[Federal Register Volume 83, Number 166 (Monday, August 27, 2018)]
[Rules and Regulations]
[Pages 43538-43556]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-18403]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Parts 9 and 721

[EPA-HQ-OPPT-2017-0464; FRL-9982-24]
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 19 chemical substances 
which were the subject of premanufacture notices (PMNs). The chemical 
substances are subject to 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 19 
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 October 26, 2018. For purposes of 
judicial review, this rule shall be promulgated at 1 p.m. (e.s.t.) on 
September 10, 2018.
    Written adverse comments on one or more of these SNURs must be 
received on or before September 26, 2018 (see Unit VI. of the 
SUPPLEMENTARY INFORMATION). If EPA receives written adverse comments on 
one or more of these SNURs before September 26, 2018, 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-2017-0464, by one of the following methods:
    <bullet> 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.
    <bullet> Mail: Document Control Office (7407M), Office of Pollution 
Prevention and Toxics (OPPT), Environmental Protection Agency, 1200 
Pennsylvania Ave. NW, Washington, DC 20460-0001.
    <bullet> 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: 
<a href="/cdn-cgi/l/email-protection#dfb2b0acacf1b4bab1b1baabb79fbaafbef1b8b0a9"><span class="__cf_email__" data-cfemail="a4c9cbd7d78acfc1cacac1d0cce4c1d4c58ac3cbd2">[email protected]</span></a>.
    For general information contact: The TSCA-Hotline, ABVI-Goodwill, 
422 South Clinton Ave., Rochester, NY 14620; telephone number: (202) 
554-1404; email address: <a href="/cdn-cgi/l/email-protection#edb9beaeacc0a5829981848388ad889d8cc38a829b"><span class="__cf_email__" data-cfemail="e4b0b7a7a5c9ac8b90888d8a81a4819485ca838b92">[email protected]</span></a>.

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:
    <bullet> Manufacturers or processors of one or more subject 
chemical substances (NAICS codes 325 and 324110), e.g., chemical 
manufacturing and petroleum refineries.
    This action may also affect certain entities through pre-existing 
import certification and export notification rules under TSCA. Chemical 
importers are subject to the TSCA section 13 (15 U.S.C. 2612) import 
certification requirements promulgated at 19 CFR 12.118 through 12.127 
and 19 CFR 127.28. Chemical importers must certify that the shipment of 
the chemical substance complies with all applicable rules and orders 
under TSCA. Importers of chemicals subject to these SNURs must certify 
their compliance with the SNUR requirements. The EPA policy in support 
of import certification appears at 40 CFR part 707, subpart B. In 
addition, any persons who export or intend to export a chemical 
substance that is the subject of this rule on or after September 26, 
2018 are subject to the export notification provisions of TSCA section 
12(b) (15 U.S.C. 2611(b)) (see Sec.  [emsp14]721.20), and must comply 
with the export notification requirements in 40 CFR part 707, subpart 
D.

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

    1. Submitting CBI. Do not submit this information to EPA through 
regulations.gov or email. Clearly mark the part or all of the 
information that you claim to be CBI. For CBI information in a disk or 
CD-ROM that you mail to EPA, mark the outside of the disk or CD-ROM as 
CBI and then identify electronically within the disk or CD-ROM the 
specific information that is claimed as CBI. In addition to one 
complete version of the comment that includes information claimed as 
CBI, a

[[Page 43539]]

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?

    1. Direct Final Rule. EPA is promulgating these SNURs using direct 
final rule 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 obligates EPA to assess 
risks that may be associated with the significant new uses under the 
conditions of use and, if appropriate, to regulate the proposed uses 
before they occur.
    2. Proposed Rule. In addition to this Direct Final Rule, elsewhere 
in this issue of the Federal Register, EPA is issuing a Notice of 
Proposed Rulemaking for this rule. If EPA receives no adverse comment, 
the Agency will not take further action on the proposed rule and the 
direct final rule will become effective as provided in this action. If 
EPA receives adverse comment on one or more of SNURs in this action by 
September 26, 2018 (see Unit VI. of the SUPPLEMENTARY INFORMATION), the 
Agency will publish in the Federal Register a timely withdrawal of the 
specific SNURs that the adverse comments pertain to, informing the 
public that the actions will not take effect. EPA would then address 
all adverse public comments in a response to comments document in a 
subsequent final rule, based on the proposed rule.

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

    Section 5(a)(2) of TSCA (15 U.S.C. 2604(a)(2)) authorizes EPA to 
determine that a use of a chemical substance is a ``significant new 
use.'' EPA must make this determination by rule after considering all 
relevant factors, including the four bulleted TSCA section 5(a)(2) 
factors listed in Unit III. Once EPA determines that a use of a 
chemical substance is a significant new use, TSCA section 5(a)(1)(B) 
requires persons to submit a significant new use notice (SNUN) to EPA 
at least 90 days before they manufacture or process the chemical 
substance for that use (15 U.S.C. 2604(a)(1)(B)(i)). TSCA furthermore 
prohibits such manufacturing or processing from commencing until EPA 
has conducted a review of the notice, made an appropriate determination 
on the notice, and taken such actions as are required in association 
with that determination (15 U.S.C. 2604(a)(1)(B)(ii)). As described in 
Unit V., the general SNUR provisions are found at 40 CFR part 721, 
subpart A.

C. Applicability of General Provisions

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

III. Significant New Use Determination

    Section 5(a)(2) of TSCA states that EPA's determination that a use 
of a chemical substance is a significant new use must be made after 
consideration of all relevant factors, including:
    <bullet> The projected volume of manufacturing and processing of a 
chemical substance.
    <bullet> The extent to which a use changes the type or form of 
exposure of human beings or the environment to a chemical substance.
    <bullet> The extent to which a use increases the magnitude and 
duration of exposure of human beings or the environment to a chemical 
substance.
    <bullet> 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 authorizes EPA to consider any other relevant factors.
    To determine what would constitute a significant new use for the 
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 19 chemical substances in 40 CFR part 721, subpart E. 
In this unit, EPA provides the following information for each chemical 
substance:
    <bullet> PMN number.
    <bullet> Chemical name (generic name, if the specific name is 
claimed as CBI).
    <bullet> Chemical Abstracts Service (CAS) Registry number (if 
assigned for non-confidential chemical identities).
    <bullet> Basis for the TSCA section 5(e) Order.
    <bullet> Information identified by EPA that would help characterize 
the potential health and/or environmental effects of the chemical 
substance in support of a request by the PMN submitter to modify the 
Order, or if a manufacturer or processor is considering submitting a 
SNUN for a significant new use designated by the SNUR. This information 
may include testing required in a TSCA section 5(e) Order to be 
conducted by the PMN submitter, as well as testing not required to be 
conducted but which would also help characterize the potential health 
and/or environmental effects of the PMN substance. Any recommendation 
for information identified by EPA was made based on EPA's consideration 
of available screening-level data, if any, as well as other available 
information on appropriate testing for the chemical substance. Further, 
any such testing identified by EPA that includes testing on vertebrates 
was made after consideration of available toxicity information, 
computational toxicology and bioinformatics, and high-throughput 
screening methods and their prediction models. EPA also recognizes that 
whether testing/further information is needed will depend on the 
specific exposure and use scenario in the SNUN. EPA encourages all SNUN 
submitters to contact EPA to discuss any potential

[[Page 43540]]

future testing. See Unit VIII. for more information.
    <bullet> CFR citation assigned in the regulatory text section of 
this rule.
    The regulatory text section of these rules specify the activities 
designated as significant new uses. Certain new uses, including 
exceedance of 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.
    These rules include 19 PMN substances that are subject to Orders 
under TSCA section 5(e)(1)(A)(ii)(I) where EPA determined that it has 
insufficient information to conduct a reasoned evaluation and the 
activities associated with the PMN substances may present unreasonable 
risk to human health or the environment. Those Orders require 
protective measures to limit exposures or otherwise mitigate the 
potential unreasonable risk. The SNURs identify as significant new uses 
any manufacturing, processing, use, distribution in commerce, or 
disposal that does not conform to the restrictions imposed by the 
underlying Orders, consistent with TSCA section 5(f)(4).
    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) 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) Orders, which are 
modeled after Occupational Safety and Health Administration (OSHA) 
Permissible Exposure Limits (PELs) provisions, include requirements 
addressing performance criteria for sampling and analytical methods, 
periodic monitoring, respiratory protection, and recordkeeping. 
However, no comparable NCEL provisions currently exist in 40 CFR part 
721, subpart B, for SNURs. Therefore, for these cases, the individual 
SNURs in 40 CFR part 721, subpart E, will state that persons subject to 
the SNUR who wish to pursue NCELs as an alternative to the Sec.  721.63 
respirator requirements may request to do so under Sec.  
[emsp14]721.30. EPA expects that persons whose Sec.  721.30 requests to 
use the NCELs approach for SNURs that 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) Order for the same 
chemical substance.

PMN Number P-15-719

    Chemical name: Benzene, 1,4-bis(alkyl)-, homopolymer (generic).
    CAS number: Not available.
    Effective date of TSCA section 5(e) Order: July 24, 2017.
    Basis for TSCA section 5(e) Order: The PMN states that the generic 
(non-confidential) use of the substance will be as a flame retardant 
synergist and radical source. Based on test data and analog data EPA 
estimates that the PMN substances will persist in the environment for 
more than two months and estimates a bioaccumulation factor of greater 
than or equal to 1,000. Because the PMN substance is expected to be 
persistent and bioaccumulative, EPA is unable to assess the potential 
risks to sediment dwelling organisms. The Order was issued under TSCA 
sections 5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), as well as 
5(a)(3)(B)(i) and 5(e)(1)(A)(i) based on findings that the substance 
may present an unreasonable risk of injury to health and the 
environment, and that the information available to the Agency is 
insufficient to permit a reasoned evaluation of the environmental 
effects of the PMN substance. To protect against potential risks, the 
Order requires:
    1. Submit to EPA certain toxicity testing prior to exceeding the 
confidential production volume limits specified in the Order;
    2. Label containers of the substance and provide Safety Data Sheets 
(SDS) or Material Safety Data Sheets (MSDS) and worker training in 
accordance with the provisions of the Hazard Communication Program 
section;
    3. Not use the substance other than for the confidential uses 
allowed in the Order;
    4. Dispose of the substance only by incineration or landfill; and
    5. Comply with the release to water provisions.
    The SNUR designates as a ``significant new use'' the absence of 
these protective measures.
    Potentially useful information: EPA has determined that certain 
information about the environmental fate, bioaccumulation, and 
environmental toxicity of the PMN substance may be potentially useful 
to characterize the effects of the PMN substance in support of a 
request by the PMN submitter to modify the Order, or if a manufacturer 
or processor is considering submitting a SNUN for a significant new use 
that will be designated by this SNUR. The submitter has agreed not to 
exceed the confidential production limit without performing specific 
aquatic toxicity, bioaccumulation and environmental fate testing.
    CFR citation: 40 CFR 721.11097.

