Significant New Use Rules on Certain Chemical Substances (20-1.5e)

Published date17 September 2020
Citation85 FR 57968
Record Number2020-18883
SectionRules and Regulations
CourtEnvironmental Protection Agency
57968
Federal Register / Vol. 85, No. 181 / Thursday, September 17, 2020 / Rules and Regulations
Privacy Act programs and reducing
costs to the public as explained in the
preamble of the DoD-level Privacy rule
published at 84 FR 14728.
This rule is not significant under
Executive Order (E.O.) 12866,
‘‘Regulatory Planning and Review.’’
Therefore, E.O. 13771, ‘‘Reducing
Regulation and Controlling Regulatory
Costs,’’ does not apply.
List of Subjects in 32 CFR Part 327
Privacy.
PART 327—[REMOVED]
Accordingly, by the authority of 5
U.S.C. 301, 32 CFR part 327 is removed.
Dated: August 19, 2020.
Aaron T. Siegel,
Alternate OSD Federal Register Liaison
Officer, Department of Defense.
[FR Doc. 2020–18522 Filed 9–16–20; 8:45 am]
BILLING CODE 5001–06–P
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Parts 9 and 721
[EPA–HQ–OPPT–2019–0596; FRL–10013–
34]
RIN 2070–AB27
Significant New Use Rules on Certain
Chemical Substances (20–1.5e)
AGENCY
: Environmental Protection
Agency (EPA).
ACTION
: Final rule.
SUMMARY
: EPA is issuing significant new
use rules (SNURs) under the Toxic
Substances Control Act (TSCA) for
chemical substances that were the
subject of premanufacture notices
(PMNs) and are subject to Orders issued
by EPA pursuant to TSCA. This action
requires persons to notify EPA at least
90 days before commencing
manufacture (defined by statute to
include import) or processing of any of
these chemical substances for an
activity that is designated as a
significant new use by this rule. The
required notification initiates EPA’s
evaluation of the chemical under the
conditions of use 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 as a result of that
determination.
DATES
: This rule is effective on
November 16, 2020. For purposes of
judicial review, this rule shall be
promulgated at 1 p.m. (EST) on October
1, 2020.
FOR FURTHER INFORMATION CONTACT
: For
technical information contact: William
Wysong, Chemical Control Division
(7405M), Office of Pollution Prevention
and Toxics, Environmental Protection
Agency, 1200 Pennsylvania Ave. NW,
Washington, DC 20460–0001; telephone
number: (202) 564–4163; email address:
wysong.william@epa.gov.
For general information contact: The
TSCA-Hotline, ABVI-Goodwill, 422
South Clinton Ave., Rochester, NY
14620; telephone number: (202) 554–
1404; email address: TSCA-Hotline@
epa.gov.
SUPPLEMENTARY INFORMATION
:
I. General Information
A. Does this action apply to me?
You may be potentially affected by
this action if you manufacture, process,
or use the chemical substances
contained in this rule. The following list
of North American Industrial
Classification System (NAICS) codes is
not intended to be exhaustive, but rather
provides a guide to help readers
determine whether this document
applies to them. Potentially affected
entities may include:
Manufacturers or processors of one
or more subject chemical substances
(NAICS codes 325 and 324110), e.g.,
chemical manufacturing and petroleum
refineries.
This action may also affect certain
entities through pre-existing import
certification and export notification
rules under TSCA. Chemical importers
are subject to the TSCA section 13 (15
U.S.C. 2612) import provisions
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, which would include 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 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.
B. How can I access the docket?
The docket includes information
considered by the Agency in developing
the proposed and final rules. The docket
for this action, identified by docket
identification (ID) number EPA–HQ–
OPPT–2019–0596, is available at http://
www.regulations.gov or at the Office of
Pollution Prevention and Toxics Docket
(OPPT Docket), Environmental
Protection Agency Docket Center (EPA/
DC), West William Jefferson Clinton
Bldg., Rm. 3334, 1301 Constitution Ave.
NW, Washington, DC. The Public
Reading Room is open from 8:30 a.m. to
4:30 p.m., Monday through Friday,
excluding legal holidays. The telephone
number for the Public Reading Room is
(202) 566–1744, and the telephone
number for the OPPT Docket is (202)
566–0280.
Due to the public health concerns
related to COVID–19, the EPA Docket
Center (EPA/DC) and Reading Room is
closed to visitors with limited
exceptions. The staff continues to
provide remote customer service via
email, phone, and webform. For the
latest status information on EPA/DC
services and docket access, visit https://
www.epa.gov/dockets.
II. Background
A. What action is the Agency taking?
EPA is finalizing SNURs under TSCA
section 5(a)(2) (15 U.S.C. 2604(a)(2)) for
chemical substances which were the
subject of PMNs P-14-865, P-15-54, P-
16-583, P-17-193, P-17-221, P-17-282, P-
17-334, P-17-386, P-18-12, P-18-18, P-
18-42, P-18-52, P-18-53, P-18-62, P-18-
74, P-18-75, P-18-160, P-18-237, P-18-
287, P-18-292, P-19-51, P-19-55, and P-
19-159.
Previously, in the Federal Register of
May 4, 2020 (85 FR 26419) (FRL–10007–
65), EPA proposed SNURs for these
chemical substances and established the
record for these SNURs in the docket
under docket ID number EPA–HQ–
OPPT–2019–0596. That docket includes
information considered by the Agency
in developing the proposed and final
rules, including public comments and
EPA’s responses to the public comments
received.
B. What is the Agency’s authority for
taking this action?
TSCA section 5(a)(2) (15 U.S.C.
2604(a)(2)) authorizes EPA to determine
that a use of a chemical substance is a
‘‘significant new use.’’ EPA must make
this determination by rule after
considering all relevant factors,
including the four bulleted TSCA
section 5(a)(2) factors listed in Unit III.
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,
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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
significant new use notice (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 sections 5(b) and 5(d)(1), the
exemptions authorized by TSCA
sections 5(h)(1), (h)(2), (h)(3), and (h)(5),
and the regulations at 40 CFR part 720.
Once EPA receives a SNUN and before
the manufacture or processing for the
significant new use can commence, EPA
must either determine that the
significant new use is not likely to
present an unreasonable risk of injury or
take such regulatory action as is
associated with an alternative
determination. If EPA determines that
the significant new 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), section 5(f)(4)
requires that the Agency consider
whether to promulgate a SNUR for any
use not conforming to the restrictions of
the TSCA Order or publish a statement
describing the reasons for not initiating
the rulemaking. TSCA section 5(a)(2)
states that EPA’s determination that a
use of a chemical substance is a
significant new use must be made after
consideration of all relevant factors,
including:
The projected volume of
manufacturing and processing of a
chemical substance.
The extent to which a use changes
the type or form of exposure of human
beings or the environment to a chemical
substance.
The extent to which a use increases
the magnitude and duration of exposure
of human beings or the environment to
a chemical substance.
The reasonably anticipated manner
and methods of manufacturing,
processing, distribution in commerce,
and disposal of a chemical substance.
In determining what would constitute
a significant new use for the chemical
substances that are the subject of these
SNURs, EPA considered relevant
information about the toxicity of the
chemical substances, and potential
human exposures and environmental
releases that may be associated with
possible uses of these chemical
substances, in the context of the four
bulleted TSCA section 5(a)(2) factors
listed in this unit.
IV. Public Comments on Proposed Rule
and EPA Responses
EPA received five comments on the
proposed rule: Three from identifying
entities and two that were anonymous.
The Agency’s responses are presented in
the Response to Public Comments
document that is available in the docket
for this rule. EPA made no changes to
the rule provisions based on these
comments.
V. Substances Subject to This Rule
EPA is establishing significant new
use and recordkeeping requirements for
chemical substances in 40 CFR part 721,
subpart E. In Unit IV. of the proposed
SNUR, EPA provided the following
information for each chemical
substance:
PMN number.
