Document ID: EPA-HQ-OPPT-2017-0366-0399
Agency: epa
Document Type: Rule
Title: Significant New Use Rules: Certain Chemical Substances
Posted Date: 2019-08-20T04:00Z

[Federal Register Volume 84, Number 161 (Tuesday, August 20, 2019)]
[Rules and Regulations]
[Pages 43266-43302]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-16099]

[[Page 43265]]

Vol. 84

Tuesday,

No. 161

August 20, 2019

Part II

Environmental Protection Agency

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40 CFR Parts 9 and 721

Significant New Use Rules on Certain Chemical Substances; Final Rule

  Federal Register / Vol. 84 , No. 161 / Tuesday, August 20, 2019 / 
Rules and Regulations  

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Parts 9 and 721

[EPA-HQ-OPPT-2017-0366; FRL-9994-72]
RIN 2070-AB27

Significant New Use Rules on Certain Chemical Substances

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 145 chemical substances which 
are the subject of premanufacture notices (PMNs). The chemical 
substances are subject to Orders issued by EPA pursuant to section 5(e) 
of TSCA. This action requires persons who intend to manufacture 
(defined by statute to include import) or process any of these 145 
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 October 21, 2019. For purposes of 
judicial review, this rule shall be promulgated at 1 p.m. (e.s.t.) on 
September 3, 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: 
moss.kenneth@epa.gov.
    For general information contact: The TSCA-Hotline, ABVI-Goodwill, 
422 South Clinton Ave., Rochester, NY 14620; telephone number: (202) 
554-1404; email address: TSCA-Hotline@epa.gov.

SUPPLEMENTARY INFORMATION: 

I. General Information

A. Does this action apply to me?

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

II. Background

A. What action is the Agency taking?

    EPA is finalizing these SNURs under TSCA section 5(a)(2) for 145 
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 1, 2018 (83 FR 37455) (FRL-9981-
16), EPA proposed a SNUR for these 145 chemical substances in 40 CFR 
part 721, subpart E, and reopened the public comment period in the 
Federal Register of October 15, 2018 (83 FR 51910) (FRL-9984-72). This 
reopened comment period closed on November 14, 2018. More information 
on the specific chemical substances subject to this final rule can be 
found in the Federal Register documents proposing the SNUR. The record 
for the SNUR was established in the docket under docket ID number EPA-
HQ-OPPT-2017-0366. That docket includes information considered by the 
Agency in developing the proposed and final rules.
    EPA received public comments on the proposed rule. Those comments 
and EPA's responses are found in Unit IV.

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

    Section 5(a)(2) of TSCA (15 U.S.C. 2604(a)(2)) authorizes EPA to 
determine that a use of a chemical substance is a ``significant new 
use.'' EPA must make this determination by rule after considering all 
relevant factors, including the four 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 Sec.  721.1(c), persons subject to these SNURs must comply with the 
same SNUN requirements and EPA regulatory procedures as submitters of 
PMNs under TSCA section 5(a)(1)(A). In particular, these requirements 
include the information submission requirements of TSCA section 5(b) 
and 5(d)(1), the exemptions authorized by TSCA section 5(h)(1), (h)(2), 
(h)(3), and (h)(5), and the regulations at 40 CFR part 720. Once 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

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the case of a determination other than not likely to present 
unreasonable risk, the applicable review period must also expire before 
manufacturing or processing for the new use may commence. If EPA 
determines that the use is not likely to present an unreasonable risk, 
EPA is required under TSCA section 5(g) to make public, and submit for 
publication in the Federal Register, a statement of EPA's findings.

III. Significant New Use Determination

    Section 5(a)(2) of TSCA states that EPA's determination that a use 
of a chemical substance is a significant new use must be made after 
consideration of all relevant factors, including:
     The projected volume of manufacturing and processing of a 
chemical substance.
     The extent to which a use changes the type or form of 
exposure of human beings or the environment to a chemical substance.
     The extent to which a use increases the magnitude and 
duration of exposure of human beings or the environment to a chemical 
substance.
     The reasonably anticipated manner and methods of 
manufacturing, processing, distribution in commerce, and disposal of a 
chemical substance.
    In determining what would constitute a significant new use for the 
chemical substances that are the subject of these SNURs, EPA considered 
relevant information about the toxicity of the chemical substances, 
likely human exposures and environmental releases associated with 
possible uses, and the four bulleted TSCA section 5(a)(2) factors 
listed in this unit. Note that when the Agency issues an order under 
TSCA section 5(e), section 5(f)(4) requires that the Agency consider 
whether to promulgate a SNUR for any use not conforming to the 
restrictions of the order or publish a statement describing the reasons 
for not initiating the rulemaking.

IV. Public Comments on Proposed Rule and EPA Responses

    EPA received public comments from 15 entities on the proposed rule. 
The Agency's responses are described below.

Anonymous Comments

    EPA received 8 anonymous comments on the proposed rule. These 
comments were general in nature and not specific to or relevant to any 
of the proposed SNURs. No response is required.

Ad Hoc Testing Policy Change

    Comment: One commenter noted that EPA has instituted an ad hoc 
testing policy change without acknowledging it has done so and without 
meeting TSCA's requirements. With these proposed SNURs, the commenter 
continues, EPA has implemented a significant departure from past policy 
and practice by ceasing to include any testing requirements or 
identifying any recommended testing. Instead, the commenter states, 
each chemical-specific description in Unit IV of the proposed rule only 
identifies ``potentially useful information'' that EPA indicates is 
only being ``provided for informational purposes;'' EPA has not defined 
what it means for information to be only potentially useful and why EPA 
does not identify the information as actually 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 preambles of each SNUR, which 
are not requirements for testing. The comment is misinformed, as 
section 5(a)(2) never has provided authority to require testing in 
SNUNs. Rather, EPA has identified recommended testing that appeared 
likely to assist with review of a SNUN. That the testing is now 
characterized as ``potentially useful'' rather than ``recommended'' 
takes into account the possibility that there may be a variety of 
information and/or data that would assist with the review of a SNUN, in 
addition to the testing that the Agency has identified. SNUN submitters 
may want to consider submitting information (i.e. exposure or toxicity 
data) that EPA had identified as potentially useful when the new 
chemical substance was originally reviewed. EPA is not establishing a 
new testing policy that is based on exposure considerations, as 
described under TSCA section 26(l)(3).
    In addition, as stated on EPA's new chemicals website (https://www.epa.gov/reviewing-new-chemicals-under-toxic-substances-control-act-tsca/actions-under-tsca-section-5): ``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. 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).''

Isocyanates

    One entity commented on proposed SNURs for two isocyanate-based 
polymers or prepolymers: Aliphatic N-alkyl urea polymer containing 
cyclohexyl groups and trimethoxy silanes (generic) (721.11029; P-15-
706) and aliphatic N-alkyl urea polymer containing aspartic ester 
groups and trimethoxy silanes (generic) (721.11030; P-15-707). For both 
of these SNURs, EPA proposed that the absence of the protective 
measures in the underlying TSCA 5(e) Order--including exceeding a 
specified weight of residual isocyanates in the PMN substances, 
consumer use, exceeding a workplace exposure limit (NCEL), and 
manufacture, processing or use without personal protective equipment--
would be reportable significant new uses.
    Comment: The commenter made the following points:
     EPA should clarify the proposed and direct final SNURs to 
the extent it is basing them on concerns with excess or residual 
isocyanate monomers. EPA appears to be basing the proposed SNURs on the 
potential for the hazards or risks of excess or residual isocyanate 
monomer in mixture with this isocyanate-based polymer or prepolymer. 
These isocyanate monomers are existing chemicals with many ongoing 
uses, including use as a monomer or use in excess or residual monomer. 
EPA has not transparently identified those monomers as being subject to 
the proposed SNURs. EPA may not use its SNUR authority to address 
ongoing uses of the isocyanate monomers.
     EPA should clarify the basis, scope, and provisions of the 
proposed SNURs. In particular, EPA should clarify its basis for both 
the imposed limitations

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on residual isocyanates and the derived New Chemical Exposure Limit 
(NCEL). EPA should also clarify the proposed regulatory text and the 
preamble of the proposed SNURs, which include inconsistent language 
regarding when respiratory and dermal protection is needed.
     EPA should defer personal protective equipment (PPE) and 
hazard communication provisions to the applicable OSHA requirements.
     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 (Jan. 15, 2015), and some others.
    In response to this commenter, another commenter stated that 
regardless of whether there are separate ongoing uses for these 
isocyanates, their presence here as residuals is directly associated 
with the manufacture of a new chemical substance that EPA has reviewed 
and for which it has determined that the PMN substance may present an 
unreasonable risk. It is therefore appropriate in this and other such 
cases that EPA promulgates SNURs that would require notification and 
EPA review of potential risks posed by the residual isocyanates present 
in the PMN substance prior to allowing expanded manufacture or use. In 
addition, these isocyanates have never been used to produce the PMN 
substance before; this particular significant new use identified by 
EPA--i.e., manufacture of the PMN substance with a residual isocyanate 
level above 0.1%--would constitute a significant new use of both the 
relevant isocyanates and the PMN substance requiring notification under 
TSCA section 5.
    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 the new chemical substances. EPA has the 
authority under section 5 of TSCA to address any risks associated with 
the manufacture, processing, and use of the new chemical substances 
even if those risks are based on the presence of existing chemical 
substances. The SNUR only 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 described 
in the proposed SNUR 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. As described in 
the Agency's 2011 Action Plan for MDI and TDI, diisocyanates are well-
known dermal and inhalation sensitizers in the workplace and have been 
documented to cause asthma, lung damage, and in severe cases, fatal 
reactions. EPA is concerned about potential health effects that may 
result from exposures of consumers or self-employed workers while using 
products containing uncured (unreacted) MDI and TDI and its related 
polyisocyanates (e.g., spray-applied foam sealants, adhesives, and 
coatings) or incidental exposures to the general population while such 
products are used in or around buildings including homes or schools. 
While workers may already be using protective controls in occupational 
settings, 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.
    With regards to deferring PPE and hazard communication requirements 
to OSHA, and to the basis for imposed limitations on residual 
isocyanates and the derived New Chemical Exposure Limit (NCEL), the 
5(e) Order included these protective measures and these comments 
constitute challenges to certain TSCA section 5(a)(3) determinations 
rather than to the basis for or the content of the SNURs, which EPA has 
promulgated using its discretion to issue SNURs under TSCA section 
5(a)(2). Because these comments are not germane to this rulemaking, EPA 
is not responding to these comments in this notice and declines to 
modify the SNURs on the basis of these comments.
    With regards to clarifying the proposed regulatory text and the 
preamble of the proposed SNURs, which include inconsistent language 
regarding when respiratory and dermal protection is needed, the 
regulatory text for Sec.  721.63 states that workers who are 
``reasonably likely to be exposed'' are required to use the personal 
protective equipment identified in the SNUR. The preamble language is a 
summary of SNUR requirements and is not intended describe every detail 
of the SNUR requirements. Persons manufacturing or processing a 
chemical substance subject to a SNUR should follow the requirements 
cited in the regulatory text of the SNUR.
    With regards to the comment about recordkeeping, the SNUR cited by 
the commenter are existing chemical SNURs where EPA determined 
recordkeeping was not needed for various reasons. 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 
these are new chemical SNURs, EPA will continue to require 
recordkeeping for all new chemical SNURs to better allow EPA to inspect 
and enforce SNUR requirements at facilities where chemicals subject to 
SNURs are manufactured and processed.

Consistency Between SNURs and Orders

(a). General
    Comment: One commenter stated that the Lautenberg Act requires that 
SNUR requirements conform with requirements of TSCA section 5(e) and 
5(f) actions and Orders or that EPA publish a statement explaining why 
EPA is not doing so, and that EPA should not deviate from prior policy 
and practice, which correctly implements the law. The commenter then 
identified instances where the Order requirements were not consistent 
with the SNUR requirements (see subsequent comments, below).
    Response: In general, EPA agrees that SNURs should be consistent 
with the underlying action or order; however, EPA has never considered 
that SNURs must have exactly the same requirements. For example, when 
an Order requires certain testing before manufacture exceeding a 
certain production limit or time limit, the corresponding SNUR requires 
notification before exceeding that time or production volume limit. It 
does not require testing before exceeding the time or production volume 
limit. Under a TSCA section 5(e) Order, It would be problematic to 
require the same test from two different entities. The purpose of the 
SNUR requirement is for the manufacturer to notify EPA and for EPA to 
determine what, if any, testing should be required based on all 
available information available. at the time of notification. In the 
sections that follow, EPA has listed those instances where the 
commenter identified differences between the Order and the SNUR and

[[Page 43269]]

either explained the differences or made the change.
(b). Protection in the Workplace
    Comment: One commenter noted that a number of the proposed SNURs 
identify a significant new use as any use where worker protection 
equipment is not provided, and that some but not all of the SNURs 
correctly mirror the corresponding 5(e) Order by requiring specific 
respirators, gloves, and other equipment to be used when the chemical 
is present in a specified ``form'' or physical state. For example, the 
Order for P-17-272 identified three forms (particulate, gas/vapor, or 
combination gas/vapor and particulate (e.g., paint spray mist)). 
However, the corresponding proposed SNUR does not identify any forms, 
rather, it only states that ``* * * [r]equirements as specified in 
Sec.  721.63(a)(1), (a)(2)(i), (iii), (iv), (a)(3). When determining 
which persons are reasonably likely to be exposed as required for Sec.  
721.63(a)(1) engineering control measures * * * or administrative 
control measures * * * shall be considered and implemented to prevent 
exposure, where feasible.'' This inconsistency is significant because 
if the form of the chemical substance is not identified in subpart E 
(i.e., in the proposed SNUR), the workplace protections required under 
Sec.  721.63(a)(1) or (a)(4) will not fully apply for the dermal and 
airborne exposures to those forms. Below are PMNs where one, or all, of 
the forms identified in the corresponding consent order are not 
specified in the proposed SNURs:
     Does not identify any of the forms identified in the 
Order: P-14-0472, P-14-0496, P-16-0358, P-17-0272-77, P-17-0278-80
     Does not identify particulate form: P-15-0707, P-16-0430, 
P-16-0513
     Does not identify gas/vapor form: P-16-0399
     Does not identify combination of gas/vapor and particulate 
(EPA provides as an example in the consent order, ``paint spray 
mist''): P-14-0630, P-15-0450, P-15-0705-07, P-16-0322, P-16-0352 
(chemicals A and B), P-16-0399, P-16-0430, P-16-0513, P-17-0032, P-17-
0033-140.
    The commenter states that EPA must eliminate these inconsistencies 
in the final SNURs and ensure that all forms triggering worker 
protections specified in the Orders are also specified in the 
corresponding final SNURs.
    Response: For P-14-472, P-14-496, P-14-630, P-15-0450, P-16-322, P-
16-358, P-16-399, P-17-272 to P-17-277, P-17-278 to P-17-280, P-15-705-
707, P-16-352, P-16-430, P-16-0513, P-17-0032 the Agency agrees that 
the form in the SNUR does not match the Order and has corrected that 
oversight in the final SNUR. For the SNURs for P-17-33 through P-17-
140, all three forms--gas, vapor, and particulate--are correctly 
identified. Any combination of these forms requires the identified 
personal protective equipment.
(c). Industrial, Commercial, and Consumer Activities--Time Limits Under 
40 CFR 721.80(p)
    Comment: One commenter noted that a number of the 5(e) Orders 
require the manufacturing (including import) to cease after a period of 
time unless certain conditions have been met. For example, the Order 
for P-15-450 establishes a time limit that triggers testing 
requirements, effective from the Notice of Commencement of Manufacture 
or Import (NOC) date, after which the chemical substance can no longer 
be manufactured by the company subject to the Order unless the testing 
is conducted. Other Orders establish a volume limit that cannot be 
exceeded unless the testing is conducted. The commenter continues by 
noting that the proposed SNURs appear to rely on 40 CFR 721.80(p) to 
effectuate this type of production limit restriction in the Orders. 40 
CFR 721.80(p) states that, where a substance is specified as being 
subject to that section, a significant new use is the ``[a]ggregate 
manufacture and importation volume for any use greater than that 
specified in subpart E of this part for the substance,'' in the 
proposed SNURs. This delineation of a significant new use clearly only 
includes a volume limitation. In prior SNURs codified in subpart E, EPA 
cites to 40 CFR 721.80(p) and correctly specifies a volume limitation. 
See, e.g., 40 CFR 721.10524 and 721.10935. The proposed SNURs covering 
the substances in P-15-450, P-16-289, P-16-399, and P-17-198 each 
propose to rely on this restriction for a time limitation. EPA's 
reliance only on cross-referencing 40 CFR 721.80(p) is problematic 
because in a number of the proposed SNURs EPA cites 40 CFR 721.80(p) as 
identifying a significant new use but then only specifies a time 
limitation (e.g., 6 months, 12 months, 6 years), not a volume 
limitation. Including only a time limitation in the SNURs in subpart E 
while also citing 40 CFR 721.80(p)--which provides only for a volume 
limitation--creates confusion regarding the actual restriction 
applicable to the substance. If EPA's intention is to impose a volume 
limitation, EPA should clearly identify the specific volume in the 
proposed SNUR. And if EPA wants to set a time limitation instead of or 
in addition to a volume limitation, EPA must spell that out in the 
proposed SNUR. For instance, in the past, EPA has set a limit at ``any 
amount after [x date].'' See, e.g., 40 CFR 721.10522, 721.10527, and 
721.10619. Regardless of the approach, EPA must ensure that the final 
SNURs capture all of the restrictions in the 5(e) Orders.
    The commenter continues that EPA's approach to specifying time 
limitations is made more confusing because the proposed SNURs fail to 
explain that the time limit originated and is specified in the Order, 
and more importantly fail to identify the trigger that starts the clock 
ticking toward the time limit. The proposed SNURs state that a 
significant new use is any use as described in 40 CFR 721.80(p), with a 
time period (e.g., six months) noted in parentheses but without any 
further explanation. While the original PMN submitter may understand 
this in the context of its Order, the commenter states, any other 
company subject to the SNUR would not. Accordingly, EPA needs to 
specify, at a minimum, when the time period commences, which based on 
the Order is upon the PMN submitter's filing of a NOC. Even then, it is 
not clear how a second company would timely know that a NOC had been 
filed by the PMN submitter, thereby triggering the time period to 
start. It is also not clear how EPA would address a situation in which 
a SNUR is finalized preceding or otherwise in the absence of the filing 
of a NOC.
    Second, the Order for P-16-0289 includes numerous time limitations 
on the manufacturing volume of the chemical substance, yet the 
corresponding proposed SNUR fails to include all but one of them. The 
proposed SNUR states that a significant new use is any use as described 
in 40 CFR 721.80(p), with ``six months'' in parentheses. In addition to 
the concern raised previously about the ambiguity of relying solely on 
a time limitation when EPA also intends to have a volume limitation, in 
this case the Order sets additional limitations that are not included 
at all in the SNUR. These include a prohibition on manufacturing unless 
the company ``measures the particle size distribution to characterize 
the particle size distribution of fractions less than 10 microns of the 
dry particle PMN substance'': (1) Twice every twelve months after the 
six months is over, if there is commercial production, until a total of 
six tests are performed; and (2) if there are changes in the 
manufacturing process that could result in different particle sizes. 
Rather than rely solely on cross-referencing 40 CFR 721.80(p), EPA 
should spell out the restrictions from the Order in the

[[Page 43270]]

proposed SNUR or cite to 40 CFR 721.80(k) and (q), which in turn cite 
to the restrictions set by the Order. Ultimately, whichever way EPA 
chooses to make this correction, EPA must make sure that the limits set 
by the final SNUR are clear, and fully conform to the limits in the 
Order.
    Response: In response to this comment, in the final rule EPA 
presents the specific time restriction rather than cross-referencing 
Sec.  721.80(p). For all the SNURs cited, the time limits refer to the 
time after--any manufacturer--begins manufacture of the PMN substance. 
Each manufacturer is permitted to manufacture up to the time limit 
identified in the SNUR from the time they begin manufacture. They are 
not required to base their time limit on the actions of other 
manufacturers or the notice of commencement. If that were the case some 
manufacturers could be required to notify EPA before they even begin 
manufacture. Therefore, EPA is removing the reference to Sec.  
721.80(p) and clarifying that ``It is a significant new use to 
manufacture for a period longer than (time period cited in the 
underlying Order).'' For those instances where there are multiple time 
limits in the Order, corresponding to multiple testing requirements, 
only the first limit will be included in the SNUR, because by the time 
of any SNUN submission, the Agency may possess new information that 
changes its initial data requirements and any new time limits would be 
the subject of EPA's finding for the SNUN.
(d). Other Discrepancies Between Orders and SNURs
    Comment: The same commenter noted the following examples of other 
discrepancies between Orders and corresponding proposed SNURs with 
respect to the specification of significant new uses for industrial, 
commercial, and consumer activities:
    For P-14-0630, the Order states that using the chemical substance 
in a consumer product that generates ``vapor'' is prohibited. The 
proposed SNUR does not include generation of vapor as a significant new 
use.
    For P-16-0273-74, the Order states that the chemical substance can 
only be imported in totes. The proposed SNUR does not include that 
limitation.
    For P-16-0495, the Order states that the chemical substance can 
only be used for a specific confidential use. The proposed SNUR sets no 
such limit. The SNUR should cite to 40 CFR 721.80(k) (``use other than 
allowed by the section 5(e) consent order'').
    For P-17-0032, the Order includes a separate volume limit for 
processing the substance. The SNUR only sets a volume limit for 
manufacture and import and not one for processing. EPA must include the 
processing limit in the SNUR.
    Response: For the SNUR for P-16-495, the Agency has corrected the 
oversight in the proposed rule and the final SNUR for that chemical 
substance now cites 40 CFR 721.80(k). For the SNUR for P-17-32, the 
Agency agrees that there was an oversight in the proposed rule. The 
final SNUR for that chemical substance now also includes the statement 
``It is a significant new use to process the substance beyond the 
confidential annual volume cited in the 5(e) Order.'' For the SNUR for 
P14-630 EPA has added generation of vapor in a consumer product as a 
significant new use because it is part of the Order but was 
inadvertently not included in the proposed rule. For the SNUR for P16-
273 and 274 the Order erroneously references in the preamble a 
requirement to import the chemicals in totes. However, this is not a 
requirement of the Order. Therefore, EPA did not include that 
requirement for the final SNUR for P-16-273 and 274.
(e). Human Health, Environmental Hazard, Exposure, and Precautionary 
Statements
    Comment: One commenter noted inconsistencies between the hazard 
communication statements that would be required by the proposed SNURs 
and those required in the corresponding 5(e) Orders.
    For P-14-0496, the SNUR is missing the ``disposal restrictions 
apply'' warning specified at 40 CFR 721.72(g)(4)(i). This warning is 
required by the underlying 5(e) Order for PMNs P14-0472 and P14-0496. 
For P-17-0272, the SNUR is missing the precautionary statement for 
developmental effects (40 CFR 721.72(g)(1)(vi)). This statement is 
required by the 5(e) Order for P-17-0272 through -0277. Given that each 
of these precautionary statements is required by the corresponding 
Orders, they must be included in the final SNURs.
    Response: This is an oversight and is corrected in the final SNURs 
for these substances.
    Comment: The same commenter noted that for two of the proposed 
SNURs associated with the Order for P-17-33 through P-17140, the 
proposed SNURs are lacking a requirement for three hazards statements: 
Toxic to fish (40 CFR 721.72(g)(3)(i)), toxic to aquatic organisms (40 
CFR 721.72(g)(3)(ii)), and disposal restrictions apply (40 CFR 
721.72(g)(4)(i)). The two SNURs are for certain halogenated sodium 
benzoate salts, 40 CFR 721.11053, and certain halogenated sodium 
benzoic acids, 40 CFR 721.11054. Because the Order applies to multiple 
substances and redacts certain information (likely health and safety 
information not eligible for redaction under TSCA section 14), it is 
not possible for the public to know whether the hazard statements are 
or are not required for the chemicals subject to the SNURs noted above. 
EPA should ensure that there are no inconsistencies between the 
requirements of the SNURs and the Order for these chemicals.
    Response: The hazard statements identified by the commenter only 
apply to the chemicals subject to the SNUR in 40 CFR 721.11055. Those 
hazard statements are not required in the Order for the chemicals 
subject to the SNUR in 40 CFR 721.11053 and 11054. EPA will finalize 
those requirements as proposed.
(f). Additional Errors in the Proposed SNURs
    Comment: For P-17-33 through P-17-140, there are three separate 
SNURs that cover the many chemicals covered by that one Order. One 
commenter noted that the SNUR for sodium benzoate salts states that a 
significant new use is any use other than those allowed in the Order, 
which is applicable to all of the substances P-17-33 through P-17-140 
(to be codified at 40 CFR 721.11053(a)(2)(iii)) (citing 40 CFR 
721.80(k)). This restriction, the commenter continues, is not specified 
in the other two SNURs (to be codified at 40 CFR 721.11054(a)(2)(iii), 
721.11055(a)(2)(iii)), and EPA must fix this error and ensure that each 
proposed SNUR contains all of the restrictions governing the relevant 
chemicals that appear in the Order.
    Response: The requirement cited in 40 CFR 11053(a)(2)(iii) for 40 
CFR 721.80(k) was erroneously included in the proposed SNUR. The Order 
for P17-33 through P17-140 does not include a restriction on use. EPA 
has removed this requirement from the final SNUR.
    Comment: Additionally, the commenter noted that P-16-352 had one 
Order covering two separate chemicals, with each having a proposed 
SNUR. The volume limitation set in the Order was for the substances 
combined. One commenter noted that both proposed SNURs contained 
errors. First, the combined volume limits set in Sec.  721.11039 are 
incorrect because it cites itself twice--``this substance and the 
substance subject to 721.11039''--instead of citing itself and the 
other PMN substance at Sec.  721.11040. 83 FR at

[[Page 43271]]

37725. Second, Sec.  721.11040 cites to an incorrect SNUR, ``Sec.  
721.9998,'' for its combined volume limit, when it should cite to the 
other PMN substance at section 721.11039 Id. EPA must ensure that the 
combined volume limitations in the final SNURs are correct.
    Response: EPA has corrected the cross-references in the final rule 
to the correct SNUR.

