Document ID: EPA-HQ-OPPT-2018-0777-0001
Agency: epa
Document Type: Proposed Rule
Title: Significant New Use Rules on Certain Chemical Substances (19-1.F)
Posted Date: 2019-07-31T04:00Z

[Federal Register Volume 84, Number 147 (Wednesday, July 31, 2019)]
[Proposed Rules]
[Pages 37199-37219]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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: (202) 564-9232; email address: 
moss.kenneth@epa.gov.
    For general information contact: The TSCA-Hotline, ABVI-Goodwill, 
422 South Clinton Ave., Rochester, NY 14620; telephone number: (202) 
554-1404; email address: TSCA-Hotline@epa.gov.

SUPPLEMENTARY INFORMATION: 

I. General Information

A. Does this action apply to me?

    You may be potentially affected by this action if you manufacture, 
process, or use the chemical substances contained in this 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:

[[Page 37200]]

     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,

[[Page 37201]]

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.

[[Page 37202]]

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

[[Page 37203]]

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).

[[Page 37204]]

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.

[[Page 37205]]

    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

[[Page 37206]]

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

[[Page 37207]]

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

[[Page 37208]]

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.

[[Page 37209]]

    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

[[Page 37210]]

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).

[[Page 37211]]

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

[[Page 37212]]

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:

[[Page 37213]]

    (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.

[[Page 37214]]

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

[[Page 37215]]

(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

[[Page 37216]]

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:

[[Page 37217]]

    (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 
process or use the substance that generates an aerosol or mist. It is a 
significant new use to exceed the confidential annual production volume 
stated in the PMN.
    (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.  721.11288   Benzene, 1-(chloromethyl)-3-methyl-.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified as benzene, 1-
(chloromethyl)-3-methyl- (P-18-134, CAS No. 620-19-9) is subject to 
reporting under this section for the significant new uses described in 
paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements, as specified in 
Sec.  721.63(a)(1), (a)(2)(i) and (iii), and (a)(3) through (5) 
(respirators must provide a National Institute for Occupational Safety 
and Health (NIOSH) assigned protection factor (APF) of at least 1000), 
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), (particulate), 
(combination gas/vapor and particulate), (b)(concentration set at 
0.1%), and (c).
    (ii) Hazard communication. Requirements, as specified in Sec.  
721.72(a) through (d), (e) (concentration set at 0.1%), (f), (g)(1)(i), 
(iii), (vi), (vii), and (ix), (respiratory irritation), (severe skin 
burns and eye damage), (sensitization (respiratory and dermal)), 
(serious eye irritation), (g)(2)(i), (ii), (iii), (iv), and (v), (g)(3) 
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.
    (iii) Industrial, Commercial, and consumer activities. 
Requirements, as specified in Sec.  721.80(k). It is a significant new 
use to vary the process or use methods described in the PMN such that 
occupational exposure is increased; and
    (iv) Release to water. Requirements, as specified in Sec.  
721.90(a)(1), (b)(1), and (c)(1).
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph (b).
    (1) Recordkeeping. Recordkeeping requirements, as specified in 
Sec.  721.125(a) through (i) and (k), are applicable to manufacturers 
and processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.
    (3) Determining whether a specific use is subject to this section. 
The provisions of Sec.  721.1725(b)(1) apply to paragraph (a)(2)(iii) 
of this section.

Sec.  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).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 1-
butanaminium,N,N,N-tributyl-,2(or 5)- [[benzoyldihydrodioxo 
[(sulfophenyl) amino]heteropolycycle]oxy]-5(or 2)-(1,1-
dimethylpropyl)benzenesulfonate (2:1) (PMN P-18-136) 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 if it 
results in inhalation exposure.
    (ii) Release to water. Requirements, as specified in Sec.  
721.90(a)(4), (b)(4), and (c)(4) where N = 19.
    (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) 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.  721.11290   Alkylsilsesquioxane, ethoxy-terminated (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 
alkylsilsesquioxane, ethoxy-terminated (PMN P-18-137) 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 resulting in inhalation exposures.
    (ii) Release to water. Requirements, as specified in Sec.  
721.90(a)(4), (b)(4), and (c)(4) where N = 58.
    (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) and (k), are applicable to 
manufacturers and processors of this substance.

