[Federal Register Volume 84, Number 147 (Wednesday, July 31, 2019)]
[Proposed Rules]
[Pages 37199-37219]
[FR Doc No: 2019-13989]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Parts 721 and 725

[EPA-HQ-OPPT-2018-0777; FRL-9994-62]
RIN 2070-AB27

Significant New Use Rules on Certain Chemical Substances (19-1.F)

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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SUMMARY: EPA is proposing significant new use rules (SNURs) under the
Toxic Substances Control Act (TSCA) for 31 chemical substances, 30 of
which were the subject of premanufacture notices (PMNs) and 1 (a
microorganism) that was the subject of a Microbial Commercial Activity
Notice (MCAN). 17 of these chemical substances are subject to Orders
issued by EPA pursuant to the TSCA. This action would require persons
who intend to manufacture (defined by statute to include import) or
process any of these 31 chemical substances for an activity that is
proposed as a significant new use to notify EPA at least 90 days before
commencing that activity. The required notification initiates EPA's
evaluation of the use, under the conditions of use for that chemical
substance, 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
by that determination.

DATES: Comments must be received on or before August 30, 2019.

ADDRESSES: Submit your comments, identified by docket identification
(ID) number EPA-HQ-OPPT-2018-0777, 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:<PHONE_NUMBER>; email address:
<EMAIL_ADDRESS>    For general information contact: The TSCA-Hotline, ABVI-Goodwill,
422 South Clinton Ave., Rochester, NY 14620; telephone number: (202)
554-1404; email address<EMAIL_ADDRESS>
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 proposed
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 final 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 proposed rule on or after August
30, 2019 are subject to the export notification provisions of TSCA
section 12(b) (15 U.S.C. 2611(b)) (see 40 CFR 721.20 or Sec.  725.920),
and must comply with the export notification requirements in 40 CFR
part 707, subpart D.

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

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

II. Background

A. What action is the Agency taking?

    EPA is proposing these SNURs under TSCA section 5(a)(2) for
chemical substances that were the subject of PMNs and an MCAN. These
proposed SNURs would require persons to notify EPA at least 90 days
before commencing the manufacture or processing of a chemical substance
for any activity proposed as a significant new use. Receipt of such
notices would allow EPA to assess risks and, if appropriate, to
regulate the significant new use before it may occur. Additional
background regarding SNURs is more fully set out in the preamble to
EPA's first direct final SNUR published in the Federal Register issue
of April 24, 1990 (55 FR 17376). Consult that preamble for further
general information on the objectives, rationale, and procedures for
SNURs and on the basis for significant new use designations, including
provisions for developing test data.

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

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

C. Applicability of General Provisions

    General provisions for SNURs appear in 40 CFR part 721, subpart A
and (for microorganisms) 40 CFR part 725, subpart L. These provisions
describe persons subject to the proposed rule, recordkeeping
requirements, and exemptions to reporting requirements, and
applicability of the rule to uses occurring before the effective date
of the rule. Provisions relating to user fees appear at 40 CFR part
700. Pursuant to Sec.  721.1(c), persons subject to SNURs must comply
with the same SNUN requirements and EPA regulatory procedures as
submitters of PMNs under TSCA section 5(a)(1)(A) (15 U.S.C.
2604(a)(1)(A)). In particular, these requirements include the
information submission requirements of TSCA section 5(b) and 5(d)(1)
(15 U.S.C. 2604(b) and 2604(d)(1)), the exemptions authorized by TSCA
section 5(h)(1), (h)(2), (h)(3), and (h)(5), and the regulations at 40
CFR part 720. Once EPA receives a SNUN, EPA must either determine that
the use is not likely to present an unreasonable risk of injury under
the conditions of use for the chemical substance or take such
regulatory action as is associated with an alternative determination
before the manufacture or processing for the significant new use can
commence. In the case of a determination other than not likely to
present unreasonable risk, the applicable review period must also
expire before manufacturing or processing for the new use may commence.
If EPA determines that the 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 determining significant new uses for the 31 chemical substances
that are the subject of these SNURs, EPA considered relevant
information about the toxicity of the chemical substances and potential
human exposures and environmental releases that may be associated with
the conditions of use for the substances, in addition to the factors in
TSCA section 5(a)(2). Note that when the Agency issues an order under
TSCA section 5(e), section 5(f)(4) requires that the Agency consider
whether to promulgate a SNUR for any use not conforming to the
restrictions of the Order or publish a statement describing the reasons
for not initiating the rulemaking.

IV. Substances Subject to This Proposed Rule

    EPA is proposing significant new use and recordkeeping requirements
for 30 chemical substances in 40 CFR part 721,

subpart E and 1 chemical substance that is a microorganism described in
MCAN J-18-41 in 40 CFR part 725. In this unit, EPA provides the
following information for each chemical substance:
     PMN or MCAN 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 SNUR or basis for the TSCA 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/MCAN 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/MCAN 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/MCAN
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 VII. for more
information.
     CFR citation assigned in the regulatory text section of
the proposed rule. The regulatory text section of each proposed rule
specifies the activities that would be 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 proposed rule, may be claimed as CBI.
    These proposed rules include 17 PMN substances that are subject to
Orders issued under TSCA section 5(e)(1)(A), as required by the
determinations made under section 5(a)(3)(B). Those Orders require
protective measures to limit exposures or otherwise mitigate the
potential unreasonable risk. The proposed SNURs would 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.
    These proposed rules also include 13 PMN substances and 1 MCAN
substance that received ``not likely to present an unreasonable risk''
determination in TSCA section 5(a)(3)(c). However, during the course of
these reviews, EPA identified concerns for certain health and/or
environmental risks if the chemicals were not used following the
limitations identified by the submitters in the notices, but the
section 5(a)(3)(C) determinations did not deem those uses as reasonably
foreseen. The proposed SNURs would identify as significant new uses any
manufacturing, processing, use, distribution in commerce, or disposal
that does not conform to those same protection measures.
    The chemicals subject to these proposed SNURs are as follows:

PMN Number: P-17-157

    Chemical name: Silane amine carbonate (generic).
    CAS number: Not available.
    Effective date of TSCA section 5(e) Order: October 15, 2018.
    Basis for TSCA section 5(e) Order: The PMN states that the generic
(non-confidential) use of the substance will be for an open, non-
dispersive use. Based on the physical/chemical properties of the PMN
substance and Structure Analysis Relationships (SAR) analysis of test
data on analogous substances, EPA has identified concerns for lung
toxicity and irritation, if the chemical substance is not used
following the limitations noted. 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 in the absence of sufficient information to permit a reasoned
evaluation, the substance may present an unreasonable risk to human
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. Use of a National Institute of Occupational Safety and Health
(NIOSH)-certified respirator with an Assigned Protection Factor (APF)
of at least 1,000 where there is a potential for inhalation exposure;
and
    3. Establishment and use of a hazard communication program,
including precautionary statements on each label and in the Safety Data
Sheet (SDS).
    The proposed SNUR would designate as a ``significant new use'' the
absence of these protective measures.
    Potentially useful information: EPA has determined that certain
information may be potentially useful to characterize the health
effects of the PMN substance in support of a request by the PMN
submitter to modify the Order, or if a manufacturer or processor is
considering submitting a SNUN for a significant new use that would be
designated by this SNUR. EPA has determined that the results of
irritation and pulmonary effects testing would help characterize the
potential health effects of the PMN substance. Although the Order does
not require this test, the Order's restrictions remain in effect until
the Order is modified or revoked by EPA based on submission of this or
other relevant information.
    CFR citation: 40 CFR 721.11267.

PMN Number: P-17-295

    Chemical name: Hydrochlorofluorolefin (generic).
    CAS number: Not Available.
    Effective date of TSCA section 5(e) Order: November 7, 2018.
    Basis for TSCA section 5(e) Order: The PMN states that the generic
use of the PMN substance will be as a refrigerant used in closed
systems for chillers (commercial comfort air conditioners) and
industrial process refrigeration. EPA identified concerns for death,
suppression of food consumption, lower weights of the thymus and
epididymides in males, and histological changes in the lungs, testes,
liver, and kidney based on an inhalation toxicity study conducted on
the PMN substance. 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 in the
absence of sufficient information to permit a reasoned evaluation, the
substance may present an unreasonable risk of injury to the health or
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. Use of NIOSH certified respirators with an APF of at least 10
where there is a potential for inhalation exposure, or compliance with
a NCEL of 23.6 mg/m\3\ as an 8-hour time-weighted average, to prevent
inhalation exposure;
    3. Establishment and use of a hazard communication program,
including human health precautionary statements on each label and in
the SDS;
    4. No domestic manufacture of the PMN substance (import only);
    5. No consumer use; and
    6. Use only as a refrigerant used in closed systems for chillers
(commercial comfort air conditioners) and industrial process
refrigeration.
    The proposed SNUR would designate as a ``significant new use'' the
absence of these protective measures.
    Potentially useful information: EPA has determined that certain
information about potential exposure to the PMN substance may be
potentially useful 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 would be designated by
this SNUR. EPA has determined that information that demonstrates
adequate control of emissions using engineering controls other than
those described in the PMN would be useful in determining the exposure
to the PMN substance. Although the Order does not require this
information, the Order's restrictions remain in effect until the Order
is modified or revoked by EPA based on submission of this or other
relevant information.
    CFR citation: 40 CFR 721.11268.

PMN Numbers: P-17-306 and P-17-307

    Chemical names: Fatty acid modified aromatic polyester polyols
(generic).
    CAS numbers: Not available.
    Effective date of TSCA section 5(e) Order: December 27, 2018.
    Basis for TSCA section 5(e) Order: The PMNs state that the generic
(non-confidential) use of the substances will be as components in foam
insulation. Based on data on primary metabolites, EPA identified
concern for ocular toxicity, bladder effects, and kidney effects. EPA
also identified concern for lung effects, irritation to eyes, mucous
membranes and lung, and anesthetization of the eye based on surfactant
properties. The Order was issued under TSCA sections 5(a)(3)(B)(ii)(I)
and 5(e)(1)(A)(ii)(I), based on a finding that in the absence of
sufficient information to permit a reasoned evaluation, that the
substances may present an unreasonable risk of injury to human health
and the environment. To protect against these risks, the Order
requires:
    1. Use of personal protective equipment involving impervious gloves
where there is a potential for dermal exposure;
    2. Establishment and use of a hazard communication program,
including human health precautionary statements on each label and in
the SDS; and
    3. Refraining from use of the PMN substances involving any
application method that generates a vapor, mist, aerosol or dust to
which workers may be exposed.
    The proposed 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 health effects of the PMN substances may be
potentially useful 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 would be designated by
this SNUR. A specific target organ toxicity test would help EPA
determine the potential effects of the PMN substances. Although the
Order does not require this test, the Order's restrictions remain in
effect until the Order is modified or revoked by EPA based on
submission of this or other relevant information.
    CFR citation: 40 CFR 721.11269 (P-17-306 and P-17-307).