Chemical Identity Correction: SNUR for P-17-278 Through P-17-280 (40 
CFR 721.11058)

    EPA has modified the generic chemical identity from ``fatty acid 
amide alkyl amine salts'' in the proposed rule to ``fatty acid derived 
imidazoline salts'' for the SNUR for P-17-278 through P-17-280 (40 CFR 
721.11058), to agree with the generic name provided in the Notice of 
Commencement of Manufacture or Import (NOC) submitted for these PMN 
substances.

Comments Specific to the Proposed SNUR at 40 CFR 721.11027: Aluminum 
Cobalt Lithium Nickel Oxide (PMN P-15-0450; CASRN 177997-13-6)

    Comment: Four entities commented on the SNUR for PMN P-15-450 (40 
CFR 721.11027), aluminum cobalt lithium nickel oxide. One commenter 
suggested a different approach for control of air releases, rather than 
the proposed significant new use of any release of the chemical 
substance to air unless using the chemical transfer and air ventilation 
processes described in the PMN, including filtering through a high-
efficiency particulate air filter with an efficiency rate of 99.99%. 
The commenter requested making the provision technology neutral 
instead, and exposure monitoring requirement more flexible (quarterly 
rather than monthly). The commenter states that there could be 
different processes to handle and transfer the PMN substance, and 
control resulting air emissions, that will provide an equivalent or 
even improved level of control. For example, the commenter continued, 
there are control technologies that may have a removal efficiency 
rating of 99.99% that are not the high-efficiency particulate filters 
mentioned in the PMN. Therefore, a specific control technology does not 
need to be identified, but rather a specific rated efficiency (99.99%) 
or control target.
    Response: The proposed SNUR provisions reflect the requirements of 
the underlying Order. In the proposed SNUR air releases are allowed 
only after the chemical transfer and air ventilation provisions 
described in the PMN which are not limited to but include HEPA filters 
that achieve 99.99% removal efficiency. This requirement remains in the 
final SNUR. The reason to include the lack of this control in the SNUR 
is to allow EPA to assess if other processes result in the same level 
of or lower air releases.
    Comment: A commenter proposed a flexible monitoring schedule in 
lieu of mandatory monthly monitoring. The commenter noted that OSHA has 
addressed monitoring frequency to assess worker exposure. Section 6(b) 
of the OSHA Act gives OSHA authority to develop chemical specific 
standards. One such standard is 29 CFR 1910.1026 Chromium (VI). The 
OSHA Chromium (VI) workplace standard contains a flexible monitoring 
requirement based on results from initial monitoring. If initial 
monitoring indicates that employee exposures are below 50% (action 
level) of the determined limit, no further monitoring is required 
unless changes in the workplace result in new or additional exposures. 
If the initial determination reveals employee exposures to be at or 
above the action level, but below the determined limit, periodic 
monitoring must be performed at least every six months. If the initial 
monitoring reveals employee exposures to be above the determined limit, 
monitoring must be conducted at least every three months. Adjustments 
to the monitoring frequency are allowed based on monitoring results. 
The preamble of the OSHA 1910.1026 Chromium (VI), P. 10341, states, 
``OSHA believes that the frequency of six months for subsequent 
periodic monitoring for exposures at or above the action level but at 
or below the PEL, and three months for exposures above the PEL, 
provides intervals that are both practical for employers and protective 
for employees. This belief is supported by OSHA's experience with 
comparable monitoring intervals in other standards, including those for 
cadmium (29 CFR 1910.1050), methylene chloride (29 CFR 1910.1052), and 
formaldehyde (29 CFR 1910.1048).'' Based on OSHA's position given 
above, the commenter noted, it could be concluded that there are no 
benefits to worker protection in conducting monitoring more frequently 
than every 3 months, even when previous exposures exceeded exposure 
limits. The monthly monitoring is resource intensive and is likely to 
demonstrate the same results each month therefore providing minimal 
value. The commenter requested that EPA allow this periodic monitoring 
to occur on a quarterly basis, instead of monthly.
    Response: Based on limited monitoring experience with the PMN 
substance, EPA believes monthly monitoring requirements as specified in 
the proposed SNUR are appropriate during the first year of 
manufacturing, processing, or use. After that time monitoring may be 
conducted quarterly if certain conditions are met. These are based on 
the requirements in the Order. Based on monitoring results EPA has 
received thus far for P-15-450, which have demonstrated monitoring 
results above and below the action level of 0.16 mg/m\3\ identified in 
the Order, the final SNUR will retain the same requirements as required 
in the Order.
    Comment: A commenter noted that 5(e) Orders on similar substances 
to that identified in P-15-450 allow metal reclamation disposal, 
whereas the Order for P-15-450 allows only landfill disposal.
    Response: In response to the comment about allowing disposal by 
metal reclamation, the Agency would need to review the specific metal 
reclamation disposal method to determine its acceptability to allow 
more flexibility in disposal methods. Because the underlying Order only 
allows disposal by landfill, the final rule only allows disposal by 
landfill.
    Comment: One commenter pointed out that the reference to 40 CFR 
721.63(a)(6) (referring to ``particulate'') in this SNUR should be 
corrected to read ``40 CFR 721.63(a)(6)(i)'' (referring to ``dust'').
    Response: The proposed SNUR term 40 CFR 721.63(a)(6) (referencing 
``particulate'') reflects the requirement in the Order for P-15-450. 
Particulate allows for both liquid and solid particles which includes 
dust. The final rule retains the reference to particulate.
    Comment 5: A commenter also requested that the SNUR not be 
finalized until a recently submitted 90-day inhalation toxicity study 
on the PMN substance is reviewed by EPA, as the testing could affect 
EPA's underlying hazard concerns.
    Response: The Agency has received and is currently reviewing the 
90-day study data described by the commenter. Preliminary indications 
are that the results of the study would not change the Agency's hazard 
concerns, or significantly alter the magnitude of the NCEL identified 
in the SNUR. It will take considerable time to determine if the study 
data will result in any changes for the Order and SNUR. EPA is issuing 
the final SNUR as proposed and will modify the Order and SNUR in the 
future based on the study data as appropriate.
    Comment: Other comments to this proposed SNUR are that the 
references to ``24 months'' and ``6 years'' for production limits (40 
CFR 721.80(p)) are

[[Page 43272]]

unclear, and that the NCEL of 0.000092 mg/m\3\ as an 8-hour time 
weighted average doesn't take into account OSHA PELs on the component 
metals.
    Response: In response to the comment regarding the time-based 
production limits in the SNUR, the time limits refer to the time after 
a manufacturer begins manufacture of the PMN substance. To exceed that 
time limit, a SNUN would need to be submitted and complete 90-day 
review by EPA. The NCEL for this chemical substance was established by 
EPA based on a 90-day inhalation study for a mixed metal oxide 
analogue. EPA's risk assessment for P-15-0450 in the public docket 
describes how the NCEL was calculated for the PMN substance based on 
the 90-day lowest observed adverse effect concentration (LOAEC). The 
analogue and data were identified by the submitter of P-15-450. As 
discussed in the previous comment and response EPA has received a 90-
day inhalation study for P-15-450, that it is still reviewing and that 
confirms the potential hazard and a similar LOAEC. Based on the results 
of both studies EPA disagrees that OSHA PELs for the component metals 
should be used to estimate the potential effect levels of the PMN 
substance.
    Comment: One commenter stated that the proposed SNUR for P-15-450 
also would require monitoring and reporting for exposures to this 
chemical at an Occupational Exposure Limit (OEL) of 0.16 mg/m\3\ on an 
8-hour TWA and is silent about how this should be sampled and measured.
    Response: The SNUR references the terms of the Order that include 
parameters for how the monitoring should be sampled and measured. The 
submitter for P-15-450 has already submitted monitoring results 
required by the Order.
    Comment: A commenter stated that the proposed NCEL presented no 
relief to the use of APF 1000 respirators, because there is currently 
no feasible monitoring method to reliably detect any constituent of the 
chemical mixture at that level of sensitivity.
    Response: While the commenter is correct, persons manufacturing, 
processing, and using the chemical substance may eventually be able to 
develop such a detection method or develop information that would 
increase the level of the NCEL that would allow a detection method to 
be developed.

Vertebrate Testing

    Comment: A commenter noted that TSCA section 4(h)(3) states: ``IN 
GENERAL.--Any person developing information for submission under this 
title on a voluntary basis and not pursuant to any request or 
requirement by the Administrator shall first attempt to develop the 
information by means of an alternative test method or strategy . . . 
before conducting new vertebrate animal testing.'' The commenter 
continued that while EPA is not required to review the means by which 
these submitters conducted this voluntary testing, it is authorized to 
do so, and that reviewing compliance with this section is an 
opportunity to communicate TSCA's requirement and EPA's preference for 
alternatives to PMN submitters. Over time, the commenter states, this 
would lead submitters to consider such alternatives before conducting 
vertebrate animal tests. They requested that EPA review compliance with 
TSCA section 4(h)(3) whenever the results of vertebrate animal testing 
are included in PMNs.
    Response: A request to review compliance with TSCA 4(h)(3) for PMNs 
and 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).

Ongoing Uses of SNUR Chemicals

    Comment: One commenter stated there is reason to believe that some 
of the restrictions set forth in the following SNURs conflict with 
ongoing uses: P-17-33, P-17-34, P-17-36, P-17-38, P-17-39, P-17-41, P-
17-42, P-17-43, P-17-45, P-17-47, P-17-50, P-17-52, P-17-55, P-17-57, 
P-17-59, P-17-61, P-17-62, and P-17-63.
    Response: EPA did not receive any further information to support 
this statement and therefore has finalized the SNURs as proposed.

V. Substances Subject to This Rule

    EPA is establishing significant new use and recordkeeping 
requirements for 145 chemical substances in 40 CFR part 721, subpart E. 
In this unit, EPA provides the following information for each chemical 
substance:
     PMN number.
     Chemical name (generic name, if the specific name is 
claimed as CBI).
     Chemical Abstracts Service (CAS) Registry number (if 
assigned for non-confidential chemical identities).
     Basis for the TSCA section 5(e) consent order.
     Information identified by EPA that would help characterize 
the potential health and/or environmental effects of the chemical 
substance in support of a request by the PMN submitter to modify the 
Order, or if a manufacturer or processor is considering submitting a 
SNUN for a significant new use designated by the SNUR. This information 
may include testing required in a TSCA section 5(e) Order to be 
conducted by the PMN submitter, as well as testing not required to be 
conducted but which would also help characterize the potential health 
and/or environmental effects of the PMN substance. Any recommendation 
for information identified by EPA was made based on EPA's consideration 
of available screening-level data, if any, as well as other available 
information on appropriate testing for the chemical substance. Further, 
any such testing identified by EPA that includes testing on vertebrates 
was made after consideration of available toxicity information, 
computational toxicology and bioinformatics, and high-throughput 
screening methods and their prediction models. EPA also recognizes that 
whether testing/further information is needed will depend on the 
specific exposure and use scenario in the SNUN. EPA encourages all SNUN 
submitters to contact EPA to discuss any potential future testing. See 
Unit VIII. for more information.
     CFR citation assigned in the regulatory text section of 
this rule.
    The regulatory text section of each rule specifies the activities 
designated as significant new uses. Certain new uses, including 
exceedance of production volume limits (i.e., limits on manufacture 
volume) and other uses designated in this rule, may be claimed as CBI. 
Unit IX. discusses a procedure companies may use to ascertain whether a 
proposed use constitutes a significant new use.
    These final rules include 145 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 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,

[[Page 43273]]

distribution in commerce, or disposal that does not conform to the 
restrictions imposed by the underlying Orders, consistent with TSCA 
section 5(f)(4).
    Where EPA determined that the PMN substance may present an 
unreasonable risk of injury to human health via inhalation exposure, 
the underlying TSCA section 5(e) Order usually requires, among other 
things, that potentially exposed employees wear specified respirators 
unless actual measurements of the workplace air show that air-borne 
concentrations of the PMN substance are below a New Chemical Exposure 
Limit (NCEL) that is established by EPA to provide adequate protection 
to human health. In addition to the actual NCEL concentration, the 
comprehensive NCELs provisions in TSCA section 5(e) Orders, which are 
modeled after Occupational Safety and Health Administration (OSHA) 
Permissible Exposure Limits (PELs) provisions, include requirements 
addressing performance criteria for sampling and analytical methods, 
periodic monitoring, respiratory protection, and recordkeeping. 
However, no comparable NCEL provisions currently exist in 40 CFR part 
721, subpart B, for SNURs. Therefore, for these cases, the individual 
SNURs in 40 CFR part 721, subpart E, will state that persons subject to 
the SNUR who wish to pursue NCELs as an alternative to the Sec.  721.63 
respirator requirements may request to do so under Sec.  721.30. EPA 
expects that persons whose Sec.  721.30 requests to use the NCELs 
approach for SNURs that are approved by EPA will be required to comply 
with NCELs provisions that are comparable to those contained in the 
corresponding TSCA section 5(e) Order for the same chemical substance.
PMN Numbers: P-14-472 and P-14-496
    Chemical names: Polyphosphoric acids, 2-[alkyl-1-oxo-2-propen-1-
yl)oxy]ethyl esters, compds. with N-(aminoiminomethyl)urea (generic) 
(P-14-472) and Polyphosphoric acids, 2-[(2-methyl-1-oxo-2-propen-1-
yl)oxy]ethyl esters, compds. with alkyl amino, polymers with Bu 
acrylate, N-(hydroxymethyl)propenamide and styrene (generic) (P-14-
496).
    CAS numbers: Not available.
    Effective date of TSCA section 5(e) Order: April 26, 2017.
    Basis for TSCA section 5(e) Order: The PMN states that the generic 
(non-confidential) uses of the PMN substances are as a site-controlled 
intermediate (P-14-472) and a paper additive (P-14-496). Based on 
Structure Activity Relationship (SAR) analysis of test data on 
acrylates/methacrylates, and other structurally similar substances, 
there is potential for irritation and sensitization for P-14-472. For 
P-14-496 there is concern for sensitization based on the presence of 
formaldehyde and concern for irritation and lung effects from the 
surfactant properties of the substance. Further, based on SAR analysis 
of test data on analogous phosphates, EPA predicts toxicity to aquatic 
organisms may occur at concentrations that exceed 3 parts per billion 
(ppb) of P-14-472 and 4 ppb of P-14-496 in surface waters. The Order 
was issued under TSCA sections 5(a)(3)(B)(i) and 5(e)(1)(A)(i), based 
on a finding that the available information is insufficient to permit a 
reasoned evaluation of the human health effects of the PMN substances. 
Further, the Order was issued under TSCA sections 5(a)(3)(B)(ii)(I) and 
5(e)(1)(A)(ii)(I), based on a finding that the substances may present 
an unreasonable risk of injury to human health and the environment. To 
protect against these risks, the Order requires:
    1. Submission of certain toxicity testing on the PMN substances 
prior to exceeding the confidential production volume limit as 
specified in the Order.
    2. Use of personal protective equipment to prevent dermal exposure.
    3. Establishment and use of a hazard communication program, 
including human health precautionary statements on each label and in 
the Safety Data Sheet (SDS).
    4. No release of the PMN substances resulting in surface water 
concentrations that exceed 3 ppb for P-14-472 and 4 ppb for P-14-496.
    5. No modification of the manufacturing process that results in 
inhalation exposure and no use involving application methods that 
generate a dust, mist, or aerosol.
    6. Use of the PMN substances only as a site-limited intermediate 
(P-14-472) and the confidential use specified in the Order (P-14-496).
    The SNUR would designate as a ``significant new use'' the absence 
of these protective measures.
    Potentially useful information: EPA has determined that certain 
information about the fate and human health toxicity of the PMN 
substances may be potentially useful to characterize the effects of the 
PMN substances in support of a request by the PMN submitter to modify 
the Order, or if a manufacturer or processor is considering submitting 
a SNUN for a significant new use that will be designated by this SNUR. 
The submitter has agreed not to exceed the confidential production 
limit without performing a skin sensitization study and a 
biodegradation test on each substance. In addition, EPA has determined 
that the results of a pulmonary effects testing of the PMN substance 
may be potentially useful in characterizing the health effects of the 
PMN substances. Although the Order does not require this additional 
testing, the Order's restrictions on manufacture, processing, 
distribution in commerce, and disposal will remain in effect until the 
Order is modified or revoked by EPA based on submission of this or 
other information that EPA determines is relevant and needed to 
evaluate a modification request.
    CFR citations: 40 CFR 721.11024 (P-14-472) and 40 CFR 721.11025 (P-
14-496).
PMN Number: P-14-630
    Chemical name: Bismuth bromide iodide oxide.
    CAS number: 340181-06-8.
    Effective date of TSCA section 5(e) Order: May 10, 2017.
    Basis for TSCA section 5(e) Order: The PMN states that the 
substance will be used as a pigment for liquid coatings solvent based 
system; a pigment for powder coatings; and a pigment for polymer 
materials. Based on test data and physical/chemical properties of the 
PMN substance, as well as SAR analysis of analogous respirable, poorly 
soluble particulates, EPA identified concerns for lung effects, 
including fibrosis. The Order was issued under TSCA sections 
5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on insufficient 
information to make a reasoned evaluation and a finding that the 
substance may present an unreasonable risk of injury to human health. 
EPA assessed risks based on the specific manufacturing, processing, 
use, distribution/transportation, treatment and disposal processes, 
process equipment, engineering controls, and handling practices 
(including worker activities and cleaning procedures) described in the 
PMN. To protect against these risks, the Order requires:
    1. Submission of certain toxicity testing on the PMN substance 
prior to exceeding the confidential production volume limit as 
specified in the Order.
    2. Use of a National Institute for Occupational Safety and Health 
(NIOSH)-certified respirator with an Assigned Protection Factor (APF) 
of at least 10 (where there is a potential for inhalation exposures) or 
compliance with a New Chemical Exposure Limit (NCEL) of 2.4 milligram/
meter\3\ (mg/m\3\) as an 8-hour time-weighted average.
    3. Establishment and use of a hazard communication program, 
including human health precautionary statements on each label and in 
the SDS.