Chemical name (generic name, if
the specific name is claimed as
confidential business information
(CBI)).
Chemical Abstracts Service (CAS)
Registry number (if assigned for non-
confidential chemical identities).
Effective date of and basis for the
TSCA Order.
Potentially Useful Information. This
is information identified by EPA that
would help characterize the potential
health and/or environmental effects of
the chemical substances 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 these rules.
The regulatory text section of these
rules specifies the activities designated
as significant new uses. Certain new
uses, including production volume
limits and other uses designated in the
rules, may be claimed as CBI.
These final rules include PMN
substances that are subject to orders
issued under TSCA section 5(e)(1)(A), as
required by the determinations made
under TSCA section 5(a)(3)(B). Those
TSCA Orders require protective
measures to limit exposures or
otherwise mitigate the potential
unreasonable risk. The final SNURs
identify as significant new uses any
manufacturing, processing, use,
distribution in commerce, or disposal
that does not conform to the restrictions
imposed by the underlying TSCA
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 Order usually requires 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). The
comprehensive NCELs provisions in
TSCA Orders include requirements
addressing performance criteria for
sampling and analytical methods,
periodic monitoring, respiratory
protection, and recordkeeping. 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
Order.
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 and as further
discussed in Unit IV. of the proposed
rule, EPA concluded that 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. Based on such
findings, TSCA 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 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 because
the Agency wants 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;
Have an opportunity to review and
evaluate data submitted in a SNUN
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before the notice submitter begins
manufacturing or processing a listed
chemical substance for the described
significant new use; and
Be obligated to make a
determination under TSCA section
5(a)(3) regarding the use described in
the SNUN, under the conditions of use.
The Agency will either determine under
TSCA section 5(a)(3)(C) that the
significant new use is not likely to
present an unreasonable risk, including
an unreasonable risk to a potentially
exposed or susceptible subpopulation
identified as relevant by the
Administrator under the conditions of
use, or make a determination under
section TSCA 5(a)(3)(A) or (B) and take
the required regulatory action associated
with the determination, before
manufacture or processing for the
significant new use of the chemical
substance can occur.
Issuance of a SNUR for a chemical
substance does not signify that the
chemical substance is listed on the
TSCA Chemical Substance Inventory
(TSCA Inventory). Guidance on how to
determine if a chemical substance is on
the TSCA Inventory is available on the
internet at https://www.epa.gov/tsca-
inventory.
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 Orders have been issued for all
the chemical substances that are the
subject of this rule, and the PMN
submitters are prohibited by the TSCA
Orders from undertaking activities
which will be designated as significant
new uses. The identities of 18 of the 24
chemical substances subject to this rule
have been claimed as confidential (per
40 CFR 720.85). Based on this, the
Agency believes that it is highly
unlikely that any of the significant new
uses described in the regulatory text of
this rule are ongoing.
Furthermore, EPA designated May 4,
2020 (the date of public release of the
proposed rule) as the cutoff date for
determining whether the new use is
ongoing. The objective of EPA’s
approach has been to ensure that a
person could not defeat a SNUR by
initiating a significant new use before
the effective date of the final rule.
In the unlikely event that a person
began commercial manufacture or
processing of the chemical substances
for a significant new use identified as of
that date, that person will have to cease
any such activity upon the effective date
of the final rule. To resume their
activities, that person would 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 development of 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, TSCA order or consent agreement
under TSCA section 4, then TSCA
section 5(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, TSCA 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 proposed rule lists
potentially useful information for all
SNURs listed in this document.
Descriptions are provided for
informational purposes. The
information identified in Unit IV. of the
proposed rule will be potentially 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.
EPA strongly encourages persons,
before performing any testing, to consult
with the Agency. 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 some of the TSCA Orders for the
chemical substances identified in this
rule, EPA has established production
volume limits in view of the lack of data
on the potential health and
environmental risks that may be posed
by the significant new uses or increased
exposure to the chemical substances.
These limits cannot be exceeded unless
the PMN submitter first submits the
results of specified tests that would
permit a reasoned evaluation of the
potential risks posed by these chemical
substances. The SNURs contain the
same production volume limits as the
TSCA 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 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 proposed
rule may not be the only means of
addressing the potential risks of the
chemical substance associated with the
designated significant new uses.
However, submitting a SNUN without
any test data or other information may
increase the likelihood that EPA will
take action under TSCA sections 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 that provide detailed
information on the following:
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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 https://
www.epa.gov/reviewing-new-chemicals-
under-toxic-substances-control-act-tsca.
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–
2019–0596.
XII. Statutory and Executive Order
Reviews
Additional information about these
statutes and Executive Orders can be
found at https://www.epa.gov/laws-
regulations-and-executive-orders.
A. Executive Order 12866: Regulatory
Planning and Review and Executive
Order 13563: Improving Regulations
and Regulatory Review
This action establishes SNURs for
several new chemical substances that
were the subject of PMNs. The Office of
Management and Budget (OMB) has
exempted these types of actions from
review under Executive Orders 12866
(58 FR 51735, October 4, 1993) and
13563 (76 FR 3821, January 21, 2011).
B. Executive Order 13771: Reducing
Regulations and Controlling Regulatory
Costs
This action is not subject to Executive
Order 13771 (82 FR 9339, February 3,
2017), because this action is not a
significant regulatory action under
Executive Order 12866.
C. 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 information
collection requirements associated with
SNURs have already been approved by
OMB under the PRA under OMB control
number 2070–0012 (EPA ICR No. 574).
This rule does not impose any burden
requiring additional OMB approval.
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. The Information Collection
Request (ICR) covering the SNUR
activities 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.
If an entity were to submit a SNUN to
the Agency, the annual burden is
estimated to average between 30 and
170 hours per response. This burden
estimate includes the time needed to
review instructions, search existing data
sources, gather and maintain the data
needed, and complete, review, and
submit the required SNUN. Send any
comments about the accuracy of the
burden estimate, and any suggested
methods for minimizing respondent
burden, including through the use of
automated collection techniques, to the
Director, Regulatory Support Division,
Office of Mission Support (2822T),
Environmental Protection Agency, 1200
Pennsylvania Ave. NW, Washington, DC
20460–0001. Please remember to
include the OMB control number in any
correspondence, but do not submit any
completed forms to this address.
D. Regulatory Flexibility Act (RFA)
Pursuant to the RFA section 605(b) (5
U.S.C. 601 et seq.), the Agency hereby
certifies that promulgation of these
SNURs would 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,
EPA has concluded that no small or
large entities presently engage in such
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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, EPA received 7 SNUNs in
Federal fiscal year (FY) 2013, 13 in
FY2014, 6 in FY2015, 10 in FY2016, 14
in FY2017, and 11 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.
E. 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.).
F. Executive Order 13132: Federalism
This action will not have a substantial
direct effect on States, on the
relationship between the national
government and the States, or on the
distribution of power and
responsibilities among the various
levels of government, as specified in
Executive Order 13132 (64 FR 43255,
August 10, 1999).
G. Executive Order 13175: Consultation
and Coordination With Indian Tribe
Governments
This action does not have Tribal
implications because it is not expected
to have substantial direct effects on
Indian Tribes. This action does not
significantly nor uniquely affect the
communities of Indian Tribal
governments, nor does it involve or
impose any requirements that affect
Indian Tribes. Accordingly, the
requirements of Executive Order 13175
(65 FR 67249, November 9, 2000), do
not apply to this action.
H. Executive Order 13045: Protection of
Children From Environmental Health
Risks and Safety Risks
This action is not subject to Executive
Order 13045 (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.
EPA interprets Executive Order 13045
as applying only to those regulatory
actions that concern environmental
health or safety risks that EPA has
reason to believe may
disproportionately affect children, per
the definition of ‘‘covered regulatory
action’’ in section 2–202 of the
Executive Order.
