[Federal Register Volume 84, Number 181 (Wednesday, September 18, 2019)]
[Rules and Regulations]
[Pages 49025-49040]
[FR Doc No: 2019-19666]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Parts 9 and 721

[EPA-HQ-OPPT-2017-0464; FRL-9998-12]
RIN 2070-AB27

Significant New Use Rules on Certain Chemical Substances (17-3)

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: EPA is issuing significant new use rules (SNURs) under the
Toxic Substances Control Act (TSCA) for 19 chemical substances which
are the subject of premanufacture notices (PMNs). The chemical
substances are subject to Orders issued by EPA pursuant to TSCA section
5(e). This action requires persons who intend to manufacture (defined
by statute to include import) or process any of these 19 chemical
substances for an activity that is designated as a significant new use
by this rule to notify EPA at least 90 days before commencing that
activity. The required notification initiates EPA's evaluation of the
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: This rule is effective on November 18, 2019. For purposes of
judicial review, this rule shall be promulgated at 1 p.m. (EST) on
October 2, 2019.

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

I. General Information

A. Does this action apply to me?

    You may be potentially affected by this action if you manufacture,
process, or use the chemical substances contained in this rule. The
following list of North American Industrial Classification System
(NAICS) codes is not intended to be exhaustive, but rather provides a
guide to help readers determine whether this document applies to them.
Potentially affected entities may include:
     Manufacturers or processors of one or more subject
chemical substances (NAICS codes 325 and 324110), e.g., chemical
manufacturing and petroleum refineries.
    This action may also affect certain entities through pre-existing
import certification and export notification rules under TSCA. Chemical
importers are subject to the TSCA section 13 (15 U.S.C. 2612) import
certification requirements promulgated at 19 CFR 12.118 through 12.127
and 19 CFR 127.28. Chemical importers must certify that the shipment of
the chemical substance complies with all applicable rules and orders
under TSCA. Importers of chemicals subject to these SNURs must certify
their compliance with the SNUR requirements. The EPA policy in support
of import certification appears at 40 CFR part 707, subpart B. In
addition, any persons who export or intend to export a chemical
substance that is the subject of this rule on or after October 18, 2019
are subject to the export notification provisions of TSCA section 12(b)
(15 U.S.C. 2611(b)) (see 40 CFR 721.20), and must comply with the
export notification requirements in 40 CFR part 707, subpart D.

II. Background

A. What action is the Agency taking?

    EPA is finalizing these SNURs under TSCA section 5(a)(2) for 19
substances which were the subject of PMNs. These SNURs require persons
who intend to manufacture or process any of these chemical substances
for an activity that is designated as a significant new use to notify
EPA at least 90 days before commencing that activity.
    In the Federal Register of August 27, 2018, (83 FR 43607) (FRL-
9982-25), EPA proposed a SNUR for these 19 chemical substances in 40
CFR part 721 subpart E. More information on the specific chemical
substances subject to this final rule can be found in the Federal
Register documents for the direct final SNUR of August 27, 2019 (83 FR
43538)(FRL-9982-24). The record for the SNUR was established in the
docket under docket ID number EPA-HQ-OPPT-2017-0464. That docket
includes information considered by the Agency in developing the
proposed and final rules.

    EPA received public comments on the proposed rule. Those comments
and EPA's responses are found in Unit IV.

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

    TSCA section 5(a)(2) (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 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)). 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.

C. Applicability of General Provisions

    General provisions for SNURs appear in 40 CFR part 721, subpart A.
These provisions describe persons subject to the rule, recordkeeping
requirements, exemptions to reporting requirements, and applicability
of the rule to uses occurring before the effective date of the rule.
Provisions relating to user fees appear at 40 CFR part 700. According
to 40 CFR721.1(c), persons subject to these SNURs must comply with the
same SNUN requirements and EPA regulatory procedures as submitters of
PMNs under TSCA section 5(a)(1)(A). In particular, these requirements
include the information submission requirements of TSCA section 5(b)
and 5(d)(1), the exemptions authorized by TSCA sections 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

    When the Agency issues an order under TSCA section 5(e), TSCA
section 5(f)(4) requires that the Agency consider whether to promulgate
a SNUR for any use not conforming to the restrictions of the TSCA
section 5(e) Order or publish a statement describing the reasons for
not initiating the rulemaking. TSCA section 5(a)(2) 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 what would constitute a significant new use for the
chemical substances that are the subject of these SNURs, EPA considered
relevant information about the toxicity of the chemical substances,
likely human exposures and environmental releases associated with
possible uses, and the four TSCA section 5(a)(2) factors listed in this
unit.

IV. Public Comments on Proposed Rule and EPA Responses

    EPA received public comments from 8 entities on the proposed rule.
The Agency's responses are described in this unit.

A. Anonymous Comments

    EPA received 5 anonymous comments on the proposed rule. All of
these comments were general in nature and not specific to or relevant
to any of the proposed SNURs. No response is required.

B. Isocyanates

    One commenter commented on proposed SNURs for these isocyanate-
based polymers or prepolymers: Polyethylene glycol polymer with
aliphatic polycarbodiimide bis(alkoxysilylpropyl) amine blocked
(generic) (PMN P-16-99, 40 CFR 721.11098); Blocked polyester
polyurethane, neutralized (generic) P-16-363, 40 CFR 721.11101);
Alkanediol, 2,2-bis (substituted alkyl)- polymer with substituted
alkane, heteromonocycles, alkenoate (generic) (P-17-170, 40 CFR
721.11107); 1,3,5-Triazine-2,4-diamine, 6-phenyl-, reaction products
with polyalkylene glycol mono- alkyl ether and 2,4-toluene diisocyanate
(generic) (P-17-222, 40 CFR 721.11111); and Fatty acids, polymers with
benzoic acid, cyclohexanedicarboxylic acid anhydride, aliphatic
diisocyanate, alkyl diol, alkyl triol, pentaerythritol, phthalic
anhydride, polyalkylene glycol amine, and aromatic dicarboxylate
sulfonic acid sodium salt (generic) (P-17-231, 40 CFR 721.11112).
    Comment. The commenter stated that EPA should clarify the proposed
SNURs to the extent it is basing them on concerns with excess or
residual isocyanate monomers in mixture with an isocyanate-based
polymer or prepolymer SNUR chemical. The commenter also stated that EPA
has not transparently identified those monomers as being subject to the
proposed SNURs and, besides, EPA may not use its SNUR authority to
address ongoing uses of the existing isocyanate monomers and must use
its TSCA section 6 authority instead.
    Response. EPA is concerned about the health effects of any residual
monomer as well as unreacted isocyanate groups on a polymer when
assessing the risks for new chemical substances. EPA has the authority
under TSCA section 5 to address any risks associated with the
manufacture, processing, and use of the new chemical substances. The
SNUR applies to activities associated with the new chemical substances.
Activities associated with the new chemical substance are not ongoing
activities of the existing chemical substance. EPA did not receive
specific, quantitative information that demonstrates the chemical
substance subject to these proposed SNURs exhibit a lower potential for
the hazards and potential risks or that they will specifically replace
a chemical substance with a higher potential for hazards and risks. EPA
is issuing the SNUR as proposed to provide the Agency with the
opportunity to review any new uses for potential unreasonable risks.
The diisocyanates, MDI and TDI, are well-known dermal and inhalation
sensitizers and have been documented to cause asthma, lung damage, and
in

severe cases, fatal reactions. EPA is concerned about potential health
effects that may result from exposures of consumers or self-employed
workers while using products containing uncured (unreacted) MDI and TDI
and its related polyisocyanates (e.g., spray- applied foam sealants,
adhesives, and coatings) or incidental exposures to the general
population. Due to the nature of the potential risk posed by these
chemicals, EPA believes it is prudent to emphasize its concern through
respiratory protection requirements where there is potential for
inhalation exposure, in addition to proposing significant new uses such
as consumer use and application method. Accordingly, the regulatory
actions for new diisocyanates reflects EPA's policy of consistent
treatment of the entire class of potentially hazardous chemicals,
regardless of their statutory status as ``new'' or ``existing''
chemicals. EPA continues to work to lessen the apparent inequity
between regulations of new and existing chemicals.
    Comment. The same commenter stated that EPA should clarify its
basis for the imposed limitations on total residual isocyanates,
because varying limitations on residual isocyanates appear in the
regulatory text for these SNURs, i.e., greater than: 0.2% residual
isocyanate (P-16-99), 0.1% residual isocyanate (P-16-363, P-17-170, P-
17-222, and P-17-231), and 0.15% residual toluene isocyanate (P-17-
222).
    Response. For each PMN substance, where there is potential risk
from residual chemicals or lower molecular weights if the polymer is
manufactured differently, EPA attempts to minimize exposure based on
information in the notification. Each of these PMNs contained
information that the polymer was manufactured at a certain molecular
weight and residual isocyanate level. EPA included restrictions for
residual isocyanate in the TSCA section 5(e) Order and the proposed
SNUR to prevent potential health risks.
    Comment. The same commenter stated that EPA should clarify the
basis for the derived New Chemical Exposure Limit (NCEL) of 0.9 mg/m\3\
(as an 8-hour time weighted average) for P-16-99. The commenter added
that the requirement to develop a validated airborne monitoring method
is overly burdensome and unnecessary and EPA should allow company
industrial hygienists to use professional judgment instead.
    Response. This substance is an alkoxysilane, with some residual
isocyanate. The NCEL of 0.9 mg/m\3\ was derived using a No Observed
Adverse Effect Level from a 90-day study on vinyltrimethoxysilane, as
described in the new chemicals program category document for
alkoxysilanes at https://www.epa.gov/reviewing-new-chemicals-under-toxic-substances-control-act-tsca/new-chemicals-program-under-tsca. The
SNUR does not require manufacturers or processors to develop validated
monitoring methods or techniques. A manufacturer would be required to
develop validated monitoring methods or techniques if they choose use
the NCEL.
    Comment. The same commenter stated that EPA should defer personal
protective equipment (PPE) and hazard communication provisions to the
applicable OSHA requirements.
    Response. The TSCA section 5(e) Orders for the chemicals in this
SNUR contain worker protection requirements, EPA proposed and is
issuing a final SNUR retaining those requirements so that all
manufacturers and processors are subject to the same requirements. If
the underlying TSCA section 5(e) Orders are modified EPA would consider
modifying the SNUR.
    Comment. The same commenter stated that EPA should delete the
provisions incorporating the recordkeeping requirements in 40 CFR
721.125, as it did in the proposed TDI SNUR, 80 FR 2068 (January 15,
2015), and some others.
    Response. The SNURs cited by the commenter are existing chemical
SNURs, where EPA determined recordkeeping was not needed. For example,
when the significant new use for an existing chemical is ``any use''
there is typically no recordkeeping required because there are no
records to be maintained that would inform EPA inspection or
enforcement. Because the SNURs in this current rule are new chemical
SNURs, EPA will continue to require recordkeeping for all new chemical
SNUR to better allow EPA to inspect and enforce SNUR requirements at
facilities where chemicals subject to SNURs are manufactured and
processed.

