  
721.90(a)(4), (b)(4), and (c)(4) (N=5).
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph (b).
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125(a) through (e), 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.  721.10774 to subpart E to read as follows:

Sec.  721.10774  Amine adduct (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as amine 
adduct (PMN P-13-239) is subject to reporting under this section for 
the significant new uses described in paragraph (a)(2) of this section. 
The requirements of this section do not apply to quantities of the PMN 
substance after they have been completely reacted (cured).
    (2) The significant new uses are:
    (i) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80(f), (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 (b).
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125 (a), (b), (c), and (i) are applicable to manufacturers and 
processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.
    (3) Determining whether a specific use is subject to this section. 
The provisions of Sec.  721.1725(b)(1) apply to paragraph (a)(2)(i) of 
this section.

0
13. Add Sec.  721.10775 to subpart E to read as follows:

Sec.  721.10775  Metal hydroxide, treated with alkenyl alkoxy silane 
(generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as metal 
hydroxide, treated with alkenyl alkoxy silane (PMN P-13-495) 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(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 (b).
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125(a), (b), (c), and (i) are applicable to manufacturers and 
processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.

0
14. Add Sec.  721.10776 to subpart E to read as follows:

Sec.  721.10776  Functionalized carbon nanotubes (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 
functionalized carbon nanotubes (PMN P-13-793) is subject to reporting 
under this section for the significant new uses described in paragraph 
(a)(2) of this section. The requirements of this section do not apply 
to quantities of the PMN substance after they have been completely 
reacted (cured).
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in Sec.  
721.63(a)(1), (a)(2)(i), and (a)(3). When determining which persons are 
reasonably likely to be exposed as required for Sec.  721.63(a)(1), 
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.
    (ii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80(j) (a significant new use is use other 
than as a thin film for electronic device applications), (v)(1), 
(v)(2), (w)(1), (w)(2), (x)(1), (x)(2), and (y)(1).
    (iii) Release to water. Requirements as specified in Sec.  
721.90(a)(1), (b)(1), and (c)(1).
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph (b).
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125(a) through (e), (i), and (k) are applicable to manufacturers 
and processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.

0
15. Add Sec.  721.10777 to subpart E to read as follows:

Sec.  721.10777  2,4-Hexadienoic acid, 3-(trimethoxysilyl)propyl ester.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified as 2,4-hexadienoic 
acid, 3-(trimethoxysilyl)propyl ester (PMN P-13-945; CAS No. 3090-13-9) 
is subject to reporting under this section for the significant new uses 
described in paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80(y)(1).
    (ii) Release to water. Requirements as specified in Sec.  
721.90(a)(4), (b)(4), and (c)(4) (N = 58).
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph (b).
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125(a), (b), (c), (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
16. Add Sec.  721.10778 to subpart E to read as follows:

Sec.  721.10778  2,4,Hexadienoic acid, 3-(trimethoxysilyl)propyl ester 
(2E,4E)-.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified as 2,4,hexadienoic 
acid, 3-(trimethoxysilyl)propyl ester (2E,4E)- (PMN P-13-946; CAS No. 
163802-53-7) is subject to reporting under this section for the 
significant new uses described in paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80(y)(1).
    (ii) Release to water. Requirements as specified in Sec.  
721.90(a)(4), (b)(4), and (c)(4) (N=58).
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph (b).

[[Page 63838]]

    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125(a), (b), (c), (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
17. Add Sec.  721.10779 to subpart E to read as follows:

Sec.  721.10779  Substituted alkene, reaction products with 
isophoronediamine (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 
substituted alkene, reaction products with isophoronediamine (PMN P-14-
28) 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(h), (y)(1), and (y)(2).
    (ii) Release to water. Requirements as specified in Sec.  
721.90(a)(4), (b)(4), and (c)(4) (N=49).
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph (b).
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125(a), (b), (c), (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
18. Add Sec.  721.10780 to subpart E to read as follows:

Sec.  721.10780  Propaneperoxoic acid, 2,2-dimethyl-, 1,1,3,3-
tetramethylbutyl ester.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified as propaneperoxoic 
acid, 2,2-dimethyl-, 1,1,3,3-tetramethylbutyl ester (PMN P-14-72; CAS 
No. 22288-41-1) is subject to reporting under this section for the 
significant new uses described in paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) 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 (b).
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125(a), (b), (c), and (k) are applicable to manufacturers and 
processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.