PMN Number P-16-99

    Chemical name: Polyethylene glycol polymer with aliphatic 
polycarbodiimide Bis(alkoxysilylpropyl) amine blocked (generic).
    CAS number: Not available.
    Effective date of TSCA section 5(e) Order: June 30, 2017.
    Basis for TSCA section 5(e) Order: The PMN states that the generic 
(non-confidential) use of the substance will be as an additive for 
industrial coatings. EPA identified concerns for irritation to all 
issues and lung toxicity based on SAR analysis of test data on 
analogous alkoxysilanes and concerns for acute toxicity, neurotoxicity 
(especially to the eye), and liver, kidney, and cardiac toxicity based 
on the release of methanol. 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 health and the 
environment. To protect against potential risks, the Order requires:
    1. Submission to EPA of certain toxicity testing prior to exceeding 
the confidential aggregate production volume limit specified in the 
Order;
    2. Use of personal protective equipment to prevent dermal exposure 
(where there is a potential for dermal exposure);
    3. Use of a National Institute for Occupational Safety and Health 
(NIOSH)-certified respirator with an Applied Protection Factor (APF) of 
at least 10 (where there is a potential for inhalation exposure) or 
compliance with a New Chemicals Exposure Limit (NCEL) of 0.9 milligrams 
per cubic meter as an 8-hour time-weighted average to prevent 
inhalation exposure. (EPA's estimates indicate that variations of the 
parameters (including batch size, number of processing sites, days per 
year of operation) of the uses identified below would not result in 
inhalation exposure that would indicate a different respirator.)
    4. Establishment and use of a hazard communication program, 
including precautionary statements on each label and in the SDS.
    5. Not use the substance other than for the use allowed in the 
Order in commercial use (as that term is defined in 40 CFR 721.3) but 
without any use in

[[Page 43541]]

a consumer setting (as that term is defined in 40 CFR 721.3);
    6. Not exceed the confidential annual production volume limit in 
the Order; and
    7. No manufacture of the substance where there is more than 0.2% 
residual isocyanate.
    The SNUR designates as a ``significant new use'' the absence of 
these protective measures.
    Potentially useful information: EPA has determined that certain 
information about the toxicity of the PMN substance may be potentially 
useful to characterize the health effects of the PMN substance in 
support of a request by the PMN submitter to modify the Order, or if a 
manufacturer or processor is considering submitting a SNUN for a 
significant new use that will be designated by this SNUR. The submitter 
has agreed not to exceed the confidential production limit without 
performing specific pulmonary and internal organ toxicity testing.
    CFR citation: 40 CFR 721.11098.

PMN Number P-16-221

    Chemical name: Fluorinated organopolysilazane (generic).
    CAS number: Not available.
    Effective date of TSCA section 5(e) Order: June 20, 2017.
    Basis for TSCA section 5(e) Order: The PMN states that the 
substance will be used as a coating agent for optical lenses. EPA 
identified human health and environmental concerns because the 
potential degradation products of the PMN substance may be persistent, 
bioaccumulative, and toxic (PBT) chemicals. EPA estimates that the PMN 
substance degradation products will persist in the environment for more 
than two months and estimates a bioaccumulation factor of greater than 
or equal to 1,000. EPA also identified concerns for liver toxicity, 
blood toxicity, male reproductive toxicity, and toxicity to aquatic 
organisms, terrestrial mammals and birds based on data for the PMN 
substance degradation product. 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 health and the 
environment. To protect against potential risks, the Order requires:
    1. Submission to EPA of certain toxicity testing before exceeding a 
total production volume of 204 kilograms, as specified in the Order;
    2. Use of personal protective equipment to prevent dermal exposure 
(where there is a potential for dermal exposures);
    3. No use of the substance other than allowed by the Order which is 
the confidential coating system described in the PMN;
    4. Manufacture not to exceed an annual manufacture volume of 100 
kilograms;
    5. Refrain from domestic manufacture in the United States (i.e., 
import only); and
    6. No release of the PMN substance to surface waters.
    The SNUR designates as a ``significant new use'' the absence of 
these protective measures.
    Potentially useful information: EPA has determined that certain 
information about the toxicity of the PMN substance may be potentially 
useful to characterize the health effects of the PMN substance in 
support of a request by the PMN submitter to modify the Order, or if a 
manufacturer or processor is considering submitting a SNUN for a 
significant new use that will be designated by this SNUR. The submitter 
has agreed not to exceed the production limit in the Order without 
performing specific internal organ toxicity testing on the degradation 
product of the PMN substance. In addition, EPA has determined that the 
results of specific organ toxicity on degradations products of the PMN 
substance may be potentially useful in characterizing the health 
effects of the PMN substance. Although the Order does not require this 
additional testing, the Order's restrictions on manufacture, 
processing, distribution in commerce, use, and disposal will remain in 
effect until the Order is modified or revoked by EPA based on 
submission of this or other information that EPA determines is relevant 
and needed to evaluate a modification request.
    CFR citation: 40 CFR 721.11099.

PMN Number P-16-359

    Chemical name: Carbopolycycle-bis(diazonium), dihalo-, chloride 
(1:2), reaction products with metal hydroxide, 4-
[(dioxoalkyl)amino]substituted benzene, 2-
[(dioxoalkyl)amino]substituted benzene, 5-[(dioxoalkyl)amino]-2-
hydroxy-substituted benzene and oxo-n-phenylalkanamide (generic).
    CAS number: Not available.
    Effective date of TSCA section 5(e) Order: June 20, 2017.
    Basis for TSCA section 5(e) Order: The PMN states that the generic 
(non-confidential) use of the substance will be as a pigment additive 
for industrial coatings. EPA identified concerns for oncogenicity and 
mutagenicity for the PMN substance degradation product. 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 health and the environment. To protect against potential 
risks, the Order requires:
    1. Submission to EPA of certain toxicity testing before exceeding 
the confidential production volume limit specified in the Order;
    2. Use of personal protective equipment to prevent dermal exposure 
(where there is a potential for inhalation exposures);
    3. Establishment and use of a hazard communication program, 
including precautionary statements on each label and in SDS;
    4. No processing or use of the substance at temperatures greater 
than 200 degrees Celsius; and
    5. No domestic manufacture of the substance.
    The SNUR designates as a ``significant new use'' the absence of 
these protective measures.
    Potentially useful information: EPA has determined that certain 
information about the fate and biodegradability of the PMN substance 
may be potentially useful to characterize the health effects of the PMN 
substance in support of a request by the PMN submitter to modify the 
Order, or if a manufacturer or processor is considering submitting a 
SNUN for a significant new use that will be designated by this SNUR. 
The submitter has agreed not to exceed the production limit in the 
Order without performing specific biodegradability and photolysis 
tests.
    CFR citation: 40 CFR 721.11100.

PMN Number P-16-363

    Chemical name: Blocked polyester polyurethane, neutralized 
(generic).
    CAS number: Not available.
    Effective date of TSCA section 5(e) Order: June 20, 2017.
    Basis for TSCA section 5(e) Order: The PMN states that the generic 
(non-confidential) use of the substance will be an open non-dispersive 
use. EPA identified concerns for irritation, sensitization, and lung 
toxicity based on analogy to diisocyanates and cationic binding to lung 
tissue. 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 
potential risks, the Order requires:
    1. Use personal protective equipment to prevent dermal exposure 
(where there is a potential for dermal exposures);
    2. Establishment and use of a hazard communication program, 
including

[[Page 43542]]

precautionary statements on each label and in the SDS;
    3. Manufacture (including import) the substance with a residual of 
free isocyanate monomers no greater than 0.1% by weight;
    4. Refraining from manufacture, processing, or use activities if it 
results in inhalation exposure to vapor, dust, mist or aerosols;
    5. Refraining from manufacture, processing, or use for consumer use 
or in commercial use (as that term is defined in 40 CFR 721.3) where 
there is use in a consumer setting (as that term is defined in 40 CFR 
721.3); and
    6. Manufacture, process, or use the substance only in an aqueous 
formulation.
    The SNUR designates as a ``significant new use'' the absence of 
these protective measures.
    Potentially useful information: EPA has determined that certain 
information about the toxicity of the PMN substance may be potentially 
useful to characterize the health effects of the PMN substance in 
support of a request by the PMN submitter to modify the Order, or if a 
manufacturer or processor is considering submitting a SNUN for a 
significant new use that will be designated by this SNUR. EPA has 
determined that the results of specific target organ toxicity testing 
and a sensitization test of the PMN substance may be potentially useful 
in characterizing the health effects of the PMN substance. Although the 
Order does not require these tests, the Order's restrictions on 
manufacture, processing, use, 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 information that EPA determines is 
relevant and needed to evaluate a modification request.
    CFR citation: 40 CFR 721.11101.

PMN Number P-16-370

    Chemical name: Methoxy-terminated polysiloxane (generic).
    CAS number: Not available.
    Effective date of TSCA section 5(e) Order: July 18, 2017.
    Basis for TSCA section 5(e) Order: The PMN states that the generic 
(non-confidential) use of the substance will be as a crosslinker for 
adhesives and coatings. EPA identified concerns for irritation to the 
skin, eyes, lung, and mucous membranes and other lung effects on 
analogy to alkoxysilanes. 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 potential risks, the Order requires:
    1. Submission to EPA of certain toxicity testing before exceeding 
the confidential production volume limit specified in the Order;
    2. Use of personal protective equipment to prevent dermal exposure 
(where there is a potential for dermal exposures);
    3. Establishment and use of a hazard communication program, 
including precautionary statements on each label and in the SDS;
    4. Use of a NIOSH-certified respirator with an APF of at least 10 
(where there is a potential for inhalation exposures) or compliance 
with a NCEL of 8.4 milligrams per cubic meter as an 8-hour time-
weighted average to prevent inhalation exposure. (EPA's estimates 
indicate that variations of the parameters (including batch size, 
number of processing sites, days per year of operation) of the uses 
identified below would not result in inhalation exposure that would 
indicate a different respirator.)
    5. Refraining from modifying the manufacture, processing, or use 
activities if it results in inhalation exposure to vapor, dust, mist or 
aerosols; and
    6. Refraining from manufacture, processing, or use for consumer use 
or in commercial use (as that term is defined in 40 CFR 721.3) where 
there is use in a consumer setting (as that term is defined in 40 CFR 
721.3).
    The SNUR designates as a ``significant new use'' the absence of 
these protective measures.
    Potentially Useful Information: EPA has determined that certain 
information about the toxicity of the PMN substance may be potentially 
useful to characterize the health effects of the PMN substance in 
support of a request by the PMN submitter to modify the Order, or if a 
manufacturer or processor is considering submitting a SNUN for a 
significant new use that will be designated by this SNUR. The submitter 
has agreed not to exceed the production limit in the Order without 
performing specific pulmonary toxicity testing.
    CFR citation: 40 CFR 721.11103.

