Document ID: EPA-HQ-OPPT-2016-0207-0001
Agency: epa
Document Type: Rule
Title: Significant New Use: Rules on Certain Chemical Substances
Posted Date: 2016-11-17T05:00Z

[Federal Register Volume 81, Number 222 (Thursday, November 17, 2016)]
[Rules and Regulations]
[Pages 81250-81274]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-27326]

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Vol. 81

Thursday,

No. 222

November 17, 2016

Part II

Environmental Protection Agency

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40 CFR Parts 9 and 721

Significant New Use Rules on Certain Chemical Substances; Final Rule

  Federal Register / Vol. 81 , No. 222 / Thursday, November 17, 2016 / 
Rules and Regulations  

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Parts 9 and 721

[EPA-HQ-OPPT-2016-0207; FRL-9953-41]
RIN 2070-AB27

Significant New Use Rules on Certain Chemical Substances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Direct final rule.

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SUMMARY: EPA is promulgating significant new use rules (SNURs) under 
the Toxic Substances Control Act (TSCA) for 57 chemical substances 
which were the subject of premanufacture notices (PMNs). The applicable 
review periods for the PMNs submitted for these 57 chemical substances 
all ended prior to June 22, 2016 (i.e., the date on which President 
Obama signed into law the Frank R. Lautenberg Chemical Safety for the 
21st Century Act which amends TSCA). Thirty-four of these chemical 
substances are subject to TSCA section 5(e) consent orders issued by 
EPA. This action requires persons who intend to manufacture (defined by 
statute to include import) or process any of these 57 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 initiates EPA's evaluation of the 
intended use within the applicable review period. Manufacture and 
processing for the significant new use is unable to commence until EPA 
has conducted a review of the notice, made an appropriate determination 
on the notice, and take such actions as are required with that 
determination.

DATES: This rule is effective on January 17, 2017. For purposes of 
judicial review, this rule shall be promulgated at 1 p.m. (e.s.t.) on 
December 1, 2016.
    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 December 19, 2016 (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 December 19, 2016, EPA will withdraw the 
relevant sections of this direct final rule before its effective date.
    For additional information on related reporting requirement dates, 
see Units I.A., VI., and VII. of the SUPPLEMENTARY INFORMATION.

ADDRESSES: Submit your comments, identified by docket identification 
(ID) number EPA-HQ-OPPT-2016-0207, by one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the online instructions for submitting comments. Do not submit 
electronically any information you consider to be Confidential Business 
Information (CBI) or other information whose disclosure is restricted 
by statute.
     Mail: Document Control Office (7407M), Office of Pollution 
Prevention and Toxics (OPPT), Environmental Protection Agency, 1200 
Pennsylvania Ave. NW., Washington, DC 20460-0001.
     Hand Delivery: To make special arrangements for hand 
delivery or delivery of boxed information, please follow the 
instructions at http://www.epa.gov/dockets/contacts.html.
    Additional instructions on commenting or visiting the docket, along 
with more information about dockets generally, is available at http://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: 
    For technical information contact: Kenneth Moss, Chemical Control 
Division (7405M), Office of Pollution Prevention and Toxics, 
Environmental Protection Agency, 1200 Pennsylvania Ave. NW., 
Washington, DC 20460-0001; telephone number: (202) 564-9232; email 
address: 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 this rule on or after December 19, 
2016 are subject to the export notification provisions of TSCA section 
12(b) (15 U.S.C. 2611(b)) (see Sec.  [emsp14]721.20), and must comply 
with the export notification requirements in 40 CFR part 707, subpart 
D.

B. What should I consider as I prepare my comments for EPA?

    1. Submitting CBI. Do not submit this information to EPA through 
regulations.gov or email. Clearly mark the part or all of the 
information that you claim to be CBI. For CBI information in a disk or 
CD-ROM that you mail to EPA, mark the outside of the disk or CD-ROM as 
CBI and then identify electronically within the disk or CD-ROM the 
specific information that is claimed as CBI. In addition to one 
complete version of the comment that includes information claimed as 
CBI, a copy of the comment that does not contain the information 
claimed as CBI must be submitted for inclusion in the public docket. 
Information so marked will not be disclosed except in accordance with 
procedures set forth in 40 CFR part 2.
    2. Tips for preparing your comments. When preparing and submitting 
your comments, see the commenting tips at http://www.epa.gov/dockets/comments.html.

II. Background

A. What action is the Agency taking?

    EPA is promulgating these SNURs using direct final procedures. 
These SNURs will require persons to notify EPA at least 90 days before 
commencing the manufacture or processing of a chemical substance for 
any activity designated by these SNURs as a significant new use. 
Receipt of such notices allows EPA to assess risks that may be 
presented by the intended uses and, if appropriate, to regulate the 
proposed use before it occurs. Additional rationale and background to 
these rules are more fully set out in the preamble to EPA's first 
direct final SNUR published in the Federal Register issue of April 24, 
1990 (55 FR 17376).

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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 (15 U.S.C. 2604(a)(1)(B)(i)). TSCA furthermore 
prohibits such manufacturing or processing from commencing until EPA 
has conducted a review of the notice, made an appropriate determination 
on the notice, and taken such actions as are required in association 
with that determination (15 U.S.C. 2604(a)(1)(B)(ii)). As described in 
Unit V., the general SNUR provisions are found at 40 CFR part 721, 
subpart A.

C. Applicability of General Provisions

    General provisions for SNURs appear in 40 CFR part 721, subpart A. 
These provisions describe persons subject to the rule, recordkeeping 
requirements, exemptions to reporting requirements, and applicability 
of the rule to uses occurring before the effective date of the rule. 
Provisions relating to user fees appear at 40 CFR part 700. According 
to Sec.  [emsp14]721.1(c), persons subject to these SNURs must comply 
with the same SNUN requirements and EPA regulatory procedures as 
submitters of PMNs under TSCA section 5(a)(1)(A). In particular, these 
requirements include the information submission requirements of TSCA 
section 5(b) and 5(d)(1), the exemptions authorized by TSCA sections 
5(h)(1), (h)(2), (h)(3), and (h)(5), and the regulations at 40 CFR part 
720. Once EPA receives a SNUN, EPA must either determine that the 
significant new use is not likely to present an unreasonable risk of 
injury or take such regulatory action as is associated with an 
alternative determination before the manufacture or processing for the 
significant new use can commence. If EPA determines that the 
significant new use is not likely to present an unreasonable risk, EPA 
is required under TSCA section 5(g) to make public, and submit for 
publication in the Federal Register, a statement of EPA's findings.

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 57 
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 57 chemical substances in 40 CFR part 721, subpart E. 
In this unit, EPA provides the following information for each chemical 
substance:
     PMN number.
     Chemical name (generic name, if the specific name is 
claimed as CBI).
     Chemical Abstracts Service (CAS) Registry number (if 
assigned for non-confidential chemical identities).
     Basis for the TSCA section 5(e) consent order or, for non-
section 5(e) SNURs, the basis for the SNUR (i.e., SNURs without TSCA 
section 5(e) consent orders).
     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 34 PMN substances that are subject to ``risk-
based'' consent orders under TSCA section 5(e)(1)(A)(ii)(I) where EPA 
determined that activities associated with the PMN substances may 
present unreasonable risk to human health or the environment. Those 
consent orders require protective measures to limit exposures or 
otherwise mitigate the potential unreasonable risk. The so-called 
``TSCA section 5(e) SNURs'' on these PMN substances are promulgated 
pursuant to Sec.  [emsp14]721.160, and are based on and consistent with 
the provisions in the underlying consent orders. The TSCA section 5(e) 
SNURs designate as a ``significant new use'' the absence of the 
protective measures required in the corresponding consent orders.
    Where EPA determined that the PMN substance may present an 
unreasonable risk of injury to human health via inhalation exposure, 
the underlying TSCA section 5(e) consent order usually requires, among 
other things, that potentially exposed employees wear specified 
respirators unless actual measurements of the workplace air show that 
air-borne concentrations of the PMN substance are below a New Chemical 
Exposure Limit (NCEL) that is established by EPA to provide adequate 
protection to human health. In addition to the actual NCEL 
concentration, the comprehensive NCELs provisions in TSCA section 5(e) 
consent orders, which are modeled after Occupational Safety and Health 
Administration (OSHA) Permissible Exposure Limits (PELs) provisions, 
include requirements addressing performance criteria for sampling and 
analytical methods, periodic monitoring, respiratory protection, and 
recordkeeping. However, no comparable NCEL provisions currently exist 
in 40 CFR part 721, subpart B, for SNURs. Therefore, for these cases, 
the individual SNURs in 40 CFR part 721, subpart E, will state that 
persons subject to the SNUR who wish to pursue NCELs as an alternative 
to the Sec.  721.63 respirator requirements may request to do so under 
Sec.  [emsp14]721.30. EPA expects that persons whose Sec.  721.30 
requests to use the NCELs approach for SNURs are approved by EPA will 
be required to comply with NCELs provisions that are comparable to 
those contained in the corresponding TSCA section 5(e) consent order 
for the same chemical substance.

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    This rule also includes SNURs on 23 PMN substances that are not 
subject to consent orders under TSCA section 5(e). These cases 
completed Agency review prior to June 22, 2016. Under TSCA, prior to 
the enactment of the Frank R. Lautenberg Chemical Safety for the 21st 
Century Act on June 22, 2016, EPA did not find that the use scenario 
described in the PMN triggered the determinations set forth under TSCA 
section 5(e). However, EPA does believe that certain changes from the 
use scenario described in the PMN could result in increased exposures, 
thereby constituting a ``significant new use.'' These so-called ``non-
TSCA section 5(e) SNURs'' are consistent with the determination made at 
the time and are promulgated pursuant to Sec.  [emsp14]721.170. EPA has 
determined that every activity designated as a ``significant new use'' 
in all non-TSCA section 5(e) SNURs issued under Sec.  [emsp14]721.170 
satisfies the two requirements stipulated in Sec.  721.170(c)(2), i.e., 
these significant new use activities, ``(i) are different from those 
described in the premanufacture notice for the substance, including any 
amendments, deletions, and additions of activities to the 
premanufacture notice, and (ii) may be accompanied by changes in 
exposure or release levels that are significant in relation to the 
health or environmental concerns identified'' for the PMN substance.

PMN Number P-11-482

    Chemical name: Bimodal mixture consisting of multi-walled carbon 
nanotubes and other classes of carbon nanotubes (generic).
    CAS number: Claimed confidential.
    Effective date of TSCA section 5(e) consent order: September 30, 
2015.
    The PMN states that the generic use of the PMN substance will be as 
a specialty additive. Based on test data on analogous respirable, 
poorly soluble particulates and nanocarbon materials, EPA identified 
concerns for pulmonary toxicity and oncogenicity. Based on test data 
for other nanocarbon materials EPA identified concerns for 
environmental toxicity. The Order was issued under TSCA sections 
5(e)(1)(A)(i) and 5(e)(1)(A)(ii)(I), based on a finding that the 
substance may present an unreasonable risk of injury to human health 
and the environment. To protect against these risks, the consent order 
requires:
    1. Use of personal protective equipment involving impervious gloves 
and protective clothing (where there is a potential for dermal 
exposures) and a National Institute for Occupational Safety and Health 
(NIOSH)-certified air purifying, tight-fitting full-face respirator 
equipped with N-100, P-100, or R-100 cartridges, or power air purifying 
particulate respirator with an Assigned Protection Factor (APF) of at 
least 50 (where there is a potential for inhalation exposures).
    2. Submission of a dustiness test within six months of notice of 
commencement of manufacture (NOC).
    3. Submission of certain physical-chemical properties data within 
the time limits specified in the consent order.
    4. Processing and use of the PMN substance only for the use 
specified in the consent order, including no application method that 
generates a vapor, mist or aerosol unless the application method occurs 
in an enclosed process.
    5. No use of the PMN substance resulting in releases to surface 
waters and disposal of the PMN substance only by landfill or 
incineration.
    The SNUR would designate as a ``significant new use'' the absence 
of these protective measures.
    Recommended testing: EPA has determined that the development of 
data on certain physical-chemical properties, as well as certain human 
health and environmental toxicity testing would help characterize 
possible effects of the substance. The submitter has agreed to provide 
a dustiness test (European Standard EU 15051) by six months from 
commencement of manufacture. In addition, the submitter has agreed to 
provide certain physical-chemical property testing as required in the 
consent order after the commencement of manufacture. Although the order 
does not require a 90-day inhalation toxicity test (OPPTS Test 
Guideline 870.3465 or Organisation for Economic Co-operation and 
Development (OECD) Test Guideline 413) in rats with a post-exposure 
observation period of up to 9 months (including BALF analysis, a 
determination of cardiovascular toxicity (clinically-based blood/plasma 
protein analyses), and histopathology of the heart), a two-year 
inhalation bioassay (OPPTS Test Guideline 870.4200), a daphnid chronic 
toxicity test (OPPTS Test Guideline 850.1300), a fish early-life stage 
toxicity test (OPPTS Test Guideline 850.1400), or an algal toxicity 
test (OCSPP Test Guideline 850.4500), the Order's restrictions on 
manufacture, processing, distribution in commerce, and disposal will 
remain in effect until the Order is modified or revoked by EPA based on 
submission of this or other relevant information.
    CFR citation: 40 CFR 721.10927.

PMN Number P-12-292

    Chemical name: Coke (coal), secondary pitch.
    Definition: A carbon-containing residue from the coking of air 
blown pitch coke oil and/or pitch distillate. Composed primarily of 
isotropic carbon, it contains small amounts of sulfur and ash 
constituents.
    CAS number: 94113-91-4.
    Effective date of TSCA section 5(e) consent order: July 1. 2015.
    Basis for TSCA section 5(e) consent order: The PMN states that the 
generic (non-confidential) use of the substance will be in the carbon 
graphite industry. Based on SAR analysis of test data on analogous 
respirable, poorly soluble particulates, subcategory carbon black, EPA 
identified concerns for lung effects and cancer to workers exposed to 
the PMN substance by the inhalation route. The Order was issued under 
TSCA sections 5(e)(1)(A)(i) and 5(e)(1)(A)(ii)(I) based on a finding 
that the substance may present an unreasonable risk of injury to human 
health. To protect against these risks, the consent order requires:
    1. Use of personal protective equipment including a NIOSH-certified 
respirator with an APF of at least 50 or compliance with a NCEL of 
0.0025 mg/m\3\ as an 8-hour time-weighted average, when there is a 
potential for inhalation exposures.
    2. Hazard communication. Establishment and use of a hazard 
communication program, including human health precautionary statements 
on each label and in the Material Safety Data Sheet (MSDS).
    3. No domestic manufacture of the PMN substance.
    4. Use of the PMN substances only for the confidential uses 
specified in the consent order.
    5. Submission of certain toxicity testing on the PMN substance 
prior to exceeding the confidential production volume limit as 
specified in the consent order of the PMN substance.
    The SNUR designates as a ``significant new use'' the absence of 
these protective measures.
    Recommended testing: EPA has determined that the development of 
data on certain physical-chemical properties, as well as certain human 
health toxicity testing would help characterize possible effects of the 
substance. The submitter has agreed to provide the physical/chemical 
properties data and a 90-day inhalation toxicity test (OPPTS Test 
Guideline 870.3465) in rats with a post-exposure observation period of 
60 days (including BALF analysis) before exceeding the

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production volume limits in the consent order. Although the order does 
not require a two-year inhalation bioassay (OPPTS Test Guideline 
870.4200), the Order's restrictions on manufacture, processing, 
distribution in commerce, and disposal will remain in effect until the 
Order is modified or revoked by EPA based on submission of this or 
other relevant information
    CFR citation: 40 CFR 721.10928.

