Significant New Use Rules on Certain Chemical Substances (20-2.5e), 70385-70409 [2021-26683]
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Federal Register / Vol. 86, No. 235 / Friday, December 10, 2021 / Rules and Regulations
more, the opportunity for this review
already exists. When the Postal Service
grants a mailer’s application for
Periodicals mailing privileges, the
Postal Service refunds to the mailer the
difference between the Periodicals
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non-Periodicals prices the mailer
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207.5.2.2b, 207.5.3.5). Any mailer
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was available to the approximately 25
percent of 289 applications for
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Postal Service in FY 2020 and 2021.
The Postal Service is revising the
process to calculate pending postage by
assigning the existing applicable class of
mail prices based upon common
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Each applicable class of mail price will
be expressed as a percentage from the
corresponding Periodicals price. This
new process will simplify the
calculation process during the
authorization review period, and the
refund process when a Periodicals
publication is approved.
We believe this revision will provide
customers with a more efficient and
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List of Subjects in 39 CFR Part 111
Administrative practice and
procedure, Postal Service.
The Postal Service adopts the
following changes to Mailing Standards
of the United States Postal Service,
Domestic Mail Manual (DMM),
incorporated by reference in the Code of
Federal Regulations. See 39 CFR 111.1.
We will publish an appropriate
amendment to 39 CFR part 111 to reflect
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Accordingly, 39 CFR part 111 is
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PART 111—[AMENDED]
1. The authority citation for 39 CFR
part 111 continues to read as follows:
2. Revise the Mailing Standards of the
United States Postal Service, Domestic
Mail Manual (DMM) as follows:
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Periodicals
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5.0 Applying for Periodicals
Authorization
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5.2 Mailing While Application
Pending
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[Renumber 5.2.3 and 5.2.4 as 5.2.4
and 5.2.5, add new 5.2.3 to read as
follows:]
5.2.3
Pending Postage
Postage for a Periodicals publication
pending authorization is calculated by
applying the applicable percent in
Exhibit 5.2.3 to PS Form 3541, Part P,
Line P–1.
Exhibit 5.2.3
Pending Postage
Pending class of mail
Percent
USPS Marketing Mail Letters ..................
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Nonprofit USPS Marketing Mail Flats .....
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Parcel Select Parcels ..............................
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Ruth B. Stevenson,
Chief Counsel, Ethics and Legal Compliance.
[FR Doc. 2021–26716 Filed 12–7–21; 11:15 am]
BILLING CODE P
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Parts 9 and 721
Significant New Use Rules on Certain
Chemical Substances (20–2.5e)
Environmental Protection
Agency (EPA).
ACTION: Final rule.
AGENCY:
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). The SNURs require persons
SUMMARY:
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who intend to manufacture (defined by
statute to include import) or process any
of these chemical substances for an
activity that is designated as a
significant new use by this rule to notify
EPA at least 90 days before commencing
that activity. The required notification
initiates EPA’s evaluation of the use,
under the conditions of use for that
chemical substance, within the
applicable review period. Persons may
not commence manufacture or
processing for the significant new use
until EPA has conducted a review of the
notice, made an appropriate
determination on the notice, and has
taken such actions as are required by
that determination.
DATES: This rule is effective on February
8, 2022. For purposes of judicial review,
this rule shall be promulgated at 1 p.m.
(e.s.t.) on December 27, 2021.
FOR FURTHER INFORMATION CONTACT: For
technical information contact: William
Wysong, New Chemicals 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
* Use Periodicals prices.
RIN 2070–AB27
Authority: 5 U.S.C. 552(a); 13 U.S.C. 301–
307; 18 U.S.C. 1692–1737; 39 U.S.C. 101,
401–404, 414, 416, 3001–3018, 3201–3220,
3401–3406, 3621, 3622, 3626, 3629, 3631–
3633, 3641, 3681–3685, and 5001.
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[EPA–HQ–OPPT–2020–0131; FRL–7842–02–
OCSPP]
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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
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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 dockets?
The dockets include 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–2020–0131, is available at
https://www.regulations.gov and 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
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A. What action is the Agency taking?
EPA is finalizing SNURs under TSCA
section 5(a)(2) for certain chemical
substances which were the subject of
PMNs. EPA will address the other
proposed SNURs in future FR notices.
Previously, EPA proposed SNURs for
these chemical substances and
established the record for these SNURs
in the following Federal Register and
docket ID number:
• October 9, 2020 (85 FR 64280)
(FRL–10011–86); Docket ID No. EPA–
HQ–OPPT–2020–0131.
The dockets include information
considered by the Agency in developing
the proposed and final rules, including
public comments and EPA’s responses
to the public comments received.
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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,
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
A. Considerations for Significant New
Use Determinations
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.
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• 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.
B. Procedures for Significant New Uses
Claimed as CBI
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) and has
referenced it to apply to other SNURs.
Under these procedures a
manufacturer or processor may request
EPA to determine whether a specific 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
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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.
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IV. Public Comments on Proposed Rule
and EPA Responses
EPA received public comments from
three identifying entities on the
proposed rules. The Agency’s responses
are presented in the Response to Public
Comments document that is available in
the public docket for this rulemaking. In
addition, EPA received three
anonymous comments. The anonymous
comments were either general in nature
and did not pertain to the proposed rule
or were broadly supportive of the rule
and requested no changes to the rule
itself; therefore, no response is required.
EPA made changes to 27 of the
proposed rules as described in the
response to 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
SNURs, 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 nonconfidential 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
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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
rules, 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
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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
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 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
TSCA section 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/tscainventory.
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.
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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 many of the
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 the
publication dates of the proposed rules
(see Unit II.) as the cutoff dates for
determining whether the new uses are
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
the abovementioned dates, 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 them or
reasonably ascertainable by them (see 40
CFR 720.50). However, upon review of
PMNs and SNUNs, the Agency has the
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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). For more information on
alternative test methods and strategies
to reduce vertebrate animal testing, visit
https://www.epa.gov/assessing-andmanaging-chemicals-under-tsca/
alternative-test-methods-and-strategiesreduce.
In some of the TSCA Orders for the
chemical substances identified in this
rule, EPA has established production
volume and time 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 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 nonexempt 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 screeninglevel 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
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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:
• 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. 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-chemicalsunder-toxic-substances-control-act-tsca.
X. 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
analyses are available in each docket
listed in Unit II.
XI. Statutory and Executive Order
Reviews
Additional information about these
statutes and Executive Orders can be
found at https://www.epa.gov/lawsregulations-and-executive-orders.
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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.
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C. Paperwork Reduction Act (PRA)
According to the 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 pursuant to 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
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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
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
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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
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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)
21 U.S.C. 331j, 346a; 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 §§ 721.11401 through
721.11403 and §§ 721.11514 through
721.11555 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.
In addition, since this action does not
involve any technical standards subject
to NTTAA section 12(d) (15 U.S.C. 272
note).
*
*
L. Congressional Review Act (CRA)
This action is subject to the CRA, 5
U.S.C. 801 et seq., and EPA will submit
a rule report containing this rule and
other required information 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: December 3, 2021.
Tala Henry,
Deputy Director, Office of Pollution
Prevention and Toxics.
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Therefore, for the reasons stated in the
preamble, 40 CFR chapter I is amended
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;
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721.11552
721.11553
721.11554
721.11555
721.11443
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721.11401 .......................
721.11402 .......................
721.11403 .......................
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2070–0012
2070–0012
2070–0012
*
721.11514
721.11515
721.11516
721.11517
721.11518
721.11519
721.11520
721.11521
721.11522
721.11523
721.11524
721.11525
721.11526
721.11527
721.11528
721.11529
721.11530
721.11531
721.11532
721.11533
721.11534
721.11535
721.11536
721.11537
721.11538
721.11539
721.11540
721.11541
721.11542
721.11543
721.11544
721.11545
721.11546
721.11547
721.11548
721.11549
721.11550
721.11551
*
*
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2070–0012
2070–0012
2070–0012
2070–0012
2070–0012
2070–0012
2070–0012
2070–0012
2070–0012
2070–0012
2070–0012
2070–0012
2070–0012
2070–0012
2070–0012
2070–0012
2070–0012
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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 §§ 721.11401 through
721.11403 and §§ 721.11514 through
721.11555 in numerical order to subpart
E to read as follows:
Subpart E—Significant New Uses for
Specific Chemical Substances
Sec.
