Document ID: EPA-HQ-OPPT-2017-0166-0001
Agency: epa
Document Type: Rule
Title: Significant New Use Rules on Certain Chemical Substances
Posted Date: 2017-10-19T04:00Z

[Federal Register Volume 82, Number 201 (Thursday, October 19, 2017)]
[Rules and Regulations]
[Pages 48637-48655]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-22239]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Parts 9 and 721

[EPA-HQ-OPPT-2017-0166; FRL-9964-42]
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 29 chemical substances 
which were the subject of premanufacture notices (PMNs). The chemical 
substances are subject to consent orders issued by EPA pursuant to 
section 5(e) of TSCA. This action requires persons who intend to 
manufacture (defined by statute to include import) or process any of 
these 29 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. 
Persons may not commence manufacture or processing for the significant 
new use until EPA has conducted a review of the notice, made an 
appropriate determination on the notice, and has taken such actions as 
are required with that determination.

DATES: This rule is effective on December 18, 2017. For purposes of 
judicial review, this rule shall be promulgated at 1 p.m. (e.s.t.) on 
November 2, 2017.
    Written adverse or critical comments, or notice of intent to submit 
adverse or critical comments, on one or more of these SNURs must be 
received on or before November 20, 2017 (see Unit VI. of the 
SUPPLEMENTARY INFORMATION). If EPA receives written adverse or critical 
comments, or notice of intent to submit adverse or critical comments, 
on one or more of these SNURs before November 20, 2017, 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-2017-0166, 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

[[Page 48638]]

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, pursuant to 40 CFR 721.20, 
any persons who export or intend to export a chemical substance that is 
the subject of this rule on or after November 20, 2017 are subject to 
the export notification provisions of TSCA section 12(b) (15 U.S.C. 
2611(b)) and must comply with the export notification requirements in 
40 CFR part 707, subpart D.

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

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

II. Background

A. What action is the Agency taking?

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

B. What is the Agency's authority for taking this action?

    Section 5(a)(2) of TSCA (15 U.S.C. 2604(a)(2)) authorizes EPA to 
determine that a use of a chemical substance is a ``significant new 
use.'' EPA must make this determination by rule after considering all 
relevant factors, including the four bulleted TSCA section 5(a)(2) 
factors listed in Unit III. Once EPA determines that a use of a 
chemical substance is a significant new use, TSCA section 5(a)(1)(B)(i) 
(15 U.S.C. 2604(a)(1)(B)(i)) 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. TSCA 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. Pursuant to 
Sec.  721.1(c), persons subject to these SNURs must comply with the 
same SNUN requirements and EPA regulatory procedures as submitters of 
PMNs under TSCA section 5(a)(1)(A) (15 U.S.C. 2604(a)(1)(A)). In 
particular, these requirements include the information submission 
requirements of TSCA sections 5(b) and 5(d)(1) (15 U.S.C. 2604(b) and 
2604(d)(1)), the exemptions authorized by TSCA sections 5(h)(1), 
5(h)(2), 5(h)(3), and 5(h)(5) (15 U.S.C. 2604(h)(1), 2604(h)(2), 
2604(h)(3), and 2604(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) (15 U.S.C. 2604(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 37 
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 29 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 consent order under TSCA section 5(e) (15 
U.S.C. 2604(e)).
     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

[[Page 48639]]

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 29 PMN substances that are subject to ``risk-
based'' consent orders under TSCA section 5(e)(1)(A)(ii)(I) (15 U.S.C. 
2604(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 SNURs are promulgated pursuant to Sec.  721.160, and are based on 
and consistent with the provisions in the underlying consent orders. 
The SNURs designate as a ``significant new use'' the absence of the 
protective measures required in the corresponding consent orders.
    Where EPA determined that the PMN substance may present an 
unreasonable risk of injury to human health via inhalation exposure, 
the underlying TSCA section 5(e) consent order usually requires, among 
other things, that potentially exposed employees wear specified 
respirators unless actual measurements of the workplace air show that 
air-borne concentrations of the PMN substance are below a New Chemical 
Exposure Limit (NCEL) that is established by EPA to provide adequate 
protection to human health. In addition to the actual NCEL 
concentration, the comprehensive NCELs provisions in TSCA section 5(e) 
consent orders, which are modeled after Occupational Safety and Health 
Administration (OSHA) Permissible Exposure Limits (PELs) provisions, 
include requirements addressing performance criteria for sampling and 
analytical methods, periodic monitoring, respiratory protection, and 
recordkeeping. However, no comparable NCEL provisions currently exist 
in 40 CFR part 721, subpart B, for SNURs. Therefore, for these cases, 
the individual SNURs in 40 CFR part 721, subpart E, will state that 
persons subject to the SNUR who wish to pursue NCELs as an alternative 
to the Sec.  721.63 respirator requirements may request to do so under 
Sec.  721.30. EPA expects that persons whose requests under Sec.  
721.30 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.

PMN Number: P-15-310

    Chemical name: 1,2,4-Benzenetricarboxylic acid, mixed decyl and 
octyl triesters.
    CAS number: Not available.
    Effective date of TSCA section 5(e) consent order: January 31, 
2017.
    Basis for TSCA section 5(e) consent order: The PMN states that the 
PMN substance will be used as a lubricant in special chain oils for 
conveyor belts. Based on submitted test data, EPA predicts blood and 
adrenal gland effects to unprotected workers from repeated dermal 
exposures. EPA also predicts endocrine disruption based on Structure 
Activity Relationship (SAR) analysis on analogous phthalates. The Order 
was issued under TSCA sections 5(a)(3)(B)(ii)(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 to prevent dermal exposure.
    2. Not use, formulate, or distribute for use other than as stated 
in the PMN.
    3. No manufacture beyond an annual production volume of 150,000 kg.
    Recommended testing: EPA has determined that the results of certain 
human health toxicity testing would help characterize the PMN 
substance. The submitter has agreed not to exceed the confidential 
production limit without performing an Extended One-Generation 
Reproductive Toxicity Study (OECD Test Guideline 443).
    CFR citation: 40 CFR 721.10996.

PMN Numbers: P-15-487, P-15-488, P-15-489, P-15-490, and P-15-491

    Chemical names: Multi-walled carbon nanotubes (generic).
    CAS numbers: Not available.
    Effective date of TSCA section 5(e) consent order: February 17, 
2017.
    Basis for TSCA section 5(e) consent order: The PMN states that the 
PMN substances will be used as additives for electro-static discharge 
(ESD) in electronic devices, electronics, and materials; additives for 
weight reduction in materials; additives to improve mechanical 
properties or electrical conductivities; heat-generating elements in 
heating devices and materials; additives for heat transfer and thermal 
emissions in electronic devices and materials; semi-conductor, 
conductive, or resistive elements in electronic circuitry and devices; 
additives to improve conductivity in electronic circuitry, energy 
storage systems, and devices; electron emitters for lighting and x-ray 
sources; additive for electromagnetic interface shielding in electronic 
devices; additives for electrodes in electronic materials and 
electronic devices; catalyst support in chemical manufacturing; coating 
additives to improve corrosion resistance or conductive properties; 
additives for fibers in structural and electrical applications; 
additives for fibers in fabrics and textiles; filter additives to 
remove nanoscale materials; semi-conducting compounding additives far 
high-voltage cable; and additives for super-hydrophobicity. A submitted 
90-day inhalation toxicity study for P-15-487 demonstrated no effects 
at 1 mg/m\3\, which was the highest dose tested. Based on SAR analysis 
on analogous carbon nanotubes (CNT), EPA predicts pulmonary toxicity 
and oncogenicity to unprotected workers from repeated inhalation 
exposures. No ecotoxicity studies on CNT are available in which a broad 
range of production methods, sources, purification, functionalization, 
etc. were investigated. EPA expects that some fraction of the PMN 
substances, if released into the environment, will eventually become 
suspended in water. The Order was issued under TSCA sections 
5(a)(3)(B)(ii)(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 to prevent dermal exposure 
and a NIOSH-certified respirator with N-100, P-100, or R-100 cartridges 
with an assigned protection factor (APF) of at least 50 (where there is 
a potential for inhalation exposure).
    2. Use of the PMN substances only for the uses specified in the 
consent order.
    3. No use in application methods that generate a dust, mist, or 
aerosol unless such application method occurs in an enclosed process.
    4. No use of the PMN substances resulting in releases to surface 
waters and disposal of the PMN substances only by landfill or 
incineration.
    Recommended testing: EPA has determined that a subchronic 90-day 
inhalation toxicity study (OPPTS 870.3465 or OECD 413), a two-year 
inhalation bioassay (OPPTS 870.4200), a fish early-life stage toxicity 
test (OCSPP Test Guideline 850.1400), a daphnid chronic toxicity test 
(OCSPP Test Guideline 850.1300), and an algal toxicity test (OCSPP Test 
Guideline 850.4500) would help characterize possible health and 
environmental

[[Page 48640]]

effects of the substances. Although the Order does not require these 
tests, 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 721.10997.

PMN Number: P-16-165

    Chemical name: Propanoic acid, iron (2+) salt (2:1).
    CAS number: 1952336-63-8.
    Effective date of TSCA section 5(e) consent order: February 15, 
2017.
    Basis for TSCA section 5(e) consent order: The PMN states that the 
PMN substance will be used as a component in a metal organic product 
that will be used in paint and ink driers, unsaturated polyester resins 
promoters, lube/grease additives, fuel additives, polymerization 
catalysts, and specialty petrochemical catalysts at less than 1 
percent. Based on submitted test data, EPA predicts liver and 
developmental toxicity to unprotected workers from repeated inhalation 
exposures. The Order was issued under TSCA sections 5(a)(3)(B)(ii)(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 a NIOSH-certified respirator with an APF of at least 10 
(where 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 Safety Data Sheet (SDS).
    3. No manufacture beyond an annual production volume of 150,000 kg.
    4. Not process or use the PMN substance for non-industrial 
applications.
    5. Not process or use the PMN substance in formulations where the 
concentration is greater than 1%.
    Recommended testing: EPA has determined that the results of certain 
human health toxicity testing would help characterize the PMN 
substance. The submitter has agreed not to exceed the confidential 
production limit without performing the prenatal development toxicity 
study (OECD 414). In addition, EPA has determined that the results of a 
combined chronic toxicity and carcinogenicity toxicity test (OPPTS 
870.4300) would help characterize the health effects of the PMN 
substance. 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 721.10998.