PMN Number P-16-376

    Chemical name: Hydroxystyrene resin (generic).
    CAS number: Not available.
    Effective date of TSCA section 5(e) Order: June 16, 2017.
    Basis for TSCA section 5(e) Order: The PMN states that the generic 
(non-confidential) use of the substance will be for photolithography. 
EPA identified potential health and environmental toxicity if the PMN 
substance is manufactured at a lower molecular weight. 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 health and the environment. To protect against potential 
risks, the Order requires manufacture of the substance at an average 
molecular weight greater than 2906 daltons and with 0.5 percent low 
weight molecular species less than 500 daltons and 1.0 percent low 
weight molecular species less than 1,000 daltons.
    The SNUR designates as a ``significant new use'' the absence of 
this protective measure.
    Potentially useful information: EPA has determined that certain 
information about the physical-chemical properties and toxicity of the 
PMN substance may be potentially useful to characterize the health and 
environmental effects of the PMN substance in support of a request by 
the PMN submitter to modify the Order, or if a manufacturer or 
processor is considering submitting a SNUN for a significant new use 
that will be designated by this SNUR. EPA has determined that the 
results of physical-chemical property tests, internal organ effects 
testing, and aquatic toxicity tests may be potentially useful in 
characterizing the health and environmental effects of the PMN 
substance. Although the Order does not require this testing, the 
Order's restrictions on manufacture, processing, distribution in 
commerce, use, and disposal will remain in effect until the Order is 
modified or revoked by EPA based on submission of this or other 
information that EPA determines is relevant and needed to evaluate a 
modification request
    CFR citation: 40 CFR 721.11104.

PMN Number P-16-487

    Chemical name: Benzenesulfonic acid 1,2-diazenediylbis[6-ethenyl]-
3-sulfophenyl diazenyl-2-sulfophenyl ethenyl salt (generic).
    CAS number: Not available.
    Effective date of TSCA section 5(e) Order: June 27, 2017.
    Basis for TSCA section 5(e) Order: The PMN states that the 
substance will be used as a yellow dye for paper. EPA identified 
concerns for developmental, reproductive, liver, kidney, and blood 
toxicity based for the azo reduction products of the substance based on 
analogue data. Based on SAR analysis for acid dyes, EPA predicts 
toxicity to aquatic organisms may occur at concentrations that exceed 
55 parts per billion (ppb) in surface waters. The

[[Page 43543]]

Order was issued under TSCA sections 5(a)(3)(B)(ii)(I) and 
5(e)(1)(A)(ii)(I), as well as 5(a)(3)(B)(ii)(II) and 
5(e)(1)(A)(ii)(II), based on a finding that the substance may present 
an unreasonable risk of injury to health and the environment and that 
the substance is or will be produced in substantial quantities and 
there is or may be significant (substantial) human exposure to the 
substance. To protect against potential risks, the Order requires:
    1. Submission to EPA of certain toxicity testing before exceeding 
the confidential production volume limits specified in the Order;
    2. Use of personal protective equipment to prevent dermal exposure 
(where there is a potential for dermal exposures);
    3. Establishment and use of a hazard communication program, 
including precautionary statements on each label and in the SDS;
    4. No manufacture of the substance in the United States (i.e. 
import only);
    5. Import the substance only as a solution;
    6. No use of the substance other than for the confidential uses 
allowed in the Order; and
    7. Not release the substance in surface waters resulting in 
concentrations that exceed 55 ppb.
    The SNUR designates as a ``significant new use'' the absence of 
these protective measures.
    Potentially useful information: EPA has determined that certain 
information about the fate and toxicity of the PMN substance may be 
potentially useful to characterize the health and environmental effects 
of the PMN substance in support of a request by the PMN submitter to 
modify the Order, or if a manufacturer or processor is considering 
submitting a SNUN for a significant new use that will be designated by 
this SNUR. The submitter has agreed not to exceed the production limit 
in the Order without performing specific photolysis, internal organ 
effects, reproductive/developmental toxicity, and aquatic toxicity 
tests.
    CFR citation: 40 CFR 721.11105.

PMN Number P-16-533

    Chemical name: Ethanaminium, alkyl-, salt with triazole (generic).
    CAS number: Not available.
    Effective date of TSCA section 5(e) Order: July 24, 2017.
    Basis for TSCA section 5(e) Order: The PMN states that the generic 
(non-confidential) use of the substance will be as a cleaning agent for 
electronics manufacture. EPA identified concerns for neurotoxicity, 
developmental and reproductive toxicity, irritation, corrosion, 
sensitization, and carcinogenicity based on analogy to benzotriazole 
and quaternary amines. Based on SAR analysis of test data on analogous 
benzotriazoles, EPA predicts toxicity to aquatic organisms may occur at 
concentrations that exceed 570 ppb 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 health and the environment. To protect against potential 
risks, the Order requires:
    1. Submission to EPA of certain toxicity testing before exceeding 
the confidential production volume limits specified in the Order;
    2. Use of personal protective equipment to prevent dermal exposure 
(where there is a potential for dermal exposure);
    3. Establishment and use of a hazard communication program, 
including precautionary statements on each label and in the SDS;
    4. Refrain from manufacture, process or use activities that result 
in inhalation exposure to vapor, dust, mist or aerosols;
    5. No use other than confidential use allowed by the Order; and
    6. No release of the substance to surface waters.
    The SNUR designates as a ``significant new use'' the absence of 
these protective measures.
    Potentially useful information: EPA has determined that certain 
information about the toxicity of the PMN substance may be potentially 
useful to characterize the health and environmental effects of the PMN 
substance in support of a request by the PMN submitter to modify the 
Order, or if a manufacturer or processor is considering submitting a 
SNUN for a significant new use that will be designated by this SNUR. 
The submitter has agreed not to exceed the production limit in the 
Order without performing specific internal organ effects testing of the 
PMN substance. In addition, EPA has determined that the results of 
acute and chronic aquatic toxicity testing may be potentially useful in 
characterizing the environmental effects of the PMN substance. Although 
the Order does not require this additional testing, the Order's 
restrictions on manufacture, processing, distribution in commerce, use, 
and disposal will remain in effect until the Order is modified or 
revoked by EPA based on submission of this or other information that 
EPA determines is relevant and needed to evaluate a modification 
request.
    CFR citation: 40 CFR 721.11105.

PMN Number P-16-595

    Chemical name: Substituted-(hydroxyalkyl)-alkyl-alkanoic acid, 
hydroxy-(substitutedalkyl)-alkyl-, polymer with alpha-hydro-omega-
hydroxypoly[oxy (alkylethanediyl)] and isocyanato-(isocyanatoalkyl)-
multialkylcycloalkane, salt, alkanol-blocked, compds. (generic).
    CAS number: Not available.
    Effective date of TSCA section 5(e) Order: June 27, 2017.
    Basis for TSCA section 5(e) Order: The PMN states that the generic 
(non-confidential) use of the substance will be as a polymer. EPA 
identified concerns for irritation to skin, eyes, and lung, kidney and 
developmental effects based on functional groups present as part of the 
PMN structure. Based on SAR analysis of test data on analogous 
polyanionic polymers, EPA identified potential environmental toxicity 
if the substance is produced with a different average molecular weight 
or proportion of repeating units. 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 health 
and the environment. To protect against potential risks, the Order 
requires:
    1. No manufacture of the substance in the United States (i.e. 
import only);
    2. Import of the substance under the confidential conditions 
required by the Order;
    3. No use of the substance other than as the confidential use 
allowed described in the Order; and
    4. No release of the substance to surface waters.
    The SNUR designates as a ``significant new use'' the absence of 
these protective measures.
    Potentially useful information: EPA has determined that certain 
information about the physical-chemical properties and toxicity of the 
PMN substance may be potentially useful to characterize the health and 
environmental effects of the PMN substance in support of a request by 
the PMN submitter to modify the Order, or if a manufacturer or 
processor is considering submitting a SNUN for a significant new use 
that will be designated by this SNUR. EPA has determined that the 
results of physical-chemical property measurements, acute toxicity 
tests, and acute and chronic aquatic toxicity tests may be potentially 
useful in characterizing the health and environmental effects of the 
PMN substance. Although the Order does not require this additional 
testing, the Order's restrictions on manufacture, processing, 
distribution in commerce, use, and disposal will remain in effect

[[Page 43544]]

until the Order is modified or revoked by EPA based on submission of 
this or other information that EPA determines is relevant and needed to 
evaluate a modification request.
    CFR citation: 40 CFR 721.11106.

