[Federal Register Volume 83, Number 160 (Friday, August 17, 2018)]
[Rules and Regulations]
[Pages 40986-41006]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-17348]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Parts 9 and 721

[EPA-HQ-OPPT-2017-0414; FRL-9971-37]
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 27 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 27 
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 16, 2018. For purposes of 
judicial review, this rule shall be promulgated at 1 p.m. (e.s.t.) on 
August 31, 2018.
    Written adverse comments on one or more of these SNURs must be 
received on or before September 17, 2018 (see Unit VI. of the 
SUPPLEMENTARY INFORMATION). If EPA receives written adverse comments on 
one or more of these SNURs before September 17, 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)

[[Page 40987]]

number EPA-HQ-OPPT-2017-0414, by one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the online instructions for submitting comments. Do not submit 
electronically any information you consider to be Confidential Business 
Information (CBI) or other information whose disclosure is restricted 
by statute.
     Mail: Document Control Office (7407M), Office of Pollution 
Prevention and Toxics (OPPT), Environmental Protection Agency, 1200 
Pennsylvania Ave. NW, Washington, DC 20460-0001.
     Hand Delivery: To make special arrangements for hand 
delivery or delivery of boxed information, please follow the 
instructions at http://www.epa.gov/dockets/contacts.html.
    Additional instructions on commenting or visiting the docket, along 
with more information about dockets generally, is available at http://www.epa.gov/dockets.

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

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this action apply to me?

    You may be potentially affected by this action if you manufacture, 
process, or use the chemical substances contained in this rule. The 
following list of North American Industrial Classification System 
(NAICS) codes is not intended to be exhaustive, but rather provides a 
guide to help readers determine whether this document applies to them. 
Potentially affected entities may include:
     Manufacturers or processors of one or more subject 
chemical substances (NAICS codes 325 and 324110), e.g., chemical 
manufacturing and petroleum refineries.
    This action may also affect certain entities through pre-existing 
import certification and export notification rules under TSCA. Chemical 
importers are subject to the TSCA section 13 (15 U.S.C. 2612) import 
certification requirements promulgated at 19 CFR 12.118 through 12.127 
and 19 CFR 127.28. Chemical importers must certify that the shipment of 
the chemical substance complies with all applicable rules and orders 
under TSCA. Importers of chemicals subject to these SNURs must certify 
their compliance with the SNUR requirements. The EPA policy in support 
of import certification appears at 40 CFR part 707, subpart B. In 
addition, any persons who export or intend to export a chemical 
substance that is the subject of this rule on or after September 17, 
2018 are subject to the export notification provisions of TSCA section 
12(b) (15 U.S.C. 2611(b)) (see Sec.  721.20), and must comply with the 
export notification requirements in 40 CFR part 707, subpart D.

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

    1. Submitting CBI. Do not submit this information to EPA through 
regulations.gov or email. Clearly mark the part or all of the 
information that you claim to be CBI. For CBI information in a disk or 
CD-ROM that you mail to EPA, mark the outside of the disk or CD-ROM as 
CBI and then identify electronically within the disk or CD-ROM the 
specific information that is claimed as CBI. In addition to one 
complete version of the comment that includes information claimed as 
CBI, a copy of the comment that does not contain the information 
claimed as CBI must be submitted for inclusion in the public docket. 
Information so marked will not be disclosed except in accordance with 
procedures set forth in 40 CFR part 2.
    2. Tips for preparing your comments. When preparing and submitting 
your comments, see the commenting tips at 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 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 17, 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.  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

[[Page 40988]]

EPA receives a SNUN, EPA must either determine that the significant new 
use is not likely to present an unreasonable risk of injury or take 
such regulatory action as is associated with an alternative 
determination before the manufacture or processing for the significant 
new use can commence. If EPA determines that the significant new use is 
not likely to present an unreasonable risk, EPA is required under TSCA 
section 5(g) to make public, and submit for publication in the Federal 
Register, a statement of EPA's findings.

III. Significant New Use Determination

    Section 5(a)(2) of TSCA states that EPA's determination that a use 
of a chemical substance is a significant new use must be made after 
consideration of all relevant factors, including:
     The projected volume of manufacturing and processing of a 
chemical substance.
     The extent to which a use changes the type or form of 
exposure of human beings or the environment to a chemical substance.
     The extent to which a use increases the magnitude and 
duration of exposure of human beings or the environment to a chemical 
substance.
     The reasonably anticipated manner and methods of 
manufacturing, processing, distribution in commerce, and disposal of a 
chemical substance.
    In addition to these factors enumerated in TSCA section 5(a)(2), 
the statute 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 27 chemical substances in 40 CFR part 721, subpart E. 
In this unit, EPA provides the following information for each chemical 
substance:
     PMN number.
     Chemical name (generic name, if the specific name is 
claimed as CBI).
     Chemical Abstracts Service (CAS) Registry number (if 
assigned for non-confidential chemical identities).
     Basis for the TSCA section 5(e) Order.
     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 
future testing. See Unit VIII. for more information.
     CFR citation assigned in the regulatory text section of 
this rule.
    The regulatory text section of each rule specifies 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 27 PMN substances that are subject to Orders 
issued 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.  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 Numbers: P-12-277, P-12-278, P-12-280, P-12-281, P-12-282, P-12-
283, and P-12-284

    Chemical names: Alkanes, C20-28, chloro (P-12-277), 
Slack waxes (petroleum), chloro (P-12-278), Hexacosane, chloro derivs. 
and octacosane, chloro derivs. (P-12-280), Alkanes, C20-24, 
chloro (P-12-281), Alkanes, C14-16, chloro (P-12-282), 
Tetradecane, chloro derivs. (P-12-283), and Octadecane, chloro derivs. 
(P-12-284).
    CAS numbers: 2097144-43-7 (P-12-277), 2097144-44-8 (P-12-278), 
2097144-46-0 and 2097144-47-1 (P-12-280), 2097144-45-9 (P-12-281), 
1372804-76-6 (P-12-282), 198840-65-2 (P-12-283), 2097144-48-2 (P-12-
284).
    Effective date of TSCA section 5(e) Order: June 5, 2017.
    Basis for TSCA section 5(e) Order: The PMNs state that the PMN 
substances will be used as flame retardants and plasticizers in 
polyvinyl chloride (PVC), polymers, and rubber; flame retardants, 
plasticizers, and

[[Page 40989]]

lubricants in adhesives, caulk, sealants, and coatings; additives in 
lubricants including metalworking fluids; and flame retardants and 
waterproofers in textiles. Based on the physical/chemical properties of 
the PMN substances (as described in the New Chemical Program's PBT 
category at 64 FR 60194; November 4, 1999; FRL-6097-7) and test data on 
structurally similar medium-chain chlorinated paraffins (MCCP), the PMN 
substances are a potentially persistent, bioaccumulative, and toxic 
(PBT) chemicals. EPA estimates that the PMN substances will persist in 
the environment more than 2 months and estimates a bioaccumulation 
factor of greater than or equal to 1,000. Based on data on MCCP, EPA 
has identified concerns for systemic toxicity as well as aquatic and 
terrestrial toxicity. The Order was issued under TSCA sections 
5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on a finding that the 
substances may present an unreasonable risk of injury to health or the 
environment. To protect against these risks, the Order requires:
    1. Submission of certain toxicity testing on the representative 
congener groups prior to exceeding a certain time period specified in 
the Order.
    2. Use of the PMN substances only for the uses specified in the 
Order: Flame retardants and plasticizers in PVC, polymers, and rubber; 
flame retardants, plasticizers, and lubricants in adhesives, caulk, 
sealants, and coatings; additives in lubricants including metalworking 
fluids; and flame retardants and waterproofers in textiles.
    The SNUR would designate as a ``significant new use'' the absence 
of these protective measures.
    Potentially useful information: EPA has determined that certain 
information about the fate, and terrestrial and aquatic toxicity of the 
PMN substances may be potentially useful to characterize the effects of 
the PMN substances 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 a certain time limit 
without performing chronic aquatic and terrestrial toxicity and 
biodegradation testing.
    CFR citations: 40 CFR 721.11068 (P-12-277), 40 CFR 721.11069 (P-12-
278), 40 CFR 721.11070 (P-12-280), 40 CFR 721.11071 (P-12-281), 40 CFR 
721.11072 (P-12-282 and P-14-684), 40 CFR 721.11073 (P-12-283 and P-14-
683), and 40 CFR 721.11074 (P-12-284).