[[Page 43274]]

    4. No use of the substance in a consumer product that generates a 
dust, mist, or aerosol.
    The SNUR will designate as a ``significant new use'' the absence of 
these protective measures.
    Potentially useful information: EPA has determined that certain 
information about the human health toxicity of the PMN substance may be 
potentially useful to characterize the effects of the PMN substance in 
support of a request by the PMN submitter to modify the Order, or if a 
manufacturer or processor is considering submitting a SNUN for a 
significant new use that will be designated by this SNUR. The submitter 
has agreed not to exceed the confidential production limit without 
performing specific target organ toxicity testing. In addition, EPA has 
determined that the results of a chronic toxicity/carcinogenicity test 
of the PMN substance may be potentially useful in characterizing the 
health effects of the PMN substance. Although the Order does not 
require this additional testing, the Order's restrictions on 
manufacture, processing, distribution in commerce, and disposal will 
remain in effect until the Order is modified or revoked by EPA based on 
submission of this or other information that EPA determines is relevant 
and needed to evaluate a modification request.
    CFR citation: 40 CFR 721.11026.
PMN Number: P-15-450
    Chemical name: Aluminum cobalt lithium nickel oxide.
    CAS number: 177997-13-6.
    Effective date of TSCA section 5(e) Order: March 23, 2017.
    Basis for TSCA section 5(e) Order: The PMN states that the 
substance will be used as a mixed metal oxide for batteries. Based on 
test data on the PMN substance, EPA identified concerns for spleen and 
kidney toxicity. Based on physical/chemical properties of the PMN 
substance, as well as SAR analysis of analogous respirable, poorly 
soluble particulates, EPA identified concerns for lung effects based on 
lung overload. Based on the crystalline structure of the PMN substance, 
EPA identified concern for lung carcinogenicity. The Order was issued 
under TSCA sections 5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on 
insufficient information to make a reasoned evaluation and a finding 
that the substance may present an unreasonable risk of injury to human 
health. EPA assessed risks based on the specific manufacturing, 
processing, use, distribution/transportation, treatment and disposal 
processes, process equipment, engineering controls, and handling 
practices (including worker activities and cleaning procedures) 
described in the PMN. To protect against these risks, the Order 
requires:
    1. Submission of certain toxicity testing on the PMN substance 
prior to exceeding the time limit as specified in the Order.
    2. Use of personal protective equipment including impervious gloves 
and protective clothing (where there is a potential for dermal 
exposures).
    3. Use of a NIOSH-certified respirator with an APF of at least 
1,000 (where there is a potential for inhalation exposure) or 
compliance with a NCEL of 0.000092 ppm as an 8-hour time-weighted 
average.
    4. Use of the chemical transfer processes and air ventilation 
processes described in the PMN and the exposure monitoring requirements 
described in the Order.
    5. Establishment and use of a hazard communication program, 
including human health precautionary statements on each label and in 
the SDS.
    6. Disposal of the PMN substance by landfill only. Air releases are 
limited by processes described in the PMN, including filtering through 
a high-efficiency particulate air filter with an efficiency rate of 
99.99%.
    The SNUR will designate as a ``significant new use'' the absence of 
these protective measures.
    Potentially useful information: EPA has determined that certain 
information about the human health toxicity of the PMN substance may be 
potentially useful to characterize the effects of the PMN substance in 
support of a request by the PMN submitter to modify the Order, or if a 
manufacturer or processor is considering submitting a SNUN for a 
significant new use that will be designated by this SNUR. The submitter 
has agreed not to exceed the time limit without performing specific 
target organ toxicity testing and carcinogenicity testing. In addition, 
EPA has determined that the results of medical monitoring of the 
workers exposed to the substance during manufacturing, processing, and 
use may be potentially useful in characterizing the health effects of 
the PMN substance. Although the Order does not require this medical 
monitoring, the Order's restrictions on manufacture, processing, 
distribution in commerce, and disposal will remain in effect until the 
Order is modified or revoked by EPA based on submission of this or 
other information that EPA determines is relevant and needed to 
evaluate a modification request.
    CFR citation: 40 CFR 721.11027.
PMN Number: P-15-705
    Chemical name: Alkylarylamine (generic).
    CAS number: Not available.
    Effective date of TSCA section 5(e) Order: May 11, 2017.
    Basis for TSCA section 5(e) Order: The PMN states that the 
substance will be used as a chemical intermediate and as an additive 
and octane booster in aviation fuels.
    Based on test data on the PMN substance, EPA has identified 
concerns for dermal irritation, developmental toxicity, and blood 
effects. Based on test data on analogous anilines, EPA has identified 
concerns for cardiovascular, eye, liver, kidney, and pulmonary effects, 
as well as bladder cancer. The Order was issued under TSCA sections 
5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on insufficient 
information to make a reasoned evaluation and a finding that the 
substance may present an unreasonable risk of injury to human health. 
To protect against these risks, the Order requires:
    1. Submission of certain toxicity testing on the PMN substance 
prior to exceeding the confidential production volume limit as 
specified in the Order.
    2. Use of personal protective equipment including impervious 
gloves, full body chemical protective clothing and chemical goggles or 
equivalent eye protection (where there is a potential for dermal 
exposure).
    3. Use of a NIOSH-certified respirator with an APF of at least 
1,000 (where there is a potential for inhalation exposure) or 
compliance with a NCEL of 0.48 mg/m\3\ as an 8-hour time-weighted 
average. (EPA's estimates indicate that variations of the parameters 
(including batch size, number of processing sites, days per year of 
operation) of the uses identified below would not result in inhalation 
exposure that would indicate a different respirator.)
    4. No use of the substance in a consumer product.
    5. No use other than as a chemical intermediate or as an additive 
and octane booster in aviation fuels.
    6. Establishment and use of a hazard communication program, 
including human health precautionary statements on each label and in 
the SDS.
    7. No release of the PMN substance resulting in surface water 
concentrations that exceed 1 ppb.
    The SNUR will designate as a ``significant new use'' the absence of 
these protective measures.
    Potentially useful information: EPA has determined that certain 
information about the human health and aquatic toxicity of the PMN 
substance may be

[[Page 43275]]

potentially useful to characterize the effects of the PMN substance in 
support of a request by the PMN submitter to modify the Order, or if a 
manufacturer or processor is considering submitting a SNUN for a 
significant new use that will be designated by this SNUR. The submitter 
has agreed not to exceed the confidential production limit without 
performing specific target organ toxicity testing and a chronic aquatic 
toxicity test.
    CFR citation: 40 CFR 721.11028.
PMN Numbers: P-15-706 and P-15-707
    Chemical names: Aliphatic N-alkyl urea polymer containing 
cyclohexyl groups and trimethoxy silanes (generic) (P-15-706) and 
Aliphatic N-alkyl urea polymer containing aspartic ester groups and 
trimethoxy silanes (generic) (P-15-707).
    CAS numbers: Not available.
    Effective date of TSCA section 5(e) Order: April 26, 2017.
    Basis for TSCA section 5(e) Order: The PMNs state that the generic 
use of the substances will be as ingredients for multipurpose exterior 
coatings. Based on SAR analysis on reactive methoxy silane moieties, 
EPA has identified concerns for irritation to lungs, eyes, and mucus 
membranes. There are also concerns for acute toxicity, neurotoxicity, 
and developmental toxicity based on the presence of methanol, and for 
sensitization if there are residual isocyanates. The Order was issued 
under TSCA sections 5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on 
insufficient information to make a reasoned evaluation and a finding 
that the substances may present an unreasonable risk of injury to human 
health. To protect against these risks, the Order requires:
    1. Submission of certain toxicity testing on the PMN substance 
prior to exceeding the production limit as specified in the Order.
    2. Use of personal protective equipment including impervious gloves 
(where there is a potential for dermal exposure).
    3. Use of a NIOSH-certified respirator with an APF of at least 10 
(where there is a potential for inhalation exposure) or compliance with 
a NCEL of 0.9 mg/m\3\ as an 8-hour time-weighted average. (EPA's 
estimates indicate that variations of the parameters (including batch 
size, number of processing sites, days per year of operation) of the 
uses identified below would not result in inhalation exposure that 
would indicate a different respirator.)
    4. Establishment and use of a hazard communication program, 
including human health precautionary statements on each label and in 
the SDS.
    5. No manufacture beyond an annual production volume of 250,000 
kilograms (kg).
    6. Manufacture of the PMN substances to contain no more than 0.1% 
residual isocyanate by weight.
    7. No uses of the substances other than allowed in the Order.
    8. No use of the substances in a consumer product.
    The SNUR will designate as a ``significant new use'' the absence of 
these protective measures.
    Potentially useful information: EPA has determined that certain 
information about the human health toxicity of the PMN substances may 
be potentially useful to characterize the effects of the PMN substances 
in support of a request by the PMN submitter to modify the Order, or if 
a manufacturer or processor is considering submitting a SNUN for a 
significant new use that will be designated by this SNUR. The submitter 
has agreed not to exceed the confidential production limit without 
performing specific target organ toxicity testing for P-15-706.
    CFR citation: 40 CFR 721.11029 (P-15-706) and 40 CFR 721.11030 (P-
15-707).
PMN Numbers: P-16-273 and P-16-274
    Chemical names: Alkyl heteromonocycle, polymer with 
heteromonocycle, carboxyalkyl alkyl ethers (generic).
    CAS numbers: Not available.
    Effective date of TSCA section 5(e) Order: April 25, 2017.
    Basis for TSCA section 5(e) Order: The PMNs state that the generic 
(non-confidential) use of the substances will be as ingredients in 
metalworking fluids. Based on submitted test data for P-16-273 and 
structurally similar surfactants, EPA has identified concerns for 
dermal sensitization and irritation and lung effects. Based on 
submitted toxicity data for P-16-273, EPA estimates toxicity to aquatic 
organisms may occur for both PMNs at concentrations that exceed 10 ppb 
of the PMN substances in surface waters. The Order was issued under 
TSCA sections 5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on 
insufficient information to make a reasoned evaluation and a finding 
that the substances may present an unreasonable risk of injury to human 
health and the environment. To protect against these risks, the Order 
requires:
    1. No domestic manufacture of the PMN substances.
    2. Use of the PMN substances only: (i) For the confidential uses 
specified in the Order, (ii) at a concentration no greater than 3% of 
the metalworking fluid, and (iii) used only in closed metalworking 
systems as specified in the PMNs with no modifications in the process 
that would result in worker inhalation exposure.
    3. Use of personal protective equipment including impervious gloves 
(where there is a potential for dermal exposure).
    4. No release of the PMN substances resulting in surface water 
concentrations that exceed 10 ppb.
    The SNUR will designate as a ``significant new use'' the absence of 
these protective measures.
    Potentially useful information: EPA has determined that certain 
information about the fate and toxicity of the PMN substances may be 
potentially useful to characterize the health and environmental effects 
of the PMN substances in support of a request by the PMN submitter to 
modify the Order, or if a manufacturer or processor is considering 
submitting a SNUN for a significant new use that will be designated by 
this SNUR. EPA has determined that the results of specific target organ 
toxicity testing and a biodegradation test of the PMN substances may be 
potentially useful in characterizing the health and environmental 
effects of the PMN substances. Although the Order does not require 
these tests, the Order's restrictions on manufacture, processing, 
distribution in commerce, and disposal will remain in effect until the 
Order is modified or revoked by EPA based on submission of this or 
other information that EPA determines is relevant and needed to 
evaluate a modification request.
    CFR citation: 40 CFR 721.11031.
PMN Number: P-16-289
    Chemical name: Benzene dicarboxylic acid, polymer with alkane dioic 
acid and aliphatic diamine (generic).
    CAS number: Not available.
    Effective date of TSCA section 5(e) Order: March 24, 2017.
    Basis for TSCA section 5(e) Order: The PMN states the substance 
will be used as an extrusion compounding molding resin. Based on test 
data on analogous high molecular weight polymers, EPA has concerns for 
lung effects, which includes lung overload. The Order was issued under 
TSCA sections 5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on 
insufficient information to make a reasoned evaluation and a finding 
that the substance may present an unreasonable risk of injury to human 
health. To protect against these risks, the Order requires:

[[Page 43276]]

    1. Submission of particle size testing on the PMN substance prior 
to exceeding the time limit as specified in the Order.
    2. Manufacture of the PMN substance such that the solid particle 
form has a particle size distribution where less than 1% of the 
particles are less than 10 microns.
    The SNUR will designate as a ``significant new use'' the absence of 
these protective measures.
    Potentially useful information: EPA has determined that certain 
information about the physical/chemical characteristics of the PMN 
substance may be potentially useful to characterize the health effects 
of the PMN substance in support of a request by the PMN submitter to 
modify the Order, or if a manufacturer or processor is considering 
submitting a SNUN for a significant new use that will be designated by 
this SNUR. The submitter has agreed not to manufacture beyond a certain 
time period without measuring the particle size distribution to 
characterize the fraction of the dry particle PMN substance less than 
10 microns. In addition, EPA has determined that the results of 
specific target organ toxicity testing of the PMN substance may be 
potentially useful in characterizing the health effects of the PMN 
substance. Although the Order does not require this additional testing, 
the Order's restrictions on manufacture, processing, distribution in 
commerce, and disposal will remain in effect until the Order is 
modified or revoked by EPA based on submission of this or other 
information that EPA determines is relevant and needed to evaluate a 
modification request.
    CFR citation: 40 CFR 721.11032.
PMN Number: P-16-322
    Chemical name: Manganese cyclic (tri)amine chloride complex 
(generic).
    CAS number: Not available.
    Effective date of TSCA section 5(e) Order: April 25, 2017.
    Basis for TSCA section 5(e) Order: The PMN states that the generic 
(non-confidential) use of the substance will be as a pulp bleaching 
catalyst. Based on test data on an analog, EPA has identified concerns 
for kidney, blood, and thyroid effects, immunotoxicity, reproductive 
and developmental toxicity, and neurotoxicity. Based on test data on 
the PMN substance, EPA estimates that toxicity to aquatic organisms may 
occur at concentrations that exceed 18 ppb of the PMN substance in 
surface waters. The Order was issued under TSCA sections 
5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on insufficient 
information to make a reasoned evaluation and a finding that the 
substance may present an unreasonable risk of injury to human health 
and the environment. To protect against these risks, the Order 
requires:
    1. Submission of certain toxicity testing on the PMN substance 
prior to exceeding the confidential production volume limit as 
specified in the Order.
    2. Use of personal protective equipment to prevent dermal exposure 
(where there is a potential for dermal exposure).
    3. Use of a NIOSH-certified respirator with an APF of at least 25 
(where there is a potential for inhalation exposure) or compliance with 
a NCEL of 1.2 ppm as an 8-hour time-weighted average. (EPA's estimates 
indicate that variations of the parameters (including batch size, 
number of processing sites, days per year of operation) of the uses 
identified below would not result in inhalation exposure that would 
indicate a different respirator.)
    4. Establishment and use of a hazard communication program, 
including human health precautionary statements on each label and in 
the SDS.
    5. No domestic manufacture of the PMN substance.
    6. Process and use of the PMN substance only for the confidential 
uses and formulation percentage specified in the Order.
    7. No release of the PMN substance resulting in surface water 
concentrations that exceed 18 ppb.
    The SNUR will designate as a ``significant new use'' the absence of 
these protective measures.
    Potentially useful information: EPA has determined that certain 
information about the human health and aquatic toxicity of the PMN 
substance may be potentially useful to characterize the effects of the 
PMN substance in support of a request by the PMN submitter to modify 
the Order, or if a manufacturer or processor is considering submitting 
a SNUN for a significant new use that will be designated by this SNUR. 
The submitter has agreed not to exceed the confidential production 
limit without performing specific target organ toxicity testing, 
reproductive/developmental toxicity testing; and chronic aquatic 
toxicity testing.
    CFR citation: 40 CFR 721.11033.
PMN Numbers: P-16-338, P-16-339, P-16-439, and P-16-440
    Chemical names: Xanthylium, (sulfoaryl)-bis [(substituted aryl) 
amino]-, sulfo derivs., inner salts, metal salts (generic) (P-16-338); 
Substituted triazinyl metal salt, diazotized, coupled with substituted 
pyridobenzimidazolesulfonic acids, substituted 
pyridobenzimidazolesulfonic acids, diazotized substituted 
alkanesulfonic acid, diazotized substituted aromatic sulfonate, 
diazotized substituted aromatic sulfonate, metal salts (generic) (P-16-
339); Carbon black, (organic acidic carbocyclic)-modified, inorganic 
salt (generic) (P-16-439); and Carbon black, (organic acidic 
carbocyclic)-modified, metal salt (generic) (P-16-440).
    CAS numbers: Not available.
    Effective date of TSCA section 5(e) Order: April 11, 2017.
    Basis for TSCA section 5(e) Order: The PMN states that the generic 
(non-confidential) uses of the PMN substances will be as dyestuffs (P-
16-0338 and P-16-0339) and as coloring agents (P-16-0439 and P-16-
0440). Based on physical/chemical properties of the PMN substances and 
test data on analogous poorly respirable particles, EPA has identified 
concerns for irritation to the eyes, lungs, and mucous membranes, and 
lung effects. Further, based on SAR analysis of test data on analogous 
dyes, EPA predicts toxicity to aquatic organisms may occur at 
concentrations that exceed 200 ppb of the PMN substances in surface 
waters. The Order was issued under TSCA sections 5(a)(3)(B)(ii)(I) and 
5(e)(1)(A)(ii)(I), based on insufficient information to make a reasoned 
evaluation and a finding that the substances may present an 
unreasonable risk of injury to human health and the environment. To 
protect against these risks, the Order requires:
    1. No manufacture of the PMN substances beyond the confidential 
annual production volume specified in the Order.
    2. No domestic manufacture of the PMN substances.
    3. Import the PMN substances only according to the terms specified 
and for the confidential uses specified in the Order.
    4. No release of the PMN substances to surface waters.
    The SNUR will designate as a ``significant new use'' the absence of 
these protective measures.
    Potentially useful information: EPA has determined that certain 
information about the fate, human health toxicity, and aquatic toxicity 
of the PMN substances may be potentially useful to characterize the 
effects of the PMN substances in support of a request by the PMN 
submitter to modify the Order, or if a manufacturer or processor is 
considering submitting a SNUN for a significant new use that will be 
designated by this SNUR. EPA has determined that the results of a

[[Page 43277]]

biodegradation test, specific target organ toxicity testing, and acute 
and chronic aquatic toxicity testing of the PMN substances may be 
potentially useful in characterizing the health and environmental 
effects of the PMN substances. Although the Order does not require 
these tests, the Order's restrictions on manufacture, processing, 
distribution in commerce, and disposal will remain in effect until the 
Order is modified or revoked by EPA based on submission of this or 
other information that EPA determines is relevant and needed to 
evaluate a modification request.
    CFR citations: 40 CFR 721.11034 (P-16-338), 40 CFR 721.11035 (P-16-
339), 40 CFR 721.11036 (P-16-439), and 40 CFR 721.11037 (P-16-440).
PMN Number: P-16-350
    Chemical name: Polyaralkyl aryl ester of methacrylic acid 
(generic).
    CAS number: Not available.
    Effective date of TSCA section 5(e) Order: March 31, 2017.
    Basis for TSCA section 5(e) Order: The PMN states that the generic 
(non-confidential) use of the substance will be as a polymer reactant. 
Based on test data on methacrylate moieties, EPA has identified 
concerns for irritation and sensitization based on analogy to 
methacrylates. Based on SAR analysis of test data on structurally 
similar respirable surfactants, EPA has identified concerns for lung 
effects. The Order was issued under TSCA sections 5(a)(3)(B)(ii)(I) and 
5(e)(1)(A)(ii)(I), based on insufficient information to make a reasoned 
evaluation and a finding that the substance may present an unreasonable 
risk of injury to human health. To protect against these risks, the 
Order requires:
    1. Use of personal protective equipment including impervious gloves 
(where there is a potential for dermal exposure).
    2. Establishment and use of a hazard communication program, 
including human health precautionary statements on each label and in 
the SDS.
    3. Manufacture of the PMN substance such that it is not less than 
the minimum average molecular weight identified in the Order and does 
not contain more than the maximum weight percent of low molecular 
weight species below 1,000 Daltons.
    4. Use of the PMN substance only for the confidential use specified 
in the Order.
    The SNUR will designate as a ``significant new use'' the absence of 
these protective measures.
    Potentially useful information: EPA has determined that certain 
information about the toxicity of the PMN substance may be potentially 
useful to characterize the health effects of the PMN substance in 
support of a request by the PMN submitter to modify the Order, or if a 
manufacturer or processor is considering submitting a SNUN for a 
significant new use that will be designated by this SNUR. EPA has 
determined that the results of specific target organ toxicity testing 
and a sensitization test of the PMN substance may be potentially useful 
in characterizing the health effects of the PMN substance. Although the 
Order does not require these tests, the Order's restrictions on 
manufacture, processing, distribution in commerce, and disposal will 
remain in effect until the Order is modified or revoked by EPA based on 
submission of this or other information that EPA determines is relevant 
and needed to evaluate a modification request.
    CFR citation: 40 CFR 721.11038.
PMN Number: P-16-352
    Chemical names: Phenol, 2-[[[3-(octyloxy)propyl]imino]methyl]- (P-
16-352, chemical A) and Phenol, 2-[[[3-(decyloxy)propyl]imino]methyl]- 
(P-16-352, chemical B).
    CAS numbers: 1858221-49-4 (P-16-352, chemical A) and 1858221-50-7 
(P-16-352, chemical B).
    Effective date of TSCA section 5(e) Order: April 21, 2017.
    Basis for TSCA section 5(e) Order: The PMN states that the PMN 
substances will be used as co-catalysts in the manufacturing of release 
coatings for producing papers and films at a concentration of 1% or 
less. Based on SAR analysis of test data on analogous phenols, EPA has 
identified concerns for respiratory and dermal irritation and 
developmental toxicity. In addition, EPA has identified concerns for 
liver toxicity and reproductive effects based on the hydrolysis product 
o-hydroxybenzaldehyde. Further, based on SAR analysis of test data on 
analogous phenols, EPA predicts toxicity to aquatic organisms may occur 
at concentrations that exceed 1 ppb of the PMN substances in surface 
waters. The Order was issued under TSCA sections 5(a)(3)(B)(ii)(I) and 
5(e)(1)(A)(ii)(I), based on insufficient information to make a reasoned 
evaluation and a finding that the substances may present an 
unreasonable risk of injury to human health and the environment. To 
protect against these risks, the Order requires:
    1. Submission of certain toxicity testing on the PMN substance 
prior to exceeding the confidential production volume limit as 
specified in the Order.
    2. Use of personal protective equipment including impervious gloves 
(where there is a potential for dermal exposure).
    3. Establishment and use of a hazard communication program, 
including human health precautionary statements on each label and in 
the SDS.
    4. No domestic manufacture of the PMN substances.
    5. No manufacture of the PMN substances beyond an annual production 
volume of 250 kg/yr.
    6. No use of the PMN substances in application methods that 
generate a dust, mist, or aerosol.
    7. No release of the PMN substance resulting in surface water 
concentrations that exceed 1 ppb.
    The SNUR will designate as a ``significant new use'' the absence of 
these protective measures.
    Potentially useful information: EPA has determined that certain 
information about the human health and aquatic toxicity of the PMN 
substance may be potentially useful to characterize the effects of the 
PMN substance in support of a request by the PMN submitter to modify 
the Order, or if a manufacturer or processor is considering submitting 
a SNUN for a significant new use that will be designated by this SNUR. 
The submitter has agreed not to exceed the confidential production 
limit without performing specific target organ toxicity, reproductive/
developmental toxicity, and acute aquatic toxicity testing.
    CFR citations: 40 CFR 721.11039 (P-16-352, chemical A) and 40 CFR 
721.11040 (P-16-352, chemical B).
PMN Number: P-16-358
    Chemical name: Alkyl phenol (generic).
    CAS number: Not available.
    Effective date of TSCA section 5(e) Order: April 24, 2017.
    Basis for TSCA section 5(e) Order: The PMN states that the 
substance will be used as a chemical intermediate. Based on SAR 
analysis of test data on analogous phenols, EPA has identified concerns 
for developmental toxicity. The Order was issued under TSCA sections 
5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on insufficient 
information to make a reasoned evaluation and a finding that the 
substance may present an unreasonable risk of injury to human health. 
To protect against these risks, the Order requires:
    1. Submission of certain toxicity testing on the PMN substance 
prior to exceeding the confidential production volume limit as 
specified in the Order.
    2. Use of personal protective equipment including impervious gloves

[[Page 43278]]