PMN Number: P-17-320

    Chemical name: Dodecanedioic acid and 1,6-hexanediol polymer with
3-hydroxy-2,2-dimethylpropyl 2,2-dimethylhydracrylate, neopentylglycol,
1,2 ethanediol, adipic acid, Isophthalic acid, terephthalic acid, 2-
Oxooxopane, BayFlex 2002H and 1,1'-methylenebis(isocyanatobenzene)
(generic).
    CAS number: Not available.
    Effective date of TSCA section 5(e) Order: December 28, 2018.
    Basis for TSCA section 5(e) Order: The PMN states that the generic
use of the PMN substance will be as an industrial adhesive. EPA
identified concerns for dermal and respiratory sensitization, lung and
mucous membrane irritation and mutagenicity based on isocyanate moiety
for the low molecular weight fractions. 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 in the absence of sufficient information to permit a reasoned
evaluation the substance may present an unreasonable risk of injury to
human 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. Use of a NIOSH-certified respirator with an APF of at least 50
where there is a potential for inhalation exposure;
    3. Refraining from using the PMN substance involving any
application method that generates a vapor, mist, aerosol, or dust;
    4. Refraining from manufacturing the PMN substance with greater
than 1% residual isocyanate by weight;
    5. Refraining from using the PMN substance for consumer or
commercial use; and
    6. Establishment and use of a hazard communication program,
including human health precautionary statements on each label and the
SDS.
    The proposed 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 health effects of the PMN substance may be
potentially useful 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 would be designated by
this SNUR. EPA has also determined that sensitization and

mutagenicity effects testing of the PMN substance would be useful in
determining the health effects of the PMN substance. Although the Order
does not require this information, the Order's restrictions remain in
effect until the Order is modified or revoked by EPA based on
submission of this or other relevant information.
    CFR citation: 40 CFR 721.11270.

PMN Number: P-17-329

    Chemical name: Ethanone, 1-[4-(4-chlorophenoxy)-2-
(trifluoromethyl)phenyl]-.
    CAS number: 1417782-28-5.
    Effective date of TSCA section 5(e) Order: August 30, 2018.
    Basis for TSCA section 5(e) Order: The PMN states that the generic
(non-confidential) use of the substance will be as an intermediate used
in synthesis. EPA has identified concerns for sensitization, liver,
blood, spleen, reproductive, and aquatic toxicity at concentrations
that exceed 7 ppb based on hazard data submitted for the PMN. The Order
was issued under TSCA sections 5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I),
based on a finding that in the absence of sufficient information to
permit a reasoned evaluation, the substance may present an unreasonable
risk of injury to human health or the environment. The Order was also
issued under TSCA sections 5(a)(3)(B)(ii)(II) and 5(e)(1)(A)(ii)(II),
based on a finding that the substance is or will be produced in
substantial quantities and that the substance either enters or may
reasonably be anticipated to enter the environment in substantial
quantities, or there is or may be significant (or substantial) human
exposure to the substance. To protect against these risks, the Order
requires:
    1. Use of the PMN substance only for the confidential use specified
in the Order;
    2. No release of the PMN substance to surface waters exceeding 7
parts per billion (ppb);
    3. Use of personal protective equipment to its workers to prevent
dermal exposure where there is potential for dermal exposure;
    4. Use of NIOSH-certified respirators with an APF of at least 50
where there is potential for inhalation exposure; and
    5. Establishment and use of a hazard communication program,
including human health precautionary statements on each label and the
SDS.
    The proposed 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 environmental effects of the PMN substance may be
potentially useful 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 would be designated by
this SNUR. A chronic aquatic toxicity test would help EPA determine the
potential environmental effects of the PMN substance. Although the
Order does not require this information, the Order's restrictions
remain in effect until the Order is modified or revoked by EPA based on
submission of this or other relevant information.
    CFR citation: 40 CFR 721.11271.

PMN Numbers: P-17-367, P-17-368, P-17-369, P-17-370, P-17-371, P-17-372

    Chemical names: Vegetable oil, polymer with alkanedioic acid,
alkali lignin, diethylene glycol- and polyol-depolymd. poly(ethylene
terephthalate) waste plastics and arylcarboxylic acid anhydride
(generic) (P-17-367); Vegetable oil, polymer with alkanedioic acid,
alkali lignin, diethylene glycol- and polyol-depolymd. poly(ethylene
terephthalate) waste plastics (generic) (P-17-368); Waste plastics,
poly(ethylene terephthalate), depolymd. with diethylene glycol,
polymers with alkanedioic acid, alkali lignin and arylcarboxylic acid
anhydride (generic) (P-17-369); Waste plastics, poly(ethylene
terephthalate), depolymd. with diethylene glycol and polyol, polymers
with alkanedioic acid, alkali lignin and arylcarboxylic acid anhydride
(generic) (P-17-370); Vegetable oil, polymer with alkanedioic acid,
alkali lignin, diethylene glycol- and polyol-depolymd. poly(ethylene
terephthalate) waste plastics and arylcarboxylic acid anhydride
(generic) (P-17-371); Vegetable oil, polymer with alkanedioic acid,
alkali lignin, diethylene glycol-depolymd. poly(ethylene terephthalate)
waste plastics and arylcarboxylic acid anhydride (generic) (P-17-372).
    CAS numbers: Not available.
    Effective date of TSCA section 5(e) Order: November 2, 2018.
    Basis for TSCA section 5(e) Order: The PMNs state that the use of
the substances will be as intermediates for use in the manufacture of
polymers. EPA has estimated low human health hazard of the PMN
substances based on their estimated physical properties, and by
comparing them to structurally analogous chemical substances. If the
PMN substances are manufactured differently as polymers under the same
Chemical Abstracts Service Registry Number (CAS RN) (i.e., changes in
the proportion of repeating units, the average molecular weight,
percentage of low molecular weight components, and/or proportion of
surface active monomers), hazard concerns may result based on changes
in water solubility, dispensability, absorption, etc. Concerns may also
result from ester moieties if the PMN substances are not manufactured
as described in the PMN submissions. 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 in the absence of sufficient information to permit a reasoned
evaluation, the substances may present an unreasonable risk of injury
to human health and the environment. The Order was also issued under
TSCA sections 5(a)(3)(B)(ii)(II) and 5(e)(1)(A)(ii)(II), based on a
finding that the substances are or will be produced in substantial
quantities and that the substances either enter or may reasonably be
anticipated to enter the environment in substantial quantities, or
there is or may be significant (or substantial) human exposure to the
substances. To protect against these risks, the Order requires:
    1. Manufacture of the PMN substances with less than or equal to the
confidential percentages of low molecular weight components and not
less than the confidential average molecular weight specified in the
Order; and
    2. Hazard communication requirements if new information identifies
potential injury to human health or the environment.
    The proposed 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 physical-chemical properties and environmental
effects of the PMN substances may be potentially useful 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 would be designated by this SNUR. Physical-chemical property and
aquatic toxicity testing would help EPA determine the potential effects
of the PMN substances. Although the Order does not require this
information, the Order's restrictions remain in effect until the Order
is modified or revoked by EPA based on submission of this or other
relevant information.
    CFR citations: 40 CFR 721.11272 (P-17-367); 40 CFR 721.11273 (P-17-
368); 40 CFR 721.11274 (P-17-369); 40 CFR 721.11275 (P-17-370); 40 CFR
721.11276 (P-17-371); and 40 CFR 721.11277 (P-17-372).

PMN Number: P-17-382

    Chemical name: Amides, tallow, N,N-bis(2-hydroxypropyl).
    CAS number: 1454803-04-3.
    Basis for action: The PMN states that the use of the substance will
be as a friction modifier for automotive lubricants. Based on the
physical/chemical properties of the PMN substance and Structure
Analysis Relationships (SAR) analysis of test data on analogous
substances, EPA has identified concerns for sensitization, specific
organ toxicity, lung toxicity, and aquatic toxicity at concentrations
that exceed 11 ppb if the chemicals are not used following the
limitations noted. The intended conditions of use of the PMN substance
described in the PMN include the following protective measures:
    1. No processing resulting in an end use product containing greater
than 3% by weight of the PMN substance;
    2. No manufacture, processing or use that results in inhalation
exposures; and
    3. No release of the PMN substance to surface waters exceeding 11
ppb.
    Potentially useful information: EPA has determined that certain
information may be potentially useful to characterize the health and
environmental effects of the PMN substance if a manufacturer or
processor is considering submitting a SNUN for a significant new use
that would be designated by this proposed SNUR. EPA has determined that
the results of sensitization, pulmonary effects, specific organ
toxicity, and aquatic toxicity testing would help characterize the
potential health and environmental effects of the PMN substance.
    CFR citation: 40 CFR 721.11278.