PMN Numbers: P-16-255, P-16-256, P-16-257, P-16-258, and P-16-259

    Chemical names: 1-Butanaminium, N,N,N-tributyl-, carbonic acid 
(1:1) (P-16-255), 1-Butanaminium, N,N,N-tributyl-, methyl carbonate 
(1:1) (P-16-256), 1-Butanaminium, N,N,N-tributyl-, ethyl carbonate 
(1:1) (P-16-257), 1-Butanaminium, N,N,N-tributyl-, propyl carbonate 
(1:1) (P-16-258), 1-Butanaminium, N,N,N-tributyl-, and 1-methylethyl 
carbonate (1:1) (P-16-259)
    CAS numbers: 17351-62-1(P-16-255), 56294-05-2(P-16-256), 478796-04-
2(P-16-257), 1338579-13-7(P-16-258), and 1803407-49-9(P-16-259)
    Effective date of TSCA section 5(e) consent order: March 7, 2017.
    Basis for TSCA section 5(e) consent order: The PMN states that the 
PMN substances will be used as blocked catalysts for paints and 
coatings. Based on submitted test data, EPA predicts strong irritation 
to the skin, eyes, and mucous membranes as well as acute toxicity and 
corrosivity-related neurotoxicity from repeated dermal and inhalation 
exposures. Further, based on test data on the PMN substances, EPA 
predicts toxicity to aquatic organisms may occur at concentrations that 
exceed 34 parts per billion (ppb) of the PMN substances in surface 
waters. The Order was issued under TSCA sections 5(a)(3)(B)(ii)(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 to prevent dermal 
exposures.
    2. Establishment and use of a hazard communication program, 
including human health precautionary statements on each label and in a 
safety data sheet (SDS).
    3. Use of the PMN substances only for the use specified in the 
consent order.
    4. Use of the PMN substances at a concentration no greater than 
1.5% by weight in the final product.
    Recommended testing: EPA has determined that the results of certain 
environmental toxicity testing would help characterize the PMN 
substances. The submitter has agreed not to exceed the confidential 
production limit without performing a daphnid chronic toxicity test 
(OCSPP 850.1300).
    CFR citations: 40 CFR 721.10999 (P-16-255), 40 CFR 721.11000 (P-16-
256), 40 CFR 721.11001 (P-16-257), 40 CFR 721.11002 (P-16-258), and 40 
CFR 721.11003 (P-16-259).

PMN Number: P-16-284

    Chemical name: Anilino substituted bis-triazinyl derivative of 
4,4'-diaminostilbene-2,2'-disulfonic acid, mixed amine sodium salt 
(generic).
    CAS number: Not available.
    Effective date of TSCA section 5(e) consent order: May 12, 2017.
    Basis for TSCA section 5(e) consent order: The PMN states that the 
PMN substance will be used as an optical brightener for textiles, 
paper, and paperboard. Based on submitted test data, EPA predicts 
adrenal gland effects to unprotected workers from repeated dermal and 
inhalation exposures. The Order was issued under TSCA sections 
5(a)(3)(B)(ii)(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) Import only of the PMN substance as a solution.
    (2) Use only as an optical brightener for textiles, paper and 
paperboard.
    (3) No use of the PMN substance in application methods that 
generate a dust, mist, or aerosol unless such application method occurs 
in an enclosed process.
    (4) Non industrial use only where the PMN substance is not sold for 
``consumer use'' or for ``commercial uses'' (as the term is defined in 
Sec.  721.3) when the ``saleable goods or service'' could introduce PMN 
material into a ``consumer'' setting (as that term is defined in Sec.  
721.3).
    Recommended testing: EPA has determined that the results of 
physical/chemistry testing would help characterize the PMN substance. 
The submitter has agreed not to manufacture beyond a certain time 
period without measuring the particle size distribution to characterize 
the particle size distribution of fractions less than 10 microns of the 
dry particle PMN substance. In addition, EPA has determined that the 
results of a 90-day subchronic inhalation toxicity study (OPPTS 
870.3465 or OECD 413) would help characterize the health effects of the 
PMN substance. 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 721.11004.

PMN Numbers: P-16-309 and P-16-310

    Chemical names: 12-Hydroxystearic acid, reaction products with 
alkylene diamine and alkanoic acid (generic).

[[Page 48641]]

    CAS numbers: Not available.
    Effective date of TSCA section 5(e) consent order: February 17, 
2017.
    Basis for TSCA section 5(e) consent order: The PMN states that the 
PMN substances will be used as rheological or thixotropic agents used 
in the production of solvent based industrial coatings, high solid 
aromatic paints, adhesives, sealants, and other types of paints and 
topcoats. Based on submitted test data, EPA predicts blood and 
hematology effects. Further, based on SAR analysis of test data on 
analogous amides, EPA predicts toxicity to aquatic organisms may occur 
at concentrations that exceed 2 ppb of the PMN substances in surface 
waters. The Order was issued under TSCA sections 5(a)(3)(B)(ii)(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) No domestic manufacture of the PMN substances.
    (2) No manufacture beyond the annual production volume specified in 
the consent order.
    (3) Use of the PMN substances only for the use specified in the 
consent order.
    (4) Compliance with the release to water provisions.
    Recommended testing: EPA has determined that the results of certain 
human health and environmental toxicity testing would help characterize 
the PMN substances. The submitter has agreed not to exceed the 
confidential production limit without performing a fish early-life 
stage toxicity test (OCSPP Test Guideline 850.1400), a daphnid chronic 
toxicity test (OCSPP Test Guideline 850.1300), and an algal toxicity 
test (OCSPP Test Guideline 850.1300). In addition, EPA has determined 
that the results of a repeated dose dermal toxicity test (OPPTS Test 
Guideline 870.3200) would help characterize the human health effects of 
the PMN substances. 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 721.11005.

PMN Number: P-16-315

    Chemical name: Alkyldiene, polymer, hydroxy terminated 
alkoxysilylalkylcarbamate (generic).
    CAS number: Not available.
    Effective date of TSCA section 5(e) consent order: January 17, 
2017.
    Basis for TSCA section 5(e) consent order: The PMN states that the 
PMN substance will be used as an additive to improve the compatibility 
of the dispersibility of inorganic fillers in industrial rubber 
formulation. Based on physical/chemical properties, EPA predicts 
irritation and lung effects to unprotected workers from repeated 
inhalation and dermal exposures. The Order was issued under TSCA 
sections 5(a)(3)(B)(ii)(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) No domestic manufacture of the PMN substance.
    (2) Use of the PMN substance only for the use specified in the 
consent order.
    Recommended testing: EPA has determined that a 90-day subchronic 
inhalation test in rodents (OCSPP Harmonized Test Guideline 870.3465); 
would help characterize possible health effects of the substance. 
Although the Order does not require this test, 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 721.11006.

PMN Number: P-16-323

    Chemical name: Alkylaldehyde, reaction products with substituted 
carbomonocycle-substituted heteromonocycle-alkylene glycol 
bis[[[[substituted(oxoneoalkyl)oxy]alkyl] amino]alkyl] ether polymer 
and alkyl substituted alkanediamine, acetate salts (generic).
    CAS number: Not available.
    Effective date of TSCA section 5(e) consent order: November 22, 
2016.
    Basis for TSCA section 5(e) consent order: The PMN states that the 
PMN substance will be used as a coating resin. Based on test data on 
formaldehyde and analogous cationic polymers, EPA predicts 
sensitization, carcinogenicity, and lung effects to unprotected workers 
from repeated dermal exposures. Further, based on SAR analysis of test 
data on analogous cationic polymers, EPA predicts toxicity to aquatic 
organisms may occur at concentrations that exceed 32 ppb of the PMN 
substance in surface waters. The Order was issued under TSCA sections 
5(a)(3)(B)(ii)(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) No manufacture of the PMN such that residual formaldehyde is 
more than 0.1 weight percent of the PMN substance.
    (2) Establishment and use of a hazard communication program, 
including human health precautionary statements on each label and in 
the SDS.
    (3) Use of the PMN substance only for the use specified in the 
consent order.
    (4) No application method that generates a dust, mist, or aerosol.
    Recommended testing: EPA has determined that a 28-day subacute 
inhalation toxicity study (OECD 412), a fish acute toxicity test 
mitigated by humic acid (OCSPP Test Guideline 850.1085), an aquatic 
invertebrate, acute toxicity test, freshwater daphnids (OCSPP Test 
Guideline 850.1075), and an algal toxicity test (OCSPP Test Guideline 
850.4500) would help characterize possible health and environmental 
effects of the substance. Although the Order does not require these 
tests, 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 721.11007.