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OMB control No.
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Significant New Uses of Chemical
Substances
This action does not entail special
considerations of environmental justice
related issues as delineated by
Executive Order 12898 (59 FR 7629,
February 16, 1994).
15:55 Dec 09, 2021
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40 CFR citation
K. Executive Order 12898: Federal
Actions To Address Environmental
Justice in Minority Populations and
Low-Income Populations
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40 CFR citation
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*
721.11401 2-Propenoic acid, 2-methyl-,
methyl ester, polymer with
ethenylbenzene, ethyl 2-propenoate, 2oxiranylmethyl 2-methyl-2-propenoate
and 1,2-propanediol mono(2-methyl-2propenoate), reaction products with
diethanolamine, polymers with
substituted-alkyl acrylate, formats (salts)
(generic).
721.11402 2-Propenoic acid, 2-methyl,
methyl ester, polymer with
ethenylbenzene, ethyl 2-propenoate, 2oxiranylmethyl 2-methyl-2-propenoate
and 1,2-propanediol mono(2-methyl-2propenoate), reaction products with
diethanolamine, polymers with
substituted-alkyl methacrylate, formats
(salts) (generic).
721.11403 2-Propenoic acid, 2-methyl-,
methyl ester, polymer with
ethenylbenzene, ethyl 2-propenoate, 2oxrianylmethyl 2-methyl-2-propenoate,
and 1,2-propaneidol mono(2-methyl-2propenoate), reaction products with
diethanolamine, polymers with alkylene
glycol monoacrylate, formats (salts)
(generic).
*
*
*
*
*
721.11514 Organic sulfonate compound
(generic).
721.11515 Thiophenium, 1-(2,7disubstituted-1-naphthalenyl)tetrahydro, salt with polyfluoro-Npolyfluoroalkylsulfonyl-1alkanesulfonamide (1:1) (generic).
721.11516 Sulfonium, triphenyl-, salt with
2,3-bis(substituted) 5sulfocarbopolycyclic-2,3-carboxylate
derivative (1:1) (generic).
721.11517 Thiophenium, 1-(2,7disubstituted-1-naphthalenyl)tetrahydro, salt with polyfluoro-Npolyfluoroalkylsulfonyl-1alkanesulfonamide (1:1) (generic).
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721.11518 Sulfonium, triphenyl-, 5-(alkyl)
fluoropentane derivative (generic).
721.11519 Sulfonium, triphenyl-, salt with
substituted-alkyl 4-substituted-benzoate
(generic).
721.11520 Substituted-triphenylsulfonium,
inner salt (generic).
721.11521 Sulfonium, triphenyl-, salt with
disubstituted-heterocyclic compound
(1:1) (generic).
721.11522 Sulfonium, triphenyl-, salt with
2,4,5-trisubstituted-benzenesulfonate
(1:1) (generic).
721.11523 Substituted heterocyclic onium
compound, salt with 2,2,2-trifluoro-1(sulfomethyl)-1-(trifluoromethyl)ethyl 3[(2-methyl-1-oxo-2-propen-1yl)oxy]tricyclo[3.3.1.13,7]decane-1carboxylate (1:1), polymer with
acenaphthylene, 1-ethenyl-4-[(1ethylcyclopentyl)oxy]benzene and 4ethenylphenol, di-Me 2,2′-(1,2diazenediyl)bis[2-methylpropanoate]initiated (generic).
721.11524 Substituted heterocyclic onium
compound, salt with 2,2,2-trifluoro-1(sulfomethyl)-1-(trifluoromethyl)ethyl 3[(2-methyl-1-oxo-2-propen-1yl)oxy]tricyclo[3.3.1.13,7]decane-1carboxylate (1:1), polymer with
acenaphthylene, 1-ethenyl-4-[[1-(1methylethyl)cyclopentyl]oxy]benzene
and 4-ethenylphenol, di-Me 2,2′-(1,2diazenediyl)bis[2-methylpropanoate]initiated (generic).
721.11525 Dibenzothiophenium, aryl
substituted trifluoro-hydroxy(triheterosubstitutedalkyl)alkanoate (1:1)
(generic).
721.11526 Substituted heterocyclic onium
compound, salt with 1(difluorosulfomethyl)-2,2,2-trifluoroethyl
3-[(2-methyl-1-oxo-2-propen-1yl)oxy]tricyclo[3.3.1.13,7]decane-1carboxylate (1:1), polymer with 3ethenylphenol, 1-(1methylethyl)cyclopentyl 2-methyl-2propenoate and 1-(7oxabicyclo[2.2.1]hept-2-yl)cyclopentyl 2methyl-2-propenoate, di-Me 2,2′-(1,2diazenediyl)bis[2-methylpropenoate]initiated (generic).
721.11527 Sulfonium, triphenyl-, trifluorohydroxy(triheterosubstitutedalkyl)alkanoate (1:1)
(generic).
721.11528 Heterotrisubstituted-bile acid, 1(difluorosulfomethyl)-2,2,2-trifluoroethyl
ester, ion(1-), (5)-, triphenylsulfonium
(1:1) (generic).
721.11529 Aromatic sulfonium tricyclo
fluoroalkyl sulfonic acid salt (generic)
721.11530 Substituted,
(alkylaromatic)diaromatic salt with
trihalo[(trihaloalkyl)substituted]substituted
alkaneamide (generic).
721.11531 Triarylsulfonium substituted
oxatricycloalkyloxycarbonyl dihalo
alkane sulfonate (generic).
721.11532 Substituted triarylsulfonium
carbopolycyclic heteromonocyclic dihalo
sulfoacetate (generic).
721.11533 Substituted triarylsulfonium
substituted carbopolycyclic carboxylate
(generic).
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15:55 Dec 09, 2021
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721.11534 Sulfonium,
bis(dihalocarbomonocycle)
carbomonocycle, salt with substituted
heteropolycycle dihalo sulfoalkanoate
(1:1) (generic).
721.11535 Heteropolycycle, alkylaromatic-,
salt with dihalo-substituted alkyl
carbopolycycle carboxylate (generic).
721.11536 Sulfonium, triaryl-, salt with
polyhalo-4-sulfoalkyl polycarbocyclic
alkane-1-carboxylate (1:1) (generic).
721.11537 Sulfonium,
bis(dihalocarbomonocycle)
carbomonocycle, salt with dihalo
substituted alkyl carbopolycyclic
carboxylate (1:1) (generic).
721.11538 Sulfonium,
bis(dihalocarbomonocycle)
carbomonocycle, substituted
carbomonocyclic ester (generic).
721.11539 Heteropolycycle, aromatic-, salt
with dihalo-substituted alkyl
carbopolycycle carboxylate (1:1)
(generic).
721.11540 Triarylsulfonium
alkylestersulfonate (generic).
721.11541 Halogenated alkylbenzoic acid
(generic) (P–19–168).
721.11542 Halogenated alkylbenzoic acid
(generic) (P–19–169).
721.11543 Halogenated benzoic acid
(generic) (P–19–171).
721.11544 Halogenated benzoic acid
(generic) (P–19–172).
721.11545 Halogenated benzoic acid
(generic) (P–19–173).
721.11546 Halogenated alkylbenzoic acid
(generic) (P–19–175).
721.11547 Halogenated alkylbenzoic acid
(generic) (P–19–176).
721.11548 Halogenated alkylbenzoic acid
(generic) (P–19–177).
721.11549 Halogenated alkylbenzoic acid
(generic) (P–19–178).
721.11550 Halogenated alkylbenzoic acid
(generic) (P–19–179).
721.11551 Halogenated sodium benzoate
(generic) (P–19–180).
721.11552 Halogenated sodium benzoate
(generic) (P–19–181).
721.11553 Halogenated sodium benzoate
(generic) (P–19–182).
721.11554 Halogenated sodium
alkylbenzoate (generic) (P–19–184).