I. Executive Order 13211: Actions
Concerning Regulations That
Significantly Affect Energy Supply,
Distribution, or Use
This action is not subject to Executive
Order 13211 (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.
J. National Technology Transfer and
Advancement Act (NTTAA)
This action does not involve any
technical standards subject to NTTAA
section 12(d) (15 U.S.C. 272 note).
K. Executive Order 12898: Federal
Actions To Address Environmental
Justice in Minority Populations and
Low-Income Populations
This action does not entail special
considerations of environmental justice
related issues as delineated by
Executive Order 12898 (59 FR 7629,
February 16, 1994).
XIII. Congressional Review Act
This action is subject to the CRA (5
U.S.C. 801 et seq.), and EPA will submit
a rule report to each House of the
Congress and to the Comptroller General
of the United States. 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: August 20, 2020.
Tala Henry,
Deputy Director, Office of Pollution
Prevention and Toxics.
Therefore, for the reasons stated in the
preamble, EPA amends 40 CFR parts 9
and 721 as follows:
PART 9—OMB APPROVALS UNDER
THE PAPERWORK REDUCTION ACT
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.
2. In § 9.1, amend the table by adding
entries for §§ 721.11466 through
721.11489 in numerical order under the
undesignated center heading
‘‘Significant New Uses of Chemical
Substances’’ to read as follows:
§ 9.1 OMB approvals under the Paperwork
Reduction Act.
* * * * *
40 CFR citation OMB control No.
*****
Significant New Uses of Chemical
Substances
*****
721.11466 2070–0012
721.11467 2070–0012
721.11468 2070–0012
721.11469 2070–0012
721.11470 2070–0012
721.11471 2070–0012
721.11472 2070–0012
721.11473 2070–0012
721.11474 2070–0012
721.11475 2070–0012
721.11476 2070–0012
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40 CFR citation OMB control No.
721.11477 2070–0012
721.11478 2070–0012
721.11479 2070–0012
721.11480 2070–0012
721.11481 2070–0012
721.11482 2070–0012
721.11483 2070–0012
721.11484 2070–0012
721.11485 2070–0012
721.11486 2070–0012
721.11487 2070–0012
721.11488 2070–0012
721.11489 2070–0012
* * * * *
PART 721—SIGNIFICANT NEW USES
OF CHEMICAL SUBSTANCES
3. The authority citation for part 721
continues to read as follows:
Authority: 15 U.S.C. 2604, 2607, and
2625(c).
4. Add §§ 721.11466 through
721.11489 to subpart E to read as
follows:
Subpart E—Significant New Uses for
Specific Chemical Substances
Sec.
721.11466 Aromatic amide oxime (generic).
721.11467 Carbon nanotubes (generic).
721.11468 Aromatic hydrocarbon resin
(generic).
721.11469 Pentaerythritol ester of mixed
linear and branched carboxylic acids
(generic) (P-17-193, chemical A).
721.11470 Dipentaerythritol ester of mixed
linear and branched carboxylic acids
(generic) (P-17-193, chemical B).
721.11471 Alkylheterocyclic amine blocked
isocyanate, alkoxysilane polymer
(generic).
721.11472 Isocyanic acid,
polymethylenepolyphenylene ester,
caprolactam- and phenol-blocked.
721.11473 Benzamide, 2-(trifluoromethyl)-.
721.11474 Cashew, nutshell liq. polymer
with formaldehyde, phenol and
resorcinol.
721.11475 Polyester polyol (generic).
721.11476 Fluorinated acrylate, polymer
with alkyloxirane homopolymer
monoether with alkanediol mono(2-
methyl-2-propenoate), tert-Bu 2-
ethylhexaneperoxoate-initiated (generic).
721.11477 2,5-Furandione, polymer with 2-
ethyl-2-(hydroxymethyl)-1,3-
propanediol, 3a,4,5,6,7,7a-hexahydro-
4,7-methano-1H-inden-5(or 6)-yl ester,
ester with 2,3-dihydroxypropyl
neodecanoate, polymer with 5-
isocyanato-1-(isocyanatomethyl)-1,3,3-
trimethylcyclohexane, 2-hydroxyethyl
acrylate- and 2-hydroxyethyl
methacrylate-blocked.
721.11478 Perfluoroalkyl ethyl- and vinyl-
modified organopolysiloxane (generic).
721.11479 Perfluoroalkyl ethyl- and vinyl-
modified organopolysiloxane (generic).
721.11480 Oxirane, 2,2’-
[cyclohexylidenebis(4,1-
phenyleneoxymethylene)]bis-.
721.11481 Saturated fatty acid, reaction
products with cadmium zinc selenide
sulfide and polymeric amine (generic).
721.11482 Saturated fatty acid, reaction
products with cadmium zinc selenide
sulfide, alkylamine and polymeric amine
(generic).
721.11483 Heteropolycyclic, halo
substituted alkyl substituted- diaromatic
amino substituted carbomonocycle, halo
substituted alkyl substituted
heteropolycyclic, tetraaromatic metalloid
salt (1:1) (generic).
721.11484 Alkanediol, polymer with 5-
isocyanato-1-(isocyanatomethyl)-1,3,3-
trimethylcyclohexane, alkylaminoalkyl
methacrylate-, and
dialkylheteromonocycle-blocked
(generic).
721.11485 Alkanediol, polymer with 5-
isocyanato-1-(isocyanatomethyl)-1,3,3-
trimethylcyclohexane, alkylaminoalkyl
methacrylate-blocked (generic).
721.11486 Synthetic oil from tires (generic).
721.11487 1,3-Propanediamine, N1,N1-
dimethyl-, polymers with alkylene glycol
ether with alkyltriol (3:1) mixed
acrylates and adipates, and alkylene
glycol monoacrylate ether with alkyltriol
(3:1) (generic).
721.11488 1,3-Propanediol, 2-ethyl-2-
(hydroxymethyl)-, polymer with oxirane,
4-(dimethylamino)benzoate.
721.11489 Titanium (4+) hydroxyl-
alkylcarboxylate salt complex (generic).
* * * * *
§ 721.11466 Aromatic amide oxime
(generic).
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified
generically as aromatic amide oxime
(PMN P-14-865) 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
§ 721.63(a)(1) through (3), and (6), (b)
and (c). When determining which
persons are reasonably likely to be
exposed as required for § 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. For
purposes of § 721.63(b), concentration is
set at 1.0%.
(ii) Industrial, commercial, and
consumer activities. Requirements as
specified in § 721.80(g).
(iii) Release to water. Requirements as
specified in § 721.90(a)(4), (b)(4) and
(c)(4) where N=30.
(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
§ 721.125(a) through (e), (i) and (k) are
applicable to manufacturers and
processors of this substance.
(2) Limitations or revocation of
certain notification requirements. The
provisions of § 721.185 apply to this
section.
§ 721.11467 Carbon nanotubes (generic).
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified
generically as carbon nanotubes (PMN
P-15-54) 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 that have been (i) embedded
or incorporated into a polymer matrix
that itself has been reacted (cured) or (ii)
embedded in a permanent solid polymer
form that is not intended to undergo
further processing, except mechanical
processing.
(2) The significant new uses are:
(i) Workplace protection.
Requirements as specified in
§ 721.63(a)(1), (2)(i) and (ii), and (3)
through (6), and (c). When determining
which persons are reasonably likely to
be exposed as required for § 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. For
purposes of § 721.63(a)(5), respirators
must provide a National Institute for
Occupational Safety and Health
(NIOSH) assigned protection factor
(APF) of at least 50. For purposes of
§ 721.63(a)(6), particulate (including
solids or liquid droplets).