PMN Numbers: P-16-330 and P-16-331

    Chemical names: Hydroxy functional triglyceride polymer with 
glycerol mono-ester and 1,1'-methylenebis[4-isocyanatobenzene] (P-16-
330) and Hydroxy functional triglyceride polymer with glycerol mono-
ester and 1,1'-methylenebis[isocyanatobenzene] (P-16-331) (generic)
    CAS numbers: Not available
    Effective date of TSCA section 5(e) consent order: February 14, 
2017.
    Basis for TSCA section 5(e) consent order: The PMN states that the 
PMN substances will be used as industrial adhesives. Based on submitted 
test data, EPA predicts dermal sensitization, respiratory 
sensitization, and lung effects to unprotected workers from repeated 
inhalation and dermal exposures. The Order was issued under TSCA 
sections 5(a)(3)(B)(ii)(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. To protect against these risks, the consent order requires:
    (1) Manufacture of the PMN substances to contain no more than 0.1% 
residual isocyanate by weight.
    (2) No sale of the PMN substances for ``consumer use'' or for 
``commercial uses'' (as the term is defined in Sec.  721.3) when the 
``saleable goods or service'' could introduce PMNs material into a

[[Page 48642]]

``consumer'' setting (as that term is defined in Sec.  721.3).
    (3) Establishment and use of a hazard communication program, 
including human health precautionary statements on each label and in 
the SDS.
    Recommended testing: EPA has determined that a skin sensitization 
study (OPPTS 870.2600) and a 90-day inhalation study (OPPTS 870.3465) 
would help characterize possible health effects of the substances. 
Although the Order does not require these tests, 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 citations: 40 CFR 721.11008 (P-16-330) and 40 CFR 721.11009 (P-
16-331).

PMN Number: P-16-360

    Chemical name: Poly(oxy-1,2-ethanediyl),.alpha.-(1-
oxodocosyl)-.omega.-[(1-oxodocosyl)oxy]-.
    CAS number: 36493-27-3.
    Effective date of TSCA section 5(e) consent order: December 12, 
2016.
    Basis for TSCA section 5(e) consent order: The PMN states that the 
PMN substance will be used as a fuel additive. Based on physical/
chemical properties, EPA estimates the PMN substance would have low 
environmental hazard due to its poor water solubility. However, if the 
number of repeating ethylene oxide units in the polymer is large (i.e., 
greater than 10), the polymer would become a dispersible surfactant. 
Based on SAR analysis of test data on an analogous nonionic polymer, 
EPA predicts toxicity to aquatic organisms may occur at concentrations 
that exceed 350 ppb of the PMN substance in surface waters. The Order 
was issued under TSCA sections 5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), 
based on a finding that the substance may present an unreasonable risk 
of injury to the environment. To protect against these risks, the 
consent order requires manufacture such that no more than 33% of the 
PMN substance contains 10 or more repeating ethylene oxide units.
    Recommended testing: EPA has determined that an acute invertebrate 
toxicity test, freshwater daphnids (OCSPP Test Guideline 850.1010), a 
fish acute toxicity test, freshwater and marine (OCSPP Test Guideline 
850.1075), a fish early-life stage toxicity test (OCSPP Test Guideline 
850.1400), a daphnid chronic toxicity test (OCSPP Test Guideline 
850.1300), and an algal toxicity test (OCSPP Test Guideline 850.4500) 
would help characterize possible environmental effects of the 
substance. Although the Order does not require these tests, 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 721.11010.

PMN Number: P-16-361

    Chemical name: Pulp, cellulose, reaction products with lignin.
    CAS number: 1671062-70-6.
    Effective date of TSCA section 5(e) consent order: December 12, 
2016.
    Basis for TSCA section 5(e) consent order: The PMN states that the 
PMN substance will be used as plastic reinforcement. Based on SAR 
analysis on structurally similar respirable poorly soluble 
particulates, EPA predicts pulmonary toxicity to unprotected workers 
from repeated inhalational exposures. The Order was issued under TSCA 
sections 5(a)(3)(B)(ii)(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) Distribution of the PMN substance only in a liquid or gel 
formulation, unless the solid particle form has a particle size 
distribution where less than 0.5% of the particles are less than 10 
microns.
    (2) No use in application methods that generate a dust, mist, or 
aerosol unless such application method occurs in an enclosed process.
    Recommended testing: EPA has determined that the results of 
physical/chemical characteristics would help characterize the PMN 
substance. The submitter has agreed not to manufacture beyond a certain 
time period without measuring the particle size distribution to 
characterize the particle size distribution of fractions less than 10 
microns of the dry particle PMN substance.
    CFR citation: 40 CFR 721.11011.

PMN Numbers: P-16-365 and P-16-367

    Chemical names: Alkyl carbonate, polymer with, substituted alkanes 
and substituted heteromonocycle, substituted alkyl acrylate-blocked 
(generic) (P-16-365) and substituted heteromonocycle, polymer with 
substituted alkane and ethoxylated alkane, substituted heteromonocycle 
substituted alkyl ester-blocked (generic) (P-16-367).
    CAS numbers: Not available.
    Effective date of TSCA section 5(e) consent order: January 3, 2017.
    Basis for TSCA section 5(e) consent order: The PMN states that the 
PMN substances will be used as a UV curable coating resin for 
industrial use. Based on SAR analysis on structurally similar 
diisocyanates and acrylates, EPA predicts eye and skin irritation, 
dermal sensitization, respiratory sensitization, lung effects, 
mutagenicity, cancer, developmental, liver, and kidney toxicity to 
unprotected workers from repeated inhalation and dermal exposures. The 
Order was issued under TSCA sections 5(a)(3)(B)(ii)(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. To protect against 
these risks, the consent order requires:
    (1) Use of personal protective equipment involving impervious 
gloves (where there is a potential for dermal exposure).
    (2) Establishment and use of a hazard communication program, 
including human health precautionary statements on each label and in 
the SDS.
    (3) No manufacture, process, or use of the substances as consumer 
products.
    (4) Manufacture of the PMN substances to contain no more than 0.1 
residual isocyanate by weight.
    Recommended testing: EPA has determined that the results of a local 
lymph node assay (OPPTS 870.2600), a 90-day inhalation toxicity test 
with 60-day holding period (OPPTS 870.3465), and a two-year oral 
bioassay (OPPTS 870.4200) would help characterize possible health 
effects of the substances. Although the Order does not require these 
tests, 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 citations: 40 CFR 721.11012 (P-16-365) and 40 CFR 721.11013 (P-
16-367).

PMN Number: P-16-369

    Chemical name: Substituted heteromonocycle, telomer with 
substituted carbomonocycles, substituted alkyl ester (generic).
    CAS number: Not available.
    Effective date of TSCA section 5(e) consent order: January 23, 
2017.
    Basis for TSCA section 5(e) consent order: The PMN states that the 
PMN substance will be used as a UV curable coating resin for industrial 
use. Based on SAR analysis on structurally similar acrylates and other 
chemicals, EPA predicts eye and skin irritation, dermal sensitization, 
respiratory sensitization, lung effects, mutagenicity, cancer, 
developmental toxicity, liver, and

[[Page 48643]]

kidney toxicity to unprotected workers from repeated inhalation and 
dermal exposures. The Order was issued under TSCA sections 
5(a)(3)(B)(ii)(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 involving impervious 
gloves and protective clothing (where there is a potential for dermal 
exposure) and a NIOSH-certified respirator with an APF of at least 50 
(where there is a potential for inhalation exposure).
    (2) No manufacture, process, or use of the substance for use in a 
consumer product.
    (3) Establishment and use of a hazard communication program, 
including human health precautionary statements on each label and in 
the SDS.
    (4) Manufacture of the PMN substance to contain no more than 0.1 
residual by weight of chemicals described in the 5(e) consent order.
    Recommended testing: EPA has determined that the results of certain 
human health toxicity testing would help characterize the PMN 
substance. 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 
addition, EPA has determined that the results of a skin sensitization 
(OPPTS 870.2600), a local lymph node assay (OECD 429), and two-year 
bioassay (oral) (OPPTS 870.4200) would help characterize possible 
health effects of the substance. Although the Order does not require 
these tests, 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 721.11014.

PMN Number: P-16-387

    Chemical name: Aliphatic polycarboxylic acid, polymer with 
alicyclic polyhydric alcohol and polyoxyalkylene (generic).
    CAS number: Not available.
    Effective date of TSCA section 5(e) consent order: February 7, 
2017.
    Basis for TSCA section 5(e) consent order: The PMN states that the 
PMN substance will be used as an additive for a polymer. Based on 
physical/chemical properties of the PMN substance, EPA predicts lung 
effects to unprotected workers from repeated exposures. The Order was 
issued under TSCA sections 5(a)(3)(B)(ii)(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) Manufacture of the PMN substance such that the minimum average 
molecular weight is 18,000 daltons.
    (2) No processing or use in any manner or method that generates a 
dust, mist, or aerosol.
    (3) Establishment and use of a hazard communication program, 
including human health precautionary statements on each label and in 
the SDS.
    Recommended testing: EPA has determined that the results of a 90-
day inhalation toxicity test with 30-day holding period (OPPTS 
870.3465), a combined repeated dose toxicity study with the 
reproduction/developmental toxicity screening test (OECD 422) an acute 
fish toxicity test (OCSPP 850.1075), an acute daphnia toxicity test 
(OCSPP 850.1300), and an algal toxicity test (OCSPP 850.4500) would 
help characterize possible health and environmental effects of the 
substance. Although the Order does not require these tests, 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 721.11015.

PMN Number: P-16-398

    Chemical name: Di-ammonium di-carboxylate (generic).
    CAS number: Not available.
    Effective date of TSCA section 5(e) consent order: November 14, 
2016.
    Basis for TSCA section 5(e) consent order: The PMN states that the 
PMN substance will be used as a corrosion inhibitor. Based on test data 
on analogous anionic surfactants, EPA predicts eye and mucous membrane 
irritation and skin sensitization to unprotected workers from repeated 
dermal exposures. The Order was issued under TSCA sections 
5(a)(3)(B)(ii)(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 impervious gloves 
and protective clothing to prevent dermal exposure.
    2. Use of the PMN substance only for the use specified in the 
consent order.
    3. Establishment and use of a hazard communication program, 
including human health precautionary statements on each label and in 
the SDS.
    Recommended testing: EPA has determined that the results of certain 
human health toxicity testing would help characterize the effects of 
the PMN substance. The submitter has agreed not to exceed the 
confidential production limit without performing three skin 
sensitization studies (OECD 442B), (OECD 442C), and (OECD 442D).
    CFR citation: 40 CFR 721.11016.