PMN Number: P-17-394

    Chemical name: Substituted propanoic acid, polymer with
alkylisocyanate-substituted carbomonocycle, dialkyl carbonate, hydroxyl
alkyl substituted alkanediol, alkanediol, isocyanato substituted
carbomonocycle, alkanol substituted amines-blocked, compds. with
(alkylamino)alkanol, (generic).
    CAS number: Not available.
    Effective date of TSCA section 5(e) Order: April 12, 2018.
    Basis for TSCA section 5(e) Order: The PMN states that the use of
the PMN substance will be as a coating to improve chemical resistance.
EPA identified concerns for nasal and ocular irritation and lung
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 in the absence of
sufficient information to permit a reasoned evaluation the substance
may present an unreasonable risk of injury to human health and the
environment. To protect against these risks, the Order requires:
    1. Refraining from manufacture of the PMN substance in the United
States (import only);
    2. No use of the PMN substance other than as a coating to improve
chemical resistance;
    3. Import of the PMN substance with an average molecular weight
greater than 1,000 daltons;
    4. Import of the PMN substance to contain no more than 0.1%
residual isocyanate by weight; and
    5. Import of the PMN substance to contain no more than 4% of a
confidential component identified in the Order by weight.
    The proposed 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 environmental effects 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 would be designated by this
proposed SNUR. EPA has determined that the results of reproductive/
developmental and aquatic toxicity testing would help characterize the
potential health and environmental effects of the PMN substance.
Although the Order does not require this information, the Order's
restrictions remain in effect until the Order is modified or revoked by
EPA based on submission of this or other relevant information.
    CFR citation: 40 CFR 721.11279.

PMN Numbers: P-18-23 and P-18-24

    Chemical names: Propanediol phosphate (generic) (P-18-23) and
substituted cashew, nutshell liquid, polymer with epichlorohydrin,
phosphate (generic) (P-18-24).
    CAS numbers: Not Available.
    Effective date of TSCA section 5(e) Order: December 19, 2018.
    Basis for TSCA section 5(e) Order: The PMN states that the use of
the PMN substances will be as epoxy hardener/curatives. EPA identified
concerns for lung effects and irritation to the eyes, lungs, and mucous
membranes based on surfactant activity. EPA also identified concern for
corrosion to all tissues based on the low pH of the PMN substances.
There are also concern for liver and systemic toxicity (P-18-23) and
sensitization due to the presence of cashew nutshell liquid (P-18-24).
Based on analysis of test data on analogous chemicals, EPA predicts
toxicity to aquatic organisms may occur at concentrations greater than
3 ppb for P-18-23. Based on SAR predictions for anionic surfactants,
EPA predicts toxicity to aquatic organisms may occur at concentrations
that exceed 1 ppb for P-18-24. 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 in the
absence of sufficient information to permit a reasoned evaluation the
substance may present an unreasonable risk of injury to human health
and the environment. To protect against these risks, the Order
requires:
    1. No manufacture, processing, or use of the PMN substances
involving an application method that generates a vapor, mist, or
aerosol;
    2. No use of the PMN substances in a consumer product;
    3. Establishment and use of a hazard communication program,
including human health precautionary statements on each label and in
the SDS; and
    4. No release of the PMN substances into the waters of the United
States.
    The SNUR designates as a ``significant new use'' the absence of
these protective measures.
    Potentially useful information: EPA has determined that certain
information about the health and environmental effects of the PMN
substances may be potentially useful 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 would be
designated by this proposed SNUR. EPA has determined that the results
of specific target organ toxicity, skin irritation/corrosion,
sensitization, and aquatic toxicity testing would help characterize the
potential health and environmental effects of the PMN substance.
Although the Order does not require this information, the Order's
restrictions remain in effect until the Order is modified or revoked by
EPA based on submission of this or other relevant information.
    CFR citations: 40 CFR 721.11280 (P-18-23) and 40 CFR 721.11281 (P-
18-24).

PMN Number: P-18-41

    Chemical name: 2,5-Furandione, polymer with 2-ethyl-2-
(hydroxymethyl)-1,3-propanediol, 3a,4,5,6,7,7a-hexahydro-4,7-methano-
1H-inden-5(or 6)-yl ester, ester with 2,3-dihydroxypropyl neodecanoate.
    CAS number: Not available.

    Basis for action: The PMN states that the generic (non-
confidential) use of the substance will be as an intermediate polyol
for further reaction. Based on SAR analysis of test data on 2-
ethylhexanoic acid, EPA identified concerns for developmental toxicity
for the branched acid low molecular weight components and metabolic
degradation products of the terminal ester group of the PMN substance
if the chemicals are not used following the limitations noted. The
intended conditions of use of the PMN substance described in the PMN
include the following protective measures:
    1. No manufacture (including import) of the PMN substance with the
number average molecular weight of less than 1000 daltons; and
    2. No use of the PMN substance for other than as a chemical
intermediate.
    The proposed 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 health effects of the PMN substance may be
potentially useful if a manufacturer or processor is considering
submitting a SNUN for a significant new use that would be designated by
this proposed SNUR. EPA has determined that the results of physical
chemical properties, absorption, distribution, metabolism, and
elimination (ADME), developmental toxicity testing would help
characterize the potential health effects of the PMN substance.
    CFR Citation: 40 CFR 721.11282.

PMN Number: P-18-70

    Chemical name: Waste plastics, polyester, depolymd. with glycols,
polymers with dicarboxylic acids (generic).
    CAS number: Not available.
    Basis for action: The PMN states that the generic (non-
confidential) use of the substance will be as an intermediate for the
polyurethane industry. Based on data for a metabolite of a component of
the PMN substance EPA identified concerns for blood, bladder and
developmental toxicity if the chemicals are not used following the
limitations noted. The intended conditions of use of the PMN substance
described in the PMN include the following protective measure:
    1. No use the PMN substance other than the confidential uses stated
in the PMN submission.
    The proposed SNUR would designate as a ``significant new use'' the
absence of this protective measure.
    Potentially useful information: EPA has determined that certain
information about the health effects of the PMN substance may be
potentially useful to characterize the health effects of the PMN
substance if a manufacturer or processor is considering submitting a
SNUN for a significant new use that would be designated by this
proposed SNUR. EPA has determined that the results of specific target
organ and developmental/reproductive toxicity testing would help
characterize the potential health effects of the PMN substance.
    CFR Citation: 40 CFR 721.11283.

PMN Number: P-18-88

    Chemical name: Di(substituted-1,3-trialkylammonium) dialkylammonium
salt (generic).
    CAS number: Not available.
    Effective date of TSCA section 5(e) Order: December 17, 2018.
    Basis for TSCA section 5(e) Order: The PMN states that the generic
use of the PMN substance will be in oil and gas production. EPA
identified concerns for lung effects based on physical-chemical
properties. There are also concerns for neurotoxicity, hepatoxicity and
eye irritation based on data for analogous chemical substances. EPA has
also identified concern for aquatic toxicity due to cationic
(quarternary ammonium) surfactants. 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 in the absence of sufficient information to permit a reasoned
evaluation, the substance may present an unreasonable risk of injury to
human health and the environment. The Order was also issued under TSCA
sections 5(a)(3)(B)(ii)(II) and 5(e)(1)(A)(ii)(II), based on a finding
that the substance is or will be produced in substantial quantities and
that the substance either enters or may reasonably be anticipated to
enter the environment in substantial quantities, or there is or may be
significant (or substantial) human exposure to the substance. To
protect against these risks, the Order requires:
    1. Refraining from using the PMN substance other than for the
confidential uses identified in the Order;
    2. Refraining from manufacturing, processing, or use of the PMN
substance that would result in the generation of vapor, mist,
particulate, or aerosol;
    3. No release of the PMN substance to surface water that exceed
1000 ppb; and
    4. Establishment and use of a hazard communication program,
including human health precautionary statements on each label and in
the SDS.
    The proposed SNUR would designate as a ``significant new use'' the
absence of these protective measures.
    Potentially useful information: EPA has determined that certain
information about health effects of the PMN substance may be
potentially useful 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 would be designated by
this proposed SNUR. EPA has also determined that specific eye
irritation, specific target organ toxicity, and pulmonary effects
testing of the PMN substance would be useful in determining the effects
of the PMN substance. Although the Order does not require this
information, the Order's restrictions remain in effect until the Order
is modified or revoked by EPA based on submission of this or other
relevant information.
    CFR citation: 40 CFR 721.11284.

PMN Numbers: P-18-100 and P-18-102

    Chemical names: Substituted alkanoic acid polymer with
alkylcarbonate, alkanediols and isocyanate substituted carbomonocycles,
sodium salt, alkenoic acidsubstituted polyol reaction products-blocked
(generic) (P-18-100) and alkenoic acid, ester with
[oxybis(alkylene)]bis[alkyl-substituted alkanediol], polymer with
alkylcarbonate, alkanediols, substituted alkanoic acid and isocyanate
and alkyl substituted carbomonocycle, sodium salt (generic) (P-18-102).
    CAS numbers: Not available.
    Basis for action: The PMN states that the generic (non-
confidential) use of the substances will be as UV curable coating
resins. Based on analogy to structurally similar substances, EPA has
identified concerns for irritation, sensitization, developmental
toxicity, and liver toxicity if the chemicals are not used following
the limitations noted. The intended conditions of use of the PMN
substances described in the PMNs include the following protective
measures:
    1. No domestic manufacture in the United States (i.e., import
only); and
    2. No use of the PMN substances other than the confidential use
described in the PMNs; and
    3. No use in a consumer product.
    The proposed 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 health effects of the PMN substances may be
potentially useful if a manufacturer or processor is considering
submitting a SNUN for a significant new use that would be designated by
this proposed SNUR. EPA has determined that the results of

specific organ toxicity, reproductive/developmental toxicity, and
sensitization would help characterize the potential health effects of
the PMN substances.
    CFR Citation: 40 CFR 721.11285 (P-18-100) and 40 CFR 721.11286 (P-
18-102).

PMN Number: P-18-116

    Chemical name: Castor oil, reaction products with soybean oil.
    CAS number: 1186514-12-4.
    Basis for action: The PMN states that the generic (non-
confidential) use of the substance will be as an intermediate for
industrial chemicals. Based on the physical/chemical properties of the
PMN substance and Structure Analysis Relationships (SAR) analysis of
test data on analogous substances, EPA has identified concerns for
sensitization, and aquatic toxicity at surface water concentrations
exceeding 4 parts per billion (ppb), if the chemical substance is not
used following the limitations noted. The intended conditions of use of
the PMN substance described in the PMN include the following protective
measures:
    1. No manufacture (excluding import) of the PMN substance in the
United States;
    2. Not exceeding the confidential annual production volume stated
in the PMN submission;
    3. No use of the PMN substance other than for the confidential use
stated in the PMN submission; and
    4. No processing or use of the PMN substance resulting in
inhalation exposures to aerosols or mists.
    The proposed 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 health and environmental effects of the PMN
substance may be potentially useful to characterize if a manufacturer
or processor is considering submitting a SNUN for a significant new use
that would be designated by this proposed SNUR. EPA has determined that
the results of specific target organ and aquatic toxicity testing would
help characterize the potential health and environmental effects of the
PMN substance.
    CFR citation: 40 CFR 721.11287.