PMN Numbers P-13-718, P-13-719, P-13-720, P-13-721, P-14-655, P-14-656, 
P-14-657, and P-14-658

    Chemical name: Single-walled carbon nanotubes (generic).
    CAS number: Claimed confidential.
    Effective date of TSCA section 5(e) consent order: July 1. 2015.
    Basis for TSCA section 5(e) consent order: The PMNs state that the 
use of the PMN substances will be as: a semi-conductor, conductive, or 
resistive element in electronic circuitry and devices; an electro-
mechanical switch in electronic circuitry and devices; a film laminate 
to improve structural, electrical or electro-chemical properties of 
composite materials; a film laminate to improve conductivity in 
batteries, capacitors and fuels cells; with composite materials to 
improve their mechanical properties and electrical conductivities; 
catalyst support for use in fuel cells; in a nanoporous network in gas 
diffusion layers; for separation of chemicals; an additive to improve 
corrosion resistance of metals; an additive in lubricants and greases 
to improve wear resistance; an additive for transparency and 
conductivity in electronic devices; an additive for fibers in 
structural and electrical applications; an additive for fibers in 
fabrics and as a chemical intermediate. Based on test data on analogous 
respirable, poorly soluble particulates and other carbon nanotubes, EPA 
identified concerns for pulmonary toxicity and oncogenicity. Based on 
test data for other carbon nanotubes, EPA identified concerns for 
environmental toxicity. The Order was issued under TSCA sections 
5(e)(1)(A)(i) and 5(e)(1)(A)(ii)(I), based on a finding that the 
substances may present an unreasonable risk of injury to human health 
and the environment. To protect against these risks, the consent order 
requires:
    1. Use of personal protective equipment involving impervious gloves 
and protective clothing (where there is a potential for dermal 
exposures) and a National Institute for Occupational Safety and Health 
(NIOSH)-certified air purifying, tight-fitting full-face respirator 
equipped with N-100, P-100, or R-100 cartridges, or power air purifying 
particulate respirator with an Assigned Protection Factor (APF) of at 
least 50 (where there is a potential for inhalation exposures).
    2. Submission of certain physical-chemical data for the PMN 
substances within the time triggers specified in the consent order.
    3. Submission of certain human health testing prior to exceeding 
the confidential production volume limit specified in the consent 
order.
    4. Establishment of a medical surveillance program as specified in 
the consent order.
    5. Processing and use of the PMN substances only for the uses 
specified in the consent order, including no application method that 
generates a vapor, mist or aerosol unless the application method occurs 
in an enclosed process.
    6. No use of the PMN substances resulting in releases to surface 
waters and disposal of the PMN substances only by landfill or 
incineration.
    The SNUR would designate as a ``significant new use'' the absence 
of these protective measures.
    Recommended testing: EPA has determined that the development of 
data on certain physical-chemical properties, as well as certain human 
health and environmental toxicity testing would help characterize 
possible effects of the substance. The submitter has agreed to provide 
the physical/chemical properties data within the specified time limits. 
In addition, the submitter has agreed not to exceed the confidential 
production limit without performing a 90-day inhalation toxicity test 
(OPPTS Test Guideline 870.3465 or OECD Test Guideline 413) in rats with 
a post-exposure observation period of up to 9 months (including BALF 
analysis, a determination of cardiovascular toxicity (clinically-based 
blood/plasma protein analyses), and histopathology of the heart). 
Although the order does not require a two-year inhalation bioassay 
(OPPTS Test Guideline 870.4200), a daphnid chronic toxicity test (OPPTS 
Test Guideline 850.1300), a fish early-life stage toxicity test (OPPTS 
Test Guideline 850.1400), or an algal toxicity test (OCSPP Test 
Guideline 850.4500), the Order's restrictions on manufacture, 
processing, distribution in commerce, and disposal will remain in 
effect until the Order is modified or revoked by EPA based on 
submission of this or other relevant information.
    CFR citation: 40 CFR 721.10929.

PMN Numbers P-14-150, P-14-151, P-14-152, P-14-165, and P-14-166

    Chemical name: Fatty acid amides (generic).
    CAS number: Claimed confidential.
    Basis for Action: The PMNs states that these substances will be 
used as chemical intermediates, additives for flotation products, and 
adhesion promoters for use in asphalt applications. Based on SAR 
analysis of test data on analogous amides and aliphatic amines, EPA 
expects toxicity to aquatic organisms may occur at concentrations that 
exceed 1 ppb of PMNs P-14-150 and P-14-165, 2 ppb of PMN P-16-166, and 
4 ppb of PMNs P-14-151 and P-14-152 in surface waters. For the uses 
described in the PMNs, releases of the substances are not expected to 
result in surface water concentrations that exceed their respective 
concern concentration levels. Therefore, EPA has not determined that 
the proposed manufacturing, processing, or use of the substances may 
present an unreasonable risk. EPA has determined, however, that any use 
of the substances, excluding the uses described in the PMNs, resulting 
in releases to surface waters exceeding 1 ppb (P-15-150 and P-14-165), 
2 ppb (P-16-166), or 4 ppb (P-15-151 and P-15-152) 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 (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 P-14-150, P-14-151, and P-14-152. Further, EPA has 
determined results of a fish early-life stage toxicity test (OPPTS Test 
Guideline 850.1400); a daphnid chronic toxicity test (OPPTS Test 
Guideline 850.1300); an algal toxicity test (OCSPP Test Guideline 
850.4500); log Kow and water solubility measurements, as well as either 
the fish acute toxicity mitigated by humic acid test (OPPTS Test 
Guideline 850.1085) or the whole sediment acute toxicity invertebrates, 
freshwater test (OPPTS Test Guideline 850.1735) would help characterize 
the environmental effects of the PMN substances P-14-165 and P-14-166. 
EPA also recommends that the guidance document on aquatic toxicity 
testing of difficult substances and mixtures (OECD Test Guideline 23) 
be followed to

[[Page 81254]]

facilitate solubility in the test media, because of the low water 
solubility of the PMNs. EPA recommends conducting the water solubility 
and log Kow measurements testing first as the results may mitigate the 
need for further toxicity testing or change the testing 
recommendations.
    CFR citation: 40 CFR 721.10930.

PMN Number P-14-413

    Chemical name: Kaolin, reaction products with polysiloxane 
(generic).
    CAS number: Claimed confidential.
    Effective date of TSCA section 5(e) consent order: October 22, 
2015.
    Basis for TSCA section 5(e) consent order: The PMN states that the 
generic (non-confidential) use of the substance will be as an 
insulator. Based on SAR analysis of test data on analogous respirable, 
poorly soluble particulates, EPA identified concerns for lung effects 
to workers exposed to the PMN substance by the inhalation route. The 
Order was issued under TSCA sections 5(e)(1)(A)(i) and 
5(e)(1)(A)(ii)(I) based on a finding that the substance may present an 
unreasonable risk of injury to human health. To protect against these 
risks, the consent order requires:
    1. Use of personal protective equipment including a NIOSH-certified 
respirator with an APF of at least 1,000 or compliance with a NCEL of 
0.1 mg/m\3\ as an 8-hour time-weighted average, when there is a 
potential for inhalation exposures.
    2. Establishment and use of a hazard communication program, 
including human health precautionary statements on each label and in 
the MSDS.
    3. Submission of a 90-day inhalation study on the PMN substance 
prior to exceeding the confidential production volume limit as 
specified in the consent order of the PMN substance.
    The SNUR designates as a ``significant new use'' the absence of 
these protective measures.
    Recommended testing: The submitter has agreed to provide a 90-day 
inhalation toxicity test (OPPTS Test Guideline 870.3465) in rats with a 
post-exposure observation period of 60 days (including BALF analysis) 
before exceeding the production volume limit in the consent order. 
Although the order does not require a two-year inhalation bioassay 
(OPPTS Test Guideline 870.4200), the Order's restrictions on 
manufacture, processing, distribution in commerce, and disposal will 
remain in effect until the Order is modified or revoked by EPA based on 
submission of this or other relevant information.
    CFR citation: 40 CFR 721.10931.

PMN Numbers P-14-428, P-14-429, P-14-430, and P-14-431

    Chemical name: Fatty acid amides (generic).
    CAS number: Claimed confidential.
    Basis for Action: The consolidated PMN states that the substances 
will be used as adhesion promoters and emulsifier intermediates for use 
in asphalt applications. Based on SAR analysis of test data on 
analogous aliphatic amines, EPA predicts toxicity to aquatic organisms 
may occur at concentrations that exceed 1 ppb of P-14-428 and P-14-430, 
and 2 ppb of P-14-429 and P-14-431 in surface waters. For the uses 
described in the PMNs, releases of the substances are not expected to 
result in surface water concentrations that exceed their respective 
concentration values. Therefore, EPA has not determined that the 
proposed manufacturing, processing, or use of the substances may 
present an unreasonable risk. EPA has determined, however, that any use 
of the substances, excluding the uses described in the PMNs, resulting 
in releases to surface waters exceeding 1 ppb of P-14-428 and P-14-430, 
and 2 ppb of P-14-429 and P-14-431, may cause 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 
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 substances.
    CFR citation: 40 CFR 721.10932.

PMN Numbers P-14-523, P-14-524, P-14-525, P-14-526, and P-14-527

    Chemical name: Copolymers of perfluorinated and alkyl methacrylates 
(generic).
    CAS number: Claimed confidential.
    Effective date of TSCA section 5(e) consent order: August 24, 2015.
    Basis for TSCA section 5(e) consent order: The PMNs state that the 
generic (non-confidential) use of the substances will be as additives 
for textile finishing. Based on physical-chemical properties data, as 
well as test data on analogous perfluorinated chemicals and potential 
perfluorinated degradation products, EPA identified concerns for 
irritation to skin, eyes, lungs, mucous membranes, lung toxicity, liver 
toxicity, blood toxicity, male reproductive toxicity, immunosupression, 
and oncogenicity. EPA has concerns that these degradation products will 
persist in the environment, could bioaccumulate or biomagnify, and 
could be toxic (PBT) to people, wild mammals, and birds. The Order was 
issued under TSCA sections 5(e)(1)(A)(i), 5(e)(1)(A)(ii)(I), and 
5(e)(1)(A)(ii)(II) based on a finding that the substances may present 
an unreasonable risk of injury to the environment and human health, the 
substances may be produced in substantial quantities and may reasonably 
be anticipated to enter the environment in substantial quantities, and 
there may be significant (or substantial) human exposure to the 
substances and their potential degradation products. To protect against 
these exposures and risks, the consent order requires:
    1. Use of personal protective equipment including a NIOSH-certified 
respirator when there is a potential for inhalation exposures.
    2. 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.
    3. Manufacture of the PMN substances: (a) According to the chemical 
composition section of the consent order, including analyzing and 
reporting certain starting raw material impurities to EPA; and (b) 
within the maximum established limits of certain fluorinated impurities 
of the PMN substance as stated in the consent order.
    4. Submission of certain toxicity, physical-chemical property, and 
environmental fate testing on the PMN substance prior to exceeding the 
confidential production volume limits as specified in the consent 
order.
    5. Use of the PMN substances only for water and oil repellent use 
on military protective clothing.
    6. No distribution of the PMN substances for consumer use.
    7. No manufacture of the PMN substances in the United States.
    8. No water releases of the PMN substances exceeding 17 ppb.
    Recommended testing: EPA has determined that the results of certain 
toxicity and environmental fate testing would help characterize the PMN 
substance. The submitter has agreed to complete the testing identified 
in the testing section of the consent order by the confidential limits 
specified. In addition, EPA has determined that the results of a 90-day 
inhalation toxicity test in rats (OPPTS Test Guideline 870.3465/OECD 
Test Guideline 413)

[[Page 81255]]

with a 60-day holding period, and an avian reproduction test (OECD Test 
Guideline 206) in mallard ducks would help characterize potential human 
health and environmental effects of the PMN substances. The Order does 
not require this testing at any specified time or production volume. 
However, the Order's restrictions on manufacture, processing, 
distribution in commerce, use, and disposal of the PMN substances will 
remain in effect until the Order is modified or revoked by EPA based on 
submission of that or other relevant information.
    CFR citation: 40 CFR 721.10933.

PMN Number P-14-580

    Chemical name: Alkenoic acid, polymer with alkyl alkenoate, 
alkylalkylalkenoate, alkenoic acid and tridecafluoro alkylalkenoate, 
compds. with alkylaminoalcanol (generic).
    CAS number: Claimed confidential.
    Effective date of TSCA section 5(e) consent order: October 21, 
2015.
    Basis for TSCA section 5(e) consent order: The PMN states that the 
generic (non-confidential) use of the substance will be as a coating 
additive. Based on physical chemical properties data, as well as test 
data on analogous perfluorinated chemicals and potential perfluorinated 
degradation products, EPA identified concerns for irritation to skin, 
eyes, lungs, mucous membranes, lung toxicity, liver toxicity, blood 
toxicity, male reproductive toxicity, immunosupression, and 
oncogenicity. EPA has concerns that these degradation products will 
persist in the environment, could bioaccumulate or biomagnify, and 
could be toxic (PBT) to people, wild mammals, and birds. The Order was 
issued under TSCA sections 5(e)(1)(A)(i), 5(e)(1)(A)(ii)(I), and 
5(e)(1)(A)(ii)(II) based on a finding that the substance may present an 
unreasonable risk of injury to the environment and human health, the 
substance may be produced in substantial quantities and may reasonably 
be anticipated to enter the environment in substantial quantities, and 
there may be significant (or substantial) human exposure to the 
substance and its potential degradation products. To protect against 
these exposures and risks, the consent order requires:
    1. Use of a NIOSH-certified respirator when there is a potential 
for inhalation exposures.
    2. Use of impervious gloves where there is a potential for dermal 
exposures.
    3. 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.
    4. Manufacture of the PMN substance: (a) According to the chemical 
composition section of the consent order, including analyzing and 
reporting certain starting raw material impurities to EPA; and (b) 
within the maximum established limits of certain fluorinated impurities 
of the PMN substance as stated in the consent order.
    5. Submission of certain toxicity, physical-chemical property, and 
environmental fate testing on the PMN substance prior to exceeding the 
confidential production volume limits as specified in the consent 
order.
    6. Use of the PMN substance only for the confidential uses 
specified in the consent order.
    Recommended testing: EPA has determined that the results of certain 
toxicity and environmental fate testing would help characterize the PMN 
substance. The submitter has agreed to complete the testing identified 
in the testing section of the consent order by the confidential limits 
specified. In addition, EPA has determined that the results of a 
hydrolysis as a function of pH and temperature (OPPTS Test Guideline 
835.2130); an indirect photolysis screening test (OPPTS Test Guideline 
835.5270); a modified semi-continuous activated sludge (SCAS) test 
(OPPTS Test Guideline 835.5045 or OECD Test Guideline 302A) with 
analysis of degradation products; a simulation test-aerobic sewage 
treatment (activated sludge units) OECD Test Guideline OECD 303A); a 
phototransformation of chemicals in soils surfaces (Draft OECD Test 
Guideline Jan. 2002); an acute inhalation toxicity test (OPPTS Test 
Guideline 870.1300); and a fish short-term reproduction test (OPPTS 
Test Guideline 890.1350) would help characterize potential human health 
and environmental effects of the PMN substances. The Order does not 
require this testing at any specified time or production volume. 
However, the Order's restrictions on manufacture, processing, 
distribution in commerce, use, and disposal of the PMN substances will 
remain in effect until the Order is modified or revoked by EPA based on 
submission of that or other relevant information.
    CFR citation: 40 CFR 721.10934.