PMN Numbers: P-12-433, P-12-453, and P-12-505

    Chemical names: Alkanes, C18-20, chloro (P-12-433), 
Alkanes, C14-17, chloro (P-12-453) and Alkanes, 
C22-30, chloro (P-12-505).
    CAS numbers: 106262-85-3 (P-12-433), 85535-85-9 (P-12-453) and 
288260-42-4 (P-12-505).
    Effective date of TSCA section 5(e) Order: June 5, 2017.
    Basis for TSCA section 5(e) Order: The PMN states that the PMN 
substances will be used as flame retardants and plasticizers in PVC, 
polymers, and rubber; flame retardants, plasticizers, and lubricants in 
adhesives, caulk, sealants, and coatings; additives in lubricants 
including metalworking fluids; and flame retardants and waterproofers 
in textiles. Based on the physical/chemical properties of the PMN 
substances (as described in the New Chemical Program's PBT category at 
64 FR 60194; November 4, 1999; FRL-6097-7) and test data on 
structurally similar medium-chain chlorinated paraffins (MCCP), the PMN 
substances are potentially persistent, bioaccumulative, and toxic (PBT) 
chemicals. EPA estimates that the PMN substances will persist in the 
environment more than 2 months and estimates a bioaccumulation factor 
of greater than or equal to 1,000. Based on test data on MCCP EPA has 
identified concerns for systemic toxicity as well as aquatic and 
terrestrial toxicity. The Order was issued under TSCA sections 
5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on a finding that the 
substances may present an unreasonable risk of injury to health or the 
environment. To protect against these risks, the Order requires:
    1. Submission of certain toxicity testing on the representative 
congener groups prior to exceeding a certain time period specified in 
the Order.
    2. Use of the PMN substances only for the uses specified in the 
Order: Flame retardants and plasticizers in PVC, polymers, and rubber; 
flame retardants, plasticizers, and lubricants in adhesives, caulk, 
sealants, and coatings; additives in lubricants including metalworking 
fluids; and flame retardants and waterproofers in textiles.
    The SNUR would designate as a ``significant new use'' the absence 
of these protective measures.
    Potentially useful information: EPA has determined that certain 
information about the fate, and terrestrial and aquatic toxicity of the 
PMN substances may be potentially useful to characterize the effects of 
the PMN substances 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 a certain time limit 
without performing chronic aquatic and terrestrial toxicity and 
biodegradation testing.
    CFR citations: 40 CFR 721.11075 (P-12-433), 40 CFR 721.11076 (P-12-
453), 40 CFR 721.11077 (P-12-505).

PMN Numbers: P-14-683 and P-14-684

    Chemical names: Tetradecane, chloro derivs. (P-14-683) and Alkanes, 
C14-16, chloro (P-14-684).
    CAS numbers: 198840-65-2 (P-14-683) and 1372804-76-6 (P-14-684).
    Effective date of TSCA section 5(e) Order: May 17, 2017.
    Basis for TSCA section 5(e) Order: The PMNs state that the 
substances will be used as flame retardants and plasticizers in PVC, 
polymers, and rubber; flame retardants, plasticizers, and lubricants in 
adhesives, caulk, sealants, and coatings; additives in lubricants 
including metalworking fluids; and flame retardants and waterproofers 
in textiles. Based on the physical/chemical properties of the PMN 
substances (as described in the New Chemical Program's PBT category at 
64 FR 60194; November 4, 1999; FRL-6097-7) and test data on 
structurally similar medium-chain chlorinated paraffins (MCCP), the PMN 
substances are potentially persistent, bioaccumulative, and toxic (PBT) 
chemicals. EPA estimates that the PMN substances will persist in the 
environment more than 2 months and estimates a bioaccumulation factor 
of greater than or equal to 1,000. Further, EPA has identified concerns 
for systemic toxicity, as well as aquatic and terrestrial toxicity. The 
Order was issued under TSCA sections 5(a)(3)(B)(ii)(I) and 
5(e)(1)(A)(ii)(I), based on a finding that the substances may present 
an unreasonable risk of injury to health or the environment. To protect 
against these risks, the Order requires:
    1. Submission of certain toxicity testing on the representative 
congener groups prior to exceeding a certain time period specified in 
the Order.
    2. Use of the PMN substances only for the uses specified in the 
Order: Flame retardants and plasticizers in PVC, polymers, and rubber; 
flame retardants, plasticizers, and lubricants in adhesives, caulk, 
sealants, and coatings; additives in lubricants including metalworking 
fluids; and flame retardants and waterproofers in textiles.

[[Page 40990]]

    The SNUR would designate as a ``significant new use'' the absence 
of these protective measures.
    Potentially useful information: EPA has determined that certain 
information about the fate, and terrestrial and aquatic toxicity of the 
PMN substances may be potentially useful to characterize the effects of 
the PMN substances 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 a certain time limit 
without performing chronic aquatic and terrestrial toxicity and 
biodegradation testing.
    CFR citations: 40 CFR 721.11072 (P-12-282 and P-14-684), 40 CFR 
721.11073 (P-12-283 and P-14-683).

PMN Number: P-16-150

    Chemical name: Chloroflurocarbon (generic).
    CAS number: Not available.
    Effective date of TSCA section 5(e) Order: May 31, 2017.
    Basis for TSCA section 5(e) Order: The PMN states that the generic 
(non-confidential) use of the substance will be as an intermediate. 
Based on test data on the PMN substance, EPA identified concerns for 
acute human toxicity. Based on analogue data EPA identified concerns 
for toxicity to aquatic and terrestrial organisms. The Order was issued 
under TSCA sections 5(a)(3)(B)(ii)(I), 5(a)(3)(B)(ii)(II) 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 and that the 
substance will be produced in substantial quantities and may be 
reasonably anticipated to enter the environment in substantial 
quantities. To protect against these risks, the Order requires:
    1. Submission of certain toxicity testing on the substance prior to 
exceeding the production limits 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 of Occupational Safety and Health 
(NIOSH)-certified respirator with an assigned protection factor (APF) 
of at least 1000 (where there is a potential for inhalation exposure) 
in conjunction with a minimum set of engineering controls described in 
the PMN, or compliance with a new chemical exposure limit (NCEL) of 170 
parts per billion (ppb) as an 8-hour time-weighted average to prevent 
inhalation exposure.
    4. Use of engineering controls to limit worker exposure and air 
release of the PMN substance to the environment.
    5. Establishment and use of a hazard communication program, 
including human health precautionary statements on each label and in 
the Safety Data Sheet (SDS).
    6. Manufacture, processing, and use in an enclosed process.
    7. Use only as a chemical intermediate.
    8. No release of the substance resulting in surface water 
concentrations that exceed 240 ppb.
    The SNUR would designate as a ``significant new use'' the absence 
of these protective measures.
    Potentially useful information: EPA has determined that certain 
information about the human health and aquatic 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 target organ toxicity testing, 
reproductive and developmental toxicity testing, and acute and chronic 
aquatic toxicity testing.
    CFR citation: 40 CFR 721.11078.

PMN Number: P-16-379

    Chemical name: Silane, 1,1'-(1,2-ethanediyl)bis[1,1-dichloro-1-
methyl]-, hydrolysis products with chloroethenyldimethylsilane.
    CAS number: 1485477-78-8.
    Effective date of TSCA section 5(e) Order: June 8, 2017.
    Basis for TSCA section 5(e) Order: The PMN states that the generic 
(non-confidential) use of the substance is as a chemical intermediate 
for polymer synthesis. Based on SAR analysis of test data on analogous 
substances, EPA has identified concerns for liver toxicity and 
mutagenicity. 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 these risks, the Order requires:
    1. Submission of certain toxicity testing on the substance prior to 
exceeding the confidential production volume limit specified in the 
Order.
    2. Use of personal protective equipment including impervious gloves 
and clothing which covers any other exposed areas of the arms, legs and 
torso (where there is a potential for dermal exposure).
    3. Establishment and use of a hazard communication program, 
including human health precautionary statements on each label and in 
the SDS.
    4. No domestic manufacture of the substance.
    5. Use of the substance only for the confidential uses specified in 
the Order.
    6. No use involving application methods that generate a dust, mist, 
vapor, or aerosol.
    7. Disposal of the substance only by water or landfill.
    The SNUR would designate as a ``significant new use'' the absence 
of these protective measures.
    Potentially useful information: EPA has determined that certain 
information about the human health 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 target organ toxicity and mutagenicity testing. In 
addition, EPA has determined that the results of other specific target 
organ toxicity testing 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 721.11079.

PMN Number: P-16-410

    Chemical name: Silicophosphonate--sodium silicate (generic).
    CAS number: Not available.
    Effective date of TSCA section 5(e) Order: May 4, 2017.
    Basis for TSCA section 5(e) Order: The PMN states that the generic 
(non-confidential) use of the substance will be as an automotive engine 
fluid additive. Based on test data on the PMN substance, EPA has 
identified concerns for skin and eye irritation, corrosion, and 
systemic toxicity. The Order was issued under TSCA sections 
5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on a finding that the 
substance may present an unreasonable risk of injury to human health. 
To protect against these risks, the Order requires:

[[Page 40991]]

    1. No domestic manufacture of the substance.
    2. Use of the substance in formulations containing no greater than 
0.2% of the chemical substance and for the confidential uses specified 
in the Order.
    The SNUR would designate as a ``significant new use'' the absence 
of these protective measures.
    Potentially useful information: EPA has determined that certain 
information about the human health toxicity of the PMN substance may be 
potentially useful to characterize the effects of the 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 irritation testing 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, 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 721.11080.