PMN Number P-17-170

    Chemical name: Alkanediol, 2,2-bis (substituted alkyl)- polymer 
with substituted alkane, heteromonocycles, alkenoate (generic).
    CAS number: Not available.
    Effective date of TSCA section 5(e) Order: July 12, 2017.
    Basis for TSCA section 5(e) Order: The PMN states that the 
substance will be used as an ultraviolet curable coating resin for 
three-dimensional printing applications. EPA identified concerns for 
oncogenicity, developmental toxicity, liver and kidney effects, 
sensitization, and irritation based on analogy to acrylates. EPA also 
identified additional human health concerns and environmental toxicity 
concerns if the polymer is made differently than described in the PMN. 
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 health and the environment. To protect 
against potential risks, the Order requires:
    1. Submission to EPA of certain toxicity testing before exceeding 
the aggregate production volume limit of 105,000 kilograms specified in 
the Order;
    2. Use of personal protective equipment to prevent dermal exposure 
including gloves (where there is a potential for dermal exposures);
    3. Establishment and use of a hazard communication program, 
including precautionary statements on each label and in the SDS;
    4. Refrain from manufacture, process or use activities that result 
in inhalation exposure to vapor, dust, mist or aerosols;
    5. No use other than as an ultraviolet curable coating resin for 
three-dimensional printing applications;
    6. Manufacture of the substance with no greater than 0.1% residual 
isocyanate; and
    7. Manufacture of the substance with an average molecular weight 
greater than 1,000 daltons.
    The SNUR designates as a ``significant new use'' the absence of 
these protective measures.
    Potentially useful information: EPA has determined that certain 
information about the physical-chemical properties and toxicity of the 
PMN substance may be potentially useful to characterize the health and 
environmental effects of the PMN substance in support of a request by 
the PMN submitter to modify the Order, or if a manufacturer or 
processor is considering submitting a SNUN for a significant new use 
that will be designated by this SNUR. The submitter has agreed not to 
exceed the production limit in the Order without performing specific 
mutagenicity and sensitization testing of the PMN substance. In 
addition, EPA has determined that the results of physical-chemical 
property measurements, internal organ toxicity tests, and acute and 
chronic aquatic toxicity tests may be potentially useful in 
characterizing the environmental effects of the PMN substance. Although 
the Order does not require this additional testing, the Order's 
restrictions on manufacture, processing, distribution in commerce, use, 
and disposal will remain in effect until the Order is modified or 
revoked by EPA based on submission of this or other information that 
EPA determines is relevant and needed to evaluate a modification 
request.
    CFR citation: 40 CFR 721.11107.

PMN Number P-17-172

    Chemical name: Sulfurized alkylphenol, calcium salts (generic).
    CAS number: Not available.
    Effective date of TSCA section 5(e) Order: June 19, 2017.
    Basis for TSCA section 5(e) Order: The PMN states that the generic 
(non-confidential) use of the substance will be as a lubricating oil 
additive. EPA identified concerns for lung toxicity based on submitted 
test data and data for analogous chemicals. The Order was issued under 
TSCA sections 5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), as well as 
5(a)(3)(B)(ii)(II) and 5(e)(1)(A)(ii)(II), based on a finding that the 
substance may present an unreasonable risk of injury to human health 
and the environment, and the substance is or will be produced in 
substantial quantities and there is or may be significant (substantial) 
human exposure to the substance. To protect against potential risks, 
the Order requires:
    1. Refrain from manufacture, process or use activities that result 
in inhalation exposure to vapor, dust, mist or aerosols; and
    2. No use other than the confidential use allowed by the Order;
    The SNUR designates as a ``significant new use'' the absence of 
these protective measures.
    Potentially useful information: EPA has determined that certain 
information about the toxicity of the PMN substance may be potentially 
useful to characterize the health effects of the PMN substance in 
support of a request by the PMN submitter to modify the Order, or if a 
manufacturer or processor is considering submitting a SNUN for a 
significant new use that will be designated by this SNUR. EPA has 
determined that the results of pulmonary effects testing may be 
potentially useful in characterizing the health effects of the PMN 
substance. Although the Order does not require this additional testing, 
the Order's restrictions on manufacture, processing, distribution in 
commerce, use, and disposal will remain in effect until the Order is 
modified or revoked by EPA based on submission of this or other 
information that EPA determines is relevant and needed to evaluate a 
modification request.
    CFR citation: 40 CFR 721.11108.

PMN Number P-17-177

    Chemical name: Monoheteropentacycloalkane-4-carboxylic acid, 
substituted cyclo-alkyl ester (generic).
    CAS number: Not available.
    Effective date of TSCA section 5(e) Order: July 28, 2017.
    Basis for TSCA section 5(e) Order: The PMN states that the generic 
(non-confidential) use of the substance will be for microlithography 
for electronic device manufacturing. EPA identified human health and 
environmental concerns because the substance may be persistent, 
bioaccumulative, and toxic (PBT) chemicals. EPA estimates that the 
substance will persist in the environment for more than two months and 
estimates a bioaccumulation factor of greater than or equal to 1,000. 
EPA identified concerns for oncogenicity, developmental toxicity, liver 
and kidney effects, sensitization, and irritation based on data for 
analogous chemicals. Based on SAR estimates for esters and other 
analogous chemicals. EPA predicts toxicity to aquatic organisms may 
occur at concentrations that exceed 2 ppb 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 health and the environment. To protect against potential 
risks, the Order requires:
    1. Use of personal protective equipment to prevent dermal exposure 
(where there is a potential for dermal exposures);
    2. Establishment and use of a hazard communication program, 
including precautionary statements on each label and in the SDS;

[[Page 43545]]

    3. No manufacture of the substance in the United States (i.e. 
import only);
    4. No use other than the confidential use allowed by the Order;
    5. No exceedance of the confidential annual production volume limit 
in the Order; and
    6. No release of the substance to surface waters.
    The SNUR designates as a ``significant new use'' the absence of 
these protective measures.
    Potentially useful information: EPA has determined that certain 
information about the fate and toxicity of the PMN substance may be 
potentially useful to characterize the health and environmental effects 
of the PMN substance in support of a request by the PMN submitter to 
modify the Order, or if a manufacturer or processor is considering 
submitting a SNUN for a significant new use that will be designated by 
this SNUR. EPA has determined that the results of acute toxicity, 
mutagenicity, sensitization, internal organ toxicity, reproductive/
developmental toxicity, biodegradation, bioconcentration, and acute and 
chronic aquatic toxicity testing may be potentially useful in 
characterizing the health and environmental effects of the PMN 
substance. Although the Order does not require this additional testing, 
the Order's restrictions on manufacture, processing, distribution in 
commerce, use, and disposal will remain in effect until the Order is 
modified or revoked by EPA based on submission of this or other 
information that EPA determines is relevant and needed to evaluate a 
modification request.
    CFR citation: 40 CFR 721.11109.

PMN Number P-17-179

    Chemical name: Modified carboxypolyamine salt (generic).
    CAS number: Not available.
    Effective date of TSCA section 5(e) Order: July 31, 2017.
    Basis for TSCA section 5(e) Order: The PMN states that the 
substance will be used as a dispersive additive for pigments in 
industrial paints and coatings. EPA identified concerns for skin 
irritation and lung toxicity based on cationic binding properties. 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 health and the environment. To protect 
against potential risks, the Order requires:
    1. Submission to EPA of certain toxicity testing before excceding 
the confidential production volume limit specified in the Order;
    2. Use of personal protective equipment to prevent dermal exposure 
(where there is a potential for dermal exposures);
    3. Establishment and use of a hazard communication program, 
including precautionary statements on each label and in the SDS;
    4. Refrain from manufacture, process or use activities that result 
in inhalation exposure to vapor, dust, mist or aerosols;
    5. No use other than a dispersive additive for pigments in 
industrial paints and coatings;
    6. No processing or use of the substance in a paint or coating 
formulation greater than 1% by weight or volume; and
    7. No manufacture of the substance in the United States (i.e. 
import only).
    The SNUR designates as a ``significant new use'' the absence of 
these protective measures.
    Potentially useful information: EPA has determined that certain 
information about the toxicity of the PMN substance may be potentially 
useful to characterize the health effects of the PMN substance in 
support of a request by the PMN submitter to modify the Order, or if a 
manufacturer or processor is considering submitting a SNUN for a 
significant new use that will be designated by this SNUR. The submitter 
has agreed not to exceed the production limit in the Order without 
performing specific pulmonary effects testing of the PMN substance.
    CFR citation: 40 CFR 721.11110.

PMN Number P-17-222

    Chemical name: 1, 3,5-Triazine-2,4-diamine, 6-phenyl-, reaction 
products with polyalkylene glycol mono- alkyl ether and 2,4-toluene 
diisocyanate (generic).
    CAS number: Not available.
    Effective date of TSCA section 5(e) Order: July 28, 2017.
    Basis for TSCA section 5(e) Order: The PMN states that the generic 
(non-confidential) use of the substance will be as an additive open 
non-dispersive use. EPA identified concerns for dermal sensitization, 
respiratory sensitization, lung effects, neurotoxicity, and 
developmental toxicity based on the potential for residual 
diisocyanates. 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 health and the 
environment. To protect against potential risks, the Order requires:
    1. Refrain from manufacture, process or use activities that result 
in inhalation exposure to vapor, dust, mist or aerosols;
    2. Not sell the substance for ``consumer use'' or for ``commercial 
uses'' (as the term is defined at 40 CFR 721.3) when the ``saleable 
goods or service'' could introduce the material into a ``consumer'' 
setting (as that term is defined in 40 CFR 721.3);
    3. Use the substance only in a formulation for the use allowed in 
the Order with isocyanate residuals not greater than 0.1 percent by 
weight or volume; and
    4. Import the substance where there is no more than 0.15% residual 
toluene isocyanate.
    The SNUR designates as a ``significant new use'' the absence of 
these protective measures.
    Potentially useful information: EPA has determined that certain 
information about the toxicity of the PMN substance may be potentially 
useful to characterize the health effects of the PMN substance in 
support of a request by the PMN submitter to modify the Order, or if a 
manufacturer or processor is considering submitting a SNUN for a 
significant new use that will be designated by this SNUR. EPA has 
determined that the results of a sensitization test and pulmonary 
effects test may be potentially useful in characterizing the health 
effects of the PMN substance. Although the Order does not require this 
additional testing, the Order's restrictions on manufacture, 
processing, distribution in commerce, use, and disposal will remain in 
effect until the Order is modified or revoked by EPA based on 
submission of this or other information that EPA determines is relevant 
and needed to evaluate a modification request.
    CFR citation: 40 CFR 721.11111.

PMN Number P-17-231

    Chemical name: Fatty acids, polymers with benzoic acid, 
cyclohexanedicarboxylic acid anhydride, aliphatic diisocyanate, alkyl 
diol, alkyl triol, pentaerythritol, phthalic anhydride, polyalkylene 
glycol amine, and aromatic dicarboxylate sulfonic acid sodium salt 
(generic).
    CAS number: Not available.
    Effective date of TSCA section 5(e) Order: July 20, 2017.
    Basis for TSCA section 5(e) Order: The PMN states that the generic 
(non-confidential) use of the substance will be as a paint, stain, or 
primer coating. EPA identified concerns for dermal sensitization, 
respiratory sensitization, lung effects, neurotoxicity, and 
developmental toxicity based on the potential for residual 
diisocyanates. The Order was issued under TSCA sections

[[Page 43546]]

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 health and the 
environment.
    To protect against potential risks, the Order requires:
    1. Manufacture of the substance where there is no more than 0.1% 
residual isocyanate.
    The SNUR designates as a ``significant new use'' the absence of 
these protective measures.
    Potentially useful information: EPA has determined that certain 
information about the toxicity of the PMN substance may be potentially 
useful to characterize the health effects of the PMN substance in 
support of a request by the PMN submitter to modify the Order, or if a 
manufacturer or processor is considering submitting a SNUN for a 
significant new use that will be designated by this SNUR. EPA has 
determined that the results of a sensitization test and a pulmonary 
effects test may be potentially useful in characterizing the health 
effects of the PMN substance. Although the Order does not require this 
additional testing, the Order's restrictions on manufacture, 
processing, distribution in commerce, use, and disposal will remain in 
effect until the Order is modified or revoked by EPA based on 
submission of this or other information that EPA determines is relevant 
and needed to evaluate a modification request.
    CFR citation: 40 CFR 721.11112.

