[Federal Register Volume 84, Number 161 (Tuesday, August 20, 2019)]
[Rules and Regulations]
[Pages 43266-43302]
[FR Doc No: 2019-16099]

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:<PHONE_NUMBER>; email address:
<EMAIL_ADDRESS>    For general information contact: The TSCA-Hotline, ABVI-Goodwill,
422 South Clinton Ave., Rochester, NY 14620; telephone number: (202)
554-1404; email address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this action apply to me?

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

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

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

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

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

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

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,

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.

    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

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:

    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

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

(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

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.

    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

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:

------------------------------------------------------------------------
                    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

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.