Document ID: EPA-HQ-OPPT-2017-0414-0148
Agency: epa
Document Type: Rule
Title: Significant New Use Rules on Certain Chemical Substances
Posted Date: 2019-09-18T04:00Z

[Federal Register Volume 84, Number 181 (Wednesday, September 18, 2019)]
[Rules and Regulations]
[Pages 49040-49057]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-19667]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Parts 9 and 721

[EPA-HQ-OPPT-2017-0414; FRL-9999-26]
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 26 chemical substances which 
are the subject of premanufacture notices (PMNs) and deferring action 
on one chemical substance. 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 26 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,

[[Page 49041]]

under the conditions of use for that chemical substance, within the 
applicable review period. Persons may not commence manufacture or 
processing for the significant new use until EPA has conducted a review 
of the notice, made an appropriate determination on the notice, and has 
taken such actions as are required by that determination.

DATES: This rule is effective on November 18, 2019. For purposes of 
judicial review, this rule shall be promulgated at 1 p.m. (e.s.t.) on 
October 2, 2019.

FOR FURTHER INFORMATION CONTACT: 
    For technical information contact: Kenneth Moss, Chemical Control 
Division (7405M), Office of Pollution Prevention and Toxics, 
Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington, 
DC 20460-0001; telephone number: (202) 564-9232; email address: 
moss.kenneth@epa.gov.
    For general information contact: The TSCA-Hotline, ABVI-Goodwill, 
422 South Clinton Ave., Rochester, NY 14620; telephone number: (202) 
554-1404; email address: TSCA-Hotline@epa.gov.

SUPPLEMENTARY INFORMATION: 

I. General Information

A. Does this action apply to me?

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

II. Background

A. What action is the Agency taking?

    EPA is finalizing these SNURs under TSCA section 5(a)(2) for 26 
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. EPA is not 
finalizing the proposed SNUR at 40 CFR 721.11082 on the chemical 
substance that is the subject of PMN P-16-543, because the Agency is 
currently reviewing data submitted in support of a request to modify 
the underlying TSCA 5(e) Order that forms the basis for the proposed 
SNUR.
    In the Federal Register of August 17, 2018 (83 FR 41039) (FRL-9981-
82), EPA proposed a SNUR for 27 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 51911) (FRL-9984-69). This reopened 
comment period closed on October 30, 2018. A direct final rule was also 
published on August 17, 2018 (83 FR 40986) (9971-37) but withdrawn on 
October 11, 2018 (83 FR 51360) (9984-71) when EPA received notices of 
intent to submit adverse comments on these SNURs. 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 under docket ID number EPA-HQ-OPPT-2017-
0414. 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)).

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. Pursuant to 
40 CFR 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

    When the Agency issues an Order under TSCA section 5(e), TSCA 
section 5(f)(4) requires that the Agency consider whether to promulgate 
a SNUR for any use not conforming to the restrictions of the Order or 
publish a statement describing the reasons for not initiating the 
rulemaking. 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.

[[Page 49042]]

     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.

IV. Public Comments on Proposed Rule and EPA Responses

    EPA received public comments from 12 entities on the proposed rule. 
The Agency's responses are described in this unit.

A. Anonymous Comments

    Comment. EPA received two anonymous comments on the proposed rule. 
One of these comments was general in nature and did not pertain to the 
proposed rule.
    Response: No response is required. The second anonymous comment--
also repeated by another commenter--related to the proposed SNUR for a 
chlorofluorocarbon (P-16-150, 40 CFR 721.11078). This will be covered 
separately in this unit, under the subheading: ``Protection of 
groundwater and source water from CFC contamination''.

B. Chlorinated Paraffins (CPs)

    EPA received comments from six entities related to the proposed 
SNURs for chlorinated paraffins (CPs): 40 CFR 721.11068 (P-12-277), 40 
CFR 721.11069 (P-12-278), 40 CFR 721.11070 (P-12-280), 40 CFR 721.11071 
(P-12-281), 40 CFR 721.11072 (P-12-282 and P-14-684), 40 CFR 721.11073 
(P-12-283 and P-14-683), 40 CFR 721.11074 (P-12-284), 40 CFR 721.11075 
(P-12-433), 40 CFR 721.11076 (P-12-453), and 40 CFR 721.11077 (P-12-
505).
a. Ongoing Uses Under Old Chemical Abstract Service (CAS) Registry 
Numbers
    Comment: The commenters stated that manufacturers of these 
chemicals are already engaging in ongoing uses; new CAS registry 
numbers have been given to chemicals already in use and these new CAS 
registry numbers take time to be shared downstream and for companies to 
figure out if the SNUR substances are present in supply chains. The 
commenters add that CPs should be moved to TSCA section 6 (EPA's 
existing chemicals program) for a long-term regulatory remedy.
    Response: The Agency is aware that CPs have been in commerce 
globally for over 70 years. However, in 2009, EPA informed the U.S. 
manufacturers of CPs that they were using the wrong CAS numbers for the 
CPs that are the subject of these SNURs. Those CPs were not properly 
listed on the TSCA Inventory, and thus remained ``new chemical'' 
substances as defined under TSCA. In 2012, the major domestic 
manufacturers and importers of CPs agreed to immediately cease domestic 
manufacture and import of short-chain CPs. Additionally, the companies 
agreed to submit PMNs for the medium-and long-chain CPs for EPA to 
review under TSCA section 5. Around the same time, EPA added medium- 
and long-chain CPs to the TSCA Work Plan for existing chemical 
substances. However, given that these CPs were not listed on the TSCA 
Inventory, EPA determined it was more appropriate to manage them under 
the TSCA New Chemicals Program. The CPs in this SNUR were subsequently 
reviewed under the New Chemicals Program, and the PMN submitters were 
held to certain restrictions in TSCA section 5(e) Orders. Consistent 
with its responsibilities under TSCA section 5(f)(4), EPA is finalizing 
these SNURs to ensure that other manufacturers, importers and 
processors of these CPs are held to the same standards as the original 
PMN submitters. EPA notes that suppliers have been on notice of this 
issue for over 10 years and would have an additional 5 years to come 
into compliance under the terms of this SNUR.
b. Production Time Limit (Five Years) in the SNUR
    Comment: Several commenters said that five years was too short a 
time period by which to require SNUN notification, and that the short 
time period reignites market uncertainty on availability of these CPs. 
Commenters focused on the proposed time-based SNUR triggers and the 
potential negative impacts on the regulated community, including 
downstream processors and users of substances. The commenters 
encouraged EPA to clarify the obligations of manufacturers and 
processors of these substances under the SNURs, and the timeline for 
those obligations. The commenters also encouraged EPA to consider 
whether the SNURs could be revised to mitigate uncertainty for 
downstream users. One commenter also asked if this time-based 
notification requirement applies even if the chemical is being used for 
the uses allowed under the SNUR.
    Response: The five-year time-trigger notification requirement is 
consistent with the underlying TSCA section 5(e) Orders for the CPs. 
Processors (who are not also manufacturers/importers) are exempt from 
this notification requirement. A manufacturer (including importer) of 
the CPs subject to the SNURs has five years following their 
commencement of manufacture to submit a SNUN . This SNUR ensures that 
the PMN submitters and other entrants to the marketplace are treated 
uniformly. The TSCA 5(e) Orders limit the submitters to a five-year 
production limit. Following the effective date of the SNUR, there will 
be ample time for other manufacturers (those not currently subject to 
the TSCA section 5(e) Orders) to submit SNUNs and for the Agency to 
complete its review. If an entity decides to discontinue manufacture 
within that five-year period, there is no need for a SNUN submission 
requesting to go beyond that time limit. The time limit is independent 
of the specific use restrictions; notification is required within that 
five-year period even if the chemical is manufactured for an allowed 
end use.
    Separately, in response to a comment on another batch SNUR (public 
docket OPPT-2017-0366), to avoid confusion EPA is modifying the 
proposed SNUR to eliminate specific reference to 40 CFR 721.80 
requirements and instead stating the significant new use in plain 
English: ``It is a significant new use to manufacture (including 
import) the substance more than five years.''
c. Processors and Users SNUN Obligations
    Comment: A commenter asked if processors or users who want to use a 
substance for uses other than those allowed under the SNUR must submit 
a SNUN for that use.
    Response: Only manufacturers and processors are subject to SNUR 
notification requirements. A processor can either co-submit a SNUN with 
a manufacturer for the new use (an actual use, not the production 
limit, which applies only to manufacturers) or submit a SNUN on their 
own. After review of a SNUN, if EPA makes a finding allowing the 
significant new use, the submitter can engage in that new use but must 
wait for the SNUR to be modified accordingly before

[[Page 49043]]

distributing the substance for the new use.
d. Downstream Notification
    Comment: A commenter asked if, pursuant to 40 CFR 721.5, 
notification of downstream customers and processors of the existence of 
the SNUR is required prior to expiration of the 5-year time production 
limit or only after submission of a SNUN to exceed that limit.
    Response: The downstream notification requirements at 40 CFR 721.5 
are in force without regard to the specific SNUR requirements once the 
SNUR is effective and continues until the SNUR is revoked.
e. Use Not Currently Allowed in SNUR
    Comment: One commenter stated that the uses allowed under the SNUR 
for the CP submitted as PMN P-12-277 (40 CFR 721.11068) would hinder 
the ability to use the substance for a certain confidential (adhesives) 
use that is currently ongoing.
    Response: Because this is an ongoing use, EPA has revised the 
regulatory text of the SNUR at 40 CFR 721.11068 to add this use to 
those currently allowed uses in the proposed SNUR.
f. Too Little Time To Switch to Alternatives to CPs
    Comment: One commenter claims that industry may be using the CP 
substances subject to the SNUR for critical uses without alternatives, 
but with the short timeframe for comments and the lack of clarity 
surrounding the assignment of the CAS registry numbers, we have not 
been able to ascertain our uses. In the cases that alternatives may 
exist, transition takes beyond five years to qualify, certify, and 
implement. There is also the challenge of finding substances with an 
equivalent technical performance and proliferation within a complex 
supply base.
    Response: The Agency notes that companies have been on notice since 
2009 that EPA has been taking actions to regulate these chemical 
substances. As stated previously, EPA has publicly documented its 
concerns over these chemicals through multiple actions taken over the 
last decade: By initiating the enforcement action in 2009, publishing 
an ``Action Plan'' in 2009, reaching legal settlements with the 
manufacturers in 2012, initiating the TSCA section 5 process in 2012, 
listing the chemicals on the 2012 Work Plan, and publishing risk 
assessments in 2015 that identified environmental concerns. There is, 
therefore, no basis for EPA to further extend the five-year timeline in 
the proposed SNURs.