721.11555 Halogenated sodium
alkylbenzoate (generic) (P–19–187).
*
*
*
*
*
§ 721.11401 2-Propenoic acid, 2-methyl-,
methyl ester, polymer with ethenylbenzene,
ethyl 2-propenoate, 2-oxiranylmethyl 2methyl-2-propenoate and 1,2-propanediol
mono(2-methyl-2-propenoate), reaction
products with diethanolamine, polymers
with substituted-alkyl acrylate, formats
(salts) (generic).
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified
generically as 2-propenoic acid, 2methyl-, methyl ester, polymer with
ethenylbenzene, ethyl 2-propenoate, 2oxiranylmethyl 2-methyl-2-propenoate
and 1,2-propanediol mono(2-methyl-2propenoate), reaction products with
PO 00000
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70391
diethanolamine, polymers with
substituted-alkyl acrylate, formats (salts)
(PMN P–18–241) 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(j).
(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) Limitation 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.
§ 721.11402 2-Propenoic acid, 2-methyl,
methyl ester, polymer with ethenylbenzene,
ethyl 2-propenoate, 2-oxiranylmethyl 2methyl-2-propenoate and 1,2-propanediol
mono(2-methyl-2-propenoate), reaction
products with diethanolamine, polymers
with substituted-alkyl methacrylate, formats
(salts) (generic).
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified
generically as 2-propenoic acid, 2methyl, methyl ester, polymer with
ethenylbenzene, ethyl 2-propenoate, 2oxiranylmethyl 2-methyl-2-propenoate
and 1,2-propanediol mono(2-methyl-2propenoate), reaction products with
diethanolamine, polymers with
substituted-alkyl methacrylate, formats
(salts) (PMN P–18–244) 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(j).
(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) Limitation or revocation of certain
notification requirements. The
provisions of § 721.185 apply to this
section.
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(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.
§ 721.11403 2-Propenoic acid, 2-methyl-,
methyl ester, polymer with ethenylbenzene,
ethyl 2-propenoate, 2-oxrianylmethyl 2methyl-2-propenoate, and 1,2-propaneidol
mono(2-methyl-2-propenoate), reaction
products with diethanolamine, polymers
with alkylene glycol monoacrylate, formats
(salts) (generic).
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified
generically as 2-propenoic acid, 2methyl-, methyl ester, polymer with
ethenylbenzene, ethyl 2-propenoate, 2oxrianylmethyl 2-methyl-2-propenoate,
and 1,2-propaneidol mono(2-methyl-2propenoate), reaction products with
diethanolamine, polymers with alkylene
glycol monoacrylate, formats (salts)
(PMN P–18–245) 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(j).
(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) Limitation 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.
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§ 721.11514
(generic).
Organic sulfonate compound
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified
generically as organic sulfonate
compound (PMN P–16–539) 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 or
adhered (during the photolithographic
process) onto a semiconductor wafer
surface or similar manufactured article
used in the production of
semiconductor technologies.
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(2) The significant new uses are:
(i) Protection in the workplace.
Requirements as specified in
§ 721.63(a)(1), (a)(2)(i) and (iii), (a)(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 (e), (g)(1), (g)(2)(i) through (iii)
and (v), (g)(3)(i) and (ii), and (g)(5). For
purposes of § 721.72(e), the
concentration is set at 1.0%. For
purposes of § 721.72(g)(1), this
substance may cause: Skin irritation;
acute toxicity; skin sensitization; serious
eye damage; specific target organ
toxicity; neurotoxicity; genetic toxicity;
reproductive toxicity. 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(f), (k), and (t). It is
a significant new use to import the
substance in any physical state other
than in solution, unless in sealed
containers weighing 5 kilograms or less.
It is a significant new use to process the
substance in any way that generates a
dust, mist, or aerosol in a non-enclosed
process. It is a significant new use to
manufacture the substance longer than
18 months.
(b) Specific requirements. The
provisions of subpart A of this part
apply to this section except as modified
by this paragraph (b).
(1) Recordkeeping. Recordkeeping
requirements as specified in
§ 721.125(a) through (i) are applicable to
manufacturers and processors of this
substance.
(2) Limitation 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.
§ 721.11515 Thiophenium, 1-(2,7disubstituted-1-naphthalenyl)tetrahydro-,
salt with polyfluoro-Npolyfluoroalkylsulfonyl-1alkanesulfonamide (1:1) (generic).
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified
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Fmt 4700
Sfmt 4700
generically as thiophenium, 1-(2,7disubstituted-1naphthalenyl)tetrahydro-, salt with
polyfluoro-N-polyfluoroalkylsulfonyl-1alkanesulfonamide (1:1) (PMN P–18–
157) 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 or adhered (during
the photolithographic process) onto a
semiconductor wafer surface or similar
manufactured article used in the
production of semiconductor
technologies.
(2) The significant new uses are:
(i) Protection in the workplace.
Requirements as specified in
§ 721.63(a)(1), (a)(2)(i) and (iii), (a)(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 (e), (g)(1), (g)(2)(i) through (iii)
and (v), (g)(3)(i) and (ii), and (g)(5). For
purposes of § 721.72(e), the
concentration is set at 1.0%. For
purposes of § 721.72(g)(1), this
substance may cause: Acute toxicity;
skin sensitization; serious eye damage;
specific target organ toxicity;
neurotoxicity; genetic toxicity;
reproductive toxicity. 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(f), (k), and (t). It is
a significant new use to import the
substance in any physical state other
than in solution, unless in sealed
containers weighing 5 kilograms or less.
It is a significant new use to process the
substance in any way that generates a
dust, mist, or aerosol in a non-enclosed
process. It is a significant new use to
manufacture the substance longer than
18 months.
(b) Specific requirements. The
provisions of subpart A of this part
apply to this section except as modified
by this paragraph (b).
(1) Recordkeeping. Recordkeeping
requirements as specified in
§ 721.125(a) through (i) are applicable to
manufacturers and processors of this
substance.
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(2) Limitation 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.
jspears on DSK121TN23PROD with RULES1
§ 721.11516 Sulfonium, triphenyl-, salt with
2,3-bis(substituted) 5-sulfocarbopolycyclic2,3-carboxylate derivative (1:1) (generic).
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified
generically as sulfonium, triphenyl-, salt
with 2,3-bis(substituted) 5sulfocarbopolycyclic-2,3-carboxylate
derivative (1:1) (PMN P–18–158), 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 or
adhered (during the photolithographic
process) onto a semiconductor wafer
surface or similar manufactured article
used in the production of
semiconductor technologies.
(2) The significant new uses are:
(i) Protection in the workplace.
Requirements as specified in
§ 721.63(a)(1), (a)(2)(i) and (iii), (a)(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 (e), (g)(1), (g)(2)(i) through (iii)
and (v), (g)(3)(i), and (ii), and (g)(5). For
purposes of § 721.72(e), the
concentration is set at 1.0%. For
purposes of § 721.72(g)(1), this
substance may cause: Acute toxicity;
skin sensitization, serious eye damage;
specific target organ toxicity;
neurotoxicity; genetic toxicity;
reproductive toxicity. 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(f), (k), and (t). It is
a significant new use to import the
substance in any physical state other
than in solution, unless in sealed
containers weighing 5 kilograms or less.
It is a significant new use to process the
substance in any way that generates a
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Jkt 256001
dust, mist, or aerosol in a non-enclosed
process. It is a significant new use to
manufacture the substance longer than
18 months.
(b) Specific requirements. The
provisions of subpart A of this part
apply to this section except as modified
by this paragraph (b).
(1) Recordkeeping. Recordkeeping
requirements as specified in
§ 721.125(a) through (i) are applicable to
manufacturers and processors of this
substance.
(2) Limitation 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.
§ 721.11517 Thiophenium, 1-(2,7disubstituted-1-naphthalenyl)tetrahydro-,
salt with polyfluoro-Npolyfluoroalkylsulfonyl-1alkanesulfonamide (1:1) (generic).