PMN Number P-14-643

    Chemical name: Titanium oxide compound (generic).
    CAS number: Claimed confidential.
    Effective date of TSCA section 5(e) consent order: July 15, 2015.
    Basis for TSCA section 5(e) consent order: The PMN states that the 
generic (non-confidential) use of the substance will be as a physical 
characteristics modifier for composite articles. Based on SAR analysis 
of test data on analogous respirable, poorly soluble particulates, EPA 
identified concerns for lung effects to workers exposed to the PMN 
substance by the inhalation route. The Order was issued under TSCA 
sections 5(e)(1)(A)(i) and 5(e)(1)(A)(ii)(I) based on a finding that 
the substance may present an unreasonable risk of injury to human 
health. To protect against these risks, the consent order requires:
    1. Use of personal protective equipment including a NIOSH-certified 
respirator with an APF of at least 10 or compliance with a NCEL of 2.4 
mg/m\3\ as an 8-hour time-weighted average, when there is a potential 
for inhalation exposures.
    2. Establishment and use of a hazard communication program, 
including human health precautionary statements on each label and in 
the MSDS.
    3. Submission of a 90-day inhalation study on the PMN substance 
prior to exceeding the production volume limit specified in the consent 
order of the PMN substance.
    The SNUR designates as a ``significant new use'' the absence of 
these protective measures.
    Recommended testing: The submitter has agreed to provide a 90-day 
inhalation toxicity test (OPPTS Test Guideline 870.3465) in rats with a 
post-exposure observation period of 60 days (including BALF analysis) 
before exceeding the production volume limit in the consent order. 
Although the order does not require a two-year inhalation bioassay 
(OPPTS Test Guideline 870.4200), the Order's restrictions on 
manufacture, processing, distribution in commerce, and disposal will 
remain in effect until the Order is modified or revoked by EPA based on 
submission of this or other relevant information.
    CFR citation: 40 CFR 721.10935.

PMN Numbers P-14-688, P-14-689, P-14-690, and P-14-691

    Chemical name: Fatty acid amide hydrochlorides (generic).
    CAS number: Claimed confidential.
    Basis for Action: The PMNs state that the substances will be used 
as surfactants for use in asphalt emulsions. Based on SAR analysis of 
test data on analogous aliphatic amines, EPA predicts toxicity to 
aquatic organisms may occur at concentrations that exceed

[[Page 81256]]

1 ppb for P-14-688, P-14-689, P-14-690, and 2 ppb for P-14-691 in 
surface waters. For the uses described in the PMNs, releases of the 
substances are not expected to result in surface water concentrations 
that exceed their respective concern concentration levels. Therefore, 
EPA has not determined that the proposed manufacturing, processing, or 
use of the substances may present an unreasonable risk. EPA has 
determined, however, that any use of the substances, excluding the uses 
described in the PMNs, resulting in releases to surface waters 
exceeding 1 ppb for P-14-688, P-14-689, P-14-690, and 2 ppb for P-14-
691, 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 
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 substances. EPA 
recommends that testing be conducted on P-14-688.
    CFR citation: 40 CFR 721.10936.

PMN Numbers P-14-712, P-14-713, P-14-714, and P-14-715

    Chemical names: Plastics, wastes, pyrolyzed, bulk pyrolysate 
(generic) (P-14-712); Plastics, wastes, pyrolyzed, light distillate 
(generic) (P-14-713); Plastics, wastes, pyrolyzed, middle distillate 
(generic) (P-14-714); and Plastics, wastes, pyrolyzed, heavy distillate 
(generic) (P-14-715).
    CAS numbers: Claimed confidential.
    Effective date of TSCA section 5(e) consent order: July 27, 2015.
    Basis for TSCA section 5(e) consent order: The PMNs state that the 
generic (non-confidential) use of P-14-712 is a petroleum blend stock, 
of P-14-713 and P-14-714 is a fuel blend stock, and of P-14-715 is a 
component of grease or wax products. Based on the presence of benzene 
and naphthalene, EPA identified concerns for oncogenicity, 
immunotoxicity, liver toxicity, and blood toxicity. There is also a 
concern that polychlorinated dibenzo-p-dioxins and dibenzofurans could 
be present in the PMN substances. The Order was issued under TSCA 
sections 5(e)(1)(A)(i) and 5(e)(1)(A)(ii)(I), based on a finding that 
the substances may present an unreasonable risk of injury to human 
health and the environment. To protect against these risks, the consent 
order requires:
    1. Use of a NIOSH-certified respirator with an APF of at least 10 
(where there is a potential for inhalation exposures) or, as an 
alternative, maintaining workplace airborne concentrations of the 
chemical substances identified in the consent order at a level below 
the specified Exposure Limit (EL) of 0.1 ppm and 10 ppm respectively 
for an 8-hour time weighted average.
    2. Use of the PMN substances only for the uses specified in the 
consent order.
    3. Manufacture P-14-712 only as described in the PMN.
    4. Provide personal protective equipment to workers to prevent 
dermal exposure, where there is a potential for dermal exposures.
    5. Establishment and use of a hazard communication program, 
including human health precautionary statements on each label and in 
the MSDS.
    6. Record and report on a quarterly basis polychlorinated dibenzo-
p-dioxin and dibenzofuran levels for P-14-712.
    Recommended testing: EPA has determined that quarterly testing of 
polychlorinated dibenzo-p-dioxin and dibenzofuran levels for P-14-712 
will characterize potential health effects of the PMN substances.
    CFR citations: 40 CFR 721.10937 (P-14-712); 40 CFR 721.10938 (P-14-
713); 40 CFR 721.10939 (P-14-714); and 40 CFR 721.10940 (P-14-715).

PMN Number P-15-28

    Chemical name: Carbon silicon oxide.
    CAS number: 39345-87-4.
    Effective date of TSCA section 5(e) consent order: September 22, 
2015.
    Basis for TSCA section 5(e) consent order: The PMN states that the 
generic (non-confidential) use of P-15-28 is a colorant for industrial, 
architecture, plastics, inks and automotive applications. Based on the 
presence on data on structurally analogous poorly soluble particulates, 
EPA identified concerns for lung overload. The Order was issued under 
TSCA sections 5(e)(1)(A)(i), 5(e)(1)(A)(ii)(I), and 5(e)(1)(A)(ii)(II), 
based on a finding that the substance may present an unreasonable risk 
of injury to human health, and that the substance will be produced in 
substantial quantities and may reasonably be anticipated to enter the 
environment in substantial quantities, and there may be significant (or 
substantial) human exposure to the substance. To protect against these 
risks, the consent order requires:
    1. Use of personal protective equipment including a NIOSH-certified 
respirator with an APF of at least 10 or compliance with a NCEL of 6 
mg/m\3\ as an 8-hour time-weighted average, when there is a potential 
for inhalation exposures.
    2. Hazard communication. Establishment and use of a hazard 
communication program, including human health precautionary statements 
on each label and in the MSDS.
    3. Manufacture of the PMN substance only as described in the 
Consent Order.
    4. Submission of certain toxicity testing on the PMN substance 
within two years of submission of the NOC, as specified in the consent 
order of the PMN substance.
    Recommended testing: EPA has determined that the results of a 90-
day inhalation toxicity study, with a 60-day holding period (OPPTS Test 
Guideline 870.3465), would help characterize human health and 
environmental effects of the PMN substance. The submitter has agreed to 
conduct this test within two years of submission of the Notice of 
Commencement of Manufacture (NOC). EPA has also determined that the 
results of a Chronic Toxicity test (OPPTS Test Guideline 870.4100) via 
the inhalation route would further help characterize human health 
effects of the PMN substance, The Order does not require this testing 
at any specified time or production volume. However, the Order's 
restrictions on manufacture, processing, distribution in commerce, use, 
and disposal of the PMN substance will remain in effect until the Order 
is modified or revoked by EPA based on submission of that or other 
relevant information.
    CFR citation: 40 CFR 721.10941.

PMN Number P-15-54

    Chemical name: Carbon nanotubes (generic).
    CAS number: Claimed confidential.
    Effective date of TSCA section 5(e) consent order: August 31, 2015.
    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 
chemical intermediate. Based on test data on analogous respirable, 
poorly soluble particulates and carbon nanotubes, EPA identified 
concerns for pulmonary toxicity and oncogenicity. Based on test data 
for other nanocarbon materials EPA identified concerns for 
environmental toxicity. The Order was issued under TSCA sections 
5(e)(1)(A)(i) and 5(e)(1)(A)(ii)(I), based on a finding that the 
substance may present an unreasonable risk of injury to human health 
and the environment. To protect against these risks, the consent order 
requires:
    1. Use of personal protective equipment involving impervious gloves 
and protective clothing (where there is

[[Page 81257]]

a potential for dermal exposures) and a National Institute for 
Occupational Safety and Health (NIOSH)-certified air purifying, tight-
fitting full-face respirator equipped with N-100, P-100, or R-100 
cartridges, or power air purifying particulate respirator with an 
Assigned Protection Factor (APF) of at least 50 (where there is a 
potential for inhalation exposures).
    2. Submission of certain physical chemical properties according to 
the time limits described in the order.
    3. Submission of a 90-day inhalation study within one year of 
notice of commencement.
    4. Use of the PMN substance only as a chemical intermediate.
    5. No use of the PMN substance resulting in releases to surface 
waters and disposal of the PMN substance only by landfill or 
incineration.
    The SNUR would designate as a ``significant new use'' the absence 
of these protective measures.
    Recommended testing: EPA has determined that the development of 
data on certain physical-chemical properties, as well as certain human 
health and environmental toxicity testing would help characterize 
possible effects of the substance. The submitter has agreed to provide 
the results of certain physical-chemical property testing annually for 
at least three years after the commencement of manufacture. The 
submitter has also agreed to provide the results of a 90-day inhalation 
toxicity study already being conducted. Although the order does not 
require a daphnid chronic toxicity test (OPPTS Test Guideline 
850.1300), a fish early-life stage toxicity test (OPPTS Test Guideline 
850.1400), or an algal toxicity test (OCSPP Test Guideline 850.4500), 
the Order's restrictions on manufacture, processing, distribution in 
commerce, and disposal will remain in effect until the Order is 
modified or revoked by EPA based on submission of this or other 
relevant information.
    CFR citation: 40 CFR 721.10942.

PMN Number P-15-149

    Chemical name: Sulfonated alkylbenzene salts (generic).
    CAS number: Claimed confidential.
    Effective date of TSCA section 5(e) consent order: September 15, 
2015.
    Basis for TSCA section 5(e) consent order: The PMN states that the 
generic (non-confidential) use of the substance will be for enhanced 
oil recovery. Based on test data on analogous surfactants, EPA 
identified concerns for surfactant effects on the lung and irritation 
to eyes and mucous membranes. Further, based on structural activity 
relationship (SAR) analysis of test data on analogous anionic 
surfactants, EPA predicts toxicity to aquatic organisms may occur at 
concentrations that exceed 2 ppb of the PMN substance in surface 
waters. The Order was issued under TSCA sections 5(e)(1)(A)(i) and 
5(e)(1)(A)(ii)(I) based on a finding that the substance may present an 
unreasonable risk of injury to human health and the environment. To 
protect against these risks, the consent order requires:
    1. Hazard communication. Establishment and use of a hazard 
communication program, including environmental and human health 
precautionary statements on each label and in the MSDS.
    2. Submission of certain toxicity testing on the PMN substance 
prior to exceeding the confidential production volume limit as 
specified in the consent order of the PMN substance.
    3. Use of the PMN substance only for the confidential use specified 
in the consent order.
    4. Comply with the release to water provisions 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 a fish 
acute toxicity test, freshwater and marine (OPPTS Test Guideline 
850.1075); an acute invertebrate toxicity test, freshwater daphnids 
(OPPTS Test Guideline 850.1010); and an algal toxicity test (OCSPP Test 
Guideline 850.4500) would help characterize the environmental effects 
of the PMN substance. The submitter has agreed to complete this testing 
by the confidential production volume identified in the consent order. 
In addition, 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); acute inhalation 
toxicity test (OPPTS Test Guideline 870.1300); acute eye irritation 
test (OPPTS Test Guideline 870.2400); and acute dermal irritation test 
(OPPTS Test Guideline OPPTS 870.2500) would help characterize the 
potential environmental and human health effects of the PMN substance. 
The Order does not require these tests at any specified time or 
production volume. However, the Order's restrictions on manufacture, 
processing, distribution in commerce, use, and disposal of the PMN 
substance will remain in effect until the Order is modified or revoked 
by EPA based on submission of that or other relevant information.
    CFR citation: 40 CFR 721.10943.

PMN Number P-15-267

    Chemical name: Substituted quinoline derivative (generic).
    CAS number: Claimed confidential.
    Basis for Action: The PMN states that the generic (non-
confidential) use of the substance will be as a pesticide additive. 
Based on test data on the PMN substance, EPA identified concerns for 
chronic toxicity including blood, kidney, and spleen toxicity. As 
described in the PMN, occupational exposures are expected to be minimal 
due to the use of adequate personal protective equipment. Therefore, 
EPA has not determined that the proposed manufacturing, processing, or 
use of the substance may present an unreasonable risk. EPA has 
determined, however, that use of the substance without use of 
impervious dermal protection where there is potential for dermal 
exposures, use of a NIOSH-certified respirator with an APF of at least 
10, where there is a potential for inhalation exposures, and use other 
than as a pesticide additive may result in serious health effects. 
Based on this information, the PMN substance meets the concern criteria 
at Sec.  721.170(b)(3)(i).
    Recommended testing: EPA has determined that the results of a 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 721.10944.