PMN Number: P-16-438

    Chemical name: 3-Butenenitrile, 2-(acetyloxy)-.
    CAS number: 15667-63-7.
    Effective date of TSCA section 5(e) Order: June 23, 2017.
    Basis for TSCA section 5(e) Order: The PMN states the substance 
will be used as a chemical intermediate for a pesticide inert. Based on 
test data on the PMN substance, EPA identified concerns for acute 
toxicity, irritation to all tissues, developmental toxicity, and 
neurotoxicity. EPA identified concerns for aquatic organism toxicity 
based on submitted data. 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. Further, based on SAR analysis of test data on analogous 
vinyl/allyl esters vinyl/allyl esters nitriles and test data on the PMN 
substance, EPA predicts toxicity to aquatic organisms may occur at 
concentrations that exceed 8 ppb in surface waters. To protect against 
these risks, the Order requires:
    1. Submission of monitoring data on the substance.
    2. Use of personal protective equipment including impervious gloves 
and protective clothing (where there is a potential for dermal 
exposures) and a NIOSH-certified powered air purifying particulate 
respirator with an Assigned Protection Factor (APF) of at least 1000 
(where there is a potential for inhalation exposures).
    3. Establishment and use of a hazard communication program, 
including human health precautionary statements on each label and in 
the SDS.
    4. Manufacture, process, and use of the substance in a closed 
system as specified in the PMN.
    5. Use of the substance only as a chemical intermediate.
    6. No release of the substance into the surface waters of the 
United States.
    The SNUR would designate as a ``significant new use'' the absence 
of these protective measures.
    Potentially useful information: EPA has determined that certain 
information about the aquatic 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. EPA has 
determined that the results of chronic aquatic toxicity testing of the 
PMN substance may be potentially useful in characterizing the 
environmental effects of the PMN substance. Although the Order does not 
require these tests, the Order's restrictions on manufacture, 
processing, distribution in commerce, and use 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 721.11081.

PMN Number: P-16-543

    Chemical name: Halogenophosphoric acid metal salt (generic).
    CAS number: Not available.
    Effective date of TSCA section 5(e) Order: May 24, 2017.
    Basis for TSCA section 5(e) Order: The PMN states that the generic 
(non-confidential) use will be as a battery ingredient. Based on test 
data on the PMN substance and an analogue, EPA has identified concerns 
for irritation, corrosion, acute toxicity, immunotoxicity, 
developmental toxicity, neurotoxicity, and cancer. Further, based on 
test data on the PMN substance, EPA identified concerns for aquatic 
organism toxicity at surface water concentrations that exceed 3 ppb. 
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 these risks, the Order requires:
    1. Submission of monitoring data as specified in the Order.
    2. Use of personal protective equipment as specified in the Order 
(where there is a potential for dermal exposure).
    3. Use of a NIOSH-certified respirator with an APF of at least 1000 
(where there is a potential for inhalation exposure).
    4. Establishment and use of a hazard communication program, 
including human health precautionary statements on each label and in 
the SDS.
    5. No domestic manufacture of the substance.
    6. Use of the substance only in an enclosed process.
    7. Use of the substance only for the confidential uses specified in 
the Order.
    8. Manufacture, process, or use of the substance without the 
engineering controls required by the Order to control dermal and 
inhalation exposure.
    9. Disposal of the substance by hazardous waste incineration except 
when in wastewater.
    10. No release of the substance resulting in surface water 
concentrations that exceed 3 ppb.
    The SNUR would designate as a ``significant new use'' the absence 
of these protective measures.
    Potentially useful information: EPA has determined that certain 
information about the human health toxicity, human exposure, aquatic 
toxicity, and fate 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 to 
conduct an exposure monitoring program for employees who are reasonably 
likely to be exposed to the PMN substance and a hydrolysis product of 
the PMN substance. In addition, EPA has determined that the results of 
specific target organ toxicity, acute aquatic toxicity, and 
biodegradation testing of the PMN substance 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

[[Page 40992]]

is relevant and needed to evaluate a modification request.
    CFR citation: 40 CFR 721.11082.

PMN Number: P-16-596

    Chemical names: Alkenoic acid, reaction products with polyethylene 
glycol ether with hydroxyalkyl substituted alkane (generic).
    CAS numbers: Not available.
    Effective date of TSCA section 5(e) Order: June 5, 2017.
    Basis for TSCA section 5(e) Order: The PMN states that the 
substance will be used as a site-limited intermediate used for 
production of ultraviolet (UV) curable coating resin. Based on SAR 
analysis on structurally similar substances, EPA has identified 
concerns for irritation, sensitization, developmental toxicity, liver 
and kidney effects, and oncogenicity. 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. 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. To protect against these risks, the Order 
requires:
    1. Submission of test data on the substance prior to exceeding the 
confidential production volume limit specified in the Order.
    2. Use of personal protective equipment including impervious gloves 
(where there is a potential for dermal exposure).
    3. Establishment and use of a hazard communication program, 
including human health precautionary statements on each label and in 
the SDS.
    4. No domestic manufacture of the substance.
    5. Use of the substance only as a site-limited intermediate for the 
production of UV curable coating resin.
    6. No release of the substance to surface waters of the United 
States.
    The SNUR would designate as a ``significant new use'' the absence 
of these protective measures.
    Potentially useful information: EPA has determined that certain 
information about the human health toxicity of the PMN substance may be 
potentially useful to characterize the effects of the PMN substances 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 reproductive/developmental toxicity 
testing may be potentially useful in characterizing the health effects 
of the PMN substance. The submitter has agreed not to manufacture 
beyond a certain production volume limit without performing 
reproductive/developmental toxicity testing.
    CFR citation: 40 CFR 721.11083.

PMN Number: P-17-10

    Chemical name: Alkyl substituted alkenoic acid, alkyl ester, 
polymer with alkyl substituted alkenoate and alkenoic acid, hydroxy 
substituted[(oxoalkyl)oxy]alkyl ester, reaction products with alkanoic 
acid, dipentaerythritil and isocyanate substituted carbomonocycle, 
compds. with alkylamine (generic).
    CAS number: Not available.
    Effective date of TSCA section 5(e) Order: June 31, 2017.
    Basis for TSCA section 5(e) Order: The PMN states that the 
substance will be used as a UV curable coating resin. Based on test 
data on structurally similar substances, EPA has identified concerns 
for irritation, sensitization, developmental effects, internal organ 
effects (liver and kidney), and cancer. 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 these risks, the Order 
requires:
    1. Use of personal protective equipment including impervious gloves 
to prevent dermal exposure (where there is a potential for dermal 
exposure).
    2. Establishment and use of a hazard communication program, 
including human health precautionary statements on each label and in 
the SDS.
    3. No domestic manufacture of the substance.
    4. No manufacture, process, or use of the substance that results in 
generation of a vapor, mist, or aerosol.
    5. No manufacture of the substance where there is more than 0.1% 
residual isocyanate by weight.
    6. Use of the substance only as a UV curable coating resin.
    7. Only import the substance in totes.
    8. Manufacture of the substance to have an average molecular weight 
of greater than 2,000 daltons.
    The SNUR would designate as a ``significant new use'' the absence 
of these protective measures.
    Potentially useful information: EPA has determined that certain 
information about the human health toxicity of the PMN substance may be 
potentially useful to characterize the effects of the PMN substances 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 reproductive/developmental toxicity 
testing 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, distribution in 
commerce, and use 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 721.11084.

PMN Number: P-17-15

    Chemical name: Heteromonocycle ester with alkanediol (generic).
    CAS numbers: Not available.
    Effective date of TSCA section 5(e) Order: June 13, 2017.
    Basis for TSCA section 5(e) Order: The PMN states that the generic 
(non-confidential) use of the PMN substance is a precursor for a 
photochromatic substance. Based on SAR analysis of test data on 
analogous esters, EPA has identified concerns for irritation to skin, 
eye, and mucous membrane, and systemic toxicity. Further, based on SAR 
analysis of test data on analogous nonionic esters, EPA predicts 
toxicity to aquatic organisms may occur at concentrations that exceed 3 
ppb of the PMN substance in surface waters. The Order was issued under 
TSCA sections 5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on a 
finding that the substances may present an unreasonable risk of injury 
to health and the environment. 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. To protect against these risks, the 
Order requires:
    1. Submission of certain toxicity testing on the substance prior to 
exceeding the confidential production volume limit specified in the 
Order.
    2. Use of personal protective equipment including impervious gloves 
to prevent dermal exposure (where there is a potential for dermal 
exposure).
    3. Establishment and use of a hazard communication program, 
including human health precautionary statements on each label and in 
the SDS.
    4. No domestic manufacture of the substance.
    5. No use of the substance other than other than for the 
confidential uses identified in the Order.