(ii) Industrial, commercial, and
consumer activities. Requirements as
specified in § 721.80(k) (chemical
intermediate to manufacture
functionalized carbon nanotubes by
oxidation with nitric acid; additive in
rubber polymers to improve
mechanical/physical/chemical/
electrical properties; additive in resin
polymers to improve mechanical/
physical/chemical/electrical properties;
additive in metals to improve electrical/
thermal properties; additive in ceramics
to improve mechanical/electrical/
thermal properties; semi-conductor,
conductive, or resistive element in
electronic circuitry and devices; electric
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collector element or electrode in energy
devices; photoelectric or thermoelectric
conversion elements in energy devices;
catalyst support element or catalytic
electrode for use in energy devices;
additive for transparency and
conductivity in electronic devices; and
electro-mechanical element in actuator,
sensor, or switching devices).
(iii) Disposal. Requirements as
specified in § 721.85(a)(1) and (2), (b)(1)
and (2), and (c)(1) and (2).
(iv) Release to water. Requirements as
specified in § 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
§ 721.125(a) through (e) and (i) through
(k) are applicable to manufacturers and
processors of this substance.
(2) Limitations or revocation of
certain notification requirements. The
provisions of § 721.185 apply to this
section.
§ 721.11468 Aromatic hydrocarbon resin
(generic).
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified
generically as aromatic hydrocarbon
resin (PMN P-16-583) is subject to
reporting under this section for the
significant new uses described in
paragraph (a)(2) of this section. The
requirements of this section do not
apply to quantities of the substance after
they have been reacted (cured).
(2) The significant new uses are:
(i) Industrial, commercial, and
consumer activities. Requirements as
specified in § 721.80(k) (hot-melt sealant
for motor vehicle lamps). It is a
significant new use to manufacture the
PMN substance with an average number
molecular weight of less than 1000
grams per mole.
(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
§ 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 § 721.185 apply to this
section.
§ 721.11469 Pentaerythritol ester of mixed
linear and branched carboxylic acids
(generic) (P-17-193, chemical A).
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified
generically as pentaerythritol ester of
mixed linear and branched carboxylic
acids (PMN P-17-193, chemical A) is
subject to reporting under this section
for the significant new use described in
paragraph (a)(2) of this section.
(2) The significant new use is:
(i) Release to water. Requirements as
specified in § 721.90(a)(4), (b)(4) and
(c)(4) where N=330.
(ii) [Reserved]
(b) Specific requirements. The
provision of subpart A of this part apply
to this section except as modified by
this paragraph (b).
(1) Recordkeeping. Recordkeeping
requirements as specified in
§ 721.125(a) through (c) and (k) are
applicable to manufacturers and
processors of this substance.
(2) Limitations or revocation of
certain modification requirements. The
provisions of § 721.185 apply to this
section.
§ 721.11470 Dipentaerythritol ester of
mixed linear and branched carboxylic acids
(generic) (P-17-193, chemical B).
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified
generically as dipentaerythritol ester of
mixed linear and branched carboxylic
acids (PMN P-17-193, chemical B) is
subject to reporting under this section
for the significant new use described in
paragraph (a)(2) of this section.
(2) The significant new use is:
(i) Release to water. Requirements as
specified in § 721.90(a)(4), (b)(4) and
(c)(4) where N=330.
(ii) [Reserved]
(b) Specific requirements. The
provision of subpart A of this part apply
to this section except as modified by
this paragraph (b).
(1) Recordkeeping. Recordkeeping
requirements as specified in
§ 721.125(a) through (c) and (k) are
applicable to manufacturers and
processors of this substance.
(2) Limitations or revocation of
certain modification requirements. The
provisions of § 721.185 apply to this
section.
§ 721.11471 Alkylheterocyclic amine
blocked isocyanate, alkoxysilane polymer
(generic).
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified
generically as alkylheterocyclic amine
blocked isocyanate, alkoxysilane
polymer (PMN P-17-221) is subject to
reporting under this section for the
significant new uses described in
paragraph (a)(2) of this section. The
requirements of the TSCA Order do not
apply to quantities of the PMN
substance after they have been
completely reacted (cured).
(2) The significant new uses are:
(i) Protection in the workplace.
Requirements as specified in
§ 721.63(a)(1), (2)(i) and (iii), (3) and (6)
(particulate), (b), and (c). When
determining which persons are
reasonably likely to be exposed as
required for § 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. For purposes
of § 721.63(b), concentration is set at
1.0%.
(ii) Hazard communication.
Requirements as specified in § 721.72(a)
through (f), (g)(1)(i) and (ii), (2)(i)
through (iii) and (v), and (5). For
purposes of § 721.72(e), concentration is
set at 1.0%. 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 § 721.80(k). It is a
significant new use to formulate the
PMN to a concentration greater than
10%.
(b) Specific requirements. The
provisions of subpart A of this part
apply to this section except as modified
by this paragraph.
(1) Recordkeeping. Recordkeeping
requirements as specified in
§ 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 § 721.185 apply to this
section.
(3) Determining whether a specific use
is subject to this section. The provisions
of § 721.1725(b)(1) apply to paragraph
(a)(2)(iii).
§ 721.11472 Isocyanic acid,
polymethylenepolyphenylene ester,
caprolactam- and phenol-blocked.
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified as
isocyanic acid,
polymethylenepolyphenylene ester,
caprolactam- and phenol-blocked (PMN
P-17-282, CAS No. 2093945–13–0) is
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subject to reporting under this section
for the significant new uses described
paragraph (a)(2) of this section. The
requirements of this section do not
apply to quantities of the substance after
they have been completely reacted
(cured).
(2) The significant new uses are:
(i) Industrial, commercial, and
consumer activities. It is a significant
new use to manufacture, process, or use
the PMN substance in any manner or
method that generates inhalation
exposure to phenol or caprolactam.
(ii) Release to water. Requirements as
specified in § 721.90(a)(4), (b)(4) and
(c)(4) where N=1.
(b) Specific requirements. The
provision of subpart A of this part apply
to this section except as modified by
this paragraph (b).
(1) Recordkeeping. Recordkeeping
requirements as specified in
§ 721.125(a) through (c), (i), and (k) are
applicable to manufacturers and
processors of this substance.
(2) Limitations or revocation of
certain modification requirements. The
provisions of § 721.185 apply to this
section.
§ 721.11473 Benzamide, 2-
(trifluoromethyl)-.
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified as
benzamide, 2-(trifluoromethyl)- (PMN P-
17-334, CAS No. 360–64–5) 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
§ 721.63(a)(1), (2)(i) and (iv), (3), (4),
(6)(v) and (vi), (b) and (c). When
determining which persons are
reasonably likely to be exposed as
required for § 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. For purposes
of § 721.63(a)(6), particulate applies. For
purposes of § 721.63(b), the
concentration is set at 0.1%.
(ii) Hazard communication.
Requirements as specified in § 721.72(a)
through (f), (g)(1)(iii) through (v), and
(ix), (2)(i) through (iii) and (v), (3)(i) and
(ii), and (5). For purposes of § 721.72(e),
concentration is set at 0.1%. 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 § 721.80(f), (g) and (y)(1).
(iv) Release to water. Requirements as
specified in § 721.90(a)(4), (b)(4) and
(c)(4) where N=39.
(b) Specific requirements. The
provisions of subpart A of this part
apply to this section except as modified
by this paragraph.
(1) Recordkeeping. Recordkeeping
requirements as specified in
§ 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 § 721.185 apply to this
section.
§ 721.11474 Cashew, nutshell liq. polymer
with formaldehyde, phenol and resorcinol.