PMN Number P-15-470

    Chemical name: Algal oil amide (generic).
    CAS number: Claimed confidential.
    Basis for Action: The PMN states that the generic (non-
confidential) use of the substance will be as a chemical intermediate. 
Based on SAR analysis of test data on analogous aliphatic amines, EPA 
predicts toxicity to aquatic organisms may occur at concentrations that 
exceed 2 ppb of the PMN substance in surface waters for greater than 20 
days per year. This 20-day criterion is derived from partial life cycle 
tests (daphnid chronic and fish early life stage tests) that typically 
range from 21 to 28 days in duration. EPA predicts toxicity to aquatic 
organisms may occur if releases of the substance to surface water, from 
uses other than as described in the PMN, exceed releases from the use 
described in the PMN. For the use described in the PMN, environmental 
releases did not exceed 2 ppb for more than 20 days per year. 
Therefore, EPA has not determined that the proposed manufacturing, 
processing, or use of the substance may present an unreasonable risk. 
EPA has determined, however, that

[[Page 81258]]

any use of the substance other than as listed in the PMN may result in 
significant adverse environmental effects. Based on this information, 
the PMN substance meets the concern criteria at Sec.  
721.170(b)(4)(ii).
    Recommended testing: EPA has determined that the results of a fish 
acute toxicity test, freshwater and marine (OPPTS Test Guideline 
850.1075); an acute invertebrate toxicity test, freshwater daphnids 
(OPPTS Test Guideline 850.1010); and an algal toxicity test (OCSPP Test 
Guideline 850.4500) would help characterize the environmental effects 
of the PMN substance.
    CFR citation: 40 CFR 721.10945.

PMN Number P-15-485

    Chemical name: Bismuth compound (generic).
    CAS number: Claimed confidential.
    Effective date of TSCA section 5(e) consent order: December 21, 
2015.
    Basis for TSCA section 5(e) consent order: The PMN states that the 
generic (non-confidential) use of the substance will be as an additive 
for industrial coatings. Based on SAR analysis of test data on 
analogous respirable, poorly soluble particulates, EPA identified 
concerns for lung toxicity. The Order was issued under TSCA sections 
5(e)(1)(A)(i) and 5(e)(1)(A)(ii)(I) based on a finding that the 
substance may present an unreasonable risk of injury to human health. 
To protect against these risks, the consent order requires:
    1. Use of personal protective equipment including a NIOSH-certified 
respirator with an APF of at least 10 or compliance with a NCEL of 2.4 
mg/m\3\ as an 8-hour time-weighted average, when there is a potential 
for inhalation exposures.
    2. Establishment and use of a hazard communication program, 
including human health precautionary statements on each label and in 
the MSDS.
    3. Submission of certain toxicity testing on the PMN substance 
prior to exceeding the production volume limit as 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 a 90-
day inhalation toxicity test (OPPTS Test Guideline 870.3465) with 
special attention to histopathology (inflammation and cell 
proliferation) of the lung tissues and various parameters of the 
bronchoalveolar lavage fluid (BALF) (e.g., maker enzyme activities, 
total protein content, total cell count, cell differential, and cell 
viability) would help to characterize the health effects of the PMN 
substance. The submitter has agreed to complete this testing by the 
aggregate production volume identified in the consent order. In 
addition, EPA has determined that the results of a 2-year inhalation 
bioassay (OCSPP Test Guideline 870.4200) would help characterize the 
potential human health effects of the PMN substance. The Order does not 
require this test at any specified time or production volume. However, 
the Order's restrictions on manufacture, processing, distribution in 
commerce, use, and disposal of the PMN substance will remain in effect 
until the Order is modified or revoked by EPA based on submission of 
that or other relevant information.
    CFR citation: 40 CFR 721.10946.

PMN Numbers P-15-612, P-15-613, P-15-614, P-15-615, P-15-616, P-15-617, 
and P-15-618

    Chemical names: Sulfur thulium ytterbium yttrium oxide (P-15-612); 
Gadolinium sulfur ytterbium yttrium oxide, erbium- and thulium-doped 
(P-15-613); Neodymium sulfur yttrium oxide (P-15-614); Erbium 
gadolinium neodymium sulfur ytterbium yttrium oxide (P-15-615); Erbium 
gadolinium sulfur ytterbium yttrium oxide (P-15-616); Erbium gadolinium 
ytterbium oxide (P-15-617); and Erbium gadolinium sulfur ytterbium 
oxide (P-15-618).
    CAS numbers: 180189-40-6 (P-15-612); 1651187-84-6 (P-15-613); 
1651158-45-5 (P-15-614); 1651152-96-3 (P-15-615); 1622295-07-1 (P-15-
616); 1651152-05-4 (P-15-617); and 934388-91-7 (P-15-618).
    Effective date of TSCA section 5(e) consent order: December 21, 
2015.
    Basis for TSCA section 5(e) consent order: The PMNs state that the 
use of the substances will be as additives for brand protection and 
anti-counterfeiting inks and polymers. Based on SAR analysis of test 
data on analogous respirable, poorly soluble particulates, EPA 
identified concerns for lung toxicity. The Order was issued under TSCA 
sections 5(e)(1)(A)(i) and 5(e)(1)(A)(ii)(I) based on a finding that 
the substance may present an unreasonable risk of injury to human 
health. To protect against these risks, the consent order requires:
    1. Use of personal protective equipment including a NIOSH-certified 
respirator with an APF of at least 10 or compliance with a NCEL of 0.07 
mg/m\3\ as an 8-hour time-weighted average, when there is a potential 
for inhalation exposures.
    2. Establishment and use of a hazard communication program, 
including human health precautionary statements on each label and in 
the MSDS.
    3. Submission of certain toxicity testing on the PMN substances 
prior to exceeding the production volume limit as 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 a 90-
day inhalation toxicity test (OPPTS Test Guideline 870.3465) with 
special attention to histopathology (inflammation and cell 
proliferation) of the lung tissues and various parameters of the 
bronchoalveolar lavage fluid (BALF) (e.g., maker enzyme activities, 
total protein content, total cell count, cell differential, and cell 
viability) would help to characterize the health effects of the PMN 
substance. The submitter has agreed to complete this testing by the 
aggregate production volume identified in the consent order. In 
addition, EPA has determined that the results of a 2-year inhalation 
bioassay (OCSPP Test Guideline 870.4200) would help characterize the 
potential human health effects of the PMN substances. The Order does 
not require this test at any specified time or production volume. 
However, the Order's restrictions on manufacture, processing, 
distribution in commerce, use, and disposal of the PMN substances will 
remain in effect until the Order is modified or revoked by EPA based on 
submission of that or other relevant information.
    CFR citations: 40 CFR 721.10947 (P-15-612); 40 CFR 721.10948 (P-15-
613); 40 CFR 721.10949 (P-15-614); 40 CFR 721.10950 (P-15-615); 40 CFR 
721.10951 (P-15-616); 40 CFR 721.10952 (P-15-617); and 40 CFR 721.10953 
(P-15-618).

PMN Number P-15-655

    Chemical names: 2-Ethylhexanoic acid, compound with alkyamino 
cyclohexane (generic) (P-15-0655, chemical A); and 2-Ethylhexanoic 
acid, compound with cyclohexylamine (generic) (P-15-0655, chemical B).
    CAS numbers: Claimed confidential.
    Basis for Action: The PMN states that the generic (non-
confidential) use of the substances will be as an epoxy curing agent. 
Based on SAR analysis of test data on analogous aliphatic amines, EPA 
predicts toxicity to aquatic organisms may occur at concentrations that 
exceed 34 ppb of the PMN substances in surface waters. As described in 
the PMN, releases of the substances are not expected to result in 
surface water concentrations that exceed 34 ppb. Therefore, EPA has not

[[Page 81259]]

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 that results in releases to 
surface water concentrations exceeding 34 ppb may cause 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 acute invertebrate toxicity test, freshwater daphnids 
(OPPTS Test Guideline 850.1010); and an algal toxicity test (OCSPP Test 
Guideline 850.4500) would help characterize the environmental effects 
of the PMN substances.
    CFR citation: 40 CFR 721.10954.

PMN Number P-15-680

    Chemical name: Propenoic acid, alkyl ester, polymer with 1,3-
cyclohexanedialkylamine, reaction products with oxirane(alkoxyalkyl) 
(generic).
    CAS number: Claimed confidential.
    Basis for Action: The PMN states that the generic (non-
confidential) use of the substance will be as an ingredient in liquid 
paint coating. Based on data on the PMN substance as well as SAR 
analysis of test data on analogous aliphatic amines, EPA predicts 
toxicity to aquatic organisms may occur at concentrations that exceed 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 that results in releases to surface water 
concentrations exceeding 1 ppb may result in significant adverse 
environmental effects. Based on this information, the PMN substance 
meets the concern criteria at Sec.  721.170(b)(4)(i) and (b)(4)(ii).
    Recommended testing: EPA has determined that the results of an 
activated sludge sorption isotherm test (OPPTS Test Guideline 
835.1110); 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 721.10955.

PMN Number P-15-691

    Chemical name: Acrylic acid, polymer with polyalkylene polyamine 
(generic).
    CAS number: Claimed confidential.
    Basis for Action: The PMN states that the use of the substance will 
be as a chemical intermediate. Based on data on the PMN substance and 
SAR analysis of test data on analogous polycationic polymers, EPA 
predicts toxicity to aquatic organisms may occur at concentrations that 
exceed 5 ppb of the PMN substance in surface waters for greater than 20 
days per year. This 20-day criterion is derived from partial life cycle 
tests (daphnid chronic and fish early life stage tests) that typically 
range from 21 to 28 days in duration. EPA predicts toxicity to aquatic 
organisms may occur if releases of the substance to surface water, from 
uses other than as described in the PMN, exceed releases from the use 
described in the PMN. For the use described in the PMN, environmental 
releases did not exceed 5 ppb for more than 20 days per year. 
Therefore, EPA has not determined that the proposed manufacturing, 
processing, or use of the substance may present an unreasonable risk. 
EPA has determined, however, that any use of the substance other than 
as listed in the PMN may result in significant adverse environmental 
effects. Based on this information, the PMN substance meets the concern 
criteria at Sec.  721.170(b)(4)(i) and (b)(4)(ii).
    Recommended testing: EPA has determined that the results of a Zahn-
Wellens/EMPA Test (OPPTS Test Guideline 835.3200); a fish early-life 
stage toxicity test (OPPTS Test Guideline 850.1400); a fish acute-
toxicity test (OPPTS Test Guideline 850.1085) mitigated by humic acid 
test; and a daphnid chronic toxicity test (OPPTS Test Guideline 
850.1300); would help characterize the environmental effects of the PMN 
substance. EPA recommends that the fate testing be performed first as 
the results may mitigate the need for further toxicity testing or 
change the testing recommendations.
    CFR citation: 40 CFR 721.10956.

PMN Number P-16-30

    Chemical name: 1,2-Cyclohexanedicarboxylic acid, 1-(2-
phenylhydrazide).
    CAS number: 1807977-72-5.
    Basis for Action: The PMN states that the substance will be used as 
a curing agent in anaerobic adhesive and sealant formulations. Based on 
test data on analogous hydrazines, EPA identified concerns for blood 
toxicity, neurotoxicity, oncogenicity, and mutagenicity. Hydrazides are 
expected to be positive in the chromosome aberration test and positive 
for lung sensitization. Based on the presence of a free acid, 
irritation to moist tissue (eyes, lungs, and mucous membranes) is 
expected. As described in the PMN, occupational exposures are expected 
to be minimal due to the use of adequate personal protective equipment. 
Therefore, EPA has not determined that the proposed manufacturing, 
processing, or use of the substance may present an unreasonable risk. 
EPA has determined, however, that use of the substance without use of 
impervious gloves and impervious clothing where there is a potential 
for dermal exposures, 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 dermal toxicity test (OPPTS Test Guideline 870.3250) and a 
carcinogenicity test (OPPTS Test Guideline 870.4200) by the expected 
route of exposure in two species of rodents, would help characterize 
the human health effects of the PMN substance.
    CFR citation: 40 CFR 721.10957.

PMN Number P-16-52

    Chemical name: 2,5-Furandione, dihydro-, polymer with 1,1'-
iminobis[2-propanol], benzoate (ester), N-benzoyl derivs.
    CAS number: 592479-38-4.
    Basis for Action: The PMN states that the generic (non-
confidential) use of the substance will be as printing ink. Based on 
SAR analysis of test data on analogous esters and amides, EPA predicts 
toxicity to aquatic organisms may occur at concentrations that exceed 5 
ppb of the PMN substance in surface waters. As described in the PMN, 
releases of the substance are not expected to result in surface water 
concentrations that exceed 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 resulting in surface water concentrations 
exceeding 5 ppb may cause significant adverse environmental effects. 
Based on this information, the PMN substance meets the concern criteria 
at Sec.  721.170(b)(4)(ii).
    Recommended testing: EPA has determined that the results of a fish 
acute toxicity test, freshwater and marine (OPPTS Test Guideline

[[Page 81260]]

850.1075); an acute invertebrate toxicity test, freshwater daphnids 
(OPPTS Test Guideline 850.1010); and an algal toxicity test (OCSPP Test 
Guideline 850.4500) would help characterize the environmental effects 
of the PMN substance.
    CFR citation: 40 CFR 721.10958.

PMN Numbers P-16-56 and P-16-57

    Chemical name: Dialkyl fattyalkylamino propanamide alkylamine 
acetates (generic).
    CAS number: Claimed confidential.
    Basis for Action: The PMNs state that the generic (non-
confidential) use of the substances is in oil production. Based on 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 substances in surface waters. As described in the PMNs, 
releases of the substances 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 substances 
may present an unreasonable risk. EPA has determined, however, that any 
use of the substances that results in releases to surface water 
concentrations exceeding 1 ppb may cause significant adverse 
environmental effects. Based on this information, the PMN substances 
meets the concern criteria at Sec.  721.170(b)(4)(i).
    Recommended testing: EPA has determined that the results of a fish 
early-life stage toxicity test (OPPTS Test Guideline 850.1400); a mysid 
chronic toxicity test (OPPTS Test Guideline 850.1350); and an algal 
toxicity test (OCSPP Test Guideline 850.4500) would help characterize 
the environmental effects of the PMN substances.
    CFR citation: 40 CFR 721.10959.