PMN Numbers P-17-247 and P-17-248

    Chemical names: Branched alkyl (C=17) carboxylic acid (generic) (P-
17-247) and branched alkyl (C=18) alcohol (generic) (P-17-248).
    CAS numbers: Not available.
    Effective date of TSCA section 5(e) Order: June 29, 2017.
    Basis for TSCA section 5(e) Order: The PMNs state that the generic 
(non-confidential) use of the substances will be as chemical raw 
materials. EPA identified human health and environmental concerns 
because the substances may be persistent, bioaccumulative, and toxic 
(PBT) chemicals. EPA estimates that the substances will persist in the 
environment for more than two months and estimates a bioaccumulation 
factor of greater than or equal to 1,000. Based on analogue data EPA 
identified concerns for developmental toxicity, liver, kidney, and 
thyroid effects, dermal sensitization, and irritation. Based on SAR 
estimates for neutral organic chemicals, EPA predicts toxicity to 
aquatic organisms may occur at concentrations that exceed 1 ppb 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 health and the 
environment. To protect against potential risks, the Order requires:
    1. Submission to EPA of certain toxicity testing before exceeding 
the confidential production volume limit specified in the Order;
    2. Use of personal protective equipment to prevent dermal exposure 
(where there is a potential for dermal exposures);
    3. Establishment and use of a hazard communication program, 
including precautionary statements on each label and in the SDS;
    4. Refrain from manufacture, process or use activities that result 
in inhalation exposure to vapor, dust, mist or aerosols;
    5. No use other than as a chemical intermediate;
    6. No manufacture of the substances in the United States (i.e. 
import only); and
    7. No release of the substances to surface waters.
    The SNUR designates as a ``significant new use'' the absence of 
these protective measures.
    Potentially useful information: EPA has determined that certain 
information about the bioaccumulation and toxicity of the PMN substance 
may be potentially useful to characterize the health and environmental 
effects of the PMN substance in support of a request by the PMN 
submitter to modify the Order, or if a manufacturer or processor is 
considering submitting a SNUN for a significant new use that will be 
designated by this SNUR. The submitter has agreed not to exceed the 
production limit in the Order without performing specific 
sensitization, internal organ effect, and reproductive/developmental 
testing of the PMN substances. In addition, EPA has determined that the 
results of acute aquatic toxicity and bioaccumulation testing may be 
potentially useful in characterizing the environmental and health 
effects of the PMN substances. Although the Order does not require this 
additional testing, the Order's restrictions on manufacture, 
processing, distribution in commerce, use, and disposal will remain in 
effect until the Order is modified or revoked by EPA based on 
submission of this or other information that EPA determines is relevant 
and needed to evaluate a modification request.
    CFR citations: 40 CFR 721.11113 P-17-247 and 40 CFR 721.11114 P-17-
248.

PMN Number P-17-260

    Chemical name: Alkoxy silane modified butadiene styrene copolymer 
(generic).
    CAS number: Not available.
    Effective date of TSCA section 5(e) Order: July 10, 2017.
    Basis for TSCA section 5(e) Order: The PMN states that the generic 
(non-confidential) use of the substance will be as a resin modifier. 
EPA identified concerns for lung effects based on test data for the 
substance and data for analogous alkoxysilane non-ionic polymers. 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 
potential risks, the Order requires:
    1. Refrain from manufacture, process or use activities that result 
in inhalation exposure to vapor, dust, mist or aerosols; and
    2. No use other than the confidential use allowed by the Order;
    The SNUR designates as a ``significant new use'' the absence of 
these protective measures.
    Potentially useful information: EPA has determined that certain 
information about the toxicity of the PMN substance may be potentially 
useful to characterize the health effects of the PMN substance in 
support of a request by the PMN submitter to modify the Order, or if a 
manufacturer or processor is considering submitting a SNUN for a 
significant new use that will be designated by this SNUR. EPA has 
determined that the results of pulmonary effects test may be 
potentially useful in characterizing the health effects of the PMN 
substance. Although the Order does not require this additional testing, 
the Order's restrictions on manufacture, processing, distribution in 
commerce, use, and disposal will remain in effect until the Order is 
modified or revoked by EPA based on submission of this or other 
information that EPA determines is relevant and needed to evaluate a 
modification request.
    CFR citation: 40 CFR 721.11115.

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 19 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

[[Page 43547]]

substances. The basis for such findings is outlined in Unit IV. Based 
on these findings, TSCA section 5(e) Orders requiring the use of 
appropriate exposure controls were negotiated with the PMN submitters.
    The SNURs identify as significant new uses any manufacturing, 
processing, use, distribution in commerce, or disposal that does not 
conform to the restrictions imposed by the underlying Orders, 
consistent with TSCA section 5(f)(4).

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:
    <bullet> EPA will receive notice of any person's intent to 
manufacture or process a listed chemical substance for the described 
significant new use before that activity begins.
    <bullet> 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.
    <bullet> EPA will be able to either determine that the prospective 
manufacture or processing is not likely to present an unreasonable 
risk, or to take necessary regulatory action associated with any other 
determination, before the described significant new use of the chemical 
substance occurs.
    <bullet> EPA will identify as significant new uses any 
manufacturing, processing, use, distribution in commerce, or disposal 
that does not conform to the restrictions imposed by the underlying 
Orders, consistent with TSCA section 5(f)(4).
    Issuance of a SNUR for a chemical substance does not signify that 
the chemical substance is listed on the TSCA Chemical Substance 
Inventory (TSCA Inventory). Guidance on how to determine if a chemical 
substance is on the TSCA Inventory is available on the internet at 
http://www.epa.gov/opptintr/existingchemicals/pubs/tscainventory/index.html.

VI. Direct Final Procedures

    EPA is issuing these SNURs as a direct final rule. The effective 
date of this rule is October 26, 2018 without further notice, unless 
EPA receives written adverse comments before September 26, 2018.
    If EPA receives written adverse comments on one or more of these 
SNURs before September 26, 2018, EPA will withdraw the relevant 
sections of this direct final rule before its effective date.
    This rule establishes SNURs for a number of chemical substances. 
Any person who submits adverse 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) Orders have been issued 
for all of the chemical substances, and the PMN submitters are 
prohibited by the TSCA section 5(e) Orders from undertaking activities 
which will be designated as significant new uses. The identities of the 
19 chemical substances subject to these rules have been claimed as 
confidential and EPA has received no post-PMN bona fide submission (per 
Sec. Sec.  720.25 and 721.11) for a chemical substance covered by this 
action. 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 August 27, 2018 as the cutoff date for 
determining whether the new use is ongoing. 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 on occasion posting rules on its website a week 
or more in advance of Federal Register publication, this objective 
could be thwarted even before that publication.
    Persons who begin commercial manufacture or processing of the 
chemical substances for a significant new use identified as of that 
date will have to cease any such activity upon the effective date of 
the final rule. To resume their activities, these persons will have to 
first comply with all applicable SNUR notification requirements and 
wait 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.

VIII. Development and Submission of Information

    EPA recognizes that TSCA section 5 does not require developing any 
particular new information (e.g., generating test data) before 
submission of a SNUN. There is an exception: Development of test data 
is required where the chemical substance subject to the SNUR is also 
subject to a rule, order or consent agreement under TSCA section 4 (see 
TSCA section 5(b)(1)).
    In the absence of a TSCA section 4 test rule covering the chemical 
substance, persons are required only to submit information in their 
possession or control and to describe any other information known to or 
reasonably ascertainable by them (see 40 CFR 720.50). However, upon 
review of PMNs and SNUNs, the Agency has the authority to require 
appropriate testing. Unit IV. lists potentially useful information for 
all of the listed SNURs. Descriptions of this information is provided 
for informational purposes. EPA strongly encourages persons, before 
performing any testing, to consult with the Agency pertaining to 
protocol selection. Furthermore, pursuant to TSCA section 4(h), which 
pertains to reduction of testing in vertebrate animals, EPA encourages 
consultation with the Agency on the use of alternative test methods and 
strategies (also called New Approach Methodologies, or NAMs), if 
available, to generate the recommended test data. EPA encourages dialog 
with Agency representatives to help determine how best the submitter 
can meet both the data needs and the objective of TSCA section 4(h). 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 certain of the TSCA section 5(e) Orders for the chemical 
substances regulated under this rule, EPA has established production 
volume limits in

[[Page 43548]]

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 specified tests 
that would permit a reasoned evaluation of the potential risks posed by 
these chemical substances. Under recent TSCA section 5(e) Orders, each 
PMN submitter is required to submit each study at least 14 weeks 
(earlier TSCA section 5(e) Orders required submissions at least 12 
weeks) before reaching the specified production limit. The SNURs 
contain the same production volume limits as the TSCA section 5(e) 
Orders. Exceeding these production limits is defined as a significant 
new use. Persons who intend to exceed the production limit must notify 
the Agency by submitting a SNUN at least 90 days in advance of 
commencement of non-exempt commercial manufacture or processing.
    Any request by EPA for the triggered and pended testing described 
in the Orders was made based on EPA's consideration of available 
screening-level data, if any, as well as other available information on 
appropriate testing for the PMN substances. Further, any such testing 
request on the part of EPA that includes testing on vertebrates was 
made after consideration of available toxicity information, 
computational toxicology and bioinformatics, and high-throughput 
screening methods and their prediction models.
    The potentially useful information identified 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 or other 
information 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 generate useful information.
    SNUN submitters should be aware that EPA will be better able to 
evaluate SNUNs which provide detailed information on the following:
    <bullet> Human exposure and environmental release that may result 
from the significant new use of the chemical substances.
    <bullet> 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.  
[emsp14]721.1725(b)(1) with that under Sec.  [emsp14]721.11 into a 
single step.
    If EPA determines that the use identified in the bona fide 
submission would not be a significant new use, i.e., the use does not 
meet the criteria specified in the rule for a significant new use, that 
person can manufacture or process the chemical substance so long as the 
significant new use trigger is not met. In the case of a production 
volume trigger, this means that the aggregate annual production volume 
does not exceed that identified in the bona fide submission to EPA. 
Because of confidentiality concerns, EPA does not typically disclose 
the actual production volume that constitutes the use trigger. Thus, if 
the person later intends to exceed that volume, a new bona fide 
submission would be necessary to determine whether that higher volume 
would be a significant new use.