PMN Number: P-16-455

    Chemical name: Sodium tungsten oxide.
    CAS number: Not available.
    Effective date of TSCA section 5(e) consent order: November 2, 
2016.
    Basis for TSCA section 5(e) consent order: The PMN states that the 
PMN substance will be used as a component of infrared absorption 
material. Based on SAR analysis on structurally similar respirable 
poorly soluble particulates, EPA predicts pulmonary toxicity and 
carcinogenicity to unprotected workers from repeated inhalation 
exposures. Further, based on test data on analogous tungsten oxide, EPA 
predicts toxicity to aquatic organisms may occur at concentrations that 
exceed 1 ppb of the PMN substance in surface waters. The Order was 
issued under TSCA sections 5(a)(3)(B)(ii)(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 to prevent dermal exposure.
    2. Use of a NIOSH-certified respirator with an APF of at least 1000 
or compliance with a NCEL of 0.3 ppm as an 8-hour time-weighted average 
to prevent inhalation exposure.
    3. Establishment and use of a hazard communication program, 
including human health precautionary statements on each label and in 
the SDS.
    4. Use of the PMN substance only for the use specified in the 
consent order.
    5. No use in application methods that generate a dust, mist, or 
aerosol unless such application method occurs in an enclosed process.
    6. No use of the PMN substance resulting in releases to surface 
waters and disposal of the PMN substance only by landfill or 
incineration.
    Recommended testing: EPA has determined that the results of certain 
human health toxicity testing would help characterize the PMN 
substance. 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)

[[Page 48644]]

and a two- year inhalation bioassay test (OPPTS 870.4200).
    CFR citation: 40 CFR 721.11017.

PMN Number: P-16-503

    Chemical name: Fatty acids, tall-oil, polymers with alkanoic acid, 
substituted carbomonocycle, alkyl peroxide-initiated (generic).
    CAS number: Not available.
    Effective date of TSCA section 5(e) consent order: January 11, 
2017.
    Basis for TSCA section 5(e) consent order: The PMN states that the 
PMN substance will be used as a site-limited polymer intermediate for 
production of a deck stain coating resin additive. Based on physical/
chemical properties, EPA predicts low health hazard for the PMN 
substance when it is manufactured as described in the PMN. However, if 
the chemical substance is manufactured with a lower molecular weight 
and a higher proportion of the acid component (i.e., greater than 20%), 
the PMN substance could cause developmental effects in unprotected 
workers from repeated dermal and inhalation exposures. Further, based 
on physical/chemical properties, EPA predicts low hazard for the PMN 
substance when it is manufactured as described in the PMN due to low 
water solubility. However, if the chemical substance is manufactured 
with a higher proportion of the acid component (i.e., greater than 
20%), there is potential for aquatic toxicity. The Order was issued 
under TSCA sections 5(a)(3)(B)(ii)(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. Manufacture of the PMN substance to have an average molecular 
weight no less than 1500 daltons.
    2. Manufacture of the PMN substance to have no more than 24% by 
weight of the acid component.
    3. Use of the PMN substance only as intermediate.
    Recommended testing: EPA has determined that a combined repeated 
dose toxicity study with the reproduction/developmental toxicity 
screening test (OECD 422), water solubility test, log Kow tests, a 
compositional/component analysis (certificate of analysis), a fish 
early-life stage toxicity test (OCSPP Test Guideline 850.1400), a 
daphnid chronic toxicity test (OCSPP Test Guideline 850.1300), fish 
acute toxicity mitigated by humic acid (OCSPP Test Guideline 850.1085), 
an aquatic invertebrate, acute toxicity test, freshwater daphnids 
(OCSPP Test Guideline 850.1075), and an algal toxicity test (OCSPP Test 
Guideline 850.4500) would help characterize the physical-chemical 
properties and possible health and environmental effects of the 
substance. Although the Order does not require these tests, 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 721.11018.

PMN Number: P-16-591

    Chemical name: Alkyl bisphenol (generic).
    CAS number: Not available.
    Effective date of TSCA section 5(e) consent order: January 9, 2017.
    Basis for TSCA section 5(e) consent order: The PMN states that the 
PMN substance will be used as a component of printing ink. Based on 
test data on bisphenol analogs, EPA predicts irritation to eyes, skin, 
lung, and mucous membranes; developmental, reproductive, liver and 
kidney toxicities; dermal sensitization; photosensitization; effects to 
the adrenals and other toxic effects associated with an endocrine 
disruption mode of action to unprotected workers from repeated dermal 
and inhalation exposures. Further, based on SAR analysis of test data 
on analogous phenols, 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(a)(3)(B)(ii)(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 including impervious gloves 
and protective clothing to prevent dermal exposure and a NIOSH-
certified respirator with an APF of at least 10 to prevent inhalation 
exposure.
    2. Use of the PMN substance only for the use specified in the 
consent order.
    3. Establishment and use of a hazard communication program, 
including human health precautionary statements on each label and in 
the SDS.
    4. No use of the PMN substance resulting in releases to surface 
waters.
    Recommended testing: EPA has determined that the results of certain 
human health and environmental toxicity testing would help characterize 
the PMN substance. The submitter has agreed not to exceed the 
confidential production limit without performing the reproduction/
developmental toxicity screening test (OECD 422). In addition, EPA has 
determined that the results of a fish early-life stage toxicity test 
(OCSPP Test Guideline 850.1400) and a daphnid chronic toxicity test 
(OCSPP Test Guideline 850.1300) would help characterize the 
environmental effects of the PMN substance. Although the Order does not 
require these tests, 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 721.11019.

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 all 29 chemical 
substances, regulation was warranted under TSCA section 5(e), pending 
the development of information sufficient to make reasoned evaluations 
of the health or environmental effects of the chemical substances. The 
basis for such findings is outlined in Unit IV. Based on these 
findings, TSCA section 5(e) consent orders requiring the use of 
appropriate exposure controls were negotiated with the PMN submitters. 
The SNUR provisions for these chemical substances are consistent with 
the provisions of the TSCA section 5(e) consent orders. These SNURs are 
promulgated pursuant to Sec.  721.160 (see Unit VI.).

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 TSCA Chemical Substance Inventory (TSCA 
Inventory) 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

[[Page 48645]]

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 Inventory. Guidance on how 
to determine if a chemical substance is on the TSCA Inventory is 
available on the Internet at http://www.epa.gov/opptintr/existingchemicals/pubs/tscainventory/index.html.

VI. Direct Final Procedures

    EPA is issuing these SNURs as a direct final rule, as described in 
Sec.  721.160(c)(3). In accordance with Sec.  721.160(c)(3)(ii) the 
effective date of this rule is December 18, 2017 without further 
notice, unless EPA receives written adverse or critical comments, or 
notice of intent to submit adverse or critical comments before November 
20, 2017.
    If EPA receives written adverse or critical comments, or notice of 
intent to submit adverse or critical comments, on one or more of these 
SNURs before November 20, 2017, EPA will withdraw the relevant sections 
of this direct final rule before its effective date. EPA will then 
issue a proposed SNUR for the chemical substance(s) on which adverse or 
critical comments were received, providing a 30-day period for public 
comment.
    This rule establishes SNURs for a number of chemical substances. 
Any person who submits adverse or critical comments, or notice of 
intent to submit adverse or critical comments, must identify the 
chemical substance and the new use to which it applies. EPA will not 
withdraw a SNUR for a chemical substance not identified in the comment.

VII. Applicability of the Significant New Use Designation

    To establish a significant new use, EPA must determine that the use 
is not ongoing. The chemical substances subject to this rule have 
undergone premanufacture review. In cases where EPA has not received a 
notice of commencement (NOC) and the chemical substance has not been 
added to the TSCA Inventory, no person may commence such activities 
without first submitting a PMN. Therefore, for chemical substances for 
which an NOC has not been submitted EPA concludes that the designated 
significant new uses are not ongoing.
    When chemical substances identified in this rule are added to the 
TSCA Inventory, EPA recognizes that, before the rule is effective, 
other persons might engage in a use that has been identified as a 
significant new use. However, TSCA section 5(e) consent orders have 
been issued for these 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 19 of the 29 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 July 10, 2017 (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: TSCA section 5(b)(1) 
requires development of test data where the chemical substance subject 
to the SNUR is also subject to a rule, order or consent agreement under 
TSCA section 4 (15 U.S.C. 2603).
    In the absence of a rule order, or consent agreement under TSCA 
section 4 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 
Sec.  720.50). However, upon review of PMNs and SNUNs, the Agency has 
the authority to require appropriate testing. Unit IV. lists required 
or recommended testing for all of the listed SNURs. Descriptions of 
tests are provided for informational purposes. EPA strongly encourages 
persons, before performing any testing, to consult with the Agency 
pertaining to protocol selection. To access the OCSPP test guidelines 
referenced in this document electronically, please go to http://www.epa.gov/ocspp and select ``Test Methods and Guidelines.'' The 
Organisation for Economic Co-operation and Development (OECD) test 
guidelines are available from the OECD Bookshop at http://www.oecdbookshop.org or SourceOECD at http://www.sourceoecd.org.
    In the TSCA section 5(e) consent orders for 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 tests specified 
in the order 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

[[Page 48646]]

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

X. SNUN Submissions

    According to Sec.  721.1(c), persons submitting a SNUN must comply 
with the same notification requirements and EPA regulatory procedures 
as persons submitting a PMN, including submission of test data on 
health and environmental effects as described in Sec.  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 Sec. Sec.  720.40 and 721.25. E-PMN software is available 
electronically at https://www.epa.gov/reviewing-new-chemicals-under-toxic-substances-control-act-tsca.