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified
generically as thiophenium, 1-(2,7disubstituted-1naphthalenyl)tetrahydro-, salt with
polyfluoro-N-polyfluoroalkylsulfonyl-1alkanesulfonamide (1:1) (PMN P–18–
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 or adhered (during
the photolithographic process) onto a
semiconductor wafer surface or similar
manufactured article used in the
production of semiconductor
technologies.
(2) The significant new uses are:
(i) Protection in the workplace.
Requirements as specified in
§ 721.63(a)(1), (a)(2)(i) and (iii), (a)(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 (e), (g)(1), (g)(2)(i) through (iii)
and (v), (g)(3)(i) and (ii), and (g)(5). For
purposes of § 721.72(e), the
concentration is set at 1.0%. For
purposes of § 721.72(g)(1), this
substance may cause: Acute toxicity;
PO 00000
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Fmt 4700
Sfmt 4700
70393
skin sensitization; serious eye damage;
specific target organ toxicity;
neurotoxicity; genetic toxicity;
reproductive toxicity. 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(f), (k), and (t). It is
a significant new use to import the
substance in any physical state other
than in solution, unless in sealed
containers weighing 5 kilograms or less.
It is a significant new use to process the
substance in any way that generates a
dust, mist, or aerosol in a non-enclosed
process. It is a significant new use to
manufacture the substance longer than
18 months.
(b) Specific requirements. The
provisions of subpart A of this part
apply to this section except as modified
by this paragraph (b).
(1) Recordkeeping. Recordkeeping
requirements as specified in
§ 721.125(a) through (i) are applicable to
manufacturers and processors of this
substance.
(2) Limitation 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.
§ 721.11518 Sulfonium, triphenyl-, 5-(alkyl)
fluoropentane derivative (generic).
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified
generically as sulfonium, triphenyl-, 5(alkyl) fluoropentane derivative (PMN
P–19–33) 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 or adhered (during
the photolithographic process) onto a
semiconductor wafer surface or similar
manufactured article used in the
production of semiconductor
technologies.
(2) The significant new uses are:
(i) Protection in the workplace.
Requirements as specified in
§ 721.63(a)(1), (a)(2)(i) and (iii), (a)(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.,
E:\FR\FM\10DER1.SGM
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Federal Register / Vol. 86, No. 235 / Friday, December 10, 2021 / Rules and Regulations
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 (e), (g)(1), (a)(2)(i) through (iii)
and (v), (a)(3)(i) and (ii), and (a)(5). For
purposes of § 721.72(e), the
concentration is set at 1.0%. For
purposes of § 721.72(g)(1), this
substance may cause: Acute toxicity;
skin sensitization; serious eye damage;
specific target organ toxicity;
neurotoxicity; genetic toxicity;
reproductive toxicity. 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(f), (k), and (t). It is
a significant new use to import the
substance in any physical state other
than in solution, unless in sealed
containers weighing 5 kilograms or less.
It is a significant new use to process the
substance in any way that generates a
dust, mist, or aerosol in a non-enclosed
process. It is a significant new use to
manufacture the substance longer than
18 months.
(b) Specific requirements. The
provisions of subpart A of this part
apply to this section except as modified
by this paragraph (b).
(1) Recordkeeping. Recordkeeping
requirements as specified in
§ 721.125(a) through (i) are applicable to
manufacturers and processors of this
substance.
(2) Limitation 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.
jspears on DSK121TN23PROD with RULES1
§ 721.11519 Sulfonium, triphenyl-, salt with
substituted-alkyl 4-substituted-benzoate
(generic).
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified
generically as sulfonium, triphenyl-, salt
with substituted-alkyl 4-substitutedbenzoate (PMN P–17–178) 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 or
adhered (during the photolithographic
process) onto a semiconductor wafer
surface or similar manufactured article
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15:55 Dec 09, 2021
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used in the production of
semiconductor technologies.
(2) The significant new uses are:
(i) Protection in the workplace.
Requirements as specified in
§ 721.63(a)(1), (a)(2)(i) and (iii), (a)(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 (e), (g)(1), (g)(2)(i) through (iii)
and (v), (g)(3)(i) and (ii), and (g)(5). For
purposes of § 721.72(e), the
concentration is set at 1.0%. For
purposes of § 721.72(g)(1), this
substance may cause: Acute toxicity;
skin sensitization; serious eye damage;
specific target organ toxicity;
neurotoxicity; genetic toxicity;
reproductive toxicity. 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(f), (k), and (t). It is
a significant new use to import the
substance in any physical state other
than in solution, unless in sealed
containers weighing 5 kilograms or less.
It is a significant new use to process the
substance in any way that generates a
dust, mist, or aerosol in a non-enclosed
process. It is a significant new use to
manufacture the substance longer than
18 months.
(b) Specific requirements. The
provisions of subpart A of this part
apply to this section except as modified
by this paragraph (b).
(1) Recordkeeping. Recordkeeping
requirements as specified in
§ 721.125(a) through (i) are applicable to
manufacturers and processors of this
substance.
(2) Limitation 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.
§ 721.11520 Substitutedtriphenylsulfonium, inner salt (generic).
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified
generically as substituted-
PO 00000
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Fmt 4700
Sfmt 4700
triphenylsulfonium, inner salt (PMN P–
18–13) 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 or adhered (during
the photolithographic process) onto a
semiconductor wafer surface or similar
manufactured article used in the
production of semiconductor
technologies.
(2) The significant new uses are:
(i) Protection in the workplace.
Requirements as specified in
§ 721.63(a)(1), (a)(2)(i) and (iii), (a)(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 (e), (g)(1), (g)(2)(i) through (iii)
and (v), (g)(3)(i) and (ii), and (g)(5). For
purposes of § 721.72(e), the
concentration is set at 1.0%. For
purposes of § 721.72(g)(1), this
substance may cause: Acute toxicity;
skin sensitization; serious eye damage;
specific target organ toxicity;
neurotoxicity; genetic toxicity;
reproductive toxicity. 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(f), (k), and (t). It is
a significant new use to import the
substance in any physical state other
than in solution, unless in sealed
containers weighing 5 kilograms or less.
It is a significant new use to process the
substance in any way that generates a
dust, mist, or aerosol in a non-enclosed
process. It is a significant new use to
manufacture the substance longer than
18 months.
(b) Specific requirements. The
provisions of subpart A of this part
apply to this section except as modified
by this paragraph (b).
(1) Recordkeeping. Recordkeeping
requirements as specified in
§ 721.125(a) through (i) are applicable to
manufacturers and processors of this
substance.
(2) Limitation or revocation of certain
notification requirements. The
provisions of § 721.185 apply to this
section.
E:\FR\FM\10DER1.SGM
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(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.
jspears on DSK121TN23PROD with RULES1
§ 721.11521 Sulfonium, triphenyl-, salt with
disubstituted-heterocyclic compound (1:1)
(generic).
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified
generically as sulfonium, triphenyl-, salt
with disubstituted-heterocyclic
compound (1:1) (PMN P–18–14) 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 or
adhered (during the photolithographic
process) onto a semiconductor wafer
surface or similar manufactured article
used in the production of
semiconductor technologies.
(2) The significant new uses are:
(i) Protection in the workplace.
Requirements as specified in
§ 721.63(a)(1), (a)(2)(i) and (iii), (a)(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 (e), (g)(1), (g)(2)(i) through (iii)
and (v), (g)(3)(i) and (ii), and (g)(5). For
purposes of § 721.72(e), the
concentration is set at 1.0%. For
purposes of § 721.72(g)(1), this
substance may cause: Acute toxicity;
skin sensitization; serious eye damage;
specific target organ toxicity;
neurotoxicity; genetic toxicity;
reproductive toxicity. 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(f), (k), and (t). It is
a significant new use to import the
substance in any physical state other
than in solution, unless in sealed
containers weighing 5 kilograms or less.
It is a significant new use to process the
substance in any way that generates a
dust, mist, or aerosol in a non-enclosed
process. It is a significant new use to
manufacture the substance longer than
18 months.
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15:55 Dec 09, 2021
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(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) Limitation 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.