[[Page 40993]]

    6. No release of the substance resulting in surface water 
concentrations that exceed 3 ppb.
    The SNUR would designate as a ``significant new use'' the absence 
of these protective measures.
    Potentially useful information: EPA has determined that certain 
information about the human health and aquatic 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 reproductive/developmental toxicity and acute 
aquatic toxicity testing.
    CFR citation: 40 CFR 721.11085.

PMN Number: P-17-29

    Chemical name: Substituted carbomonocycle, polymer with 
(aminoalkyl)-alkanediamine, (haloalkyl)oxirane, dialkyl-alkanediamine 
and alkyl-alkanamine, reaction products with dialkanolamine and 
[[(alkyl)oxy]alkyl]oxirane (generic).
    CAS number: Not available.
    Effective date of TSCA section 5(e) Order: May 10, 2017.
    Basis for TSCA section 5(e) Order: The PMN states that the generic 
(non-confidential) use of the substance is an intermediate prepolymer. 
Based on the physical/chemical properties of the substance and SAR 
analysis of test data on analogous aliphatic amines, EPA has identified 
concerns for irritation, lung effects, and aquatic toxicity. The Order 
was issued under TSCA sections 5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), 
based on a finding that the substance may present an unreasonable risk 
of injury to health and the environment. To protect against these 
risks, the Order requires:
    1. Submission of certain toxicity testing on the substance prior to 
exceeding the confidential production volume limit specified in the 
Order.
    2. Use of personal protective equipment including impervious gloves 
to prevent dermal exposure (where there is a potential for dermal 
exposure).
    3. Establishment and use of a hazard communication program, 
including human health precautionary statements on each label and in 
the SDS.
    4. No use other than for the confidential uses identified in the 
Order.
    5. No use involving an application method that generates a vapor, 
mist, or aerosol.
    6. No domestic manufacture of the substance.
    The SNUR would designate as a ``significant new use'' the absence 
of these protective measures.
    Potentially useful information: EPA has determined that certain 
information about the human health and aquatic 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 irritation and acute aquatic toxicity testing. 
In addition, EPA has determined that the results of a pulmonary effects 
testing 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 721.11086.

PMN Numbers: P-17-154, P-17-155, and P-17-156

    Chemical names: Carboxylic acid amine (1:1) (generic) (P-17-154), 
Mix fatty acids compd. with amine (1:1) (generic) (P-17-155), and Mix 
fatty acids compd. with amine (1:1) (generic) (P-17-156).
    CAS number: Not available.
    Effective date of TSCA section 5(e) Order: June 15, 2017.
    Basis for TSCA section 5(e) Order: The PMN states that the generic 
(non-confidential) use of the substances is as a coating. Based on 
physical/chemical properties of the substances and SAR analysis of test 
data on amines, EPA identified concerns for irritation, corrosion, 
developmental toxicity, reproductive toxicity, neurotoxicity, and 
thyroid toxicity. Further, based on test data on analogous anionic 
surfactants and aliphatic amines, EPA identified concern for toxicity 
to aquatic organisms at surface water concentrations that exceed 240 
ppb. 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. EPA's 
estimates indicate that variations of the parameters (including batch 
size, number of processing sites, days per year of operation) of the 
uses for the chemical substance would not result in increased 
inhalation exposure. To protect against these risks, the Order 
requires:
    1. Submission of certain toxicity testing on the substances prior 
to 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 exposure).
    3. Establishment and use of a hazard communication program, 
including human health and environmental precautionary statements on 
each label and in the SDS.
    The SNUR would designate as a ``significant new use'' the absence 
of these protective measures.
    Potentially useful information: EPA has determined that certain 
information about the human health toxicity of the PMN substances may 
be potentially useful to characterize the effects of the PMN substances 
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 to not exceed a confidential production volume without 
performing reproductive/developmental toxicity testing.
    CFR citation: 40 CFR 721.11087 (P-17-154), 40 CFR 721.11088 (P-17-
155), 40 CFR 721.11089 (P-17-156).

PMN Number: P-17-218

    Chemical name: Bicyclo[2.2.1]heptane-1-methanesulfonic acid, 7,7-
dimethyl-2-oxo-, compd. with N,N-diethylethanamine (1:1).
    CAS number: 67019-84-5.
    Effective date of TSCA section 5(e) Order: May 19, 2017.
    Basis for TSCA section 5(e) Order: The PMN states that the generic 
(non-confidential) use of the substance is a processing aid for 
membrane production. Based on SAR analysis of test data on structurally 
similar respirable particles, EPA identified concerns for corrosivity, 
irritation, sensitization, developmental toxicity, specific target 
organ toxicity, and neurotoxicity. 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 these risks, the Order 
requires:
    1. Submission of certain toxicity testing on the substance prior to

[[Page 40994]]

exceeding the confidential production volume limit specified in the 
Order.
    2. Use of personal protective equipment including impervious gloves 
to prevent dermal exposure (where there is a potential for dermal 
exposure).
    3. Establishment and use of a hazard communication program, 
including human health precautionary statements on each label and in 
the SDS.
    4. No manufacture, processing, or use involving an application 
method that generates a vapor, mist, aerosol, or dust.
    The SNUR would designate as a ``significant new use'' the absence 
of these protective measures.
    Potentially useful information: EPA has determined that certain 
information about the human health 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 a skin sensitization study. In addition, EPA has determined 
that the results of reproductive/developmental toxicity testing 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, and use 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 721.11090.

PMN Number: P-17-226

    Chemical name: Manganese(2+), bisoctahydro-1,4,7-trimethyl-1H-
1,4,7-triazonine-.kappa.N1,.kappa.N4,.kappa.N7)tri-.mu.-oxidi-, 
hexafluorophosphate(1-) (1:2).
    CAS number: 116633-52-4.
    Effective date of TSCA section 5(e) Order: June 15, 2017.
    Basis for TSCA section 5(e) Order: The PMN states the generic (non-
confidential) use of the substance will be as a detergent additive. 
Based on test data on the substance and analogue test data, EPA has 
identified concerns for eye irritation, thyroid, blood, and liver 
toxicity, male reproductive toxicity, neurotoxicity, immunosuppression, 
respiratory sensitization, and mutagenicity. Based on test data on the 
substance and test data on analogous neutral organics, EPA identified 
concern for toxicity to aquatic organisms at surface water 
concentrations that exceed 240 ppb. 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 these risks, the Order 
requires:
    1. Use of personal protective equipment to prevent dermal exposure 
(where there is a potential for dermal exposure).
    2. Establishment and use of a hazard communication program, 
including human health precautionary statements on each label and in 
the SDS.
    3. No use other than the confidential use allowed in the Order.
    4. No domestic manufacture of the substance.
    5. No processing without appropriate engineering controls to 
prevent inhalation exposure, including dust removal with 99.9% 
efficiency when loading or unloading the substance in powder form.
    6. No release of the substance resulting in surface water 
concentrations that exceed 240 ppb.
    The SNUR would designate as a ``significant new use'' the absence 
of these protective measures.
    Potentially useful information: EPA has determined that certain 
information about the human health 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. EPA has 
determined that the results of specific target organ toxicity testing 
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, and use 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 721.11091.

PMN Numbers: P-17-228 and P-17-229

    Chemical names: 2'-Fluoro-4''-alkyl-4-propyl-1,1':4'1''-terphenyl 
(generic) (P-17-228) and 4-ethyl-2'-fluoro-4''-alkyl-1,1':4'1''-
terphenyl (generic) (P-17-229).
    CAS numbers: Not available.
    Effective date of TSCA section 5(e) Order: May 18, 2017.
    Basis for TSCA section 5(e) Order: The PMN states that the generic 
(non-confidential) use of the substances is a coating for displays. 
Based on the physical/chemical properties of the substances (as 
described in the New Chemical Program's PBT category at 64 FR 60194; 
November 4, 1999; FRL-6097-7) and test data on structurally similar 
substances, the substances are potentially persistent, bioaccumulative, 
and toxic (PBT) chemicals. EPA estimates that the substances will 
persist in the environment more than 2 months and estimates a 
bioaccumulation factor of greater than or equal to 1,000. Further, 
based on test data on structurally similar chemicals, EPA has 
identified concerns for reproductive effects, adrenal and liver 
toxicity. The Order was issued under TSCA sections 5(a)(3)(B)(ii)(I) 
and 5(e)(1)(A)(ii)(I), based on a finding that the substances may 
present an unreasonable risk of injury to health and the environment. 
To protect against these risks, the Order requires:
    1. Use of personal protective equipment including impervious gloves 
to prevent dermal exposure (where there is a potential for dermal 
exposure).
    2. Establishment and use of a hazard communication program, 
including human health precautionary statements on each label and in 
the SDS.
    3. No manufacture beyond the confidential annual production volume 
limit specified in the Order.
    4. No processing or use of the substances in an application method 
that generates a dust, mist, or aerosol.
    The SNUR would designate as a ``significant new use'' the absence 
of these protective measures.
    Potentially useful information: EPA has determined that certain 
information about the fate and human health toxicity of the PMN 
substances may be potentially useful to characterize the effects of the 
PMN substances 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 biodegradation and reproductive/
developmental toxicity testing of the PMN substances may be potentially 
useful in characterizing the 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

[[Page 40995]]

information that EPA determines is relevant and needed to evaluate a 
modification request.
    CFR citations: 40 CFR 721.11092 (P-17-228) and 40 CFR 721.11093 (P-
17-229).