C. Isocyanates

    Comment: One commenter stated that--generally for isocyanate SNURs, 
but in this rule specifically the proposed SNUR for PMN P-17-10 
(721.11084), in which EPA proposed that exceeding the specified weight 
of residual isocyanates in the PMN chemical substance would be a 
significant new use--EPA should clarify the extent it is basing the 
SNUR 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.
    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. That commenter continued that 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, the commenter states 
that 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 TSCA section 5 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 
ongoing 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.
    Comment: One commenter stated that 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 molecular weight limitations. In addition, the 
commenter added that EPA should defer personal protective equipment 
(PPE) and hazard communication provisions to the applicable OSHA 
requirements.
    Response: With regards to the basis for imposed limitations on 
residual isocyanates and molecular weight limitations, for each PMN 
substance such as P-17-10 where there is potential risk from residual 
chemicals or lower molecular weights if the polymer is manufactured 
differently, EPA attempts to minimize exposure based on

[[Page 49044]]

information in the notification about how the chemical is manufactured. 
The PMN for P-17-10 contained information that the polymer was 
manufactured at a certain molecular weight and residual isocyanate 
level less than 0.1%. EPA included these as restrictions in the TSCA 
section 5(e) Order and the proposed SNUR to prevent potential health 
risks. Regarding deferring PPE and hazard communication requirements to 
OSHA, because the TSCA section 5(e) Orders for the chemicals in this 
SNUR contain worker protection requirements, EPA proposed and is 
issuing a final SNUR retaining those requirements so that all 
manufacturers and processors are subject to the same requirements. If 
the underlying TSCA section 5(e) Orders are modified EPA would consider 
modifying the SNUR. For PMNs currently in review EPA will continue to 
determine when PPE and hazard communication provisions can be addressed 
by other applicable requirements or if a specific finding for a PMN 
requires PPE and hazard communication provisions under TSCA.
    Comment: The same commenter states that 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.
    Response: The regulatory text for 40 CFR 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 to 
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.
    Comment: The same commenter stated that EPA should delete the 
provisions incorporating the recordkeeping requirements in 40 CFR 
721.125, as it did in the proposed TDI SNUR, 80 FR 2068 (Jan. 15, 
2015), and some others.
    Response: The SNURs cited by the commenter are existing chemical 
SNURs where EPA determined recordkeeping was not needed. For example, 
when the significant new use for an existing chemical is ``any use'' 
there is typically no recordkeeping required because there are no 
records to be maintained that would inform EPA inspection or 
enforcement. Because these are new chemical SNURs EPA will continue to 
require recordkeeping for all new chemical SNUR to better allow EPA to 
inspect and enforce SNUR requirements at facilities where chemicals 
subject to SNURs are manufactured and processed.

D. Deviation From EPA's PBT Policy

    Comment: One commenter stated that EPA has deviated from its 
Persistent, Bioaccumulative, and Toxic (PBT) New Chemical Substances 
Testing Policy (see final policy statement at 64 FR 60194; November 4, 
1999) and failed to explain those deviations. Comments relate to the 
previously mentioned CPs, plus two other chemicals (P-17-228, 40 CFR 
721.11092) and P-17-229, 40 CFR 721.11093).
    Response: The policy statement, which is not a rule and accordingly 
has no binding effect, provides guidance criteria for persistence, 
bioaccumulation, and toxicity for new chemicals and advises the 
industry about our regulatory approach for chemicals meeting the 
criteria. Establishment of a PBT category alerts potential PMN 
submitters to possible assessment or regulatory issues associated with 
PBT new chemicals review. It also provides a vehicle by which the 
Agency may gauge the flow of PBT chemical substances through the TSCA 
New Chemicals Program and measure the results of its risk screening and 
risk management activities for PBT new chemical substances; as such, it 
is a major element in the Agency's overall strategy to further reduce 
risks from PBT pollutants.
    The TSCA section 5(e) Orders for the CPs do state that at least 
some congener groups present in the PMN substances may be ``persistent 
to very persistent, with estimated half-lives in air exceeding 2 days 
and estimated half-lives in water or sediments exceeding 2 months'' and 
``bioaccumulative to very bioaccumulative based on multiple lines of 
evidence, including: Log Kow values, modeled BCFs, laboratory-measured 
BCFs, field-measured BAFs, field-measured BMFs, laboratory-measured 
biota-sediment bioaccumulation factors (BSAFs) and the presence of 
MCCPs in human and wildlife biota.'' The TSCA section 5(e) Order for 
the other two substances (P-17-228, 40 CFR 721.11092 and P-17-229, 40 
CFR 721.11093), identifies PBT concerns as well, based on physical 
chemical properties of those substances. The policy statement notes 
that even for ``very'' P and ``very'' B cases, where ``because of the 
increased concern, more stringent control action would be a likely 
outcome, . . . it would not be appropriate to automatically trigger a 
``ban pending testing'' at these cutoffs given the uncertainties about 
substance properties, release, and environmental behavior that normally 
characterize PMN review.'' Accordingly, the Agency evaluates each PMN 
based on the use, exposure and release information submitted, and makes 
a case by case risk management decision. In fact, the TSCA section 5(e) 
Orders for the CPs state that EPA has determined that because medium-
chain CPs similar to the PMN substances have been manufactured, 
processed and used for the uses described in the PMN for more than 40 
years, manufacture, processing, distribution in commerce, use and 
disposal of the PMN substances in accordance with the provisions of the 
TSCA section 5(e) order do not create an unreasonable risk of injury to 
health or the environment. The proposed SNUR terms for the CPs and the 
other 2 substances (P-17-228, 40 CFR 721.11092; and P-17-229, 40 CFR 
721.11093) reflect the Agency's determination under their respective 
TSCA section 5(e) Orders, that the controls stipulated in the 
underlying TSCA section 5(e) Orders are protective or human health and 
environment, pending submission of further information that is 
identified in the TSCA section 5(e) Orders.

E. EPA Must Ensure That the Docket Is Complete

    Comment: One commenter stated that the TSCA section 5(e) Order and 
Risk Assessment for the CP PMNs P-14-683 and P-14-684, plus the testing 
strategy for all the CP PMNs included in a previous docket, are not in 
the docket for this SNUR.
    Response: This is an oversight. The TSCA section 5(e) Order and 
risk assessment for P-14-683 and P-14-684 have now been added to the 
docket. Note, however, that the chemical identities, risk assessment, 
and terms of the TSCA section 5(e) Order are identical to those for P-
12-283 and P-12-282, respectively, which are already in the docket. As 
a result, EPA has not reopened the public comment period, because the 
public had an opportunity to review the available risk assessment and 
TSCA section 5(e) Order requirements that apply to P-16-683 and P-14-
684. Each CP PMN 5(e) Order contains the current iteration of the 
testing strategy as specific testing requirements required by a certain 
date. EPA refers the public to the docket for the December 23, 2015 (80 
FR 79886) ``Chlorinated Paraffins; Request for Available Information on 
PMN Risk Assessments'' (EPA-HQ-OPPT-2015-0789) for the original testing 
strategy for CPs.

[[Page 49045]]

F. Consistency Between Orders and SNURs: Hierarchy of Controls

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

G. Other Inconsistencies Between Orders and SNURs

    Comment: A commenter noted the following inconsistencies between 
certain proposed SNUR and underlying TSCA section 5(e) Order 
restrictions. For P-17-218, the TSCA section 5(e) Order requires that 
the substance not be manufactured or processed ``involving a method 
that generates a vapor, mist, aerosol, or dust,'' whereas the proposed 
SNUR does not contain the same restrictions, and rather only has an 
analogous restriction regarding the use of the PMN substance. For P-17-
154, the TSCA section 5(e) Order calls for chemical goggles or 
equivalent eye protection, while the SNUR does not. For the CP PMNs, 
the TSCA section 5(e) Orders state that the 5-year time limit is on 
manufacturing, processing, distribution in commerce, use, and disposal, 
while the proposed SNUR simply states it is a limit on manufacturing.
    Response: For the SNUR for P-17-218, the Agency agrees that there 
was an oversight in the proposed rule. The final SNUR for that chemical 
substance no longer cites 40 CFR 721.80(y)(1) and (2), but rather 
include the overarching statement ``It is a significant new use to 
manufacture, process or use the substance involving a method that 
generates a vapor, mist, aerosol, or dust.'' For the SNUR for P-17-154, 
the Agency agrees that there was an oversight in the proposed rule. The 
final SNUR for that chemical substance will include the restriction 
found at 40 CFR 721.63(a)(2)(iii), which corresponds to chemical 
goggles or equivalent eye protection. For the CP PMNs, even though the 
5-year time limit in the TSCA section 5(e) Order prohibited 
manufacture, processing, distribution in commerce, use, and disposal 
for the Company submitting the PMN, EPA's previous practice for all 
other SNURS and intent for these SNURs was not to prohibit activities 
other than manufacturing by other entities based on a testing 
requirement for manufacturers. The SNUR requirement will continue to 
apply only to manufacturers or importers.