§ 721.11522 Sulfonium, triphenyl-, salt with
2,4,5-trisubstituted-benzenesulfonate (1:1)
(generic).
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified
generically as sulfonium, triphenyl-, salt
with 2,4,5-trisubstitutedbenzenesulfonate (1:1) (PMN P–18–37)
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 or
adhered (during the photolithographic
process) onto a semiconductor wafer
surface or similar manufactured article
used in the production of
semiconductor technologies.
(2) The significant new uses are:
(i) Protection in the workplace.
Requirements as specified in
§ 721.63(a)(1), (a)(2)(i) and (iii), (a)(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 (e), (g)(1), (g)(2)(i) through (iii)
and (v), (g)(3)(i) and (ii), and (g)(5). For
purposes of § 721.72(e), the
concentration is set at 1.0%. For
purposes of § 721.72(g)(1), this
substance may cause: Acute toxicity;
skin sensitization; serious eye damage;
specific target organ toxicity;
neurotoxicity; genetic toxicity;
reproductive toxicity. Alternative
hazard and warning statements that
meet the criteria of the Globally
Harmonized System and OSHA Hazard
Communication Standard may be used.
PO 00000
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Fmt 4700
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70395
(iii) Industrial, commercial, and
consumer activities. Requirements as
specified in § 721.80(f), (k), and (t). It is
a significant new use to import the
substance in any physical state other
than in solution, unless in sealed
containers weighing 5 kilograms or less.
It is a significant new use to process the
substance in any way that generates a
dust, mist, or aerosol in a non-enclosed
process. It is a significant new use to
manufacture the substance longer than
18 months.
(b) Specific requirements. The
provisions of subpart A of this part
apply to this section except as modified
by this paragraph (b).
(1) Recordkeeping. Recordkeeping
requirements as specified in
§ 721.125(a) through (i) are applicable to
manufacturers and processors of this
substance.
(2) Limitation 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.
§ 721.11523 Substituted heterocyclic
onium compound, salt with 2,2,2-trifluoro-1(sulfomethyl)-1-(trifluoromethyl)ethyl 3-[(2methyl-1-oxo-2-propen-1yl)oxy]tricyclo[3.3.1.13,7]decane-1carboxylate (1:1), polymer with
acenaphthylene, 1-ethenyl-4-[(1ethylcyclopentyl)oxy]benzene and 4ethenylphenol, di-Me 2,2′-(1,2diazenediyl)bis[2-methylpropanoate]initiated (generic).
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified
generically as substituted heterocyclic
onium compound, salt with 2,2,2trifluoro-1-(sulfomethyl)-1(trifluoromethyl)ethyl 3-[(2-methyl-1oxo-2-propen-1yl)oxy]tricyclo[3.3.1.13,7]decane-1carboxylate (1:1), polymer with
acenaphthylene, 1-ethenyl-4-[(1ethylcyclopentyl)oxy]benzene and 4ethenylphenol, di-Me 2,2′-(1,2diazenediyl)bis[2-methylpropanoate]initiated (PMN P–19–78) 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 or
adhered (during the photolithographic
process) onto a semiconductor wafer
surface or similar manufactured article
used in the production of
semiconductor technologies.
(2) The significant new uses are:
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(i) Protection in the workplace.
Requirements as specified in
§ 721.63(a)(1), (a)(2)(i) and (iii), (a)(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 (e), (g)(1), (g)(2)(i) through (iii)
and (v), (g)(3)(i) and (ii), and (g)(5). For
purposes of § 721.72(e), the
concentration is set at 1.0%. For
purposes of § 721.72(g)(1), this
substance may cause: Acute toxicity;
skin sensitization; serious eye damage;
specific target organ toxicity;
neurotoxicity; genetic toxicity;
reproductive toxicity. 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(f), (k), and (t). It is
a significant new use to import the
substance in any physical state other
than in solution, unless in sealed
containers weighing 5 kilograms or less.
It is a significant new use to process the
substance in any way that generates a
dust, mist, or aerosol in a non-enclosed
process. It is a significant new use to
manufacture the substance longer than
18 months.
(b) Specific requirements. The
provisions of subpart A of this part
apply to this section except as modified
by this paragraph (b).
(1) Recordkeeping. Recordkeeping
requirements as specified in
§ 721.125(a) through (i) are applicable to
manufacturers and processors of this
substance.
(2) Limitation 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.
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§ 721.11524 Substituted heterocyclic
onium compound, salt with 2,2,2-trifluoro-1(sulfomethyl)-1-(trifluoromethyl)ethyl 3-[(2methyl-1-oxo-2-propen-1yl)oxy]tricyclo[3.3.1.13,7]decane-1carboxylate (1:1), polymer with
acenaphthylene, 1-ethenyl-4-[[1-(1methylethyl)cyclopentyl]oxy]benzene and 4ethenylphenol, di-Me 2,2′-(1,2diazenediyl)bis[2-methylpropanoate]initiated (generic).
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified
generically as substituted heterocyclic
onium compound, salt with 2,2,2trifluoro-1-(sulfomethyl)-1(trifluoromethyl)ethyl 3-[(2-methyl-1oxo-2-propen-1yl)oxy]tricyclo[3.3.1.13,7]decane-1carboxylate (1:1), polymer with
acenaphthylene, 1-ethenyl-4-[[1-(1methylethyl)cyclopentyl]oxy]benzene
and 4-ethenylphenol, di-Me 2,2′-(1,2diazenediyl)bis[2-methylpropanoate]initiated (PMN P–19–79) 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 or
adhered (during the photolithographic
process) onto a semiconductor wafer
surface or similar manufactured article
used in the production of
semiconductor technologies.
(2) The significant new uses are:
(i) Protection in the workplace.
Requirements as specified in
§ 721.63(a)(1), (a)(2)(i) and (iii), (a)(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 (e), (g)(1), (g)(2)(i) through (iii)
and (v), (g)(3)(i) and (ii), and (g)(5). For
purposes of § 721.72(e), the
concentration is set at 1.0%. For
purposes of § 721.72(g)(1), this
substance may cause: Acute toxicity;
skin sensitization; serious eye damage;
specific target organ toxicity;
neurotoxicity; genetic toxicity;
reproductive toxicity. 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(f), (k), and (t). It is
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a significant new use to import the
substance in any physical state other
than in solution, unless in sealed
containers weighing 5 kilograms or less.
It is a significant new use to process the
substance in any way that generates a
dust, mist, or aerosol in a non-enclosed
process. It is a significant new use to
manufacture the substance longer than
18 months.
(b) Specific requirements. The
provisions of subpart A of this part
apply to this section except as modified
by this paragraph (b).
(1) Recordkeeping. Recordkeeping
requirements as specified in
§ 721.125(a) through (i) are applicable to
manufacturers and processors of this
substance.
(2) Limitation 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.
§ 721.11525 Dibenzothiophenium, aryl
substituted trifluoro-hydroxy(triheterosubstitutedalkyl)alkanoate (1:1)
(generic).
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified
generically as dibenzothiophenium, aryl
substituted trifluoro-hydroxy(triheterosubstitutedalkyl)alkanoate
(1:1) (PMN P–19–111) 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 or
adhered (during the photolithographic
process) onto a semiconductor wafer
surface or similar manufactured article
used in the production of
semiconductor technologies.
(2) The significant new uses are:
(i) Protection in the workplace.
Requirements as specified in
§ 721.63(a)(1), (a)(2)(i) and (iii), (a)(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 (e), (g)(1), (g)(2)(i) through (iii)
and (v), (g)(3)(i) and (ii), and (g)(5). For
purposes of § 721.72(e), the
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concentration is set at 1.0%. For
purposes of § 721.72(g)(1), this
substance may cause: Acute toxicity;
skin sensitization; serious eye damage;
specific target organ toxicity;
neurotoxicity; genetic toxicity;
reproductive toxicity. 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(f), (k), and (t). It is
a significant new use to import the
substance in any physical state other
than in solution, unless in sealed
containers weighing 5 kilograms or less.
It is a significant new use to process the
substance in any way that generates a
dust, mist, or aerosol in a non-enclosed
process. It is a significant new use to
manufacture the substance longer than
18 months.