X. SNUN Submissions

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

XI. Economic Analysis

    EPA has evaluated the potential costs of establishing SNUN 
requirements for potential manufacturers and processors of the chemical 
substances subject to this rule. EPA's complete economic analysis is 
available in the docket under docket ID number EPA-HQ-OPPT-2017-0464.

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 and TSCA section 5(e) 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

[[Page 43549]]

already been approved by OMB pursuant to PRA under OMB control number 
2070-0012 (EPA ICR No. 574). This action does not impose any burden 
requiring additional OMB approval. If an entity were to submit a SNUN 
to the Agency, the annual burden is estimated to average between 30 and 
170 hours per response. This burden estimate includes the time needed 
to review instructions, search existing data sources, gather and 
maintain the data needed, and complete, review, and submit the required 
SNUN.
    Send any comments about the accuracy of the burden estimate, and 
any suggested methods for minimizing respondent burden, including 
through the use of automated collection techniques, to the Director, 
Collection Strategies Division, Office of Environmental Information 
(2822T), Environmental Protection Agency, 1200 Pennsylvania Ave. NW, 
Washington, DC 20460-0001. Please remember to include the OMB control 
number in any correspondence, but do not submit any completed forms to 
this address.

C. Regulatory Flexibility Act (RFA)

    On February 18, 2012, EPA certified pursuant to RFA section 605(b) 
(5 U.S.C. 601 et seq.), that promulgation of a SNUR does not have a 
significant economic impact on a substantial number of small entities 
where the following are true:
    1. A significant number of SNUNs would not be submitted by small 
entities in response to the SNUR.
    2. The SNUR submitted by any small entity would not cost 
significantly more than $8,300.
    A copy of that certification is available in the docket for this 
action.
    This action is within the scope of the February 18, 2012 
certification. Based on the Economic Analysis discussed in Unit XI. and 
EPA's experience promulgating SNURs (discussed in the certification), 
EPA believes that the following are true:
    <bullet> A significant number of SNUNs would not be submitted by 
small entities in response to the SNUR.
    <bullet> 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. 1501 et seq.).

E. Executive Order 13132

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

F. Executive Order 13175

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

G. Executive Order 13045

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

H. Executive Order 13211

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

I. National Technology Transfer and Advancement Act (NTTAA)

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

J. Executive Order 12898

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

XIII. Congressional Review Act

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

List of Subjects

40 CFR Part 9

    Environmental protection, Reporting and recordkeeping requirements.

40 CFR Part 721

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

    Dated: August 17, 2018.
Jeffery T. Morris,
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.  [emsp14]9.1, add the following sections in numerical order 
under the undesignated center heading ``Significant New Uses of 
Chemical Substances'' to read as follows:

[[Page 43550]]

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

* * * * *

------------------------------------------------------------------------
                                                            OMB control
                     40 CFR citation                            No.
------------------------------------------------------------------------
 
                                * * * * *
------------------------------------------------------------------------
               Significant New Uses of Chemical Substances
------------------------------------------------------------------------
 
                                * * * * *
721.11097...............................................       2070-0012
721.11098...............................................       2070-0012
721.11099...............................................       2070-0012
721.11100...............................................       2070-0012
721.11101...............................................       2070-0012
721.11102...............................................       2070-0012
721.11103...............................................       2070-0012
721.11104...............................................       2070-0012
721.11105...............................................       2070-0012
721.11106...............................................       2070-0012
721.11107...............................................       2070-0012
721.11108...............................................       2070-0012
721.11109...............................................       2070-0012
721.11110...............................................       2070-0012
721.11111...............................................       2070-0012
721.11112...............................................       2070-0012
721.11113...............................................       2070-0012
721.11114...............................................       2070-0012
721.11115...............................................       2070-0012
 
                                * * * * *
------------------------------------------------------------------------

* * * * *

PART 721--[AMENDED]

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

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


0
4. Add Sec.  [emsp14]721.11097 to subpart E to read as follows:


Sec.  [emsp14]721.11097  Benzene, 1,4-bis(alkyl)-, homopolymer 
(generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically benzene, 
1,4-bis(alkyl)-, homopolymer (PMN P-15-719) 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)(concentrations set at 1.0 percent), (f), 
(g)(4)(i), (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.
    (ii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80(k) and (q).
    (iii) Disposal. Requirements as specified in Sec.  721.85(a)(1), 
(2), (b)(1), (2), (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.
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125(a), (b), (c), and (f) 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)(iii) 
of this section.

0
5. Add Sec.  [emsp14]721.11098 to subpart E to read as follows:


Sec.  [emsp14]721.11098  Polyethylene glycol polymer with aliphatic 
polycarbodiimide bis(alkoxysilylpropyl) amine blocked (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 
polyethylene glycol polymer with aliphatic polycarbodiimide 
bis(alkoxysilylpropyl) amine blocked (PMN P-16-99) is subject to 
reporting under this section for the significant new uses described in 
paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in Sec.  
721.63(a)(1), (a)(2)(i), (a)(3), (a)(4), when determining which persons 
are reasonably likely to be exposed as required for Sec.  721.63(a)(1) 
and (a)(4), engineering control measures (e.g., enclosure or 
confinement of the operation, general and local ventilation) or 
administrative control measures (e.g., workplace policies and 
procedures) shall be considered and implemented to prevent exposure, 
where feasible, (a)(5) (respirators must provide a National Institute 
for Occupational Safety and Health (NIOSH) with an assigned protection 
factor (APF) of at least 10), (a)(6)(particulate), (b)(concentrations 
set at 1.0 percent) and (c).
    (A) As an alternative to the respirator requirements in paragraph 
(a)(2)(i) of this section, a manufacturer or processor may choose to 
follow the new chemical exposure limit (NCEL) provision listed in the 
TSCA section 5(e) Order for this substance. The NCEL is 0.9 mg/m\3\ as 
an 8-hour time weighted average. Persons who wish to pursue NCELs as an 
alternative to Sec.  721.63 respirator requirements may request to do 
so under Sec.  721.30. Persons whose Sec.  721.30 requests to use the 
NCELs approach are approved by EPA will be required to follow NCELs 
provisions comparable to those contained in the corresponding TSCA 
section 5(e) Order.
    (B) [Reserved]
    (ii) Hazard communication. Requirements as specified in Sec.  
721.72(a) through (e)(concentration set 1.0 percent), (f), (g)(1)(ii), 
(g)(2)(ii), (iii), (use respiratory protection or maintain workplace 
airborne concentrations at or below an 8-hour time-weighted average of 
0.9 mg/m<SUP>3</SUP>), 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(k), (q) and (t). It is a significant new 
use to process or use the chemical substance other than for commercial 
use but without any use in a consumer setting. It is a significant new 
use to manufacture the chemical substance containing greater than 0.2% 
residual isocyanate.
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125(a) through (i) are applicable to manufacturers and processors 
of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.
    (3) Determining whether a specific use is subject to this section. 
The provisions of Sec.  721.1725(b)(1) apply to paragraph (a)(2)(iii) 
of this section.

0
6. Add Sec.  [emsp14]721.11099 to subpart E to read as follows:


Sec.  [emsp14]721.11099  Fluorinated organopolysilazane (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as a 
fluorinated organopolysilazane (PMN P-16-221) is subject to reporting 
under this section for the significant new uses described in paragraph 
(a)(2) of this section.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in Sec.  
721.63(a)(1), (a)(3), (a)(4), when determining which persons are 
reasonably likely to be exposed as required for Sec.  721.63(a)(1) 
engineering

[[Page 43551]]

control measures (e.g., enclosure or confinement of the operation, 
general and local ventilation) or administrative control measures 
(e.g., workplace policies and procedures) shall be considered and 
implemented to prevent exposure, where feasible, (a)(6)(particulate), 
(a)(6)(v), (vi), (b)(concentrations set at 1.0 percent), and (c).
    (ii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80(f), (p) (204 kilograms) and (s)(100 
kilograms). It is a significant new use to use the substance other than 
in confidential coating system allowed in the Order.
    (iii) Release to water. Requirements as specified in Sec.  
721.90(a)(1), (b)(1), and (c)(1).
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125(a) through (e), (i), and (k) are applicable to manufacturers 
and processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.
    (3) Determining whether a specific use is subject to this section. 
The provisions of Sec.  721.1725(b)(1) apply to paragraph (a)(2)(iii) 
of this section.

0
7. Add Sec.  [emsp14]721.11100 to subpart E to read as follows:


Sec.  [emsp14]721.11100  Carbopolycycle-bis(diazonium), dihalo-, 
chloride (1:2), reaction products with metal hydroxide, 4-
[(dioxoalkyl)amino]substituted benzene, 2-
[(dioxoalkyl)amino]substituted benzene, 5-[(dioxoalkyl)amino]-2-
hydroxy-substituted benzene and oxo-n-phenylalkanamide (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 
carbopolycycle-bis(diazonium), dihalo-, chloride (1:2), reaction 
products with metal hydroxide, 4-[(dioxoalkyl)amino] substituted 
benzene, 2-[(dioxoalkyl)amino]substituted benzene, 5-[(dioxoalkyl) 
amino] 2-hydroxy-substituted benzene and oxo-n-phenylalkanamide (PMN P-
16-359) is subject to reporting under this section for the significant 
new uses described in paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in Sec.  
721.63(a)(1), (a)(3), (a)(4), when determining which persons are 
reasonably likely to be exposed as required for Sec.  721.63(a)(1), 
engineering control measures (e.g., enclosure or confinement of the 
operation, general and local ventilation) or administrative control 
measures (e.g., workplace policies and procedures) shall be considered 
and implemented to prevent exposure, where feasible, 
(a)(6)(particulate), (b)(concentrations set at 0.1 percent) and (c).
    (ii) Hazard communication. Requirements as specified in Sec.  
721.72(a) through (e)(concentration set 0.1 percent), (f), (g)(1)(iv), 
(vii), (g)(2)(i), (ii), (do not process or use at greater than 200 
degrees Celsius), 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 (f) and (q). It is a significant new use 
to process or use the PMN substance at a temperature greater than 200 
degrees C.
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125(a) through (i) are applicable to manufacturers and processors 
of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.
    (3) Determining whether a specific use is subject to this section. 
The provisions of Sec.  721.1725(b)(1) apply to paragraph (a)(2)(iii) 
of this section.