PMN Number: P-18-134

    Chemical name: Benzene, 1-(chloromethyl)-3-methyl-.
    CAS number: 620-19-9.
    Effective date of TSCA section 5(e) Order: November 1, 2018.
    Basis for TSCA section 5(e) Order: The PMN states that the generic
(non-confidential) use of the PMN substance will be as a chemical
intermediate. EPA identified concerns for severe skin burns and eye
damage, serious eye irritation, respiratory irritation, skin
irritation, and oral toxicity based on structural alerts and
information in the submitted SDS. Based on test data submitted with the
PMN, there are also concerns for skin irritation and sensitization.
Mutagenicity, carcinogenicity, neurotoxicity, developmental toxicity,
and respiratory and dermal sensitization are of concern based on
analysis of test data on an analog. Risks for lung toxicity and
carcinogenicity via inhalation cancer via dermal exposure were
identified to workers based on analysis of test data on an analogue
substance. Based on QSAR predictions for analogous chemicals, EPA also
predicts toxicity to aquatic organisms. The Order was issued under TSCA
sections 5(a)(3)(B)(ii)(I) and 5(e)(I)(A)(ii)(I), based on a finding
that in the absence of sufficient information to permit a reasoned
evaluation the substance may present an unreasonable risk of injury to
human 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. Use of a NIOSH-certified respirator with an APF of at least 1000
to prevent inhalation exposure where there is potential for inhalation
exposure;
    3. Establishment and use of a hazard communication program,
including human health precautionary statements on each label and in
the SDS;
    4. Refrain from varying the process or use methods described in the
PMN such that occupational exposure is increased;
    5. Refrain from using the PMN substance other than for the
confidential use allowed in the Order; and
    6. No release of the PMN substance into the waters of the United
States.
    The proposed 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 health and environmental effects of the PMN
substance may be potentially useful 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 would be
designated by this proposed SNUR. EPA has also determined that the
results or specific target organ toxicity, reproductive/developmental
toxicity testing, aquatic toxicity testing, and carcinogenicity testing
would help characterize the potential human and environmental effects
of the PMN substance. Although the Order does not require this
information, the Order's restrictions remain in effect until the Order
is modified or revoked by EPA based on submission of this or other
relevant information.
    CFR citation: 40 CFR 721.11288.

PMN Number: P-18-136

    Chemical name: 1-Butanaminium,N,N,N-tributyl-,2(or 5)-
[[benzoyldihydrodioxo[(sulfophenyl) amino]heteropolycycle]oxy]-5(or 2)-
(1,1-dimethylpropyl)benzenesulfonate (2:1) (generic).
    CAS number: Not available.
    Basis for action: The PMN states that the generic (non-
confidential) use of the substance will be as a coloring agent. Based
on the physical/chemical properties of the PMN substance and Structure
Analysis Relationships (SAR) analysis of test data on analogous
substances, EPA has identified concerns for systemic toxicity, and
aquatic toxicity at surface water concentrations exceeding 19 parts per
billion (ppb), if the chemical substance is not used following the
limitations noted. The intended conditions of use of the PMN substance
described in the PMN include the following protective measures:
    1. No manufacture, processing, or use of the PMN substance if it
results in inhalation exposure; and
    2. No release of the PMN substance to surface water that exceed 19
ppb.
    The proposed SNUR would designate as a ``significant new use'' the
absence of these protective measures.
    Potentially useful information: EPA has determined that certain
information may be potentially useful to characterize the health and
environmental effects of the PMN substance if a manufacturer or
processor is considering submitting a SNUN for a significant new use
that would be designated by this proposed SNUR. EPA has determined that
the results of specific target organ toxicity, and aquatic toxicity
testing would help characterize the potential health and environmental
effects of the PMN substance.
    CFR citation: 40 CFR 721.11289.

PMN Number: P-18-137

    Chemical name: Alkylsilsesquioxane, ethoxy-terminated (generic).
    CAS number: Not available.
    Basis for action: The PMN states that the use of the substance will
be as a water repellent for fiber-reinforced cement products in
construction materials, like fiber-cement board. Based on the physical/
chemical

properties of the PMN substance, data on the PMN substance, and
Structure Analysis Relationships (SAR) analysis of test data on
analogous substances, EPA has identified concerns for liver toxicity,
lung toxicity by waterproofing of lung membranes, irritation,
developmental toxicity, and aquatic toxicity at surface water
concentrations exceeding 58 parts per billion (ppb), if the chemical
substance is not used following the limitations noted. The intended
conditions of use of the PMN substance described in the PMN include the
following protective measures:
    1. No release of the PMN substance to surface waters that exceed 58
ppb; and
    2. No processing or use of the PMN substance in any manner that
results in inhalation exposures.
    The proposed SNUR would designate as a ``significant new use'' the
absence of these protective measures.
    Potentially useful information: EPA has determined that certain
information may be potentially useful to characterize the health and
environmental effects of the PMN substance if a manufacturer or
processor is considering submitting a SNUN for a significant new use
that would be designated by this proposed SNUR. EPA has determined that
the results of physical-chemical property testing, absorption,
distribution, metabolism, elimination (ADME) testing, pulmonary
effects, and specific target organ and aquatic toxicity testing would
help characterize the potential health and environmental effects of the
PMN substance.
    CFR citation: 40 CFR 721.11290.

PMN Number: P-18-219

    Chemical name: Polythioether, short chain diol polymer terminated
with aliphatic diisocyanate (generic).
    CAS number: Not available.
    Basis for action: The PMN states that the generic (non-
confidential) use of the substance will be as an intermediate for
topcoat. Based on test data on the PMN substance and on test data on
analogous chemical substances, EPA has identified concerns for
irritation, sensitization and lung effect if the chemical is not used
following the limitations noted. The intended conditions of use of the
PMN substance described in the PMN include the following protective
measures:
    1. No manufacture (including import) the PMN substance with
molecular weight greater than 10,000 daltons; and
    2. No manufacture (including import) the PMN substance with free
isocyanate residuals greater than 0.01% by weight.
    The proposed 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 PMN substance may be potentially useful to
characterize the health effects of the PMN substance if a manufacturer
or processor is considering submitting a SNUN for a significant new use
that would be designated by this proposed SNUR. EPA has determined that
the results of absorption, specific target organ toxicity, irritation
and sensitization testing would help characterize the potential health
effects of the PMN substance.
    CFR citation: 40 CFR 721.11291.

PMN Numbers: P-18-224 and P-18-225

    Chemical names: Alkenoic acid, polymer with alkenylcarbomonocycle,
[alkanediylbis(substituted alkylene)] bis[heteromonocycle] and
(alkylalkenyl) aromatic, salt (generic) (P-18-224) and Alkenoic acid,
polymer with substituted alkyloxirane, alkenylcarbomonocycle, alkyl
substituted alkyl alkanediol and (alkylalkenyl) aromatic salt (generic)
(P-18-225).
    CAS numbers: Not available.
    Basis for action: The PMNs state that the generic (non-
confidential) use of the substances will be as a component of ink.
Based on analogy to structurally similar substances, EPA has identified
concerns for carcinogenicity, neurotoxicity and developmental toxicity
and lung effects if the chemicals are not used following the
limitations noted. The intended conditions of use of the PMN substances
described in the PMNs include the following protective measures:
    1. No manufacture, processing or use of the PMN substances that
results in inhalation exposures; and
    2. Manufacture of the PMN substances with acid content no greater
than 20% by weight.
    The proposed SNUR would designate as a ``significant new use'' the
absence of these protective measures.
    Potentially useful information: EPA has determined that certain
information may be potentially useful to characterize the health
effects of the PMN substances if a manufacturer or processor is
considering submitting a SNUN for a significant new use that would be
designated by this proposed SNUR. EPA has determined that the results
of absorption, neurotoxicity and pulmonary effects testing of the PMN
substances may be potentially useful in characterizing the health
effects of the PMN substances.
    CFR citation: 40 CFR 721.11292 (P-18-224) and 40 CFR 721.11293 (P-
18-225).

PMN Number: P-18-233

    Chemical name: Alkyl alkenoic acid, alkyl ester, telomer with
alkylthiol, substituted carbomonocycle, substituted alkyl alkyl
alkenoate and hydroxyalkyl alkenoate, tertbutyl alkyl peroxoate-
initiated, (generic).
    CAS number: Not available.
    Basis for action: The PMN states that the generic (non-
confidential) use of the substance will be as a coating agent. Based on
data for analogous compounds, EPA has identified concerns for systemic,
reproductive and developmental, and lung toxicity if the chemical is
not used following the limitations noted. The intended conditions of
use of the PMN substance described in the PMN include the following
protective measure:
    1. No manufacturing (including import) in a solid form.
    The proposed SNUR would designate as a ``significant new use'' the
absence of this protective measure.
    Potentially useful information: EPA has determined that certain
information may be potentially useful to characterize the health
effects of the PMN substance if a manufacturer or processor is
considering submitting a SNUN for a significant new use that would be
designated by this proposed SNUR. EPA has determined that the results
of absorption and metabolism, systemic, reproductive, and developmental
toxicity testing would help characterize the potential health effects
of the PMN substance.
    CFR citations: 40 CFR 721.11294.