C. Deviation From EPA's PBT Policy

    Comment. One commenter suggests that EPA has deviated from its
Persistent, Bioaccumulative, and Toxic (PBT) New Chemical Substances
Testing Policy (see final policy statement at 64 FR 60194; November 4,
1999) and failed to explain those deviations. Comments relate to the
chemical substances described in PMNs P-15-719, P-16-221, P-17-177, P-
17-247, and P-17-248, which met criteria identified in the 1999 Policy
Statement for persistence, bioaccumulation potential, and toxicity that
would indicate they should be controlled more stringently, up to a ban
on commercialization pending development of certain testing.
    Response. These comments constitute challenges to certain TSCA
section 5(a)(3) determinations rather than to the basis for or the
content of the SNURs. EPA is not responding to these comments in this
notice and declines to withdraw the SNURs on the basis of these
comments, since they are not relevant to this rulemaking. The 1999
policy statement, which is not a rule, provides guidance criteria for
persistence, bioaccumulation, and toxicity for new chemicals and
advises the industry about our regulatory approach for chemicals
meeting the criteria. Establishment of a PBT category alerts potential
PMN submitters to possible assessment or regulatory issues associated
with PBT new chemicals review. It also provides a vehicle by which the
Agency may gauge the flow of PBT chemical substances through the TSCA
New Chemicals Program and measure the results of its risk screening and
risk management activities for PBT new chemical substances; as such, it
is a major element in the Agency's overall strategy to further reduce
risks from PBT pollutants.
    The TSCA section 5(e) Orders for these PMNs do state that EPA
estimates that the substances will persist in the environment for more
than two months and estimates a bioaccumulation factor of greater than
or equal to 1,000. The policy statement notes that even for ``very'' P
(persistence in the environment for more than six months) and ``very''
B cases (bioaccumulation factor of greater than 5,000), where ``because
of the increased concern, more stringent control action would be a
likely outcome, . . . it would not be appropriate to automatically
trigger a ``ban pending testing'' at these cutoffs given the
uncertainties about substance properties, release, and environmental
behavior that normally characterize PMN review.'' Accordingly, the
Agency evaluates each PMN based on the use, exposure and release
information submitted, and makes a case by case risk management
decision. The proposed SNUR terms for these substances reflect the
Agency's determination under their respective TSCA section 5(e) Orders,
that the controls stipulated in those TSCA section 5(e) Orders are
protective or human health and environment, pending submission of
further information that is identified in the TSCA section 5(e) Orders.

D. Ad Hoc Testing Policy Change

    Comment. One commenter noted that EPA has instituted an ad hoc
testing

policy change without acknowledging it has done so and without meeting
TSCA's requirements. With these proposed SNURs, the commenter
continues, EPA has implemented a significant departure from past policy
and practice by ceasing to include any testing requirements or
identifying any recommended testing. Instead, the commenter states,
each chemical-specific description in Unit IV. of the proposed rule
only identifies ``potentially useful information'' that EPA indicates
is only being ``provided for informational purposes;'' EPA has not
defined what it means for information to be only potentially useful and
why EPA does not identify the information as useful or necessary.
Finally, the commenter states that, moreover, EPA provides no
explanation for why it no longer identifies testing as ``recommended
testing,'' as it previously did, and instead only describes the
associated information as ``potentially useful.''
    Response. The comment pertains to the preamble of each SNUR, which
are not requirements for testing. EPA has modified language in its
regulatory documents to ensure consistency with TSCA section 4(h)
requirements to reduce testing on vertebrates to the extent
practicable. TSCA section 5(e) Orders will now contain a statement of
need that explains the basis for any decision that requires the use of
vertebrate animals. In addition, EPA is modifying language in its legal
documents describing test requirements to reflect a preference for
tiered testing and use of non-vertebrate testing strategies first and
using that test data to inform whether higher tiered testing (including
testing of vertebrates) is necessary. Similarly, EPA is modifying
language in its SNURs to more generally describe the information EPA
believes would help characterize chemical properties, fate and/or the
potential human health and environmental effects associated with a
significant new use of the chemical substance, rather than list
specific recommended tests. EPA is encouraging companies to consult
with the Agency on the potential for use of alternative test methods
and strategies (also called New Approach Methodologies, or NAMs) to
generate data to inform risk assessment. 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).

E. Consistency Between SNURs and TSCA Section 5(e) Orders

    Comment. One commenter noted that for P-16-0533, P-16-0570, P-16-
0363, P-17-0170, P-17-0179, and P-17-0247-48, the corresponding TSCA
section 5(e) Orders prohibit distribution of the substance until it has
been completely cured, while the proposed SNURs do not contain a
corresponding notification requirement applicable to a company that
intends to distribute the uncured substance. The commenter concludes
that the final SNURs must do so. The commenter further notes that for
P-16-0595 and P-17-0260 the proposed SNURs state that ``[t]he
requirements of this section do not apply to quantities of the
substance after they have been reacted (cured),'' while the underlying
TSCA section 5(e) Order contains no such provision to lift its
restrictions. The commenter concludes that the final SNURs should not
provide an exemption from the requirements of the SNUR where such an
exemption is not provided in the TSCA section 5(e) Orders.
    Response. For P-16-370 (P-16-570 is not contained in the proposed
SNUR), P-16-363, P-17-170, P-17-179, and P-17-247-248, the TSCA section
5(e) Orders do not prohibit distribution of the substances until they
are completely reacted (cured). The TSCA section 5(e) Orders allow
distribution under certain conditions. The terms of the TSCA section
5(e) Orders including the distribution requirements are exempted for
these PMNs when they have been fully reacted (cured). The final SNURs
for these substances will contain the same exemption. Manufacturers and
processors distributing chemicals in commerce subject to SNURs are
subject to the notification requirements found in 40 CFR 721.5(a)(2).
The TSCA section 5(e) Orders for P-16-533, P-16-595, and P-17-260 do
not contain an exemption if the substance is completely reacted
(cured). To be consistent with the TSCA section 5(e) Order, the final
SNURs for these three substances will not contain that exemption.

F. Generic Chemical Names Must Comply With the Requirements of TSCA and
EPA's Guidance

    Comment. One commenter noted that prior to finalizing the SNUR for
certain chemical substances identified, EPA must ensure that the
generic names for these chemicals comply with the law and conform to
EPA's Generic Name Guidance (83 FR 30173; June 27, 2018). The commenter
continued that despite TSCA's requirement for generic names to be
specific as practicable, and EPA's stated preference in its guidance
for masking only a single structural element, we have identified a
number of generic names covered by proposed SNURs that are or appear to
be far from sufficiently specific. The specific chemical substances
identified in this batch proposed SNUR were P-16-0221: Fluorinated
organopolysilazane; P-16-0370: Methoxy-terminated polysiloxanes; P-16-
0376: Hydroxystyrene resin; P-17-0179: Modified carboxypolyamine salt;
P-17-0247: Branched alkyl (C=17) carboxylic acid; and P-17-0248:
Branched alkyl (C=18) alcohol.
    Response. The statute, regulations, and guidance stipulate that
generic names should be as specific as practicable and reveal the
specific chemical identity to the maximum extent possible. See TSCA
section 14(c)(1)(C), 40 CFR 720.85(a)(2-3), and ``Guidance for Creating
Generic Names for Confidential Chemical Substance Identity Reporting
under TSCA'' (see 83 FR 30173; June 27, 2018). EPA declares PMNs
incomplete if they include generic names for confidential substances
that are overly generic. However, EPA more thoroughly examines generic
names provided after commencement of manufacture or import (i.e., in a
Notice of Commencement, or NOC), in accordance with 40 CFR
720.85(b)(6). Because this may occur after finalization of a SNUR, a
generic name provided in a SNUR may be improved upon regarding its
specificity at a later date when the NOC is submitted to the Agency.
Persons should also keep in mind that they do not have the benefit of
seeing the full chemical identities of confidential substances which is
necessary for determining the acceptability of generic names for such
substances. Generic names that may appear overly generic may be
acceptable for simple chemical substances that have very few functional
groups or structural features.