(b) Specific requirements. The
provisions of subpart A of this part
apply to this section except as modified
by this paragraph (b).
(1) Recordkeeping. Recordkeeping
requirements as specified in
§ 721.125(a) through (i) are applicable to
manufacturers and processors of this
substance.
(2) Limitation 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.
jspears on DSK121TN23PROD with RULES1
§ 721.11526 Substituted heterocyclic
onium compound, salt with 1(difluorosulfomethyl)-2,2,2-trifluoroethyl 3[(2-methyl-1-oxo-2-propen-1yl)oxy]tricyclo[3.3.1.13,7]decane-1carboxylate (1:1), polymer with 3ethenylphenol, 1-(1-methylethyl)cyclopentyl
2-methyl-2-propenoate and 1-(7oxabicyclo[2.2.1]hept-2-yl)cyclopentyl 2methyl-2-propenoate, di-Me 2,2′-(1,2diazenediyl)bis[2-methylpropenoate]initiated (generic).
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified
generically as substituted heterocyclic
onium compound, salt with 1(difluorosulfomethyl)-2,2,2trifluoroethyl 3-[(2-methyl-1-oxo-2propen-1yl)oxy]tricyclo[3.3.1.13,7]decane-1carboxylate (1:1), polymer with 3ethenylphenol, 1-(1methylethyl)cyclopentyl 2-methyl-2propenoate and 1-(7oxabicyclo[2.2.1]hept-2-yl)cyclopentyl
2-methyl-2-propenoate, di-Me 2,2′-(1,2diazenediyl)bis[2-methylpropenoate]-
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initiated (PMN P–19–112) 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 or
adhered (during the photolithographic
process) onto a semiconductor wafer
surface or similar manufactured article
used in the production of
semiconductor technologies.
(2) The significant new uses are:
(i) Protection in the workplace.
Requirements as specified in
§ 721.63(a)(1), (a)(2)(i) and (iii), (a)(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 (e), (g)(1), (g)(2)(i) through (iii)
and (v), (g)(3)(i) and (ii), and (g)(5). For
purposes of § 721.72(e), the
concentration is set at 1.0%. For
purposes of § 721.72(g)(1), this
substance may cause: Acute toxicity;
skin sensitization; serious eye damage;
specific target organ toxicity;
neurotoxicity; genetic toxicity;
reproductive toxicity. 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(f), (k), and (t). It is
a significant new use to import the
substance in any physical state other
than in solution, unless in sealed
containers weighing 5 kilograms or less.
It is a significant new use to process the
substance in any way that generates a
dust, mist, or aerosol in a non-enclosed
process. It is a significant new use to
manufacture the substance longer than
18 months.
(b) Specific requirements. The
provisions of subpart A of this part
apply to this section except as modified
by this paragraph (b).
(1) Recordkeeping. Recordkeeping
requirements as specified in
§ 721.125(a) through (i) are applicable to
manufacturers and processors of this
substance.
(2) Limitation or revocation of certain
notification requirements. The
provisions of § 721.185 apply to this
section.
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(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.
§ 721.11527 Sulfonium, triphenyl-,
trifluoro-hydroxy(triheterosubstitutedalkyl)alkanoate (1:1)
(generic).
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified
generically as sulfonium, triphenyl-,
trifluoro-hydroxy(triheterosubstitutedalkyl)alkanoate
(1:1) (PMN P–19–114) 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 or
adhered (during the photolithographic
process) onto a semiconductor wafer
surface or similar manufactured article
used in the production of
semiconductor technologies.
(2) The significant new uses are:
(i) Protection in the workplace.
Requirements as specified in
§ 721.63(a)(1), (a)(2)(i) and (iii), (a)(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 (e), (g)(1), (g)(2)(i) through (iii)
and (v), (g)(3)(i) and (ii), and (g)(5). For
purposes of § 721.72(e), the
concentration is set at 1.0%. For
purposes of § 721.72(g)(1), this
substance may cause: Acute toxicity;
skin sensitization; serious eye damage;
specific target organ toxicity;
neurotoxicity; genetic toxicity;
reproductive toxicity. 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(f), (k), and (t). It is
a significant new use to import the
substance in any physical state other
than in solution, unless in sealed
containers weighing 5 kilograms or less.
It is a significant new use to process the
substance in any way that generates a
dust, mist, or aerosol in a non-enclosed
process. It is a significant new use to
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manufacture the substance longer than
18 months.
(b) Specific requirements. The
provisions of subpart A of this part
apply to this section except as modified
by this paragraph (b).
(1) Recordkeeping. Recordkeeping
requirements as specified in
§ 721.125(a) through (i) are applicable to
manufacturers and processors of this
substance.
(2) Limitation 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.
jspears on DSK121TN23PROD with RULES1
§ 721.11528 Heterotrisubstituted-bile acid,
1-(difluorosulfomethyl)-2,2,2-trifluoroethyl
ester, ion(1-), (5)-, triphenylsulfonium (1:1)
(generic).
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified
generically as heterotrisubstituted-bile
acid, 1-(difluorosulfomethyl)-2,2,2trifluoroethyl ester, ion(1-), (5)-,
triphenylsulfonium (1:1) (PMN P–19–
133) 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 or adhered (during
the photolithographic process) onto a
semiconductor wafer surface or similar
manufactured article used in the
production of semiconductor
technologies.
(2) The significant new uses are:
(i) Protection in the workplace.
Requirements as specified in
§ 721.63(a)(1), (a)(2)(i) and (iii), (a)(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 (e), (g)(1), (g)(2)(i) through (iii)
and (v), (g)(3)(i) and (ii), and (g)(5). For
purposes of § 721.72(e), the
concentration is set at 1.0%. For
purposes of § 721.72(g)(1), this
substance may cause: Acute toxicity;
skin sensitization; serious eye damage;
specific target organ toxicity;
neurotoxicity; genetic toxicity;
reproductive toxicity.
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(iii) Industrial, commercial, and
consumer activities. Requirements as
specified in § 721.80(f), (k), and (t). It is
a significant new use to import the
substance in any physical state other
than in solution, unless in sealed
containers weighing 5 kilograms or less.
It is a significant new use to process the
substance in any way that generates a
dust, mist, or aerosol in a non-enclosed
process. It is a significant new use to
manufacture the substance longer than
18 months.
(b) Specific requirements. The
provisions of subpart A of this part
apply to this section except as modified
by this paragraph (b).
(1) Recordkeeping. Recordkeeping
requirements as specified in
§ 721.125(a) through (i) are applicable to
manufacturers and processors of this
substance.
(2) Limitation 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.
§ 721.11529 Aromatic sulfonium tricyclo
fluoroalkyl sulfonic acid salt (generic).
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified
generically as aromatic sulfonium
tricyclo fluoroalkyl sulfonic acid salt
(PMN P–18–16) 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 or adhered (during
the photolithographic process) onto a
semiconductor wafer surface or similar
manufactured article used in the
production of semiconductor
technologies.
(2) The significant new uses are:
(i) Protection in the workplace.
Requirements as specified in
§ 721.63(a)(1), (a)(2)(i) and (iii), (a)(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 (e), (g)(1), (g)(2)(i) through (iii)
and (v), (g)(3)(i) and (ii), and (g)(5). For
purposes of § 721.72(e), the
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concentration is set at 1.0%. For
purposes of § 721.72(g)(1), this
substance may cause: Acute toxicity;
skin sensitization; serious eye damage;
specific target organ toxicity;
neurotoxicity; genetic toxicity;
reproductive toxicity. 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(f), (k), and (t). It is
a significant new use to import the
substance in any physical state other
than in solution, unless in sealed
containers weighing 5 kilograms or less.
It is a significant new use to use or
process the substance in any way that
generates a dust, mist, or aerosol in a
non-enclosed process. It is a significant
new use to manufacture the substance
longer than 18 months.
(b) Specific requirements. The
provisions of subpart A of this part
apply to this section except as modified
by this paragraph (b).
(1) Recordkeeping. Recordkeeping
requirements as specified in
§ 721.125(a) through (i) are applicable to
manufacturers and processors of this
substance.