PMN Number: P-17-261

    Chemical name: Poly(oxy-1,2-ethanediyl),-.alpha.-(2-
benzoylbenzoyl)-.omega.-[(2-benzoylbenzoyl)oxy]-.
    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 
substance will be used as a difunctional type II photoinitiator for use 
in inks and coatings. Based on physical/chemical properties, SAR 
analysis and test data on analogous esters with branched polyols, EPA 
has identified concerns for corrosion of the skin, eyes, and mucous 
membranes, developmental toxicity, systemic toxicity, and blood 
effects. 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. 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 for the chemical substance would not result in 
increased inhalation exposure. To protect against these risks, the 
Order requires:
    1. Submission of certain toxicity testing on the substance prior to 
exceeding the confidential production volume limit specified in the 
Order.
    2. Use of personal protective equipment including impervious gloves 
(where there is a potential for dermal exposure).
    3. Establishment and use of a hazard communication program, 
including human health precautionary statements on each label and in 
the SDS.
    4. No domestic manufacture of the substance.
    The SNUR would designate as a ``significant new use'' the absence 
of these protective measures.
    Potentially useful information: EPA has determined that certain 
information about the human health 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 in the Order 
without performing irritation testing.
    CFR citation: 40 CFR 721.11094.

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 27 chemical 
substances regulation was warranted under TSCA section 5(e), pending 
the development of information sufficient to make reasoned evaluations 
of the health or environmental effects of the chemical substances. The 
basis for such findings is outlined in Unit IV. Based on these 
findings, TSCA section 5(e) 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:
     EPA will receive notice of any person's intent to 
manufacture or process a listed chemical substance for the described 
significant new use before that activity begins.
     EPA will have an opportunity to review and evaluate data 
submitted in a SNUN before the notice submitter begins manufacturing or 
processing a listed chemical substance for the described significant 
new use.
     EPA will be able to either determine that the prospective 
manufacture or processing is not likely to present an unreasonable 
risk, or to take necessary regulatory action associated with any other 
determination, before the described significant new use of the chemical 
substance occurs.
     EPA will 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 direct final rules. The effective 
date of these rules is September 17, 2018 without further notice, 
unless EPA receives written adverse comments before September 17, 2018.
    If EPA receives written adverse comments on one or more of these 
SNURs before September 17, 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 13 
of the 27 chemical substances subject to this rule have been claimed as 
confidential and EPA has received no post-PMN bona fide submissions 
(per Sec. Sec.  720.25 and 721.11) 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.

[[Page 40996]]

    Therefore, EPA designates August 17, 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.
    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 are 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 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.
    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:
     Human exposure and environmental release that may result 
from the significant new use of the chemical substances.
     Information on risks posed by the chemical substances 
compared to risks posed by potential substitutes.

IX. Procedural Determinations

    By this rule, EPA is establishing certain significant new uses 
which have been claimed as CBI subject to Agency confidentiality 
regulations at 40 CFR part 2 and 40 CFR part 720, subpart E. Absent a 
final determination or other disposition of the confidentiality claim 
under 40 CFR part 2 procedures, EPA is required to keep this 
information confidential. EPA promulgated a procedure to deal with the 
situation where a specific significant new use is CBI, at Sec.  
721.1725(b)(1).
    Under these procedures a manufacturer or processor may request EPA 
to determine whether a proposed use would be a significant new use 
under the rule. The manufacturer or processor must show that it has a 
bona fide intent to manufacture or process the chemical substance and 
must identify the specific use for which it intends to manufacture or 
process the chemical substance. If EPA concludes that the person has 
shown a bona fide intent to manufacture or process the chemical 
substance, EPA will tell the person whether the use identified in the 
bona fide submission would be a significant new use under the rule. 
Since most of the chemical identities of the chemical substances 
subject to these SNURs are also CBI, manufacturers and processors can 
combine the bona fide submission under the procedure in Sec.  
721.1725(b)(1) with that under Sec.  721.11 into a single step.
    If EPA determines that the use identified in the bona fide 
submission would not be a significant new use, i.e., the use does not 
meet the criteria specified in the rule for a significant new use, that 
person can manufacture or process the chemical substance so long as the 
significant new use trigger is not met. In the case of a production 
volume trigger, this means that the aggregate annual production volume 
does not exceed that identified in the bona fide submission to EPA. 
Because of confidentiality concerns, EPA does not typically disclose 
the actual production volume that constitutes the use trigger. Thus, if 
the person later intends to exceed that volume, a new bona fide 
submission would be necessary to determine whether that higher volume 
would be a significant new use.

[[Page 40997]]

X. SNUN Submissions

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

XI. Economic Analysis

    EPA has evaluated the potential costs of establishing SNUN 
requirements for potential manufacturers and processors of the chemical 
substances subject to this rule. EPA's complete economic analysis is 
available in the docket under docket ID number EPA-HQ-OPPT-2017-0414.

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

C. Regulatory Flexibility Act (RFA)

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

D. Unfunded Mandates Reform Act (UMRA)

    Based on EPA's experience with proposing and finalizing SNURs, 
State, local, and Tribal governments have not been impacted by these 
rulemakings, and EPA does not have any reasons to believe that any 
State, local, or Tribal government will be impacted by this action. As 
such, EPA has determined 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

[[Page 40998]]

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 3, 2018.
Mark A. Hartman,
Acting Director, Office of Pollution Prevention and Toxics.

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

PART 9--[AMENDED]

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

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


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


Sec.  9.1   OMB approvals under the Paperwork Reduction Act.

* * * * *

------------------------------------------------------------------------
                                                                  OMB
                       40 CFR citation                          control
                                                                  No.
------------------------------------------------------------------------
 
                                * * * * *
------------------------------------------------------------------------
               Significant New Uses of Chemical Substances
------------------------------------------------------------------------
 
                                * * * * *
721.11068...................................................   2070-0012
721.11069...................................................   2070-0012
721.11070...................................................   2070-0012
721.11071...................................................   2070-0012
721.11072...................................................   2070-0012
721.11073...................................................   2070-0012
721.11074...................................................   2070-0012
721.11075...................................................   2070-0012
721.11076...................................................   2070-0012
721.11077...................................................   2070-0012
721.11078...................................................   2070-0012
721.11079...................................................   2070-0012
721.11080...................................................   2070-0012
721.11081...................................................   2070-0012
721.11082...................................................   2070-0012
721.11083...................................................   2070-0012
721.11084...................................................   2070-0012
721.11085...................................................   2070-0012
721.11086...................................................   2070-0012
721.11087...................................................   2070-0012
721.11088...................................................   2070-0012
721.11089...................................................   2070-0012
721.11090...................................................   2070-0012
721.11091...................................................   2070-0012
721.11092...................................................   2070-0012
721.11093...................................................   2070-0012
721.11094...................................................   2070-0012
 
                                * * * * *
------------------------------------------------------------------------

* * * * *

PART 721--[AMENDED]

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

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


0
4. Add Sec.  721.11068 to subpart E to read as follows:


Sec.  721.11068   Alkanes, C20-28, chloro.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified as alkanes, 
C20-28, chloro (PMN P-12-277, CAS No. 2097144-43-7) is 
subject to reporting under this section for the significant new uses 
described in paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80(k) (flame retardants and plasticizers in 
polyvinyl chloride, polymers, and rubber; flame retardant, plasticizer, 
and lubricant in adhesives, caulk, sealants, and coatings; additive in 
lubricants including metalworking fluids; and flame retardant and 
waterproofer in textiles). It is a significant new use to manufacture 
the chemical substance more than 5 years.
    (ii) [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph (b).
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125(a) through (c) and (i) are applicable to manufacturers and 
processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.

0
5. Add Sec.  721.11069 to subpart E to read as follows:


Sec.  721.11069   Slack waxes (petroleum), chloro.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified as slack waxes 
(petroleum), chloro (PMN P-12-278, CAS No. 2097144-44-8) 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) (flame retardants and plasticizers in 
polyvinyl chloride, polymers, and rubber; flame retardant, plasticizer, 
and lubricant in adhesives, caulk, sealants, and coatings; additive in 
lubricants including metalworking fluids; and flame retardant and 
waterproofer in textiles). It is a significant new use to manufacture 
the chemical substance more than 5 years.
    (ii) [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph (b).
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125(a) through (c) and (i) are applicable to manufacturers and 
processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.