G. Generic Use Descriptions

    Comment. One commenter noted that despite EPA having provided PMN
submitters instructions to the contrary, many of these generic use
descriptions are overly broad or vague. The commenter provided these
examples in this batch proposed SNUR: P-16-363: open, non-dispersive
use; P-16-595: polymer; P-17-260: resin modifier; P-17-222: additive
open non-dispersive use; and these described by the commenter as
``slightly better'': P-16-99: additive for industrial coatings; P-16-
359: pigment additive for industrial

coatings; P-16-376: photolithography; and P-17-247/48: chemical raw
materials. The commenter stated that these generic use descriptions do
not comply with EPA's own 2015 ``Instruction Manual for Reporting under
the TSCA Sec.  5 New Chemicals Program,'' which calls for the generic
use description to include both (1) a description of the category of
use, which ``should reveal the intended category of use to the maximum
extent possible;'' and (2) a characterization of the ``degree of
containment,'' with examples cited such as ``destructive use'' or
``open, non-dispersive use.'' Both components are needed; EPA's manual
states: ``a generic use description that solely describes the degree of
containment such as `open, non-dispersive use' is not acceptable.''
While a few of the examples cited previously come closer than others,
the commenter concludes, none of them comply with the instructions.
    Response. EPA notes the generic use description issue, with regards
to PMN reporting. However, this comment does not pertain to the
findings or requirements of the proposed SNURs. Accordingly, EPA is not
making any changes to the final SNURs based on these comments.

H. Significant New Uses Should Be for Any Uses Other Than What EPA Has
Evaluated

    Comment. One commenter suggested that EPA should generally
designate as a significant new use any use of a chemical substance
other than the specific uses EPA evaluated in its PMN review and
determined are not likely to present an unreasonable risk. The
commenter identified P-17-247/248 as SNURs where the specific use is
claimed as confidential by the PMN submitter, but the TSCA section 5(e)
Order and SNURs restrict generically to use only as an intermediate,
and it is not clear that EPA examined other intermediate uses beyond
the specific use identified in the PMNs. The commenter believes that
EPA must also require notification for any type of chemical
intermediate use other than that which EPA has reviewed. The commenter
also noted that the SNURs for P-16-359 and 16-370 do not include
designation of any use that would require notification (only process
restrictions, no consumer use, application method, etc.).
    Response. The commenter suggested approach is overly broad. TSCA
requires that EPA evaluate new chemicals under their conditions of use,
including the intended, known and reasonably foreseen circumstances of
manufacture, processing, distribution in commerce, use and disposal.
Based upon EPA's review of the relevant PMNs, the Agency identified
uses that are appropriate for designation as ``significant new uses''
in order to ensure that EPA has an opportunity to review those uses in
a SNUN submission at a later date and address any unreasonable risks at
that time. TSCA section 5(a)(2) does not require EPA to take the broad
approach advocated by the commenter. EPA believes a more tailored
approach is warranted to avoid unduly burdensome regulations.

I. Misleading Use of 40 CFR 721.80 Reference

    Comment. One commenter noted that certain proposed SNURs state that
a significant new use related to Industrial, commercial, and consumer
activities is listed as ``requirements as specified in Sec.  721.80''
without specifying one of the 25 possible restrictions in that section.
    Response. EPA understands the confusion and has deleted reference
to 40 CFR 721.80 where no specific section is cited and simply writes
the applicable significant new use, i.e., ``Industrial, commercial, and
consumer activities. It is a significant new use to . . . .''

J. Consistency Between TSCA section 5(e) Orders and SNURs: Hierarchy of
Controls

    Comment. One commenter stated that the provisions in many of the
proposed SNURs that address ``protection in the workplace'' are not
consistent with the underlying TSCA section 5(e) Orders, and unlike the
TSCA section 5(e) Orders, do not accurately and sufficiently invoke the
Industrial Hygiene Hierarchy of Controls (HOC), which is a foundational
element of OSHA and NIOSH policy. The commenter also cites two TSCA
section 5(e) Orders or preambles to the SNURs for P-16-221 and P-16-370
that either fail to include language requiring preference for
engineering and administrative controls over PPE or only include a
general statement that encourages such controls.
    Response. EPA believes that although the SNURs may not precisely
mimic the language in the underlying TSCA section 5(e) Orders, the
SNURs do incorporate the same requirements for HOC as found in the TSCA
section 5(e) Orders. The commenter refers to this language generally
used in TSCA section 5(e) Orders: ``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 to each person who is reasonably likely to be
[dermally exposed/exposed by inhalation] in the work area to the PMN
substance * * *. Where engineering, work practice, and administrative
controls are not feasible or, if feasible, do not prevent exposure,
each person subject to this exposure must be provided with, and is
required to wear, [personal protective equipment]. * * * '' The
corresponding SNUR language is shortened to this: ``engineering control
measures (e.g., enclosure or confinement of the operation, general and
local ventilation) or administrative control measures (e.g., workplace
policies and procedures) shall be considered and implemented to prevent
exposure, where feasible''. The language in the specific references
under 40 CFR 721.63(a) regarding establishing a program to protect
workers incorporates both the HOC and worker protection requirements of
the SNUR. EPA believes that the intent and requirements are identical
between the TSCA section 5(e) Orders and SNURs and that adding a phrase
referring to PPE where engineering controls are not feasible would not
serve to further clarify this SNUR notification requirement.

K. SNURs Should Include Workplace Protection Provisions Under 40 CFR
721.63

    Comment. The same commenter noted that many of the SNURs do not
include specific provisions to incorporate requirements for protection
in the workplace regulations codified at 40 CFR 721.63. Specific SNURs
cited were for PMNs P-16-376, P-16-595, P-17-172, P-17-222, P-17-231,
and P-17-260. None of the TSCA section 5(e) Orders contained workplace
controls.
    Response. For the TSCA section 5(e) Orders listed, EPA achieved the
necessary risk reduction in the workplace via provisions other than
specific worker protection requirements. For P-16-376, the TSCA section
5(e) Order requires manufacture of the substance at a certain molecular
weight and molecular weight distribution that effectively controls risk
``upstream,'' for the inherent hazard of the substance. For P-16-595,
the TSCA section 5(e) Order requires certain (confidential) conditions
of use that address potential risk. A bona fide and SNUN would be
required before any other conditions of use can be evaluated and
approved. For P-17-172, P-17-222, and P-17-260, lung toxicity concerns
are addressed by prohibition on inhalation exposures, plus (in the case
of P-17-222, a

limitation on isocyanate residuals). P-17-231 achieves risk reduction
solely via restriction on residual isocyanate in the manufactured
substance.

L. Deferring Workplace Protections to OSHA or NIOSH

    Comment. One commenter favored the idea that EPA should leave
workplace protection to OSHA and NIOSH. Another commenter argued
against that view, stating that nothing in the TSCA statute supports
the assertion that EPA should rely on OSHA to regulate new chemicals in
the workplace, see 15 U.S.C. 2604(f)(5); and due to the limitations on
OSHA's authority, the protections for workers would not meet TSCA's
requirement to ``protect against an unreasonable risk of injury to
health or the environment.'' 15 U.S.C. 2604(e).
    Response. To the extent these comments argue that the Agency should
or should not have issued orders under sections 5(e) or 5(f) of TSCA
that include worker protection conditions, EPA believes they are beyond
the scope of the SNUR for which EPA specifically solicited comments and
are properly directed to the TSCA section 5(a)(3) determinations that
pertain to the underlying PMNs for the SNUR. EPA is therefore not
responding to these comments.
    However, EPA in response to comments that pertain specifically to
the SNUR, i.e., those regarding the uses that should be subject to the
SNUR, as well as the assertion that EPA must include certain worker
protection provisions in the SNURs on the basis of TSCA section
5(f)(4), EPA disagrees with the comment that, with respect to scenarios
where EPA expects that worker protection requirements under other
federal/state authorities would mitigate risks to workers, EPA must
designate all uses without those protections as ``significant new
uses''. TSCA section 5(a)(2) does not mandate that any specific uses be
designated as significant. Instead, EPA has discretion as to which new
uses to designate as significant. In exercising its discretion under
TSCA section 5(a)(2), EPA expects compliance with federal and state
laws, such as worker protection standards or disposal restrictions,
unless case-specific facts indicate otherwise. Further, any workplace
risks will be mitigated if exposures are appropriately controlled, and
EPA expects that employers will require and workers will use the
appropriate controls (e.g., personal protective equipment such as
impervious gloves and/or respirators), consistent with the Safety Data
Sheet prepared by the PMN submitter, in a manner adequate to protect
them.

M. Clarification of SNUR for P-17-222 (40 CFR 721.11111)

    Comment. One commenter noted that in this proposed SNUR, EPA placed
a notification requirement based on the concentration of residual
isocyanate in the chemical as imported but has failed to include a
similar express notification requirement on manufacturing.
Specifically, the proposed SNUR (and the corresponding TSCA section
5(e) Order) states that ``[i]t is a significant new use to import the
chemical substance containing greater than 0.15 percent residual
isocyanate.'' As written, the commenter continues, the TSCA section
5(e) Order and SNUR appear to allow domestic manufacture of the
chemical without any limit on the residual level of isocyanate.
    One commenter also noted that for P-17-222, the TSCA section 5(e)
Order restricts the chemical to be imported ``to contain maximum
residual of toluene diisocyanate (TDI) no greater than 0.15 weight
percent.'' In contrast, the proposed SNUR states that a significant new
use is ``import [of] the chemical substance containing greater than
0.15 percent residual isocyanate.'' The TSCA section 5(e) Order also
prohibits processing and use of the chemical if it ``contain[s]
residual of toluene diisocyanate (TDI) greater than 0.15 weight
percent.'' In contrast, the SNUR applies that numerical residual limit
only to import of the substance. In order to be consistent with the
TSCA section 5(e) Order, the commenter states, the final SNUR must
designate as a significant new use any import, processing, or use of
the chemical containing greater than 0.15 percent residual toluene
diisocyanate (TDI).
    Response: The Agency agrees that there was an oversight in the
proposed rule. The final SNUR for that chemical substance is corrected
to read ``It is a significant new use to manufacture, process, or use
the chemical substance containing greater than 0.15 percent residual
toluene isocyanate.'' Note that manufacture includes import. In
addition, the previous sentence in the same proposed SNUR will be
corrected to read ``It is a significant new use to modify the
manufacture, process or use activities if it results in inhalation
exposure to vapor, mist, aerosol, or dust of (replacing to) the
substance.''