PMN Number: P-18-279

    Chemical name: Substituted heteromonocycle, polymer with
substituted alkanediol and diisocyanate substituted carbomonocyle,
alkylene glycol acrylate-blocked (generic).
    CAS number: Not available.
    Basis for action: The PMN states that the use of the substance will
be as a UV curable coating resin. Based on the physical/chemical
properties of the PMN substance and test data on structurally similar
substances, EPA has identified concerns for sensitization and
irritation if the chemical is not used following the limitations noted.
The intended conditions of use of the PMN substance described in the
PMN include the following protective measure:
    1. Use of NIOSH-certified respirator with an APF of 1000 when there
is inhalation exposure from spray application.
    The proposed SNUR would designate as a ``significant new use'' the
absence of this protective measure.
    Potentially useful information: EPA has determined that certain
information

about the health effects of the PMN substance may be potentially useful
to characterize the effects of the PMN substance if a manufacturer or
processor is considering submitting a SNUN for a significant new use
that would be designated by this proposed SNUR. EPA has determined that
the results of corrosion/irritation and sensitization testing would
help characterize the potential health effects of the PMN substance.
    CFR citation: 40 CFR 721.11295.

MCAN Number: J-18-41

    Chemical name: Arsenic detecting strain of E. coli with extra-
chromosomal elements, including an intergeneric screening marker
(generic).
    CAS number: Not available.
    Basis for action: The MCAN states that the use of the substance
will be to detect arsenic in small water samples. Based on the
inclusion of antibiotic resistance genes in the MCAN microorganism,
conferring resistance to clinically important antibiotics, EPA has
identified concerns for loss of therapeutic value of these antibiotics
if the resistance gene were to be horizontally transferred to a
pathogen in the environment and if infections caused by those pathogens
are treated with these antibiotics. There is low potential for gene
transfer, and due to the low expected releases, the risks from this
MCAN microorganism are low under the intended conditions of use. The
intended conditions of use of the MCAN microorganism described in the
MCAN include the following protective measures:
    1. No domestic manufacture within the United States (i.e., import
only); and
    2. No use of the MCAN microorganism other than to detect arsenic in
small water samples.
    The proposed 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 environmental fate and transfer of the antibiotic
resistance gene in the MCAN microorganism may be potentially useful to
characterize the health and environmental effects of the MCAN
microorganism if a manufacturer or processor is considering submitting
a SNUN for a significant new use that would be designated by this
proposed SNUR. EPA has determined that the results of a study of
transformation of intergeneric DNA (blaTEM-1) from the MCAN
microorganism (either living or inactivated) into microbes in the
environment would help characterize the potential health and
environmental effects of the MCAN microorganism.
    CFR citation: 40 CFR 725.1079.

V. Rationale and Objectives of the Proposed Rule

A. Rationale

    During review of the PMNs submitted for the chemical substances
that are subject to these proposed SNURs, EPA concluded that for 17
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/MCAN
submitters. The SNURs would 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).
    During review of the other 14 chemical substances that are the
subject of these SNURs and as further discussed in Unit IV, EPA
identified circumstances different from the intended conditions of use
identified in the PMNs that raised potential risk concerns. EPA
determined that deviations from the protective measures identified in
the submissions could result in changes in the type or form of exposure
to the chemical substances and/or increased exposures to the chemical
substances and/or changes in the reasonably anticipated manner and
methods of manufacturing, processing, distribution in commerce, and
disposal of the chemical substances, and therefore warranted SNURs. The
SNURs would identify as significant new uses any manufacturing,
processing, use, distribution in commerce, or disposal that does not
conform to the protection measures in the submission.

B. Objectives

    EPA is proposing these SNURs for specific chemical substances which
have undergone premanufacture review because the Agency wants to
achieve the following objectives with respect to the significant new
uses that would be designated in this proposed rule:
     EPA would 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 would be required 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 would be required 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.
    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. Applicability of the Proposed 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 proposed 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 proposed 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 17 of the 31 chemical substances, and the PMN submitters are
prohibited by the TSCA section 5(e) Orders from undertaking activities
which would be designated as significant new uses. The identities of 27
of the 31 chemical substances subject to this proposed rule have been
claimed as confidential (per Sec. Sec.  720.85 and 725.85) 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 proposed rule are
ongoing.
    Therefore, EPA designates July 31, 2019 as the cutoff date for
determining whether the new use is ongoing. The objective of EPA's
approach is to ensure that a person cannot defeat a SNUR by initiating
a significant new use before the effective date of the final rule.

    Persons who begin commercial manufacture or processing of the
chemical substances for a significant new use identified as of that
date would have to cease any such activity upon the effective date of
the final rule. To resume their activities, these persons would have to
first comply with all applicable SNUR notification requirements and
wait until 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.

VII. 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 and 725.155).
However, upon review of PMNs and SNUNs, the Agency has the authority to
require appropriate testing. Unit IV. lists potentially useful
information identified by EPA that would help characterize the
potential health and/or environmental effects of the PMN/SNUN substance
for all of the listed SNURs. EPA recognizes that the 2016 Lautenberg
Amendments have led to modifications in our approach to testing
requirements, including an increased consideration of alternatives to
vertebrate testing. Descriptions of tests/information needs are
provided for informational purposes only and EPA strongly encourages
persons, before performing any testing, to consult with the Agency
pertaining to protocol selection. 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 potentially useful information. EPA
encourages dialogue 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 test guidelines are available from the
OECD Bookshop at http://www.oecdbookshop.org or SourceOECD at http://www.sourceoecd.org.
    The potentially useful information listed in Unit IV. may not be
the only means of addressing the potential risks of the chemical
substance. EPA recommends that potential SNUN submitters contact EPA
early enough so that they will be able to conduct the appropriate
tests.
    SNUN submitters should be aware that EPA will be better able to
evaluate SNUNs which provide detailed information on the following:
     Human exposure and environmental release that may result
from the significant new use of the chemical substances.

VIII. SNUN Submissions

    According to 40 CFR 721.1(c), persons submitting a SNUN must comply
with the same notification requirements and EPA regulatory procedures
as persons submitting a PMN or MCAN, including submission of test data
on health and environmental effects as described in 40 CFR 720.50 or
Sec.  725.160. SNUNs must be submitted on EPA Form No. 7710-25,
generated using e-PMN software, and submitted to the Agency in
accordance with the procedures set forth in 40 CFR 720.40 and Sec.
721.25 (or 40 CFR 725.25 and Sec.  725.27). E-PMN software is available
electronically at http://www.epa.gov/opptintr/newchems.

IX. Economic Analysis

    EPA has evaluated the potential costs of establishing SNUN
requirements for potential manufacturers and processors of the chemical
substances subject to this proposed rule. EPA's complete economic
analysis is available in the docket under docket ID number EPA-HQ-OPPT-
2018-0777.

X. Statutory and Executive Order Reviews

A. Executive Order 12866

    This proposed rule would establish SNURs for several new chemical
substances that were the subject of PMNs, an MCAN, 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.
    The information collection requirements related to this proposed
rule 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,
Regulatory Support Division, Office of Mission Support (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)

    Pursuant to section 605(b) of the Regulatory Flexibility Act (RFA)
(5 U.S.C. 601 et seq.), the Agency hereby certifies that promulgation
of this proposed SNUR would not have a significant adverse economic
impact on a substantial number of small entities. The requirement to
submit a SNUN applies to any person (including small or large entities)
who intends to engage in any activity described in the final rule as a
``significant new use.'' Because these uses are ``new,'' based on all
information currently available to EPA, it appears that no small or
large entities presently engage in such activities. A SNUR requires
that any person who intends to engage in such activity in the future
must first notify EPA by submitting a SNUN. Although some small
entities may decide to pursue a

significant new use in the future, EPA cannot presently determine how
many, if any, there may be. However, EPA's experience to date is that,
in response to the promulgation of SNURs covering over 1,000 chemicals,
the Agency receives only a small number of notices per year. For
example, the number of SNUNs received was seven in Federal fiscal year
(FY) 2013, 13 in FY2014, six in FY2015, 10 in FY2016, 14 in FY2017, and
18 in FY2018 and only a fraction of these were from small businesses.
In addition, the Agency currently offers relief to qualifying small
businesses by reducing the SNUN submission fee from $16,000 to $2,800.
This lower fee reduces the total reporting and recordkeeping of cost of
submitting a SNUN to about $10,116 for qualifying small firms.
Therefore, the potential economic impacts of complying with this
proposed SNUR are not expected to be significant or adversely impact a
substantial number of small entities. In a SNUR that published in the
Federal Register of June 2, 1997 (62 FR 29684) (FRL-5597-1), the Agency
presented its general determination that final SNURs are not expected
to have a significant economic impact on a substantial number of small
entities, which was provided to the Chief Counsel for Advocacy of the
Small Business Administration.

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 proposed rule would 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 11632

    This proposed rule would 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 proposed rule would not have Tribal implications because it is
not expected to have substantial direct effects on Indian Tribes. This
proposed rule would not significantly nor uniquely affect the
communities of Indian Tribal governments, nor would 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 proposed rule 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 proposed rule 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 proposed rule is not expected to affect energy supply,
distribution, or use and because this proposed rule is not a
significant regulatory action under Executive Order 12866.

I. National Technology Transfer and Advancement Act (NTTAA)

    In addition, since this proposed rule would 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 proposed rule 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).

List of Subjects

40 CFR Parts 721 and 725

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

    Dated: June 24, 2019.
Tala Henry,
Deputy Director, Office of Pollution Prevention and Toxics.

    Therefore, it is proposed that 40 CFR chapter I be amended as
follows:

PART 721--SIGNIFICANT NEW USES OF CHEMICAL SUBSTANCES

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

     Authority:  15 U.S.C. 2604, 2607, 2613, and 2625(c).