H. Typographical Error in the Proposed SNUR Preamble

    Comment: A commenter notes that the preamble to the proposed SNUR 
for P-16-543 lists one of the TSCA section 5(e) Order restrictions as 
``Manufacture, process, or use of the substance without the engineering 
controls required by the Order to control dermal and inhalation 
exposure,'' where it should say ``No manufacture . . . etc.''
    Response: The Agency is deferring final action on this SNUR due to 
ongoing review of data to support a modification to the underlying TSCA 
5(e) Order that forms to basis for the SNUR.

I. Incomplete Listing of Engineering Controls

    Comment: A commenter noted that the preamble to the SNUR for P-17-
226 has an incomplete listing of engineering controls contained in the 
underlying TSCA section 5(e) Order. In particular, bullet 5 in the 
preamble states ``No processing without appropriate engineering 
controls to prevent inhalation exposure, including dust removal with 
99.9% efficiency when loading or unloading the substance in powder 
form.''
    Response: The referenced bullet 5 is the only TSCA section 5(e) 
Order requirement regarding engineering controls. The SNUR and preamble 
will remain as proposed.

J. Protection in the Workplace Provisions

    Comment: A commenter suggested that EPA should add provisions 
addressing protection in the workplace to proposed SNURs that currently 
do not--and the underlying TSCA section 5(e) Orders do not--include any 
such provision. The commenter also states that EPA should not defer 
workplace protections to OSHA or NIOSH.
    Response: EPA disagrees with the comment that, with respect to 
scenarios where EPA expects that worker protection requirements under 
other federal/state authorities would mitigate risks to workers, EPA 
must designate all uses without those protections as ``significant new 
uses''. As discussed in a previous response to comment, because the 
TSCA section 5(e) Orders for the chemicals in this SNUR contain certain 
requirements to address unreasonable risks, EPA proposed and is issuing 
a final SNUR retaining the same requirements so that all manufacturers 
and processors are subject to similar requirements. If the underlying 
TSCA section 5(e) Orders are modified to include worker protection 
requirements, EPA would consider modifying the SNUR. When exercising 
its discretion regarding which new uses should be designated as 
significant under TSCA section 5(a)(2), EPA expects compliance with 
federal and state laws, such as worker protection standards or disposal 
restrictions, unless case-specific facts indicate otherwise. Further, 
EPA expects that employers will require and workers will use the 
appropriate controls (e.g., personal protective equipment such as 
impervious gloves and/or respirators), consistent with the Safety Data 
Sheet prepared by the PMN submitter, in a manner adequate to protect 
them.

[[Page 49046]]

K. EPA Needs To Add Limits on Water Releases in Three of the SNURs

    Comment: One commenter noted that the proposed SNURs for P-17-154, 
P-17-155, and P-17-156 contain no limits on water releases, even though 
the underlying TSCA section 5(e) Order for these chemical substances 
mention an aquatic toxicity Concentration of Concern (CoC) of 240 ppb. 
By comparison, another proposed rule (P-17-226, 721.11091) does contain 
a surface water limit of the same amount.
    Response: Based on review of the available information available 
for these four PMNs, the Agency made different determinations. While 
the hazards for the PMN substances that the commenter compared are 
similar, their predicted environmental fate was not. EPA estimates for 
removal during wastewater treatment for P-17-154, P-17-155, and P-17-
156 was 90%. Wastewater treatment removal for the reaction products of 
P-17-226 during wastewater treatment was estimated to be as low as 0% 
and to contain some chemical components that are very persistent and 
bioaccumulative. Based on this information EPA decided to include a 
surface water limit for P-17-226 but not for P-17-154, P-17-155, and P-
17-156.

L. Protection of Groundwater and Source Water From CFC Contamination

    Comment: Two commenters--one anonymous--raised concerns related to 
the proposed SNUR for a substance generically described as 
``chlorofluorocarbon'' (P-16-150, 40 CFR 721.11078), which includes 
proposed significant new uses involving workplace protection, 
restriction to use as a chemical intermediate and a water discharge 
limit. The commenters suggested that chlorofluorocarbons (CFCs) in 
general should not be approved under SNURs, as CFCs already 
contaminates certain groundwater drinking water supplies, which 
increases the costs and difficulty to remove this containment to 
provide safe drinking water, and there are potential health problems 
and future environmental issues.
    Response: EPA's review of this chemical did identify potential for 
health and environmental effects if this chemical is limited to certain 
concentrations in surface waters or drinking water. EPA's assessment of 
the chemical as an intermediate only identified limited releases to air 
after incineration and water releases to surface waters after 
wastewater treatment. These releases would be significantly below any 
levels of concern for health and environmental effects for the 
chemical. Because of the potential hazards, the TSCA section 5(e) Order 
did not allow, and the SNUR contains reporting requirements before, 
levels in surface waters exceed 240 ppb or any use of the chemical 
other than as a chemical intermediate. EPA would receive notification 
of and evaluate any new uses of the chemical that could result in 
releases causing health and environmental effects.

M. Modification of One Order and Associated SNUR

    Subsequent to the publication of the proposed SNUR for P-16-410 
(721.11080), the PMN submitter requested a modification to the 
underlying TSCA section 5(e) Order to increase the allowable percent 
concentration of the PMN substance from 0.2% to 23% as an automotive 
engine fluid additive in imported product formulations for industrial 
use only. EPA evaluated the information submitted by the PMN submitter 
and determined that increasing the concentration of the PMN substance 
in imported product to 23% will not result in risk to workers or 
consumers. As a result, EPA modified the TSCA section 5(e) Order to 
allow this increase in percent concentration and has accordingly 
modified that provision in the associated final SNUR.

V. Substances Subject to This Rule

    EPA is establishing significant new use and recordkeeping 
requirements for 26 chemical substances in 40 CFR part 721, subpart E. 
In Unit IV of the original direct final rule in the Federal Register of 
August 17, 2018 (83 FR 40986), EPA provides the following information 
for each chemical substance:
     PMN number.
     Chemical name (generic name, if the specific name is 
claimed as CBI).
     Chemical Abstracts Service (CAS) Registry number (if 
assigned for non-confidential chemical identities).
     Basis for the TSCA section 5(e) Order.
     Potentially Useful Information. This is information 
identified by EPA that would help characterize the potential health 
and/or environmental effects of the chemical substance in support of a 
request by the PMN submitter to modify the Order, or if a manufacturer 
or processor is considering submitting a SNUN for a significant new use 
designated by the SNUR.
     CFR citation assigned in the regulatory text section of 
this rule.
    The regulatory text section of each rule specifies the activities 
designated as significant new uses. Certain new uses, including 
exceedance of production volume limits (i.e., limits on manufacture 
volume) and other uses designated in this rule, may be claimed as CBI. 
Unit IX. discusses a procedure companies may use to ascertain whether a 
proposed use constitutes a significant new use.
    These final rules include 26 PMN substances that are subject to 
Orders under TSCA section 5(e)(1)(A), as required by the determinations 
made under TSCA section 5(a)(3)(B). 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 40 CFR 
721.63 respirator requirements may request to do so under 40 CFR 
721.30. EPA expects that persons whose 40 CFR 721.30 requests to use 
the NCELs approach for SNURs that are approved by EPA will be required 
to comply with NCELs provisions that are comparable to those contained 
in the corresponding TSCA section 5(e) Order for the same chemical 
substance.

[[Page 49047]]

VI. Rationale and Objectives of the Rule

A. Rationale

    During review of the PMNs submitted for the chemical substances 
that are subject to these SNURs, EPA concluded that for all 26 chemical 
substances regulation was warranted under TSCA section 5(e), pending 
the development of information sufficient to make reasoned evaluations 
of the health or environmental effects of the chemical substances. The 
basis for such findings is outlined in Unit IV of the original direct 
final rule in the Federal Register of August 17, 2018 (83 FR 40986). 
Based on these findings, TSCA section 5(e) Orders requiring the use of 
appropriate exposure controls were negotiated with the PMN submitters. 
As a general matter, EPA believes it is necessary to follow TSCA 
section 5(e) Orders with a SNUR that identifies the absence of those 
protective measures as Significant New Uses to ensure that all 
manufacturers and processors--not just the original submitter--are held 
to the same standard.

B. Objectives

    EPA is issuing these SNURs for specific chemical substances which 
have undergone premanufacture review because the Agency wants to 
achieve the following objectives with regard to the significant new 
uses designated in this rule:
     To receive notice of any person's intent to manufacture or 
process a listed chemical substance for the described significant new 
use before that activity begins.
     To have an opportunity to review and evaluate data 
submitted in a SNUN before the notice submitter begins manufacturing or 
processing a listed chemical substance for the described significant 
new use.
     To be able to either determine that the prospective 
manufacture or processing is not likely to present an unreasonable 
risk, or to take necessary regulatory action associated with any other 
determination, before the described significant new use of the chemical 
substance occurs.
     To identify as significant new uses any manufacturing, 
processing, use, distribution in commerce, or disposal that does not 
conform to the restrictions imposed by the underlying TSCA section 5(e) 
Orders, consistent with TSCA section 5(f)(4).
    Issuance of a SNUR for a chemical substance does not signify that 
the chemical substance is listed on the TSCA Chemical Substance 
Inventory (TSCA Inventory). Guidance on how to determine if a chemical 
substance is on the TSCA Inventory is available on the internet at 
http://www.epa.gov/opptintr/existingchemicals/pubs/tscainventory/index.html.