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-2017-0166.

XII. Statutory and Executive Order Reviews

A. Executive Order 12866

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

B. Paperwork Reduction Act (PRA)

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

C. Regulatory Flexibility Act (RFA)

    On February 18, 2012, EPA certified pursuant to RFA section 605(b) 
(5 U.S.C. 605(b)), that promulgation of a SNUR does not have a 
significant economic impact on a substantial number of small entities 
where the following are true:

[[Page 48647]]

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

D. Unfunded Mandates Reform Act (UMRA)

    Based on EPA's experience with proposing and finalizing SNURs, 
State, local, and Tribal governments have not been impacted by these 
rulemakings, and EPA does not have any reasons to believe that any 
State, local, or Tribal government will be impacted by this action. As 
such, EPA has determined that this action does not impose any 
enforceable duty, contain any unfunded mandate, or otherwise have any 
effect on small governments subject to the requirements of UMRA 
sections 202, 203, 204, or 205 (2 U.S.C. 1502, 1503, 1504, or 1505 et 
seq.).

E. Executive Order 13132

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

F. Executive Order 13175

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

G. Executive Order 13045

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

H. Executive Order 13211

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

I. National Technology Transfer and Advancement Act (NTTAA)

    In addition, since this action does not involve any technical 
standards, NTTAA section 12(d) (15 U.S.C. 272 note), does not apply to 
this action.

J. Executive Order 12898

    This action does not entail special considerations of environmental 
justice related issues as delineated by Executive Order 12898, entitled 
``Federal Actions to Address Environmental Justice in Minority 
Populations and Low-Income Populations'' (59 FR 7629, February 16, 
1994).

XIII. Congressional Review Act

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

List of Subjects

40 CFR Part 9

    Environmental protection, Reporting and recordkeeping requirements.

40 CFR Part 721

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

    Dated: July 7, 2017.
Maria J. Doa,
Director, Chemical Control Division, Office of Pollution Prevention and 
Toxics.
    Therefore, 40 CFR parts 9 and 721 are amended as follows:

PART 9--[AMENDED]

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

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

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

Sec.  9.1  OMB approvals under the Paperwork Reduction Act.

* * * * *

------------------------------------------------------------------------
                                                            OMB control
                     40 CFR citation                            No.
------------------------------------------------------------------------
 
                               * * * * *
               Significant New Uses of Chemical Substances
 
                                * * * * *
721.10996...............................................       2070-0012
721.10997...............................................       2070-0012
721.10998...............................................       2070-0012
721.10999...............................................       2070-0012
721.11000...............................................       2070-0012
721.11001...............................................       2070-0012
721.11002...............................................       2070-0012
721.11003...............................................       2070-0012
721.11004...............................................       2070-0012
721.11005...............................................       2070-0012
721.11006...............................................       2070-0012
721.11007...............................................       2070-0012
721.11008...............................................       2070-0012
721.11009...............................................       2070-0012
721.11010...............................................       2070-0012
721.11011...............................................       2070-0012
721.11012...............................................       2070-0012
721.11013...............................................       2070-0012
721.11014...............................................       2070-0012
721.11015...............................................       2070-0012
721.11016...............................................       2070-0012
721.11017...............................................       2070-0012
721.11018...............................................       2070-0012
721.11019...............................................       2070-0012
 
                                * * * * *
------------------------------------------------------------------------

* * * * *

[[Page 48648]]

PART 721--[AMENDED]

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

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

0
4. Add Sec.  721.10996 to subpart E to read as follows:

Sec.  721.10996  1,2,4-Benzenetricarboxylic acid, mixed decyl and octyl 
triesters.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified as 1,2,4-
benzenetricarboxylic acid, mixed decyl and octyl triesters (PMN P-15-
310) 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) and (3) and (b) (concentration set at 1.0 percent).
    (ii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80(p) (2,440,000 kilograms), (s) (150,000 
kilograms). It is a significant new use to use the PMN substance other 
than as a lubricant in chain oils for conveyor belts.
    (iii) Hazard communication program. A significant new use of the 
substance is any manner or method of manufacture or processing 
associated with any use of the substance without providing risk 
notification as follows:
    (A) If as a result of the test data required under the TSCA section 
5(e) consent order for the substance, the employer becomes aware that 
the substance may present a risk of injury to human health or the 
environment, the employer must incorporate this new information, and 
any information on methods for protecting against such risk, into a 
MSDS as described in Sec.  721.72(c) within 90 days from the time the 
employer becomes aware of the new information. If the substance is not 
being manufactured, processed, or used in the employer's workplace, the 
employer must add the new information to a MSDS before the substance is 
reintroduced into the workplace.
    (B) The employer must ensure that persons who will receive the PMN 
substance from the employer, or who have received the PMN substance 
from the employer within 5 years from the date the employer becomes 
aware of the new information described in paragraph (a)(2)(iii)(A) of 
this section, are provided an MSDS containing the information required 
under paragraph (a)(2)(iii)(A) of this section within 90 days from the 
time the employer becomes aware of the new information.
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph (b).
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125(a) through (f) and (i) are applicable to manufacturers and 
processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.

0
5. Add Sec.  721.10997 to subpart E to read as follows:

Sec.  721.10997  Multiwalled carbon nanotubes (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substances identified generically as 
multiwalled carbon nanotubes (PMN P-15-487/488/489/490/491) are subject 
to reporting under this section for the significant new uses described 
in paragraph (a)(2) of this section. The requirements of this section 
do not apply when the PMN substances have been incorporated into a 
polymer matrix that has been reacted (cured) or embedded in a permanent 
solid polymer form that is not intended to undergo further processing 
except mechanical processing.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in Sec.  
721.63(a)(1), (a)(2)(i) and (ii), (a)(3), (4), and (6) (particulate), 
and (c). When determining which persons are reasonably likely to be 
exposed as required for Sec.  721.63(a)(1) and (4), engineering control 
measures (e.g., enclosure or confinement of the operation, general and 
local ventilation) or administrative control measures (e.g., workplace 
policies and procedures) shall be considered and implemented to prevent 
exposure, where feasible. The following National Institute for 
Occupational Safety and Health (NIOSH)-certified respirators with an 
APF of at least 50 meet the requirements of Sec.  721.63(a)(4):
    (A) A NIOSH-certified air-purifying, tight-fitting full-face 
respirator equipped with N-100, P-100, or R-100 cartridges.
    (B) Any NIOSH-certified powered air-purifying respirator equipped 
with a tight-fitting full facepiece and equipped with HEPA filters.
    (C) Any NIOSH-certified negative pressure (demand) supplied-air 
respirator equipped with a full facepiece.
    (ii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80(k) (additives for electro-static discharge 
in electronic devices, electronics, and materials; additives for weight 
reduction in materials; additives to improve mechanical properties or 
electrical conductivities; heat-generating elements in heating devices 
and materials; additives for heat transfer and thermal emissions in 
electronic devices and materials; semi-conductor, conductive, or 
resistive elements in electronic circuity and devices; additives to 
improve conductivity in electronic circuitry, energy storage systems, 
and devices; electron emitters for lighting and x-ray sources; additive 
for electromagnetic interface shielding in electronic devices; 
additives for electrodes in electronic materials and electronic 
devices; catalyst support in chemical manufacturing; coating additives 
to improve corrosion resistance of conductive properties; additives for 
fibers in structural and electrical applications; additives for fibers 
in fabrics and textiles; filter additives to remove nanoscale 
materials; semi-conducting compounding additives for high-voltage 
cable; and additives for super-hydrophobicity). A significant new use 
is any use involving an application method that generates a dust, mist 
or aerosol.
    (iii) Disposal. Requirements as specified in Sec.  721.85(a)(1) and 
(2), (b)(1) and (2), and (c)(1) and (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 (b).
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125(a) through (e) and (i) through (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
6. Add Sec.  721.10998 to subpart E to read as follows:

Sec.  721.10998  Propanoic acid, iron (2+) salt (2:1).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified as propanoic acid, 
iron (2+) salt (2:1) (CAS #1952336-63-8) (PMN P-16-165) is subject to 
reporting under this section for the significant new uses described in 
paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in Sec.  
721.63(a)(4) and (5) (particulate) and (b) (concentration set at 1.0 
percent).