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified as
cashew nutshell liq. polymer with
formaldehyde, phenol and resorcinol
(PMN P-17-386, CAS No. 2044014–81–
3) 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
§ 721.63(a)(1), (3) through (5), (6)(v) and
(vi), (b), and (c). When determining
which persons are reasonably likely to
be exposed as required for § 721.63(a)(1)
and (a)(4), engineering control measures
(e.g., enclosure or confinement of the
operation, general and local ventilation)
or administrative control measures (e.g.,
workplace policies and procedures)
shall be considered and implemented to
prevent exposure, where feasible. For
purposes of § 721.63(a)(5), respirators
must provide a National Institute for
Occupational Safety and Health
(NIOSH) assigned protection factor
(APF) of at least 50. For purposes of
§ 721.63(a)(6), particulate (including
combination gas/vapor and particulate).
For purposes of § 721.63(b),
concentration is set at 1.0%.
(ii) Hazard communication.
Requirements as specified in § 721.72(a)
through (f), (g)(1)(i), (2)(i) and (ii), (iv)
and (v), (4)(iii), and (5). For purposes of
§ 721.72(e), concentration is set at 1.0%.
For purposes of § 721.72(g)(1) skin and
respiratory sensitization. Alternative
hazard and warning statements that
meet the criteria of the Globally
Harmonized System and OSHA Hazard
Communication Standard may be used.
(iii) Industrial, commercial, and
consumer activities. Requirements as
specified in § 721.80(o). It is a
significant new use to manufacture the
substance for more than one year.
(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
§ 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 § 721.185 apply to this
section.
§ 721.11475 Polyester polyol (generic).
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified
generically as polyester polyol (PMN P-
18-12) is subject to reporting under this
section for the significant new use
described in paragraph (a)(2) of this
section.
(2) The significant new uses are:
(i) Release to water. Requirements as
specified in § 721.90(a)(4), (b)(4) and
(c)(4) where N=1.
(ii) [Reserved]
(b) Specific requirements. The
provision of subpart A of this part apply
to this section except as modified by
this paragraph (b).
(1) Recordkeeping. Recordkeeping
requirements as specified in
§ 721.125(a) through (c) and (k) are
applicable to manufacturers and
processors of this substance.
(2) Limitations or revocation of
certain modification requirements. The
provisions of § 721.185 apply to this
section.
§ 721.11476 Fluorinated acrylate, polymer
with alkyloxirane homopolymer monoether
with alkanediol mono(2-methyl-2-
propenoate), tert-Bu 2-
ethylhexaneperoxoate-initiated (generic).
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified
generically as fluorinated acrylate,
polymer with alkyloxirane
homopolymer monoether with
alkanediol mono(2-methyl-2-
propenoate), tert-Bu 2-
ethylhexaneperoxoate-initiated (PMN P-
18-18) 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:
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(i) Industrial, commercial, and
consumer activities. Requirements as
specified in § 721.80(f), (t) and (y)(1).
(ii) Releases to water. Requirements as
specified in § 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
§ 721.125(a) through (c), (i), and (k) are
applicable to manufacturers and
processors of this substance.
(2) Limitations or revocation of
certain notification requirements. The
provisions of § 721.185 apply to this
section.
(3) Determining whether a specific use
is subject to this section. The provisions
of § 721.1725(b)(1) apply to paragraph
(a)(2)(i) of this section.
§ 721.11477 2,5-Furandione, polymer with
2-ethyl-2-(hydroxymethyl)-1,3-propanediol,
3a,4,5,6,7,7ahexahydro- 4,7-methano-1H-
inden-5(or 6)-yl ester, ester with 2,3-
dihydroxypropyl neodecanoate, polymer
with 5-isocyanato-l-(isocyanatomethyl)-1,3,
3-trimethylcyclohexane, 2-hydroxyethyl
acrylate- and 2-hydroxyethyl methacrylate-
blocked.
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified as
2,5-furandione, polymer with 2-ethyl-2-
(hydroxymethyl)-1,3-propanediol,
3a,4,5,6,7,7ahexahydro- 4,7-methano-
1H-inden-5(or 6)-yl ester, ester with 2,3-
dihydroxypropyl neodecanoate,
polymer with 5-isocyanato-l-
(isocyanatomethyl)-1,3, 3-
trimethylcyclohexane, 2-hydroxyethyl
acrylate- and 2-hydroxyethyl
methacrylate-blocked (PMN P-18-42,
CAS No. 2245262–16–0) 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
completely reacted (cured).
(2) The significant new uses are:
(i) Protection in the workplace.
Requirements as specified in
§ 721.63(a)(1), (2)(i) through (iv) and (3),
and (c). When determining which
persons are reasonably likely to be
exposed as required for § 721.63(a)(1),
engineering control measures (e.g.,
enclosure or confinement of the
operation, general and local ventilation)
or administrative control measures (e.g.,
workplace policies and procedures)
shall be considered and implemented to
prevent exposure, where feasible.
(ii) Hazard communication.
Requirements as specified in § 721.72(a)
through (d), (f), (g)(1)(i) and (ii), (iv),
(vii) and (ix), (2)(i) through (iii) and (v),
and (5). For purposes of § 721.72(g)(1)
eye irritation. For purposes of
§ 721.72(g)(2) avoid eye contact.
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 § 721.80(k), (o) and (y)(1).
(b) Specific requirements. The
provisions of subpart A of this part
apply to this section except as modified
by this paragraph.
(1) Recordkeeping. Recordkeeping
requirements as specified in
§ 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 § 721.185 apply to this
section.
(3) Determining whether a specific use
is subject to this section. The provisions
of § 721.1725(b)(1) apply to paragraph
(a)(2)(iii).
§ 721.11478 Perfluoroalkyl ethyl- and vinyl-
modified organopolysiloxane (generic).
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified
generically as perfluoroalkyl ethyl- and
vinyl-modified organopolysiloxane
(PMN P-18-52) 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
completely reacted (cured).
(2) The significant new uses are:
(i) Protection in the workplace.
Requirements as specified in
§ 721.63(a)(1) through (6) and (c). When
determining which persons are
reasonably likely to be exposed as
required by § 721.63(a)(1) and (a)(4),
engineering control measures (e.g.,
enclosure or confinement of the
operation, general and local ventilation)
or administrative control measures (e.g.,
workplace policies and procedures)
shall be considered and implemented to
prevent exposure, where feasible. For
purposes of § 721.63(a)(5), respirators
must provide a National Institute for
Occupational Safety and Health
(NIOSH) assigned protection factor
(APF) of at least 1,000). For purposes of
§ 721.63(a)(6) combination gas/vapor
and particulate.
(A) As an alternative to respirator
requirements in paragraph (a)(2)(i) of
this section, manufacturer or processor
may choose to follow the new chemical
exposure limit (NCEL) provision listed
in the TSCA section 5(e) consent order
for this substance. The NCEL is 0.0015
mg/m3 as an 8-hour time weighted
average. Persons who wish to pursue
NCELs as an alternative to § 721.63
respirator requirements may request to
do so under § 721.30. Persons whose
§ 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)
consent order.
(B) [Reserved]
(ii) Hazard communication.
Requirements as specified in § 721.72(a)
through (d), (f), (g)(1)(vi), (2)(i) through
(v), and (5). Alternative hazard and
warning statements that meet the
criteria of the Globally Harmonized
System (GHS) and OSHA Hazard
Communication Standard may be used.
For purposes of § 721.72(g)(1) specific
target organ toxicity. For purposes of
§ 721.72(g)(2)(iv), use respiratory
protection or maintain workplace
airborne concentrations at or below an
8-hour time-weighted average of 0.0015
mg/m3.
(iii) Industrial, commercial, and
consumer activities. Requirements as
specified in § 721.80(f) and (t) (420
kilograms).
(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
§ 721.125(a) through (i) are applicable to
manufacturers and processors of this
substance.
(2) Limitations or revocation of
certain modification requirements. The
provisions of § 721.185 apply to this
section.
§ 721.11479 Perfluoroalkyl ethyl- and vinyl-
modified organopolysiloxane (generic).