(where there is a potential for dermal exposure).
    3. Establishment and use of a hazard communication program, 
including human health precautionary statements on each label and in 
the SDS.
    4. Use of the PMN substance only as a chemical intermediate.
    5. No manufacture, process, or use of the PMN substance in any 
manner or method that generates a dust, mist, or aerosol or in a non-
enclosed process.
    6. No release of the PMN substance to surface waters.
    The SNUR will designate as a ``significant new use'' the absence of 
these protective measures.
    Potentially useful information: EPA has determined that certain 
information about the human health toxicity of the PMN substance may be 
potentially useful to characterize the effects of the PMN substance in 
support of a request by the PMN submitter to modify the Order, or if a 
manufacturer or processor is considering submitting a SNUN for a 
significant new use will be designated by this SNUR. The submitter has 
agreed not to exceed the confidential production limit without 
performing specific target organ toxicity and reproductive/
developmental toxicity tests.
    CFR citation: 40 CFR 721.11041.
PMN Number: P-16-364
    Chemical name: Nitrile-butadiene-acrylate terpolymers (generic).
    CAS number: Not available.
    Effective date of TSCA section 5(e) Order: March 31, 2017
    Basis for TSCA section 5(e) Order: The PMN states that the generic 
(non-confidential) use of the substance will be as a chemical 
intermediate. Based on SAR analysis of test data on structurally 
similar respirable particles, EPA has identified concerns for lung 
effects, including lung overload. The Order was issued under TSCA 
sections 5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on insufficient 
information to make a reasoned evaluation and a finding that the 
substance may present an unreasonable risk of injury to human health. 
To protect against these risks, the Order requires:
    1. Use of the PMN substance only as a site-limited chemical 
intermediate.
    2. Establishment and use of a hazard communication program, 
including human health precautionary statements on each label and in 
the SDS.
    3. No manufacture, process, or use of the PMN substance if it 
contains more than 5% of the particle size distribution less than 10 
microns.
    The SNUR will designate as a ``significant new use'' the absence of 
these protective measures.
    Potentially useful information: EPA has determined that certain 
information about the toxicity of the PMN substance may be potentially 
useful to characterize the effects of the PMN substance in support of a 
request by the PMN submitter to modify the Order, or if a manufacturer 
or processor is considering submitting a SNUN for a significant new use 
that will be designated by this SNUR. EPA has determined that the 
results of specific target organ toxicity testing of the PMN substance 
may be potentially useful in characterizing the health effects of the 
PMN substance. Although the Order does not require this test, the 
Order's restrictions on manufacture, processing, distribution in 
commerce, and disposal will remain in effect until the Order is 
modified or revoked by EPA based on submission of this or other 
information that EPA determines is relevant and needed to evaluate a 
modification request.
    CFR citation: 40 CFR 721.11042.
PMN Number: P-16-399
    Chemical name: Starch, polymer with 2-propenoic acid, potassium 
salt, oxidized.
    CAS number: 1638117-09-5.
    Effective date of TSCA section 5(e) Order: April 6, 2017.
    Basis for TSCA section 5(e) Order: The PMN states that the 
substance will be used as an agricultural soil amendment for field 
crops, agricultural soil amendment for turf applications and direct 
soil injection with fertilizers, and a compound to be used in 
preparation of advanced seed coatings. Based on SAR analysis of test 
data on structurally similar respirable particles, EPA has identified 
concerns for lung effects, including lung overload. The Order was 
issued under TSCA sections 5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), 
based on insufficient information to make a reasoned evaluation and a 
finding that the substance may present an unreasonable risk of injury 
to human health. The Order was also issued under TSCA sections 
5(a)(3)(B)(ii)(II) and 5(e)(1)(A)(ii)(II), based on a finding that the 
substance that the substance is or will be produced in substantial 
quantities and that the substance either enters or may reasonably be 
anticipated to enter the environment in substantial quantities, or 
there is or may be significant (or substantial) human exposure to the 
substance. To protect against these risks, the Order requires:
    1. Submission of certain toxicity testing on the PMN substance 
prior to exceeding the time limit as specified in the Order.
    2. Use of personal protective equipment including impervious gloves 
(where there is a potential for dermal exposure).
    3. Establishment and use of a hazard communication program, 
including human health precautionary statements on each label and in 
the SDS.
    4. Manufacture of the substance with a particulate size greater 
than 30 microns.
    The SNUR will designate as a ``significant new use'' the absence of 
these protective measures.
    Potentially useful information: EPA has determined that certain 
information about the toxicity of the PMN substance may be potentially 
useful to characterize the health and environmental effects of the PMN 
substance in support of a request by the PMN submitter to modify the 
Order, or if a manufacturer or processor is considering submitting a 
SNUN for a significant new use that will be designated by this SNUR. 
The submitter has agreed not to manufacture beyond a certain time limit 
without performing an acute aquatic toxicity test. In addition, EPA has 
determined that the results of specific target organ toxicity testing 
of the PMN substance may be potentially useful in characterizing the 
health effects of the PMN substance. Although the Order does not 
require this additional testing, the Order's restrictions on 
manufacture, processing, distribution in commerce, and disposal will 
remain in effect until the Order is modified or revoked by EPA based on 
submission of this or other information that EPA determines is relevant 
and needed to evaluate a modification request.
    CFR citation: 40 CFR 721.11043.
PMN Number: P-16-430
    Chemical name: Pentanedioic acid, 2-methyl-.
    CAS number: 617-62-9.
    Effective date of TSCA section 5(e) Order: May 17, 2017.
    Basis for TSCA section 5(e) Order: The PMN states the generic (non-
confidential) use of the substance will be as a filler. Based on test 
data on the PMN substance, EPA has identified concerns for systemic and 
reproductive toxicity. Based on structural analysis on the acid groups 
and test data, EPA has identified concerns for dermal and respiratory 
irritation. Further, based on test data on the PMN substance and test 
data on analogous neutral organics, EPA predicts toxicity to aquatic 
organisms may occur at concentrations that exceed 14 ppb of the PMN 
substance in surface waters. The Order was issued under TSCA sections 
5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on insufficient

[[Page 43279]]

information to make a reasoned evaluation and a finding that the 
substance may present an unreasonable risk of injury to human health 
and the environment. EPA assessed risks based on the specific 
processing, use, distribution/transportation, treatment and disposal 
processes, process equipment, engineering controls, and handling 
practices (including worker activities and cleaning procedures) 
described in the PMN. To protect against these risks, the Order 
requires:
    1. Use of personal protective equipment including impervious gloves 
(where there is a potential for dermal exposure).
    2. Use of a NIOSH-certified respirator with an APF of at least 10 
(where there is a potential for inhalation exposure). (EPA's estimates 
indicate that variations of the parameters (including batch size, 
number of processing sites, days per year of operation) of the uses 
identified below would not result in inhalation exposure that would 
indicate a different respirator.)
    3. Establishment and use of a hazard communication program, 
including human health precautionary statements on each label and in 
the SDS.
    4. No domestic manufacture of the PMN substance.
    5. Import of the PMN substance at or below the maximum 
concentration specified in the Order.
    6. No release of the PMN substance resulting in surface water 
concentrations that exceed 14 ppb.
    The SNUR will designate as a ``significant new use'' the absence of 
these protective measures.
    Potentially useful information: EPA has determined that certain 
information about the human health toxicity of the PMN substance may be 
potentially useful to characterize the effects of the substance in 
support of a request by the PMN submitter to modify the Order, or if a 
manufacturer or processor is considering submitting a SNUN for a 
significant new use that will be designated by this SNUR. EPA has 
determined that the results of specific target organ toxicity testing 
of the PMN substance may be potentially useful in characterizing the 
health effects of the PMN substance. Although the Order does not 
require this test, the Order's restrictions on manufacture, processing, 
distribution in commerce, and disposal will remain in effect until the 
Order is modified or revoked by EPA based on submission of this or 
other information.
    CFR citation: 40 CFR 721.11044.
PMN Number: P-16-495
    Chemical name: 2-Pentanol, 4-methyl-, reaction products with 
phosphorus oxide (P2O5), compounds with alkylamine (generic).
    CAS number: Not available.
    Effective date of TSCA section 5(e) Order: April 25, 2017.
    Basis for TSCA section 5(e) Order: The PMN states that the generic 
use (non-confidential) of the substance will be as a lubricant 
additive. Based on test data on the substance, EPA has identified 
concerns for systemic effects, sensitization and irritation to the eyes 
and skin. Based on physical/chemical properties, EPA has concerns for 
lung effects, including lung surfactancy. Further, based on test data 
on analogous aliphatic amines for the cation and neutral organics for 
the anion as well as test data on the PMN substance, EPA predicts 
toxicity to aquatic organisms may occur at concentrations that exceed 
200 ppb of the PMN substance in surface waters. The Order was issued 
under TSCA sections 5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on 
insufficient information to make a reasoned evaluation and a finding 
that the substance may present an unreasonable risk of injury to human 
health and the environment. To protect against these risks, the Order 
requires:
    1. Submission of certain toxicity testing on the PMN substance 
prior to exceeding the confidential production volume limit as 
specified in the Order.
    2. Use of personal protective equipment (where there is a potential 
for dermal exposure).
    3. Establishment and use of a hazard communication program, 
including human health precautionary statements on each label and in 
the SDS.
    4. No manufacture in any manner or method that results in 
inhalation exposure.
    5. No use of the PMN substance in an application method that 
generates a vapor, mist, or aerosol.
    6. No release of the PMN substance resulting in surface water 
concentrations that exceed 200 ppb.
    The SNUR will designate as a ``significant new use'' the absence of 
these protective measures.
    Potentially useful information: EPA has determined that certain 
information about the human health and aquatic toxicity of the PMN 
substance may be potentially useful to characterize the effects of the 
PMN substance effects of the PMN substance in support of a request by 
the PMN submitter to modify the Order, or if a manufacturer or 
processor is considering submitting a SNUN for a significant new use 
that will be designated by this SNUR. The submitter has agreed not to 
exceed the confidential production limit without performing chronic 
aquatic toxicity tests. In addition, EPA has determined that the 
results of specific target organ toxicity testing of the PMN substance 
may be potentially useful in characterizing the health effects of the 
PMN substance. Although the Order does not require this additional 
testing, the Order's restrictions on manufacture, processing, 
distribution in commerce, and disposal will remain in effect until the 
Order is modified or revoked by EPA based on submission of this or 
other information that EPA determines is relevant and needed to 
evaluate a modification request.
    CFR citation: 40 CFR 721.11045.
PMN Number: P-16-513
    Chemical name: Hydroxy alkylbiphenyl (generic).
    CAS number: Not available.
    Effective date of TSCA section 5(e) Order: May 2, 2017.
    Basis for TSCA section 5(e) Order: The PMN states that the 
substance will be used as a chemical intermediate. Based on test data 
on an analog, EPA has identified concerns for developmental toxicity, 
systemic toxicity, blood effects, and corrosion of the skin, eyes, and 
mucous membranes. Further, based on SAR analysis of test data on 
analogous amides, EPA predicts toxicity to aquatic organisms may occur 
at concentrations that exceed 17 ppb of the PMN substances in surface 
waters. The Order was issued under TSCA sections 5(a)(3)(B)(ii)(I) and 
5(e)(1)(A)(ii)(I), based on insufficient information to make a reasoned 
evaluation and a finding that the substances may present an 
unreasonable risk of injury to human health and the environment. To 
protect against these risks, the Order requires:
    1. Submission of certain toxicity testing on the PMN substance 
prior to exceeding the confidential production volume limit as 
specified in the Order.
    2. Use of personal protective equipment (where there is a potential 
for dermal exposure).
    3. Use of a NIOSH-certified respirator with an APF of at least 50 
(where there is a potential for inhalation exposure). (EPA's estimates 
indicate that variations of the parameters (including batch size, 
number of processing sites, days per year of operation) of the uses 
identified below would not result in inhalation exposure that would 
indicate a different respirator.)
    4. Use of the PMN substance only as a chemical intermediate.
    5. No release of the PMN substance resulting in surface water 
concentrations that exceed 17 ppb.

[[Page 43280]]

    The SNUR will designate as a ``significant new use'' the absence of 
these protective measures.
    Potentially useful information: EPA has determined that certain 
information about the human health and aquatic toxicity of the PMN 
substance may be potentially useful to characterize the effects of the 
PMN substance in support of a request by the PMN submitter to modify 
the Order, or if a manufacturer or processor is considering submitting 
a SNUN for a significant new use that will be designated by this SNUR. 
The submitter has agreed not to exceed the confidential production 
limit without performing specific target organ toxicity and 
reproductive/developmental toxicity testing. In addition, EPA has 
determined that the results of acute aquatic toxicity tests may be 
potentially useful in characterizing the environmental effects of the 
PMN substance. Although the Order does not require these additional 
tests, the Order's restrictions on manufacture, processing, 
distribution in commerce, and disposal will remain in effect until the 
Order is modified or revoked by EPA based on submission of this or 
other information that EPA determines is relevant and needed to 
evaluate a modification request.
    CFR citation: 40 CFR 721.11046.
PMN Numbers: P-16-534, P-16-535, and P-16-536
    Chemical names: Alkyl alkenoic acid, polymer with 
alkenylcarbomonocycle telomer with substituted alkanoic acid hydroxyl 
alkyl substituted alkenyl substituted alkyl ester, polyalkylene glycol 
alkyl ether alkyl alkenoate, dialkylene glycol diheteromonocyclic ether 
and alkylcarbomonocyclic alkenoate, metal salt (generic) (P-16-534); 
Alkyl alkenoic acid, polymer with alkenylcarbomonocycle telomer with 
substituted alkanoic acid hydroxyl alkyl substituted alkenyl 
substituted alkyl ester, alkanediol diheteromonocyclic ether, 
polyalkylene glycol alkyl ether alkyl alkenoate and 
alkylcarbomonocyclic alkenoate, metal salt (generic) (P-16-535); and 
Alkyl alkenoic acid, polymer with bis heteromonocyclic substituted 
alkyl carbomonocycle, alkenylcarbomonocycle telomer with substituted 
alkanoic acid hydroxyl alkyl substituted alkenyl substituted alkyl 
ester, polyalkylene glycol alkyl ether alkyl alkenoate and 
alkylcarbomonocyclic alkenoate, metal salt (generic) (P-16-536).
    CAS numbers: Not available.
    Effective date of TSCA section 5(e) Order: April 4, 2017.
    Basis for TSCA section 5(e) Order: The PMN states that the generic 
(non-confidential) use of the substances will be a component of ink. 
Based on test data on structurally similar respirable particles, EPA 
has identified concerns for lung effects if inhaled, based on lung 
overload. In addition, EPA has identified ecotoxicity concerns for the 
substances if made with an acid component exceeding 20% of the 
molecular weight due potential for increased absorption and solubility. 
The Order was issued under TSCA sections 5(a)(3)(B)(ii)(I) and 
5(e)(1)(A)(ii)(I), based on insufficient information to make a reasoned 
evaluation and a finding that the substances may present an 
unreasonable risk of injury to human health and the environment. To 
protect against these risks, the Order requires:
    1. Manufacture of the PMN substances such that the minimum average 
molecular weight is 1,800 daltons and the carboxylic acid content does 
not exceed 20%.
    2. No domestic manufacture of the PMN substances.
    3. Process or use of the PMN substances only for the use specified 
in the Order.
    The SNUR will designate as a ``significant new use'' the absence of 
these protective measures.
    Potentially useful information: EPA has determined that certain 
information about the human health and aquatic toxicity of the PMN 
substances may be potentially useful to characterize the effects of the 
substances in support of a request by the PMN submitter to modify the 
Order, or if a manufacturer or processor is considering submitting a 
SNUN for a significant new use that will be designated by this SNUR. 
EPA has determined that the results of specific target organ toxicity 
testing and an acute aquatic toxicity test of the PMN substances may be 
potentially useful in characterizing the health and environmental 
effects of the PMN substances. Although the Order does not require 
these tests, the Order's restrictions on manufacture, processing, 
distribution in commerce, and disposal will remain in effect until the 
Order is modified or revoked by EPA based on submission of this or 
other information that EPA determines is relevant and needed to 
evaluate a modification request.
    CFR citations: 40 CFR 721.11047 (P-16-534), 40 CFR 721.11048 (P-16-
535), and 40 CFR 721.11049 (P-16-536).
PMN Numbers: P-16-549, P-16-550, P-16-551, P-16-553, P-16-555, P-16-
556, P-16-557, P-16-558, P-16-560, P-16-561, P-16-562, P-16-563, P-16-
564, P-16-565, and P-16-567
    Chemical names: Alkaline functionalized methacrylate-substituted 
polymer (generic) (P-16-549, P-16-550, and P-16-551); Quaternary 
alkylamine functionalized methacrylate-substituted polymer (generic) 
(P-16-553); Neutral alcohol functionalized methacrylate-substituted 
polymer (generic) (P-16-555 and P-16-556); Neutral alkyl salt 
functionalized methacrylate-substituted polymer (generic) (P-16-557, P-
16-558, and P-16-560); Acid functionalized methacrylate-substituted 
polymer (generic) (P-16-561, P-16-562, P-16-563, P-16-564, and P-16-
565); and Alkylamine functionalized methacrylate-substituted polymer 
(generic) (P-16-567).
    CAS numbers: Not available.
    Effective date of TSCA section 5(e) Order: May 2, 2017.
    Basis for TSCA section 5(e) Order: The PMN states the substances 
will be use as crosslinked resins for chromatographic separation of 
biomolecules and biocatalysts. Based on test data on structurally 
similar respirable particles, EPA has identified concerns for lung 
effects, including lung overload. EPA has also identified irritation 
concerns for skin and eyes. The Order was issued under TSCA sections 
5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on insufficient 
information to make a reasoned evaluation and a finding that the 
substances may present an unreasonable risk of injury to human health. 
To protect against these risks, the Order requires:
    1. Use of personal protective equipment including impervious gloves 
(where there is a potential for dermal exposure).
    2. Manufacture of the PMN substances only in the physical form of 
spherical beads and with less than 0.1% below a particle size of 10 
microns.
    3. No domestic manufacture of the PMN substances.
    4. Process or use of the PMN substances only for the uses specified 
in the Order.
    The SNUR will designate as a ``significant new use'' the absence of 
these protective measures.
    Potentially useful information: EPA has determined that certain 
information about the human health toxicity of the PMN substances may 
be potentially useful to characterize the effects of the substances in 
support of a request by the PMN submitter to modify the Order, or

[[Page 43281]]

if a manufacturer or processor is considering submitting a SNUN for a 
significant new use that will be designated by this SNUR. EPA has 
determined that the results of specific target organ toxicity testing 
of the PMN substances may be potentially useful in characterizing the 
health effects of the PMN substances. Although the Order does not 
require this testing, the Order's restrictions on manufacture, 
processing, distribution in commerce, and disposal will remain in 
effect until the Order is modified or revoked by EPA based on 
submission of this or other information that EPA determines is relevant 
and needed to evaluate a modification request.
    CFR citations: 40 CFR 721.11050.
PMN Number: P-16-579
    Chemical name: Waste plastics, poly(ethylene terephthalate), 
depolymd. with polypropylene glycol ether with glycerol (3:1), polymers 
with alkenoic and alkanoic acids (generic).
    CAS number: Not available.
    Effective date of TSCA section 5(e) Order: March 13, 2017.
    Basis for TSCA section 5(e) Order: The PMN states that the 
substance will be used as an ultraviolet curable coating resin. Based 
on test data on similar structural moieties, EPA has identified 
concerns for dermal and respiratory sensitization and irritation of 
mucous membranes. In addition, EPA has identified human health and 
environmental concerns for the substance if made with lower molecular 
weight due potential for increased absorption and solubility. The Order 
was issued under TSCA sections 5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), 
based on insufficient information to make a reasoned evaluation and a 
finding that the substances may present an unreasonable risk of injury 
to human health and the environment. To protect against these risks, 
the Order requires:
    1. Use of personal protective equipment including gloves and 
protective clothing (where there is a potential for dermal exposure).
    2. Use of a NIOSH-certified full-face respirator with an APF of at 
least 50 (where there is a potential for inhalation exposure). (EPA's 
estimates indicate that variations of the parameters (including batch 
size, number of processing sites, days per year of operation) of the 
uses identified below would not result in inhalation exposure that 
would indicate a different respirator.)
    3. Establishment and use of a hazard communication program, 
including human health precautionary statements on each label and in 
the SDS.
    4. No manufacture of the PMN substance with an average molecular 
weight less than 1,100 Daltons.
    5. Use of the PMN substance only as an ultraviolet curable coating 
resin.
    The SNUR will designate as a ``significant new use'' the absence of 
these protective measures.
    Potentially useful information: EPA has determined that certain 
information about the physical-chemical properties and human health and 
aquatic toxicity of the PMN substance may be potentially useful to 
characterize the effects of the substance in support of a request by 
the PMN submitter to modify the Order, or if a manufacturer or 
processor is considering submitting a SNUN for a significant new use 
that will be designated by this SNUR. EPA has determined that 
measurement of certain physical-chemical properties, the results of 
specific target organ toxicity, reproductive/developmental toxicity, 
sensitization, and acute and chronic aquatic toxicity testing may be 
potentially useful in characterizing the health and environmental 
effects of the PMN substances. Although the Order does not require 
these tests, the Order's restrictions on manufacture, processing, 
distribution in commerce, and disposal will remain in effect until the 
Order is modified or revoked by EPA based on submission of this or 
other information that EPA determines is relevant and needed to 
evaluate a modification request.
    CFR citation: 40 CFR 721.11051.
PMN Number: P-17-32
    Chemical name: 1,3,5-Naphthalenetrisulfonic acid.
    CAS number: 6654-64-4.
    Effective date of TSCA section 5(e) Order: March 22, 2017.
    Basis for TSCA section 5(e) Order: The PMN states that the generic 
(non-confidential) use of the substance is for monitoring of oil/gas 
well performance. Based on test data on an analog and physical/chemical 
properties of the PMN substance, EPA has identified concerns for dermal 
and respiratory irritation, developmental toxicity, and blood effects. 
The Order was issued under TSCA sections 5(a)(3)(B)(ii)(I) and 
5(e)(1)(A)(ii)(I), based on insufficient information to make a reasoned 
evaluation and a finding that the substance may present an unreasonable 
risk of injury to human health. To protect against these risks, the 
Order requires:
    1. Submission of certain toxicity testing on the PMN substance 
prior to exceeding the confidential production volume limit as 
specified in the Order.
    2. Use of personal protective equipment including NIOSH-approved 
respirator (APF 50) and impervious gloves (where there is a potential 
for inhalation or dermal exposure). (EPA's estimates indicate that 
variations of the parameters (including batch size, number of 
processing sites, days per year of operation) of the uses identified 
below would not result in inhalation exposure that would indicate a 
different respirator.)
    3. Establishment and use of a hazard communication program, 
including human health precautionary statements on each label and in 
the SDS.
    4. No manufacture or processing of the PMN substance beyond a 
confidential annual production volume specified in the Order.
    5. No manufacture, processing, or use using application methods 
that intentionally generate a vapor, mist or aerosol.
    The SNUR will designate as a ``significant new use'' the absence of 
these protective measures.
    Potentially useful information: EPA has determined that certain 
information about the human health toxicity of the PMN substance may be 
potentially useful to characterize the effects of the PMN substance in 
support of a request by the PMN submitter to modify the Order, or if a 
manufacturer or processor is considering submitting a SNUN for a 
significant new use that will be designated by this SNUR. The submitter 
has agreed not to exceed the confidential production limit without 
performing specific target organ toxicity and developmental toxicity 
testing.
    CFR citation: 40 CFR 721.11052.
PMN Numbers: P-17-33, P-17-34, P-17-36, P-17-38, P-17-39, P-17-41, P-
17-42, P-17-43, P-17-45, P-17-47, P-17-50, P-17-52, P-17-55, P-17-57, 
P-17-59, P-17-61, P-17-62, P-17-63, P-17-64, P-17-66, P-17-67, P-17-69, 
P-17-71, P-17-72, P-17-73, P-17-75, P-17-76, P-17-79, P-17-80, P-17-83, 
P-17-85, P-17-87, P-17-90, P-17-91, P-17-93
    Chemical names and CAS Numbers:

[[Page 43282]]

------------------------------------------------------------------------
                    Chemical name                           CAS No.
------------------------------------------------------------------------
Benzoic acid, 2-fluoro-, sodium salt (1:1) (P-17-33).          6654-64-4
Benzoic acid, 4-fluoro-, sodium salt (1:1) (P-17-34).           499-90-1
Benzoic acid, 2,3,4,5-tetrafluoro-, sodium salt (1:1)         67852-79-3
 (P-17-36)...........................................
Benzoic acid, 2-(trifluoromethyl)-, sodium salt (1:1)          2966-44-1
 (P-17-38)...........................................
Benzoic acid, 4-(trifluoromethyl)-, sodium salt (1:1)         25832-58-0
 (P-17-39)...........................................
Benzoic acid, 2,5-difluoro-, sodium salt (1:1) (P-17-        522651-42-9
 41).................................................
Benzoic acid, 3-fluoro-, sodium salt (1:1) (P-17-42).           499-57-0
Benzoic acid, 2,6-difluoro-, sodium salt (1:1) (P-17-          6185-28-0
 43).................................................
Benzoic acid, 3,5-difluoro-, sodium salt (1:1) (P-17-        530141-39-0
 45).................................................
Benzoic acid, 2,4-difluoro-, sodium salt (1:1) (P-17-          1765-08-8
 47).................................................
Benzoic acid, 3,4-difluoro-, sodium salt (1:1) (P-17-        522651-44-1
 50).................................................
Benzoic acid, 3,4,5-trifluoro-, sodium salt (1:1) (P-       1180493-12-2
 17-52)..............................................
Benzoic acid, 2,3,4-trifluoro-, sodium salt (1:1) (P-        402955-41-3
 17-55)..............................................
Benzoic acid, 2,4,5-trifluoro-, sodium salt (1:1) (P-        522651-48-5
 17-57)..............................................
Benzoic acid, 2,3-difluoro-, sodium salt (1:1) (P-17-       1604819-08-0
 59).................................................
Benzoic acid, 3-(trifluoromethyl)-, sodium salt (1:1)         69226-41-1
 (P-17-61)...........................................
Benzoic acid, 2-chloro-, sodium salt (1:1) (P-17-62).         17264-74-3
Benzoic acid, 4-chloro-, sodium salt (1:1) (P-17-63).          3686-66-6
Benzoic acid, 3-chloro-, sodium salt (1:1) (P-17-64).         17264-88-9
Benzoic acid, 2,3-dichloro-, sodium salt (1:1) (P-17-        118537-84-1
 66).................................................
Benzoic acid, 2,5-dichloro-, sodium salt (1:1) (P-17-         63891-98-5
 67).................................................
Benzoic acid, 3,5-dichloro-, sodium salt (1:1) (P-17-        154862-40-5
 69).................................................
Benzoic acid, 2,6-dichloro-, sodium salt (1:1) (P-17-         10007-84-8
 71).................................................
Benzoic acid, 3,4-dichloro-, sodium salt (1:1) (P-17-         17274-10-1
 72).................................................
Benzoic acid, 2,4-dichloro-, sodium salt (1:1) (P-17-         38402-11-8
 73).................................................
Benzoic acid, 2-chloro-4-fluoro-, sodium salt (P-17-         855471-43-1
 75).................................................
Benzoic acid, 3-chloro-4-fluoro-, sodium salt (P-17-        1421761-18-3
 76).................................................
Benzoic acid, 5-chloro-2-fluoro-, sodium salt (P-17-        1382106-78-6
 79).................................................
Benzoic acid, 4-chloro-3-fluoro-, sodium salt (P-17-        1421029-88-0
 80).................................................
Benzoic acid, 4-chloro-2-fluoro-, sodium salt (P-17-        1382106-64-0
 83).................................................
Benzoic acid, 5-bromo-2-chloro-, sodium salt (P-17-         1938142-12-1
 85).................................................
Benzoic acid, 3-bromo-4-fluoro-, sodium salt (P-17-          938142-13-2
 87).................................................
Benzoic acid, 2-bromo-5-fluoro-, sodium salt (P-17-         1938142-14-3
 90).................................................
Benzoic acid, 4-bromo-2-fluoro-, sodium salt (P-17-         1938142-15-4
 91).................................................
Benzoic acid, 4-bromo-3-fluoro-, sodium salt (P-17-         1535169-81-3
 93).................................................
------------------------------------------------------------------------

    Effective date of TSCA section 5(e) Order: March 22, 2017.
    Basis for TSCA section 5(e) Order: The PMNs state that the generic 
(non-confidential) use of the substances are for monitoring of oil/gas 
well performance. Based on test data on an analog, EPA has identified 
concerns for reproductive, developmental and neuro-toxicity, as well as 
lung toxicity and dermal irritation. The Order was issued under TSCA 
sections 5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on insufficient 
information to make a reasoned evaluation and a finding that the 
substances may present an unreasonable risk of injury to human health. 
EPA assessed risks based on the specific manufacturing, processing, 
use, process equipment, engineering controls, and handling practices 
(including worker activities and cleaning procedures) described in the 
PMN. To protect against these risks, the Order requires:
    1. Submission of certain toxicity testing on the PMN substances 
prior to exceeding the production volume limit as specified in the 
Order.
    2. Use of personal protective equipment including impervious gloves 
(where there is a potential for dermal exposure).
    3. Use of a NIOSH-certified respirator with an APF of at least 50 
(where there is a potential for inhalation exposure) or compliance with 
a NCEL of 0.0184 ppm as an 8-hour time-weighted average.
    4. Use of processes, process equipment, engineering controls, and 
handling practices specified in the Order for manufacturing and 
processing.
    5. Establishment and use of a hazard communication program, 
including human health precautionary statements on each label and in 
the SDS.
    6. No manufacture or process of the PMN substances beyond a 
confidential annual production volume specified in the Order.
    The SNUR will designate as a ``significant new use'' the absence of 
these protective measures.
    Potentially useful information: EPA has determined that certain 
information about the human health toxicity of the PMN substances may 
be potentially useful to characterize the effects of the PMN substances 
in support of a request by the PMN submitter to modify the Order, or if 
a manufacturer or processor is considering submitting a SNUN for a 
significant new use that will be designated by this SNUR. The submitter 
has agreed not to exceed the confidential production limit without 
performing specific target organ toxicity testing on P-17-0091.
    CFR citations: 40 CFR 721.11053.
PMN Numbers: P-17-35, P-17-37, P-17-40, P-17-44, P-17-46, P-17-48, P-
17-51, P-17-53, P-17-54, P-17-56, P-17-58, P-17-60, P-17-65, P-17-68, 
P-17-70, P-17-74, P-17-77, P-17-78, P-17-81, P-17-82, P-17-84, P-17-88, 
P-17-89, P-17-92, P-17-97
    Chemical names and CAS Numbers:

------------------------------------------------------------------------
                    Chemical name                           CAS No.
------------------------------------------------------------------------
Benzoic acid, 2,3,4,5-tetrafluoro- (P-17-35).........          1201-31-6
Benzoic acid, 2-(trifluoromethyl)- (P-17-37).........           433-97-6
Benzoic acid, 2,5-difluoro- (P-17-40)................          2991-28-8
Benzoic acid, 2,6-difluoro- (P-17-44)................           385-00-2

[[Page 43283]]

 
Benzoic acid, 3,5-difluoro- (P-17-46)................           455-40-3
Benzoic acid, 2,4-difluoro- (P-17-48)................          1583-58-0
Benzoic acid, 3,4-difluoro- (P-17-51)................           455-86-7
Benzoic acid, 3,4,5-trifluoro- (P-17-53).............        121602-93-5
Benzoic acid, 2,3,4-trifluoro- (P-17-54).............         61079-72-9
Benzoic acid, 2,4,5-trifluoro- (P-17-56).............           446-17-3
Benzoic acid, 2,3-difluoro- (P-17-58)................          4519-39-5
Benzoic acid, 3-(trifluoromethyl)- (P-17-60).........           454-92-2
Benzoic acid, 2,3-dichloro-(P-17-65).................            50-45-3
Benzoic acid, 3,5-dichloro- (P-17-68)................            51-36-5
Benzoic acid, 2,6-dichloro-(P-17-70).................            50-30-6
Benzoic acid, 2-chloro-4-fluoro- (P-17-74)...........          2252-51-9
Benzoic acid, 5-chloro-2-fluoro- (P-17-77)...........           394-30-9
Benzoic acid, 3-chloro-4-fluoro- (P-17-78)...........           403-16-7
Benzoic acid, 4-chloro-3-fluoro- (P-17-81)...........           403-17-8
Benzoic acid, 4-chloro-2-fluoro- (P-17-82)...........           446-30-0
Benzoic acid, 5-bromo-2-chloro- (P-17-84)............         21739-92-4
Benzoic acid, 3-bromo-4-fluoro- (P-17-88)............         11007-16-5
Benzoic acid, 2-bromo-5-fluoro- (P-17-89)............           394-28-5
Benzoic acid, 4-bromo-3-fluoro- (P-17-92)............        153556-42-4
Benzoic acid, 4-bromo-2-fluoro- (P-17-97)............        112704-79-7
------------------------------------------------------------------------

    Effective date of TSCA section 5(e) Order: March 22, 2017.
    Basis for TSCA section 5(e) Order: The PMNs state that the generic 
(non-confidential) use of the substances are for monitoring of oil/gas 
well performance. Based on test data on an analog, EPA has identified 
concerns for reproductive, developmental and neuro-toxicity, as well as 
lung toxicity and dermal irritation. The Order was issued under TSCA 
sections 5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on insufficient 
information to make a reasoned evaluation and a finding that the 
substances may present an unreasonable risk of injury to human health. 
EPA assessed risks based on the specific manufacturing, processing, 
use, process equipment, engineering controls, and handling practices 
(including worker activities and cleaning procedures) described in the 
PMN. To protect against these risks, the Order requires:
    1. Submission of certain toxicity testing on the PMN substances 
prior to exceeding the production volume limit as specified in the 
Order.
    2. Use of personal protective equipment including impervious gloves 
(where there is a potential for dermal exposure).
    3. Use of a NIOSH-certified respirator with an APF of at least 50 
(where there is a potential for inhalation exposure) or compliance with 
a NCEL of 0.0184 ppm as an 8-hour time-weighted average to prevent 
inhalation exposure.
    4. Use of processes, process equipment, engineering controls, and 
handling practices specified in the Order for manufacturing and 
processing.
    5. Establishment and use of a hazard communication program, 
including human health precautionary statements on each label and in 
the SDS.
    6. No manufacture or process of the PMN substances beyond a 
confidential annual production volume specified in the Order.
    The SNUR will designate as a ``significant new use'' the absence of 
these protective measures.
    Potentially useful information: EPA has determined that certain 
information about the human health toxicity of the PMN substances may 
be potentially useful to characterize the effects of the PMN substances 
in support of a request by the PMN submitter to modify the Order, or if 
a manufacturer or processor is considering submitting a SNUN for a 
significant new use that will be designated by this SNUR. The submitter 
has agreed not to exceed the confidential production limit without 
performing specific target organ toxicity and reproductive/
developmental toxicity testing on both P-17-35 and P-17-37.
    CFR citations: 40 CFR 721.11054.
PMN Numbers: P-17-94, P-17-95, P-17-96, P-17-98, P-17-99, P-17-100, P-
17-101, P-17-102, P-17-103, P-17-104, P-17-105, P-17-114, P-17-122, P-
17-123, P-17-124, P-17-125, P-17-126, P-17-127, P-17-128, P-17-129, P-
17-130, P-17-131, P-17-132, P-17-133, P-17-134, P-17-135, P-17-136, P-
17-137, P-17-138, P-17-139, and P-17-140
    Chemical names and CAS Numbers:

------------------------------------------------------------------------
                    Chemical name                           CAS No.
------------------------------------------------------------------------
Benzoic acid, 2,3,4,5-tetrafluoro-, ethyl ester (P-17-       122894-73-9
 94).................................................
Benzoic acid, 4-(trifluoromethyl)-, ethyl ester (P-17-          583-02-8
 95).................................................
Benzoic acid, 2-(trifluoromethyl)-, ethyl ester (P-17-          577-62-8
 96).................................................
Benzoic acid, 2,6-difluoro-, ethyl ester (P-17-98)...         19064-14-3
Benzoic acid, 2,5-difluoro-, ethyl ester (P-17-99)...           708-25-8
Benzoic acid, 2,3,4-trifluoro-, ethyl ester (P-17-           351354-50-2
 100)................................................
Benzoic acid, 2-bromo-5-fluoro-, ethyl ester (P-17-          351354-50-2
 101)................................................
Benzoic acid, 3,5-difluoro-, ethyl ester (P-17-102)..           350-19-6
Benzoic acid, 5-bromo-2-chloro-, ethyl ester (P-17-           76008-73-6
 103)................................................
Benzoic acid, 3-chloro-, ethyl ester (P-17-104)......          1128-76-3
Benzoic acid, 2-chloro-, ethyl ester (P-17-105)......          7335-25-3
Benzoic acid, 3-chloro-4-fluoro-, ethyl ester (P-17-         137521-81-4
 114)................................................
Benzoic acid, 4-bromo-2-fluoro-, ethyl ester (P-17-          474709-71-2
 122)................................................
Benzoic acid, 2-bromo-4,5-difluoro-, ethyl ester (P-         144267-97-0
 17-123).............................................
Benzoic acid, 4-bromo-3-fluoro-, ethyl ester (P-17-         1130165-74-0
 124)................................................
Benzoic acid, 3-bromo-4-fluoro-, ethyl ester (P-17-           23233-33-2
 125)................................................

[[Page 43284]]

 
Benzoic acid, 4-chloro-2-fluoro-, ethyl ester (P-17-           4793-20-8
 126)................................................
Benzoic acid, 2,5-dichloro-, ethyl ester (P-17-127)..         35112-27-7
Benzoic acid, 4-chloro-3-fluoro-, ethyl ester (P-17-         203573-08-4
 128)................................................
Benzoic acid, 2-chloro-4-fluoro-, ethyl ester (P-17-         167758-87-4
 129)................................................
Benzoic acid, 5-chloro-2-fluoro-, ethyl ester (P-17-         773139-56-3
 130)................................................
Benzoic acid, 2,4-difluoro-, ethyl ester (P-17-131)..        108928-00-3
Benzoic acid, 3,4-difluoro-, ethyl ester (P-17-132)..        144267-96-9
Benzoic acid, 3,4,5-trifluoro-, ethyl ester (P-17-           495405-09-9
 133)................................................
Benzoic acid, 2,4,5-trifluoro-, ethyl ester (P-17-           351354-41-1
 134)................................................
Benzoic acid, 3-(trifluoromethyl)-, ethyl ester (P-17-        76783-59-0
 135)................................................
Benzoic acid, 2,3-difluoro-, ethyl ester (P-17-136)..        773134-65-9
Benzoic acid, 2,6-dichloro-, ethyl ester (P-17-137)..         81055-73-4
Benzoic acid, 3,5-dichloro-, ethyl ester (P-17-138)..         91085-56-2
Benzoic acid, 2,4-dichloro-, ethyl ester (P-17-139)..         56882-52-1
Benzoic acid, 3,4-dichloro-, ethyl ester (P-17-140)..         28394-58-3
------------------------------------------------------------------------

    Effective date of TSCA section 5(e) Order: March 22, 2017.
    Basis for TSCA section 5(e) Order: The PMNs state that the 
substances are for monitoring oil/gas well performance. Based on test 
data on an analog, EPA has identified concerns for reproductive, 
developmental and neuro-toxicity, as well as lung toxicity and dermal 
irritation. Further, based on SAR analysis of test data on analogous 
neutral organics, EPA predicts toxicity to aquatic organisms may occur 
at concentrations that exceed 15 ppb of the PMN substances in surface 
waters. The Order was issued under TSCA sections 5(a)(3)(B)(ii)(I) and 
5(e)(1)(A)(ii)(I), based on insufficient information to make a reasoned 
evaluation and a finding that the substances may present an 
unreasonable risk of injury to human health and the environment. EPA 
assessed risks based on the specific manufacturing, processing, use, 
process equipment, engineering controls, and handling practices 
(including worker activities and cleaning procedures) described in the 
PMNs. To protect against these risks, the Order requires:
    1. Submission of certain toxicity testing on the PMN substances 
prior to exceeding the production volume limit as specified in the 
Order.
    2. Use of personal protective equipment including impervious gloves 
(where there is a potential for dermal exposure).
    3. Use of a NIOSH-certified respirator with an APF of at least 
1,000 (where there is a potential for inhalation exposure) or 
compliance with a NCEL of 0.0184 ppm as an 8-hour time-weighted 
average.
    4. Use of processes, process equipment, engineering controls, and 
handling practices specified in the Order for manufacturing and 
processing.
    5. Establishment and use of a hazard communication program, 
including human health precautionary statements on each label and in 
the SDS.
    6. No manufacture or process of the PMN substances beyond a 
confidential annual production volume specified in the Order.
    7. No release of the PMN substances resulting in surface water 
concentrations that exceed 15 ppb.
    The SNUR will designate as a ``significant new use'' the absence of 
these protective measures.
    Potentially useful information: EPA has determined that certain 
information about the human health and aquatic toxicity of the PMN 
substances may be potentially useful to characterize the effects of the 
PMN substances in support of a request by the PMN submitter to modify 
the Order, or if a manufacturer or processor is considering submitting 
a SNUN for a significant new use that will be designated by this SNUR. 
The submitter has agreed not to exceed the confidential production 
limit without performing specific target organ toxicity and 
reproductive/developmental toxicity testing on P-17-127; specific 
target organ toxicity testing on P-17-101; and acute aquatic toxicity 
testing on both P-17-101 and P-17-127.
    CFR citations: 40 CFR 721.11055.
PMN Number: P-17-198
    Chemical name: Neodymium aluminium alkyl polymer complexes 
(generic).
    CAS number: Not available.
    Effective date of TSCA section 5(e) Order: April 27, 2017.
    Basis for TSCA section 5(e) Order: The PMN states the generic (non-
confidential) use of the substance will be as a catalyst in a closed 
process. Based on physical/chemical properties of the substance and 
test data on the PMN substance, EPA has identified concerns for dermal 
and respiratory irritation, corrosion, developmental toxicity, and lung 
effects. The Order was issued under TSCA sections 5(a)(3)(B)(ii)(I) and 
5(e)(1)(A)(ii)(I), based on insufficient information to make a reasoned 
evaluation and a finding that the substance may present an unreasonable 
risk of injury to human health. To protect against these risks, the 
Order requires:
    1. Submission of glove permeation testing on the PMN substance 
prior to exceeding the production volume limit as specified in the 
Order.
    2. Use of personal protective equipment including impervious gloves 
(where there is a potential for dermal exposure).
    3. Establishment and use of a hazard communication program, 
including human health precautionary statements on each label and in 
the SDS.
    4. No domestic manufacture of the PMN substance.
    5. No use in any manner or method where there is potential for 
inhalation exposure.
    6. Use of the PMN substance in a closed system as specified in the 
PMN.
    The SNUR will designate as a ``significant new use'' the absence of 
these protective measure.
    Potentially useful information: EPA has determined that the results 
of glove permeability testing will help characterize the effectiveness 
of protective measures to mitigate human health risk of the PMN 
substance in support of a request by the PMN submitter to modify the 
Order, or if a manufacturer or processor is considering submitting a 
SNUN for a significant new use that will be designated by this SNUR. 
The submitter has agreed not to manufacture beyond a certain time 
period without performing glove permeability testing.
    CFR citation: 40 CFR 721.11056.
PMN Numbers: P-17-272, P-17-273, P-17-274, P-17-275, P-17-276 and P-17-
277
    Chemical name: Fatty acid amide alkyl amine salts (generic).
    CAS numbers: Not available.

[[Page 43285]]

    Effective date of TSCA section 5(e) Order: August 4, 2017.
    Basis for TSCA section 5(e) Order: The PMNs state that the generic 
(non-confidential) use of the substances will be as a component in 
asphalt emulsion. Based on SAR analysis of test data on analogous 
substances, EPA has identified concerns for dermal and respiratory 
irritation, corrosion, developmental toxicity, systemic effect, 
sensitization and lung effects. The Order was issued under TSCA 
sections 5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on insufficient 
information to make a reasoned evaluation and a finding that the 
substances may present an unreasonable risk of injury to human health 
and environment. To protect against these risks, the Order requires:
    1. Use of the PMN substances only for the use specified in the 
Order.
    2. Use of personal protective equipment for workers exposed 
dermally to the PMN substances (including impervious gloves, chemical 
goggles or equivalent eye protection and clothing which covers any 
other exposed areas of the arms and torso).
    3. No modification of the manufacture, process or use of the PMN 
substances if it results in inhalation exposure to vapor, dust, mist or 
aerosol.
    4. Establishment and use of a hazard communication program, 
including human health precautionary statements on each label and in 
the SDS.
    5. No release of the PMN substances into the waters of the United 
States.
    The SNUR will designate as a ``significant new use'' the absence of 
these protective measures.
    Potentially useful information: EPA has determined that certain 
information about the human health and aquatic toxicity of the PMN 
substances may be potentially useful to characterize the effects of the 
PMN substances in support of a request by the PMN submitter to modify 
the Order, or if a manufacturer or processor is considering submitting 
a SNUN for a significant new use that will be designated by this SNUR. 
EPA has determined that the results of specific target organ toxicity 
testing of the PMN substances, and acute and chronic aquatic toxicity 
testing of the PMN substances may be potentially useful in 
characterizing the health and environmental effects of the PMN 
substances. Although the Order does not require these tests, the 
Order's restrictions on manufacture, processing and distribution in 
commerce, will remain in effect until the Order is modified or revoked 
by EPA based on submission of this or other information that EPA 
determines is relevant and needed to evaluate a modification request.
    CFR citations: 40 CFR 721.11057.
PMN Numbers: P-17-278, P-17-279 and P-17-280
    Chemical name: Fatty acid derived imidazoline salts (generic).
    CAS numbers: Not available.
    Effective date of TSCA section 5(e) Order: August 4, 2017.
    Basis for TSCA section 5(e) Order: The PMNs state that the generic 
(non-confidential) use of the substances will be as a component in 
asphalt emulsion. Based on SAR analysis of test data on analogous 
substances, EPA has identified concerns for irritation, corrosion, 
developmental toxicity, systemic effect, sensitization and lung 
effects. The Order was issued under TSCA sections 5(a)(3)(B)(ii)(I) and 
5(e)(1)(A)(ii)(I), based on insufficient information to make a reasoned 
evaluation and a finding that the substances may present an 
unreasonable risk of injury to human health and environment. To protect 
against these risks, the Order requires:
    1. Use of the PMN substances only for the use specified in the 
Order.
    2. Use of personal protective equipment for workers exposed 
dermally to the PMN substances (including impervious gloves, chemical 
goggles or equivalent eye protection and clothing which covers any 
other exposed areas of the arms and torso).
    3. No modification of the manufacture, process or use of the PMN 
substances if it results in inhalation exposure to vapor, dust, mist or 
aerosol.
    4. Establishment and use of a hazard communication program, 
including human health precautionary statements on each label and in 
the SDS.
    5. No release of the PMN substances into the waters of the United 
States.
    The SNUR will designate as a ``significant new use'' the absence of 
these protective measures.
    Potentially useful information: EPA has determined that certain 
information about the human health and aquatic toxicity of the PMN 
substances may be potentially useful to characterize the effects of the 
PMN substances in support of a request by the PMN submitter to modify 
the Order, or if a manufacturer or processor is considering submitting 
a SNUN for a significant new use that will be designated by this SNUR. 
EPA has determined that the results of specific target organ toxicity 
testing and acute and chronic aquatic toxicity testing of the PMN 
substances may be potentially useful in characterizing the health and 
environmental effects of the PMN substances. Although the Order does 
not require these tests, the Order's restrictions on manufacture, 
processing and distribution in commerce will remain in effect until the 
Order is modified or revoked by EPA based on submission of this or 
other information that EPA determines is relevant and needed to 
evaluate a modification request.
    CFR citations: 40 CFR 721.11058.