0
19. Add Sec.  721.10781 to subpart E to read as follows:

Sec.  721.10781  Fatty acid amide hydrochlorides (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substances identified generically as fatty 
acid amide hydrochlorides (PMNs P-14-89, P-14-90, P-14-91 and P-14-92) 
are subject to reporting under this section for the significant new 
uses described in paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Release to water. Requirements as specified in Sec.  
721.90(a)(4), (b)(4), and (c)(4) (where N=110 for PMNs P-14-89 and P-
14-92; N=240 for PMN P-14-90; N=53 for PMN P-14-91).
    (ii) [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph (b).
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125(a), (b), (c), and (k) are applicable to manufacturers and 
processors of these substances.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.

0
20. Add Sec.  721.10782 to subpart E to read as follows:

Sec.  721.10782  Fatty acid amides (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substances identified generically as fatty 
acid amides (PMN P-14-158, P-14-159, P-14-161, P-14-162, and P-14-163) 
are subject to reporting under this section for the significant new 
uses described in paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Release to water. Requirements as specified in Sec.  721.90 
(a)(4), (b)(4), and (c)(4) (where N=1 for PMNs P-14-158, P-14-159, P-
14-161, and P-14-163; N=140 for PMN P-14-162).
    (ii) [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph (b).
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125(a), (b), (c), and (k) are applicable to manufacturers and 
processors of these substances.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.

0
21. Add Sec.  721.10783 to subpart E to read as follows:

Sec.  721.10783  Fatty acid amide acetates (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substances identified generically as fatty 
acid amide acetates (PMNs P-14-173, P-14-175, P-14-176, P-14-177, P-14-
178, P-14-179, P-14-180, P-14-181, P-14-182, P-14-183, P-14-184, P-14-
185, P-14-186, P-14-187, P-14-188, P-14-190, P-14-191, P-14-192 and P-
14-193) are subject to reporting under this section for the significant 
new uses described in paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Release to water. Requirements as specified in Sec.  721. 90 
(a)(4), (b)(4), and (c)(4) (where N = concentration of concern as 
follows):

------------------------------------------------------------------------
                                                          Concentration
                        PMN No.                             of concern
                                                              (ppb)
------------------------------------------------------------------------
P-14-173, P-14-175, P-14-178, P-14-179, P-14-181, P-14-                1
 183, P-14-184, P-14-192, P-14-193.....................
P-14-176, P-14-180, P-14-185, P-14-186, P-14-187, P-14-                2
 190...................................................
P-14-177, P-14-188.....................................                3
P-14-191...............................................                4
P-14-182...............................................              140
------------------------------------------------------------------------

    (ii) [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph (b).
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125(a), (b), (c), and (k) are applicable to manufacturers and 
processors of these substances.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.

0
22. Add Sec.  721.10784 to subpart E to read as follows:

Sec.  721.10784  Mixed butyltin mercaptoester sulfides (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substances identified generically as mixed 
butyltin mercaptoester sulfides (PMNs P-14-216, P-14-217, and P-14-218) 
are subject to reporting under this section for the significant new 
uses described in

[[Page 63839]]

paragraph (a)(2) of this section. The requirements of this section do 
not apply to quantities of the PMN substances after they have been 
completely reacted (cured) or permanently entrained into a solid 
polyvinyl chloride matrix.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in Sec.  
721.63(a)(1), (a)(2)(i) through (iv), (a)(3), (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)(1) 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.
    (ii) Hazard communication program. Requirements as specified in 
Sec.  721.72(a) through (e)(concentration set at 1.0 percent), (f), 
(g)(1)(i), (g)(1)(ii), (g)(1)(iii), (g)(1)(iv), (g)(1)(v), 
(g)(1)(viii), (g)(1)(ix), (g)(2)(i), (g)(2)(ii), (g)(2)(iii), 
(g)(2)(v), (g)(3)(i), (g)(3)(ii), (g)(4)(i), and (g)(5).
    (iii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80. A significant new use is any use other 
than as a stabilizer in polyvinyl chloride (PVC) at a concentration of 
no greater than 2 percent.
    (iv) Release to water. Requirements as specified in Sec.  
721.90(a)(4), (b)(4), and (c)(4) (N=0.5).
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph (b).
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125(a) through (i) and (k) are applicable to manufacturers and 
processors of these substances.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.