N. CBI and Disclosure of Health and Safety Information

    Comment. One commenter stated that TSCA does not extend CBI
protection to any health and safety study which is submitted under
TSCA, including underlying information and occupational exposure
studies. In addition to the scientific analyses developed by EPA (e.g.,
engineering reports, Structure Activity Team reports), which fall under
this definition, other information that is generally required to be
submitted with PMNs, such as toxicity studies, information on worker
exposure, and the majority of information in Safety Data Sheets, also
fall under this definition. EPA must disclose this information to the
public. Despite these mandates, the commenter argues that EPA has
failed to disclose this health and safety information. The comment
states that EPA's SAT reports, engineering reports, and exposure
reports all constitute or contain health and safety information that
EPA must disclose, yet for P-16-359 (as an example provided by the
commenter) EPA has largely redacted these documents.
    Response. EPA recognizes that TSCA section 14 does not protect from
disclosure certain confidential information described in TSCA section
14(b), including health and safety information. However, TSCA section
14 does not require that EPA make a final confidentiality determination
for all information submitted under TSCA and claimed as CBI as part of
a PMN review, and EPA has not made a determination regarding the
eligibility for confidential treatment of the information referenced in
the comment. Here, EPA balanced the need for sufficient information in
the public record to fully explain the bases for its decisions with the
protections for CBI in TSCA section 14. With regard to EPA technical
support reports underlying the section 5 determination, they are not
covered by TSCA section 14(b)(2), which specifically refers to health
and safety studies submitted to EPA. EPA provided sufficient
information in the public record to fully explain the bases for its
decisions while preserving the submitter's confidentiality claims.

O. Vertebrate Testing

    Comment. A commenter cited the TSCA section 5(e) Orders for P-15-
719, P-16-99, P-16-221, P-16-370, P-16-487, P-16-533, P-17-170, P-17-
179, and P-17-247 that require animal testing by a specified production
volume. The commenter requested that wherever EPA require vertebrate
animal testing, it include the statutorily-mandated explanation of the
bases for the such decision in each particular case. In addition, the
commenter requested that EPA contact the PMN

submitters for P-16-533, P-17-170, and P-17-247 to inform them that the
local lymph node assay for skin sensitization should be replaced with a
defined approach as identified in section 5 of the draft EPA policy
document Strategic Plan to Promote the Development and Implementation
of Alternative Test Methods Within the TSCA Program (see https://www.epa.gov/assessing-and-managing-chemicals-under-tsca/strategic-plan-reduce-use-vertebrate-animals-chemical).
    Response. A request to review compliance with TSCA section 4(h)(3)
for PMNs and TSCA section 5(e) Orders is not relevant to the proposed
SNUR. Because SNURs do not require testing and only suggest the type of
information that could address hazards identified by EPA, they include
opportunities for EPA to engage submitters considering conducting
testing. For SNURs with time or production volume limits, or if a SNUN
submitter is required to conduct testing, EPA will include
consideration of TSCA section 4(h)(3). When a company consults with EPA
before submitting any SNUN as recommended by EPA when issuing SNURs,
EPA will also have an opportunity to consider what testing if any
should be conducted including consideration of TSCA section 4(h)(3).

V. Substances Subject to This Rule

    EPA is establishing significant new use and recordkeeping
requirements for 19 chemical substances in 40 CFR part 721, subpart E.
In Unit IV. of the original August 27, 2018 direct final rule (83 FR
43538) (9982-24), EPA provides the following information for each
chemical substance:
     PMN number.
     Chemical name (generic name, if the specific name is
claimed as CBI).
     Chemical Abstracts Service (CAS) Registry number (if
assigned for non-confidential chemical identities).
     Basis for the TSCA section 5(e) Order.
     Potentially Useful Information. This is information
identified by EPA that would help characterize the potential health
and/or environmental effects of the chemical substance in support of a
request by the PMN submitter to modify the TSCA section 5(e) Order, or
if a manufacturer or processor is considering submitting a SNUN for a
significant new use designated by the SNUR.
     CFR citation assigned in the regulatory text section of
this rule.
    The regulatory text section of each rule specifies the activities
designated as significant new uses. Certain new uses, including
exceedance of production volume limits (i.e., limits on manufacture
volume) and other uses designated in this rule, may be claimed as CBI.
Unit IX. discusses a procedure companies may use to ascertain whether a
proposed use constitutes a significant new use.
    These final rules include 19 PMN substances that are subject to
Orders under TSCA section 5(e)(1)(A)(ii)(I) where EPA determined that
activities associated with the PMN substances may present unreasonable
risk to human health or the environment. Those TSCA section 5(e) Orders
require protective measures to limit exposures or otherwise mitigate
the potential unreasonable risk. The SNURs identify as significant new
uses any manufacturing, processing, use, distribution in commerce, or
disposal that does not conform to the restrictions imposed by the
underlying TSCA section 5(e) 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 40 CFR
721.63 respirator requirements may request to do so under 40 CFR
721.30. EPA expects that persons whose 40 CFR 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.

VI. Rationale and Objectives of the Rule

A. Rationale

    During review of the PMNs submitted for the chemical substances
that are subject to these SNURs, EPA concluded that for all 19 chemical
substances regulation was warranted under TSCA section 5(e), pending
the development of information sufficient to make reasoned evaluations
of the health or environmental effects of the chemical substances. The
basis for such findings is outlined in Unit IV. Based on these
findings, TSCA section 5(e) Orders requiring the use of appropriate
exposure controls were negotiated with the PMN submitters. As a general
matter, EPA believes it is necessary to follow TSCA section 5(e) Orders
with a SNUR that identifies the absence of those protective measures as
Significant New Uses to ensure that all manufacturers and processors--
not just the original submitter--are held to the same standard.

B. Objectives

    EPA is issuing these SNURs for specific chemical substances which
have undergone premanufacture review because the Agency wants to
achieve the following objectives with regard to the significant new
uses designated in this rule:
     To 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 TSCA section 5(e)
Orders, consistent with TSCA section 5(f)(4).
     To 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.
     To have an opportunity to review and evaluate data
submitted in a SNUN before the notice submitter begins manufacturing or
processing a listed chemical substance for the described significant
new use.
     To be able to either determine that the prospective
manufacture or processing is not likely to present an unreasonable
risk, or to take necessary regulatory action associated with any other
determination, before the described significant new use of the chemical
substance occurs.
    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.

VII. Applicability of the Significant New Use Designation

    To establish a significant new use, EPA must determine that the use
is not ongoing. The chemical substances subject to this rule have
undergone premanufacture review. In cases where EPA has not received a
notice of commencement (NOC) and the chemical substance has not been
added to the TSCA Inventory, no person may commence such activities
without first submitting a PMN. Therefore, for chemical substances for
which an NOC has not been submitted EPA concludes that the designated
significant new uses are not ongoing.
    When chemical substances identified in this rule are added to the
TSCA Inventory, EPA recognizes that, before the rule is effective,
other persons might engage in a use that has been identified as a
significant new use. However, TSCA section 5(e) Orders have been issued
for all the chemical substances, and the PMN submitters are prohibited
by the TSCA section 5(e) Orders from undertaking activities which will
be designated as significant new uses. The identities of all 19
chemical substances subject to this rule have been claimed as
confidential and EPA has not received any post-PMN bona fide submission
(per 40 CFR 720.25 and 721.11) for a chemical substance covered by this
action. Based on this, the Agency believes that it is highly unlikely
that any of the significant new uses described in the regulatory text
of this rule are ongoing.
    Furthermore, EPA designated August 27, 2018 (the date of public
release of the proposed and direct final rules) as the cutoff date for
determining whether the new use is ongoing. The objective of EPA's
approach has been to ensure that a person could not defeat a SNUR by
initiating a significant new use before the effective date of the final
rule.
    In the unlikely event that a person began commercial manufacture or
processing of the chemical substances for a significant new use
identified as of August 27, 2018, that person will have to cease any
such activity upon the effective date of the final rule. To resume
their activities, these persons will have to first comply with all
applicable SNUR notification requirements and wait until EPA has
conducted a review of the notice, made an appropriate determination on
the notice, and has taken such actions as are required with that
determination.