[[Page 48649]]

When determining which persons are reasonably likely to be exposed as 
required for Sec.  721.63(a)(4), engineering control measures (e.g., 
enclosure or confinement of the operation, general and local 
ventilation) or administrative control measures (e.g., workplace 
policies and procedures) shall be considered and implemented to prevent 
exposure, where feasible. The following National Institute for 
Occupational Safety and Health (NIOSH)-certified respirators with an 
APF of at least 10 meet the requirements of Sec.  721.63(a)(4):
    (A) NIOSH-certified respirator with an N-100, P-100, or R-100 
cartridge.
    (B) NIOSH-certified power air purifying respirator with a hood or 
helmet and with appropriate gas/vapor (acid gas, organic vapor, or 
substance specific) cartridges in combination with HEPA filters.
    (C) NIOSH-certified continuous flow supplied-air respirator 
equipped with a loose fitting facepiece, hood, or helmet.
    (ii) Hazard communication. Requirements as specified in Sec.  
721.72(a) through (e) (concentration set at 1.0 percent), (f), 
(g)(1)(iv) and (ix), (g)(2)(ii), (iii), and (iv), and (g)(5). 
Alternative hazard and warning statements that meet the criteria of the 
Globally Harmonized System (GHS) and OSHA Hazard Communication Standard 
may be used.
    (iii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80(l), (p) (270,000 kilograms), (s) (5,000 
kilograms). It is a significant new use to use the substance in 
formulations where the concentration is greater than 1 percent.
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph (b).
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125(a) through (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
7. Add Sec.  721.10999 to subpart E to read as follows:

Sec.  721.10999  1-Butanaminium, N,N,N-tributyl-, carbonic acid (1:1).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified as 1-butanaminium, 
N,N,N-tributyl-, carbonic acid (1:1) (PMN P-16-255; CAS No. 17351-62-1) 
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) and (3) and (b) (concentration set at 1.0 percent).
    (ii) Hazard communication. Requirements as specified in Sec.  
721.72(a) through (e) (concentration set at 1.0 percent), (f), 
(g)(1)(i) and (ii), (g)(2)(i), (ii), (iii), and (v), (g)(3)(i) and 
(ii), and (g)(5) and Notice to users: Minimize release to water. 
Alternative hazard and warning statements that meet the criteria of the 
Globally Harmonized System (GHS) and OSHA Hazard Communication Standard 
may be used.
    (iii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80(p) (64,000 kilograms aggregate of P-16-
255, P-16-256, P-16-257, P-16-258, and P-16-259). It is a significant 
new use to manufacture, process, or use the substance other than as a 
blocked catalyst for paints and coatings. It is a significant new use 
to spray apply the PMN substance where the concentration of any 
combination of P-16-255, P-16-256, P-16-257, P-16-258, and P-16-259 in 
the final paint/coating formulation exceeds 1.5% by weight.
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph (b).
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125(a) through (i) are applicable to manufacturers and processors 
of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.

0
8. Add Sec.  721.11000 to subpart E to read as follows:

Sec.  721.11000  1-Butanaminium, N,N,N-tributyl-, methyl carbonate 
(1:1).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified as 1-Butanaminium, 
N,N,N-tributyl-, methyl carbonate (1:1) (PMN P-16-256; CAS No. 56294-
05-2) is subject to reporting under this section for the significant 
new uses described in paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in Sec.  
721.63(a)(1) and (3) and (b) (concentration set at 1.0 percent).
    (ii) Hazard communication. Requirements as specified in Sec.  
721.72(a) through (e) (concentration set at 1.0 percent), (f), 
(g)(1)(i) and (ii), (g)(2)(i), (ii), (iii), and (v), (g)(3)(i) and 
(ii), and (g)(5) and Notice to users: Minimize release to water. 
Alternative hazard and warning statements that meet the criteria of the 
Globally Harmonized System (GHS) and OSHA Hazard Communication Standard 
may be used.
    (iii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80(p) (64,000 kilograms aggregate of P-16-
255, P-16-256, P-16-257, P-16-258, and P-16-259). It is a significant 
new use to manufacture, process, or use the substance other than as a 
blocked catalyst for paints and coatings. It is a significant new use 
to spray apply the PMN substance where the concentration of any 
combination of P-16-255, P-16-256, P-16-257, P-16-258, and P-16-259 in 
the final paint/coating formulation exceeds 1.5% by weight.
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph (b).
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125(a) through (i) are applicable to manufacturers and processors 
of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.

0
9. Add Sec.  721.11001 to subpart E to read as follows:

Sec.  721.11001  1-Butanaminium, N,N,N-tributyl-, ethyl carbonate 
(1:1).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified as 1-butanaminium, 
N,N,N-tributyl-, ethyl carbonate (1:1) (PMN P-16-257; CAS No. 478796-
04-2) is subject to reporting under this section for the significant 
new uses described in paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in Sec.  
721.63(a)(1) and (3) and (b) (concentration set at 1.0 percent).
    (ii) Hazard communication. Requirements as specified in Sec.  
721.72(a) through (e) (concentration set at 1.0 percent), (f), 
(g)(1)(i) and (ii), (g)(2)(i), (ii), (iii), and (v), (g)(3)(i) and 
(ii), and (g)(5) and Notice to users: Minimize release to water. 
Alternative hazard and warning statements that meet the criteria of the 
Globally Harmonized System (GHS) and OSHA Hazard Communication Standard 
may be used.
    (iii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80(p)(64,000 kilograms aggregate of P-16-255, 
P-16-256, P-16-257, P-16-258, and P-16-259). It is a significant new 
use to

[[Page 48650]]

manufacture, process, or use the substance other than as a blocked 
catalyst for paints and coatings. It is a significant new use to spray 
apply the PMN substance where the concentration of any combination of 
P-16-255, P-16-256, P-16-257, P-16-258, and P-16-259 in the final 
paint/coating formulation exceeds 1.5% by weight.
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph (b).
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125(a) through (i) are applicable to manufacturers and processors 
of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.

0
10. Add Sec.  721.11002 to subpart E to read as follows:

Sec.  721.11002  1-Butanaminium, N,N,N-tributyl-, propyl carbonate 
(1:1).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified as 1-butanaminium, 
N,N,N-tributyl-, propyl carbonate (1:1) (PMN P-16-258: CAS No. 1338579-
13-7) 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) and (3) and (b) (concentration set at 1.0 percent).
    (ii) Hazard communication. Requirements as specified in Sec.  
721.72(a) through (e) (concentration set at 1.0 percent), (f), 
(g)(1)(i) and (ii), (g)(2)(i), (ii), (iii), and (v), (g)(3)(i) and 
(ii), and (g)(5) and Notice to users: Minimize release to water. 
Alternative hazard and warning statements that meet the criteria of the 
Globally Harmonized System (GHS) and OSHA Hazard Communication Standard 
may be used.
    (iii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80(p) (64,000 kilograms aggregate of P-16-
255, P-16-256, P-16-257, P-16-258, and P-16-259). It is a significant 
new use to manufacture, process, or use the substance other than as a 
blocked catalyst for paints and coatings. It is a significant new use 
to spray apply the PMN substance where the concentration of any 
combination of P-16-255, P-16-256, P-16-257, P-16-258, and P-16-259 in 
the final paint/coating formulation exceeds 1.5% by weight.
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph (b).
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125(a) through (i) are applicable to 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
11. Add Sec.  721.11003 to subpart E to read as follows:

Sec.  721.11003  1-Butanaminium, N,N,N-tributyl-, and 1-methylethyl 
carbonate.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified as 1-butanaminium, 
N,N,N-tributyl-, and 1-methylethyl carbonate (PMN P-16-259; CAS No. 
1803407-49-9) is subject to reporting under this section for the 
significant new uses described in paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in Sec.  
721.63(a)(1) and (3) and (b) (concentration set at 1.0 percent).
    (ii) Hazard communication. Requirements as specified in Sec.  
721.72(a) through (e) (concentration set at 1.0 percent), (f), 
(g)(1)(i) and (ii), (g)(2)(i), (ii), (iii), and (v), (g)(3)(i) and 
(ii), (g)(4) (Notice to users: Minimize release to water), and (g)(5). 
Alternative hazard and warning statements that meet the criteria of the 
Globally Harmonized System (GHS) and OSHA Hazard Communication Standard 
may be used.
    (iii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80(p) (64,000 kilograms aggregate of P-16-
255, P-16-256, P-16-257, P-16-258, and P-16-259). It is a significant 
new use to manufacture, process, or use the substance other than as a 
blocked catalyst for paints and coatings. It is a significant new use 
to spray apply the PMN substance where the concentration of any 
combination of P-16-255, P-16-256, P-16-257, P-16-258, and P-16-259 in 
the final paint/coating formulation exceeds 1.5% by weight.
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph (b).
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125(a) through (i) are applicable to manufacturers and processors 
of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.

0
12. Add Sec.  721.11004 to subpart E to read as follows:

Sec.  721.11004  Anilino substituted bis-triazinyl derivative of 4,4'-
diaminostilbene-2,2'-disulfonic acid, mixed amine sodium salt 
(generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as anilino 
substituted bis-triazinyl derivative of 4,4'-diaminostilbene-2,2'-
disulfonic acid, mixed amine sodium salt (PMN P-16-284) is subject to 
reporting under this section for the significant new uses described in 
paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80(f). It is a significant new use to import 
or use the substance other than in a solution. It is a significant new 
use to use the substance other than as an optical brightener for 
textiles, paper, and paperboard. It is a significant new use to use the 
substance for non-industrial use or sell the substance for ``consumer 
use'' or for ``commercial uses'' (as the term is defined at Sec.  
721.3) when the ``saleable goods or service'' could introduce the 
substance into a ``consumer'' setting (as that term is defined in Sec.  
721.3). It is a significant new use to use the substance for an 
application method that generates a dust, mist, or aerosol unless the 
application method occurs in an enclosed process.
    (ii) [Reserved].
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph (b).
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125(a) through (c) and (i) are applicable to manufacturers and 
processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.

0
13. Add Sec.  721.11005 to subpart E to read as follows:

Sec.  721.11005  12-Hydroxystearic acid, reaction products with 
alkylene diamine and alkanoic acid (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substances identified generically as 12-
Hydroxystearic acid, reaction products with alkylene diamine and 
alkanoic acid (PMNs P-16-309 and P-16-310) are subject to reporting 
under this section for the significant new uses described in paragraph 
(a)(2) of this section.

[[Page 48651]]

    (2) The significant new uses are:
    (i) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80(f), (q), and (t). It is a significant new 
use to use the PMN substance other than as a rheological or thixotropic 
agent used in the production of solvent based industrial coatings, high 
solid aromatic paints, adhesives, sealants, and other types of paints 
and topcoats.
    (ii) Releases 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 (b).
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125(a) through (c), (i), and (k) are applicable to manufacturers 
and processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.
    (3) Determining whether a specific use is subject to this section. 
The provisions of Sec.  721.1725(b)(1) apply to paragraph (a)(2)(ii) of 
this section.