0
2. Add Sec. Sec.  721.11267 through 721.11295 to subpart E to read as
follows:

Subpart E--Significant New Uses for Specific Chemical Substances

* * * * *
Sec.
721.11267 Silane amine carbonate (generic).
721.11268 Hydrochlorofluorolefin (generic).
721.11269 Fatty acid modified aromatic polyester polyols (generic).
721.11270 Dodecanedioic acid and 1,6-hexanediol polymer with 3-
hydroxy-2,2-dimethylpropyl 2,2-dimethylhydracrylate,
neopentylglycol, 1,2 ethanediol, adipic acid, Isophthalic acid,
terephthalic acid, 2-Oxooxopane, BayFlex 2002H and 1,1'-
methylenebis(isocyanatobenzene) (generic).
721.11271 Ethanone, 1-[4-(4-chlorophenoxy)-2-
(trifluoromethyl)phenyl].
721.11272 Vegetable oil, polymer with alkanedioic acid, alkali
lignin, diethylene glycol- and polyol-depolymd. poly(ethylene
terephthalate) waste plastics and arylcarboxylic acid anhydride
(generic).
721.11273 Vegetable oil, polymer with alkanedioic acid, alkali
lignin, diethylene glycol- and polyol-depolymd. poly(ethylene
terephthalate) waste plastics (generic).
721.11274 Waste plastics, poly(ethylene terephthalate), depolymd.
with diethylene glycol, polymers with alkanedioic acid, alkali
lignin and arylcarboxylic acid anhydride (generic).
721.11275 Waste plastics, poly(ethylene terephthalate), depolymd.
with diethylene glycol and polyl, polymers with alkanedioic acid,
alkali lignin and arylcarboxylic acid anhydride (generic).
721.11276 Vegetable oil, polymer with alkanedioic acid, alkali
lignin, diethylene glycol- and polyol-depolymd. poly(ethylene
terephthalate) waste plastics and arylcarboxylic acid anhydride
(generic).
721.11277 Vegetable oil, polymer with alkanedioic acid, alkali
lignin, diethylene glycol-depolymd. poly(ethylene terephthalate)
waste plastics and arylcarboxylic acid anhydride (generic).
721.11278 Amides, tallow, N,N-bis(2-hydroxypropyl).

721.11279 Substituted propanoic acid, polymer with alkylisocyanate-
substituted carbomonocycle, dialkyl carbonate, hydroxyl alkyl
substituted alkanediol, alkanediol, isocyanato substituted
carbomonocycle, alkanol substituted amines-blocked, compds. with
(alkylamino)alkanol (generic).
721.11280 Propanediol phosphate (generic).
721.11281 Substituted cashew, nutshell liquid, polymer with
epichlorohydrin, phosphate (generic).
721.11282 2,5-Furandione, polymer with 2-ethyl-2-(hydroxymethyl)-
1,3-propanediol, 3a,4,5,6,7,7a-hexahydro-4,7-methano-1H-inden-5(or
6)-yl ester, ester with 2,3-dihydroxypropyl neodecanoate.
721.11283 Waste plastics, polyester, depolymd. with glycols,
polymers with dicarboxylic acids (generic).
721.11284 Di(substituted-1,3-trialkylammonium) dialkylammonium salt
(generic).
721.11285 Substituted alkanoic acid polymer with alkylcarbonate,
alkanediols and isocyanate substituted carbomonocycles, sodium salt,
alkenoic acidsubstituted polyol reaction products-blocked (generic).
721.11286 Alkenoic acid, ester with [oxybis(alkylene)]bis[alkyl-
substituted alkanediol], polymer with alkylcarbonate, alkanediols,
substituted alkanoic acid and isocyanate and alkyl substituted
carbomonocycle, sodium salt (generic).
721.11287 Castor oil, reaction products with soybean oil.
721.11288 Benzene, 1-(chloromethyl)-3-methyl-.
721.11289 1-Butanaminium,N,N,N-tributyl-,2(or 5)-
[[benzoyldihydrodioxo [(sulfophenyl) amino]heteropolycycle]oxy]-5(or
2)-(1,1-dimethylpropyl)benzenesulfonate (2:1) (generic).
721.11290 Alkylsilsesquioxane, ethoxy-terminated (generic).
721.11291 Polythioether, short chain diol polymer terminated with
aliphatic diisocyanate (generic).
721.11292 Alkenoic acid, polymer with alkenylcarbomonocycle,
[alkanediylbis(substituted alkylene)] bis[heteromonocycle] and
(alkylalkenyl) aromatic, salt (generic).
721.11293 Alkenoic acid, polymer with substituted alkyloxirane,
alkenylcarbomonocycle, alkyl substituted alkyl alkanediol and
(alkylalkenyl) aromatic salt (generic).
721.11294 Alkyl alkenoic acid, alkyl ester, telomer with alkylthiol,
substituted carbomonocycle, substituted alkyl alkyl alkenoate and
hydroxyalkyl alkenoate, tertbutyl alkyl peroxoate-initiated,
(generic).
721.11295 Substituted heteromonocycle, polymer with substituted
alkanediol and diisocyanate substituted carbomonocyle, alkylene
glycol acrylate-blocked (generic).

Sec.  721.11267   Silane amine carbonate (generic).

    (a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as silane
amine carbonate (PMN P-17-157) 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), (4), and (5) (respirators must provide a
National Institute for Occupational Safety and Health (NIOSH) assigned
protection factor (APF) of at least 1,000. 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)(6)(v), (vi), and (b) (concentrations set at 1.0%).
    (ii) Requirements, as specified in Sec.  721.72(a) through (d), (e)
(concentrations set at 1.0%), (f), (g)(1)(i) and (ii), (g)(2)(i)
through (v), and (g)(5). Alternative hazard and warning statements that
meet the criteria of the Globally Harmonized System and OSHA Hazard
Communication Standard may be used.
    (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 (h), are applicable to manufacturers and
processors of this substance.
    (2) Limitations or revocation of certain notification requirements.
The provisions of Sec.  721.185 apply to this section.

Sec.  721.11268   Hydrochlorofluorolefin (generic).

    (a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance generically identified as
hydrochlorofluoroolefin (PMN P-17-295) 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) through (5) (respirators must provide a National
Institute for Occupational Safety and Health (NIOSH) assigned
protection factor (APF) of at least 10). 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)(6)(v) and (vi), and (b) (concentrations set at 1.0%).
    (A) As an alternative to the respirator requirements in this
paragraph (a)(2)(i), 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 23.6 mg/m\3\ (3.9
ppm) 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.
    (ii) Requirements, as specified in Sec.  721.72(a) through (d), (e)
(concentrations set at 1.0%), (f), (g)(1)(iv) and (vi), (fatality),
(g)(2)(i) through (iv) (use respiratory protection or maintain
workplace airborne concentrations at or below an 8-hour time-weighted
average of 23.6 mg/m\3\ (3.9 ppm), and (v)
    (i) Industrial, commercial, and consumer activities. Requirements,
as specified in Sec.  721.80(f), (k) (a refrigerant used in closed
systems for chillers (commercial comfort air conditioners) and
industrial process refrigeration), and (o).
    (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.

Sec.  721.11269  Fatty acid modified aromatic polyester polyols
(generic).

    (a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substances generically identified as fatty
acid modified aromatic polyester polyols (PMN P-17-306 and PMN P-17-
307) are subject to reporting under this section for the

significant new uses described in paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements, as specified in
Sec.  721.63(a)(1), (a)(2)(i), (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)(iv),
(ocular effects), (g)(2)(i), (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. It is a
significant new to for any application method that generates a vapor,
mist, aerosol or dust to which workers may be exposed.
    (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.

Sec.  721.11270  Dodecanedioic acid and 1,6-hexanediol polymer with 3-
hydroxy-2,2-dimethylpropyl 2,2-dimethylhydracrylate, neopentylglycol,
1,2 ethanediol, adipic acid, Isophthalic acid, terephthalic acid, 2-
Oxooxopane, BayFlex 2002H and 1,1'-methylenebis(isocyanatobenzene)
(generic).

    (a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance generically identified as
Dodecanedioic acid and 1,6-hexanediol polymer with 3-hydroxy-2,2-
dimethylpropyl 2,2-dimethylhydracrylate, neopentylglycol, 1,2
ethanediol, adipic acid, Isophthalic acid, terephthalic acid, 2-
Oxooxopane, BayFlex 2002H and 1,1'-methylenebis(isocyanatobenzene) (PMN
P-17-320) 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) through (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, (5) (respirators
must provide a National Institute for Occupational Safety and Health
(NIOSH) assigned protection factor (APF) of at least 50), (a)(6)(v) and
(vi), (particulate), and (c).
    (ii) Hazard communication. Requirements, as specified in Sec.
721.72(a) through (d), (f), (g)(1)(i) and (ii), (mutagenicity),
(g)(2)(i), (ii), (iv), (v), and (g)(5). Alternative hazard and warning
statements that meet the criteria of the Globally Harmonized System and
OSHA Hazard Communication Standard may be used.
    (iii) Industrial, commercial, and consumer activities.
Requirements, as specified in Sec.  721.80(o) and (y)(1) and (2). It is
a significant new use to manufacture the substance containing more than
1% residual isocyanate by weight,
    (b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
    (1) Recordkeeping. Recordkeeping requirements, as specified in
Sec.  721.125(a) through (i) are applicable to manufacturers and
processors of this substance.
    (2) Limitations or revocation of certain notification requirements.
The provisions of Sec.  721.185 apply to this section.

Sec.  721.11271  Ethanone, 1-[4-(4-chlorophenoxy)-2-
(trifluoromethyl)phenyl].

    (a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as ethanone, 1-[4-(4-
chlorophenoxy)-2-(trifluoromethyl)phenyl]- (PMN P-17-329, CAS No.
1417782-28-5) 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) through (iv), (a)(3) and (4), when
determining which persons are reasonably likely to be exposed as
required for Sec.  721.63(a)(1), (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, (5) (respirators must provide a National
Institute for Occupational Safety and Health (NIOSH) assigned
protection factor (APF) of at least 50), (a)(6)(v) and (vi),
(particulate), and (c).
    (ii) Hazard communication. Requirements, as specified in Sec.
721.72(a) through (d), (f), (g)(1)(ii), (iv), (vi), (sensitization),
(g)(2)(i), (ii), (iv), and (v), (g)(3)(i) and (ii), (g)(4) (do not
release to water at concentrations that exceed 7 parts per billion),
and (5). Alternative hazard and warning statements that meet the
criteria of the Globally Harmonized System (GHS) and OSHA Hazard
Communication Standard may be used.
    (iii) Industrial, commercial, and consumer activities.
Requirements, as specified in Sec.  721.80(k).
    (iv) Release to water. Requirements, as specified in Sec.
721.90(a)(4), (b)(4), and (c)(4) where N = 7.
    (b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements, as specified in
Sec.  721.125(a) through (i), and (k) are applicable to manufacturers
and processors of this substance.
    (2) Limitations or revocation of certain notification requirements.
The provisions of Sec.  721.185 apply to this section.
    (3) Determining whether a specific use is subject to this section.
The provisions of Sec.  721.1725(b)(1) apply to paragraph (a)(2)(iii)
of this section.