VIII. Development and Submission of Information

    EPA recognizes that TSCA section 5 does not require developing any
particular new information (e.g., generating test data) before
submission of a SNUN. There is an exception:
    If a person is required to submit information for a chemical
substance pursuant to a rule, order or consent agreement under TSCA
section 4 (15 U.S.C. 2603), then TSCA section 5(b)(1)(A) (15 U.S.C.
2604(b)(1)(A)) requires such information to be submitted to EPA at the
time of submission of the SNUN.
    In the absence of a rule, order, or consent agreement under TSCA
section 4 covering the chemical substance, persons are required only to
submit information in their possession or control and to describe any
other information known to or reasonably ascertainable by them (see 40
CFR 720.50). However, upon review of PMNs and SNUNs, the Agency has the
authority to require appropriate testing. Unit IV. of the original
direct final SNUR (83 FR 43538) lists potentially useful information
for all SNURs listed here. Descriptions of this information is provided
for informational purposes. The potentially useful information
identified will be useful to EPA's evaluation in the event that someone
submits a SNUN for the significant new use. Companies who are
considering submitting a SNUN are encouraged, but not required, to
develop the information on the substance, which may assist with EPA's
analysis of the SNUN.
    EPA strongly encourages persons, before performing any testing, to
consult with the Agency pertaining to protocol selection. Furthermore,
pursuant to TSCA section 4(h), which pertains to reduction of testing
on vertebrate animals, EPA encourages consultation with the Agency on
the use of alternative test methods and strategies (also called New
Approach Methodologies, or NAMs), if available, to generate the
recommended test data. EPA encourages dialog with Agency
representatives to help determine how best the submitter can meet both
the data needs and the objective of TSCA section 4(h).
    In certain of the TSCA section 5(e) Orders for the chemical
substances regulated under this rule, EPA has established production
volume limits in view of the lack of data on the potential health and
environmental risks that may be posed by the significant new uses or
increased exposure to the chemical substances. These limits cannot be
exceeded unless the PMN submitter first submits the results of
specified tests that would permit a reasoned evaluation of the
potential risks posed by these chemical substances. The SNURs contain
the same production volume limits as the TSCA section 5(e) Orders.
Exceeding these production limits is defined as a significant new use.
Persons who intend to exceed the production limit must notify the
Agency by submitting a SNUN at least 90 days in advance of commencement
of non-exempt commercial manufacture or processing.
    Any request by EPA for the triggered and pended testing described
in the TSCA section 5(e) Orders was made based on EPA's consideration
of available screening-level data, if any, as well as other available
information on appropriate testing for the PMN substances. Further, any
such testing request on the part of EPA that includes testing on
vertebrates was made after consideration of available toxicity
information, computational toxicology and bioinformatics, and high-
throughput screening methods and their prediction models.
    The potentially useful information identified in Unit IV. may not
be the only means of addressing the potential risks of the chemical
substance. However, submitting a SNUN without any test data or other
information may increase the likelihood that EPA will take action under
TSCA section 5(e) or 5(f). 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.
     Information on risks posed by the chemical substances
compared to risks posed by potential substitutes.

IX. Procedural Determinations

    By this rule, EPA is establishing certain significant new uses
which have been claimed as CBI subject to Agency confidentiality
regulations at 40 CFR part 2 and 40 CFR part 720, subpart E. Absent a
final determination or other disposition of the confidentiality claim
under 40 CFR part 2 procedures, EPA is required to keep this
information confidential. EPA promulgated a procedure to deal with the
situation where a specific significant new use is CBI, at 40 CFR
721.1725(b)(1).
    Under these procedures a manufacturer or processor may request

EPA to determine whether a proposed use would be a significant new use
under the rule. The manufacturer or processor must show that it has a
bona fide intent to manufacture or process the chemical substance and
must identify the specific use for which it intends to manufacture or
process the chemical substance. If EPA concludes that the person has
shown a bona fide intent to manufacture or process the chemical
substance, EPA will tell the person whether the use identified in the
bona fide submission would be a significant new use under the rule.
Since most of the chemical identities of the chemical substances
subject to these SNURs are also CBI, manufacturers and processors can
combine the bona fide submission under the procedure in 40 CFR
721.1725(b)(1) with that under 40 CFR 721.11 into a single step.
    If EPA determines that the use identified in the bona fide
submission would not be a significant new use, i.e., the use does not
meet the criteria specified in the rule for a significant new use, that
person can manufacture or process the chemical substance so long as the
significant new use trigger is not met. In the case of a production
volume trigger, this means that the aggregate annual production volume
does not exceed that identified in the bona fide submission to EPA.
Because of confidentiality concerns, EPA does not typically disclose
the actual production volume that constitutes the use trigger. Thus, if
the person later intends to exceed that volume, a new bona fide
submission would be necessary to determine whether that higher volume
would be a significant new use.

X. SNUN Submissions

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

XI. Economic Analysis

    EPA has evaluated the potential costs of establishing SNUN
requirements for potential manufacturers and processors of the chemical
substances subject to this rule. EPA's complete economic analysis is
available in the docket under docket ID number EPA-HQ-OPPT-2017-0366.

XII. Statutory and Executive Order Reviews

    Additional information about these statutes and Executive Orders
can be found at http://www2.epa.gov/laws-regulations/laws-and-executive-orders.

A. Executive Order 12866: Regulatory Planning and Review and Executive
Order 13563: Improving Regulation and Regulatory Review

    This action establishes SNURs for several new chemical substances
that were the subject of PMNs and TSCA section 5(e) Orders. The Office
of Management and Budget (OMB) has exempted these types of actions from
review under Executive Orders 12866 (58 FR 51735, October 4, 1993) and
13563 (76 FR 3821, January 21, 2011).

B. Paperwork Reduction Act (PRA)

    According to PRA (44 U.S.C. 3501 et seq.), an agency may not
conduct or sponsor, and a person is not required to respond to a
collection of information that requires OMB approval under PRA, unless
it has been approved by OMB and displays a currently valid OMB control
number. The OMB control numbers for EPA's regulations in title 40 of
the CFR, after appearing in the Federal Register, are listed in 40 CFR
part 9, and included on the related collection instrument or form, if
applicable. EPA is amending the table in 40 CFR part 9 to list the OMB
approval number for the information collection requirements contained
in this action. This listing of the OMB control numbers and their
subsequent codification in the CFR satisfies the display requirements
of PRA and OMB's implementing regulations at 5 CFR part 1320. This
Information Collection Request (ICR) was previously subject to public
notice and comment prior to OMB approval, and given the technical
nature of the table, EPA finds that further notice and comment to amend
it is unnecessary. As a result, EPA finds that there is ``good cause''
under section 553(b)(3)(B) of the Administrative Procedure Act (5
U.S.C. 553(b)(3)(B)) to amend this table without further notice and
comment.
    The information collection requirements related to this action have
already been approved by OMB pursuant to PRA under OMB control number
2070-0012 (EPA ICR No. 574). This action does not impose any burden
requiring additional OMB approval. If an entity were to submit a SNUN
to the Agency, the annual burden is estimated to average between 30 and
170 hours per response. This burden estimate includes the time needed
to review instructions, search existing data sources, gather and
maintain the data needed, and complete, review, and submit the required
SNUN.
    Send any comments about the accuracy of the burden estimate, and
any suggested methods for minimizing respondent burden, including
through the use of automated collection techniques, to the Director,
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 RFA section 605(b) (5 U.S.C. 601 et seq.), the Agency
hereby certifies that promulgation of this SNUR will not have a
significant adverse economic impact on a substantial number of small
entities. The requirement to submit a SNUN applies to any person
(including small or large entities) who intends to engage in any
activity described in the final rule as a ``significant new use.''
Because these uses are ``new,'' based on all information currently
available to EPA, it appears that no small or large entities presently
engage in such activities. A SNUR requires that any person who intends
to engage in such activity in the future must first notify EPA by
submitting a SNUN. Although some small entities may decide to pursue a
significant new use in the future, EPA cannot presently determine how
many, if any, there may be. However, EPA's experience to date is that,
in response to the promulgation of SNURs covering over 1,000 chemicals,
the Agency receives only a small number of notices per year. For
example, the number of SNUNs received was seven in Federal fiscal year
(FY) 2013, 13 in FY2014, six in FY2015, 10 in FY2016, 14 in FY2017, and
18 in FY2018 and only a fraction of these were from small businesses.
In addition, the Agency currently offers relief to qualifying small
businesses by reducing the SNUN submission fee from $16,000 to $2,800.
This lower fee reduces the total reporting and recordkeeping of cost of
submitting a SNUN to about $10,116 for qualifying small firms.
Therefore, the potential economic impacts of complying with this 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 action does not impose any
enforceable duty, contain any unfunded mandate, or otherwise have any
effect on small governments subject to the requirements of UMRA
sections 202, 203, 204, or 205 (2 U.S.C. 1501 et seq.).

E. Executive Order 13132: Federalism

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

F. Executive Order 13175: Consultation and Coordination With Indian
Tribal Governments

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

G. Executive Order 13045: Protection of Children From Environmental
Health Risks and Safety Risks

    EPA interprets Executive Order 13045 (62 FR 19885, April 23, 1997),
as applying only to those regulatory actions that concern health or
safety risks, such that the analysis required under section 5-501 of
Executive Order 13045 has the potential to influence the regulation.
This action is not subject to Executive Order 13045 because it does not
establish an environmental standard intended to mitigate health or
safety risks disproportionately affecting children.

H. Executive Order 13211: Actions Concerning Regulations That
Significantly Affect Energy Supply, Distribution, or Use

    This action is not a ``significant energy action'' as defined in
Executive Order 13211 (66 FR 28355, May 22, 2001), because it is not
likely to have a significant adverse effect on energy supply,
distribution, or use.

I. National Technology Transfer and Advancement Act (NTTAA)

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

J. Executive Order 12898: Federal Actions To Address Environmental
Justice in Minority Populations and Low-Income Populations

    This action does not entail special considerations of environmental
justice related issues as delineated by Executive Order 12898 (59 FR
7629, February 16, 1994).

XIII. Congressional Review Act

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

List of Subjects

40 CFR Part 9

    Environmental protection, Reporting and recordkeeping requirements.

40 CFR Part 721

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

    Dated: September 3, 2019.
Tala Henry,
Deputy Director, Office of Pollution Prevention and Toxics.