0
14. Add Sec.  721.11006 to subpart E to read as follows:

Sec.  721.11006  Alkyldiene, polymer, hydroxy terminated 
alkoxysilylalkylcarbamate.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 
alkyldiene, polymer, hydroxy terminated alkoxysilylalkylcarbamate (PMN 
P-16-315) is subject to reporting under this section for the 
significant new uses described in paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80(f). It is a significant new use to process 
the substance in a manner that results in inhalation exposure. It is a 
significant new use to use the PMN substance other than as an additive 
to improve the compatibility and dispersibility of inorganic filler in 
industrial rubber formulations.
    (ii) [Reserved].
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph (b).
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125(a) through (c) and (i) are applicable to manufacturers and 
processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.

0
15. Add Sec.  721.11007 to subpart E to read as follows:

Sec.  721.11007  Alkylaldehyde, reaction products with substituted 
carbomonocycle-substituted heteromonocycle-alkylene glycol 
bis[[[[substituted(oxoneoalkyl)oxy]alkyl] amino]alkyl] ether polymer 
and alkyl substituted alkanediamine, acetate salts (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 
alkylaldehyde, reaction products with substituted carbomonocycle-
substituted heteromonocycle-alkylene glycol 
bis[[[[substituted(oxoneoalkyl)oxy]alkyl] amino]alkyl] ether polymer 
and alkyl substituted alkanediamine, acetate salts (generic) (PMN P-16-
323) 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. Requirements as specified in Sec.  
721.72(a) through (e) (concentration set at 0.1 percent), (f), (g)(1) 
(respiratory tract irritation), (g)(1)(i) and (vii), (g)(2)(i), (ii), 
and (iii), (g)(3)(i) and (ii), and (g)(5). Alternative hazard and 
warning statements that meet the criteria of the Globally Harmonized 
System (GHS) and OSHA Hazard Communication Standard may be used.
    (ii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80(j). It is a significant new use to 
manufacture the PMN substance to contain a residual of formaldehyde 
greater than 0.1 weight percent. It is a significant new use to 
manufacture the substance in a manner that results in inhalation 
exposure.
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph (b).
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125(a) through (c), (f), (g), and (h) 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
16. Add Sec.  721.11008 to subpart E to read as follows:

Sec.  721.11008  Hydroxy functional triglyceride polymer with glycerol 
mono-ester and 1,1'-methylenebis[4-isocyanatobenzene] (generic).

    (a) Chemical substances and significant new uses subject to 
reporting. (1) The chemical substance identified generically as hydroxy 
functional triglyceride polymer with glycerol mono-ester and 1,1'-
methylenebis[4-isocyanatobenzene] (PMN P-16-330) 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), (iii), and (iv), (a)(3), and (b) 
(concentration set at 0.1 percent)
    (ii) Hazard communication. Requirements as specified in Sec.  
721.72(a) through (e) (concentration set at 1.0 percent), (f), 
(g)(1)(i) and (ii), (g)(2)(i), (ii), (iii), and (v), and (g)(5). 
Alternative hazard and warning statements that meet the criteria of the 
Globally Harmonized System (GHS) and OSHA Hazard Communication Standard 
may be used.
    (iii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80. It is a significant new use to 
manufacture the PMN substance to contain a residual of isocyanate 
greater than 0.1 weight percent. It is a significant new use to sell 
the substance for ``consumer use'' or for ``commercial uses'' (as the 
term is defined at Sec.  721.3) when the ``saleable goods or service'' 
could introduce the substance into a ``consumer'' setting (as that term 
is defined in Sec.  721.3).
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph (b).
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125(a) through (i) are applicable to manufacturers and processors 
of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.

0
17. Add Sec.  721.11009 to subpart E to read as follows:

Sec.  721.11009  Hydroxy functional triglyceride polymer with glycerol 
mono-ester and 1,1'-methylenebis[isocyanatobenzene] (generic).

    (a) Chemical substances and significant new uses subject to 
reporting. (1) The chemical substance identified generically as hydroxy 
functional triglyceride polymer with glycerol

[[Page 48652]]

mono-ester and 1,1'-methylenebis[isocyanatobenzene] (PMN P-16-331) 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), (iii), and (iv), (a)(3), and (b) 
(concentration set at 0.1 percent).
    (ii) Hazard communication. Requirements as specified in Sec.  
721.72(a) through (e) (concentration set at 1.0 percent), (f), 
(g)(1)(i) and (ii), (g)(2)(i), (ii), (iii), and (v), and (g)(5). 
Alternative hazard and warning statements that meet the criteria of the 
Globally Harmonized System (GHS) and OSHA Hazard Communication Standard 
may be used.
    (iii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80. It is a significant new use to 
manufacture the PMN substance to contain a residual of isocyanate 
greater than 0.1 weight percent. It is a significant new use to sell 
the substance for ``consumer use'' or for ``commercial uses'' (as the 
term is defined at Sec.  721.3) when the ``saleable goods or service'' 
could introduce the substance into a ``consumer'' setting (as that term 
is defined in Sec.  721.3).
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph (b).
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125(a) through (i) are applicable to manufacturers and processors 
of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.

0
18. Add Sec.  721.11010 to subpart E to read as follows:

Sec.  721.11010  Poly(oxy-1,2-ethanediyl),.alpha.-(1-
oxodocosyl)-.omega.-[(1-oxodocosyl)oxy]-

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 
poly(oxy-1,2-ethanediyl),.alpha.-(1-oxodocosyl)-.omega.-[(1-
oxodocosyl)oxy]- (PMN P-16-360; CAS No. 36493-27-3) 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) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80. It is a significant new use to 
manufacture the PMN substance such that more than 33% contains 10 or 
more repeating ethylene oxide units.
    (ii) [Reserved].
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph (b).
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125(a) through (c) and (i) are applicable to manufacturers and 
processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.

0
19. Add Sec.  721.11011 to subpart E to read as follows:

Sec.  721.11011  Pulp, cellulose, reaction products with lignin.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as pulp, 
cellulose, reaction products with lignin (PMN P-16-361; CAS No. 167062-
70-6) is subject to reporting under this section for the significant 
new uses described in paragraph (a)(2) of this section. The 
requirements of this section do not apply to quantities of the PMN 
substance after they have been incorporated into a polymer matrix.
    (2) The significant new uses are:
    (i) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80(y)(1). It is a significant new use to 
manufacture, process, or use the PMN substance other than in a liquid 
or gel formulation, unless the solid particle form has a particle size 
distribution where less than 0.5% of the particles are less than 10 
microns. It is a significant new use to manufacture the solid particle 
form more than six months without measuring the particle size 
distribution to characterize the particle size distribution of 
fractions less than 10 microns of the dry particle PMN substance and 
sending the results of the measurement to EPA.
    (ii) [Reserved].
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph (b).
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125(a) through (c) and (i) are applicable to manufacturers and 
processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.

0
20. Add Sec.  721.11012 to subpart E to read as follows:

Sec.  721.11012  Alkyl carbonate, polymer with, substituted alkanes and 
substituted heteromonocycle, substituted alkyl acrylate-blocked 
(generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as alkyl 
carbonate, polymer with, substituted alkanes and substituted 
heteromonocycle, substituted alkyl acrylate-blocked (generic) (PMN P-
16-365) 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) and (3) and (b) (concentration set at 0.1 percent).
    (ii) Hazard communication. Requirements as specified in Sec.  
721.72(a) through (e) (concentration set at 0.1 percent), (f), (g)(1) 
(lung effects), (g)(1) (sensitization), (g)(1)(vii), (g)(2)(i), (ii), 
(iii), and (v), and (g)(5).
    (iii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80. It is a significant new use to 
manufacture the substance to contain a residual of isocyanate greater 
than 0.1 weight percent. It is a significant new use to sell the 
substance for ``consumer use'' or for ``commercial uses'' (as the term 
is defined at Sec.  721.3) when the ``saleable goods or service'' could 
introduce the substance into a ``consumer'' setting (as that term is 
defined in Sec.  721.3).
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph (b).
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125(a) through (i) are applicable to manufacturers and processors 
of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.

0
21. Add Sec.  721.11013 to subpart E to read as follows:

Sec.  721.11013  Substituted heteromonocycle, polymer with substituted 
alkane and ethoxylated alkane, substituted heteromonocycle substituted 
alkyl ester-blocked (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 
substituted heteromonocycle, polymer with substituted alkane and 
ethoxylated alkane, substituted heteromonocycle

[[Page 48653]]

substituted alkyl ester-blocked (PMN P-16-367) is subject to reporting 
under this section for the significant new uses described in paragraph 
(a)(2) of this section. The requirements of this section do not apply 
to quantities of the PMN substance after they have been completely 
reacted (cured).
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in Sec.  
721.63(a)(1) and (3) and (b) (concentration set at 0.1 percent).
    (ii) Hazard communication. Requirements as specified in Sec.  
721.72(a) through (e) (concentration set at 0.1 percent), (f), (g)(1) 
(lung effects), (g)(1) (sensitization), (g)(1)(vii), (g)(2)(i), (ii), 
(iii), and (v), and (g)(5).
    (iii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80. It is a significant new use to 
manufacture the substance to contain a residual of isocyanate greater 
than 0.1 weight percent. It is a significant new use to sell the 
substance for ``consumer use'' or for ``commercial uses'' (as the term 
is defined at Sec.  721.3) when the ``saleable goods or service'' could 
introduce the substance into a ``consumer'' setting (as that term is 
defined in Sec.  721.3).
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph (b).
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125(a) through (i) are applicable to manufacturers and processors 
of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.