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 145 
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.

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 regards to the significant new 
uses designated in this rule:
     EPA will receive notice of any person's intent to 
manufacture or process a listed chemical substance for the described 
significant new use before that activity begins.
     EPA will have an opportunity to review and evaluate data 
submitted in a SNUN before the notice submitter begins manufacturing or 
processing a listed chemical substance for the described significant 
new use.
     EPA will be able to either determine that the prospective 
manufacture or processing is not likely to present an unreasonable 
risk, or to take necessary regulatory action associated with any other 
determination, before the described significant new use of the chemical 
substance occurs.
     EPA will identify as significant new uses any 
manufacturing, processing, use, distribution in commerce, or disposal 
that does not conform to the restrictions imposed by the underlying 
Orders, consistent with TSCA section 5(f)(4).
    Issuance of a SNUR for a chemical substance does not signify that 
the chemical substance is listed on the TSCA Chemical Substance 
Inventory

[[Page 43286]]

(TSCA Inventory). Guidance on how to determine if a chemical substance 
is on the TSCA Inventory is available on the internet at http://www.epa.gov/opptintr/existingchemicals/pubs/tscainventory/index.html.

VII. Applicability of the Significant New Use Designation

    To establish a significant new use, EPA must determine that the use 
is not ongoing. The chemical substances subject to this rule have 
undergone premanufacture review. In cases where EPA has not received a 
notice of commencement (NOC) and the chemical substance has not been 
added to the TSCA Inventory, no person may commence such activities 
without first submitting a PMN. Therefore, for chemical substances for 
which a 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) consent orders have 
been issued for all the chemical substances, and the PMN submitters are 
prohibited by the TSCA section 5(e) consent orders from undertaking 
activities which will be designated as significant new uses. The 
identities of 38 of the 145 chemical substances subject to this rule 
have been claimed as confidential and EPA has received one post-PMN 
bona fide submission (per Sec. Sec.  720.25 and 721.11) for a chemical 
substance covered by this action. Based on this, the Agency believes 
that it is highly unlikely that any of the significant new uses 
described in the regulatory text of this rule are ongoing.
    EPA designated August 1, 2018 (the date of public release of the 
proposed rule) 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 1, 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. lists potentially 
useful information for all SNURs listed here. Descriptions of this 
information is provided for informational purposes. The potentially 
useful information identified in Unit IV. 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 
in vertebrate animals, EPA encourages consultation with the Agency on 
the use of alternative test methods and strategies (also called New 
Approach Methodologies, or NAMs), if available, to generate the 
recommended test data. EPA encourages dialog with Agency 
representatives to help determine how best the submitter can meet both 
the data needs and the objective of TSCA section 4(h).
    In certain of the TSCA section 5(e) Orders for the chemical 
substances regulated under this rule, EPA has established production 
volume limits in view of the lack of data on the potential health and 
environmental risks that may be posed by the significant new uses or 
increased exposure to the chemical substances. These limits cannot be 
exceeded unless the PMN submitter first submits the results of 
specified tests that would permit a reasoned evaluation of the 
potential risks posed by these chemical substances. Under recent TSCA 
section 5(e) Orders, each PMN submitter is required to submit each 
study at least 14 weeks (earlier TSCA section 5(e) Orders required 
submissions at least 12 weeks) before reaching the specified production 
limit. The SNURs contain the same production volume limits as the TSCA 
section 5(e) Orders. Exceeding these production limits is defined as a 
significant new use. Persons who intend to exceed the production limit 
must notify the Agency by submitting a SNUN at least 90 days in advance 
of commencement of non-exempt commercial manufacture or processing.
    Any request by EPA for the triggered and pended testing described 
in the Orders was made based on EPA's consideration of available 
screening-level data, if any, as well as other available information on 
appropriate testing for the PMN substances. Further, any such testing 
request on the part of EPA that includes testing on vertebrates was 
made after consideration of available toxicity information, 
computational toxicology and bioinformatics, and high-throughput 
screening methods and their prediction models.
    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

[[Page 43287]]

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

X. SNUN Submissions

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

XI. Economic Analysis

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

XII. Statutory and Executive Order Reviews

A. Executive Order 12866

    This action establishes SNURs for several new chemical substances 
that were the subject of PMNs and TSCA section 5(e) consent orders. The 
Office of Management and Budget (OMB) has exempted these types of 
actions from review under Executive Order 12866, entitled ``Regulatory 
Planning and Review'' (58 FR 51735, October 4, 1993).

B. Paperwork Reduction Act (PRA)

    According to PRA (44 U.S.C. 3501 et seq.), an agency may not 
conduct or sponsor, and a person is not required to respond to a 
collection of information that requires OMB approval under PRA, unless 
it has been approved by OMB and displays a currently valid OMB control 
number. The OMB control numbers for EPA's regulations in title 40 of 
the CFR, after appearing in the Federal Register, are listed in 40 CFR 
part 9, and included on the related collection instrument or form, if 
applicable. EPA is amending the table in 40 CFR part 9 to list the OMB 
approval number for the information collection requirements contained 
in this action. This listing of the OMB control numbers and their 
subsequent codification in the CFR satisfies the display requirements 
of PRA and OMB's implementing regulations at 5 CFR part 1320. This 
Information Collection Request (ICR) was previously subject to public 
notice and comment prior to OMB approval, and given the technical 
nature of the table, EPA finds that further notice and comment to amend 
it is unnecessary. As a result, EPA finds that there is ``good cause'' 
under section 553(b)(3)(B) of the Administrative Procedure Act (5 
U.S.C. 553(b)(3)(B)) to amend this table without further notice and 
comment.
    The information collection requirements related to this action have 
already been approved by OMB pursuant to PRA under OMB control number 
2070-0012 (EPA ICR No. 574). This action does not impose any burden 
requiring additional OMB approval. If an entity were to submit a SNUN 
to the Agency, the annual burden is estimated to average between 30 and 
170 hours per response. This burden estimate includes the time needed 
to review instructions, search existing data sources, gather and 
maintain the data needed, and complete, review, and submit the required 
SNUN.
    Send any comments about the accuracy of the burden estimate, and 
any suggested methods for minimizing respondent burden, including 
through the use of automated collection techniques, to the Director, 
Regulatory Support Division, Office of Mission Support (2822T), 
Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington, 
DC 20460-0001. Please remember to include the OMB control number in any 
correspondence, but do not submit any completed forms to this address.

C. Regulatory Flexibility Act (RFA)

    Pursuant to section 605(b) of the Regulatory Flexibility Act (RFA) 
(5 U.S.C. 601 et seq.), the Agency hereby certifies that promulgation 
of this 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)

[[Page 43288]]

(FRL-5597-1), the Agency presented its general determination that final 
SNURs are not expected to have a significant economic impact on a 
substantial number of small entities, which was provided to the Chief 
Counsel for Advocacy of the Small Business Administration.

D. Unfunded Mandates Reform Act (UMRA)

    Based on EPA's experience with proposing and finalizing SNURs, 
State, local, and Tribal governments have not been impacted by these 
rulemakings, and EPA does not have any reasons to believe that any 
State, local, or Tribal government will be impacted by this action. As 
such, EPA has determined that this action does not impose any 
enforceable duty, contain any unfunded mandate, or otherwise have any 
effect on small governments subject to the requirements of UMRA 
sections 202, 203, 204, or 205 (2 U.S.C. 1501 et seq.).

E. Executive Order 13132

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

F. Executive Order 13175

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

G. Executive Order 13045

    This action is not subject to Executive Order 13045, entitled 
``Protection of Children from Environmental Health Risks and Safety 
Risks'' (62 FR 19885, April 23, 1997), because this is not an 
economically significant regulatory action as defined by Executive 
Order 12866, and this action does not address environmental health or 
safety risks disproportionately affecting children.

H. Executive Order 13211

    This action is not subject to Executive Order 13211, entitled 
``Actions Concerning Regulations That Significantly Affect Energy 
Supply, Distribution, or Use'' (66 FR 28355, May 22, 2001), because 
this action is not expected to affect energy supply, distribution, or 
use and because this action is not a significant regulatory action 
under Executive Order 12866.

I. National Technology Transfer and Advancement Act (NTTAA)

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

J. Executive Order 12898

    This action does not entail special considerations of environmental 
justice related issues as delineated by Executive Order 12898, entitled 
``Federal Actions to Address Environmental Justice in Minority 
Populations and Low-Income Populations'' (59 FR 7629, February 16, 
1994).

XIII. Congressional Review Act

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

List of Subjects

40 CFR Part 9

    Environmental protection, Reporting and recordkeeping requirements.

40 CFR Part 721

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

    Dated: July 18, 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.  721.11024 through 721.11028 and 
721.11031through 721.11058 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
------------------------------------------------------------------------
 
                                * * * * *
721.11024...............................................       2070-0012
721.11025...............................................       2070-0012
721.11026...............................................       2070-0012
721.11027...............................................       2070-0012
721.11028...............................................       2070-0012
721.11031...............................................       2070-0012
721.11032...............................................       2070-0012
721.11033...............................................       2070-0012
721.11034...............................................       2070-0012
721.11035...............................................       2070-0012
721.11036...............................................       2070-0012
721.11037...............................................       2070-0012
721.11038...............................................       2070-0012
721.11039...............................................       2070-0012
721.11040...............................................       2070-0012
721.11041...............................................       2070-0012
721.11042...............................................       2070-0012
721.11043...............................................       2070-0012
721.11044...............................................       2070-0012
721.11045...............................................       2070-0012
721.11046...............................................       2070-0012
721.11047...............................................       2070-0012
721.11048...............................................       2070-0012
721.11049...............................................       2070-0012
721.11050...............................................       2070-0012
721.11051...............................................       2070-0012
721.11052...............................................       2070-0012
721.11053...............................................       2070-0012
721.11054...............................................       2070-0012
721.11055...............................................       2070-0012
721.11056...............................................       2070-0012
721.11057...............................................       2070-0012
721.11058...............................................       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.  721.11024 to subpart E to read as follows:

[[Page 43289]]

Sec.  721.11024   Polyphosphoric acids, 2-[alkyl-1-oxo-2-propen-1-
yl)oxy]ethyl esters, compds. with N-(aminoiminomethyl)urea (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 
polyphosphoric acids, 2-[alkyl-1-oxo-2-propen-1-yl)oxy]ethyl esters, 
compds. with N-(aminoiminomethyl)urea (PMN P-14-472) is subject to 
reporting under this section for the significant new uses described in 
paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in Sec.  
721.63(a)(1), (3), and (6) (particulate) and (c).
    (ii) Hazard communication. Requirements as specified in Sec.  
721.72(a) through (f), (g)(1)(i) and (ii), (sensitization), (g)(2)(i) 
and (v), (g)(3)(i) and (ii), (g)(4)(i), and (g)(5). Alternative hazard 
and warning statements that meet the criteria of the Globally 
Harmonized System (GHS) and OSHA Hazard Communication Standard may be 
used.
    (iii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80(h), (q), and (y)(1). It is a significant 
new use to have manufacturing activities that result in inhalation 
exposure.
    (iv) Release to water. Requirements as specified in Sec.  
721.90(a)(4), (b)(4), and (c)(4) where N=3.
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph (b).
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125(a) through (i) and (k) are applicable to manufacturers and 
processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.
    (3) Determining whether a specific use is subject to this section. 
The provisions of Sec.  721.1725(b)(1) apply to paragraph (a)(2)(iii) 
of this section.

0
5. Add Sec.  721.11025 to subpart E to read as follows:

Sec.  721.11025   Polyphosphoric acids, 2-[(2-methyl-1-oxo-2-propen-1-
yl)oxy]ethyl esters, compds. with alkyl amino, polymers with Bu 
acrylate, N-(hydroxymethyl)propenamide and styrene (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 
polyphosphoric acids, 2-[(2-methyl-1-oxo-2-propen-1-yl)oxy]ethyl 
esters, compds. with alkyl amino, polymers with Bu acrylate, N-
(hydroxymethyl)propenamide and styrene (PMN P-14-496) is subject to 
reporting under this section for the significant new uses described in 
paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in Sec.  
721.63(a)(1), (3), and (6) (particulate) and (c).
    (ii) Hazard communication. Requirements as specified in Sec.  
721.72(a) through (f), (g)(1)(i) and (ii), (sensitization), (g)(2)(i) 
and (v), (g)(3)(i) and (ii), (g)(4)(i), and (g)(5). Alternative hazard 
and warning statements that meet the criteria of the Globally 
Harmonized System (GHS) and OSHA Hazard Communication Standard may be 
used.
    (iii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80(k), (q), and (y)(1). It is a significant 
new use to have manufacturing activities that result in inhalation 
exposure.
    (iv) Release to water. Requirements as specified in Sec.  
721.90(a)(4), (b)(4), and (c)(4) where N=4.
    (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
6. Add Sec.  721.11026 to subpart E to read as follows:

Sec.  721.11026   Bismuth bromide iodide oxide.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified as bismuth bromide 
iodide oxide (PMN P-14-630, CAS No. 340181-06-8) is subject to 
reporting under this section for the significant new uses described in 
paragraph (a)(2) of this section. The requirements of this section do 
not apply to quantities of the substance after they have been reacted 
(cured).
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in Sec.  
721.63(a)(4), when determining which persons are reasonably likely to 
be exposed as required for Sec.  721.63(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 (NIOSH) assigned 
protection factor (APF) of at least 10), (a)(6) (particulate), 
(a)(6)(v) and (vi), (b) (concentration set at 1.0%), 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 2.4 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 at 1.0%), (f), (g)(1)(ii), 
(g)(2)(ii), (use respiratory protection or maintain workplace airborne 
concentrations at or below an 8-hour time-weighted average of 2.4 mg/
m\3\), and (g)(5). Alternative hazard and warning statements that meet 
the criteria of the Globally Harmonized System (GHS) and OSHA Hazard 
Communication Standard may be used.
    (iii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80(q). It is a significant new use to vary or 
alter, the manufacturing, processing, and use, distribution/
transportation, treatment and disposal processes, process equipment, 
engineering controls, and handling practices (including worker 
activities and cleaning procedures) described in the PMN in such a way 
as to change the magnitude of inhalation exposure. It is a significant 
new use to use the substance for a consumer product that generates a 
dust, vapor, mist, or aerosol.
    (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 (d) and (f) through

[[Page 43290]]

(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
7. Add Sec.  721.11027 to subpart E to read as follows:

Sec.  721.11027  Aluminum cobalt lithium nickel oxide.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified as aluminum cobalt 
lithium nickel oxide (PMN P-15-450, CAS No. 177997-13-6) is subject to 
reporting under this section for the significant new uses described in 
paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in Sec.  
721.63(a)(1), (3), and (4), when determining which persons are 
reasonably likely to be exposed as required for Sec.  721.63(a)(1) and 
(4), engineering control measures (e.g., enclosure or confinement of 
the operation, general and local ventilation) or administrative control 
measures (e.g., workplace policies and procedures) shall be considered 
and implemented to prevent exposure, where feasible, (a)(5) 
(respirators must provide a National Institute for Occupational Safety 
and Health (NIOSH) assigned protection factor (APF) of at least 1,000), 
(a)(6) (particulate), (a)(6)(v) and (vi), (b) (concentration set at 
0.1%), and (c). It is a significant new use to manufacture or process 
the substance without the chemical transfer processes and air 
ventilation processes described in the PMN and the exposure monitoring 
requirements described in the corresponding TSCA section 5(e) Order.
    (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 0.000092 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 0.1%), (f), (g)(1)(ii), (this 
substance may cause damage to the lung, kidney, and spleen), 
(g)(1)(vii), (g)(2)(i), (ii), and (iii), (when using this substance 
wear protective gloves/protective clothing/eye protection/face 
protection), the following human health precautionary statement must 
appear on the SDS as specified in Sec.  721.72(c): (When using this 
substance use respiratory protection or maintain workplace airborne 
concentrations at or below an 8-hour time-weighted average of 0.000092 
mg/m\3\), (g)(2)(v), and (g)(5). Alternative hazard and warning 
statements that meet the criteria of the Globally Harmonized System 
(GHS) and OSHA Hazard Communication Standard may be used.
    (iii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80. It is a significant new use to 
manufacture the substance for a period longer than 24 months.
    (iv) Disposal. Requirements as specified in Sec.  721.85(a)(2), 
(b)(2), and (c)(2). It is a significant new use to release this 
chemical substance to air unless using the chemical transfer and air 
ventilation processes described in P-15-0450 including filtering 
through a high-efficiency particulate air filter with an efficiency 
rate of 99.99% before release to air.
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph (b).
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125(a) through (j) are applicable to manufacturers and processors 
of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.
    (3) Determining whether a specific use is subject to this section. 
The provisions of Sec.  721.1725(b)(1) apply to paragraph (a)(2)(iii) 
of this section.

0
8. Add Sec.  721.11028 to subpart E to read as follows:

Sec.  721.11028  Alkylarylamine (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 
alkylarylamine (PMN P-15-705) 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), and (iii), (a)(3) and (4), when 
determining which persons are reasonably likely to be exposed as 
required for Sec.  721.63(a)(1) and (4), engineering control measures 
(e.g., enclosure or confinement of the operation, general and local 
ventilation) or administrative control measures (e.g., workplace 
policies and procedures) shall be considered and implemented to prevent 
exposure, where feasible, (a)(5) (respirators must provide a National 
Institute for Occupational Safety and Health (NIOSH) assigned 
protection factor (APF) of at least 1,000), (a)(6) (particulate), 
(a)(6)(v), (vi), (v), and (vi), (b)(concentration set at 0.1%), 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 0.48 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 at 0.1%), (f), (g)(1)(i), 
(ii), (iv), (vi), (vii), and (ix), (g)(2)(i), (ii), and (iii), (use 
respiratory protection or maintain workplace airborne concentrations at 
or below an 8-hour time-weighted average of 0.48 mg/m\3\), (g)(2)(v), 
(g)(3)(ii), (g)(4)(i), and (g)(5). Alternative hazard and warning 
statements that meet the criteria of the Globally Harmonized System 
(GHS) and OSHA Hazard Communication Standard may be used.
    (iii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80(o) and (q). It is a significant new use to 
use the substance other than as a chemical intermediate or as an 
additive and octane booster in aviation fuels.
    (iv) Release to water. Requirements as specified in Sec.  
721.90(a)(4), (b)(4), and (c)(4) where N=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.

[[Page 43291]]

    (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
9. Add Sec.  721.11029 to subpart E to read as follows:

Sec.  721.11029  Aliphatic N-alkyl urea polymer containing cyclohexyl 
groups and trimethoxy silanes (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 
aliphatic N-alkyl urea polymer containing cyclohexyl groups and 
trimethoxy silanes (PMN P-15-706) is subject to reporting under this 
section for the significant new uses described in paragraph (a)(2) of 
this section. The requirements of this section do not apply to 
quantities of the substance after they have been reacted (cured).
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in Sec.  
721.63(a)(1), (a)(2)(i), (iii), and (iv), (a)(3) and (4), when 
determining which persons are reasonably likely to be exposed as 
required for Sec.  721.63(a)(1) and (4), engineering control measures 
(e.g., enclosure or confinement of the operation, general and local 
ventilation) or administrative control measures (e.g., workplace 
policies and procedures) shall be considered and implemented to prevent 
exposure, where feasible, (a)(5)(respirators must provide a National 
Institute for Occupational Safety and Health (NIOSH) assigned 
protection factor (APF) of at least 10), (a)(6) (particulate), 
(a)(6)(v) and (vi), (b) (concentration set at 1.0%), 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 at 1.0%), (f), (g)(1)(ii) and 
(ix), (g)(2)(i), (ii), and (iii), (use respiratory protection or 
maintain workplace airborne concentrations at or below an 8-hour time-
weighted average of 0.9 mg/m\3\), (g)(2)(v), and (g)(5). Alternative 
hazard and warning statements that meet the criteria of the Globally 
Harmonized System (GHS) and OSHA Hazard Communication Standard may be 
used.
    (iii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80(k), (o), (p) (594,000 kilograms, P-15-706 
and P-15-707 combined), and (t) (250,000 kilograms, P-15-706 and P-15-
707 combined). A significant new use is any manufacture, processing, or 
use of the PMN substance with more than 0.1% residual isocyanate by 
weight.
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph (b).
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125(a) through (i) are applicable to manufacturers and processors 
of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.
    (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.  721.11030 to subpart E to read as follows:

Sec.  721.11030  Aliphatic N-alkyl urea polymer containing aspartic 
ester groups and trimethoxy silanes (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 
aliphatic N-alkyl urea polymer containing aspartic ester groups and 
trimethoxy silanes (PMN P-15-707) is subject to reporting under this 
section for the significant new uses described in paragraph (a)(2) of 
this section. The requirements of this section do not apply to 
quantities of the substance after they have been reacted (cured).
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in Sec.  
721.63(a)(1), (a)(2)(i), (iii), and (iv), (a)(3) and (4), when 
determining which persons are reasonably likely to be exposed as 
required for Sec.  721.63(a)(1) and (4), engineering control measures 
(e.g., enclosure or confinement of the operation, general and local 
ventilation) or administrative control measures (e.g., workplace 
policies and procedures) shall be considered and implemented to prevent 
exposure, where feasible, (a)(5) (respirators must provide a National 
Institute for Occupational Safety and Health (NIOSH) assigned 
protection factor (APF) of at least 10), (a)(6)(i), (v), and (vi), (b) 
(concentration set at 1.0%), 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 at 1.0%), (f), (g)(1)(ii) and 
(ix), (g)(2)(i), (ii), and (iii), (use respiratory protection or 
maintain workplace airborne concentrations at or below an 8-hour time-
weighted average of 0.9 mg/m\3\), (g)(2)(v), and (g)(5). Alternative 
hazard and warning statements that meet the criteria of the Globally 
Harmonized System (GHS) and OSHA Hazard Communication Standard may be 
used.
    (iii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80(k), (o), (p) (594,000 kilograms, P-15-706 
and P-15-707 combined), and (t)(250,000 kilograms, P-15-706 and P-15-
707 combined). A significant new use is any manufacture, processing, or 
use of the PMN substance with more than 1% residual isocyanate by 
weight.
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph (b).
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125(a) through (i) are applicable to manufacturers and processors 
of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.
    (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
11. Add Sec.  721.11031 to subpart E to read as follows:

[[Page 43292]]

Sec.  721.11031  Alkyl heteromonocycle, polymer with heteromonocycle, 
carboxyalkyl alkyl ether (generic).