Sec.  721.11272  Vegetable oil, polymer with alkanedioic acid, alkali
lignin, diethylene glycol- and polyol-depolymd. poly(ethylene
terephthalate) waste plastics and arylcarboxylic acid anhydride
(generic).

    (a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance generically identified as
vegetable oil, polymer with alkanedioic acid, alkali lignin, diethylene
glycol- and polyol-depolymd. poly(ethylene terephthalate) waste
plastics and arylcarboxylic acid anhydride (P-17-367) is subject to
reporting under this section for the significant new uses described in
paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Hazard communication program. A significant new use of these
substances is any manner or method of manufacture, import, or
processing associated with any use of these substances without
providing risk notification as follows:

    (A) If as a result of the test data required under the Order for
the substance, the employer becomes aware that the substance may
present a risk of injury to human health or the environment, the
employer must incorporate this new information, and any information on
methods for protecting against such risk, into an SDS as described in
Sec.  721.72 (c) within 90 days from the time the employer becomes
aware of the new information. If the substance is not being
manufactured, processed, or used in the employer's workplace, the
employer must add the new information to an SDS before the substance is
reintroduced into the workplace.
    (B) The employer must ensure that persons who will receive the PMN
substance from the employer, or who have received the PMN substance
from the employer within 5 years from the date the employer becomes
aware of the new information described in paragraph (a)(2)(i)(A) of
this section, are provided an SDS containing the information required
under paragraph (a)(2)(i)(A) of this section within 90 days from the
time the employer becomes aware of the new information.
    (ii) Industrial, commercial, and consumer activities. It is a
significant new use to manufacture, process, or use the substance with
greater than the confidential percentages of low molecular weight
components and less than the confidential average molecular weight
specified in the Order.
    (b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements, as specified in
Sec.  721.125(a) through (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.

Sec.  721.11273  Vegetable oil, polymer with alkanedioic acid, alkali
lignin, diethylene glycol- and polyol-depolymd. poly(ethylene
terephthalate) waste plastics (generic).

    (a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substances generically identified as
vegetable oil, polymer with alkanedioic acid, alkali lignin, diethylene
glycol- and polyol-depolymd. poly(ethylene terephthalate) waste
plastics (P-17-368) is subject to reporting under this section for the
significant new uses described in paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Hazard communication program. A significant new use of these
substances is any manner or method of manufacture, import, or
processing associated with any use of these substances without
providing risk notification as follows:
    (A) If as a result of the test data required under the Order for
the substance, the employer becomes aware that the substances may
present a risk of injury to human health or the environment, the
employer must incorporate this new information, and any information on
methods for protecting against such risk, into an SDS as described in
Sec.  721.72(c) within 90 days from the time the employer becomes aware
of the new information. If the substance is not being manufactured,
processed, or used in the employer's workplace, the employer must add
the new information to an SDS before the substance is reintroduced into
the workplace.
    (B) The employer must ensure that persons who will receive the PMN
substance from the employer, or who have received the PMN substance
from the employer within 5 years from the date the employer becomes
aware of the new information described in paragraph (a)(2)(i)(A) of
this section, are provided an SDS containing the information required
under paragraph (a)(2)(i)(A) of this section within 90 days from the
time the employer becomes aware of the new information.
    (ii) Industrial, commercial, and consumer activities. It is a
significant new use to manufacture, process, or use the substance with
greater than the confidential percentages of low molecular weight
components and less than the confidential average molecular weight
specified in the Order.
    (b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements, as specified in
Sec.  721.125(a) through (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.

Sec.  721.11274  Waste plastics, poly(ethylene terephthalate),
depolymd. with diethylene glycol, polymers with alkanedioic acid,
alkali lignin and arylcarboxylic acid anhydride (generic).

    (a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substances generically identified as waste
plastics, poly(ethylene terephthalate), depolymd. with diethylene
glycol, polymers with alkanedioic acid, alkali lignin and
arylcarboxylic acid anhydride (P-17-369) is subject to reporting under
this section for the significant new uses described in paragraph (a)(2)
of this section.
    (2) The significant new uses are:
    (i) Hazard communication program. A significant new use of these
substances is any manner or method of manufacture, import, or
processing associated with any use of these substances without
providing risk notification as follows:
    (A) If as a result of the test data required under the Order for
the substance, the employer becomes aware that the substance may
present a risk of injury to human health or the environment, the
employer must incorporate this new information, and any information on
methods for protecting against such risk, into an SDS as described in
Sec.  721.72(c) within 90 days from the time the employer becomes aware
of the new information. If the substance is not being manufactured,
processed, or used in the employer's workplace, the employer must add
the new information to an SDS before the substance is reintroduced into
the workplace.
    (B) The employer must ensure that persons who will receive the PMN
substance from the employer, or who have received the PMN substance
from the employer within 5 years from the date the employer becomes
aware of the new information described in paragraph (a)(2)(i)(A) of
this section, are provided an SDS containing the information required
under paragraph (a)(2)(i)(A) of this section within 90 days from the
time the employer becomes aware of the new information.
    (ii) Industrial, commercial, and consumer activities. It is a
significant new use to manufacture, process, or use the substance with
greater than the confidential percentages of low molecular weight
components and less than the confidential average molecular weight
specified in the Order.
    (b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements, as specified in
Sec.  721.125(a) through (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.

Sec.  721.11275  Waste plastics, poly(ethylene terephthalate),
depolymd. with diethylene glycol and polyl, polymers with alkanedioic
acid, alkali lignin and arylcarboxylic acid anhydride (generic).

    (a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substances generically identified as waste
plastics, poly(ethylene terephthalate), depolymd. with diethylene
glycol and polyol, polymers with alkanedioic acid, alkali lignin and
arylcarboxylic acid anhydride (P-17-370) is subject to reporting under
this section for the significant new uses described in paragraph (a)(2)
of this section.
    (2) The significant new uses are:
    (i) Hazard communication program. A significant new use of these
substances is any manner or method of manufacture, import, or
processing associated with any use of these substances without
providing risk notification as follows:
    (A) If as a result of the test data required under the Order for
the substance, the employer becomes aware that the substance may
present a risk of injury to human health or the environment, the
employer must incorporate this new information, and any information on
methods for protecting against such risk, into an SDS as described in
Sec.  721.72(c) within 90 days from the time the employer becomes aware
of the new information. If the substance is not being manufactured,
processed, or used in the employer's workplace, the employer must add
the new information to an SDS before the substance is reintroduced into
the workplace.
    (B) The employer must ensure that persons who will receive the PMN
substance from the employer, or who have received the PMN substance
from the employer within 5 years from the date the employer becomes
aware of the new information described in paragraph (a)(2)(i)(A) of
this section, are provided an SDS containing the information required
under paragraph (a)(2)(i)(A) of this section within 90 days from the
time the employer becomes aware of the new information.
    (ii) Industrial, commercial, and consumer activities. It is a
significant new use to manufacture, process, or use the substance with
greater than the confidential percentages of low molecular weight
components and less than the confidential average molecular weight
specified in the Order.
    (b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements, as specified in
Sec.  721.125(a) through (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.

Sec.  721.11276  Vegetable oil, polymer with alkanedioic acid, alkali
lignin, diethylene glycol- and polyol-depolymd. poly(ethylene
terephthalate) waste plastics and arylcarboxylic acid anhydride
(generic).

    (a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substances generically identified as
vegetable oil, polymer with alkanedioic acid, alkali lignin, diethylene
glycol- and polyol-depolymd. poly(ethylene terephthalate) waste
plastics and arylcarboxylic acid anhydride (P-17-371) is subject to
reporting under this section for the significant new uses described in
paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Hazard communications program. A significant new use of these
substances is any manner or method of manufacture, import, or
processing associated with any use of these substances without
providing risk notification as follows:
    (A) If as a result of the test data required under the Order for
the substance, the employer becomes aware that the substance may
present a risk of injury to human health or the environment, the
employer must incorporate this new information, and any information on
methods for protecting against such risk, into an SDS, as described in
Sec.  721.72(c), within 90 days from the time the employer becomes
aware of the new information. If the substance is not being
manufactured, processed, or used in the employer's workplace, the
employer must ad the new information to an SDS before the substance is
reintroduced into the workplace.
    (B) The employer must ensure that persons who will receive the PMN
substance from the employer, or who have received the PMN substance
from the employer within 5 years form the date the employer becomes
aware of the new information described in paragraph (a)(2)(i)(A) of
this section, are provided an SDS containing the information required
under paragraph (a)(2)(i)(A) of this section within 90 days form the
time the employer becomes aware of the new information.
    (ii) Industrial, commercial, and consumer activities. It is a
significant new use to manufacture, process, or use the substance with
greater than the confidential percentages of low molecular weight
components and less than the confidential average molecular weight
specified in the Order.
    (b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements, as specified in
Sec.  721.125(a) through (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.

Sec.  721.11277   Vegetable oil, polymer with alkanedioic acid, alkali
lignin, diethylene glycol-depolymd. poly(ethylene terephthalate) waste
plastics and arylcarboxylic acid anhydride (generic).

    (a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substances generically identified as
vegetable oil, polymer with alkanedioic acid, alkali lignin, diethylene
glycol-depolymd. poly(ethylene terephthalate) waste plastics and
arylcarboxylic acid anhydride (P-17-372) is subject to reporting under
this section for the significant new uses described in paragraph (a)(2)
of this section.
    (2) The significant new uses are:
    (i) Hazard communication program. A significant new use of these
substances is any manner or method of manufacture, import, or
processing associated with any use of these substances without
providing risk notification as follows:
    (A) If as a result of the test data required under the Order for
the substance, the employer becomes aware that the substance may
present a risk of injury to human health or the environment, the
employer must incorporate this new information, and any information on
methods for protecting against such risk, into an SDS, as described in
Sec.  721.72(c), within 90 days from the time the employer becomes
aware of the new information. If the substance is not being
manufactured, processed, or used in the employer's workplace, the
employer must add the new information to an SDS before the substance is
reintroduced into the workplace.
    (B) The employer must ensure that persons who will receive the PMN
substance from the employer, or who have received the PMN substance
from the employer within 5 years from the date the employer becomes
aware of the new information described in paragraph

(a)(2)(i)(A) of this section, are provided an SDS containing the
information required under paragraph (a)(2)(i)(A) of this section
within 90 days from the time the employer becomes aware of the new
information.
    (ii) Industrial, commercial, and consumer activities. It is a
significant new use to manufacture, process, or use the substance with
greater than the confidential percentages of low molecular weight
components and less than the confidential average molecular weight
specified in the Order.
    (b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements, as specified in
Sec.  721.125(a) through (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.