PMN Number P-16-58

    Chemical name: Dialkylaminopropylaminopropanoate ester (generic).
    CAS number: Claimed confidential.
    Basis for Action: The PMN states that the substance will be used as 
a chemical intermediate. Based on SAR analysis of test data on 
analogous aliphatic amines, EPA predicts toxicity to aquatic organisms 
may occur at concentrations that exceed 14 ppb of the PMN substance in 
surface waters. As described in the PMN, releases of the substance are 
not expected to result in surface water concentrations that exceed 14 
ppb. Therefore, EPA has not determined that the proposed manufacturing, 
processing, or use of the substance may present an unreasonable risk. 
EPA has determined, however, that any use of the substance resulting in 
surface water concentrations exceeding 14 ppb may cause significant 
adverse environmental effects. Based on this information, the PMN 
substance meets the concern criteria at Sec.  721.170(b)(4)(ii).
    Recommended testing: EPA has determined that the results of a fish 
acute toxicity test, freshwater and marine (OPPTS Test Guideline 
850.1075); an acute invertebrate toxicity test, freshwater daphnids 
(OPPTS Test Guideline 850.1010); and an algal toxicity test (OCSPP Test 
Guideline 850.4500) would help characterize the environmental effects 
of the PMN substance.
    CFR citation: 40 CFR 721.10960.

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 34 of the 57 
chemical substances, regulation was warranted under TSCA section 5(e), 
pending the development of information sufficient to make reasoned 
evaluations of the health or environmental effects of the chemical 
substances. The basis for such findings is outlined in Unit IV. Based 
on these findings, TSCA section 5(e) consent orders requiring the use 
of appropriate exposure controls were negotiated with the PMN 
submitters. The SNUR provisions for these chemical substances are 
consistent with the provisions of the TSCA section 5(e) consent orders. 
These SNURs are promulgated pursuant to Sec.  [emsp14]721.160 (see Unit 
VI.).
    In the other 23 cases, where the uses are not regulated under a 
TSCA section 5(e) consent order, EPA determined that one or more of the 
criteria of concern established at Sec.  [emsp14]721.170 were met, as 
discussed in Unit IV.

B. Objectives

    EPA is issuing these SNURs for specific chemical substances which 
have undergone premanufacture review because the Agency wants to 
achieve the following objectives with regard to the significant new 
uses designated in this rule:
     EPA will receive notice of any person's intent to 
manufacture or process a listed chemical substance for the described 
significant new use before that activity begins.
     EPA will have an opportunity to review and evaluate data 
submitted in a SNUN before the notice submitter begins manufacturing or 
processing a listed chemical substance for the described significant 
new use.
     EPA will be able to either determine that the prospective 
manufacture or processing is not likely to present an unreasonable 
risk, or to take necessary regulatory action associated with any other 
determination, before the described significant new use of the chemical 
substance occurs.
     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.  [emsp14]721.160(c)(3) and Sec.  [emsp14]721.170(d)(4). In 
accordance with Sec.  [emsp14]721.160(c)(3)(ii) and Sec.  
[emsp14]721.170(d)(4)(i)(B), the effective date of this rule is January 
17, 2017 without further notice, unless EPA receives written adverse or 
critical comments, or notice of intent to submit adverse or critical 
comments before December 19, 2016.
    If EPA receives written adverse or critical comments, or notice of 
intent to submit adverse or critical comments, on one or more of these 
SNURs before December 19, 2016, EPA will withdraw the relevant sections 
of this direct final rule before its effective date. EPA will then 
issue a proposed SNUR for the chemical substance(s) on which adverse or 
critical comments were received, providing a 30-day period for public 
comment.
    This rule establishes SNURs for a number of chemical substances. 
Any person who submits adverse or critical comments, or notice of 
intent to submit adverse or critical comments, must identify the 
chemical substance and the new use to which it applies. EPA will not 
withdraw a SNUR for a chemical substance not identified in the comment.

VII. Applicability of Rule to Uses Occurring Before Effective Date of 
the Final Rule

    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

[[Page 81261]]

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 34 of the 57 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 57 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 November 9, 2016 (the date of public 
release/web posting of this rule) as the cutoff date for determining 
whether the new use is ongoing. This designation varies slightly from 
EPA's past practice of designating the date of Federal Register 
publication as the date for making this determination. The objective of 
EPA's approach has been to ensure that a person could not defeat a SNUR 
by initiating a significant new use before the effective date of the 
direct final rule. In developing this rule, EPA has recognized that, 
given EPA's practice of now posting rules on its Web site a week or 
more in advance of Federal Register publication, this objective could 
be thwarted even before that publication. Thus, EPA has slightly 
modified its approach in this rulemaking and plans to follow this 
modified approach in future significant new use rulemakings.
    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. Development and Submission of Information

    EPA recognizes that TSCA section 5 does not require developing any 
particular new information (e.g., generating test data) before 
submission of a SNUN. There is an exception: development of test data 
is required where the chemical substance subject to the SNUR is also 
subject to a rule, order or consent agreement under TSCA section 4 (see 
TSCA section 5(b)(1)).
    In the absence of a TSCA section 4 test rule covering the chemical 
substance, persons are required only to submit information in their 
possession or control and to describe any other information known to or 
reasonably ascertainable by them (see 40 CFR 720.50). However, upon 
review of PMNs and SNUNs, the Agency has the authority to require 
appropriate testing. In cases where EPA issued a TSCA section 5(e) 
consent order that requires or recommends certain testing, Unit IV. 
lists those tests. Unit IV. also lists recommended testing for non-5(e) 
SNURs. Descriptions of tests are provided for informational purposes. 
EPA strongly encourages persons, before performing any testing, to 
consult with the Agency pertaining to protocol selection. To access the 
OCSPP test guidelines referenced in this document electronically, 
please go to http://www.epa.gov/ocspp and select ``Test Methods and 
Guidelines.'' The Organisation for Economic Co-operation and 
Development (OECD) test guidelines are available from the OECD Bookshop 
at http://www.oecdbookshop.org or SourceOECD at http://www.sourceoecd.org. 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 at 
least 14 weeks (earlier TSCA section 5(e) consent orders required 
submissions at least 12 weeks) before reaching the specified production 
limit. Listings of the tests specified in the TSCA section 5(e) consent 
orders are included in Unit IV. The SNURs contain the same production 
volume limits as the TSCA section 5(e) consent orders. Exceeding these 
production limits is defined as a significant new use. Persons who 
intend to exceed the production limit must notify the Agency by 
submitting a SNUN at least 90 days in advance of commencement of non-
exempt commercial manufacture 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 
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

[[Page 81262]]

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.  [emsp14]721.1(c), persons submitting a SNUN must 
comply with the same notification requirements and EPA regulatory 
procedures as persons submitting a PMN, including submission of test 
data on health and environmental effects as described in 40 CFR 720.50. 
SNUNs must be submitted on EPA Form No. 7710-25, generated using e-PMN 
software, and submitted to the Agency in accordance with the procedures 
set forth in 40 CFR 720.40 and Sec.  721.25. E-PMN software is 
available electronically at http://www.epa.gov/opptintr/newchems.

XI. Economic Analysis

    EPA has evaluated the potential costs of establishing SNUN 
requirements for potential manufacturers and processors of the chemical 
substances subject to this rule. EPA's complete economic analysis is 
available in the docket under docket ID number EPA-HQ-OPPT-2016-0207.

XII. Scientific Standards, Evidence, and Available Information

    EPA has used scientific information, technical procedures, 
measures, methods, protocols, methodologies, and models consistent with 
the risk assessment documents included in the public docket. These 
information sources supply information relevant to whether a particular 
use would be a significant new use, based on relevant factors including 
those listed under TSCA section 5(a)(2).
    The clarity and completeness of the data, assumptions, methods, 
quality assurance, and analyses employed in EPA's decision are 
documented, as applicable and to the extent necessary for purposes of 
this significant new use rule, in Unit II and in the documents noted 
above. EPA recognizes, based on the available information, that there 
is variability and uncertainty in whether any particular significant 
new use would actually present an unreasonable risk. For precisely this 
reason, it is appropriate to secure a future notice and review process 
for these uses, at such time as they are known more definitely. The 
extent to which the various information, procedures, measures, methods, 
protocols, methodologies or models used in EPA's decision have been 
subject to independent verification or peer review is adequate to 
justify their use, collectively, in the record for a significant new 
use rule.

XIII. Statutory and Executive Order Reviews

A. Executive Order 12866

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

B. Paperwork Reduction Act (PRA)

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

C. Regulatory Flexibility Act (RFA)

    On February 18, 2012, EPA certified pursuant to RFA section 605(b) 
(5 U.S.C. 601 et seq.), that promulgation of a SNUR does not have a 
significant economic impact on a substantial number of small entities 
where the following are true:
    1. A significant number of SNUNs would not be submitted by small 
entities in response to the SNUR.
    2. The SNUR submitted by any small entity would not cost 
significantly more than $8,300.
    A copy of that certification is available in the docket for this 
action.
    This action is within the scope of the February 18, 2012 
certification. Based on the Economic Analysis discussed in Unit XI. and 
EPA's experience promulgating SNURs (discussed in the certification), 
EPA believes that the following are true:
     A significant number of SNUNs would not be submitted by 
small entities in response to the SNUR.
     Submission of the SNUN would not cost any small entity 
significantly more than $8,300.

[[Page 81263]]

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

D. Unfunded Mandates Reform Act (UMRA)

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

E. Executive Order 13132

    This action will not have a substantial direct effect on States, on 
the relationship between the national government and the States, or on 
the distribution of power and responsibilities among the various levels 
of government, as specified in Executive Order 13132, entitled 
``Federalism'' (64 FR 43255, August 10, 1999).

F. Executive Order 13175

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

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: November 3, 2016.
Maria J. Doa,
Director, Chemical Control Division, Office of Pollution Prevention and 
Toxics.
    Therefore, 40 CFR parts 9 and 721 are amended as follows:

PART 9--[AMENDED]

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

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

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

Sec.  [emsp14]9.1  OMB approvals under the Paperwork Reduction Act.

* * * * *

------------------------------------------------------------------------
                                                           OMB  Control
                     40 CFR citation                            No.
------------------------------------------------------------------------
 
                                * * * * *
------------------------------------------------------------------------
 
               Significant New Uses of Chemical Substances
------------------------------------------------------------------------
 
                                * * * * *
721.10927...............................................       2070-0012
721.10928...............................................       2070-0012
721.10929...............................................       2070-0012
721.10930...............................................       2070-0012
721.10931...............................................       2070-0012
721.10932...............................................       2070-0012
721.10933...............................................       2070-0012
721.10934...............................................       2070-0012
721.10935...............................................       2070-0012
721.10936...............................................       2070-0012
721.10937...............................................       2070-0012
721.10938...............................................       2070-0012
721.10939...............................................       2070-0012
721.10940...............................................       2070-0012
721.10941...............................................       2070-0012
721.10942...............................................       2070-0012
721.10943...............................................       2070-0012
721.10944...............................................       2070-0012
721.10945...............................................       2070-0012
721.10946...............................................       2070-0012
721.10947...............................................       2070-0012
721.10948...............................................       2070-0012
721.10949...............................................       2070-0012
721.10950...............................................       2070-0012
721.10951...............................................       2070-0012
721.10952...............................................       2070-0012
721.10953...............................................       2070-0012
721.10954...............................................       2070-0012
721.10955...............................................       2070-0012
721.10956...............................................       2070-0012
721.10957...............................................       2070-0012
721.10958...............................................       2070-0012
721.10959...............................................       2070-0012
721.10960...............................................       2070-0012
 
                                * * * * *
------------------------------------------------------------------------

* * * * *

PART 721--[AMENDED]

0
3. The authority citation for part 721 continues to read as follows:

    Authority:  15 U.S.C. 2604, 2607, and 2625(c).

0
4. Add Sec.  [emsp14]721.10927 to subpart E to read as follows:

Sec.  [emsp14]721.10927  Bimodal mixture consisting of multi-walled 
carbon nanotubes and other classes of carbon nanotubes (generic).

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

[[Page 81264]]

consisting of multi-walled carbon nanotubes and other classes of carbon 
nanotubes (PMN P-11-482) is subject to reporting under this section for 
the significant new uses described in paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in Sec.  
721.63(a)(1), (a)(2)(i), (a)(2)(ii), (a)(3), (a)(4), (a)(6) 
(particulate), and (c). When determining which persons are reasonably 
likely to be exposed as required for Sec.  721.63(a)(1) and (a)(4), 
engineering control measures (e.g., enclosure or confinement of the 
operation, general and local ventilation) or administrative control 
measures (e.g., workplace policies and procedures) shall be considered 
and implemented to prevent exposure, where feasible. A National 
Institute for Occupational Safety and Health (NIOSH)-certified air 
purifying, tight-fitting full-face respirator equipped with N-100, P-
100, or R-100 cartridges, or power air purifying particulate respirator 
with an Assigned Protection Factor (APF) of at least 50 meets the 
requirements of Sec.  721.63(a)(4).
    (ii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80(k) and (q). A significant new use is any 
use involving an application method that generates a vapor, mist or 
aerosol.
    (iii) Disposal. Requirements as specified in Sec.  721.85(a)(1), 
(a)(2), (b)(1), (b)(2), (c)(1), and (c)(2).
    (iv) Release to water. Requirements as specified in Sec.  
721.90(a)(1), (b)(1), and (c)(1).
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125(a) through (e), (i), (j), 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)(ii) of 
this section.

0
5. Add Sec.  [emsp14]721.10928 to subpart E to read as follows:

Sec.  [emsp14]721.10928  Coke (coal), secondary pitch; a carbon-
containing residue from the coking of air blown pitch coke oil and/or 
pitch distillate; composed primarily of isotropic carbon, it contains 
small amounts of sulfur and ash constituents.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified as coke (coal), 
secondary pitch. Definition: A carbon-containing residue from the 
coking of air blown pitch coke oil and/or pitch distillate. Composed 
primarily of isotropic carbon, it contains small amounts of sulfur and 
ash constituents (PMN P-12-292; CAS No. 94113-91-4) 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)(4), (a)(6)(particulate), (b)(concentration set at 0.1 
percent), and (c). When determining which persons are reasonably likely 
to be exposed as required for Sec.  721.63(a)(1) and (a)(4), 
engineering control measures (e.g., enclosure or confinement of the 
operation, general and local ventilation) or administrative control 
measures (e.g., workplace policies and procedures) shall be considered 
and implemented to prevent exposure, where feasible. A National 
Institute for Occupational Safety and Health (NIOSH)-certified air 
purifying, tight-fitting full-face respirator equipped with N-100, P-
100, or R-100 cartridges, or power air purifying particulate respirator 
with an Assigned Protection Factor (APF) of at least 50 meets the 
requirements of Sec.  721.63(a)(4).
    (A) As an alternative to the respirator requirements in paragraph 
(a)(2)(i) of this section, a manufacturer or processor may choose to 
follow the new chemical exposure limit (NCEL) provision listed in the 
TSCA section 5(e) consent order for this substance. The NCEL is 0.0025 
mg/m\3\ as an 8-hour time weighted average. Persons who wish to pursue 
NCELs as an alternative to Sec.  721.63 respirator requirements may 
request to so under Sec.  721.30. Persons whose Sec.  721.30 requests 
to use the NCELs approach are approved by EPA will be required to 
follow NCELs provisions comparable to those contained in the 
corresponding TSCA section 5(e) consent order.
    (B) [Reserved]
    (ii) Hazard communication program. Requirements as specified in 
Sec.  721.72(a) through (e)(concentration set at 0.1 percent), (f), 
(g)(1)(vii), (g)(2)(ii), (g)(2)(iv), (g)(1)(This substance may cause 
lung effects), and (g)(5).
    (iii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80(f), (k), and (q).
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125(a) through (d), and (f) through (i) are applicable to 
manufacturers and processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.
    (3) Determining whether a specific use is subject to this section. 
The provisions of Sec.  721.1725(b)(1) apply to paragraph (a)(2)(iii) 
of this section.