VII. Applicability of the Significant New Use Designation

    To establish a significant new use, EPA must determine that the use 
is not ongoing. The chemical substances subject to this rule have 
undergone premanufacture review. In cases where EPA has not received a 
notice of commencement (NOC) and the chemical substance has not been 
added to the TSCA Inventory, no person may commence such activities 
without first submitting a PMN. Therefore, for chemical substances for 
which an NOC has not been submitted EPA concludes that the designated 
significant new uses are not ongoing.
    When chemical substances identified in this rule are added to the 
TSCA Inventory, EPA recognizes that, before the rule is effective, 
other persons might engage in a use that has been identified as a 
significant new use. However, TSCA section 5(e) Orders have been issued 
for all of the chemical substances, and the PMN submitters are 
prohibited by the TSCA section 5(e) Orders from undertaking activities 
which will be designated as significant new uses. The identities of 12 
of the 26 chemical substances subject to this final rule have been 
claimed as confidential and EPA has received one post-PMN bona fide 
submission (per 40 CFR 720.25 and 721.11) for a chemical substance 
covered by this action. Based on this, the Agency believes that it is 
highly unlikely that any of the significant new uses described in the 
regulatory text of this rule are ongoing.
    EPA designated August 17, 2018 (the date of publication of the 
direct final and proposed rules in the Federal Register) as the cutoff 
date for determining whether the new use is ongoing. The objective of 
EPA's approach has been to ensure that a person could not defeat a SNUR 
by initiating a significant new use before the effective date of the 
final rule.
    In the unlikely event that a person began commercial manufacture or 
processing of the chemical substances for a significant new use 
identified as of August 17, 2018, that person will have to cease any 
such activity upon the effective date of the final rule. To resume 
their activities, these persons will have to first comply with all 
applicable SNUR notification requirements and wait until EPA has 
conducted a review of the notice, made an appropriate determination on 
the notice, and has taken such actions as are required with that 
determination.

VIII. Development and Submission of Information

    EPA recognizes that TSCA section 5 does not require developing any 
particular new information (e.g., generating test data) before 
submission of a SNUN. There is an exception: If a person is required to 
submit information for a chemical substance pursuant to a rule, order 
or consent agreement under TSCA section 4 (15 U.S.C. 2603), then TSCA 
section 5(b)(1)(A) (15 U.S.C. 2604(b)(1)(A)) requires such information 
to be submitted to EPA at the time of submission of the SNUN.
    In the absence of a rule, order, or consent agreement under TSCA 
section 4 covering the chemical substance, persons are required only to 
submit information in their possession or control and to describe any 
other information known to or reasonably ascertainable by them (see 40 
CFR 720.50). However, upon review of PMNs and SNUNs, the Agency has the 
authority to require appropriate testing. Unit IV of the original 
direct final rule in the Federal Register of August 17, 2018 (83 FR 
40986) lists potentially useful information for all SNURs listed here. 
Descriptions of this information is provided for informational 
purposes. The potentially useful information identified in Unit IV of 
the original direct final rule will be useful to EPA's evaluation in 
the event that someone submits a SNUN for the significant new use. 
Companies who are considering submitting a SNUN are encouraged, but not 
required, to develop the information on the substance, which may assist 
with EPA's analysis of the SNUN.
    EPA strongly encourages persons, before performing any testing, to 
consult with the Agency pertaining to protocol selection. Furthermore, 
pursuant to TSCA section 4(h), which pertains to reduction of testing 
in vertebrate animals, EPA encourages consultation with the Agency on 
the use of alternative test methods and strategies (also called New 
Approach Methodologies, or NAMs), if available, to generate the 
recommended test data. EPA encourages dialog with Agency 
representatives to help determine how best the submitter can meet both 
the data needs and the objective of TSCA section 4(h).
    In certain of the TSCA section 5(e) Orders for the chemical 
substances regulated under this rule, EPA has established production 
volume limits in view of the lack of data on the potential health and 
environmental risks that may be posed by the significant new uses or

[[Page 49048]]

increased exposure to the chemical substances. These limits cannot be 
exceeded unless the PMN submitter first submits the results of 
specified tests that would permit a reasoned evaluation of the 
potential risks posed by these chemical substances. The SNURs contain 
the same production volume limits as the TSCA section 5(e) Orders. 
Exceeding these production limits is defined as a significant new use. 
Persons who intend to exceed the production limit must notify the 
Agency by submitting a SNUN at least 90 days in advance of commencement 
of non-exempt commercial manufacture or processing.
    Any request by EPA for the triggered and pended testing described 
in the TSCA section 5(e) Orders was made based on EPA's consideration 
of available screening-level data, if any, as well as other available 
information on appropriate testing for the PMN substances. Further, any 
such testing request on the part of EPA that includes testing on 
vertebrates was made after consideration of available toxicity 
information, computational toxicology and bioinformatics, and high-
throughput screening methods and their prediction models.
    The potentially useful information identified in Unit IV. of the 
original direct final rule may not be the only means of addressing the 
potential risks of the chemical substance. However, submitting a SNUN 
without any test data or other information may increase the likelihood 
that EPA will take action under TSCA section 5(e) or 5(f). EPA 
recommends that potential SNUN submitters contact EPA early enough so 
that they will be able to conduct the appropriate tests.
    SNUN submitters should be aware that EPA will be better able to 
evaluate SNUNs which provide detailed information on the following:
     Human exposure and environmental release that may result 
from the significant new use of the chemical substances.
     Information on risks posed by the chemical substances 
compared to risks posed by potential substitutes.

IX. Procedural Determinations

    By this rule, EPA is establishing certain significant new uses 
which have been claimed as CBI subject to Agency confidentiality 
regulations at 40 CFR part 2 and 40 CFR part 720, subpart E. Absent a 
final determination or other disposition of the confidentiality claim 
under 40 CFR part 2 procedures, EPA is required to keep this 
information confidential. EPA promulgated a procedure to deal with the 
situation where a specific significant new use is CBI, at 40 CFR 
721.1725(b)(1).
    Under these procedures a manufacturer or processor may request EPA 
to determine whether a proposed use would be a significant new use 
under the rule. The manufacturer or processor must show that it has a 
bona fide intent to manufacture or process the chemical substance and 
must identify the specific use for which it intends to manufacture or 
process the chemical substance. If EPA concludes that the person has 
shown a bona fide intent to manufacture or process the chemical 
substance, EPA will tell the person whether the use identified in the 
bona fide submission would be a significant new use under the rule. 
Since most of the chemical identities of the chemical substances 
subject to these SNURs are also CBI, manufacturers and processors can 
combine the bona fide submission under the procedure in 40 CFR 
721.1725(b)(1) with that under 40 CFR 721.11 into a single step.
    If EPA determines that the use identified in the bona fide 
submission would not be a significant new use, i.e., the use does not 
meet the criteria specified in the rule for a significant new use, that 
person can manufacture or process the chemical substance so long as the 
significant new use trigger is not met. In the case of a production 
volume trigger, this means that the aggregate annual production volume 
does not exceed that identified in the bona fide submission to EPA. 
Because of confidentiality concerns, EPA does not typically disclose 
the actual production volume that constitutes the use trigger. Thus, if 
the person later intends to exceed that volume, a new bona fide 
submission would be necessary to determine whether that higher volume 
would be a significant new use.

X. SNUN Submissions

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

XI. Economic Analysis

    EPA has evaluated the potential costs of establishing SNUN 
requirements for potential manufacturers and processors of the chemical 
substances subject to this rule. EPA's complete economic analysis is 
available in the docket under docket ID number EPA-HQ-OPPT-2017-0414.

XII. Statutory and Executive Order Reviews

A. Executive Order 12866

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

B. Paperwork Reduction Act (PRA)

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

[[Page 49049]]

needed, and complete, review, and submit the required SNUN.
    Send any comments about the accuracy of the burden estimate, and 
any suggested methods for minimizing respondent burden, including 
through the use of automated collection techniques, to the Director, 
Regulatory Support Division, Office of Mission Support (2822T), 
Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington, 
DC 20460-0001. Please remember to include the OMB control number in any 
correspondence, but do not submit any completed forms to this address.

C. Regulatory Flexibility Act (RFA)

    Pursuant to RFA section 605(b), 5 U.S.C. 601 et seq., the Agency 
hereby certifies that promulgation of this SNUR will not have a 
significant adverse economic impact on a substantial number of small 
entities. The requirement to submit a SNUN applies to any person 
(including small or large entities) who intends to engage in any 
activity described in the final rule as a ``significant new use.'' 
Because these uses are ``new,'' based on all information currently 
available to EPA, it appears that no small or large entities presently 
engage in such activities. A SNUR requires that any person who intends 
to engage in such activity in the future must first notify EPA by 
submitting a SNUN. Although some small entities may decide to pursue a 
significant new use in the future, EPA cannot presently determine how 
many, if any, there may be. However, EPA's experience to date is that, 
in response to the promulgation of SNURs covering over 1,000 chemicals, 
the Agency receives only a small number of notices per year. For 
example, the number of SNUNs received was seven in Federal fiscal year 
(FY) 2013, 13 in FY2014, six in FY2015, 10 in FY2016, 14 in FY2017, and 
18 in FY2018 and only a fraction of these were from small businesses. 
In addition, the Agency currently offers relief to qualifying small 
businesses by reducing the SNUN submission fee from $16,000 to $2,800. 
This lower fee reduces the total reporting and recordkeeping of cost of 
submitting a SNUN to about $10,116 for qualifying small firms. 
Therefore, the potential economic impacts of complying with this SNUR 
are not expected to be significant or adversely impact a substantial 
number of small entities. In a SNUR that published in the Federal 
Register of June 2, 1997 (62 FR 29684) (FRL-5597-1), the Agency 
presented its general determination that final SNURs are not expected 
to have a significant economic impact on a substantial number of small 
entities, which was provided to the Chief Counsel for Advocacy of the 
Small Business Administration.

D. Unfunded Mandates Reform Act (UMRA)

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

E. Executive Order 13132

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

F. Executive Order 13175

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

G. Executive Order 13045

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

H. Executive Order 13211

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

I. National Technology Transfer and Advancement Act (NTTAA)

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

J. Executive Order 12898

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

XIII. Congressional Review Act

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

List of Subjects

40 CFR Part 9

    Environmental protection, Reporting and recordkeeping requirements.

40 CFR Part 721

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

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

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

PART 9--[AMENDED]

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

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

0
2. In Sec.  9.1, add tSec. Sec.  721.11068 through 721.11094 in 
numerical order under the

[[Page 49050]]

undesignated center heading ``Significant New Uses of Chemical 
Substances'' to read as follows:

Sec.  9.1  OMB approvals under the Paperwork Reduction Act.