[[Page 37218]]

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

Sec.  721.11291   Polythioether, short chain diol polymer terminated 
with aliphatic diisocyanate (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 
polythioether, short chain diol polymer terminated with aliphatic 
diisocyanate (PMN P-18-219) 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 the PMN substance with molecular 
weight greater than 10,000 daltons. It is a significant new use to 
manufacture the PMN substance with, free isocyanate residuals greater 
than 0.01% by weight.
    (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.

Sec.  721.11292   Alkenoic acid, polymer with alkenylcarbomonocycle, 
[alkanediylbis(substituted alkylene)] bis[heteromonocycle] and 
(alkylalkenyl) aromatic, salt (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 
alkenoic acid, polymer with alkenylcarbomonocycle, [alkanediylbis 
(substituted alkylene)] bis[heteromonocycle] and (alkylalkenyl) 
aromatic, salt (PMN P-18-224) 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 resulting in inhalation exposures. It is a significant new use 
to manufacture the substance to contain an acid content greater than 
20% by weight.
    (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.

Sec.  721.11293   Alkenoic acid, polymer with substituted alkyloxirane, 
alkenylcarbomonocycle, alkyl substituted alkyl alkanediol and 
(alkylalkenyl) aromatic salt (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 
alkenoic acid, polymer with substituted alkyloxirane, 
alkenylcarbomonocycle, alkyl substituted alkyl alkanediol and 
(alkylalkenyl) aromatic salt (PMN P-18-225) is subject to reporting 
under this section for the significant new uses described in paragraph 
(a)(2) of this section.
    (2) The significant new uses are:
    (i) Industrial, commercial, and consumer activities. Requirements, 
as specified in Sec.  721.80. It is a significant new use to 
manufacture, process or use the substance in any manner resulting in 
inhalation exposures. It is a significant new use to manufacture the 
substance to contain an acid content greater than 20% by weight.
    (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.

Sec.  721.11294   Alkyl alkenoic acid, alkyl ester, telomer with 
alkylthiol, substituted carbomonocycle, substituted alkyl alkyl 
alkenoate and hydroxyalkyl alkenoate, tertbutyl alkyl peroxoate-
initiated, (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as alkyl 
alkenoic acid, alkyl ester, telomer with alkylthiol, substituted 
carbomonocycle, substituted alkyl alkyl alkenoate and hydroxyalkyl 
alkenoate, tertbutyl alkyl peroxoate-initiated (PMN P-18-233) 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(w)(2).
    (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.

Sec.  721.11295   Substituted heteromonocycle, polymer with substituted 
alkanediol and diisocyanate substituted carbomonocyle, alkylene glycol 
acrylate-blocked (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance generically identified as 
substituted heteromonocycle, polymer with substituted alkanediol and 
diisocyanate substituted carbomonocyle, alkylene glycol acrylate-
blocked (PMN P-18-279) 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) (only persons subject to inhalation exposure from 
spray application are subject to these requirements), (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, and (5) (respirator 
must provide a National Institute for Occupational Safety and Health 
(NIOSH) assigned protection factor (APF) of at least 1,000).
    (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 (d), are applicable to manufacturers and 
processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.

[[Page 37219]]

PART 725--REPORTING REQUIREMENTS AND REVIEW PROCESSES FOR 
MICROORGANISMS

0
3. The authority citation for part 725 continues to read as follows:

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

0
 4. Add Sec.  725.1079 to subpart M to read as follows:

Sec.  725.1079   Arsenic detecting strain of E. coli with extra-
chromosomal elements, including an intergeneric screening marker 
(generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as Arsenic 
detecting strain of E. coli with extra-chromosomal elements, including 
an intergeneric screening marker (MCAN J-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(f). It is a significant new use to use the 
microorganism other than to detect arsenic in small water samples.
    (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.

[FR Doc. 2019-13989 Filed 7-30-19; 8:45 am]
 BILLING CODE 6560-50-P