0
22. Add Sec.  721.11014 to subpart E to read as follows:

Sec.  721.11014  Substituted heteromonocycle, telomer with substituted 
carbomonocycles, substituted alkyl ester (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 
substituted heteromonocycle, telomer with substituted carbomonocycles, 
substituted alkyl ester (PMN P-16-369) is subject to reporting under 
this section for the significant new uses described in paragraph (a)(2) 
of this section. The requirements of this section do not apply to 
quantities of the PMN substance after they have been completely reacted 
(cured).
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in Sec.  
721.63(a)(1), (3), and (4), (a)(6) (particulate), (a)(6)(v) and (vi), 
and (b) (concentration set at 0.1 percent). The following National 
Institute for Occupational Safety and Health (NIOSH)-certified 
respirators with an APF of at least 50 meet the requirements of Sec.  
721.63(a)(4):
    (A) Any NIOSH-certified air-purifying full facepiece respirator 
equipped with N100 (if oil aerosols absent), R-100, or P-100 filter(s).
    (B) Any NIOSH-certified powered air-purifying respirator equipped 
with a tight-fitting full facepiece and equipped with HEPA filters.
    (C) Any NIOSH-certified negative pressure (demand) supplied-air 
respirator equipped with a full facepiece.
    (D) Any NIOSH-certified continuous flow supplied-air respirator 
equipped with a tight-fitting full facepiece (half or full facepiece).
    (E) Any NIOSH-certified negative pressure (demand) self-contained 
breathing apparatus (SCBA) equipped with a hood or helmet or a full 
facepiece.
    (ii) Hazard communication. Requirements as specified in Sec.  
721.72(a) through (e) (concentration set at 0.1 percent), (f), (g)(1) 
(lung effects), (g)(1) (sensitization), (g)(1)(vii), (g)(2)(i), (ii), 
(iii), and (v), and (g)(5).
    (iii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80(q). It is a significant new use to 
manufacture the substance to contain residuals greater than 0.1 weight 
percent of chemicals described in the 5(e) consent order. It is a 
significant new use to sell the substance for ``consumer use'' or for 
``commercial uses'' (as the term is defined at Sec.  721.3) when the 
``saleable goods or service'' could introduce the substance into a 
``consumer'' setting (as that term is defined in Sec.  721.3).
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph (b).
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125(a) through (i) are applicable to 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
23. Add Sec.  721.11015 to subpart E to read as follows:

Sec.  721.11015  Aliphatic polycarboxylic acid, polymer with alicyclic 
polyhydric alcohol and polyoxyalkylene (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 
aliphatic polycarboxylic acid, polymer with alicyclic polyhydric 
alcohol and polyoxyalkylene (PMN P-16-387) 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. Requirements as specified in Sec.  
721.72(a) through (e) (concentration set at 1.0 percent), (f), 
(g)(1)(ii), (g)(2)(ii), (g)(3)(i) and (ii), and (g)(5). Alternative 
hazard and warning statements that meet the criteria of the Globally 
Harmonized System (GHS) and OSHA Hazard Communication Standard may be 
used.
    (ii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80(y)(1) and (2). It is a significant new use 
to manufacture the substance with a molecular weight less than 18,000 
daltons.
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph (b).
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125(a) through (c) 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.  721.11016 to subpart E to read as follows:

Sec.  721.11016  Di-ammonium di-carboxylate (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as di-
ammonium di-carboxylate (PMN P-16-398) 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), (iii), and (iv), (a)(3), and (b) 
(concentration set at 1.0 percent).
    (ii) Hazard communication. Requirements as specified in Sec.  
721.72(a) through (e) (concentration set at 1.0 percent), (f), (g)(1) 
(skin sensitization), (g)(1)(i), (g)(2)(i) and (v), and (g)(5). 
Alternative hazard and warning statements that meet the criteria of the 
Globally Harmonized System (GHS) and

[[Page 48654]]

OSHA Hazard Communication Standard may be used.
    (iii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80(j) and (q).
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph (b).
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125(a) through (i) are applicable to 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
25. Add Sec.  721.11017 to subpart E to read as follows:

Sec.  721.11017  Sodium tungsten oxide.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified as sodium tungsten 
oxide (PMN P-16-455) is subject to reporting under this section for the 
significant new uses described in paragraph (a)(2) of this section. The 
requirements of this section do not apply to quantities of the 
substance that have been incorporated into a polymer matrix.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in Sec.  
721.63(a)(1), (3), (4), and (6) (particulate). The following National 
Institute for Occupational Safety and Health (NIOSH)-certified 
respirators with an APF of at least 1000 meet the requirements of Sec.  
721.63(a)(4):
    (A) Any NIOSH-certified powered air purifying full facepiece 
respirator equipped with appropriate gas/vapor (acid gas, organic 
vapor, or substance specific) cartridges.
    (B) Any NIOSH-certified continuous flow supplied-air respirator 
equipped with a full facepiece.
    (C) Any NIOSH-certified pressure-demand or other positive pressure 
mode supplied-air respirator equipped with a full facepiece.
    (D) Any NIOSH-certified continuous flow supplied-air respirator 
equipped with a full facepiece.
    (E) Any NIOSH-certified pressure-demand or other positive pressure 
mode supplied-air respirator equipped with a full facepiece.
    (1) As an alternative to the respiratory requirements listed here, 
a manufacturer or processor may choose to follow the New Chemical 
Exposure Limit (NCEL) provisions listed in the TSCA section 5(e) 
consent order for this substance. The NCEL is 0.3 mg/m\3\ as an 8-hour 
time weighted average verified by actual monitoring data.
    (2) [Reserved].
    (ii) Hazard communication. Requirements as specified in Sec.  
721.72(a) through (e) (concentration set at 0.1 percent), (f), (g)(1) 
(lung effects), (g)(1)(vii), (g)(2)(ii), (iii), and (iv), (g)(3)(ii), 
(g)(4)(i) and (iii), and (g)(5).
    (iii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80(q). It is a significant new use to use the 
PMN substance other than as a component of infrared absorption 
material. It is a significant new use for any application method that 
generates a dust, mist, or aerosol, unless such application method 
occurs in an enclosed process.
    (iv) Disposal. Requirements as specified in Sec.  721.85(a)(1) and 
(2), (b)(1) and (2), and (c)(1) and (2).
    (v) Releases to water. Requirements as specified in Sec.  
721.90(a)(1), (b)(1), and (c)(1).
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph (b).
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125(a) through (k) are applicable to manufacturers and processors 
of 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
26. Add Sec.  721.11018 to subpart E to read as follows:

Sec.  721.11018  Fatty acids, tall-oil, polymers with alkanoic acid, 
substituted carbomonocycle, alkyl peroxide-initiated (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as fatty 
acids, tall-oil, polymers with alkanoic acid, substituted 
carbomonocycle, alkyl peroxide-initiated (PMN P-16-503) is subject to 
reporting under this section for the significant new uses described in 
paragraph (a)(2) of this section. The requirements of this section do 
not apply to quantities of the PMN substance that have been completely 
reacted (cured).
    (2) The significant new uses are:
    (i) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80(g). It is a significant new use to 
manufacture the substance to have an average molecular weight less than 
1500 daltons. It is a significant new use to manufacture the substance 
to have more than 24% by weight of the acid component identified in the 
5(e) consent order.
    (ii) [Reserved].
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph (b).
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125(a) through (c) and (i) are applicable to manufacturers and 
processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.
    (3) Determining whether a specific use is subject to this section. 
The provisions of Sec.  721.1725(b)(1) apply to paragraph (a)(2)(ii) of 
this section.

0
27. Add Sec.  721.11019 to subpart E to read as follows:

Sec.  721.11019  Alkyl bisphenol (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as alkyl 
bisphenol (PMN P-16-591) 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), (ii), and (iv), (a)(3) and (4), (a)(6)(v) and 
(vi), (a)(6) (particulate), and (b) (concentration set at 1.0 percent). 
When determining which persons are reasonably likely to be exposed as 
required for Sec.  721.63(a)(4), engineering control measures (e.g., 
enclosure or confinement of the operation, general and local 
ventilation) or administrative control measures (e.g., workplace 
policies and procedures) shall be considered and implemented to prevent 
exposure, where feasible. The following National Institute for 
Occupational Safety and Health (NIOSH)-certified respirators with an 
APF of at least 10 meet the requirements of Sec.  721.63(a)(4):
    (A) NIOSH-certified respirator with an N-100, P-100, or R-100 
cartridge.
    (B) NIOSH-certified power air purifying respirator with a hood or 
helmet and with appropriate gas/vapor (acid gas, organic vapor, or 
substance specific) cartridges in combination with HEPA filters.

[[Page 48655]]

    (C) NIOSH-certified continuous flow supplied-air respirator 
equipped with a loose fitting facepiece, hood, or helmet.
    (ii) Hazard communication. Requirements as specified in Sec.  
721.72(a) through (e) (concentration set at 0.1 percent), (f), (g)(1) 
(dermal sensitization), (g)(1) (endocrine disruption), (g)(1) 
(reproductive effects), (g)(1)(i), (ii), (iv), and (ix), (g)(2)(i), 
(ii), (iii), (iv), and (v), (g)(3)(i) and (ii), (g)(4)(iii), and 
(g)(5). Alternative hazard and warning statements that meet the 
criteria of the Globally Harmonized System (GHS) and OSHA Hazard 
Communication Standard may be used.
    (iii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80(q). It is a significant new use to use the 
PMN substance in thermal paper printing
    (iv) Releases to water. Requirements as specified in Sec.  
721.90(a)(1), (b)(1), and (c)(1).
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph (b).
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125(a) through (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.

    Editorial note: This document was received for publication by 
the Office of the Federal Register on October 10, 2017.

[FR Doc. 2017-22239 Filed 10-18-17; 8:45 am]
BILLING CODE 6560-50-P