Significant New Use Rules on Certain Chemical Substances (17-3), 49025-49040 [2019-19666]

Agencies

• ENVIRONMENTAL PROTECTION AGENCY

[Federal Register Volume 84, Number 181 (Wednesday, September 18, 2019)]
[Rules and Regulations]
[Pages 49025-49040]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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: (202) 564-9232; email address: 
[email protected].
    For general information contact: The TSCA-Hotline, ABVI-Goodwill, 
422 South Clinton Ave., Rochester, NY 14620; telephone number: (202) 
554-1404; email address: [email protected].

SUPPLEMENTARY INFORMATION: 

I. General Information

A. Does this action apply to me?

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

[[Page 49026]]

    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

[[Page 49027]]

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

[[Page 49028]]

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

[[Page 49029]]

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

[[Page 49030]]

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

[[Page 49031]]

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 
https://www.epa.gov/opptintr/

[[Page 49032]]

existingchemicals/pubs/tscainventory/.

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

[[Page 49033]]

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 https://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 https://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

[[Page 49034]]

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

[[Page 49035]]

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

[[Page 49036]]

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).

[[Page 49037]]

    (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)-

[[Page 49038]]

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).

[[Page 49039]]

    (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

[[Page 49040]]

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