(2) Limitation 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.
§ 721.11530 Substituted,
(alkylaromatic)diaromatic salt with trihalo[(trihaloalkyl)substituted]substituted
alkaneamide (generic).
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified
generically as substituted,
(alkylaromatic)diaromatic salt with
trihalo[(trihaloalkyl)substituted]substituted
alkaneamide (PMN P–18–297) 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 or
adhered (during the photolithographic
process) onto a semiconductor wafer
surface or similar manufactured article
used in the production of
semiconductor technologies.
(2) The significant new uses are:
(i) Protection in the workplace.
Requirements as specified in
§ 721.63(a)(1), (a)(2)(i) and (iii), (a)(3),
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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 (e), (g)(1), (g)(2)(i) through (iii)
and (v), (g)(3)(i) and (ii), and (g)(5). For
purposes of § 721.72(e), the
concentration is set at 1.0%. For
purposes of § 721.72(g)(1), this
substance may cause: Acute toxicity;
skin sensitization; serious eye damage;
specific target organ toxicity;
neurotoxicity; genetic toxicity;
reproductive toxicity. 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(f), (k), and (t). It is
a significant new use to import the
substance in any physical state other
than in solution, unless in sealed
containers weighing 5 kilograms or less.
It is a significant new use to process the
substance in any way that generates a
dust, mist, or aerosol in a non-enclosed
process. It is a significant new use to
manufacture the substance longer than
18 months.
(b) Specific requirements. The
provisions of subpart A of this part
apply to this section except as modified
by this paragraph (b).
(1) Recordkeeping. Recordkeeping
requirements as specified in
§ 721.125(a) through (i) are applicable to
manufacturers and processors of this
substance.
(2) Limitation 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.
jspears on DSK121TN23PROD with RULES1
§ 721.11531 Triarylsulfonium substituted
oxatricycloalkyloxycarbonyl dihalo alkane
sulfonate (generic).
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified
generically as triarylsulfonium
substituted oxatricycloalkyloxycarbonyl
dihalo alkane sulfonate (PMN P–18–
311) is subject to reporting under this
section for the significant new uses
described in paragraph (a)(2) of this
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section. The requirements of this section
do not apply to quantities of the
substance after they have been
completely reacted or adhered (during
the photolithographic process) onto a
semiconductor wafer surface or similar
manufactured article used in the
production of semiconductor
technologies.
(2) The significant new uses are:
(i) Protection in the workplace.
Requirements as specified in
§ 721.63(a)(1), (a)(2)(i) and (iii), (a)(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 (e), (g)(1), (g)(2)(i) through (iii)
and (v), (g)(3)(i) and (ii), and (g)(5). For
purposes of § 721.72(e), the
concentration is set at 1.0%. For
purposes of § 721.72(g)(1), this
substance may cause: Acute toxicity;
skin sensitization; serious eye damage;
specific target organ toxicity;
neurotoxicity; genetic toxicity;
reproductive toxicity. 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(f), (k), and (t). It is
a significant new use to import the
substance in any physical state other
than in solution, unless in sealed
containers weighing 5 kilograms or less.
It is a significant new use to process the
substance in any way that generates a
dust, mist, or aerosol in a non-enclosed
process. It is a significant new use to
manufacture the substance longer than
18 months.
(b) Specific requirements. The
provisions of subpart A of this part
apply to this section except as modified
by this paragraph (b).
(1) Recordkeeping. Recordkeeping
requirements as specified in
§ 721.125(a) through (i) are applicable to
manufacturers and processors of this
substance.
(2) Limitation 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.
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70399
§ 721.11532 Substituted triarylsulfonium
carbopolycyclic heteromonocyclic dihalo
sulfoacetate (generic).
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified
generically as substituted
triarylsulfonium carbopolycyclic
heteromonocyclic dihalo sulfoacetate
(PMN P–18–314) 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 or adhered (during
the photolithographic process) onto a
semiconductor wafer surface or similar
manufactured article used in the
production of semiconductor
technologies.
(2) The significant new uses are:
(i) Protection in the workplace.
Requirements as specified in
§ 721.63(a)(1), (a)(2)(i) and (iii), (a)(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 (e), (g)(1), (g)(2)(i) through (iii)
and (v), (g)(3)(i) and (ii), and (g)(5). For
purposes of § 721.72(e), the
concentration is set at 1.0%. For
purposes of § 721.72(g)(1), this
substance may cause: Acute toxicity;
skin sensitization; serious eye damage;
specific target organ toxicity;
neurotoxicity; genetic toxicity;
reproductive toxicity. 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(f), (k), and (t). It is
a significant new use to import the
substance in any physical state other
than in solution, unless in sealed
containers weighing 5 kilograms or less.
It is a significant new use to process the
substance in any way that generates a
dust, mist, or aerosol in a non-enclosed
process. It is a significant new use to
manufacture the substance longer than
18 months.
(b) Specific requirements. The
provisions of subpart A of this part
apply to this section except as modified
by this paragraph (b).
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(1) Recordkeeping. Recordkeeping
requirements as specified in
§ 721.125(a) through (i) are applicable to
manufacturers and processors of this
substance.
(2) Limitation 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.
jspears on DSK121TN23PROD with RULES1
§ 721.11533 Substituted triarylsulfonium
substituted carbopolycyclic carboxylate
(generic).
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified
generically as substituted
triarylsulfonium substituted
carbopolycyclic carboxylate (PMN P–
18–315) 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 or adhered (during
the photolithographic process) onto a
semiconductor wafer surface or similar
manufactured article used in the
production of semiconductor
technologies.
(2) The significant new uses are:
(i) Protection in the workplace.
Requirements as specified in
§ 721.63(a)(1), (a)(2)(i) and (iii), (a)(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 (e), (g)(1), (g)(2)(i) through (iii)
and (v), (g)(3)(i) and (ii), and (g)(5). For
purposes of § 721.72(e), the
concentration is set at 1.0%. For
purposes of § 721.72(g)(1), this
substance may cause: Acute toxicity;
skin sensitization; serious eye damage;
specific target organ toxicity;
neurotoxicity; genetic toxicity;
reproductive toxicity. 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(f), (k), and (t). It is
a significant new use to import the
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substance in any physical state other
than in solution, unless in sealed
containers weighing 5 kilograms or less.
It is a significant new use to process the
substance in any way that generates a
dust, mist, or aerosol in a non-enclosed
process. It is a significant new use to
manufacture the substance longer than
18 months.
(b) Specific requirements. The
provisions of subpart A of this part
apply to this section except as modified
by this paragraph (b).
(1) Recordkeeping. Recordkeeping
requirements as specified in
§ 721.125(a) through (i) are applicable to
manufacturers and processors of this
substance.
(2) Limitation 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.
§ 721.11534 Sulfonium,
bis(dihalocarbomonocycle)
carbomonocycle, salt with substituted
heteropolycycle dihalo sulfoalkanoate (1:1)
(generic).
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified
generically as sulfonium,
bis(dihalocarbomonocycle)
carbomonocycle, salt with substituted
heteropolycycle dihalo sulfoalkanoate
(1:1) (PMN P–18–304) 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 or
adhered (during the photolithographic
process) onto a semiconductor wafer
surface or similar manufactured article
used in the production of
semiconductor technologies.
(2) The significant new uses are:
(i) Protection in the workplace.
Requirements as specified in
§ 721.63(a)(1), (a)(2)(i) and (iii), (a)(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 (e), (g)(1), (g)(2)(i) through (iii)
and (v), (g)(3)(i) and (ii), and (g)(5). For
PO 00000
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Sfmt 4700
purposes of § 721.72(e), the
concentration is set at 1.0%. For
purposes of § 721.72(g)(1), this
substance may cause: Acute toxicity;
skin sensitization; serious eye damage;
specific target organ toxicity;
neurotoxicity; genetic toxicity;
reproductive toxicity. 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(f), (k), and (t). It is
a significant new use to import the
substance in any physical state other
than in solution, unless in sealed
containers weighing 5 kilograms or less.