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

PART 9--[AMENDED]

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

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

0
2. In Sec.  9.1, add Sec. Sec.  721.11097 through 11115 in numerical
order under the undesignated center heading ``Significant New Uses of
Chemical Substances'' to read as follows:

Sec.  9.1  OMB approvals under the Paperwork Reduction Act.

* * * * *

------------------------------------------------------------------------
                                                            OMB control
                     40 CFR citation                            No.
------------------------------------------------------------------------

                                * * * * *
Significant New Uses of Chemical Substances.............

                                * * * * *
721.11097...............................................       2070-0012
721.11098...............................................       2070-0012
721.11099...............................................       2070-0012
721.11100...............................................       2070-0012
721.11101...............................................       2070-0012
721.11102...............................................       2070-0012
721.11103...............................................       2070-0012
721.11104...............................................       2070-0012
721.11105...............................................       2070-0012
721.11106...............................................       2070-0012
721.11107...............................................       2070-0012
721.11108...............................................       2070-0012
721.11109...............................................       2070-0012
721.11110...............................................       2070-0012
721.11111...............................................       2070-0012
721.11112...............................................       2070-0012
721.11113...............................................       2070-0012
721.11114...............................................       2070-0012
721.11115...............................................       2070-0012

                                * * * * *
------------------------------------------------------------------------

* * * * *

PART 721--[AMENDED]

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

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

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

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

    (a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically benzene,
1,4-bis(alkyl)-, homopolymer (PMN P-15-719) is subject to reporting
under this section for the significant new uses described in paragraph
(a)(2) of this section.
    (2) The significant new uses are:
    (i) Hazard communication. Requirements as specified in Sec.
721.72(a) through (e) (concentrations set at 1.0 percent), (f),
(g)(4)(i), (iii), and (g)(5). Alternative hazard and warning

statements that meet the criteria of the Globally Harmonized System
(GHS) and OSHA Hazard Communication Standard may be used.
    (ii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec.  721.80(k) and (q).
    (iii) Disposal. Requirements as specified in Sec.  721.85(a)(1),
(2), (b)(1), (2), (c)(1), and (2).
    (iv) Release to water. Requirements as specified in Sec.
721.90(a)(1), (b)(1), and (c)(1).
    (b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a), (b), (c), and (f) through (k) are applicable to
manufacturers and processors of this substance.
    (2) Limitations or revocation of certain notification requirements.
The provisions of Sec.  721.185 apply to this section.
    (3) Determining whether a specific use is subject to this section.
The provisions of Sec.  721.1725(b)(1) apply to paragraph (a)(2)(iii)
of this section.

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

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

    (a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
polyethylene glycol polymer with aliphatic polycarbodiimide
bis(alkoxysilylpropyl) amine blocked (PMN P-16-99) is subject to
reporting under this section for the significant new uses described in
paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(1), (a)(2)(i), (a)(3), (a)(4), when determining which persons
are reasonably likely to be exposed as required for Sec.  721.63(a)(1)
and (a)(4), engineering control measures (e.g., enclosure or
confinement of the operation, general and local ventilation) or
administrative control measures (e.g., workplace policies and
procedures) shall be considered and implemented to prevent exposure,
where feasible, (a)(5) (respirators must provide a National Institute
for Occupational Safety and Health with an assigned protection factor
of at least 10), (a)(6)(particulate), (b)(concentrations set at 1.0
percent) and (c).
    (A) As an alternative to the respirator requirements in paragraph
(a)(2)(i) of this section, a manufacturer or processor may choose to
follow the new chemical exposure limit (NCEL) provision listed in the
TSCA section 5(e) Order for this substance. The NCEL is 0.9 mg/m\3\ as
an 8-hour time weighted average. Persons who wish to pursue NCELs as an
alternative to Sec.  721.63 respirator requirements may request to do
so under Sec.  721.30. Persons whose Sec.  721.30 requests to use the
NCELs approach are approved by EPA will be required to follow NCELs
provisions comparable to those contained in the corresponding TSCA
section 5(e) Order.
    (B) [Reserved]
    (ii) Hazard communication. Requirements as specified in Sec.
721.72(a) through (e)(concentration set 1.0 percent), (f), (g)(1)(ii),
(g)(2)(ii), (iii), (use respiratory protection or maintain workplace
airborne concentrations at or below an 8-hour time-weighted average of
0.9 mg/m3), 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), (q) and (t). It is a significant new
use to manufacture, process, or use the chemical substance for consumer
use or for commercial uses that could introduce the substance into a
consumer setting. It is a significant new use to manufacture the
chemical substance containing greater than 0.2% residual isocyanate.
    (b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (i) are applicable to manufacturers and processors
of this substance.
    (2) Limitations or revocation of certain notification requirements.
The provisions of Sec.  721.185 apply to this section.
    (3) Determining whether a specific use is subject to this section.
The provisions of Sec.  721.1725(b)(1) apply to paragraph (a)(2)(iii)
of this section.

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

Sec.  721.11099  Fluorinated organopolysilazane (generic).

    (a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as a
fluorinated organopolysilazane (PMN P-16-221) is subject to reporting
under this section for the significant new uses described in paragraph
(a)(2) of this section.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(1), (a)(3), (a)(4), when determining which persons are
reasonably likely to be exposed as required for Sec.  721.63(a)(1)
engineering control measures (e.g., enclosure or confinement of the
operation, general and local ventilation) or administrative control
measures (e.g., workplace policies and procedures) shall be considered
and implemented to prevent exposure, where feasible,
(a)(6)(particulate), (v), (vi), (b)(concentrations set at 1.0 percent),
and (c).
    (ii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec.  721.80(f), (p)(204 kilograms) and (s)(100
kilograms). It is a significant new use to use the substance other than
in the confidential coating system allowed in the corresponding TSCA
section 5(e) Order.
    (iii) Release to water. Requirements as specified in Sec.
721.90(a)(1), (b)(1), and (c)(1).
    (b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (e), (i), and (k) are applicable to manufacturers
and processors of this substance.
    (2) Limitations or revocation of certain notification requirements.
The provisions of Sec.  721.185 apply to this section.
    (3) Determining whether a specific use is subject to this section.
The provisions of Sec.  721.1725(b)(1) apply to paragraph (a)(2)(iii)
of this section.

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

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

    (a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
carbopolycycle-bis(diazonium), dihalo-, chloride (1:2), reaction
products with metal hydroxide, 4-[(dioxoalkyl) amino] substituted
benzene, 2-[(dioxoalkyl) amino] substituted benzene, 5-[(dioxoalkyl)
amino] 2-hydroxy-substituted benzene and oxo-n-phenylalkanamide (PMN P-
16-359) is subject to reporting under this section for the significant

new uses described in paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(1), (a)(3), (a)(4), when determining which persons are
reasonably likely to be exposed as required for Sec.  721.63(a)(1),
engineering control measures (e.g., enclosure or confinement of the
operation, general and local ventilation) or administrative control
measures (e.g., workplace policies and procedures) shall be considered
and implemented to prevent exposure, where feasible,
(a)(6)(particulate), (b)(concentrations set at 0.1 percent) and (c).
    (ii) Hazard communication. Requirements as specified in Sec.
721.72(a) through (e)(concentration set 0.1 percent), (f), (g)(1)(iv),
(vii), (g)(2)(i), (ii), (do not process or use at greater than 200
degrees Celsius), and (g)(5). Alternative hazard and warning statements
that meet the criteria of the Globally Harmonized System and OSHA
Hazard Communication Standard may be used.
    (iii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec.  721.80(f) and (q). It is a significant new use to
process or use the PMN substance at a temperature greater than 200
degrees C.
    (b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (i) are applicable to manufacturers and processors
of this substance.
    (2) Limitations or revocation of certain notification requirements.
The provisions of Sec.  721.185 apply to this section.
    (3) Determining whether a specific use is subject to this section.
The provisions of Sec.  721.1725(b)(1) apply to paragraph (a)(2)(iii)
of this section.

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

Sec.  721.11101  Blocked polyester polyurethane, neutralized (generic).

    (a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as blocked
polyester polyurethane, neutralized (PMN P-16-363) is subject to
reporting under this section for the significant new uses described in
paragraph (a)(2) of this section. The requirements of this section do
not apply to quantities of the substance after they have been reacted
(cured).
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(1), when determining which persons are reasonably likely to
be exposed as required for Sec.  721.63(a)(1) engineering control
measures (e.g., enclosure or confinement of the operation, general and
local ventilation) or administrative control measures (e.g., workplace
policies and procedures) shall be considered and implemented to prevent
exposure, where feasible, (a)(2)(i) through (iii), (a)(3),
(a)(6)(particulate), (v), (vi) (b)(concentrations set at 0.1 percent)
and (c).
    (ii) Hazard communication. Requirements as specified in Sec.
721.72(a) through (e)(concentration set 0.1 percent), (f), (g)(1)(i),
(ii), (g)(2)(i), (ii), (iii), (iv), and (g)(5). Alternative hazard and
warning statements that meet the criteria of the Globally Harmonized
System and OSHA Hazard Communication Standard may be used.
    (iii) Industrial, commercial, and consumer activities. It is a
significant new use to manufacture, process, or use the substance with
a residual of free isocyanate monomers greater than 0.1 percent by
weight. It is a significant new use to modify manufacture, process or
use activities if it results in inhalation exposure to vapor, dust,
mist or aerosols to the substance. It is a significant new use to
manufacture, process, or use the substance for consumer use or for
commercial uses that could introduce the substance into a consumer
setting. It is a significant new use to manufacture, process, or use
the substance other than in an aqueous formulation.
    (b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (i) are applicable to manufacturers and processors
of this substance.
    (2) Limitations or revocation of certain notification requirements.
The provisions of Sec.  721.185 apply to this section.