------------------------------------------------------------------------
                                                            OMB control
                     40 CFR citation                            No.
------------------------------------------------------------------------
 
                                * * * * *
------------------------------------------------------------------------
               Significant New Uses of Chemical Substances
------------------------------------------------------------------------
 
                                * * * * *
721.11068...............................................       2070-0012
721.11069...............................................       2070-0012
721.11070...............................................       2070-0012
721.11071...............................................       2070-0012
721.11072...............................................       2070-0012
721.11073...............................................       2070-0012
721.11074...............................................       2070-0012
721.11075...............................................       2070-0012
721.11076...............................................       2070-0012
721.11077...............................................       2070-0012
721.11078...............................................       2070-0012
721.11079...............................................       2070-0012
721.11080...............................................       2070-0012
721.11081...............................................       2070-0012
721.11083...............................................       2070-0012
721.11084...............................................       2070-0012
721.11085...............................................       2070-0012
721.11086...............................................       2070-0012
721.11087...............................................       2070-0012
721.11088...............................................       2070-0012
721.11089...............................................       2070-0012
721.11090...............................................       2070-0012
721.11091...............................................       2070-0012
721.11092...............................................       2070-0012
721.11093...............................................       2070-0012
721.11094...............................................       2070-0012
 
                                * * * * *
------------------------------------------------------------------------

* * * * *

PART 721--[AMENDED]

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

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

0
4. Add Sec. Sec.  721.11068 through 721.11094 to subpart E to read as 
follows:

Subpart E--Significant New Uses for Specific Chemical Substances

Sec.
* * * * *
721.11068 Alkanes, C20-28, chloro.
721.11069 Slack waxes (petroleum), chloro.
721.11070 Hexacosane, chloro derivs. and octacosane, chloro derivs.
721.11071 Alkanes, C20-24, chloro.
721.11072 Alkanes, C14-16, chloro.
721.11073 Tetradecane, chloro derivs.
721.11074 Octadecane, chloro derivs.
721.11075 Alkanes, C18-20, chloro.
721.11076 Alkanes, C14-17, chloro.
721.11077 Alkanes, C22-30, chloro.
721.11078 Chlorofluorocarbon (generic).
721.11079 Silane, 1,1'-(1,2-ethanediyl)bis[1,1-dichloro-1-methyl]-, 
hydrolysis products with chloroethenyldimethylsilane.
721.11080 Silicophosphonate--sodium silicate (generic).
721.11081 3-Butenenitrile, 2-(acetyloxy).
721.11082 [Reserved]
721.11083 Alkenoic acid, reaction products with polyethylene glycol 
ether with hydroxyalkyl substituted alkane (generic).
721.11084 Alkyl substituted alkenoic acid, alkyl ester, polymer with 
alkyl substituted alkenoate and alkenoic acid, hydroxy 
substituted[(oxoalkyl)oxy]alkyl ester, reaction products with 
alkanoic acid, dipentaerythritil and isocyanate substituted 
carbomonocycle, compds. with alkylamine (generic).
721.11085 Heteromonocycle ester with alkanediol (generic).
721.11086 Substituted carbomonocycle, polymer with (aminoalkyl)-
alkanediamine, (haloalkyl)oxirane, dialkyl-alkanediamine and alkyl-
alkanamine, reaction products with dialkanolamine and 
[[(alkyl)oxy]alkyl]oxirane (generic).
721.11087 Carboxylic acid amine (1:1) (generic).
721.11088 Mix fatty acids compd with amine (1:1) (generic).
721.11089 Mix fatty acids compd with amine (1:1) (generic).
721.11090 Bicyclo[2.2.1]heptane-1-methanesulfonic acid, 7,7-
dimethyl-2-oxo-, compd. with N,N-diethylethanamine (1:1).
721.11091 Manganese (2+), bisoctahydro-1,4,7-trimethyl-1H-1,4,7-
triazonine-.kappa.N1,.kappa.N4,.kappa.N7) tri-.mu.-oxidi-, 
hexafluorophosphate(1-) (1:2).
721.11092 2'-Fluoro-4''-alkyl-4-propyl-1,1':4'1''-terphenyl 
(generic).
721.11093 4-ethyl-2'-fluoro-4''-alkyl-1,1':4',1''-terphenyl 
(generic).
721.11094 Poly(oxy-1,2-ethanediyl),alpha-(2-benzoyl)-omega-[(2-
benzoylbenzoyl)oxy]-.
* * * * *

Sec.  721.11068  Alkanes, C20-28, chloro.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified as alkanes, 
C20-28, chloro (PMN P-12-277, CAS No. 2097144-43-7) is 
subject to reporting under this section for the significant new uses 
described in paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Industrial, commercial, and consumer activities. It is a 
significant new use to use the substance for other than as a flame 
retardants and plasticizers in polyvinyl chloride, polymers, and 
rubber; flame retardant, plasticizer, and lubricant in adhesives, 
caulk, sealants, and coatings; additive in lubricants including 
metalworking fluids; and flame retardant and waterproofer in textiles; 
and a confidential adhesives additive use. It is a significant new use 
to manufacture the chemical substance more than 5 years.
    (ii) [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph (b).
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125(a) through (c) and (i) are applicable to manufacturers and 
processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.

Sec.  721.11069  Slack waxes (petroleum), chloro.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified as slack waxes 
(petroleum), chloro (PMN P-12-278, CAS No. 2097144-44-8) is subject to 
reporting under this section for the significant new uses described in 
paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80(k) (flame retardants and plasticizers in 
polyvinyl chloride, polymers, and rubber; flame retardant, plasticizer, 
and lubricant in adhesives, caulk, sealants, and coatings; additive in 
lubricants including metalworking fluids; and flame retardant and 
waterproofer in textiles). It is a significant new use to manufacture 
the chemical substance more than 5 years.
    (ii) [Reserved].
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph (b).
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125(a) through (c) and (i) are applicable to manufacturers and 
processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.

Sec.  721.11070  Hexacosane, chloro derivs. and octacosane, chloro 
derivs.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified as hexacosane, chloro 
derivs. and octacosane, chloro derivs. (PMN P-12-280, CAS Nos. 2097144-
46-0 and 2097144-47-1) is subject to reporting under this section for 
the significant new uses described in paragraph (a)(2) of this section.

[[Page 49051]]

    (2) The significant new uses are:
    (i) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80(k) (flame retardants and plasticizers in 
polyvinyl chloride, polymers, and rubber; flame retardant, plasticizer, 
and lubricant in adhesives, caulk, sealants, and coatings; additive in 
lubricants including metalworking fluids; and flame retardant and 
waterproofer in textiles). It is a significant new use to manufacture 
the chemical substance more than 5 years.
    (ii) [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph (b).
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125(a) through (c) and (i) are applicable to manufacturers and 
processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.

Sec.  721.11071  Alkanes, C20-24, chloro.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified as alkanes, 
C20-24, chloro (PMN P-12-281, CAS No. 2097144-45-9) is 
subject to reporting under this section for the significant new uses 
described in paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80(k) (flame retardants and plasticizers in 
polyvinyl chloride, polymers, and rubber; flame retardant, plasticizer, 
and lubricant in adhesives, caulk, sealants, and coatings; additive in 
lubricants including metalworking fluids; and flame retardant and 
waterproofer in textiles). It is a significant new use to manufacture 
the chemical substance more than 5 years.
    (ii) [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph (b).
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125(a) through (c) and (i) are applicable to manufacturers and 
processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.

Sec.  721.11072  Alkanes, C14-16, chloro.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified as alkanes, 
C14-16, chloro (PMNs P-12-282 and P-14-684, CAS No. 1372804-
76-6) is subject to reporting under this section for the significant 
new uses described in paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80(k) (flame retardants and plasticizers in 
polyvinyl chloride, polymers, and rubber; flame retardant, plasticizer, 
and lubricant in adhesives, caulk, sealants, and coatings; additive in 
lubricants including metalworking fluids; and flame retardant and 
waterproofer in textiles). It is a significant new use to manufacture 
the chemical substance more than 5 years.
    (ii) [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph (b).
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125(a) through (c) and (i) are applicable to manufacturers and 
processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.

Sec.  721.11073  Tetradecane, chloro derivs.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified as tetradecane, chloro 
derivs. (PMNs P-12-283 and P-14-683, CAS No. 198840-65-2) is subject to 
reporting under this section for the significant new uses described in 
paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80(k) (flame retardants and plasticizers in 
polyvinyl chloride, polymers, and rubber; flame retardant, plasticizer, 
and lubricant in adhesives, caulk, sealants, and coatings; additive in 
lubricants including metalworking fluids; and flame retardant and 
waterproofer in textiles). It is a significant new use to manufacture 
the chemical substance more than 5 years.
    (ii) [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph (b).
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125(a) through (c) and (i) are applicable to manufacturers and 
processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.

Sec.  721.11074  Octadecane, chloro derivs.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified as octadecane, chloro 
derivs. (PMN P-12-284, CAS No. 2097144-48-2) is subject to reporting 
under this section for the significant new uses described in paragraph 
(a)(2) of this section.
    (2) The significant new uses are:
    (i) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80(k) (flame retardants and plasticizers in 
polyvinyl chloride, polymers, and rubber; flame retardant, plasticizer, 
and lubricant in adhesives, caulk, sealants, and coatings; additive in 
lubricants including metalworking fluids; and flame retardant and 
waterproofer in textiles). It is a significant new use to manufacture 
the chemical substance more than 5 years.
    (ii) [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph (b).
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125(a) through (c) and (i) are applicable to manufacturers and 
processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.