0
8. Add Sec.  [emsp14]721.11101 to subpart E to read as follows:


Sec.  [emsp14]721.11101  Blocked polyester polyurethane, neutralized 
(generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as blocked 
polyester polyurethane, neutralized (PMN P-16-363) 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 after they have been reacted 
(cured).
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in Sec.  
721.63(a)(1), when determining which persons are reasonably likely to 
be exposed as required for Sec.  721.63(a)(1) engineering control 
measures (e.g., enclosure or confinement of the operation, general and 
local ventilation) or administrative control measures (e.g., workplace 
policies and procedures) shall be considered and implemented to prevent 
exposure, where feasible, (a)(2)(i), (ii), (iii), (a)(3), 
(a)(6)(particulate), (a)(6)(v), (vi) (b)(concentrations set at 0.1 
percent) and (c).
    (ii) Hazard communication. Requirements as specified in Sec.  
721.72 (a) through (e)(concentration set 0.1 percent), (f), (g)(1)(i), 
(ii), (g)(2)(i), (ii), (iii), (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 It is a significant new use to 
manufacture, process, or use the substance with a residual of free 
isocyanate monomers greater than 0.1 percent by weight. It is a 
significant new use to modify manufacture, process or use activities if 
it results in inhalation exposure to vapor, dust, mist or aerosols to 
the substance. It is a significant new use to manufacture, process, or 
use the substance for consumer use, or for commercial uses when the 
saleable goods or service could introduce the substance into a consumer 
setting. It is a significant new use to manufacture, process, or use 
the substance other than in an aqueous formulation.
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125(a) through (i) are applicable to manufacturers and processors 
of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.

0
9. Add Sec.  [emsp14]721.11102 to subpart E to read as follows:


Sec.  [emsp14]721.11102  Methoxy-terminated polysiloxane (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 
methoxy-terminated polysiloxane (PMN P-16-370) 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 after they have been reacted (cured).
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in

[[Page 43552]]

Sec.  721.63(a)(1), (a)(2)(i), (ii), (iii), (a)(3), (a)(4), when 
determining which persons are reasonably likely to be exposed as 
required for Sec.  721.63(a)(1) and (a)(4), engineering control 
measures (e.g., enclosure or confinement of the operation, general and 
local ventilation) or administrative control measures (e.g., workplace 
policies and procedures) shall be considered and implemented to prevent 
exposure, where feasible, (a)(5) (respirators must provide a National 
Institute for Occupational Safety and Health (NIOSH) assigned 
protection factor (APF) of at least 25), (a)(6)(particulate), 
(a)(6)(v), (vi), (b)(concentrations set at 1.0 percent), and (c).
    (A) As an alternative to the respirator requirements in paragraph 
(a)(2)(i) of this section, a manufacturer or processor may choose to 
follow the new chemical exposure limit (NCEL) provision listed in the 
TSCA section 5(e) Order for this substance. The NCEL is 8.4 milligrams 
per cubic meter as an 8-hour time weighted average. Persons who wish to 
pursue NCELs as an alternative to Sec.  721.63 respirator requirements 
may request to do so under Sec.  721.30. Persons whose Sec.  721.30 
requests to use the NCELs approach are approved by EPA will be required 
to follow NCELs provisions comparable to those contained in the 
corresponding TSCA section 5(e) Order.
    (B) [Reserved]
    (ii) Hazard communication. Requirements as specified in Sec.  
721.72(a) through (e)(concentration set 1.0 percent), (f), (g)(1)(i), 
(ii), (g)(2)(i), (ii), (iii), (use respiratory protection or maintain 
workplace airborne concentrations at or below an 8-hour time-weighted 
average of 8.4 mg/m3), (g)(2)(v), (do not use for spray application), 
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), and (y)(1). It is a significant new 
use to manufacture, process, or use the substance for consumer use, or 
for commercial uses when the saleable goods or service could introduce 
the substance into a consumer setting.
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125(a) through (i) are applicable to manufacturers and processors 
of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.
    (3) Determining whether a specific use is subject to this section. 
The provisions of Sec.  721.1725(b)(1) apply to paragraph (a)(2)(iii) 
of this section.

0
10. Add Sec.  [emsp14]721.11103 to subpart E to read as follows:


Sec.  [emsp14]721.11103  Hydroxystyrene resin (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 
hydroxystyrene resin (PMN P-16-376) 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 with an average molecular weight less than 2906 
daltons and to have greater than 0.5 percent low weight molecular 
species less than 500 daltons and 1.0 percent low weight molecular 
species less than 1000 daltons.
    (ii) [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125(a) 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.  [emsp14]721.11104 to subpart E to read as follows:


Sec.  [emsp14]721.11104  Benzenesulfonic acid 1,2-diazenediylbis[6-
ethenyl]-3-sulfophenyl diazenyl-2-sulfophenyl ethenyl salt (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 
benzenesulfonic acid 1,2-diazenediylbis[6-ethenyl]-3-sulfophenyl 
diazenyl-2-sulfophenyl ethenyl salt (PMN P-16-487) is subject to 
reporting under this section for the significant new uses described in 
paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in Sec.  
721.63(a)(1), (a)(2)(i), (a)(3), when determining which persons are 
reasonably likely to be exposed as required for Sec.  721.63(a)(1) 
engineering control measures (e.g., enclosure or confinement of the 
operation, general and local ventilation) or administrative control 
measures (e.g., workplace policies and procedures) shall be considered 
and implemented to prevent exposure, where feasible, (b) (concentration 
set 1.0 percent), and (c).
    (ii) Hazard communication. Requirements as specified in Sec.  
721.72(a) through (e)(concentration set 1.0 percent), (f), (g)(1)(iv), 
(vi), (ix), (blood effects), (g)(2)(i), (v), (g)(3)(i), (ii), 
(g)(4)(water release restrictions apply), 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(f), (k), and (q). It is a significant new 
use to import the substance other than in solution.
    (iv) Release to water. Requirements as specified in Sec.  
721.90(a)(4), (b)(4), and (c)(4) where N = 55.
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125(a) through (i) are applicable to manufacturers and processors 
of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.
    (3) Determining whether a specific use is subject to this section. 
The provisions of Sec.  721.1725(b)(1) apply to paragraph (a)(2)(iii) 
of this section.

0
12. Add Sec.  [emsp14]721.11105 to subpart E to read as follows:


Sec.  [emsp14]721.11105  Ethanaminium, alkyl-, salt with triazole 
(generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 
ethanaminium, alkyl-, salt with triazole (PMN P-16-533) 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 after they have been reacted 
(cured).
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in Sec.  
721.63(a)(1), (a)(2)(i), (ii), (iii), (a)(3), when determining which 
persons are reasonably likely to be exposed as

[[Page 43553]]

required for Sec.  721.63(a)(1) engineering control measures (e.g., 
enclosure or confinement of the operation, general and local 
ventilation) or administrative control measures (e.g., workplace 
policies and procedures) shall be considered and implemented to prevent 
exposure, where feasible, (a)(6)(particulate), (a)(6)(v), (vi), (b) 
(concentration set 0.1 percent), and (c).
    (ii) Hazard communication. Requirements as specified in Sec.  
721.72(a) through (e)(concentration set 0.1 percent), (f), (g)(1)(i), 
(iii), (v), (vii), (ix), (g)(2)(i), (ii), (iii), (v), (g)(3)(i), (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(k) and (q). It is a significant new use to 
modify the manufacture, process or use activities if it results in 
inhalation exposure to vapor, dust, mist or aerosols to the substance.
    (iv) Release to water. Requirements as specified in Sec.  
721.90(a)(1), (b)(1), and (c)(1).
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125(a) through (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)(iii) 
of this section.

0
13. Add Sec.  [emsp14]721.11106 to subpart E to read as follows:


Sec.  [emsp14]721.11106  Substituted-(hydroxyalkyl)-alkyl-alkanoic 
acid, hydroxy-(substitutedalkyl)-alkyl-, polymer with alpha-hydro-
omega-hydroxypoly[oxy (alkylethanediyl)] and isocyanato-
(isocyanatoalkyl)-multialkylcycloalkane, salt, alkanol-blocked, compds. 
(generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 
substituted-(hydroxyalkyl)-alkyl-alkanoic acid, hydroxy-
(substitutedalkyl)-alkyl-, polymer with alpha-hydro-omega-hydroxypoly 
[oxy(alkylethanediyl)] and isocyanato-(isocyanatoalkyl)-
multialkylcycloalkane, salt, alkanol-blocked, compds. (PMN P-16-595) 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 after they have 
been reacted (cured).
    (2) The significant new uses are:
    (i) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80(f) and (k). It is a significant new use to 
import the substance other than as required in the Order.
    (ii) Release to water. Requirements as specified in Sec.  
721.90(a)(1), (b)(1), and (c)(1).
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125(a) (b), (c), (i), and (k) are applicable to manufacturers and 
processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.
    (3) Determining whether a specific use is subject to this section. 
The provisions of Sec.  721.1725(b)(1) apply to paragraph (a)(2)(iii) 
of this section.