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

Sec.  721.11102  Methoxy-terminated polysiloxane (generic).

    (a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
methoxy-terminated polysiloxane (PMN P-16-370) is subject to reporting
under this section for the significant new uses described in paragraph
(a)(2) of this section. The requirements of this section do not apply
to quantities of the substance after they have been reacted (cured).
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(1), (a)(2)(i), (ii), (iii), (a)(3), (a)(4), when determining
which persons are reasonably likely to be exposed as required for Sec.
721.63(a)(1) and (a)(4), engineering control measures (e.g., enclosure
or confinement of the operation, general and local ventilation) or
administrative control measures (e.g., workplace policies and
procedures) shall be considered and implemented to prevent exposure,
where feasible, (a)(5) (respirators must provide a National Institute
for Occupational Safety and Health assigned protection factor of at
least 25), (a)(6)(particulate), (v), (vi), (b)(concentrations set at
1.0 percent), and (c).
    (A) As an alternative to the respirator requirements in paragraph
(a)(2)(i) of this section, a manufacturer or processor may choose to
follow the new chemical exposure limit (NCEL) provision listed in the
TSCA section 5(e) Order for this substance. The NCEL is 8.4 milligrams
per cubic meter as an 8-hour time weighted average. Persons who wish to
pursue NCELs as an alternative to Sec.  721.63 respirator requirements
may request to do so under Sec.  721.30. Persons whose Sec.  721.30
requests to use the NCELs approach are approved by EPA will be required
to follow NCELs provisions comparable to those contained in the
corresponding TSCA section 5(e) Order.
    (B) [Reserved]
    (ii) Hazard communication. Requirements as specified in Sec.
721.72(a) through (e)(concentration set 1.0 percent), (f), (g)(1)(i),
(ii), (g)(2)(i), (ii), (iii), (use respiratory protection or maintain
workplace airborne concentrations at or below an 8-hour time-weighted
average of 8.4 mg/m3), (g)(2)(v), (do not use for spray application),
and (g)(5). Alternative hazard and warning statements that meet the
criteria of the Globally Harmonized System and OSHA Hazard
Communication Standard may be used.
    (iii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec.  721.80(q), and (y)(1). It is a significant new
use to manufacture, process, or use the substance for consumer use or
for commercial uses that could introduce the substance into a consumer
setting.
    (b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).

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

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

Sec.  721.11103  Hydroxystyrene resin (generic).

    (a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
hydroxystyrene resin (PMN P-16-376) is subject to reporting under this
section for the significant new uses described in paragraph (a)(2) of
this section.
    (2) The significant new uses are:
    (i) Industrial, commercial, and consumer activities. Requirements
as specified in Sec.  721.80. It is a significant new use to
manufacture the PMN substance with an average molecular weight less
than 2906 daltons and to have greater than 0.5 percent low weight
molecular species less than 500 daltons and 1.0 percent low weight
molecular species less than 1000 daltons.
    (ii) [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (i) are applicable to manufacturers and processors
of this substance.
    (2) Limitations or revocation of certain notification requirements.
The provisions of Sec.  721.185 apply to this section.

0
11. Add Sec.  721.11104 to subpart E to read as follows:

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

    (a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
benzenesulfonic acid 1,2-diazenediylbis[6-ethenyl]-3-sulfophenyl
diazenyl-2-sulfophenyl ethenyl salt (PMN P-16-487) is subject to
reporting under this section for the significant new uses described in
paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(1), (a)(2)(i), (a)(3), when determining which persons are
reasonably likely to be exposed as required for Sec.  721.63(a)(1)
engineering control measures (e.g., enclosure or confinement of the
operation, general and local ventilation) or administrative control
measures (e.g., workplace policies and procedures) shall be considered
and implemented to prevent exposure, where feasible, (b)(concentration
set 1.0 percent), and (c).
    (ii) Hazard communication. Requirements as specified in Sec.
721.72(a) through (e)(concentration set 1.0 percent), (f), (g)(1)(iv),
(vi), (ix), (blood effects), (g)(2)(i), (v), (g)(3)(i), (ii),
(g)(4)(water release restrictions apply), and (g)(5). Alternative
hazard and warning statements that meet the criteria of the Globally
Harmonized System and OSHA Hazard Communication Standard may be used.
    (iii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec.  721.80 (f), (k), and (q). It is a significant new
use to import the substance other than in solution.
    (iv) Release to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4), and (c)(4) where N = 55.
    (b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (i) are applicable to manufacturers and processors
of this substance.
    (2) Limitations or revocation of certain notification requirements.
The provisions of Sec.  721.185 apply to this section.
    (3) Determining whether a specific use is subject to this section.
The provisions of Sec.  721.1725(b)(1) apply to paragraph (a)(2)(iii)
of this section.

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

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

    (a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
ethanaminium, alkyl-, salt with triazole (PMN P-16-533) is subject to
reporting under this section for the significant new uses described in
paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(1), (a)(2)(i), (ii), (iii), (a)(3), when determining which
persons are reasonably likely to be exposed as required for Sec.
721.63(a)(1) engineering control measures (e.g., enclosure or
confinement of the operation, general and local ventilation) or
administrative control measures (e.g., workplace policies and
procedures) shall be considered and implemented to prevent exposure,
where feasible, (a)(6)(particulate), (v), (vi), (b)(concentration set
0.1 percent), and (c).
    (ii) Hazard communication. Requirements as specified in Sec.
721.72(a) through (e)(concentration set 0.1 percent), (f), (g)(1)(i),
(iii), (v), (vii), (ix), (g)(2)(i) through (iii), (v), (g)(3)(i), (ii),
(g)(4)(iii), and (g)(5). Alternative hazard and warning statements that
meet the criteria of the Globally Harmonized System and OSHA Hazard
Communication Standard may be used.
    (iii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec.  721.80(k) and (q). It is a significant new use to
modify the manufacture, process or use activities if it results in
inhalation exposure to vapor, dust, mist or aerosols to the substance.
    (iv) Release to water. Requirements as specified in Sec.
721.90(a)(1), (b)(1), and (c)(1).
    (b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (i) and (k) are applicable to manufacturers and
processors of this substance.
    (2) Limitations or revocation of certain notification requirements.
The provisions of Sec.  721.185 apply to this section.
    (3) Determining whether a specific use is subject to this section.
The provisions of Sec.  721.1725(b)(1) apply to paragraph (a)(2)(iii)
of this section.

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

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

    (a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
substituted-(hydroxyalkyl)-alkyl-alkanoic acid, hydroxy-
(substitutedalkyl)-alkyl-, polymer with alpha-hydro-omega-hydroxypoly
[oxy(alkylethanediyl)] and isocyanato-(isocyanatoalkyl)-

multialkylcycloalkane, salt, alkanol-blocked, compds. (PMN P-16-595) is
subject to reporting under this section for the significant new uses
described in paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Industrial, commercial, and consumer activities. Requirements
as specified in Sec.  721.80(f) and (k). It is a significant new use to
import the substance other than as required in the corresponding TSCA
section 5(e) Order.
    (ii) Release to water. Requirements as specified in Sec.
721.90(a)(1), (b)(1), and (c)(1).
    (b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) (b), (c), (i), and (k) are applicable to manufacturers and
processors of this substance.
    (2) Limitations or revocation of certain notification requirements.
The provisions of Sec.  721.185 apply to this section.
    (3) Determining whether a specific use is subject to this section.
The provisions of Sec.  721.1725(b)(1) apply to paragraph (a)(2)(iii)
of this section.

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

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

    (a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
alkanediol, 2,2-bis (substituted alkyl)- polymer with substituted
alkane, heteromonocycles, alkenoate (PMN P-17-170) is subject to
reporting under this section for the significant new uses described in
paragraph (a)(2) of this section. The requirements of this section do
not apply to quantities of the PMN substance after they have been
reacted (cured).
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(1), (a)(2)(i), (a)(3), when determining which persons are
reasonably likely to be exposed as required for Sec.  721.63(a)(1)
engineering control measures (e.g., enclosure or confinement of the
operation, general and local ventilation) or administrative control
measures (e.g., workplace policies and procedures) shall be considered
and implemented to prevent exposure, where feasible, (b)(concentration
set 0.1 percent), and (c).
    (ii) Hazard communication. Requirements as specified in Sec.
721.72 (a) through (e)(concentration set 0.1 percent), (f), (g)(1)(i),
(ii), (v), (vii), (ix), (g)(2)(i), (v), (g)(4) and (g)(5). Alternative
hazard and warning statements that meet the criteria of the Globally
Harmonized System and OSHA Hazard Communication Standard may be used.
    (iii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec.  721.80(k) (ultraviolet curable coating resin for
three-dimensional printing applications) and (p)(105,000 kilograms). It
is a significant new use to modify the manufacture, process or use
activities if it results in inhalation exposure to vapor, dust, mist or
aerosols to the substance. It is a significant new use to manufacture
the chemical substance containing greater than 0.1 percent residual
isocyanate or an average molecular weight below 1,000 daltons.
    (b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (i) are applicable to manufacturers and processors
of this substance.
    (2) Limitations or revocation of certain notification requirements.
The provisions of Sec.  721.185 apply to this section.
    (3) Determining whether a specific use is subject to this section.
The provisions of Sec.  721.1725(b)(1) apply to paragraph (a)(2)(iii)
of this section.

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

Sec.  721.11108  Sulfurized alkylphenol, calcium salts (generic).