Sec.  721.11075  Alkanes, C18-20, chloro.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified as alkanes, 
C18-20, chloro (PMN P-12-433, CAS No. 106262-85-3) is 
subject to reporting under this section for the significant new uses 
described in paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80(k) (flame retardants and plasticizers in 
polyvinyl chloride, polymers, and rubber; flame retardant, plasticizer, 
and lubricant in adhesives, caulk, sealants, and coatings; additive in 
lubricants including metalworking fluids; and flame retardant and 
waterproofer in textiles). It is a significant new use to manufacture 
the chemical substance more than 5 years.
    (ii) [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part

[[Page 49052]]

apply to this section except as modified by this paragraph (b).
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125(a) through (c) and (i) are applicable to manufacturers and 
processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.

Sec.  721.11076  Alkanes, C14-17, chloro.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified as alkanes, 
C14-17, chloro (PMN P-12-453, CAS No. 85535-85-9) is subject 
to reporting under this section for the significant new uses described 
in paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80(k) (flame retardants and plasticizers in 
polyvinyl chloride polymers, and rubber; flame retardant, plasticizer, 
and lubricant in adhesives, caulk, sealants, and coatings; additive in 
lubricants including metalworking fluids; and flame retardant and 
waterproofer in textiles). It is a significant new use to manufacture 
the chemical substance more than 5 years.
    (ii) [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph (b).
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125(a) through (c) and (i) are applicable to manufacturers and 
processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.

Sec.  721.11077  Alkanes, C22-30, chloro.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified as alkanes, 
C22-30, chloro (PMN P-12-505, CAS No. 288260-42-4) is 
subject to reporting under this section for the significant new uses 
described in paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80(k) (flame retardants and plasticizers in 
polyvinyl chloride, polymers, and rubber; flame retardant, plasticizer, 
and lubricant in adhesives, caulk, sealants, and coatings; additive in 
lubricants including metalworking fluids; and flame retardant and 
waterproofer in textiles). It is a significant new use to manufacture 
the chemical substance more than 5 years.
    (ii) [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph (b).
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125(a) through (c) and (i) are applicable to manufacturers and 
processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.

Sec.  721.11078  Chlorofluorocarbon (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 
chlorofluorocarbon (PMN P-16-150) is subject to reporting under this 
section for the significant new uses described in paragraph (a)(2) of 
this section.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in Sec.  
721.63(a)(1), (3), and (4), when determining which persons are 
reasonably likely to be exposed as required for Sec.  721.63(a)(1) and 
(4), engineering control measures (e.g., enclosure or confinement of 
the operation, general and local ventilation) or administrative control 
measures (e.g., workplace policies and procedures) shall be considered 
and implemented to prevent exposure, where feasible, (a)(5) 
(respirators must provide a National Institute for Occupational Safety 
and Health (NIOSH) assigned protection factor (APF) of at least 1,000), 
(a)(6)(liquid), and (c).
    (A) As an alternative to the respirator requirements in paragraph 
(a)(2)(i) of this section, a manufacturer or processor may choose to 
follow the new chemical exposure limit (NCEL) provision listed in the 
TSCA section 5(e) Order for this substance. The NCEL is 170 ppb as an 
8-hour time weighted average. Persons who wish to pursue NCELs as an 
alternative to Sec.  721.63 respirator requirements may request to do 
so under Sec.  721.30. Persons whose Sec.  721.30 requests to use the 
NCELs approach are approved by EPA will be required to follow NCELs 
provisions comparable to those contained in the corresponding TSCA 
section 5(e) Order.
    (B) [Reserved]
    (ii) Hazard communication. Requirements as specified in Sec.  
721.72(a) through (d), (f), (g)(1)(fatal if inhaled), (g)(2)(ii), (iv), 
(use respiratory protection or maintain workplace airborne 
concentrations at or below an 8-hour time-weighted average of 170 ppb), 
(g)(2)(v), (g)(3)(i), (ii), (g)(4)(release to water restrictions 
apply), and (g)(5). Alternative hazard and warning statements that meet 
the criteria of the Globally Harmonized System (GHS) and OSHA Hazard 
Communication Standard may be used.
    (iii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80(a) through (c), (g), and (q). It is a 
significant new use to manufacture, process, or use the PMN substance 
without the engineering controls described in the corresponding TSCA 
section 5(e) Order to prevent worker and environmental exposures. It is 
a significant new use to manufacture the chemical substance more than 
one year.
    (iv) Release to water. Requirements as specified in Sec.  
721.90(a)(4), (b)(4), and (c)(4) where N= 240.
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph (b).
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125(a) through (i) and (k) are applicable to manufacturers and 
processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.
    (3) Determining whether a specific use is subject to this section. 
The provisions of Sec.  721.1725(b)(1) apply to paragraph (a)(2)(iii) 
of this section.

Sec.  721.11079  Silane, 1,1'-(1,2-ethanediyl)bis[1,1-dichloro-1-
methyl]-, hydrolysis products with chloroethenyldimethylsilane.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified as Silane, 1,1'-(1,2-
ethanediyl)bis[1,1-dichloro-1-methyl]-, hydrolysis products with 
chloroethenyldimethylsilane (PMN P-16-379, CAS No. 1485477-78-8) is 
subject to reporting under this section for the significant new uses 
described in paragraph (a)(2) of this section. The requirements of this 
section do not apply to quantities of the substance after they have 
been reacted (cured).
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in Sec.  
721.63(a)(1), (a)(2)(i), (iv), (a)(3), when determining which persons 
are reasonably likely to be exposed as required for Sec.  721.63(a)(1) 
engineering control measures (e.g., enclosure or

[[Page 49053]]

confinement of the operation, general and local ventilation) or 
administrative control measures (e.g., workplace policies and 
procedures) shall be considered and implemented to prevent exposure, 
where feasible, (a)(6)(particulate), (a)(6)(v), (vi), (b)(concentration 
set at 1.0%), and (c).
    (ii) Hazard communication. Requirements as specified in Sec.  
721.72(a) through (e)(concentration set at 1.0%), (f), (g)(1) (liver 
toxicity), (mutagenicity), (g)(2)(i), (ii), (iii), (v), (g)(4)(i), (do 
not incinerate), and (g)(5). Alternative hazard and warning statements 
that meet the criteria of the Globally Harmonized System (GHS) and OSHA 
Hazard Communication Standard may be used.
    (iii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80(f), (k), (q), (y)(1) and (2).
    (iv) Disposal. Requirements as specified in Sec.  721.85(a) 
(water), (a)(2), (b) (water), (b)(2), (c) (water), and (c)(2).
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph (b).
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125(a) through (j) are applicable to manufacturers and processors 
of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.
    (3) Determining whether a specific use is subject to this section. 
The provisions of Sec.  721.1725(b)(1) apply to paragraph (a)(2)(iii) 
of this section.

Sec.  721.11080  Silicophosphonate--sodium silicate (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 
silicophosphonate--sodium silicate (PMN P-16-410) is subject to 
reporting under this section for the significant new uses described in 
paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80(f) and (k). A significant new use is any 
use in formulations containing greater than 23% of the chemical 
substance.
    (ii) [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph (b).
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125(a) through (c) and (i) are applicable to manufacturers and 
processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.
    (3) Determining whether a specific use is subject to this section. 
The provisions of Sec.  721.1725(b)(1) apply to paragraph (a)(2)(i) of 
this section.

Sec.  721.11081  3-Butenenitrile, 2-(acetyloxy).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified as 3-butenenitrile, 2-
(acetyloxy) (PMN P-16-438, CAS No. 15667-63-7) is subject to reporting 
under this section for the significant new uses described in paragraph 
(a)(2) of this section.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in Sec.  
721.63(a)(1), (a)(2)(i), (ii), (iii), (a)(3), (a)(4), when determining 
which persons are reasonably likely to be exposed as required for Sec.  
721.63(a)(1) and (4), engineering control measures (e.g., enclosure or 
confinement of the operation, general and local ventilation) or 
administrative control measures (e.g., workplace policies and 
procedures) shall be considered and implemented to prevent exposure, 
where feasible, (a)(5) (respirators must provide a National Institute 
for Occupational Safety and Health (NIOSH) assigned protection factor 
(APF) of at least 1000), (a)(6)(particulate), (a)(6)(v), (vi), 
(b)(concentration set at 1.0%), and (c). It is a significant new use to 
manufacture, process or use the substance without following the 
monitoring procedure as specified in the worker protection section of 
the corresponding TSCA section 5(e) Order.
    (ii) Hazard communication. Requirements as specified in Sec.  
721.72(a) through (e)(concentration set at 1.0%), (f), (g)(1)(fatal if 
swallowed), (fatal if in contact with skin), (toxic if inhaled), 
(g)(2)(i), (ii), (iii), (iv), (v), (g)(3)(i), (ii), (g)(4)(i), (ii), 
(iii), and (g)(5). Alternative hazard and warning statements that meet 
the criteria of the Globally Harmonized System (GHS) and OSHA Hazard 
Communication Standard may be used.
    (iii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80(g). It is a significant new use to 
manufacture or use the substance other than in an enclosed system as 
described in the PMN.
    (iv) Release to water. Requirements as specified in Sec.  
721.90(a)(1), (b)(1), and (c)(1).
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph (b).
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125(a) through (i) and (k) are applicable to manufacturers and 
processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.
    (3) Determining whether a specific use is subject to this section. 
The provisions of Sec.  721.1725(b)(1) apply to paragraph (a)(2)(iii) 
of this section.