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified
generically as perfluoroalkyl ethyl- and
vinyl-modified organopolysiloxane
(PMN P-18-53) 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
completely reacted (cured).
(2) The significant new uses are:
(i) Protection in the workplace.
Requirements as specified in
§ 721.63(a)(1), (3) through (6), and (c).
When determining which persons are
reasonably likely to be exposed as
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required by § 721.63(a)(1) and (a)(4),
engineering control measures (e.g.,
enclosure or confinement of the
operation, general and local ventilation)
or administrative control measures (e.g.,
workplace policies and procedures)
shall be considered and implemented to
prevent exposure, where feasible. For
purposes of § 721.63(a)(5), respirators
must provide a National Institute for
Occupational Safety and Health
(NIOSH) assigned protection factor
(APF) of at least 1,000. For purposes of
§ 721.63(a)(6), combination gas/vapor
and particulate.
(A) As an alternative to 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) consent order
for this substance. The NCEL is 0.0015
mg/m3 as an 8-hour time weighted
average. Persons who wish to pursue
NCELs as an alternative to § 721.63
respirator requirements may request to
do so under § 721.30. Persons whose
§ 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)
consent order.
(B) [Reserved]
(ii) Hazard communication.
Requirements as specified in § 721.72(a)
through (d), (f), (g)(1)(vi), (2)(i) through
(v), and (5). Alternative hazard and
warning statements that meet the
criteria of the Globally Harmonized
System (GHS) and OSHA Hazard
Communication Standard may be used.
For purposes of § 721.72(g)(1) specific
target organ toxicity. For purposes of
§ 721.72(g)(2)(iv), use respiratory
protection or maintain workplace
airborne concentrations at or below an
8-hour time-weighted average of 0.0015
mg/m3.
(iii) Industrial, commercial, and
consumer activities. Requirements as
specified in § 721.80(f) and (t) (336
kilograms).
(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
§ 721.125(a) through (i) are applicable to
manufacturers and processors of this
substance.
(2) Limitations or revocation of
certain modification requirements. The
provisions of § 1721.185 apply to this
section.
§ 721.11480 Oxirane, 2,2-
[cyclohexylidenebis(4,1-
phenyleneoxymethylene)]bis-.
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical identified as oxirane,
2,2-[cyclohexylidenebis(4,1-
phenyleneoxymethylene)]bis- (PMN P-
18-62, CAS No. 13446–84–9) is subject
to reporting under this section for the
significant new use 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
completely reacted (cured).
(2) The significant new uses are:
(i) Protection in the workplace.
Requirements as specified in
§ 721.63(a)(1), (3) through (6), (b), and
(c). When determining which persons
are reasonably likely to be exposed as
required for § 721.63(a)(1) and (a)(4),
engineering control measures (e.g.,
enclosure or confinement of the
operation, general and local ventilation)
or administrative control measures (e.g.,
workplace policies and procedures)
shall be considered and implemented to
prevent exposure, where feasible. For
purposes of § 721.63(a)(5), respirators
must provide a National Institute for
Occupational Safety and Health
(NIOSH) assigned protection factor
(APF) of at least 1,000. For purposes of
§ 721.63(a)(6), particulate (including
solids or liquid droplets). For purposes
of § 721.63(b), concentration is set at
0.1%.
(ii) Hazard communication.
Requirements as specified in § 721.72(a)
through (f), and (g)(1)(vi), (vii), (2)(i)
through (iii) (use respiratory protection
when spraying), (v), (3)(i) and (ii), (4)(i),
and (5). Alternative hazard and warning
statements that meet the criteria of the
Globally Harmonized System (GHS) and
OSHA Hazard Communication Standard
may be used. For purposes of
§ 721.72(g)(1) specific target organ
toxicity. For purposes of § 721.72(e),
concentration is set at 0.1%.
(iii) Industrial, commercial, and
consumer activities. Requirements as
specified in § 721.80(k). It is a
significant new use to manufacture or
process the PMN substance in any
manner which generates inhalation
exposures.
(iv) Release to water. Requirements as
specified in § 721.90(a)(4), (b)(4) and
(c)(4) where N=1.
(b) Specific requirements. The
provision of subpart A of this part apply
to this section as modified by this
paragraph (b).
(1) Recordkeeping. Recordkeeping
requirements as specified in
§ 721.125(a) through (i) and (k) are
applicable to manufacturers and
processors of this substance.
(2) Limitations or revocation of
certain modification requirements. The
provisions of § 721.185 apply to this
section.
(3) Determining whether a specific use
is subject to this section. The provisions
of § 721.1725 (b)(1) apply to paragraph
(a)(2)(iii) of this section.
§ 721.11481 Saturated fatty acid, reaction
products with cadmium zinc selenide
sulfide and polymeric amine (generic).
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical identified generically
as saturated fatty acid, reaction products
with cadmium zinc selenide sulfide and
polymeric amine (PMN P-18-74) is
subject to reporting under this section
for the significant new use described in
paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Protection in the workplace.
Requirements as specified in
§ 721.63(a)(1), (3) and (6), and (c). When
determining which persons are
reasonably likely to be exposed as
required for § 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. For purposes
of § 721.63(a)(6), particulate (including
solids or liquid droplets).
(ii) Hazard communication.
Requirements as specified in § 721.72(a)
through (d), (f), and (g)(1)(i) and (vii),
(2)(i) through (iii), and (v), (3)(i) and (ii),
(4)(i) and (iii) and (5). For purposes of
§ 721.72(g)(1) pulmonary toxicity, eye
damage, specific target organ toxicity,
and skin sensitization. Alternative
hazard and warning statements that
meet the criteria of the Globally
Harmonized System and OSHA Hazard
Communication Standard may be used.
(iii) Industrial, commercial, and
consumer activities. Requirements as
specified in § 721.80(k) (chemical
intermediate for a quantum dot used as
an optical down-converter (50%), and
quantum dot in an optical down-
converter (50%)). It is a significant new
use to manufacture, process, or use the
PMN substance in other than a liquid
formulation. It is a significant new use
to manufacture or process the PMN
substance in any manner which
generates inhalation exposures. It is a
significant new use to manufacture the
PMN substance with a cadmium
percentage greater than the confidential
level identified in the TSCA Order.
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(iv) Disposal. It is a significant new
use to dispose of the PMN substance in
any manner other than by incineration
in a permitted hazardous waste
incinerator.
(v) Release to water. Requirements as
specified in § 721.90(a)(1), (b)(1) and
(c)(1).
(b) Specific requirements. The
provision of subpart A of this part apply
to this section as modified by this
paragraph (b).
(1) Recordkeeping. Recordkeeping
requirements as specified in
§ 721.125(a) through (d), and (f) through
(k) are applicable to manufacturers and
processors of this substance.
(2) Limitations or revocation of
certain modification requirements. The
provisions of § 721.185 apply to this
section.
(3) Determining whether a specific use
is subject to this section. The provisions
of § 721.1725 (b)(1) apply to paragraph
(a)(2)(iii) of this section.
§ 721.11482 Saturated fatty acid, reaction
products with cadmium zinc selenide
sulfide, alkylamine and polymeric amine
(generic).
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical identified generically
as saturated fatty acid, reaction products
with cadmium zinc selenide sulfide,
alkylamine and polymeric amine (PMN
P-18-75) is subject to reporting under
this section for the significant new use
described in paragraph (a)(2) of this
section.
(2) The significant new uses are:
(i) Protection in the workplace.
Requirements as specified in
§ 721.63(a)(1), (3) and (6), and (c). When
determining which persons are
reasonably likely to be exposed as
required for § 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. For purposes
of § 721.63(a)(6), particulate (including
solids or liquid droplets).
(ii) Hazard communication.