0
23. Add Sec.  721.10785 to subpart E to read as follows:

Sec.  721.10785  Mixed methyltin mercaptoester sulfides (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as mixed 
methyltin mercaptoester sulfides (PMN P-14-231) is subject to reporting 
under this section for the significant new uses described in paragraph 
(a)(2) of this section. The requirements of this section do not apply 
to quantities of the PMN substance after it has been completely reacted 
(cured) or permanently entrained into a solid polyvinyl chloride 
matrix.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in Sec.  
721.63(a)(1), (a)(2)(i) through (iv), (a)(3), (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)(1), 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.
    (ii) Hazard communication program. Requirements as specified in 
Sec.  721.72(a) through (e)(concentration set at 1.0 percent), (f), 
(g)(1)(i), (g)(1)(ii), (g)(1)(iii), (g)(1)(iv), (g)(1)(v), 
(g)(1)(viii), (g)(1)(ix), (g)(2)(i), (g)(2)(ii), (g)(2)(iii), 
(g)(2)(v), (g)(3)(i), (g)(3)(ii), (g)(4)(i), and (g)(5).
    (iii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80. A significant new use is any use other 
than as a stabilizer in polyvinyl chloride at a concentration of no 
greater than 2 percent.
    (iv) Release to water. Requirements as specified in Sec.  
721.90(a)(4), (b)(4), and (c)(4) (N=0.5).
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph (b).
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125(a) through (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
24. Add Sec.  721.10786 to subpart E to read as follows:

Sec.  721.10786  Trisubsituted ethoxylated carbomonocycle (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 
trisubsituted ethoxylated carbomonocycle (PMN P-14-234) 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=24).
    (ii) [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph (b).
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125(a), (b), (c), and (k) are applicable to manufacturers and 
processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.

0
25. Add Sec.  721.10787 to subpart E to read as follows:

Sec.  721.10787  Multi-functional novolac type epoxy resin (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as multi-
functional novolac type epoxy resin (PMN P-14-270) is subject to 
reporting under this section for the significant new uses described in 
paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Release to water. Requirements as specified in Sec.  
721.90(a)(4), (b)(4), and (c)(4) (N=1).
    (ii) [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph (b).
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125(a), (b), (c), and (k) are applicable to manufacturers and 
processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.

0
26. Add Sec.  721.10788 to subpart E to read as follows:

Sec.  721.10788  Alkanedioic acids, polymer with substituted 
propanediol, alkanediols, and polyethylene glycol and MDI (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 
alkanedioic acids, polymer with substituted propanediol, alkanediols, 
and polyethylene glycol and MDI (PMN P-14-357) is subject to reporting 
under this section for the significant new uses described in paragraph 
(a)(2) of this section.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in Sec.  
721.63(a)(4), (a)(6)(ii), (a)(6)(v), and (c). When determining which 
persons are reasonably likely to be exposed as required for Sec.  
721.63(a)(4), engineering control measures (e.g., enclosure or 
confinement of the operation, general and local ventilation) or 
administrative control measures (e.g., workplace policies and 
procedures) shall be considered and implemented to prevent exposure, 
where feasible. The following National Institute for Occupational

[[Page 63840]]

Safety and Health (NIOSH)-certified respirators with an Assigned 
Protection Factor (APF) of at least 10 meet the requirements of Sec.  
721.63(a)(4):
    (A) NIOSH-certified power air-purifying respirator with a hood or 
helmet and with appropriate gas/vapor (acid gas, organic vapor, or 
substance specific) cartridges in combination with HEPA filters.
    (B) NIOSH-certified continuous flow supplied-air respirator 
equipped with a loose fitting face piece, hood, or helmet.
    (C) NIOSH-certified negative pressure (demand) supplied-air 
respirator with a full face piece.
    (ii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80(o) and (y)(1).
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph (b).
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125(a), (b), (c), (d), and (i) are applicable to manufacturers and 
processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.

[FR Doc. 2014-24916 Filed 10-24-14; 8:45 am]
BILLING CODE 6560-50-P