0
6. Add Sec.  [emsp14]721.10929 to subpart E to read as follows:

Sec.  [emsp14]721.10929  Single-walled carbon nanotubes (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substances identified generically as single 
walled carbon nanotubes (PMNs P-13-718, P-13-719, P-13-720, P-13-721, 
P-14-655, P-14-656, P-14-657, and P-14-658) are subject to reporting 
under this section for the significant new uses described in paragraph 
(a)(2) of this section. The requirements of this rule do not apply to 
the PMN substance when it is embedded or incorporated into a polymer 
matrix that itself has been reacted (cured), embedded in a permanent 
solid polymer form that is not intended to undergo further processing, 
except mechanical processing, or incorporated into an article as 
defined at 40 CFR 720.3(c).
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in Sec.  
721.63(a)(1), (a)(2)(i), (a)(2)(ii), (a)(3), (a)(4), 
(a)(6)(particulate), (b), and (c). When determining which persons are 
reasonably likely to be exposed as required for Sec.  721.63(a)(1) and 
(a)(4), engineering control measures (e.g., enclosure or confinement of 
the operation, general and local ventilation) or administrative control 
measures (e.g., workplace policies and procedures) shall be considered 
and implemented to prevent exposure, where feasible. A National 
Institute for Occupational Safety and Health (NIOSH)-certified air 
purifying, tight-fitting full-face respirator equipped with N-100, P-
100, or R-100 cartridges, or power air purifying particulate respirator 
with an Assigned Protection Factor (APF) of at least 50 meets the 
requirements of Sec.  721.63(a)(4).
    (ii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80(k)(A significant new use is use other than 
as: A semi-conductor, conductive, or resistive element in electronic 
circuitry and devices; an electro-mechanical switch in electronic 
circuitry and devices; a film laminate to improve structural,

[[Page 81265]]

electrical or electro-chemical properties of composite materials; a 
film laminate to improve conductivity in batteries, capacitors and 
fuels cells; with composite materials to improve their mechanical 
properties and electrical conductivities; catalyst support for use in 
fuel cells; in a nanoporous network in gas diffusion layers; for 
separation of chemicals; an additive to improve corrosion resistance of 
metals; an additive in lubricants and greases to improve wear 
resistance; an additive for transparency and conductivity in electronic 
devices; an additive for fibers in structural and electrical 
applications; an additive for fibers in fabrics and as a chemical 
intermediate) and (q). A significant new use is any use involving an 
application method that generates a vapor, mist or aerosol unless such 
application method occurs in an enclosed process. An enclosed process 
is defined as an operation that is designed and operated so that there 
is no release associated with normal or routine production processes 
into the environment of any substance present in the operation. An 
operation with inadvertent or emergency pressure relief releases 
remains an enclosed process so long as measures are taken to prevent 
worker exposure to and environmental contamination from the releases.
    (iii) Disposal. Requirements as specified in Sec.  721.85(a)(1), 
(a)(2), (b)(1), (b)(2), (c)(1), and (c)(2).
    (iv) Release to water. Requirements as specified in Sec.  
721.90(a)(1), (b)(1), and (c)(1).
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125(a) through (e), (i), (j), 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)(ii) of 
this section.

0
7. Add Sec.  721.10930 to subpart E to read as follows:

Sec.  721.10930  Fatty acid amides (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substances identified generically as fatty 
acid amides (PMNs P-14-150, P-14-151, P-14-152, P-14-165, and P-14-166) 
are subject to reporting under this section for the significant new 
uses described in paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80. A significant new use of the substances 
is any use other than as chemical intermediates, additives for 
flotation products, or adhesion promoters for use in asphalt 
applications where the surface water concentrations described under 
paragraph (a)(3)(i) of this section are exceeded.
    (ii) [Reserved]
    (3) The significant new uses for any use other than as chemical 
intermediates, additives for flotation products, or adhesion promoters 
for use in asphalt applications 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-15-150 and P-14-
165), (N=2 for PMN P-14-166), and (N=4 for PMNs P-14-151 and P-14-152).
    (ii) [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125(a), (b), (c), (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
8. Add Sec.  721.10931 to subpart E to read as follows:

Sec.  721.10931  Kaolin, reaction products with polysiloxane (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as kaolin, 
reaction products with polysiloxane (PMN P-14-413) is subject to 
reporting under this section for the significant new uses described in 
paragraph (a)(2) of this section.
    (i) Protection in the workplace. Requirements as specified in Sec.  
721.63(a)(1), (a)(4), (a)(6) (particulate), (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) and (a)(4), 
engineering control measures (e.g., enclosure or confinement of the 
operation, general and local ventilation) or administrative control 
measures (e.g., workplace policies and procedures) shall be considered 
and implemented to prevent exposure, where feasible. A NIOSH-certified 
powered air purifying full facepiece respirator with an Assigned 
Protection Factor (APF) of at least 1,000 equipped with an appropriate 
gas/vapor (acid gas, organic vapor, or substance specific) cartridge in 
combination with HEPA filters or a NIOSH-certified continuous flow 
supplied air respirator equipped with a full facepiece meet the 
requirements of Sec.  721.63(a)(4).
    (A) As an alternative to the respirator requirements in paragraph 
(a)(2)(i) of this section, a manufacturer or processor may choose to 
follow the new chemical exposure limit (NCEL) provision listed in the 
TSCA section 5(e) consent order for this substance. The NCEL is 0.1 mg/
m\3\ as an 8-hour time weighted average. Persons who wish to pursue 
NCELs as an alternative to Sec.  721.63 respirator requirements may 
request to do so under Sec.  721.30. Persons whose Sec.  721.30 
requests to use the NCELs approach are approved by EPA will be required 
to follow NCELs provisions comparable to those contained in the 
corresponding TSCA section 5(e) consent order.
    (B) [Reserved]
    (ii) Hazard communication program. Requirements as specified in 
Sec.  721.72(a), through (e) (concentration set at 1.0 percent), (f), 
(g)(1)(ii), (g)(2)(ii), (g)(2)(iii), (g)(2)(iv), and (g)(5).
    (iii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80(q).
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125(a) through (d), and (f), through (i) are applicable to 
manufacturers and processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.
    (3) Determining whether a specific use is subject to this section. 
The provisions of Sec.  721.1725(b)(1) apply to paragraph (a)(2)(iii) 
of this section.

0
9. Add Sec.  721.10932 to subpart E to read as follows:

Sec.  721.10932  Fatty acid amides (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substances identified generically as fatty 
acid amides (PMNs P-14-428, P-14-429, P-14-430, and P-14-431) are 
subject to reporting under this section for the significant new uses 
described in paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Industrial, commercial, and consumer activities. Requirements 
as

[[Page 81266]]

specified in Sec.  721.80. A significant new use of the substances is 
any use other than as emulsifier intermediates or adhesion promoters 
for use in asphalt applications where the surface water concentrations 
described under paragraph (a)(3)(i) of this section are exceeded.
    (ii) [Reserved]
    (3) The significant new uses for any use other than as emulsifier 
intermediates or adhesion promoters for use in asphalt applications 
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-14-428 and P-14-
429) and (N=2 for PMNs P-14-429 and P-14-431).
    (ii) [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125(a), (b), (c), (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
10. Add Sec.  721.10933 to subpart E to read as follows:

Sec.  721.10933  Copolymers of perfluorinated and alkyl methacrylates 
(generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substances identified generically as 
copolymers of perfluorinated and alkyl methacrylates (PMNs P-14-523, P-
14-524, P-14-525, P-14-526, and P-14-527) 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) Protection in the workplace. Requirements as specified in Sec.  
721.63(a)(1), (a)(4), (a)(6) (particulate, gas/vapor or a combination 
gas/vapor and particulate)), 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) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80(f), (k) (analysis and reporting and 
limitations of maximum impurity levels of certain impurities), (o) and 
(q). It is a significant new use to use the PMN substance other than 
for water and oil repellent use on military protective clothing.
    (iii) Release to water. Requirements as specified in Sec.  
721.90(a)(4), (b)(4), and (c)(4) where N=17.
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125(a) through (e), 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.  721.10934 to subpart E to read as follows:

Sec.  721.10934  Alkenoic acid, polymer with alkyl alkenoate, 
alkylalkylalkenoate, alkenoic acid and tridecafluoro alkylalkenoate, 
compds. with alkylaminoalcanol (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 
alkenoic acid, polymer with alkyl alkenoate, alkylalkylalkenoate, 
alkenoic acid and tridecafluoro alkylalkenoate, compds. with 
alkylaminoalcanol (PMN P-14-580) 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)(4), (a)(6) (particulate, gas/vapor or a combination 
gas/vapor and particulate), 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) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80(k) (analysis and reporting and limitations 
of maximum impurity levels of certain impurities; and use other 
described in the consent order) and (q).
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125(a) through (e), 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 paragraphs (a)(2)(ii) 
of this section.

0
12. Add Sec.  721.10935 to subpart E to read as follows:

Sec.  721.10935  Titanium oxide compound (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 
titanium oxide compound (PMN P-14-643) 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)(4) (respirators must provide a National Institute for 
Occupational Safety and Health (NIOSH) assigned protection factor of at 
least 10), (a)(6) (particulate), (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) and (a)(4), 
engineering control measures (e.g., enclosure or confinement of the 
operation, general and local ventilation) or administrative control 
measures (e.g., workplace policies and procedures) shall be considered 
and implemented to prevent exposure, where feasible.
    (A) As an alternative to the respirator requirements in paragraph 
(a)(2)(i) of this section, a manufacturer or processor may choose to 
follow the new chemical exposure limit (NCEL) provision listed in the 
TSCA section 5(e) consent order for this substance. The NCEL is 2.4 mg/
m\3\ as an 8-hour time weighted average. Persons who wish to pursue 
NCELs as an alternative to Sec.  721.63 respirator requirements may 
request to do so under Sec.  721.30. Persons whose Sec.  721.30 
requests to use the NCELs approach are approved by EPA will be required 
to follow NCELs provisions comparable to those contained in the 
corresponding TSCA section 5(e) consent order.
    (B) [Reserved]
    (ii) Hazard communication program. Requirements as specified in 
Sec.  721.72(a), through (e) (concentration set at 1.0 percent), (f), 
(g)(1)(ii), (g)(2)(ii), (g)(2)(iii), and (g)(2)(iv), and (g)(5).

[[Page 81267]]

    (iii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80(p) (4,300,000 kilograms).
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125(a) through (d), and (f), through (i) are applicable to 
manufacturers and processors of this.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.

0
13. Add Sec.  721.10936 to subpart E to read as follows:

Sec.  721.10936  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-14-688, P-14-689, P-14-690, and P-14-
691) are subject to reporting under this section for the significant 
new uses described in paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80. A significant new use of the substances 
is any use other than as surfactants for use in asphalt applications 
where the surface water concentrations described under paragraph 
(a)(3)(i) of this section are exceeded.
    (ii) [Reserved]
    (3) The significant new uses for any use other than as surfactants 
for use in asphalt applications are:
    (i) Release to water. Requirements as specified in Sec.  
721.90(a)(4), (b)(4), and (c)(4) (N=1 for PMNs P-14-688, P-14-689, and 
P-14-690) and (N=2 for PMN P-14-691).
    (ii) [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125(a), (b), (c), (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
14. Add Sec.  721.10937 to subpart E to read as follows:

Sec.  721.10937  Plastics, wastes, pyrolyzed, bulk pyrolysate 
(generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 
plastics, wastes, pyrolyzed, bulk pyrolysate (PMN P-14-712) is subject 
to reporting under this section for the significant new uses described 
in paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in Sec.  
721.63(a)(1), (a)(2)(i), (a)(3), (a)(4) (respirators must provide a 
National Institute for Occupational Safety and Health (NIOSH) assigned 
protection factor of at least 10), (a)(6)(v), (a)(6)(vi), 
(a)(6)(particulate or a combination gas/vapor and particulate), 
(b)(concentration set at 0.1 percent), and (c). When determining which 
persons are reasonably likely to be exposed as required for Sec.  
721.63(a)(1) and (a)(4), engineering control measures (e.g., enclosure 
or confinement of the operation, general and local ventilation) or 
administrative control measures (e.g., workplace policies and 
procedures) shall be considered and implemented to prevent exposure, 
where feasible.
    (A) As an alternative to the respirator requirements in paragraph 
(a)(2)(i) of this section, a manufacturer or processor may choose to 
follow the exposure limit (EL) provision listed in the TSCA section 
5(e) consent order for this substance. The EL is both 0.1 ppm for 
benzene and 10 ppm for naphthalene as an 8-hour time weighted average.
    (B) [Reserved]
    (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)(vi), 
(g)(1)(vii), (g)(1)(viii), (g)(1)(ix), (g)(2)(i), (g)(2)(ii), 
(g)(2)(iii), (g)(2)(v), (g)(3)(i), (g)(3)(i), and (g)(5).
    (iii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80(k). It is a significant new use to 
manufacture this substance other than as described in the PMN. It is a 
significant new use to manufacture this substance without testing the 
substance for polychlorinated dibenzo-p-dioxin and dibenzofuran 
impurities using EPA Method 8290A at each facility of manufacture, 
conducting the testing every quarter that the PMN substance is 
manufactured, submitting the results of any testing conducted, or 
providing test results more than 45 days after receiving them.
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125(a) through (i) are applicable to manufacturers and processors 
of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.
    (3) Determining whether a specific use is subject to this section. 
The provisions of Sec.  721.1725(b)(1) apply to paragraph (a)(2)(iii) 
of this section.