Requirements as specified in § 721.72(a)
through (d), (f), and (g)(1)(i) and (vii),
(2)(i) through (iii), and (v), (3)(i) and (ii),
(4)(i) and (iii) and (5). For purposes of
§ 721.72(g)(1) pulmonary toxicity, eye
damage, specific target organ toxicity,
and skin sensitization. Alternative
hazard and warning statements that
meet the criteria of the Globally
Harmonized System and OSHA Hazard
Communication Standard may be used.
(iii) Industrial, commercial, and
consumer activities. Requirements as
specified in § 721.80 (k)(quantum dot in
an optical down-converter). It is a
significant new use to manufacture,
process, or use the PMN substance in
other than a liquid formulation. It is a
significant new use to manufacture or
process the PMN substance in any
manner which generates inhalation
exposures. It is a significant new use to
manufacture the PMN substance with a
cadmium percentage greater than the
confidential value stated in the TSCA
Order.
(iv) Disposal. It is a significant new
use to dispose of the PMN substance in
any manner other than by incineration
in a permitted hazardous waste
incinerator.
(v) Release to water. Requirements as
specified in § 721.90(a)(1), (b)(1) and
(c)(1).
(b) Specific requirements. The
provision of subpart A of this part apply
to this section as modified by this
paragraph (b).
(1) Recordkeeping. Recordkeeping
requirements as specified in
§ 721.125(a) through (d) and (f) through
(k) are applicable to manufacturers and
processors of this substance.
(2) Limitations or revocation of
certain modification requirements. The
provisions of § 721.185 apply to this
section.
(3) Determining whether a specific use
is subject to this section. The provisions
of § 721.1725 (b)(1) apply to paragraph
(a)(2)(iii) of this section.
§ 721.11483 Heteropolycyclic, halo
substituted alkyl substituted-diaromatic
amino substituted carbomonocycle, halo
substituted alkyl substituted
heteropolycyclic, tetraaromatic metalloid
salt (1:1) (generic).
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified
generically as heteropolycyclic, halo
substituted alkyl substituted- diaromatic
amino substituted carbomonocycle, halo
substituted alkyl substituted
heteropolycyclic, tetraaromatic
metalloid salt (1:1) (PMN P-18-160) 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 completely reacted
(cured).
(2) The significant new uses are:
(i) Protection in the workplace.
Requirements as specified in
§ 721.63(a)(1), (2)(i) through (iv), and (3)
through (6). When determining which
persons are reasonably likely to be
exposed as required for § 721.63(a)(1)
and (a)(4), engineering control measures
(e.g., enclosure or confinement of the
operation, general and local ventilation)
or administrative (e.g., workplace
policies and procedures) shall be
considered and implemented to prevent
exposure, where feasible. For purposes
of § 721.63(a)(5), respirators must
provide a National Institute for
Occupational Safety and Health
(NIOSH) assigned protection factor
(APF) of at least 50. For purposes of
§ 721.63(a)(6), particulate (including
solids or liquid droplets).
(ii) Hazard communication.
Requirements as specified in § 721.72(a)
through (d), (f), (g)(1), (2)(i) through (v),
(3)(i) and (ii) and (4)(iii). For purposes
of § 721.72(g)(1) acute toxicity,
neurotoxicity, photosensitization, and
eye irritation. 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 § 721.80(f), (t), and (w)(1),
(3) and (4). It is a significant new use to
manufacture the substance for more
than 18 months.
(iv) Release to water. Requirements as
specified in § 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
§ 721.125(a) through (c), (i), and (k) are
applicable to manufacturers and
processors of this substance.
(2) Limitations or revocation of
certain notification requirements. The
provisions of § 721.185 apply to this
section.
(3) Determining whether a specific use
is subject to this section. The provisions
of § 721.1725 (b)(1) apply to paragraph
(a)(2)(iii) of this section.
§ 721.11484. Alkanediol, polymer with 5-
isocyanato-1-(isocyanatomethyl)-1,3,3-
trimethylcyclohexane, alkylaminoalkyl
methacrylate-, and dialkylheteromonocycle-
blocked (generic).
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified
generically as alkanediol, polymer with
5-isocyanato-1-(isocyanatomethyl)-1,3,3-
trimethylcyclohexane, alkylaminoalkyl
methacrylate-, and
dialkylheteromonocycle-blocked (PMN
P-18-237) 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
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substance after they have been reacted
(cured).
(2) The significant new uses are:
(i) Industrial, commercial, and
consumer activities. It is a significant
new use to manufacture, process, or use
the PMN substance in any manner or
method that generates dust, spray,
vapor, mist, or aerosol.
(ii) Releases to water. Requirements as
specified in § 721.90(a)(4), (b)(4) and
(c)(4) where N=1.
(b) Specific requirements. The
provisions of subpart A of this part
apply to this section except as modified
by this paragraph (b).
(1) Recordkeeping. Recordkeeping
requirements as specified in
§ 721.125(a) through (c), (i), and (k) are
applicable to manufacturers and
processors of this substance.
(2) Limitations or revocation of
certain notification requirements. The
provisions of § 721.185 apply to this
section.
§ 721.11485 Alkanediol, polymer with 5-
isocyanato-1-(isocyanatomethyl)-1,3,3-
trimethylcyclohexane, alkylaminoalkyl
methacrylate-blocked (generic).
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified
generically as alkanediol, polymer with
5-isocyanato-1-(isocyanatomethyl)-1,3,3-
trimethylcyclohexane, alkylaminoalkyl
methacrylate-blocked (PMN P-18-292) is
subject to reporting under this section
for the significant new uses described in
paragraph (a)(2) of this section. The
requirements of this section do not
apply to quantities of the substance after
they have been reacted (cured).
(2) The significant new uses are:
(i) Industrial, commercial, and
consumer activities. It is a significant
new use to manufacture, process, or use
the PMN substance in any manner or
method that generates dust, spray,
vapor, mist, or aerosol.
(ii) Releases to water. Requirements as
specified in § 721.90(a)(4), (b)(4) and
(c)(4) where N = 1.
(b) Specific requirements. The
provisions of subpart A of this part
apply to this section except as modified
by this paragraph (b).
(1) Recordkeeping. Recordkeeping
requirements as specified in
§ 721.125(a) through (c), (i), and (k) are
applicable to manufacturers and
processors of this substance.
(2) Limitations or revocation of
certain notification requirements. The
provisions of § 721.185 apply to this
section.
§ 721.11486 Synthetic oil from tires
(generic).
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified
generically as synthetic oil from tires
(PMN P-18-287) 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 § 721.80(k) and (o).
(ii) Disposal. Requirements as
specified in § 721.85(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
§ 721.125(a) through (c), (i) and (j) are
applicable to manufacturers and
processors of this substance.
(2) Limitations or revocation of
certain notification requirements. The
provisions of § 721.185 apply to this
section.
(3) Determining whether a specific use
is subject to this section. The provisions
of § 721.1725(b)(1) apply to paragraph
(a)(2)(i) of this section.
§ 721.11487 1,3-Propanediamine, N1,N1-
dimethyl-, polymers with alkylene glycol
ether with alkyltriol (3:1) mixed acrylates
and adipates, and alkylene glycol
monoacrylate ether with alkyltriol (3:1)
(generic).
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified
generically as 1,3-propanediamine,
N1,N1-dimethyl-, polymers with
alkylene glycol ether with alkyltriol
(3:1) mixed acrylates and adipates, and
alkylene glycol monoacrylate ether with
alkyltriol (3:1) (PMN P-19-51) 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
completely reacted (cured).
(2) The significant new uses are:
(i) Hazard communication.
Requirements as specified in § 721.72(a)
through (f), and (g)(1)(i) and (iv), (2)(i)
through (v), (3)(i) and (ii), (4)(i) and (ii)
and (5). For purposes of § 721.72(g)(1)
eye irritation, skin sensitization, and
respiratory sensitization. Alternative
hazard and warning statements that
meet the criteria of the Globally
Harmonized System (GHS) and OSHA
Hazard Communication Standard may
be used. For purposes of § 721.72(e),
concentration is set at 0.1%.