    (a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
sulfurized alkylphenol, calcium salts (PMN P-17-172) is subject to
reporting under this section for the significant new uses described in
paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Industrial, commercial, and consumer activities. Requirements
as specified in Sec.  721.80(k). It is a significant new use to modify
the manufacture, process or use activities if it results in inhalation
exposure to vapor, dust, mist or aerosols to the substance.
    (ii) [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a), (b), (c), and (i) are applicable to manufacturers and
processors of this substance.
    (2) Limitations or revocation of certain notification requirements.
The provisions of Sec.  721.185 apply to this section.
    (3) Determining whether a specific use is subject to this section.
The provisions of Sec.  721.1725(b)(1) apply to paragraph (a)(2)(iii)
of this section.

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

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

    (a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
monoheteropentacycloalkane-4-carboxylic acid, substituted cyclo-alkyl
ester (PMN P-17-177) is subject to reporting under this section for the
significant new uses described in paragraph (a)(2) of this section. The
requirements of this section do not apply to quantities of the
substance after they have been reacted (cured).
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(1), (a)(3), when determining which persons are reasonably
likely to be exposed as required for Sec.  721.63(a)(1) engineering
control measures (e.g., enclosure or confinement of the operation,
general and local ventilation) or administrative control measures
(e.g., workplace policies and procedures) shall be considered and
implemented to prevent exposure, where feasible, (b)(concentration set
0.1 percent), and (c).
    (ii) Hazard communication. Requirements as specified in Sec.
721.72(a) through (e)(concentration set 0.1 percent), (f), (g)(1)(i),
(ii), (iv), (vi), (vii), (ix), (skin, eye, and mucous membrane
irritation), (g)(2)(i) through (iii), (v), (g)(3)(i), (ii), (g)(4)(i)
through (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(f), (k), and (t).
    (iv) Release to water. Requirements as specified in Sec.
721.90(a)(1), (b)(1), and (c)(1).
    (b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).

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

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

Sec.  721.11110  Modified carboxypolyamine salt (generic).

    (a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
modified carboxypolyamine salt (PMN P-17-179) is subject to reporting
under this section for the significant new uses described in paragraph
(a)(2) of this section. The requirements of this section do not apply
to quantities of the substance after they have been reacted (cured).
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(1), (a)(2)(i), (iv), (a)(3), when determining which persons
are reasonably likely to be exposed as required for Sec.  721.63(a)(1)
engineering control measures (e.g., enclosure or confinement of the
operation, general and local ventilation) or administrative control
measures (e.g., workplace policies and procedures) shall be considered
and implemented to prevent exposure, where feasible,
(a)(6)(particulate), (v), (vi), (b)(concentration set 0.1 percent), and
(c).
    (ii) Hazard communication. Requirements as specified in Sec.
721.72(a) through (e)(concentration set 0.1 percent), (f), (g)(1)(i),
(ii), (g)(2)(i), (ii), (v), (g)(3)(i), (ii), and (g)(5). Alternative
hazard and warning statements that meet the criteria of the Globally
Harmonized System and OSHA Hazard Communication Standard may be used.
    (iii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec.  721.80(f), (k)(dispersive additive for pigments
in industrial paints and coatings) and (q). It is a significant new use
to process or use the substance in a paint or coating formulation
greater than 1 percent by weight or volume. It is a significant new use
to process or use the substance resulting in inhalation exposure to a
vapor, dust, mist or aerosol at greater than 1 percent by weight or
volume.
    (b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (i) are applicable to manufacturers and processors
of this substance.
    (2) Limitations or revocation of certain notification requirements.
The provisions of Sec.  721.185 apply to this section.
    (3) Determining whether a specific use is subject to this section.
The provisions of Sec.  721.1725(b)(1) apply to paragraph (a)(2)(iii)
of this section.

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

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

    (a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as 1,3,5-
triazine-2,4-diamine, 6-phenyl-, reaction products with polyalkylene
glycol mono- alkyl ether and 2,4-toluene diisocyanate (PMN P-17-222) is
subject to reporting under this section for the significant new uses
described in paragraph (a)(2) of this section. The requirements of this
section do not apply to quantities of the PMN substance after they have
been reacted (cured).
    (2) The significant new uses are:
    (i) Industrial, commercial, and consumer activities. It is a
significant new use to use the substance in a formulation for the use
allowed in the corresponding TSCA section 5(e) Order with isocyanate
residuals greater than 0.1 percent by weight or volume. It is a
significant new use to manufacture, process, or use the substance for
consumer use or for commercial uses that could introduce the substance
into a consumer setting. It is a significant new use to modify the
manufacture, process or use activities if it results in inhalation
exposure to vapor, dust, mist or aerosols of the substance. It is a
significant new use to manufacture, process, or use the substance
containing greater than 0.15 percent residual toluene diisocyanate.
    (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), (b), (c), and (i) are applicable to manufacturers and
processors of this substance.
    (2) Limitations or revocation of certain notification requirements.
The provisions of Sec.  721.185 apply to this section.
    (3) Determining whether a specific use is subject to this section.
The provisions of Sec.  721.1725(b)(1) apply to paragraph (a)(2)(i) of
this section.

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

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

    (a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as fatty
acids, polymers with benzoic acid, cyclohexanedicarboxylic acid
anhydride, aliphatic diisocyanate, alkyl diol, alkyl triol,
pentaerythritol, phthalic anhydride, polyalkylene glycol amine, and
aromatic dicarboxylate sulfonic acid sodium salt (PMN P-17-231) is
subject to reporting under this section for the significant new uses
described in paragraph (a)(2) of this section. The requirements of this
section do not apply to quantities of the substance after they have
been reacted (cured).
    (2) The significant new uses are:
    (i) Industrial, commercial, and consumer activities. Requirements
as specified in Sec.  721.80. It is a significant new use to
manufacture the chemical substance containing greater than 0.1 percent
residual isocyanate.
    (ii) [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a), (b), (c), and (i) are applicable to manufacturers and
processors of this substance.
    (2) Limitations or revocation of certain notification requirements.
The provisions of Sec.  721.185 apply to this section.

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

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

    (a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
branched alkyl (C=17) carboxylic acid (PMN P-17-247) is subject to
reporting under this section for the significant new uses described in
paragraph (a)(2) of this section. The

requirements of this section do not apply to quantities of the
substance after they have been reacted (cured).
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(1), (a)(2)(i) through (iii), (a)(3), when determining which
persons are reasonably likely to be exposed as required for Sec.
721.63(a)(1) engineering control measures (e.g., enclosure or
confinement of the operation, general and local ventilation) or
administrative control measures (e.g., workplace policies and
procedures) shall be considered and implemented to prevent exposure,
where feasible, (b)(concentration set 1.0 percent), and (c).
    (ii) Hazard communication. Requirements as specified in Sec.
721.72 (a) through (e)(concentration set 1.0 percent), (f),
(g)(1)(irritation), (sensitization), (iv), (vi), (ix), (g)(2)(i)
through (iii), (v), (g)(3)(i), (ii), (g)(4)(iii), and (g)(5).
Alternative hazard and warning statements that meet the criteria of the
Globally Harmonized System and OSHA Hazard Communication Standard may
be used.
    (iii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec.  721.80(f), (g) and (q). It is a significant new
use to modify the manufacture, process or use activities if it results
in inhalation exposure to vapor, dust, mist or aerosols to the
substance.
    (iv) Release to water. Requirements as specified in Sec.
721.90(a)(1), (b)(1), and (c)(1).
    (b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (i) and (k) are applicable to manufacturers and
processors of this substance.
    (2) Limitations or revocation of certain notification requirements.
The provisions of Sec.  721.185 apply to this section.
    (3) Determining whether a specific use is subject to this section.
The provisions of Sec.  721.1725(b)(1) apply to paragraph (a)(2)(iii)
of this section.

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

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

    (a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
branched alkyl (C=18) alcohol (PMN P-17-248) is subject to reporting
under this section for the significant new uses described in paragraph
(a)(2) of this section. The requirements of this section do not apply
to quantities of the substance after they have been reacted (cured).
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(1), (a)(2)(i), (ii), (iii), (a)(3), when determining which
persons are reasonably likely to be exposed as required for Sec.
721.63(a)(1) engineering control measures (e.g., enclosure or
confinement of the operation, general and local ventilation) or
administrative control measures (e.g., workplace policies and
procedures) shall be considered and implemented to prevent exposure,
where feasible, (b)(concentration set 1.0 percent), and (c).
    (ii) Hazard communication. Requirements as specified in Sec.
721.72(a) through (e)(concentration set 1.0 percent), (f),
(g)(1)(irritation), (sensitization), (iv), (vi), (ix), (g)(2)(i)
through (iii), (v), (g)(3)(i) and (ii), (g)(4)(iii), and (g)(5).
Alternative hazard and warning statements that meet the criteria of the
Globally Harmonized System and OSHA Hazard Communication Standard may
be used.
    (iii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec.  721.80(f), (g) and (q). It is a significant new
use to modify the manufacture, process or use activities if it results
in inhalation exposure to vapor, dust, mist or aerosols to the
substance.
    (iv) Release to water. Requirements as specified in Sec.
721.90(a)(1), (b)(1), and (c)(1).
    (b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (i) and (k) are applicable to manufacturers and
processors of this substance.
    (2) Limitations or revocation of certain notification requirements.
The provisions of Sec.  721.185 apply to this section.
    (3) Determining whether a specific use is subject to this section.
The provisions of Sec.  721.1725(b)(1) apply to paragraph (a)(2)(iii)
of this section.

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

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

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

[FR Doc. 2019-19666 Filed 9-17-19; 8:45 am]
 BILLING CODE 6560-50-P