    (a) Chemical substances and significant new uses subject to 
reporting. (1) The chemical substances identified generically as alkyl 
heteromonocycle, polymer with heteromonocycle, carboxyalkyl alkyl ether 
(PMNs P-16-273 and P-16-0274) are subject to reporting under this 
section for the significant new uses described in paragraph (a)(2) of 
this section.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in Sec.  
721.63(a)(1), (a)(2)(i) and (iii), (a)(3), (b) (concentration set at 
1.0%), and (c). 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.
    (ii) Hazard communication. Requirements as specified in Sec.  
721.72(a) through (e) (concentration set at 1.0%), (f), (g)(1)(i) and 
(ii), (dermal sensitization), (g)(2)(i), (ii), (iii), and (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 (GHS) and OSHA Hazard Communication Standard may be used.
    (iii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80(f). It is a significant new use to use the 
substances for the uses specified in the TSCA 5(e) Order, at a 
concentration greater than 3% of the metal working fluid and use other 
than the closed metal working systems as specified in the PMNs with no 
modifications in the process that would result in worker inhalation 
exposure.
    (iv) Release to water. Requirements as specified in Sec.  
721.90(a)(4), (b)(4), and (c)(4) where N=10.
    (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
12. Add Sec.  721.11032 to subpart E to read as follows:

Sec.  721.11032   Benzene dicarboxylic acid, polymer with alkane dioic 
acid and aliphatic diamine (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified as generically as 
benzene dicarboxylic acid, polymer with alkane dioic acid and aliphatic 
diamine (PMN P-16-289) 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) (manufacture only in a form with a 
particle size distribution where less than 1.0 percent of the particles 
are less than 10 microns). It is a significant new use to manufacture 
the substance for a period longer than six months.
    (ii) [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph (b).
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125(a) through (c) and (i) are applicable to manufacturers and 
processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.

0
13. Add Sec.  721.11033 to subpart E to read as follows:

Sec.  721.11033   Manganese cyclic (tri)amine chloride complex 
(generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 
manganese cyclic (tri)amine chloride complex (PMN P-16-322) 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), (3), and (4), when determining which persons are 
reasonably likely to be exposed as required for Sec.  721.63(a)(1) and 
(4), engineering control measures (e.g., enclosure or confinement of 
the operation, general and local ventilation) or administrative control 
measures (e.g., workplace policies and procedures) shall be considered 
and implemented to prevent exposure, where feasible, (a)(5)(respirators 
must provide a National Institute for Occupational Safety and Health 
(NIOSH) assigned protection factor (APF) of at least 25), (a)(6) 
(particulate), (a)(6)(v) and (vi), (b) (concentration set at 1.0%), 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 1.2 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 at 1.0%), (f), (g)(1)(iv), 
(vi), (viii), and (ix), (g)(2)(i), (ii), and (iii), (use respiratory 
protection or maintain workplace airborne concentrations at or below an 
8-hour time-weighted average of 1.2 mg/m\3\), (g)(2)(v), (g)(3) (this 
substance may be toxic to algae. This substance may be harmful to 
invertebrates), (g)(4)(i) and (ii), (do not release to water to yield 
surface water concentrations above 18 ppb.), and (g)(5). Alternative 
hazard and warning statements that meet the criteria of the Globally 
Harmonized System (GHS) and OSHA Hazard Communication Standard may be 
used.
    (iii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80(f), (k), and (q).
    (iv) Release to water. Requirements as specified in Sec.  
721.90(a)(4), (b)(4), and (c)(4) where N=18.
    (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.

[[Page 43293]]

0
14. Add Sec.  721.11034 to subpart E to read as follows:

Sec.  721.11034   Xanthylium, (sulfoaryl)--bis [(substituted aryl) 
amino]-, sulfo derivs., inner salts, metal salts (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 
xanthylium, (sulfoaryl)--bis [(substituted aryl) amino]-, sulfo 
derivs., inner salts, metal salts (PMN P-16-338) 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), (k), and (t).
    (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) through (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)(i) of 
this section.

0
15. Add Sec.  721.11035 to subpart E to read as follows:

Sec.  721.11035   Substituted triazinyl metal salt, diazotized, coupled 
with substituted pyridobenzimidazolesulfonic acids, substituted 
pyridobenzimidazolesulfonic acids, diazotized substituted 
alkanesulfonic acid, diazotized substituted aromatic sulfonate, 
diazotized substituted aromatic sulfonate, metal salts (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 
substituted triazinyl metal salt, diazotized, coupled with substituted 
pyridobenzimidazolesulfonic acids, substituted 
pyridobenzimidazolesulfonic acids, diazotized substituted 
alkanesulfonic acid, diazotized substituted aromatic sulfonate, 
diazotized substituted aromatic sulfonate, metal salts (PMN P-16-339) 
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), (k), and (t).
    (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) through (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)(i) of 
this section.

0
16. Add Sec.  721.11036 to subpart E to read as follows:

Sec.  721.11036   Carbon black, (organic acidic carbocyclic)-modified, 
inorganic salt (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as carbon 
black, (organic acidic carbocyclic)-modified, inorganic salt (PMN P-16-
439) 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), (k), and (t).
    (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) through (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)(i) of 
this section.

0
17. Add Sec.  721.11037 to subpart E to read as follows:

Sec.  721.11037   Carbon black, (organic acidic carbocyclic)-modified, 
metal salt (generic).

    (a) Chemical substance and significant new uses subject to 
reporting.
    (1) The chemical substance identified generically as carbon black, 
(organic acidic carbocyclic)-modified, metal salt (PMN P-16-440) 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), (k), and (t).
    (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) through (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)(i) of 
this section.

0
18. Add Sec.  721.11038 to subpart E to read as follows:

Sec.  721.11038   Polyaralkyl aryl ester of methacrylic acid (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified as generically as 
polyaralkyl aryl ester of methacrylic acid (PMN P-16-350) 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, and (c).
    (ii) Hazard communication. Requirements as specified in Sec.  
721.72(a) through (d), (f), (g)(1)(i) and (ii), (sensitization), 
(mutagenicity), (g)(2)(i), (ii), (iii), and (v), and (g)(5). 
Alternative hazard and warning statements that meet the criteria of the 
Globally Harmonized System (GHS) and OSHA Hazard Communication Standard 
may be used.

[[Page 43294]]

    (iii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80(k). It is a significant new use to 
manufacture the substance lower than the minimum average molecular 
weight identified in the corresponding TSCA section 5(e) Order and to 
contain more than the maximum weight percent of low molecular weight 
species below 1,000 daltons identified in the Order.
    (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
19. Add Sec.  721.11039 to subpart E to read as follows:

Sec.  721.11039  Phenol, 2-[[[3-(octyloxy)propyl]imino]methyl]-.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified as phenol, 2-[[[3-
(octyloxy)propyl]imino]methyl]- (PMN P-16-352, chemical A; CAS No. 
1858221-49-4) is subject to reporting under this section for the 
significant new uses described in paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in Sec.  
721.63(a)(1), (a)(2)(i), (a)(3), (a)(6) (particulate), (a)(6)(v) and 
(vi), (b) (concentration set at 1.0%), and (c). 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.
    (ii) Hazard communication. Requirements as specified in Sec.  
721.72(a) through (e) (concentration set at 1.0%), (f), (g)(1)(i), 
(iv), (vi), and (ix), (g)(2)(i) and (v), (g)(3)(i) and (ii), and 
(g)(5). Alternative hazard and warning statements that meet the 
criteria of the Globally Harmonized System (GHS) and OSHA Hazard 
Communication Standard may be used.
    (iii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80(f), (p)(10,500 and 13,000 kilograms, 
respectively, for the total of this substance and the substance subject 
to Sec.  721.11040), (t)(250 kilograms for the total of this substance 
and the substance subject to Sec.  721.11040), and (y)(1).
    (iv) Release to water. Requirements as specified in Sec.  
721.90(a)(4), (b)(4), and (c)(4) where N=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.

0
20. Add Sec.  721.11040 to subpart E to read as follows:

Sec.  721.11040   Phenol, 2-[[[3-(decyloxy)propyl]imino]methyl]-.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified as phenol, 2-[[[3-
(decyloxy)propyl]imino]methyl]- (PMN P-16-352, chemical B; CAS No. 
1858221-50-7) is subject to reporting under this section for the 
significant new uses described in paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in Sec.  
721.63(a)(1), (a)(2)(i), (a)(3), (a)(6) (particulate), (a)(6)(v) and 
(vi), (b) (concentration set at 1.0%), and (c). 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.
    (ii) Hazard communication. Requirements as specified in Sec.  
721.72(a) through (e) (concentration set at 1.0%), (f), (g)(1)(i), 
(iv), (vi), and (ix), (g)(2)(i) and (v), (g)(3)(i) and (ii), and 
(g)(5). Alternative hazard and warning statements that meet the 
criteria of the Globally Harmonized System (GHS) and OSHA Hazard 
Communication Standard may be used.
    (iii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80(f), (p) (10,500 and 13,000 kilograms 
respectively for the total of this substance and the substance subject 
to Sec.  721.11039), (t) (250 kilograms for the total of this substance 
and the substance subject to Sec.  721.11039), and (y)(1).
    (iv) Release to water. Requirements as specified in Sec.  
721.90(a)(4), (b)(4), and (c)(4) where N=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.

0
21. Add Sec.  721.11041 to subpart E to read as follows:

Sec.  721.11041   Alkyl phenol (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as alkyl 
phenol (PMN P-16-358) 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), (iii), and (iv), (a)(3), when determining 
which persons are reasonably likely to be exposed as required for Sec.  
721.63(a)(1), engineering control measures (e.g., enclosure or 
confinement of the operation, general and local ventilation) or 
administrative control measures (e.g., workplace policies and 
procedures) shall be considered and implemented to prevent exposure, 
where feasible, (b)(concentration set at 1.0%), and (c).
    (ii) Hazard communication. Requirements as specified in Sec.  
721.72(a) through (e) (concentration set at 1.0%), (f), (g)(1)(ix), 
(g)(2)(i), (ii), (iii), and (v), (g)(4)(iii), and (g)(5). Alternative 
hazard and warning statements that meet the criteria of the Globally 
Harmonized System (GHS) and OSHA Hazard Communication Standard may be 
used.
    (iii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80(a) through (c), (g), (q), and (y)(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).

[[Page 43295]]

    (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.  721.11042 to subpart E to read as follows:

Sec.  721.11042   Nitrile-butadiene-acrylate terpolymers (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 
nitrile-butadiene-acrylate terpolymers PMN P-16-364) 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)(concentration set at 1.0%), (f), (g)(1)(ii), 
(g)(2)(ii), and (g)(5). Alternative hazard and warning statements that 
meet the criteria of the Globally Harmonized System (GHS) and OSHA 
Hazard Communication Standard may be used.
    (ii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80(h), (k) (manufacture of the substance with 
a particle size distribution where greater than 5.0 percent of the 
particles are less than 10 microns).
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph (b).
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125(a) through (c) and (f) 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
23. Add Sec.  721.11043 to subpart E to read as follows:

Sec.  721.11043   Starch, polymer with 2-propenoic acid, potassium 
salt, oxidized.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified as starch, polymer 
with 2-propenoic acid, potassium salt, oxidized (PMN P-16-399, CAS No. 
1638117-09-5) is subject to reporting under this section for the 
significant new uses described in paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in Sec.  
721.63(a)(1), (a)(6) (particulate), (a)(6)(v) and (vi), when 
determining which persons are reasonably likely to be exposed as 
required for Sec.  721.63(a)(1), engineering control measures (e.g., 
enclosure or confinement of the operation, general and local 
ventilation) or administrative control measures (e.g., workplace 
policies and procedures) shall be considered and implemented to prevent 
exposure, where feasible, (b)(concentration set at 1.0%), and (c).
    (ii) Hazard communication. Requirements as specified in Sec.  
721.72(a) through (d), (e)(concentration set 1.0%), (f), (g)(1)(ii), 
(g)(2)(ii), and (g)(5). Alternative hazard and warning statements that 
meet the criteria of the Globally Harmonized System (GHS) and OSHA 
Hazard Communication Standard may be used.
    (iii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80(k) (manufacture of the substance with a 
particulate size less than 30 microns). It is a significant new use to 
manufacture the substance for a period longer than 12 months.
    (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 (d) and (f) 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
24. Add Sec.  721.11044 to subpart E to read as follows:

Sec.  721.11044   Pentanedioic acid, 2-methyl-.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified as pentanedioic acid, 
2-methyl- (PMN P-16-430, CAS No. 617-62-9) is subject to reporting 
under this section for the significant new uses described in paragraph 
(a)(2) of this section.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in Sec.  
721.63 (a)(1), (a)(2)(i), (a)(3) and (4), when determining which 
persons are reasonably likely to be exposed as required for Sec.  
721.63(a)(1) and (4), engineering control measures (e.g., enclosure or 
confinement of the operation, general and local ventilation) or 
administrative control measures (e.g., workplace policies and 
procedures) shall be considered and implemented to prevent exposure, 
where feasible, (a)(5)(respirators must provide a National Institute 
for Occupational Safety and Health (NIOSH) assigned protection factor 
(APF) of at least 10), (a)(6) (particulate), (a)(6)(v) and (vi), (b) 
(concentration set at 1.0%), and (c).
    (ii) Hazard communication. Requirements as specified in Sec.  
721.72(a) through (e) (concentration set at 1.0%), (f), (g)(1)(i), 
(ii), and (vi), (g)(2)(i), (ii), (iii), (iv), and (v), (g)(3)(i) and 
(ii), (g)(4)(i), and (g)(5). Alternative hazard and warning statements 
that meet the criteria of the Globally Harmonized System (GHS) and OSHA 
Hazard Communication Standard may be used.
    (iii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80(f) and (k)(import of the substance at or 
below the maximum concentration specified in the corresponding TSCA 
section 5(e) Order).
    (iv) Release to water. Requirements as specified in Sec.  
721.90(a)(4), (b)(4), and (c)(4) where N=14.
    (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
25. Add Sec.  721.11045 to subpart E to read as follows:

Sec.  721.11045   2-Pentanol, 4-methyl-, reaction products with 
phosphorus oxide (P2O5), compounds with alkylamine (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified as generically as 2-
pentanol, 4-methyl-, reaction products with phosphorus oxide (P2O5), 
compounds with alkylamine (PMN P-16-495) 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) and (3), when determining which persons are reasonably 
likely to be exposed as required for

[[Page 43296]]

Sec.  721.63(a)(1), engineering control measures (e.g., enclosure or 
confinement of the operation, general and local ventilation) or 
administrative control measures (e.g., workplace policies and 
procedures) shall be considered and implemented to prevent exposure, 
where feasible, (a)(6) (particulate), (b) (concentration set at 1.0%), 
and (c).
    (ii) Hazard communication. Requirements as specified in Sec.  
721.72(a) through (e) (concentration set at 1.0%), (f), (g)(1)(i), 
(ii), and (iv), (g)(2)(i), (ii), and (v), (g)(3)(i) and (ii), 
(g)(4)(i), and (g)(5). Alternative hazard and warning statements that 
meet the criteria of the Globally Harmonized System (GHS) and OSHA 
Hazard Communication Standard may be used.
    (iii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80(k), (q), and (y)(1). A significant new use 
is any manner or method of manufacturing that results in inhalation 
exposure.
    (iv) Release to water. Requirements as specified in Sec.  
721.90(a)(4), (b)(4), and (c)(4) where N=200.
    (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
26. Add Sec.  721.11046 to subpart E to read as follows:

Sec.  721.11046   Hydroxy alkylbiphenyl (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as hydroxy 
alkylbiphenyl (PMN P-16-513) is subject to reporting under this section 
for the significant new uses described in paragraph (a)(2) of this 
section.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in Sec.  
721.63(a)(1), (3), and (4), when determining which persons are 
reasonably likely to be exposed as required for Sec.  721.63(a)(1) and 
(4), engineering control measures (e.g., enclosure or confinement of 
the operation, general and local ventilation) or administrative control 
measures (e.g., workplace policies and procedures) shall be considered 
and implemented to prevent exposure, where feasible, (a)(5) 
(respirators must provide a National Institute for Occupational Safety 
and Health (NIOSH) assigned protection factor (APF) of at least 50), 
(a)(6) (particulate), (a)(6)(v) and (vi), (b) (concentration set at 
1.0%), and (c).
    (ii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80(g) and (q).
    (iii) Release to water. Requirements as specified in Sec.  
721.90(a)(4), (b)(4), and (c)(4) where N=17.
    (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)(ii) of 
this section.

0
27. Add Sec.  721.11047 to subpart E to read as follows:

Sec.  721.11047   Alkyl alkenoic acid, polymer with 
alkenylcarbomonocycle telomer with substituted alkanoic acid hydroxyl 
alkyl substituted alkenyl substituted alkyl ester, polyalkylene glycol 
alkyl ether alkyl alkenoate, dialkylene glycol diheteromonocyclic ether 
and alkylcarbomonocyclic alkenoate, metal salt (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as alkyl 
alkenoic acid, polymer with alkenylcarbomonocycle telomer with 
substituted alkanoic acid hydroxyl alkyl substituted alkenyl 
substituted alkyl ester, polyalkylene glycol alkyl ether alkyl 
alkenoate, dialkylene glycol diheteromonocyclic ether and 
alkylcarbomonocyclic alkenoate, metal salt (PMN P-16-534) 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 
manufacture the substance such that the lowest number average molecular 
weight is less than 1,800 daltons and the carboxylic acid content 
exceeds 20 percent.
    (ii) [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph (b).
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125(a) through (c) and (i) are applicable to manufacturers and 
processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.
    (3) Determining whether a specific use is subject to this section. 
The provisions of Sec.  721.1725(b)(1) apply to paragraph (a)(2)(iii) 
of this section.

0
28. Add Sec.  721.11048 to subpart E to read as follows:

Sec.  721.11048   Alkyl alkenoic acid, polymer with 
alkenylcarbomonocycle telomer with substituted alkanoic acid hydroxyl 
alkyl substituted alkenyl substituted alkyl ester, alkanediol 
diheteromonocyclic ether, polyalkylene glycol alkyl ether alkyl 
alkenoate and alkylcarbomonocyclic alkenoate, metal salt (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as alkyl 
alkenoic acid, polymer with alkenylcarbomonocycle telomer with 
substituted alkanoic acid hydroxyl alkyl substituted alkenyl 
substituted alkyl ester, alkanediol diheteromonocyclic ether, 
polyalkylene glycol alkyl ether alkyl alkenoate and 
alkylcarbomonocyclic alkenoate, metal salt (PMN P-16-535) 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 
manufacture the substance such that the lowest number average molecular 
weight is less than 1,800 daltons and the carboxylic acid content 
exceeds 20 percent.
    (ii) [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph (b).
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125(a) through (c) and (i) are applicable to manufacturers and 
processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.
    (3) Determining whether a specific use is subject to this section. 
The provisions

[[Page 43297]]

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

0
29. Add Sec.  721.11049 to subpart E to read as follows:

Sec.  721.11049   Alkyl alkenoic acid, polymer with bis 
heteromonocyclic substituted alkyl carbomonocycle, 
alkenylcarbomonocycle telomer with substituted alkanoic acid hydroxyl 
alkyl substituted alkenyl substituted alkyl ester, polyalkylene glycol 
alkyl ether alkyl alkenoate and alkylcarbomonocyclic alkenoate, metal 
salt (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as alkyl 
alkenoic acid, polymer with bis heteromonocyclic substituted alkyl 
carbomonocycle, alkenylcarbomonocycle telomer with substituted alkanoic 
acid hydroxyl alkyl substituted alkenyl substituted alkyl ester, 
polyalkylene glycol alkyl ether alkyl alkenoate and 
alkylcarbomonocyclic alkenoate, metal salt (PMN P-16-536) 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 
manufacture the substance such that the lowest number average molecular 
weight is less than 1,800 daltons, and the carboxylic acid content 
exceeds 20 percent.
    (ii) [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph (b).
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125(a) through (c) and (i) are applicable to manufacturers and 
processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.
    (3) Determining whether a specific use is subject to this section. 
The provisions of Sec.  721.1725(b)(1) apply to paragraph (a)(2)(iii) 
of this section.

0
30. Add Sec.  721.11050 to subpart E to read as follows:

Sec.  721.11050   Certain functionalized methacrylate-substituted 
polymers.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substances listed in Table 1 of this 
section 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 
substances after they have been reacted (cured).

  Table 1 to Sec.   721.11050--Functionalized Methacrylate-Substituted
                                Polymers
------------------------------------------------------------------------
           PMN No.                           Chemical name
------------------------------------------------------------------------
P-16-549....................  Alkaline functionalized methacrylate-
                               substituted polymer (generic).
P-16-550....................  Alkaline functionalized methacrylate-
                               substituted polymer (generic).
P-16-551....................  Alkaline functionalized methacrylate-
                               substituted polymer (generic).
P-16-553....................  Quaternary alkylamine functionalized
                               methacrylate-substituted polymer
                               (generic).
P-16-555....................  Neutral alcohol functionalized
                               methacrylate-substituted polymer
                               (generic).
P-16-556....................  Neutral alcohol functionalized
                               methacrylate-substituted polymer
                               (generic).
P-16-557....................  Neutral alkyl salt functionalized
                               methacrylate-substituted polymer
                               (generic).
P-16-558....................  Neutral alkyl salt functionalized
                               methacrylate-substituted polymer
                               (generic).
P-16-560....................  Neutral alkyl salt functionalized
                               methacrylate-substituted polymer
                               (generic).
P-16-561....................  Acid functionalized methacrylate-
                               substituted polymer (generic).
P-16-562....................  Acid functionalized methacrylate-
                               substituted polymer (generic).
P-16-563....................  Acid functionalized methacrylate-
                               substituted polymer (generic).
P-16-564....................  Acid functionalized methacrylate-
                               substituted polymer (generic).
P-16-565....................  Acid functionalized methacrylate-
                               substituted polymer (generic).
P-16-567....................  Alkylamine functionalized methacrylate-
                               substituted polymer (generic).
------------------------------------------------------------------------

    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in Sec.  
721.63(a)(1), (a)(2)(i) and (iii), (a)(3), when determining which 
persons are reasonably likely to be exposed as required for Sec.  
721.63(a)(1), engineering control measures (e.g., enclosure or 
confinement of the operation, general and local ventilation) or 
administrative control measures (e.g., workplace policies and 
procedures) shall be considered and implemented to prevent exposure, 
where feasible, (a)(6) (particulate), (b) (concentration set at 1.0%), 
and (c).
    (ii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80(f) and (k) (crosslinked resin used for 
chromatographic separation of biomolecules and biocatalysts). It is a 
significant new use to import the substance in any form other than 
spherical beads with 0.1 percent less than 10 microns.
    (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) 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
31. Add Sec.  721.11051 to subpart E to read as follows:

Sec.  721.11051   Waste plastics, poly(ethylene terephthalate), 
depolymd. with polypropylene glycol ether with glycerol (3:1), polymers 
with alkenoic and alkanoic acids (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as waste 
plastics, poly(ethylene terephthalate), depolymd. with polypropylene 
glycol ether with glycerol (3:1), polymers with alkenoic and alkanoic 
acids (PMN P-16-579) 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) and (4), when determining which persons 
are reasonably likely to be exposed as required for Sec.  721.63(a)(1) 
and (4), engineering control measures (e.g., enclosure or confinement 
of the operation, general and local ventilation) or administrative 
control measures (e.g., workplace policies and procedures) shall be 
considered and implemented to prevent exposure, where feasible, (a)(5) 
(respirators must provide a National

[[Page 43298]]

Institute for Occupational Safety and Health (NIOSH) assigned 
protection factor (APF) of at least 50), (a)(6) (particulate), (b) 
(concentration set 1.0%), and (c).
    (ii) Hazard communication. Requirements as specified in Sec.  
721.72(a) through (e) (concentration set at 1.0%), (f), (g)(1) 
(required label statements: This substance may cause respiratory and 
dermal irritation. This substance may cause irritation of the mucous 
membranes. This substance may cause respiratory and dermal 
sensitization. This substance may cause mutagenicity), (g)(2)(i) 
through (v), and (g)(5). Alternative hazard and warning statements that 
meet the criteria of the Globally Harmonized System (GHS) and OSHA 
Hazard Communication Standard may be used.
    (iii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80(k) (an ultraviolet curable coating resin). 
It is a significant new use to manufacture the substance with an 
average molecular weight less than 1,100 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.