0
14. Add Sec.  [emsp14]721.11107 to subpart E to read as follows:


Sec.  [emsp14]721.11107  Alkanediol, 2,2-bis (substituted alkyl)- 
polymer with substituted alkane, heteromonocycles, alkenoate (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 
alkanediol, 2,2-bis (substituted alkyl)- polymer with substituted 
alkane, heteromonocycles, alkenoate (PMN P-17-170) 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 
reacted (cured).
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in Sec.  
721.63(a)(1), (a)(2)(i), (a)(3), when determining which persons are 
reasonably likely to be exposed as required for Sec.  721.63(a)(1) 
engineering control measures (e.g., enclosure or confinement of the 
operation, general and local ventilation) or administrative control 
measures (e.g., workplace policies and procedures) shall be considered 
and implemented to prevent exposure, where feasible, (b)(concentration 
set 0.1 percent), and (c)
    (ii) Hazard communication. Requirements as specified in Sec.  
721.72(a) through (e)(concentration set 0.1 percent), (f), (g)(1)(i), 
(ii), (v), (vii), (ix), (g)(2)(i), (v), (g)(4) 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 (k)(ultraviolet curable coating resin for 
three dimensional printing applications) and (p)(105,000 kilograms). It 
is a significant new use to modify the manufacture, process or use 
activities if it results in inhalation exposure to vapor, dust, mist or 
aerosols to the substance. It is a significant new use to manufacture 
the chemical substance containing greater than 0.1 percent residual 
isocyanate or an average molecular weight below 1,000 daltons.
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125(a) through (i) are applicable to manufacturers and processors 
of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.
    (3) Determining whether a specific use is subject to this section. 
The provisions of Sec.  721.1725(b)(1) apply to paragraph (a)(2)(iii) 
of this section.

0
15. Add Sec.  [emsp14]721.11108 to subpart E to read as follows:


Sec.  [emsp14]721.11108  Sulfurized alkylphenol, calcium salts 
(generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 
sulfurized alkylphenol, calcium salts (PMN P-17-172) is subject to 
reporting under this section for the significant new uses described in 
paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80(k). It is a significant new use to modify 
the manufacture, process or use activities if it results in inhalation 
exposure to vapor, dust, mist or aerosols to the substance.
    (ii) [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part

[[Page 43554]]

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

0
16. Add Sec.  [emsp14]721.11109 to subpart E to read as follows:


Sec.  [emsp14]721.11109  Monoheteropentacycloalkane-4-carboxylic acid, 
substituted cyclo-alkyl ester (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 
monoheteropentacycloalkane-4-carboxylic acid, substituted cyclo-alkyl 
ester (PMN P-17-177) 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 after they have been reacted (cured).
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in Sec.  
721.63(a)(1), (a)(3), when determining which persons are reasonably 
likely to be exposed as required for Sec.  721.63(a)(1) engineering 
control measures (e.g., enclosure or confinement of the operation, 
general and local ventilation) or administrative control measures 
(e.g., workplace policies and procedures) shall be considered and 
implemented to prevent exposure, where feasible, (b)(concentration set 
0.1 percent), and (c).
    (ii) Hazard communication. Requirements as specified in Sec.  
721.72(a) through (e)(concentration set 0.1 percent), (f), (g)(1)(i), 
(ii), (iv), (vi), (vii), (ix), (skin, eye, and mucous membrane 
irritation), (g)(2)(i), (ii), (iii), (v), (g)(3)(i), (ii), (g)(4)(i), 
(ii), (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(f), (k), and (t).
    (iv) Release to water. Requirements as specified in Sec.  
721.90(a)(1), (b)(1), and (c)(1).
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125(a) through (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)(iii) 
of this section.

0
17. Add Sec.  [emsp14]721.11110 to subpart E to read as follows:


Sec.  [emsp14]721.11110  Modified carboxypolyamine salt (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 
modified carboxypolyamine salt (PMN P-17-179) 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 after they have been reacted (cured).
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in Sec.  
721.63(a)(1), (a)(2)(i), (iv), (a)(3), when determining which persons 
are reasonably likely to be exposed as required for Sec.  721.63(a)(1) 
engineering control measures (e.g., enclosure or confinement of the 
operation, general and local ventilation) or administrative control 
measures (e.g., workplace policies and procedures) shall be considered 
and implemented to prevent exposure, where feasible, 
(a)(6)(particulate), (a)(6)(v), (vi), (b)(concentration set 0.1 
percent), and (c).
    (ii) Hazard communication. Requirements as specified in Sec.  
721.72(a) through (e)(concentration set 0.1 percent), (f), (g)(1)(i), 
(ii), (g)(2)(i), (ii), (v), (g)(3)(i), (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.
    (iii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80(f), (k)(dispersive additive for pigments 
in industrial paints and coatings) and (q). It is a significant new use 
to process or use the substance in a paint or coating formulation 
greater than 1 percent by weight or volume. It is a significant new use 
to process or use the substance resulting in inhalation exposure to a 
vapor, dust, mist or aerosol at greater than 1 percent by weight or 
volume.
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125(a) through (i) are applicable to manufacturers and processors 
of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.
    (3) Determining whether a specific use is subject to this section. 
The provisions of Sec.  721.1725(b)(1) apply to paragraph (a)(2)(iii) 
of this section.

0
18. Add Sec.  [emsp14]721.11111 to subpart E to read as follows:


Sec.  [emsp14]721.11111  1,3,5-Triazine-2,4-diamine, 6-phenyl-, 
reaction products with polyalkylene glycol mono- alkyl ether and 2,4-
toluene diisocyanate (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 1,3,5-
triazine-2,4-diamine, 6-phenyl-, reaction products with polyalkylene 
glycol mono-alkyl ether and 2,4-toluene diisocyanate (PMN P-17-222) 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 reacted (cured).
    (2) The significant new uses are:
    (i) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80(k)(use of the substance in the formulation 
for the use allowed in the Order with isocyanate residuals not greater 
than 0.1 percent by weight or volume). It is a significant new use to 
process or use the chemical substance other than for commercial use but 
without any use in a consumer setting. It is a significant new use to 
modify the manufacture, process or use activities if it results in 
inhalation exposure to vapor, dust, mist or aerosols to the substance. 
It is a significant new use to import the chemical substance containing 
greater than 0.15 percent residual isocyanate.
    (ii) [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125(a), (b), (c), and (i) are applicable to manufacturers and 
processors of this substance.

[[Page 43555]]

    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.
    (3) Determining whether a specific use is subject to this section. 
The provisions of Sec.  721.1725(b)(1) apply to paragraph (a)(2)(i) of 
this section.

0
19. Add Sec.  [emsp14]721.11112 to subpart E to read as follows:


Sec.  [emsp14]721.11112  Fatty acids, polymers with benzoic acid, 
cyclohexanedicarboxylic acid anhydride, aliphatic diisocyanate, alkyl 
diol, alkyl triol, pentaerythritol, phthalic anhydride, polyalkylene 
glycol amine, and aromatic dicarboxylate sulfonic acid sodium salt 
(generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as fatty 
acids, polymers with benzoic acid, cyclohexanedicarboxylic acid 
anhydride, aliphatic diisocyanate, alkyl diol, alkyl triol, 
pentaerythritol, phthalic anhydride, polyalkylene glycol amine, and 
aromatic dicarboxylate sulfonic acid sodium salt (PMN P-17-231) is 
subject to reporting under this section for the significant new uses 
described in paragraph (a)(2) of this section. The requirements of this 
section do not apply to quantities of the substance after they have 
been reacted (cured).
    (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 chemical substance containing greater than 0.1 percent 
residual isocyanate.
    (ii) [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125(a), (b), (c), and (i) are applicable to manufacturers and 
processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.

0
20. Add Sec.  [emsp14]721.11113 to subpart E to read as follows:


Sec.  [emsp14]721.11113  Branched alkyl (C = 17) carboxylic acid 
(generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 
branched alkyl (C = 17) carboxylic acid (PMN P-17-247) 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 after they have been reacted 
(cured).
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in Sec.  
721.63(a)(1), (a)(2)(i), (ii), (iii), (a)(3), when determining which 
persons are reasonably likely to be exposed as required for Sec.  
721.63(a)(1) engineering control measures (e.g., enclosure or 
confinement of the operation, general and local ventilation) or 
administrative control measures (e.g., workplace policies and 
procedures) shall be considered and implemented to prevent exposure, 
where feasible, (b)(concentration set 1.0 percent), and (c).
    (ii) Hazard communication. Requirements as specified in Sec.  
721.72(a) through (e)(concentration set 1.0 percent), (f), 
(g)(1)(irritation), (sensitization), (g)(1)(iv), (vi), (ix), (g)(2)(i), 
(ii), (iii), (v), (g)(3)(i), (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(f), (g) and (q). It is a significant new 
use to modify the manufacture, process or use activities if it results 
in inhalation exposure to vapor, dust, mist or aerosols to the 
substance.
    (iv) Release to water. Requirements as specified in Sec.  
721.90(a)(1), (b)(1), and (c)(1).
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125(a) through (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)(iii) 
of this section.

0
21. Add Sec.  [emsp14]721.11114 to subpart E to read as follows:


Sec.  [emsp14]721.11114  Branched alkyl (C = 18) alcohol (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 
branched alkyl (C = 18) alcohol (PMN P-17-248) 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 after they have been reacted (cured).
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in Sec.  
721.63(a)(1), (a)(2)(i), (ii), (iii), (a)(3), when determining which 
persons are reasonably likely to be exposed as required for Sec.  
721.63(a)(1) engineering control measures (e.g., enclosure or 
confinement of the operation, general and local ventilation) or 
administrative control measures (e.g., workplace policies and 
procedures) shall be considered and implemented to prevent exposure, 
where feasible, (b)(concentration set 1.0 percent), and (c).
    (ii) Hazard communication. Requirements as specified in Sec.  
721.72(a) through (e)(concentration set 1.0 percent), (f), 
(g)(1)(irritation), (sensitization), (g)(1)(iv), (vi), (ix), (g)(2)(i), 
(ii),)(iii), (v), (g)(3)(i), (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(f), (g) and (q). It is a significant new 
use to modify the manufacture, process or use activities if it results 
in inhalation exposure to vapor, dust, mist or aerosols to the 
substance.
    (iv) Release to water. Requirements as specified in Sec.  
721.90(a)(1), (b)(1), and (c)(1).
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125(a) through (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)(iii) 
of this section.

0
22. Add Sec.  [emsp14]721.11115 to subpart E to read as follows:


Sec.  [emsp14]721.11115  Alkoxy silane modified butadiene styrene 
copolymer (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as alkoxy 
silane modified

[[Page 43556]]

butadiene styrene copolymer (PMN P-17-260) 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 after they have been reacted (cured).
    (2) The significant new uses are:
    (i) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80(k). It is a significant new use to modify 
the manufacture, process or use activities if it results in inhalation 
exposure to vapor, dust, mist or aerosols to the substance.
    (ii) [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125(a), (b), (c), and (i) are applicable to manufacturers and 
processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.
    (3) Determining whether a specific use is subject to this section. 
The provisions of Sec.  721.1725(b)(1) apply to paragraph (a)(2)(i) of 
this section.

[FR Doc. 2018-18403 Filed 8-24-18; 8:45 am]
 BILLING CODE 6560-50-P


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