0
15. Add Sec.  721.10938 to subpart E to read as follows:

Sec.  721.10938  Plastics, wastes, pyrolyzed, light distillate 
(generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 
plastics, wastes, pyrolyzed, light distillate (PMN P-14-713) is subject 
to reporting under this section for the significant new uses described 
in paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in Sec.  
721.63(a)(1), (a)(2)(i), (a)(3), (a)(4)(respirators must provide a 
National Institute for Occupational Safety and Health (NIOSH) assigned 
protection factor of at least 10), (a)(6)(v), (a)(6)(vi), 
(a)(6)(particulate or a combination gas/vapor and particulate), 
(b)(concentration set at 0.1 percent), and (c). When determining which 
persons are reasonably likely to be exposed as required for Sec.  
721.63(a)(1) and (a)(4), engineering control measures (e.g., enclosure 
or confinement of the operation, general and local ventilation) or 
administrative control measures (e.g., workplace policies and 
procedures) shall be considered and implemented to prevent exposure, 
where feasible.
    (A) As an alternative to the respirator requirements in paragraph 
(a)(2)(i) of this section, a manufacturer or processor may choose to 
follow the exposure limit (EL) provision listed in the TSCA section 
5(e) consent order for this substance. The EL is both 0.1 ppm for 
benzene and 10 ppm for naphthalene as an 8-hour time weighted average.
    (B) [Reserved]
    (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)(vi), 
(g)(1)(vii), (g)(1)(viii), (g)(1)(ix), (g)(2)(i), (g)(2)(ii), 
(g)(2)(iii), (g)(2)(v), (g)(3)(i), (g)(3)(i), and (g)(5).

[[Page 81268]]

    (iii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80 (k).
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125(a) through (i) are applicable to manufacturers and processors 
of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.
    (3) Determining whether a specific use is subject to this section. 
The provisions of Sec.  721.1725(b)(1) apply to paragraph (a)(2)(iii) 
of this section.

0
16. Add Sec.  721.10939 to subpart E to read as follows:

Sec.  721.10939  Plastics, wastes, pyrolyzed, middle distillate 
(generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 
plastics, wastes, pyrolyzed, middle distillate (PMN P-14-714) is 
subject to reporting under this section for the significant new uses 
described in paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in Sec.  
721.63(a)(1), (a)(2)(i), (a)(3), (a)(4)(respirators must provide a 
National Institute for Occupational Safety and Health (NIOSH) assigned 
protection factor of at least 10), (a)(6)(v), (a)(6)(vi), 
(a)(6)(particulate or a combination gas/vapor and particulate), 
(b)(concentration set at 0.1 percent), and (c). When determining which 
persons are reasonably likely to be exposed as required for Sec.  
721.63(a)(1) and (a)(4), engineering control measures (e.g., enclosure 
or confinement of the operation, general and local ventilation) or 
administrative control measures (e.g., workplace policies and 
procedures) shall be considered and implemented to prevent exposure, 
where feasible.
    (A) As an alternative to the respirator requirements in paragraph 
(a)(2)(i) of this section, a manufacturer or processor may choose to 
follow the exposure limit (EL) provision listed in the TSCA section 
5(e) consent order for this substance. The EL is both 0.1 ppm for 
benzene and 10 ppm for naphthalene as an 8-hour time weighted average.
    (B) [Reserved]
    (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)(vi), 
(g)(1)(vii), (g)(1)(viii), (g)(1)(ix), (g)(2)(i), (g)(2)(ii), 
(g)(2)(iii), (g)(2)(v), (g)(3)(i), (g)(3)(i), and (g)(5).
    (iii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80(k).
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125(a) through (i) are applicable to manufacturers and processors 
of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.
    (3) Determining whether a specific use is subject to this section. 
The provisions of Sec.  721.1725(b)(1) apply to paragraph (a)(2)(iii) 
of this section.

0
17. Add Sec.  721.10940 to subpart E to read as follows:

Sec.  721.10940  Plastics, wastes, pyrolyzed, heavy distillate 
(generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 
plastics, wastes, pyrolyzed, heavy distillate (PMN P-14-715) is subject 
to reporting under this section for the significant new uses described 
in paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in Sec.  
721.63(a)(1), (a)(2)(i), (a)(3), (a)(4)(respirators must provide a 
National Institute for Occupational Safety and Health (NIOSH) assigned 
protection factor of at least 10), (a)(6)(v), (a)(6)(vi), (a)(6) 
(particulate or a combination gas/vapor and particulate), 
(b)(concentration set at 0.1 percent), and (c). When determining which 
persons are reasonably likely to be exposed as required for Sec.  
721.63(a)(1) and (a)(4), engineering control measures (e.g., enclosure 
or confinement of the operation, general and local ventilation) or 
administrative control measures (e.g., workplace policies and 
procedures) shall be considered and implemented to prevent exposure, 
where feasible.
    (A) As an alternative to the respirator requirements in paragraph 
(a)(2)(i) of this section, a manufacturer or processor may choose to 
follow the exposure limit (EL) provision listed in the TSCA section 
5(e) consent order for this substance. The EL is both 0.1 ppm for 
benzene and 10 ppm for naphthalene as an 8-hour time weighted average.
    (B) [Reserved]
    (ii) Hazard communication program. Requirements as specified in 
Sec.  721.72(a) through (e) (concentration set at 1.0 percent), (f), 
(g)(1)(i), through (g)(1)(ix), (g)(2)(i), through (g)(2)(iii), 
(g)(2)(v), (g)(3)(i), (g)(3)(ii), and (g)(5).
    (iii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80(k).
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125(a) through (i) are applicable to manufacturers and processors 
of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.
    (3) Determining whether a specific use is subject to this section. 
The provisions of Sec.  721.1725(b)(1) apply to paragraph (a)(2)(iii) 
of this section.

0
18. Add Sec.  721.10941 to subpart E to read as follows:

Sec.  721.10941  Carbon silicon oxide.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified as carbon silicon 
oxide (PMN P-15-28; CAS No. 39345-87-4) is subject to reporting under 
this section for the significant new uses described in paragraph (a)(2) 
of this section.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in Sec.  
721.63(a)(1), (a)(2)(i), (a)(3), (a)(4) (respirators must provide a 
National Institute for Occupational Safety and Health (NIOSH) assigned 
protection factor of at least 10), (a)(6)(v), (a)(6)(vi), (a)(6) 
(particulate or a combination gas/vapor and particulate), (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) and (a)(4), engineering control measures (e.g., enclosure 
or confinement of the operation, general and local ventilation) or 
administrative control measures (e.g., workplace policies and 
procedures) shall be considered and implemented to prevent exposure, 
where feasible.
    (A) As an alternative to the respirator requirements in paragraph 
(a)(2)(i) of this section, a manufacturer or processor may choose to 
follow the new chemical exposure limit (NCEL) provision listed in the 
TSCA section 5(e) consent order for this substance. The NCEL is 6 mg/
m\3\ as an 8-hour time weighted average. Persons who wish to pursue 
NCELs as an alternative to Sec.  721.63

[[Page 81269]]

respirator requirements may request to do so under Sec.  721.30. 
Persons whose Sec.  721.30 requests to use the NCELs approach are 
approved by EPA will be required to follow NCELs provisions comparable 
to those contained in the corresponding TSCA section 5(e) consent 
order.
    (B) [Reserved]
    (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)(2)(i), (g)(2)(ii), (g)(2)(iv), (g)(2)(v), 
and (g)(5).
    (iii) Industrial, commercial, and consumer activities. It is a 
significant new use to manufacture the PMN substance other than 
specified in the TSCA section 5(e) consent order. Requirements as 
specified in Sec.  721.80(p) (within 24 months of submission of a 
Notice of Commencement of Manufacture).
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125(a) through (i) are applicable to manufacturers and processors 
of this.
    (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
19. Add Sec.  721.10942 to subpart E to read as follows:

Sec.  721.10942  Carbon nanotubes (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as carbon 
nanotubes (PMN P-15-54) is subject to reporting under this section for 
the significant new uses described in paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in Sec.  
721.63(a)(1), (a)(2)(i), (a)(2)(ii), (a)(3), (a)(4), (a)(6) 
(particulate), and (c). When determining which persons are reasonably 
likely to be exposed as required for Sec.  721.63(a)(1) and (a)(4), 
engineering control measures (e.g., enclosure or confinement of the 
operation, general and local ventilation) or administrative control 
measures (e.g., workplace policies and procedures) shall be considered 
and implemented to prevent exposure, where feasible. A National 
Institute for Occupational Safety and Health (NIOSH)-certified 
respirator with an Assigned Protection Factor (APF) of at least 50 with 
an N-100, P-100, or R-100 cartridge meets the requirements of Sec.  
721.63(a)(4).
    (ii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80(k)(chemical intermediate) and (p)(one 
year).
    (iii) Disposal. Requirements as specified in Sec.  721.85(a)(1), 
(a)(2), (b)(1), (b)(2), (c)(1), and (c)(2).
    (iv) Release to water. Requirements as specified in Sec.  
721.90(a)(1), (b)(1), and (c)(1).
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125(a) through (e), (i), (j), and (k) are applicable to 
manufacturers and processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.

0
20. Add Sec.  721.10943 to subpart E to read as follows:

Sec.  721.10943  Sulfonated alkylbenzene salts (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 
sulfonated alkylbenzene salts (PMN P-15-149) 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. 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) (serious eye damage), (g)(2)(i), 
(g)(2)(ii), (g)(2)(iii), (g)(2)(v), (g)(3)(i), (g)(3)(ii), (g)(4)(i) 
and (g)(5).
    (ii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80(k) and (q).
    (iii) Release to water. Requirements as specified in Sec.  
721.90(a)(4), (b)(4), and (c)(4) (N=2).
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125(a), (b), (c), (f), (g), (h), (i), and (k) are applicable to 
manufacturers 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
21. Add Sec.  721.10944 to subpart E to read as follows:

Sec.  721.10944  Substituted quinoline derivative (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 
substituted quinoline derivative (PMN P-15-267) is subject to reporting 
under this section for the significant new uses described in paragraph 
(a)(2) of this section.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in Sec.  
721.63(a)(1), (a)(3), (a)(4) (respirators must provide a National 
Institute for Occupational Safety and Health (NIOSH) assigned 
protection factor of at least 10), (a)(6) (particulate), 
(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) and (a)(4), engineering control measures (e.g., enclosure 
or confinement of the operation, general and local ventilation) or 
administrative control measures (e.g., workplace policies and 
procedures) shall be considered and implemented to prevent exposure, 
where feasible.
    (ii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80(j).
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125(a), through (e), 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
22. Add Sec.  721.10945 to subpart E to read as follows:

Sec.  721.10945  Algal oil amide (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as algal 
oil amide (PMN P-15-470) is subject to reporting under this section for 
the significant new uses described in paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80(j).
    (ii) [Reserved]

[[Page 81270]]

    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125(a), (b), (c), and (i) are applicable to manufacturers and 
processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.
    (3) Determining whether a specific use is subject to this section. 
The provisions of Sec.  721.1725(b)(1) apply to paragraph (a)(2)(i) of 
this section.

0
23. Add Sec.  721.10946 to subpart E to read as follows:

Sec.  721.10946  Bismuth compound (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as bismuth 
compound (PMN P-15-485) is subject to reporting under this section for 
the significant new uses described in paragraph (a)(2) of this section. 
The requirements of this order do not apply when the chemical substance 
has 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)(4) (respirators must provide a National Institute for 
Occupational Safety and Health (NIOSH) assigned protection factor of at 
least 10), (a)(6) (particulate), (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) and (a)(4), engineering 
control measures (e.g., enclosure or confinement of the operation, 
general and local ventilation) or administrative control measures 
(e.g., workplace policies and procedures) shall be considered and 
implemented to prevent exposure, where feasible.
    (A) As an alternative to the respirator requirements in paragraph 
(a)(2)(i) of this section, a manufacturer or processor may choose to 
follow the new chemical exposure limit (NCEL) provision listed in the 
TSCA section 5(e) consent order for this substance. The NCEL is 2.4 mg/
m\3\ as an 8-hour time weighted average. Persons who wish to pursue 
NCELs as an alternative to Sec.  721.63 respirator requirements may 
request to do so under Sec.  721.30. Persons whose Sec.  721.30 
requests to use the NCELs approach are approved by EPA will be required 
to follow NCELs provisions comparable to those contained in the 
corresponding TSCA section 5(e) consent order.
    (B) [Reserved]
    (ii) Hazard communication program. Requirements as specified in 
Sec.  721.72(a) through (e) (concentration set at 1.0 percent), (f), 
(g)(1)(ii), (g)(2)(ii), (g)(2)(iii), and (g)(2)(iv), and (g)(5).
    (iii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80(p) (360,000 kilograms).
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125(a) through (d), and (f), through (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
24. Add Sec.  721.10947 to subpart E to read as follows:

Sec.  721.10947  Sulfur thulium ytterbium yttrium oxide.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified as sulfur thulium 
ytterbium yttrium oxide (PMN P-15-612; CAS No. 180189-40-6) 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)(4) (respirators must provide a National Institute for 
Occupational Safety and Health (NIOSH) assigned protection factor of at 
least 10), (a)(6) (particulate), (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) and (a)(4), 
engineering control measures (e.g., enclosure or confinement of the 
operation, general and local ventilation) or administrative control 
measures (e.g., workplace policies and procedures) shall be considered 
and implemented to prevent exposure, where feasible.
    (A) As an alternative to the respirator requirements in paragraph 
(a)(2)(i) of this section, a manufacturer or processor may choose to 
follow the new chemical exposure limit (NCEL) provision listed in the 
TSCA section 5(e) consent order for this substance. The NCEL is 0.07 
mg/m\3\ as an 8-hour time weighted average. Persons who wish to pursue 
NCELs as an alternative to Sec.  721.63 respirator requirements may 
request to do so under Sec.  721.30. Persons whose Sec.  721.30 
requests to use the NCELs approach are approved by EPA will be required 
to follow NCELs provisions comparable to those contained in the 
corresponding TSCA section 5(e) consent order.
    (B) [Reserved]
    (ii) Hazard communication program. Requirements as specified in 
Sec.  721.72(a), (b), (c), (d), (e) (concentration set at 1.0 percent), 
(f), (g)(1)(ii), (g)(2)(ii), (g)(2)(iii), and (g)(2)(iv), and (g)(5).
    (iii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80(p) (6,000 kilograms, aggregate of PMNs P-
15-612, P-15-613, P-15-614, P-15-615, P-15-616, P-15-617, P-15-618, 
combined).
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125(a), (b), (c), (d), (f), (g), (h), 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
25. Add Sec.  721.10948 to subpart E to read as follows:

Sec.  721.10948  Gadolinium sulfur ytterbium yttrium oxide, erbium- and 
thulium-doped.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified as (PMN P-15-613; CAS 
No, 1651187- 84-6) 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)(4) (respirators must provide a National Institute for 
Occupational Safety and Health (NIOSH) assigned protection factor of at 
least 10), (a)(6) (particulate), (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) and (a)(4), 
engineering control measures (e.g., enclosure or confinement of the 
operation, general and local ventilation) or administrative control 
measures (e.g., workplace policies and procedures) shall be considered 
and implemented to prevent exposure, where feasible.
    (A) As an alternative to the respirator requirements in paragraph 
(a)(2)(i) of this section, a manufacturer or processor may choose to 
follow the new chemical exposure limit (NCEL) provision listed in the 
TSCA section 5(e) consent order for this substance. The NCEL is 0.07 
mg/m\3\ as an 8-hour time weighted

[[Page 81271]]

average. Persons who wish to pursue NCELs as an alternative to Sec.  
721.63 respirator requirements may request to do so under Sec.  721.30. 
Persons whose Sec.  721.30 requests to use the NCELs approach are 
approved by EPA will be required to follow NCELs provisions comparable 
to those contained in the corresponding TSCA section 5(e) consent 
order.
    (B) [Reserved]
    (ii) Hazard communication program. Requirements as specified in 
Sec.  721.72(a), through (e) (concentration set at 1.0 percent), (f), 
(g)(1)(ii), (g)(2)(ii), (g)(2)(iii), and (g)(2)(iv), and (g)(5).
    (iii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80(p)(6,000 kilograms, aggregate of PMNs P-
15-612, P-15-613, P-15-614, P-15-615, P-15-616, P-15-617, P-15-618, 
combined).
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125(a), (b), (c), (d), (f), (g), (h), 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
26. Add Sec.  [emsp14]721.10949 to subpart E to read as follows:

Sec.  [emsp14]721.10949  Neodymium sulfur yttrium oxide.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified as neodymium sulfur 
yttrium oxide (PMN P-15-614; CAS No. 1651158-45-5) is subject to 
reporting under this section for the significant new uses described in 
paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in Sec.  
721.63(a)(1), (a)(4)(respirators must provide a National Institute for 
Occupational Safety and Health (NIOSH) assigned protection factor of at 
least 10), (a)(6)(particulate), (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) and (a)(4), engineering 
control measures (e.g., enclosure or confinement of the operation, 
general and local ventilation) or administrative control measures 
(e.g., workplace policies and procedures) shall be considered and 
implemented to prevent exposure, where feasible.
    (A) As an alternative to the respirator requirements in paragraph 
(a)(2)(i) of this section, a manufacturer or processor may choose to 
follow the new chemical exposure limit (NCEL) provision listed in the 
TSCA section 5(e) consent order for this substance. The NCEL is 0.07 
mg/m\3\ as an 8-hour time weighted average. Persons who wish to pursue 
NCELs as an alternative to Sec.  721.63 respirator requirements may 
request to do so under Sec.  721.30. Persons whose Sec.  721.30 
requests to use the NCELs approach are approved by EPA will be required 
to follow NCELs provisions comparable to those contained in the 
corresponding TSCA section 5(e) consent order.
    (B) [Reserved]
    (ii) Hazard communication program. Requirements as specified in 
Sec.  721.72(a) through (e) (concentration set at 1.0 percent), (f), 
(g)(1)(ii), (g)(2)(ii), (g)(2)(iii), and (g)(2)(iv), and (g)(5).
    (iii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80(p)(6,000 kilograms, aggregate of PMNs P-
15-612, P-15-613, P-15-614, P-15-615, P-15-616, P-15-617, P-15-618, 
combined).
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125(a), (b), (c), (d), (f), (g), (h), 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
27. Add Sec.  [emsp14]721.10950 to subpart E to read as follows:

Sec.  [emsp14]721.10950  Erbium gadolinium neodymium sulfur ytterbium 
yttrium oxide (P-15-615).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified as erbium gadolinium 
neodymium sulfur ytterbium yttrium oxide (PMN P-15-615; CAS No. 
1651152-96-3) is subject to reporting under this section for the 
significant new uses described in paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in Sec.  
721.63(a)(1), (a)(4)(respirators must provide a National Institute for 
Occupational Safety and Health (NIOSH) assigned protection factor of at 
least 10), (a)(6)(particulate), (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) and (a)(4), engineering 
control measures (e.g., enclosure or confinement of the operation, 
general and local ventilation) or administrative control measures 
(e.g., workplace policies and procedures) shall be considered and 
implemented to prevent exposure, where feasible.
    (A) As an alternative to the respirator requirements in paragraph 
(a)(2)(i) of this section, a manufacturer or processor may choose to 
follow the new chemical exposure limit (NCEL) provision listed in the 
TSCA section 5(e) consent order for this substance. The NCEL is 0.07 
mg/m\3\ as an 8-hour time weighted average. Persons who wish to pursue 
NCELs as an alternative to Sec.  721.63 respirator requirements may 
request to do so under Sec.  721.30. Persons whose Sec.  721.30 
requests to use the NCELs approach are approved by EPA will be required 
to follow NCELs provisions comparable to those contained in the 
corresponding TSCA section 5(e) consent order.
    (B) [Reserved]
    (ii) Hazard communication program. Requirements as specified in 
Sec.  721.72(a) through (e) (concentration set at 1.0 percent), (f), 
(g)(1)(ii), (g)(2)(ii), (g)(2)(iii), and (g)(2)(iv), and (g)(5).
    (iii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80(p)(6,000 kilograms, aggregate of PMNs P-
15-612, P-15-613, P-15-614, P-15-615, P-15-616, P-15-617, P-15-618, 
combined).
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125 (a) through (d), and (f), through (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
28. Add Sec.  [emsp14]721.10951 to subpart E to read as follows:

Sec.  [emsp14]721.10951  Erbium gadolinium sulfur ytterbium yttrium 
oxide.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified as erbium gadolinium 
sulfur ytterbium yttrium oxide (P-15-616; CAS No. 1622295-07-1) is 
subject to reporting under this section for the significant new uses 
described in paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in Sec.  
721.63(a)(1), (a)(4)(respirators must provide a National Institute for 
Occupational Safety and Health (NIOSH) assigned protection factor of at 
least 10), (a)(6)(particulate),

[[Page 81272]]

(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) and (a)(4), engineering control measures (e.g., enclosure 
or confinement of the operation, general and local ventilation) or 
administrative control measures (e.g., workplace policies and 
procedures) shall be considered and implemented to prevent exposure, 
where feasible.
    (A) As an alternative to the respirator requirements in paragraph 
(a)(2)(i) of this section, a manufacturer or processor may choose to 
follow the new chemical exposure limit (NCEL) provision listed in the 
TSCA section 5(e) consent order for this substance. The NCEL is 0.07 
mg/m\3\ as an 8-hour time weighted average. Persons who wish to pursue 
NCELs as an alternative to Sec.  721.63 respirator requirements may 
request to do so under Sec.  721.30. Persons whose Sec.  721.30 
requests to use the NCELs approach are approved by EPA will be required 
to follow NCELs provisions comparable to those contained in the 
corresponding TSCA section 5(e) consent order.
    (B) [Reserved]
    (ii) Hazard communication program. Requirements as specified in 
Sec.  721.72(a) through (e) (concentration set at 1.0 percent), (f), 
(g)(1)(ii), (g)(2)(ii), (g)(2)(iii), and (g)(2)(iv), and (g)(5).
    (iii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80(p)(6,000 kilograms, aggregate of PMNs P-
15-612, P-15-613, P-15-614, P-15-615, P-15-616, P-15-617, P-15-618, 
combined).
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125 (a) through (d), and (f),through (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
29. Add Sec.  [emsp14]721.10952 to subpart E to read as follows:

Sec.  721.10952  Erbium gadolinium ytterbium oxide.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified as erbium gadolinium 
ytterbium oxide (PMN P-15-617; CAS No. 1651152-05-4) 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)(4)(respirators must provide a National Institute for 
Occupational Safety and Health (NIOSH) assigned protection factor of at 
least 10), (a)(6)(particulate), (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) and (a)(4), engineering 
control measures (e.g., enclosure or confinement of the operation, 
general and local ventilation) or administrative control measures 
(e.g., workplace policies and procedures) shall be considered and 
implemented to prevent exposure, where feasible.
    (A) As an alternative to the respirator requirements in paragraph 
(a)(2)(i) of this section, a manufacturer or processor may choose to 
follow the new chemical exposure limit (NCEL) provision listed in the 
TSCA section 5(e) consent order for this substance. The NCEL is 0.07 
mg/m\3\ as an 8-hour time weighted average. Persons who wish to pursue 
NCELs as an alternative to Sec.  721.63 respirator requirements may 
request to do so under Sec.  721.30. Persons whose Sec.  721.30 
requests to use the NCELs approach are approved by EPA will be required 
to follow NCELs provisions comparable to those contained in the 
corresponding TSCA section 5(e) consent order.
    (B) [Reserved]
    (ii) Hazard communication program. Requirements as specified in 
Sec.  721.72(a) through (e) (concentration set at 1.0 percent), (f), 
(g)(1)(ii), (g)(2)(ii), (g)(2)(iii), and (g)(2)(iv), and (g)(5).
    (iii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80(p)(6,000 kilograms, aggregate of PMNs P-
15-612, P-15-613, P-15-614, P-15-615, P-15-616, P-15-617, P-15-618, 
combined).
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125 (a) through (d), and (f), through (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
30. Add Sec.  [emsp14]721.10953 to subpart E to read as follows:

Sec.  721.10953  Erbium gadolinium sulfur ytterbium oxide.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified as erbium gadolinium 
sulfur ytterbium oxide (PMN P-15-618; CAS No. 934388-91-7) is subject 
to reporting under this section for the significant new uses described 
in paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in Sec.  
721.63(a)(1), (a)(4)(respirators must provide a National Institute for 
Occupational Safety and Health (NIOSH) assigned protection factor of at 
least 10), (a)(6)(particulate), (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) and (a)(4), engineering 
control measures (e.g., enclosure or confinement of the operation, 
general and local ventilation) or administrative control measures 
(e.g., workplace policies and procedures) shall be considered and 
implemented to prevent exposure, where feasible.
    (A) As an alternative to the respirator requirements in paragraph 
(a)(2)(i) of this section, a manufacturer or processor may choose to 
follow the new chemical exposure limit (NCEL) provision listed in the 
TSCA section 5(e) consent order for this substance. The NCEL is 0.07 
mg/m\3\ as an 8-hour time weighted average. Persons who wish to pursue 
NCELs as an alternative to Sec.  721.63 respirator requirements may 
request to do so under Sec.  721.30. Persons whose Sec.  721.30 
requests to use the NCELs approach are approved by EPA will be required 
to follow NCELs provisions comparable to those contained in the 
corresponding TSCA section 5(e) consent order.
    (B) [Reserved]
    (ii) Hazard communication program. Requirements as specified in 
Sec.  721.72(a) through (e) (concentration set at 1.0 percent), (f), 
(g)(1)(ii), (g)(2)(ii), (g)(2)(iii), and (g)(2)(iv), and (g)(5).
    (iii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80(p)(6,000 kilograms, aggregate of PMNs P-
15-612, P-15-613, P-15-614, P-15-615, P-15-616, P-15-617, P-15-618, 
combined).
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125(a) through (d), (f), through (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
31. Add Sec.  [emsp14]721.10954 to subpart E to read as follows:

[[Page 81273]]

Sec.  [emsp14]721.10954  2-Ethylhexanoic acid, compound with alkyamino 
cyclohexane (generic); and 2-Ethylhexanoic acid, compound with 
cyclohexylamine (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substances identified generically as 2-
ethylhexanoic acid, compound with alkyamino cyclohexane (PMN P-15-0655, 
chemical A); and 2-ethylhexanoic acid, compound with cyclohexylamine 
(PMN P-15-0655, chemical B) 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 = 34.
    (ii) [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125(a), (b), (c), and (k) are applicable to manufacturers and 
processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.

0
32. Add Sec.  721.10955 to subpart E to read as follows:

Sec.  721.10955  Propenoic acid, alkyl ester, polymer with 1,3-
cyclohexanedialkylamine, reaction products with oxirane(alkoxyalkyl) 
(generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 
propenoic acid, alkyl ester, polymer with 1,3-cyclohexanedialkylamine, 
reaction products with oxirane(alkoxyalkyl) (PMN P-15-680) 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) where N = 1.
    (ii) [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125(a), (b), (c), and (k) are applicable to manufacturers and 
processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.

0
33. Add Sec.  721.10956 to subpart E to read as follows:

Sec.  721.10956  Acrylic acid, polymer with polyalkylene polyamine 
(generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as acrylic 
acid, polymer with polyalkylene polyamine (PMN P-15-691) 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(g).
    (ii) [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125(a), (b), (c), and (k) are applicable to manufacturers and 
processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.

0
34. Add Sec.  [emsp14]721.10957 to subpart E to read as follows:

Sec.  [emsp14]721.10957  1,2-Cyclohexanedicarboxylic acid, 1-(2-
phenylhydrazide).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified as (1,2-
cyclohexanedicarboxylic acid, 1-(2-phenylhydrazide) (PMN P-16-30; CAS 
No. 1807977-72-5) is subject to reporting under this section for the 
significant new uses described in paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in Sec.  
721.63(a)(1), (a)(2)(i), (a)(2)(ii), (a)(3), (a)(6)(particulate), 
(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) [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125(a) through (e) 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
35. Add Sec.  [emsp14]721.10958 to subpart E to read as follows:

Sec.  [emsp14]721.10958  2,5-Furandione, dihydro-, polymer with 1,1'-
iminobis[2-propanol], benzoate (ester), N-benzoyl derivs.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified as 2,5-furandione, 
dihydro-, polymer with 1,1'-iminobis[2-propanol], benzoate (ester), N-
benzoyl derivs. (PMN P-16-52; CAS No. 592479-38-4) 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) where N = 5.
    (ii) [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (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
36. Add Sec.  [emsp14]721.10959 to subpart E to read as follows:

Sec.  [emsp14]721.10959  Dialkyl fattyalkylamino propanamide alkylamine 
acetates (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substances identified generically as 
dialkyl fattyalkylamino propanamide alkylamine acetates (PMNs P-16-56 
and P-16-57) 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.
    (ii) [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125(a), (b), (c), and (k) are applicable to manufacturers and 
processors of this substance.

[[Page 81274]]

    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.

0
37. Add Sec.  [emsp14]721.10960 to subpart E to read as follows:

Sec.  [emsp14]721.10960  Dialkylaminopropylaminopropanoate ester 
(generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 
dialkylaminopropylaminopropanoate ester (PMN P-16-58) 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) where N = 14.
    (ii) [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125(a), (b), (c), and (k) are applicable to manufacturers and 
processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.

[FR Doc. 2016-27326 Filed 11-16-16; 8:45 am]
 BILLING CODE 6560-50-P