0
32. Add Sec.  721.11052 to subpart E to read as follows:

Sec.  721.11052   1,3,5-Naphthalenetrisulfonic acid.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified as 1,3,5-
naphthalenetrisulfonic acid (PMN P-17-32, CAS No. 6654-64-4) is subject 
to reporting under this section for the significant new uses described 
in paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in Sec.  
721.63(a)(1), (a)(2)(i) and (iv), (a)(3) and (4), when determining 
which persons are reasonably likely to be exposed as required for Sec.  
721.63(a)(1) and (4), engineering control measures (e.g., enclosure or 
confinement of the operation, general and local ventilation) or 
administrative control measures (e.g., workplace policies and 
procedures) shall be considered and implemented to prevent exposure, 
where feasible, (a)(5) (respirators must provide a National Institute 
for Occupational Safety and Health (NIOSH) assigned protection factor 
of at least 50, (a)(6)(v) and (vi), (particulate), (b) (concentration 
set at 1.0%), and (c).
    (ii) Hazard communication. Requirements as specified in Sec.  
721.72(a) through (e) (concentration set at 1.0%), (f), (g)(1)(i), 
(ii), (iv), and (ix), (g)(2)(i), (ii), (iii), and (v), and (g)(5). 
Alternative hazard and warning statements that meet the criteria of the 
Globally Harmonized System (GHS) and OSHA Hazard Communication Standard 
may be used.
    (iii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80(q) and (t). It is a significant new use to 
process the substance beyond the confidential annual volume cited in 
the TSCA 5(e) Order.
    (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
33. Add Sec.  721.11053 to subpart E to read as follows:

Sec.  721.11053   Certain halogenated sodium benzoate salts.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substances listed in Table 1 of this 
section is subject to reporting under this section for the significant 
new uses described in paragraph (a)(2) of this section.

                         Table 1 to Sec.   721.11053--Halogenated Sodium Benzoate Salts
----------------------------------------------------------------------------------------------------------------
           PMN No.                            CAS No.                               Chemical name
----------------------------------------------------------------------------------------------------------------
P-17-33......................  6654-64-4...........................  Benzoic acid, 2-fluoro-, sodium salt (1:1).
P-17-34......................  499-90-1............................  Benzoic acid, 4-fluoro-, sodium salt (1:1).
P-17-36......................  67852-79-3..........................  Benzoic acid, 2,3,4,5-tetrafluoro-, sodium
                                                                      salt (1:1).
P-17-38......................  2966-44-1...........................  Benzoic acid, 2-(trifluoromethyl)-, sodium
                                                                      salt (1:1).
P-17-39......................  25832-58-0..........................  Benzoic acid, 4-(trifluoromethyl)-, sodium
                                                                      salt (1:1).
P-17-41......................  522651-42-9.........................  Benzoic acid, 2,5-difluoro-, sodium salt
                                                                      (1:1).
P-17-42......................  499-57-0............................  Benzoic acid, 3-fluoro-, sodium salt (1:1).
P-17-43......................  6185-28-0...........................  Benzoic acid, 2,6-difluoro-, sodium salt
                                                                      (1:1).
P-17-45......................  530141-39-0.........................  Benzoic acid, 3,5-difluoro-, sodium salt
                                                                      (1:1).
P-17-47......................  1765-08-8...........................  Benzoic acid, 2,4-difluoro-, sodium salt
                                                                      (1:1).
P-17-50......................  522651-44-1.........................  Benzoic acid, 3,4-difluoro-, sodium salt
                                                                      (1:1).
P-17-52......................  1180493-12-2........................  Benzoic acid, 3,4,5-trifluoro-, sodium salt
                                                                      (1:1).
P-17-55......................  402955-41-3.........................  Benzoic acid, 2,3,4-trifluoro-, sodium salt
                                                                      (1:1).
P-17-57......................  522651-48-5.........................  Benzoic acid, 2,4,5-trifluoro-, sodium salt
                                                                      (1:1).
P-17-59......................  1604819-08-0........................  Benzoic acid, 2,3-difluoro-, sodium salt
                                                                      (1:1).
P-17-61......................  69226-41-1..........................  Benzoic acid, 3-(trifluoromethyl)-, sodium
                                                                      salt (1:1).
P-17-62......................  17264-74-3..........................  Benzoic acid, 2-chloro-, sodium salt (1:1).
P-17-63......................  3686-66-6...........................  Benzoic acid, 4-chloro-, sodium salt (1:1).
P-17-64......................  17264-88-9..........................  Benzoic acid, 3-chloro-, sodium salt (1:1).
P-17-66......................  118537-84-1.........................  Benzoic acid, 2,3-dichloro-, sodium salt
                                                                      (1:1).
P-17-67......................  63891-98-5..........................  Benzoic acid, 2,5-dichloro-, sodium salt
                                                                      (1:1).
P-17-69......................  154862-40-5.........................  Benzoic acid, 3,5-dichloro-, sodium salt
                                                                      (1:1).
P-17-71......................  10007-84-8..........................  Benzoic acid, 2,6-dichloro-, sodium salt
                                                                      (1:1).
P-17-72......................  17274-10-1..........................  Benzoic acid, 3,4-dichloro-, sodium salt
                                                                      (1:1).
P-17-73......................  38402-11-8..........................  Benzoic acid, 2,4-dichloro-, sodium salt
                                                                      (1:1).
P-17-75......................  855471-43-1.........................  Benzoic acid, 2-chloro-4-fluoro-, sodium
                                                                      salt.

[[Page 43299]]

 
P-17-76......................  1421761-18-3........................  Benzoic acid, 3-chloro-4-fluoro-, sodium
                                                                      salt.
P-17-79......................  1382106-78-6........................  Benzoic acid, 5-chloro-2-fluoro-, sodium
                                                                      salt.
P-17-80......................  1421029-88-0........................  Benzoic acid, 4-chloro-3-fluoro-, sodium
                                                                      salt.
P-17-83......................  1382106-64-0........................  Benzoic acid, 4-chloro-2-fluoro-, sodium
                                                                      salt.
P-17-85......................  1938142-12-1........................  Benzoic acid, 5-bromo-2-chloro-, sodium
                                                                      salt.
P-17-87......................  938142-13-2.........................  Benzoic acid, 3-bromo-4-fluoro-, sodium
                                                                      salt.
P-17-90......................  1938142-14-3........................  Benzoic acid, 2-bromo-5-fluoro-, sodium
                                                                      salt.
P-17-91......................  1938142-15-4........................  Benzoic acid, 4-bromo-2-fluoro-, sodium
                                                                      salt.
P-17-93......................  1535169-81-3........................  Benzoic acid, 4-bromo-3-fluoro-, sodium
                                                                      salt.
----------------------------------------------------------------------------------------------------------------

    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in Sec.  
721.63(a)(1), (a)(2)(i) and (iv), (a)(3), when determining which 
persons are reasonably likely to be exposed as required for Sec.  
721.63(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 (NIOSH) assigned protection factor 
of at least 50), (a)(6) (particulate), (a)(6)(v) and (vi), (b) 
(concentration set at 1.0%), 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 0.0184 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 at 1.0%), (f), (g)(1)(i), 
(ii), (iii), (iv), (vi), and (ix), (g)(2)(i), (ii), and (iii), (use 
respiratory protection or maintain workplace airborne concentrations at 
or below an 8-hour time-weighted average of 0.0184 mg/m\3\), (g)(2)(v), 
and (g)(5). Alternative hazard and warning statements that meet the 
criteria of the Globally Harmonized System (GHS) and OSHA Hazard 
Communication Standard may be used.
    (iii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80(q) and (t). It is a significant new use to 
manufacture or process the substances other than for the processes 
described in the corresponding TSCA section 5(e) Order.
    (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
34. Add Sec.  721.11054 to subpart E to read as follows:

Sec.  721.11054   Certain halogenated benzoic acids.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substances listed in Table 1 of this 
section is subject to reporting under this section for the significant 
new uses described in paragraph (a)(2) of this section.

                             Table 1 to Sec.   721.11054--Halogenated Benzoic Acids
----------------------------------------------------------------------------------------------------------------
           PMN No.                            CAS No.                               Chemical name
----------------------------------------------------------------------------------------------------------------
P-17-35......................  1201-31-6...........................  Benzoic acid, 2,3,4,5-tetrafluoro-.
P-17-37......................  433-97-6............................  Benzoic acid, 2-(trifluoromethyl)-.
P-17-40......................  2991-28-8...........................  Benzoic acid, 2,5-difluoro-.
P-17-44......................  385-00-2............................  Benzoic acid, 2,6-difluoro-.
P-17-46......................  455-40-3............................  Benzoic acid, 3,5-difluoro-.
P-17-48......................  1583-58-0...........................  Benzoic acid, 2,4-difluoro-.
P-17-51......................  455-86-7............................  Benzoic acid, 3,4-difluoro-.
P-17-53......................  121602-93-5.........................  Benzoic acid, 3,4,5-trifluoro-.
P-17-54......................  61079-72-9..........................  Benzoic acid, 2,3,4-trifluoro-.
P-17-56......................  446-17-3............................  Benzoic acid, 2,4,5-trifluoro-.
P-17-58......................  4519-39-5...........................  Benzoic acid, 2,3-difluoro-.
P-17-60......................  454-92-2............................  Benzoic acid, 3-(trifluoromethyl)-.
P-17-65......................  50-45-3.............................  Benzoic acid, 2,3-dichloro-.
P-17-68......................  51-36-5.............................  Benzoic acid, 3,5-dichloro-.
P-17-70......................  50-30-6.............................  Benzoic acid, 2,6-dichloro-.
P-17-74......................  2252-51-9...........................  Benzoic acid, 2-chloro-4-fluoro-.
P-17-77......................  394-30-9............................  Benzoic acid, 5-chloro-2-fluoro-.
P-17-78......................  403-16-7............................  Benzoic acid, 3-chloro-4-fluoro-.
P-17-81......................  403-17-8............................  Benzoic acid, 4-chloro-3-fluoro-.
P-17-82......................  446-30-0............................  Benzoic acid, 4-chloro-2-fluoro-.
P-17-84......................  21739-92-4..........................  Benzoic acid, 5-bromo-2-chloro-.
P-17-88......................  11007-16-5..........................  Benzoic acid, 3-bromo-4-fluoro-.

[[Page 43300]]

 
P-17-89......................  394-28-5............................  Benzoic acid, 2-bromo-5-fluoro-.
P-17-92......................  153556-42-4.........................  Benzoic acid, 4-bromo-3-fluoro-.
P-17-97......................  112704-79-7.........................  Benzoic acid, 4-bromo-2-fluoro-.
----------------------------------------------------------------------------------------------------------------

    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in Sec.  
721.63(a)(1), (a)(2)(i) and (v), (a)(3) and (4), when determining which 
persons are reasonably likely to be exposed as required for Sec.  
721.63(a)(1) and (4), engineering control measures (e.g., enclosure or 
confinement of the operation, general and local ventilation) or 
administrative control measures (e.g., workplace policies and 
procedures) shall be considered and implemented to prevent exposure, 
where feasible, (a)(5) (respirators must provide a National Institute 
for Occupational Safety and Health (NIOSH) assigned protection factor 
of at least 50, (a)(6) (particulate), (a)(6)(v) and (vi), (b) 
(concentration set at 1.0%), 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 0.0184 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 at 1.0%), (f), (g)(1)(i), 
(ii), (iii), (iv), (vi), and (ix), (g)(2)(i), (ii), and (iii), (use 
respiratory protection or maintain workplace airborne concentrations at 
or below an 8-hour time-weighted average of 0.0184 mg/m\3\), (g)(2)(v), 
and (g)(5). Alternative hazard and warning statements that meet the 
criteria of the Globally Harmonized System (GHS) and OSHA Hazard 
Communication Standard may be used.
    (iii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80(q) and (t). It is a significant new use to 
manufacture or process the substances other than for the processes 
described in the corresponding TSCA section 5(e) Order.
    (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
35. Add Sec.  721.11055 to subpart E to read as follows:

Sec.  721.11055   Certain halogenated benzoic acids ethyl esters.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substances listed in Table 1 of this 
section is subject to reporting under this section for the significant 
new uses described in paragraph (a)(2) of this section.

                       Table 1 to Sec.   721.11055--Halogenated Benzoic Acid Ethyl Esters
----------------------------------------------------------------------------------------------------------------
           PMN No.                            CAS No.                               Chemical name
----------------------------------------------------------------------------------------------------------------
P-17-94......................  122894-73-9.........................  Benzoic acid, 2,3,4,5-tetrafluoro-, ethyl
                                                                      ester.
P-17-95......................  583-02-8............................  Benzoic acid, 4-(trifluoromethyl)-, ethyl
                                                                      ester.
P-17-96......................  577-62-8............................  Benzoic acid, 2-(trifluoromethyl)-, ethyl
                                                                      ester.
P-17-98......................  19064-14-3..........................  Benzoic acid, 2,6-difluoro-, ethyl ester.
P-17-99......................  708-25-8............................  Benzoic acid, 2,5-difluoro-, ethyl ester.
P-17-100.....................  351354-50-2.........................  Benzoic acid, 2,3,4-trifluoro-, ethyl
                                                                      ester.
P-17-101.....................  351354-50-2.........................  Benzoic acid, 2-bromo-5-fluoro-, ethyl
                                                                      ester.
P-17-102.....................  350-19-6............................  Benzoic acid, 3,5-difluoro-, ethyl ester.
P-17-103.....................  76008-73-6..........................  Benzoic acid, 5-bromo-2-chloro-, ethyl
                                                                      ester.
P-17-104.....................  1128-76-3...........................  Benzoic acid, 3-chloro-, ethyl ester.
P-17-105.....................  7335-25-3...........................  Benzoic acid, 2-chloro-, ethyl ester.
P-17-114.....................  137521-81-4.........................  Benzoic acid, 3-chloro-4-fluoro-, ethyl
                                                                      ester.
P-17-122.....................  474709-71-2.........................  Benzoic acid, 4-bromo-2-fluoro-, ethyl
                                                                      ester.
P-17-123.....................  144267-97-0.........................  Benzoic acid, 2-bromo-4,5-difluoro-, ethyl
                                                                      ester.
P-17-124.....................  1130165-74-0........................  Benzoic acid, 4-bromo-3-fluoro-, ethyl
                                                                      ester.
P-17-125.....................  23233-33-2..........................  Benzoic acid, 3-bromo-4-fluoro-, ethyl
                                                                      ester.
P-17-126.....................  4793-20-8...........................  Benzoic acid, 4-chloro-2-fluoro-, ethyl
                                                                      ester.
P-17-127.....................  35112-27-7..........................  Benzoic acid, 2,5-dichloro-, ethyl ester.
P-17-128.....................  203573-08-4.........................  Benzoic acid, 4-chloro-3-fluoro-, ethyl
                                                                      ester.
P-17-129.....................  167758-87-4.........................  Benzoic acid, 2-chloro-4-fluoro-, ethyl
                                                                      ester.
P-17-130.....................  773139-56-3.........................  Benzoic acid, 5-chloro-2-fluoro-, ethyl
                                                                      ester.
P-17-131.....................  108928-00-3.........................  Benzoic acid, 2,4-difluoro-, ethyl ester.
P-17-132.....................  144267-96-9.........................  Benzoic acid, 3,4-difluoro-, ethyl ester.
P-17-133.....................  495405-09-9.........................  Benzoic acid, 3,4,5-trifluoro-, ethyl
                                                                      ester.
P-17-134.....................  351354-41-1.........................  Benzoic acid, 2,4,5-trifluoro-, ethyl
                                                                      ester.
P-17-135.....................  76783-59-0..........................  Benzoic acid, 3-(trifluoromethyl)-, ethyl
                                                                      ester.
P-17-136.....................  773134-65-9.........................  Benzoic acid, 2,3-difluoro-, ethyl ester.
P-17-137.....................  81055-73-4..........................  Benzoic acid, 2,6-dichloro-, ethyl ester.

[[Page 43301]]

 
P-17-138.....................  91085-56-2..........................  Benzoic acid, 3,5-dichloro-, ethyl ester.
P-17-139.....................  56882-52-1..........................  Benzoic acid, 2,4-dichloro-, ethyl ester.
P-17-140.....................  28394-58-3..........................  Benzoic acid, 3,4-dichloro-, ethyl ester.
----------------------------------------------------------------------------------------------------------------

    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in Sec.  
721.63(a)(1), (a)(2)(i) and (v), (a)(3) and (4), when determining which 
persons are reasonably likely to be exposed as required for Sec.  
721.63(a)(1) and (4), engineering control measures (e.g., enclosure or 
confinement of the operation, general and local ventilation) or 
administrative control measures (e.g., workplace policies and 
procedures) shall be considered and implemented to prevent exposure, 
where feasible, (a)(5) (respirators must provide a National Institute 
for Occupational Safety and Health (NIOSH) assigned protection factor 
of at least 1000), (a)(6) (particulate), (a)(6)(v) and (vi), (b) 
(concentration set at 1.0%), 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 0.0184 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 at 1.0%), (f), (g)(1)(i), 
(ii), (iii), (iv), (vi), and (ix), (g)(2)(i), (ii), and (iii), (use 
respiratory protection or maintain workplace airborne concentrations at 
or below an 8-hour time-weighted average of 0.0184 mg/m\3\), (g)(2)(v), 
(g)(3)(i) and (ii), (g)(4)(i), and (g)(5). Alternative hazard and 
warning statements that meet the criteria of the Globally Harmonized 
System (GHS) and OSHA Hazard Communication Standard may be used.
    (iii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80(q) and (t). It is a significant new use to 
manufacture or process the substances other than for processes 
described in the corresponding TSCA section 5(e) Order.
    (iv) Release to water. Requirements as specified in Sec.  
721.90(a)(4), (b)(4), and (c)(4) where N=15 ppb.
    (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
36. Add Sec.  721.11056 to subpart E to read as follows:

Sec.  721.11056   Neodymium aluminium alkyl polymer complexes 
(generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 
neodymium aluminium alkyl polymer complexes (PMN P-17-198) 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), and (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%), and (c).
    (ii) Hazard communication. Requirements as specified in Sec.  
721.72(a) through (e) (concentration set 1.0%), (f), (g)(1)(ix), (the 
substance may react violently with water, (this substance may cause 
skin irritation and corrosion), (this substance may cause respiratory 
complications, irritation, and corrosion), (g)(2)(i), (ii), (iii), 
(when using this substance use in closed system to prevent any 
inhalation exposure), (when using this substance use skin and eye 
protection), and (g)(5). Alternative hazard and warning statements that 
meet the criteria of the Globally Harmonized System (GHS) and OSHA 
Hazard Communication Standard may be used.
    (iii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80(c) (it is a significant new use to process 
the substance in manner that results in inhalation exposure) and (f). 
It is a significant new use to manufacture the substance for a period 
longer than 8 months.
    (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
37. Add Sec.  721.11057 to subpart E to read as follows:

Sec.  721.11057   Fatty acid amide alkyl amine salts (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substances identified generically as fatty 
acid amide alkyl amine salts (PMN P-17-272, P-17-273, P-17-274, P-17-
275, P-17-276 and P-17-277) are 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 substances after they have been reacted (cured).
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in Sec.  
721.63(a)(1), (a)(2)(i), (iii), and (iv), (a)(3), and (a)(6) 
(particulate), (a)(6)(v) and (vi). When determining which persons are 
reasonably likely to be exposed as required for Sec.  721.63(a)(1), 
engineering control measures (e.g.,

[[Page 43302]]

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.
    (ii) Hazard communication. Requirements as specified in Sec.  
721.72(a) through (e) (concentration set at 1.0%), (f), (g)(1)(vi), 
(skin irritation), (respiratory complication), (internal organ effect), 
(systemic effect), (sensitization), (g)(2)(i), (ii), (iii), and (v), 
(g)(3)(i) and (ii), (g)(4)(i) and (iii), and (g)(5). Alternative hazard 
and warning statements that meet the criteria of the Globally 
Harmonized System (GHS) and OSHA Hazard Communication Standard may be 
used.
    (iii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80(k) and (y)(1).
    (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
38. Add Sec.  721.11058 to subpart E to read as follows:

Sec.  721.11058   Fatty acid derived imidazoline salts (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substances identified generically as fatty 
acid derived imidazoline salts (PMN P-17-278, P-17-279 and P-17-280) 
are 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 substances after they 
have been reacted (cured).
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in Sec.  
721.63(a)(1), (a)(2)(i), (iii), and (iv), (a)(3), and (a)(6) 
(particulate), and (a)(6)(v) and (vi). 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.
    (ii) Hazard communication. Requirements as specified in Sec.  
721.72(a) through (e) (concentration set at 1.0%), (f), (g)(1) (skin 
irritation), (respiratory complication), (internal organ 
effect),(systemic effect), (sensitization), (g)(2)(i), (ii), (iii), and 
(v), (g)(3)(i) and (ii), (g)(4)(i) and (iii), and (g)(5). Alternative 
hazard and warning statements that meet the criteria of the Globally 
Harmonized System (GHS) and OSHA Hazard Communication Standard may be 
used.
    (iii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80(k) and (y)(1).
    (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.

[FR Doc. 2019-16099 Filed 8-19-19; 8:45 am]
 BILLING CODE 6560-50-P