Sec.  721.11082  [Reserved]

Sec.  721.11083  Alkenoic acid, reaction products with polyethylene 
glycol ether with hydroxyalkyl substituted alkane (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 
alkenoic acid, reaction products with polyethylene glycol ether with 
hydroxyalkyl substituted alkane (PMN P-16-596) is subject to reporting 
under this section for the significant new uses described in paragraph 
(a)(2) of this section. The requirements of this section do not apply 
to quantities of the substance after they have been reacted (cured).
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in Sec.  
721.63(a)(1), (a)(2)(i), (a)(3), when determining which persons are 
reasonably likely to be exposed as required for Sec.  721.63(a)(1) 
engineering control measures (e.g., enclosure or confinement of the 
operation, general and local ventilation) or administrative control 
measures (e.g., workplace policies and procedures) shall be considered 
and implemented to prevent exposure, where feasible, (b)(concentration 
set at 0.1%), and (c).
    (ii) Hazard communication. Requirements as specified in Sec.  
721.72 (a) through (e) (concentration set at 0.1%), (f), (g)(1)(i), 
(dermal sensitization), (g)(1)(iv), (cancer, if inhaled), (g)(1)(ix), 
(g)(2)(i), (ii), (iii), (v), (g)(4)(iii), and (g)(5). Alternative 
hazard and warning statements that meet the criteria of the Globally 
Harmonized System (GHS) and OSHA Hazard Communication Standard may be 
used.
    (iii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80(f), (k), and (q).
    (iv) Release to water. Requirements as specified in Sec.  
721.90(a)(1), (b)(1), and (c)(1).

[[Page 49054]]

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

Sec.  721.11084  Alkyl substituted alkenoic acid, alkyl ester, polymer 
with alkyl substituted alkenoate and alkenoic acid, hydroxy 
substituted[(oxoalkyl)oxy]alkyl ester, reaction products with alkanoic 
acid, dipentaerythritil and isocyanate substituted carbomonocycle, 
compds. with alkylamine (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as alkyl 
substituted alkenoic acid, alkyl ester, polymer with alkyl substituted 
alkenoate and alkenoic acid, hydroxy substituted[(oxoalkyl)oxy]alkyl 
ester, reaction products with alkanoic acid, dipentaerythritil and 
isocyanate substituted carbomonocycle, compds. with alkylamine (PMN P-
17-10) is subject to reporting under this section for the significant 
new uses described in paragraph (a)(2) of this section. The 
requirements of this section do not apply to quantities of the 
substance after they have been reacted (cured).
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in Sec.  
721.63(a)(1), (a)(2)(i), (a)(3), when determining which persons are 
reasonably likely to be exposed as required for Sec.  721.63(a)(1), 
engineering control measures (e.g., enclosure or confinement of the 
operation, general and local ventilation) or administrative control 
measures (e.g., workplace policies and procedures) shall be considered 
and implemented to prevent exposure, where feasible, 
(a)(6)(particulate), (a)(6)(v), (vi), (b)(concentration set at 0.1%), 
and (c).
    (ii) Hazard communication. Requirements as specified in Sec.  
721.72(a) through (e)(concentration set at 0.1%), (f), (g)(1)(i), 
(sensitization), (g)(1)(vii), (systemic effects), (g)(1)(ix), 
(g)(2)(i), (ii), (iii), (v), and (g)(5). Alternative hazard and warning 
statements that meet the criteria of the Globally Harmonized System 
(GHS) and OSHA Hazard Communication Standard may be used.
    (iii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80(f), (k)(ultraviolet curable coating 
resin), and (y)(1). It is a significant new use to manufacture the 
chemical substance with an average molecular weight below 2,000 daltons 
or containing greater than 0.1% residual isocyanate. It is a 
significant new use to import the substance other than in totes.
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph (b).
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125(a) through (i) are applicable to manufacturers and processors 
of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.

Sec.  721.11085  Heteromonocycle ester with alkanediol (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 
heteromonocycle ester with alkanediol (PMN P-17-15) is subject to 
reporting under this section for the significant new uses described in 
paragraph (a)(2) of this section. The requirements of this section do 
not apply to quantities of the substance after they have been reacted 
(cured).
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in Sec.  
721.63(a)(1), (a)(2)(i), (iii), (iv), (a)(3), when determining which 
persons are reasonably likely to be exposed as required for Sec.  
721.63(a)(1) engineering control measures (e.g., enclosure or 
confinement of the operation, general and local ventilation) or 
administrative control measures (e.g., workplace policies and 
procedures) shall be considered and implemented to prevent exposure, 
where feasible, (b)(concentration set at 1.0%), and (c).
    (ii) Hazard communication. Requirements as specified in Sec.  
721.72(a) through (e) (concentration set at 1.0%), (f), (g)(1)(i), 
(g)(2)(i), (ii), (iii), (v), (g)(3)(i), (ii), (g)(4) (release to water 
restrictions apply), and (g)(5). Alternative hazard and warning 
statements that meet the criteria of the Globally Harmonized System 
(GHS) and OSHA Hazard Communication Standard may be used.
    (iii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80(f), (k), and (q).
    (iv) Release to water. Requirements as specified in Sec.  
721.90(a)(4), (b)(4), and (c)(4) where N=3.
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph (b).
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125(a) through (i) and (k) are applicable to manufacturers and 
processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.
    (3) Determining whether a specific use is subject to this section. 
The provisions of Sec.  721.1725(b)(1) apply to paragraph (a)(2)(iii) 
of this section.

Sec.  721.11086  Substituted carbomonocycle, polymer with (aminoalkyl)-
alkanediamine, (haloalkyl)oxirane, dialkyl-alkanediamine and alkyl-
alkanamine, reaction products with dialkanolamine and 
[[(alkyl)oxy]alkyl]oxirane (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 
substituted carbomonocycle, polymer with (aminoalkyl)-alkanediamine, 
(haloalkyl)oxirane, dialkyl-alkanediamine and alkyl-alkanamine, 
reaction products with dialkanolamine and [[(alkyl)oxy]alkyl]oxirane 
(PMN P-17-29) is subject to reporting under this section for the 
significant new uses described in paragraph (a)(2) of this section. The 
requirements of this section do not apply to quantities of the 
substance after they have been reacted (cured).
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in Sec.  
721.63(a)(1), (a)(2)(i), (ii), (iii), (a)(3), when determining which 
persons are reasonably likely to be exposed as required for Sec.  
721.63(a)(1) engineering control measures (e.g., enclosure or 
confinement of the operation, general and local ventilation) or 
administrative control measures (e.g., workplace policies and 
procedures) shall be considered and implemented to prevent exposure, 
where feasible, (b)(concentration set at 1.0%), and (c).
    (ii) Hazard communication. Requirements as specified in Sec.  
721.72(a) through (e)(concentration set at 1.0%), (f), (g)(1)(i), (eye 
irritation), (g)(1)(ii), (g)(2)(i), (ii), (iii), (v), (g)(3)(i), (ii), 
(g)(4)(iii), and (g)(5). Alternative hazard and warning statements that 
meet the criteria of the Globally Harmonized System (GHS) and OSHA 
Hazard Communication Standard may be used.
    (iii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80(f), (k), (q), and (y)(1).

[[Page 49055]]

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

Sec.  721.11087  Carboxylic acid amine (1:1) (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 
carboxylic acid amine (1:1) (PMN P-17-154) is subject to reporting 
under this section for the significant new uses described in paragraph 
(a)(2) of this section. The requirements of this section do not apply 
to quantities of the substance after they have been reacted (cured).
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in Sec.  
721.63(a)(1), (a)(2)(i), (ii), (iv), (a)(3), when determining which 
persons are reasonably likely to be exposed as required for Sec.  
721.63(a)(1) engineering control measures (e.g., enclosure or 
confinement of the operation, general and local ventilation) or 
administrative control measures (e.g., workplace policies and 
procedures) shall be considered and implemented to prevent exposure, 
where feasible, (a)(6)(particulate), (a)(6)(v), (vi), (b)(concentration 
set at 1.0%), and (c).
    (ii) Hazard communication. Requirements as specified in Sec.  
721.72(a) through (e)(concentration set at 1.0%), (f), (g)(1)(i), (ii), 
(iii), (thyroid effects), (g)(1)(vi), (ix), (g)(2)(i), (ii), (iii), 
(v), (g)(3)(i), (ii), and (g)(5). Alternative hazard and warning 
statements that meet the criteria of the Globally Harmonized System 
(GHS) and OSHA Hazard Communication Standard may be used.
    (iii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80(q).
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph (b).
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125(a) through (i) are applicable to manufacturers and processors 
of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.
    (3) Determining whether a specific use is subject to this section. 
The provisions of Sec.  721.1725(b)(1) apply to paragraph (a)(2)(iii) 
of this section.

Sec.  721.11088  Mix fatty acids compd with amine (1:1) (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as mix 
fatty acids compd with amine (1:1) (PMN P-17-155) is subject to 
reporting under this section for the significant new uses described in 
paragraph (a)(2) of this section. The requirements of this section do 
not apply to quantities of the PMN substance after they have been 
reacted (cured).
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in Sec.  
721.63(a)(1), (a)(2)(i), (ii), (iv), (a)(3), when determining which 
persons are reasonably likely to be exposed as required for Sec.  
721.63(a)(1) engineering control measures (e.g., enclosure or 
confinement of the operation, general and local ventilation) or 
administrative control measures (e.g., workplace policies and 
procedures) shall be considered and implemented to prevent exposure, 
where feasible, (a)(6)(particulate), (a)(6)(v), (vi), (b)(concentration 
set at 1.0%), and (c).
    (ii) Hazard communication. Requirements as specified in Sec.  
721.72(a) through (e)(concentration set at 1.0%), (f), (g)(1)(i), (ii), 
(iii), (thyroid effects), (g)(1)(vi), (ix), (g)(2)(i), (ii), (iii), 
(v), (g)(3)(i), (ii), and (g)(5). Alternative hazard and warning 
statements that meet the criteria of the Globally Harmonized System 
(GHS) and OSHA Hazard Communication Standard may be used.
    (iii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80(q).
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph (b).
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125(a) through (i) are applicable to manufacturers and processors 
of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.
    (3) Determining whether a specific use is subject to this section. 
The provisions of Sec.  721.1725(b)(1) apply to paragraph (a)(2)(iii) 
of this section.

