[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:
[email protected].
For general information contact: The TSCA-Hotline, ABVI-Goodwill,
422 South Clinton Ave., Rochester, NY 14620; telephone number: (202)
554-1404; email address: [email protected].
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this action apply to me?
You may be potentially affected by this action if you manufacture,
process, or use the chemical substances contained in this rule. The
following list of North American Industrial Classification System
(NAICS) codes is not intended to be exhaustive, but rather provides a
guide to help readers determine whether this document applies to them.
Potentially affected entities may include:
Manufacturers or processors of one or more subject
chemical substances (NAICS codes 325 and 324110), e.g., chemical
manufacturing and petroleum refineries.
This action may also affect certain entities through pre-existing
import certification and export notification rules under TSCA. Chemical
importers are subject to the TSCA section 13 (15 U.S.C. 2612) import
certification requirements promulgated at 19 CFR 12.118 through 12.127
and 19 CFR 127.28. Chemical importers must certify that the shipment of
the chemical substance complies with all applicable rules and Orders
under TSCA. Importers of chemicals subject to these SNURs must certify
their compliance with the SNUR requirements. The EPA policy in support
of import certification appears at 40 CFR part 707, subpart B. In
addition, any persons who export or intend to export a chemical
substance that is the subject of this rule on or after October 18, 2019
are subject to the export notification provisions of TSCA section 12(b)
(15 U.S.C. 2611(b)) (see 40 CFR 721.20), and must comply with the
export notification requirements in 40 CFR part 707, subpart D.
II. Background
A. What action is the Agency taking?
EPA is finalizing these SNURs under TSCA section 5(a)(2) for 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