(ii) Industrial, commercial, and
consumer activities. Requirements as
specified in § 721.80(f) and (k).
(iii) Release to water. Requirements as
specified in § 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.
(1) Recordkeeping. Recordkeeping
requirements as specified in
§ 721.125(a) through (d), (f) through (i),
and (k) are applicable to manufacturers
and processors of this substance.
(2) Limitations or revocation of
certain notification requirements. The
provisions of § 721.185 apply to this
section.
(3) Determining whether a specific use
is subject to this section. The provisions
of § 721.1725(b)(1) apply to paragraph
(a)(2)(ii) of this section.
§ 721.11488 1,3-Propanediol, 2-ethyl-2-
(hydroxymethyl)-, polymer with oxirane, 4-
(dimethylamino)benzoate.
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified as
1,3-propanediol, 2-ethyl-2-
(hydroxymethyl)-, polymer with
oxirane, 4-(dimethylamino)benzoate
(PMN P-19-55, CAS No. 2067275–86–7)
is subject to reporting under this section
for the significant new uses described in
paragraph (a)(2) if this section. The
requirements of this section do not
apply to quantities of the PMN
substance after they have been
completely reacted (cured).
(2) The significant new uses are:
(i) Industrial, commercial, and
consumer activities. Requirements as
specified in § 721.80(k)(photo initiator
within UV curable coating/ink
formulations). It is a significant new use
to manufacture, process, or use the PMN
substance in any manner that results in
inhalation exposure.
(ii) Release to water. Requirements as
specified in § 721.90(a)(4), (b)(4) and
(c)(4) where N = 12.
(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
§ 721.125(a) through (c), (i), and (k) are
applicable to manufacturers and
processors of this substance.
(2) Limitations or revocation of
certain modification requirements. The
provisions of § 1721.185 apply to this
section.
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57980
Federal Register / Vol. 85, No. 181 / Thursday, September 17, 2020 / Rules and Regulations
§ 721.11489 Titanium (4+) hydroxyl-
alkylcarboxylate salt complex (generic).
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified
generically as titanium (4+) hydroxyl-
alkylcarboxylate salt complex (PMN P-
19-159) 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
completely reacted (cured).
(2) The significant new uses are:
(i) Industrial, commercial, and
consumer activities. It is a significant
new use to manufacture, process, or use
the PMN substance in any manner or
method that generates inhalation
exposure.
(ii) Release to water. Requirements as
specified in § 721.90(a)(4), (b)(4) and
(c)(4) where N = 1.
(b) Specific requirements. The
provision of subpart A of this part apply
to this section except as modified by
this paragraph (b).
(1) Recordkeeping. Recordkeeping
requirements as specified in
§ 721.125(a) through (c), (i), and (k) are
applicable to manufacturers and
processors of this substance.
(2) Limitations or revocation of
certain notification requirements. The
provisions of § 721.185 apply to this
section.
[FR Doc. 2020–18883 Filed 9–16–20; 8:45 am]
BILLING CODE 6560–50–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
42 CFR Part 414
[CMS–5533–N]
Medicare Program; Alternative
Payment Model (APM) Incentive
Payment Advisory for Clinicians—
Request for Current Billing Information
for Qualifying APM Participants
AGENCY
: Centers for Medicare &
Medicaid Services (CMS), Health and
Human Services (HHS).
ACTION
: Payment advisory.
SUMMARY
: This advisory is to alert
certain clinicians who are Qualifying
APM participants (QPs) and eligible to
receive an Alternative Payment Model
(APM) Incentive Payment that CMS
does not have the current billing
information needed to disburse the
payment. This advisory provides
information to these clinicians on how
to update their billing information to
receive this payment.
DATES
: This advisory is effective on
September 14, 2020.
FOR FURTHER INFORMATION CONTACT
:
Tanya Dorm, (410) 786–2206.
SUPPLEMENTARY INFORMATION
:
I. Background
Under the Medicare Quality Payment
Program, an eligible clinician who
participates in an Advanced Alternative
Payment Model (APM) and meets the
applicable payment amount or patient
count thresholds for a performance year
is a Qualifying APM Participant (QP) for
that year. An eligible clinician who is a
QP for a year based on their
performance in a QP Performance
Period earns a 5 percent lump sum APM
Incentive Payment that is paid in a
payment year that occurs 2 years after
the QP Performance Period. The amount
of the APM Incentive Payment is equal
to 5 percent of the estimated aggregate
payments for covered professional
services furnished by the QP during the
calendar year immediately preceding
the payment year.
II. Provisions of the Advisory
The Centers for Medicare & Medicaid
Services (CMS) has identified those
eligible clinicians who earned an APM
Incentive Payment in CY 2020 based on
their CY 2018 QP status.
When CMS disbursed the CY 2020
APM Incentive Payments, CMS was
unable to verify current Medicare billing
information for some QPs and was
therefore unable to issue payment. In
order to successfully disburse the APM
Incentive Payment, CMS is requesting
assistance in identifying current
Medicare billing information for these
QPs.
CMS has compiled a list of QPs we
have identified as having unverified
billing information. These QPs, and any
others who anticipated receiving an
APM Incentive Payment but have not,
should follow the instructions to
provide CMS with updated billing
information at the following web
address: https://qpp-cm-prod-content.
s3.amazonaws.com/uploads/1112/2020
%20APM%20Incentive%20Payment
%20Notice.pdf.
If you have any questions concerning
submission of information through the
website, please contact the QPP Help
Desk at 1–866–288–8292.
All submissions must be received no
later than November 13, 2020.
The Administrator of the Centers for
Medicare & Medicaid Services (CMS),
Seema Verma, having reviewed and
approved this document, authorizes
Vanessa Garcia, who is the Federal
Register Liaison, to electronically sign
this document for purposes of
publication in the Federal Register.
Vanessa Garcia,
Federal Register Liaison, Centers for Medicare
& Medicaid Services.
[FR Doc. 2020–20488 Filed 9–14–20; 11:15 am]
BILLING CODE 4120–01–P
FEDERAL COMMUNICATIONS
COMMISSION
47 CFR Parts 1, 2, 25, 27 and 101
[GN Docket No. 18–122; FCC 20–22; FRS
17048]
Expanding Flexible Use of the 3.7 to
4.2 GHz Band
AGENCY
: Federal Communications
Commission.
ACTION
: Final rule; corrections and
announcement of compliance date.
SUMMARY
: In this document, the
Commission corrects a typographical
error in the 3.7 GHz Report and Order,
FCC 20–22, published on April 23,
2020, and announces that the Office of
Management and Budget has approved
the information collection requirements
associated with the rules adopted in the
Federal Communications Commission’s
3.7 GHz Report and Order, requiring the
Relocation Payment Clearinghouse and
the Relocation Coordinator to each make
real-time, public disclosures of the
content and timing of and the parties to
communications, if any, from or to
applicants in the Commission’s auction
for overlay licenses in the 3.7 GHz
Service, and that compliance with the
new rules is now required. This
document is consistent with the 3.7 GHz
Report and Order, which states that the
Commission will publish a document in
the Federal Register announcing a
compliance date for the new rule
sections.
DATES
: Effective date: The corrections
are effective September 17, 2020.
Compliance date: Compliance with 47
CFR 27.1413(c)(6) and 27.1414(b)(4)(i),
published at 85 FR 22804 on April 23,
2020, is required on September 17,
2020.
FOR FURTHER INFORMATION CONTACT
:
Anna Gentry, Mobility Division,
Wireless Telecommunications Bureau,
at (202) 418–7769 or Anna.Gentry@
fcc.gov.
SUPPLEMENTARY INFORMATION
: This
document corrects a typographical error
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