Sec.  721.11089  Mix fatty acids compd with amine (1:1) (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as mix 
fatty acids compd with amine (1:1) (PMN P-17-156) is subject to 
reporting under this section for the significant new uses described in 
paragraph (a)(2) of this section. The requirements of this section do 
not apply to quantities of the substance after they have been reacted 
(cured).
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in Sec.  
721.63(a)(1), (a)(2)(i), (iii), (iv), (a)(3), when determining which 
persons are reasonably likely to be exposed as required for Sec.  
721.63(a)(1) engineering control measures (e.g., enclosure or 
confinement of the operation, general and local ventilation) or 
administrative control measures (e.g., workplace policies and 
procedures) shall be considered and implemented to prevent exposure, 
where feasible, (a)(6)(particulate), (a)(6)(v), (vi), (b)(concentration 
set a 1.0%), and (c).
    (ii) Hazard communication. Requirements as specified in Sec.  
721.72(a) through (e)(concentration set at 1.0%), (f), (g)(1)(i), (ii), 
(iii), (thyroid effects), (g)(1)(vi), (ix), (g)(2)(i), (ii), (iii), 
(v), (g)(3)(i), (ii), and (g)(5). Alternative hazard and warning 
statements that meet the criteria of the Globally Harmonized System 
(GHS) and OSHA Hazard Communication Standard may be used.
    (iii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80(q).
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph (b).
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125(a) through (i) are applicable to manufacturers and processors 
of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.
    (3) Determining whether a specific use is subject to this section. 
The provisions of Sec.  721.1725(b)(1) apply to paragraph (a)(2)(iii) 
of this section.

[[Page 49056]]

Sec.  721.11090  Bicyclo[2.2.1]heptane-1-methanesulfonic acid, 7,7-
dimethyl-2-oxo-, compd. with N,N-diethylethanamine (1:1).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified as 
bicyclo[2.2.1]heptane-1-methanesulfonic acid, 7,7-dimethyl-2-oxo-, 
compd. with N,N-diethylethanamine (1:1) (PMN P-17-218. CAS No. 67019-
84-5) is subject to reporting under this section for the significant 
new uses described in paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in Sec.  
721.63(a)(1), (a)(2)(i), (a)(3), when determining which persons are 
reasonably likely to be exposed as required for Sec.  721.63(a)(1) 
engineering control measures (e.g., enclosure or confinement of the 
operation, general and local ventilation) or administrative control 
measures (e.g., workplace policies and procedures) shall be considered 
and implemented to prevent exposure, where feasible, 
(a)(6)(particulate), (a)(6)(v), (vi), (b)(concentration set 1.0%), and 
(c).
    (ii) Hazard communication. Requirements as specified in Sec.  
721.72(a) through (e)(concentration set at 1.0%), (f), (g)(1)(i), 
(corrosivity), (sensitization), (g)(1)(iii), (iv), (ix), (g)(2)(i), 
(ii), (iii), (v), and (g)(5). Alternative hazard and warning statements 
that meet the criteria of the Globally Harmonized System (GHS) and OSHA 
Hazard Communication Standard may be used.
    (iii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80(q), (y)(1) and (2).
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph (b).
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125(a) through (i) are applicable to manufacturers and processors 
of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.
    (3) Determining whether a specific use is subject to this section. 
The provisions of Sec.  721.1725(b)(1) apply to paragraph (a)(2)(iii) 
of this section.

Sec.  721.11091  Manganese (2+), bisoctahydro-1,4,7-trimethyl-1H-1,4,7-
triazonine-.kappa.N1,.kappa.N4,.kappa.N7) tri-.mu.-oxidi-, 
hexafluorophosphate(1-) (1:2).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified as manganese (2+), 
bisoctahydro-1,4,7-trimethyl-1H-1,4,7-
triazonine-.kappa.N1,.kappa.N4,.kappa.N7) tri-.mu.-oxidi-, 
hexafluorophosphate(1-) (1:2) (1:1) (PMN P-17-226, CAS No. 116633-52-4) 
is subject to reporting under this section for the significant new uses 
described in paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in Sec.  
721.63(a)(1), (a)(2)(i), (ii), (iii), (a)(3), when determining which 
persons are reasonably likely to be exposed as required for Sec.  
721.63(a)(1) engineering control measures (e.g., enclosure or 
confinement of the operation, general and local ventilation) or 
administrative control measures (e.g., workplace policies and 
procedures) shall be considered and implemented to prevent exposure, 
where feasible, (a)(6)(particulate), (b) (concentration set at 0.1%), 
and (c).
    (ii) Hazard communication. Requirements as specified in Sec.  
721.72(a) through (e)(concentration set at 0.1%), (f), (g)(1)(eye 
irritation), (respiratory sensitization), (g)(1)(iii), (iv), (vi), 
(vii), (viii), (g)(2)(i), (ii), (iii), (v), (g)(3)(i), (ii), 
(g)(4)(release to water provisions apply), and (g)(5). Alternative 
hazard and warning statements that meet the criteria of the Globally 
Harmonized System (GHS) and OSHA Hazard Communication Standard may be 
used.
    (iii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80(f) and (k). It is a significant new use to 
process or use the substance without engineering controls to prevent 
exposure, including dust removal with 99.9% efficiency when loading or 
unloading the substance in powder form.
    (iv) Release to water. Requirements as specified in Sec.  
721.90(a)(4), (b)(4), and (c)(4) where N=240.
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph (b).
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125(a) through (i) and (k) are applicable to manufacturers and 
processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.
    (3) Determining whether a specific use is subject to this section. 
The provisions of Sec.  721.1725(b)(1) apply to paragraph (a)(2)(iii) 
of this section.

Sec.  721.11092  2'-Fluoro-4''-alkyl-4-propyl-1,1':4'1''-terphenyl 
(generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 2'-
fluoro-4''-alkyl-4-propyl-1,1':4'1''-terphenyl (PMN P-17-228) is 
subject to reporting under this section for the significant new uses 
described in paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in Sec.  
721.63(a)(1), (a)(2)(i), (a)(3), when determining which persons are 
reasonably likely to be exposed as required for Sec.  721.63(a)(1) 
engineering control measures (e.g., enclosure or confinement of the 
operation, general and local ventilation) or administrative control 
measures (e.g., workplace policies and procedures) shall be considered 
and implemented to prevent exposure, where feasible, (b) (concentration 
set at 1.0%), and (c).
    (ii) Hazard communication. Requirements as specified in Sec.  
721.72(a) through (e)(concentration set at 1.0%), (f), (g)(1)(vi), 
(adrenal effects), (liver effects), (g)(2)(i), (ii), (iii), (v), and 
(g)(5). Alternative hazard and warning statements that meet the 
criteria of the Globally Harmonized System (GHS) and OSHA Hazard 
Communication Standard may be used.
    (iii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80(t) and (y)(1).
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph (b).
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125(a) through (i) are applicable to manufacturers and processors 
of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.
    (3) Determining whether a specific use is subject to this section. 
The provisions of Sec.  721.1725(b)(1) apply to paragraph (a)(2)(iii) 
of this section.

Sec.  721.11093  4-ethyl-2'-fluoro-4''-alkyl-1,1'4',1''-terphenyl 
(generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 4-
ethyl-2'-fluoro-4''-alkyl-1,1':4'',1'-terphenyl (PMN P-17-229) is 
subject to reporting under this section for the significant new uses 
described in paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in

[[Page 49057]]

Sec.  721.63(a)(1), (a)(2)(i), (a)(3), when determining which persons 
are reasonably likely to be exposed as required for Sec.  721.63(a)(1) 
engineering control measures (e.g., enclosure or confinement of the 
operation, general and local ventilation) or administrative control 
measures (e.g., workplace policies and procedures) shall be considered 
and implemented to prevent exposure, where feasible, (b)(concentration 
set 1.0%), and (c).
    (ii) Hazard communication. Requirements as specified in Sec.  
721.72(a) through (e)(concentration set 1.0%), (f), (g)(1)(vi), 
(adrenal effects), (liver effects), (g)(2)(i), (ii), (iii), (v), and 
(g)(5).
    (iii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80(t) and (y)(1).
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph (b).
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125(a) through (i) are applicable to manufacturers and processors 
of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.
    (3) Determining whether a specific use is subject to this section. 
The provisions of Sec.  721.1725(b)(1) apply to paragraph (a)(2)(iii) 
of this section.

Sec.  721.11094  Poly(oxy-1,2-ethanediyl),alpha-(2-benzoyl)-omega-[(2-
benzoylbenzoyl)oxy]-.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified as poly(oxy-1,2-
ethanediyl),alpha-(2-benzoyl)-omega-[(2-benzoylbenzoyl)oxy]- (PMN P-17-
261; CAS No. 1246194-73-9) is subject to reporting under this section 
for the significant new uses described in paragraph (a)(2) of this 
section. The requirements of this section do not apply to quantities of 
the substance after they have been reacted (cured).
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in Sec.  
721.63(a)(1), (a)(2)(i), (a)(3), when determining which persons are 
reasonably likely to be exposed as required for Sec.  721.63(a)(1) 
engineering control measures (e.g., enclosure or confinement of the 
operation, general and local ventilation) or administrative control 
measures (e.g., workplace policies and procedures) shall be considered 
and implemented to prevent exposure, where feasible, (b)(concentration 
set at 1.0%), and (c).
    (ii) Hazard communication. Requirements as specified in Sec.  
721.72(a) through (e) (concentration set at 1.0%), (f), 
(g)(1)(irritation), (photosensitization), (g)(2)(i), (ii), (iii), (v), 
and (g)(5).
    (iii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80(f) and (q).
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph (b).
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125(a) through (i) are applicable to manufacturers and processors 
of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.
    (3) Determining whether a specific use is subject to this section. 
The provisions of Sec.  721.1725(b)(1) apply to paragraph (a)(2)(iii) 
of this section.

[FR Doc. 2019-19667 Filed 9-17-19; 8:45 am]
 BILLING CODE 6560-50-P