0
6. Add Sec.  721.11070 to subpart E to read as follows:

[[Page 40999]]

Sec.  721.11070   Hexacosane, chloro derivs. and octacosane, chloro 
derivs.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified as hexacosane, chloro 
derivs. and octacosane, chloro derivs. (PMN P-12-280, CAS Nos. 2097144-
46-0 and 2097144-47-1) is subject to reporting under this section for 
the significant new uses described in paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80(k) (flame retardants and plasticizers in 
polyvinyl chloride, polymers, and rubber; flame retardant, plasticizer, 
and lubricant in adhesives, caulk, sealants, and coatings; additive in 
lubricants including metalworking fluids; and flame retardant and 
waterproofer in textiles). It is a significant new use to manufacture 
the chemical substance more than 5 years.
    (ii) [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph (b).
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125(a) through (c) and (i) are applicable to manufacturers and 
processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.

0
7. Add Sec.  721.11071 to subpart E to read as follows:


Sec.  721.11071   Alkanes, C20-24, chloro.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified as alkanes, 
C20-24, chloro (PMN P-12-281, CAS No. 2097144-45-9) is 
subject to reporting under this section for the significant new uses 
described in paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80(k) (flame retardants and plasticizers in 
polyvinyl chloride, polymers, and rubber; flame retardant, plasticizer, 
and lubricant in adhesives, caulk, sealants, and coatings; additive in 
lubricants including metalworking fluids; and flame retardant and 
waterproofer in textiles). It is a significant new use to manufacture 
the chemical substance more than 5 years.
    (ii) [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph (b).
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125(a) through (c) and (i) are applicable to manufacturers and 
processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.

0
8. Add Sec.  721.11072 to subpart E to read as follows:


Sec.  721.11072   Alkanes, C14-16, chloro.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified as alkanes, 
C14-16, chloro (PMNs P-12-282 and P-14-684, CAS No. 1372804-
76-6) is subject to reporting under this section for the significant 
new uses described in paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80(k) (flame retardants and plasticizers in 
polyvinyl chloride, polymers, and rubber; flame retardant, plasticizer, 
and lubricant in adhesives, caulk, sealants, and coatings; additive in 
lubricants including metalworking fluids; and flame retardant and 
waterproofer in textiles). It is a significant new use to manufacture 
the chemical substance more than 5 years.
    (ii) [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph (b).
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125(a) through (c) and (i) are applicable to manufacturers and 
processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.

0
9. Add Sec.  721.11073 to subpart E to read as follows:


Sec.  721.11073   Tetradecane, chloro derivs.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified as tetradecane, chloro 
derivs. (PMNs P-12-283 and P-14-683, CAS No. 198840-65-2) is subject to 
reporting under this section for the significant new uses described in 
paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80(k) (flame retardants and plasticizers in 
polyvinyl chloride, polymers, and rubber; flame retardant, plasticizer, 
and lubricant in adhesives, caulk, sealants, and coatings; additive in 
lubricants including metalworking fluids; and flame retardant and 
waterproofer in textiles). It is a significant new use to manufacture 
the chemical substance more than 5 years.
    (ii) [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph (b).
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125(a) through (c) and (i) are applicable to manufacturers and 
processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.

0
10. Add Sec.  721.11074 to subpart E to read as follows:


Sec.  721.11074   Octadecane, chloro derivs.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified as octadecane, chloro 
derivs. (PMN P-12-284, CAS No. 2097144-48-2) is subject to reporting 
under this section for the significant new uses described in paragraph 
(a)(2) of this section.
    (2) The significant new uses are:
    (i) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80(k) (flame retardants and plasticizers in 
polyvinyl chloride, polymers, and rubber; flame retardant, plasticizer, 
and lubricant in adhesives, caulk, sealants, and coatings; additive in 
lubricants including metalworking fluids; and flame retardant and 
waterproofer in textiles). It is a significant new use to manufacture 
the chemical substance more than 5 years.
    (ii) [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph (b).
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125(a) through (c) and (i) are applicable to manufacturers and 
processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.

0
11. Add Sec.  721.11075 to subpart E to read as follows:


Sec.  721.11075   Alkanes, C18-20, chloro.

    (a) Chemical substance and significant new uses subject to 
reporting.

[[Page 41000]]

(1) The chemical substance identified as alkanes, C18-20, 
chloro (PMN P-12-433, CAS No. 106262-85-3) is subject to reporting 
under this section for the significant new uses described in paragraph 
(a)(2) of this section.
    (2) The significant new uses are:
    (i) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80(k) (flame retardants and plasticizers in 
polyvinyl chloride, polymers, and rubber; flame retardant, plasticizer, 
and lubricant in adhesives, caulk, sealants, and coatings; additive in 
lubricants including metalworking fluids; and flame retardant and 
waterproofer in textiles). It is a significant new use to manufacture 
the chemical substance more than 5 years.
    (ii) [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph (b).
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125(a) through (c) and (i) are applicable to manufacturers and 
processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.

0
12. Add Sec.  721.11076 to subpart E to read as follows:


Sec.  721.11076   Alkanes, C14-17, chloro.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified as alkanes, 
C14-17, chloro (PMN P-12-453, CAS No. 85535-85-9) is subject 
to reporting under this section for the significant new uses described 
in paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80(k) (flame retardants and plasticizers in 
polyvinyl chloride polymers, and rubber; flame retardant, plasticizer, 
and lubricant in adhesives, caulk, sealants, and coatings; additive in 
lubricants including metalworking fluids; and flame retardant and 
waterproofer in textiles). It is a significant new use to manufacture 
the chemical substance more than 5 years.
    (ii) [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph (b).
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125(a) through (c) and (i) are applicable to manufacturers and 
processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.

0
13. Add Sec.  721.11077 to subpart E to read as follows:


Sec.  721.11077   Alkanes, C22-30, chloro.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified as alkanes, 
C22-30, chloro (PMN P-12-505, CAS No. 288260-42-4) is 
subject to reporting under this section for the significant new uses 
described in paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80(k) (flame retardants and plasticizers in 
polyvinyl chloride, polymers, and rubber; flame retardant, plasticizer, 
and lubricant in adhesives, caulk, sealants, and coatings; additive in 
lubricants including metalworking fluids; and flame retardant and 
waterproofer in textiles). It is a significant new use to manufacture 
the chemical substance more than 5 years.
    (ii) [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph (b).
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125(a) through (c) and (i) are applicable to manufacturers and 
processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.

0
14. Add Sec.  721.11078 to subpart E to read as follows:


Sec.  721.11078   Chloroflurocarbon (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 
chloroflurocarbon (PMN P-16-150) is subject to reporting under this 
section for the significant new uses described in paragraph (a)(2) of 
this section.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in Sec.  
721.63(a)(1), (3), and (4), when determining which persons are 
reasonably likely to be exposed as required for Sec.  721.63(a)(1) and 
(4), engineering control measures (e.g., enclosure or confinement of 
the operation, general and local ventilation) or administrative control 
measures (e.g., workplace policies and procedures) shall be considered 
and implemented to prevent exposure, where feasible, (a)(5) 
(respirators must provide a National Institute for Occupational Safety 
and Health (NIOSH) assigned protection factor (APF) of at least 1,000), 
(a)(6) (liquid), 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 170 ppb 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 (d), (f), (g)(1) (fatal if inhaled), (g)(2)(ii), 
(iv), (use respiratory protection or maintain workplace airborne 
concentrations at or below an 8-hour time-weighted average of 170 ppb), 
(g)(2)(v), (g)(3)(i), (ii), (g)(4) (release to water 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(a) through (c), (g), and (q). It is a 
significant new use to manufacture, process, or use the PMN substance 
without the engineering controls described in the corresponding TSCA 
section 5(e) Order to prevent worker and environmental exposures. It is 
a significant new use to manufacture the chemical substance more than 
one year.
    (iv) Release to water. Requirements as specified in Sec.  
721.90(a)(4), (b)(4), and (c)(4) where N = 240.
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph (b).
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125(a) through (i) and (k) are applicable to manufacturers and 
processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.

[[Page 41001]]

    (3) Determining whether a specific use is subject to this section. 
The provisions of Sec.  721.1725(b)(1) apply to paragraph (a)(2)(iii) 
of this section.