Sec.  721.11278  Amides, tallow, N,N-bis(2-hydroxypropyl).

    (a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as amides, tallow, N,
N-bis (2-hydroxypropyl) (PMN P-17-382; CAS No. 1454803-04-3) 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. It is a
significant new use to manufacture, process or use the substance in any
manner that results in inhalation exposures. It is a significant new
use to process the substance resulting in an end use product containing
greater than 3% by weight of the substance.
    (ii) Release to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4), and (c)(4) where N = 11.
    (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) though (c), (i), and (k), are applicable to
manufacturers and processors of this substance.
    (2) Limitations or revocation of certain notification requirements.
The provisions of Sec.  721.185 apply to this section.

Sec.  721.11279  Substituted propanoic acid, polymer with
alkylisocyanate-substituted carbomonocycle, dialkyl carbonate, hydroxyl
alkyl substituted alkanediol, alkanediol, isocyanato substituted
carbomonocycle, alkanol substituted amines-blocked, compds. with
(alkylamino)alkanol (generic).

    (a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance generically identified as
substituted propanoic acid, polymer with alkylisocyanate-substituted
carbomonocycle, dialkyl carbonate, hydroxyl alkyl substituted
alkanediol, alkanediol, isocyanato substituted carbomonocycle, alkanol
substituted amines-blocked, compds. with (alkylamino)alkanol (PMN P-17-
394) is subject to reporting under this section for the significant new
uses described in paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Industrial, commercial, and consumer activities. Requirements,
as specified in Sec.  721.80(f). It is a significant new use to use the
substance for any use other than as a coating to improve chemical
resistance. It is a significant new use to import the substance with
average molecular weight greater than 1,000 daltons, containing greater
than 0.1% residual isocyanate by weight, or with greater than 4% of the
confidential chemical component specified in the Order.
    (ii) [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
    (1) Recordkeeping. Recordkeeping requirements, as specified in
Sec.  721.125(a) through (c) and (i), are applicable to manufacturers
and processors of this substance.
    (2) Limitations or revocation of certain notification requirements.
The provisions of Sec.  721.185 apply to this section.
    (3) Determining whether a specific use is subject to this section.
The provisions of Sec.  721.1725(b)(1) apply to paragraph (a)(2)(i) of
this section.

Sec.  721.11280  Propanediol phosphate (generic).

    (a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance generically identified as
propanediol phosphate (PMN P-18-23) 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) Hazard communication. Requirements, as specified in Sec.
721.72(a) through (d), (f), (g)(1)(i), (ii), and (iv), (eye
irritation), (g)(2)(i), (ii), and (v), (use eye protection), (avoid eye
contact), (g)(3)(i) and (ii), (g)(4)(iii), and (g)(5). Alternative
hazard and warning statements that meet the criteria of the Globally
Harmonized System and OSHA Hazard Communication Standard may be used.
    (ii) Industrial, commercial, and consumer activities. Requirements,
as specified in Sec.  721.80(o). It is a significant new use to
manufacture, process, or use the substance in any manner that generates
a vapor, spray, mist, or aerosol.
    (iii) Release to water. Requirements, as specified in Sec.
721.90(a)(1), (b)(1), and (c)(1).
    (b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
    (1) Recordkeeping. Recordkeeping requirements, as specified in
Sec.  721.125(a) through (c), (f) 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.

Sec.  721.11281  Substituted cashew, nutshell liquid, polymer with
epichlorohydrin, phosphate (generic).

    (a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance generically identified as
substituted cashew, nutshell liquid, polymer with epichlorohydrin,
phosphate (generic) (PMN P-18-24) 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) Hazard communication. Requirements, as specified in Sec.
721.72(a) through (d), (f), (g)(1)(i) and (ii), (eye irritation),
(g)(2)(i), (ii), and (v), (use eye protection), (avoid eye contact),
(g)(3)(i) and (ii), (g)(4)(iii), and (g)(5). Alternative hazard and
warning statements that meet the criteria of the Globally Harmonized
System and OSHA Hazard Communication Standard may be used.
    (ii) Industrial, commercial, and consumer activities. Requirements,
as specified in Sec.  721.80(o). It is a significant new use to
manufacture, process, or use the substance in any

manner that generates a vapor, spray, mist, or aerosol.
    (iii) Release to water. Requirements, as specified in Sec.
721.90(a)(1), (b)(1), and (c)(1).
    (b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
    (1) Recordkeeping. Recordkeeping requirements, as specified in
Sec.  721.125 125(a) through (c), (f) 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.

Sec.  721.11282   2,5-Furandione, polymer with 2-ethyl-2-
(hydroxymethyl)-1,3-propanediol, 3a,4,5,6,7,7a-hexahydro-4,7-methano-
1H-inden-5(or 6)-yl ester, ester with 2,3-dihydroxypropyl neodecanoate.

    (a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as 2,5-furandione,
polymer with 2-ethyl-2-(hydroxymethyl)-1,3-propanediol, 3a,4,5,6,7,7a-
hexahydro-4,7-methano-1H-inden-5(or 6)-yl ester, ester with 2,3-
dihydroxypropyl neodecanoate (PMN P-18-41) is subject to reporting
under this section for the significant new uses described in paragraph
(a)(2) of this section.
    (2) The significant new uses are:
    (i) Industrial, commercial, and consumer activities. Requirements,
as specified in Sec.  721.80(g). It is a significant new use to
manufacture (including import) the substance with the number average
molecular weight of less than 1000 daltons.
    (ii) [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (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.

Sec.  721.11283   Waste plastics, polyester, depolymd. with glycols,
polymers with dicarboxylic acids (generic).

    (a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance generically identified as waste
plastics, polyester, depolymd. with glycols, polymers with dicarboxylic
acids (PMN P-18-70) is subject to reporting under this section for the
significant new uses described in paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Industrial, commercial, and consumer activities. Requirements,
as specified in Sec.  721.80(j).
    (ii) [Reserved]
    (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) though (c) and (i), are applicable to manufacturers
and processors of this substance.
    (2) Limitations or revocation of certain notification requirements.
The provisions of Sec.  721.185 apply to this section.
    (3) Determining whether a specific use is subject to this section.
The provisions of Sec.  721.1725(b)(1) apply to paragraph (a)(2)(ii) of
this section

Sec.  721.11284   Di(substituted-1,3-trialkylammonium) dialkylammonium
salt (generic).

    (a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
di(substituted-1,3-trialkylammonium) dialkylammonium salt (PMN P-18-88)
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) Hazard communication. Requirements, as specified in Sec.
721.72(a) through (d), (e) (concentration set at 1.0%), (f),
(g)(1)(ii), (iii), and (iv), (g)(2)(i), (ii), (iii), and (v), and
(g)(5). Alternative hazard and warning statements that meet the
criteria of the Globally Harmonized System and OSHA Hazard
Communication Standard may be used.
    (ii) Industrial, commercial, and consumer activities. Requirements,
as specified in Sec.  721.80(k). It is a significant new use to
manufacture, process, or use the substance in any manner that results
in the generation of a vapor, mist, particulate, or aerosol.
    (iii) Release to water. Requirements, as specified in Sec.
721.90(a)(4), (b)(4), and (c)(4) where N = 1000.
    (b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
    (1) Recordkeeping. Recordkeeping requirements, as specified in
Sec.  721.125(a), (b), (c), (f), (g), (h), (i), and (k), are applicable
to manufacturers and processors of this substance.
    (2) Limitations or revocation of certain notification requirements.
The provisions of Sec.  721.185 apply to this section.
    (3) Determining whether a specific use is subject to this section.
The provisions of Sec.  721.1725(b)(1) apply to paragraph (a)(2)(iii)
of this section.

Sec.  721.11285   Substituted alkanoic acid polymer with
alkylcarbonate, alkanediols and isocyanate substituted carbomonocycles,
sodium salt, alkenoic acid substituted polyol reaction products-blocked
(generic).

    (a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
substituted alkanoic acid polymer with alkylcarbonate, alkanediols and
isocyanate substituted carbomonocycles, sodium salt, alkenoic
acidsubstituted polyol reaction products-blocked (PMN P-18-100) 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), (j), and (o).
    (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) though (c) and (i), are applicable to manufacturers
and processors of this substance.
    (2) Limitations or revocation of certain notification requirements.
The provisions of Sec.  721.185 apply to this section.
    (3) Determining whether a specific use is subject to this section.
The provisions of Sec.  721.1725(b)(1) apply to paragraph (a)(2)(ii) of
this section

Sec.  721.11286   Alkenoic acid, ester with
[oxybis(alkylene)]bis[alkyl-substituted alkanediol], polymer with
alkylcarbonate, alkanediols, substituted alkanoic acid and isocyanate
and alkyl substituted carbomonocycle, sodium salt (generic).

    (a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
alkenoic acid, ester with [oxybis(alkylene)]bis[alkyl-substituted
alkanediol], polymer with alkylcarbonate, alkanediols, substituted
alkanoic acid and isocyanate and alkyl substituted carbomonocycle,
sodium salt (PMN P-18-102) 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), (j), and (o).
    (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) though (c) and (i), are applicable to manufacturers
and processors of this substance.
    (2) Limitations or revocation of certain notification requirements.
The provisions of Sec.  721.185 apply to this section.
    (3) Determining whether a specific use is subject to this section.
The provisions of Sec.  721.1725(b)(1) apply to paragraph (a)(2)(ii) of
this section.

Sec.  721.11287   Castor oil, reaction products with soybean oil.

    (a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as castor oil,
reaction products with soybean oil (PMN P-18-116) 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 (j). It is a significant new use to