0
15. Add Sec.  721.11079 to subpart E to read as follows:


Sec.  721.11079   Silane, 1,1'-(1,2-ethanediyl)bis[1,1-dichloro-1-
methyl]-, hydrolysis products with chloroethenyldimethylsilane.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified as Silane, 1,1'-(1,2-
ethanediyl)bis[1,1-dichloro-1-methyl]-, hydrolysis products with 
chloroethenyldimethylsilane (PMN P-16-379, CAS No. 1485477-78-8) 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 at 1.0%), 
and (c).
    (ii) Hazard communication. Requirements as specified in Sec.  
721.72(a) through (e)(concentration set at 1.0%), (f), (g)(1) (liver 
toxicity), (mutagenicity), (g)(2)(i), (ii), (iii), (v), (g)(4)(i), (do 
not incinerate), 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), (q), (y)(1) and (2).
    (iv) Disposal. Requirements as specified in Sec.  721.85(a) 
(water), (a)(2), (b) (water), (b)(2), (c) (water), and (c)(2).
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph (b).
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125(a) through (j) are applicable to manufacturers and processors 
of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.
    (3) Determining whether a specific use is subject to this section. 
The provisions of Sec.  721.1725(b)(1) apply to paragraph (a)(2)(iii) 
of this section.

0
16. Add Sec.  721.11080 to subpart E to read as follows:


Sec.  721.11080   Silicophosphonate--sodium silicate (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 
silicophosphonate--sodium silicate (PMN P-16-410) is subject to 
reporting under this section for the significant new uses described in 
paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80(f) and (k). A significant new use is any 
use in formulations containing greater than 0.2% of the chemical 
substance.
    (ii) [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph (b).
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125(a) through (c) and (i) are applicable to manufacturers and 
processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.
    (3) Determining whether a specific use is subject to this section. 
The provisions of Sec.  721.1725(b)(1) apply to paragraph (a)(2)(i) of 
this section.

0
17. Add Sec.  721.11081 to subpart E to read as follows:


Sec.  721.11081   3-Butenenitrile, 2-(acetyloxy).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified as 3-butenenitrile, 2-
(acetyloxy) (PMN P-16-438, CAS No. 15667-63-7) is subject to reporting 
under this section for the significant new uses described in paragraph 
(a)(2) of this section.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in Sec.  
721.63(a)(1), (a)(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 (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 1000), (a)(6)(particulate), (a)(6)(v), (vi), 
(b)(concentration set at 1.0%), and (c). It is a significant new use to 
manufacture, process or use the substance without following the 
monitoring procedure as specified in the worker protection section of 
the corresponding TSCA section 5(e) Order.
    (ii) Hazard communication. Requirements as specified in Sec.  
721.72(a) through (e)(concentration set at 1.0%), (f), (g)(1) (fatal if 
swallowed), (fatal if in contact with skin), (toxic if inhaled), 
(g)(2)(i), (ii), (iii), (iv), (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(g). It is a significant new use to 
manufacture or use the substance other than in an enclosed system as 
described in the PMN.
    (iv) Release to water. Requirements as specified in Sec.  
721.90(a)(1), (b)(1), and (c)(1).
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph (b).
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125(a) through (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
18. Add Sec.  721.11082 to subpart E to read as follows:


Sec.  721.11082   Halogenophosphoric acid metal salt (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 
halogenophosphoric acid metal salt (PMN P-16-543) is subject to 
reporting under this section for the significant new uses described in 
paragraph (a)(2) of this section.
    (2) The significant new uses are:

[[Page 41002]]

    (i) Protection in the workplace. Requirements as specified in Sec.  
721.63(a)(1), (a)(2)(the confidential dermal protection described in 
the corresponding TSCA section 5(e) Order ``the Order''), (a)(2)(ii), 
(iii), (iv), (a)(3), (a)(4), when determining which persons are 
reasonably likely to be exposed as required for Sec.  721.63(a)(1) and 
(4), engineering control measures (e.g., enclosure or confinement of 
the operation, general and local ventilation) or administrative control 
measures (e.g., workplace policies and procedures) shall be considered 
and implemented to prevent exposure, where feasible, (a)(5) 
(respirators must provide a National Institute for Occupational Safety 
and Health (NIOSH) assigned protection factor of at least 1,000), 
(a)(6) (particulate), (a)(6)(v), (vi), (b)(concentration set at 0.1%), 
and (c). It is a significant new use to manufacture, process or use the 
substance without following the monitoring procedure as specified in 
the worker protection section of the Order.
    (ii) Hazard communication. Requirements as specified in Sec.  
721.72(a) through (e) (concentration set at 0.1%), (f), (g)(1)(i), 
(ii), (iii), (iv), (v), (vii), (viii), (ix), (g)(2)(i), (ii), (iii), 
(use protective engineering controls or equipment for dermal and 
inhalation protection, (g)(3)(i), (ii), (g)(4)(i), (ii), (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(c), (f), and (k). It is a significant new 
use to vary or alter, the manufacturing, processing, and use, 
distribution/transportation, treatment and disposal processes, process 
equipment, engineering controls, and handling practices (including 
worker activities and cleaning procedures) described in the PMN in such 
a way as to increase the magnitude of inhalation exposure.
    (iv) Disposal. Requirements as specified in Sec.  721.85. It is a 
significant new use to dispose of the substance other than by hazardous 
waste incineration according to 40 CFR parts 260 through 299 unless the 
substance is in waste water. When the substance is in wastewater it may 
be disposed of as required in paragraph (a)(2)(v) of this section.
    (v) Release to water. Requirements as specified in Sec.  
721.90(a)(4), (b)(4), and (c)(4) where N=3.
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph (b).
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125(a) through (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 paragraphs (a)(2)(i) 
and (iii) of this section.

0
19. Add Sec.  721.11083 to subpart E to read as follows:


Sec.  721.11083   Alkenoic acid, reaction products with polyethylene 
glycol ether with hydroxyalkyl substituted alkane (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 
alkenoic acid, reaction products with polyethylene glycol ether with 
hydroxyalkyl substituted alkane (PMN P-16-596) 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), (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 at 0.1%), and (c).
    (ii) Hazard communication. Requirements as specified in Sec.  
721.72 (a) through (e)(concentration set at 0.1%), (f), (g)(1)(i), 
(dermal sensitization), (g)(1)(iv), (cancer, if inhaled), (g)(1)(ix), 
(g)(2)(i), (ii), (iii), (v), (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), (k), and (q).
    (iv) Release to water. Requirements as specified in Sec.  
721.90(a)(1), (b)(1), and (c)(1).
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph (b).
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125(a) through (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
20. Add Sec.  721.11084 to subpart E to read as follows:


Sec.  721.11084   Alkyl substituted alkenoic acid, alkyl ester, polymer 
with alkyl substituted alkenoate and alkenoic acid, hydroxy 
substituted[(oxoalkyl)oxy]alkyl ester, reaction products with alkanoic 
acid, dipentaerythritil and isocyanate substituted carbomonocycle, 
compds. with alkylamine (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as alkyl 
substituted alkenoic acid, alkyl ester, polymer with alkyl substituted 
alkenoate and alkenoic acid, hydroxy substituted[(oxoalkyl)oxy]alkyl 
ester, reaction products with alkanoic acid, dipentaerythritil and 
isocyanate substituted carbomonocycle, compds. with alkylamine (PMN P-
17-10) 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), (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 at 0.1%), 
and (c).
    (ii) Hazard communication. Requirements as specified in Sec.  
721.72(a) through (e) (concentration set at 0.1%), (f), (g)(1)(i), 
(sensitization), (g)(1)(vii), (systemic effects), (g)(1)(ix), 
(g)(2)(i), (ii), (iii), (v), and (g)(5). Alternative hazard and warning 
statements that meet the criteria of the Globally Harmonized System 
(GHS) and OSHA Hazard Communication Standard may be used.

[[Page 41003]]

    (iii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80(f), (k) (ultraviolet curable coating 
resin), and (y)(1). It is a significant new use to manufacture the 
chemical substance with an average molecular weight below 2,000 daltons 
or containing greater than 0.1% residual isocyanate. It is a 
significant new use to import the substance other than in totes.
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph (b).
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125(a) through (i) are applicable to manufacturers and processors 
of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.

0
21. Add Sec.  721.11085 to subpart E to read as follows:


Sec.  721.11085   Heteromonocycle ester with alkanediol (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 
heteromonocycle ester with alkanediol (PMN P-17-15) 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), (iii), (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, (b) (concentration set at 1.0%), and (c).
    (ii) Hazard communication. Requirements as specified in Sec.  
721.72(a) through (e) (concentration set at 1.0%), (f), (g)(1)(i), 
(g)(2)(i), (ii), (iii), (v), (g)(3)(i), (ii), (g)(4) (release to water 
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).
    (iv) Release to water. Requirements as specified in Sec.  
721.90(a)(4), (b)(4), and (c)(4) where N=3.
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph (b).
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125(a) through (i) 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.  721.11086 to subpart E to read as follows:


Sec.  721.11086   Substituted carbomonocycle, polymer with 
(aminoalkyl)-alkanediamine, (haloalkyl)oxirane, dialkyl-alkanediamine 
and alkyl-alkanamine, reaction products with dialkanolamine and 
[[(alkyl)oxy]alkyl]oxirane (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 
substituted carbomonocycle, polymer with (aminoalkyl)-alkanediamine, 
(haloalkyl)oxirane, dialkyl-alkanediamine and alkyl-alkanamine, 
reaction products with dialkanolamine and [[(alkyl)oxy]alkyl]oxirane 
(PMN P-17-29) 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 at 1.0%), and (c).
    (ii) Hazard communication. Requirements as specified in Sec.  
721.72(a) through (e) (concentration set at 1.0%), (f), (g)(1)(i), (eye 
irritation), (g)(1)(ii), (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), (k), (q), and (y)(1).
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph (b).
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125(a) 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
23. Add Sec.  721.11087 to subpart E to read as follows:


Sec.  721.11087   Carboxylic acid amine (1:1) (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 
carboxylic acid amine (1:1) (PMN P-17-154) 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), (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 at 1.0%), and (c).
    (ii) Hazard communication. Requirements as specified in Sec.  
721.72(a) through (e) (concentration set at 1.0%), (f), (g)(1)(i), 
(ii), (iii), (thyroid effects), (g)(1)(vi), (ix), (g)(2)(i), (ii), 
(iii), (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(q).

[[Page 41004]]

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

0
24. Add Sec.  721.11088 to subpart E to read as follows:


Sec.  721.11088   Mix fatty acids compd with amine (1:1) (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as mix 
fatty acids compd with amine (1:1) (PMN P-17-155) 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), (ii), (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 at 1.0%), and (c).
    (ii) Hazard communication. Requirements as specified in Sec.  
721.72(a) through (e)(concentration set at 1.0%), (f), (g)(1)(i), (ii), 
(iii), (thyroid effects), (g)(1)(vi), (ix), (g)(2)(i), (ii), (iii), 
(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(q).
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph (b).
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125(a) through (i) are applicable to manufacturers and processors 
of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.
    (3) Determining whether a specific use is subject to this section. 
The provisions of Sec.  721.1725(b)(1) apply to paragraph (a)(2)(iii) 
of this section.

0
25. Add Sec.  721.11089 to subpart E to read as follows:


Sec.  721.11089   Mix fatty acids compd with amine (1:1) (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as mix 
fatty acids compd with amine (1:1) (PMN P-17-156) 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), (iii), (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 a 1.0%), and (c).
    (ii) Hazard communication. Requirements as specified in Sec.  
721.72(a) through (e)(concentration set at 1.0%), (f), (g)(1)(i), (ii), 
(iii), (thyroid effects), (g)(1)(vi), (ix), (g)(2)(i), (ii), (iii), 
(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(q).
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph (b).
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125(a) through (i) are applicable to manufacturers and processors 
of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.
    (3) Determining whether a specific use is subject to this section. 
The provisions of Sec.  721.1725(b)(1) apply to paragraph (a)(2)(iii) 
of this section.

0
26. Add Sec.  721.11090 to subpart E to read as follows:


Sec.  721.11090   Bicyclo[2.2.1]heptane-1-methanesulfonic acid, 7,7-
dimethyl-2-oxo-, compd. with N,N-diethylethanamine (1:1).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified as 
bicyclo[2.2.1]heptane-1-methanesulfonic acid, 7,7-dimethyl-2-oxo-, 
compd. with N,N-diethylethanamine (1:1) (PMN P-17-218. CAS No. 67019-
84-5) is subject to reporting under this section for the significant 
new uses described in paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in Sec.  
721.63(a)(1), (a)(2)(i), (a)(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 1.0%), and (c).
    (ii) Hazard communication. Requirements as specified in Sec.  
721.72(a) through (e) (concentration set at 1.0%), (f), (g)(1)(i), 
(corrosivity), (sensitization), (g)(1)(iii), (iv), (ix), (g)(2)(i), 
(ii), (iii), (v), and (g)(5). Alternative hazard and warning statements 
that meet the criteria of the Globally Harmonized System (GHS) and OSHA 
Hazard Communication Standard may be used.
    (iii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80(q), (y)(1) and (2).
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph (b).
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125(a) through (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

[[Page 41005]]

of Sec.  721.1725(b)(1) apply to paragraph (a)(2)(iii) of this section.

0
27. Add Sec.  721.11091 to subpart E to read as follows:


Sec.  721.11091   Manganese (2+), bisoctahydro-1,4,7-trimethyl-1H-
1,4,7-triazonine-.kappa.N1,.kappa.N4,.kappa.N7) tri-.mu.-oxidi-, 
hexafluorophosphate(1-) (1:2).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified as manganese (2+), 
bisoctahydro-1,4,7-trimethyl-1H-1,4,7-
triazonine-.kappa.N1,.kappa.N4,.kappa.N7) tri-.mu.-oxidi-, 
hexafluorophosphate(1-) (1:2) (1:1) (PMN P-17-226, CAS No. 116633-52-4) 
is subject to reporting under this section for the significant new uses 
described in paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in Sec.  
721.63(a)(1), (a)(2)(i), (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, (a)(6) (particulate), (b) (concentration set at 0.1%), 
and (c).
    (ii) Hazard communication. Requirements as specified in Sec.  
721.72(a) through (e) (concentration set at 0.1%), (f), (g)(1) (eye 
irritation), (respiratory sensitization), (g)(1)(iii), (iv), (vi), 
(vii), (viii), (g)(2)(i), (ii), (iii), (v), (g)(3)(i), (ii), (g)(4) 
(release to water provisions 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) and (k). It is a significant new use to 
process or use the substance without engineering controls to prevent 
exposure, including dust removal with 99.9% efficiency when loading or 
unloading the substance in powder form.
    (iv) Release to water. Requirements as specified in Sec.  
721.90(a)(4), (b)(4), and (c)(4) where N=240.
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph (b).
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125(a) through (i) and (k) are applicable to manufacturers and 
processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.
    (3) Determining whether a specific use is subject to this section. 
The provisions of Sec.  721.1725(b)(1) apply to paragraph (a)(2)(iii) 
of this section.

0
28. Add Sec.  721.11092 subpart E to read as follows:


Sec.  721.11092   2'-Fluoro-4''-alkyl-4-propyl-1,1':4'1''-terphenyl 
(generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 2'-
fluoro-4''-alkyl-4-propyl-1,1':4'1''-terphenyl (PMN P-17-228) 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 at 1.0%), and (c).
    (ii) Hazard communication. Requirements as specified in Sec.  
721.72(a) through (e)(concentration set at 1.0%), (f), (g)(1)(vi), 
(adrenal effects), (liver effects), (g)(2)(i), (ii), (iii), (v), and 
(g)(5). Alternative hazard and warning statements that meet the 
criteria of the Globally Harmonized System (GHS) and OSHA Hazard 
Communication Standard may be used.
    (iii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80(t) and (y)(1).
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph (b).
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125(a) 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
29. Add Sec.  721.11093 to subpart E to read as follows:


Sec.  721.11093   4-ethyl-2'-fluoro-4''-alkyl-1,1':4',1''-terphenyl 
(generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 4-
ethyl-2'-fluoro-4''-alkyl-1,1':4',1''-terphenyl (PMN P-17-229) 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%), and (c).
    (ii) Hazard communication. Requirements as specified in Sec.  
721.72(a) through (e) (concentration set 1.0%), (f), (g)(1)(vi), 
(adrenal effects), (liver effects), (g)(2)(i), (ii), (iii), (v), and 
(g)(5).
    (iii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80(t) and (y)(1).
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph (b).
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125(a) 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
30. Add Sec.  721.11094 to subpart E to read as follows:


Sec.  721.11094   Poly(oxy-1,2-ethanediyl),alpha-(2-benzoyl)-omega-[(2-
benzoylbenzoyl)oxy]-.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified as poly(oxy-1,2-
ethanediyl),alpha-(2-benzoyl)-omega-[(2-benzoylbenzoyl)oxy]- (PMN P-17-
261) 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

[[Page 41006]]

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), (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 at 1.0%), and (c).
    (ii) Hazard communication. Requirements as specified in Sec.  
721.72(a) through (e) (concentration set at 1.0%), (f), (g)(1) 
(irritation), (photosensitization), (g)(2)(i), (ii), (iii), (v), and 
(g)(5).
    (iii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80(f) and (q).
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph (b).
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125(a) through (i) are applicable to manufacturers and processors 
of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.
    (3) Determining whether a specific use is subject to this section. 
The provisions of Sec.  721.1725(b)(1) apply to paragraph (a)(2)(iii) 
of this section.

[FR Doc. 2018-17348 Filed 8-16-18; 8:45 am]
 BILLING CODE 6560-50-P