It is a significant new use to process the
substance in any way that generates a
dust, mist, or aerosol in a non-enclosed
process. It is a significant new use to
manufacture the substance longer than
18 months.
(b) Specific requirements. The
provisions of subpart A of this part
apply to this section except as modified
by this paragraph (b).
(1) Recordkeeping. Recordkeeping
requirements as specified in
§ 721.125(a) through (i) are applicable to
manufacturers and processors of this
substance.
(2) Limitation 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.
§ 721.11535 Heteropolycycle,
alkylaromatic-, salt with dihalo-substituted
alkyl carbopolycycle carboxylate (generic).
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified
generically heteropolycycle,
alkylaromatic-, salt with dihalosubstituted alkyl carbopolycycle
carboxylate (PMN P–18–316) 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 or
adhered (during the photolithographic
process) onto a semiconductor wafer
surface or similar manufactured article
used in the production of
semiconductor technologies.
(2) The significant new uses are:
(i) Protection in the workplace.
Requirements as specified in
§ 721.63(a)(1), (a)(2)(i) and (iii), (a)(3),
and (c). When determining which
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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 (e), (g)(1), (g)(2)(i) through (iii)
and (v), (g)(3)(i) and (ii), and (g)(5). For
purposes of § 721.72(e), the
concentration is set at 1.0%. For
purposes of § 721.72(g)(1), this
substance may cause: Acute toxicity;
skin sensitization; serious eye damage;
specific target organ toxicity;
neurotoxicity; genetic toxicity;
reproductive toxicity. 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(f), (k), and (t). It is
a significant new use to import the
substance in any physical state other
than in solution, unless in sealed
containers weighing 5 kilograms or less.
It is a significant new use to process the
substance in any way that generates a
dust, mist, or aerosol in a non-enclosed
process. It is a significant new use to
manufacture the substance longer than
18 months.
(b) Specific requirements. The
provisions of subpart A of this part
apply to this section except as modified
by this paragraph (b).
(1) Recordkeeping. Recordkeeping
requirements as specified in
§ 721.125(a) through (i) are applicable to
manufacturers and processors of this
substance.
(2) Limitation 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.
jspears on DSK121TN23PROD with RULES1
§ 721.11536 Sulfonium, triaryl-, salt with
polyhalo-4-sulfoalkyl polycarbocyclic
alkane-1-carboxylate (1:1) (generic).
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified
generically as sulfonium, triaryl-, salt
with polyhalo-4-sulfoalkyl
polycarbocyclic alkane-1-carboxylate
(1:1) (PMN P–18–338) is subject to
reporting under this section for the
significant new uses described in
paragraph (a)(2) of this section. The
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requirements of this section do not
apply to quantities of the substance after
they have been completely reacted or
adhered (during the photolithographic
process) onto a semiconductor wafer
surface or similar manufactured article
used in the production of
semiconductor technologies.
(2) The significant new uses are:
(i) Protection in the workplace.
Requirements as specified in
§ 721.63(a)(1), (a)(2)(i) and (iii), (a)(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 (e), (g)(1), (g)(2)(i) through (iii)
and (v), (g)(3)(i) and (ii), and (g)(5). For
purposes of § 721.72(e), the
concentration is set at 1.0%. For
purposes of § 721.72(g)(1), this
substance may cause: Acute toxicity;
skin sensitization; serious eye damage;
specific target organ toxicity;
neurotoxicity; genetic toxicity;
reproductive toxicity. 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(f), (k), and (t). It is
a significant new use to import the
substance in any physical state other
than in solution, unless in sealed
containers weighing 5 kilograms or less.
It is a significant new use to process the
substance in any way that generates a
dust, mist, or aerosol in a non-enclosed
process. It is a significant new use to
manufacture the substance longer than
18 months.
(b) Specific requirements. The
provisions of subpart A of this part
apply to this section except as modified
by this paragraph (b).
(1) Recordkeeping. Recordkeeping
requirements as specified in
§ 721.125(a) through (i) are applicable to
manufacturers and processors of this
substance.
(2) Limitation 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.
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70401
§ 721.11537 Sulfonium,
bis(dihalocarbomonocycle)
carbomonocycle, salt with dihalo
substituted alkyl carbopolycyclic
carboxylate (1:1) (generic).
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified
generically as sulfonium,
bis(dihalocarbomonocycle)
carbomonocycle, salt with dihalo
substituted alkyl carbopolycyclic
carboxylate (1:1) (PMN P–19–76) 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 or
adhered (during the photolithographic
process) onto a semiconductor wafer
surface or similar manufactured article
used in the production of
semiconductor technologies.
(2) The significant new uses are:
(i) Protection in the workplace.
Requirements as specified in
§ 721.63(a)(1), (a)(2)(i) and (iii), (a)(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 (e), (g)(1), (g)(2)(i) through (iii)
and (v), (g)(3)(i) and (ii), and (g)(5). For
purposes of § 721.72(e), the
concentration is set at 1.0%. For
purposes of § 721.72(g)(1), this
substance may cause: Acute toxicity;
skin sensitization; serious eye damage;
specific target organ toxicity;
neurotoxicity; genetic toxicity;
reproductive toxicity. 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(f), (k), and (t). It is
a significant new use to import the
substance in any physical state other
than in solution, unless in sealed
containers weighing 5 kilograms or less.
It is a significant new use to process the
substance in any way that generates a
dust, mist, or aerosol in a non-enclosed
process. It is a significant new use to
manufacture the substance longer than
18 months.
(b) Specific requirements. The
provisions of subpart A of this part
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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) Limitation 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.
jspears on DSK121TN23PROD with RULES1
§ 721.11538 Sulfonium,
bis(dihalocarbomonocycle)
carbomonocycle, substituted
carbomonocyclic ester (generic).
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified
generically as sulfonium,
bis(dihalocarbomonocycle)
carbomonocycle, substituted
carbomonocyclic ester (PMN P–19–115)
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 or
adhered (during the photolithographic
process) onto a semiconductor wafer
surface or similar manufactured article
used in the production of
semiconductor technologies.
(2) The significant new uses are:
(i) Protection in the workplace.
Requirements as specified in
§ 721.63(a)(1), (a)(2)(i) and (iii), (a)(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 (e), (g)(1), (g)(2)(i) through (iii)
and (v), (g)(3)(i) and (ii), and (g)(5). For
purposes of § 721.72(e), the
concentration is set at 1.0%. For
purposes of § 721.72(g)(1), this
substance may cause: Acute toxicity;
skin sensitization; serious eye damage;
specific target organ toxicity;
neurotoxicity; genetic toxicity;
reproductive toxicity. Alternative
hazard and warning statements that
meet the criteria of the Globally
Harmonized System and OSHA Hazard
Communication Standard may be used.
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(iii) Industrial, commercial, and
consumer activities. Requirements as
specified in § 721.80(f), (k), and (t). It is
a significant new use to import the
substance in any physical state other
than in solution, unless in sealed
containers weighing 5 kilograms or less.
It is a significant new use to process the
substance in any way that generates a
dust, mist, or aerosol in a non-enclosed
process. It is a significant new use to
manufacture the substance longer than
18 months.
(b) Specific requirements. The
provisions of subpart A of this part
apply to this section except as modified
by this paragraph (b).
(1) Recordkeeping. Recordkeeping
requirements as specified in
§ 721.125(a) through (i) are applicable to
manufacturers and processors of this
substance.
(2) Limitation 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.
§ 721.11539 Heteropolycycle, aromatic-,
salt with dihalo-substituted alkyl
carbopolycycle carboxylate (1:1) (generic).
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified
generically as heteropolycycle,
aromatic-, salt with dihalo-substituted
alkyl carbopolycycle carboxylate (1:1)
(PMN P–19–142) 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 or adhered (during
the photolithographic process) onto a
semiconductor wafer surface or similar
manufactured article used in the
production of semiconductor
technologies.
(2) The significant new uses are:
(i) Protection in the workplace.
Requirements as specified in
§ 721.63(a)(1), (a)(2)(i) and (iii), (a)(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 (e), (g)(1), (g)(2)(i) through (iii)
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and (v), (g)(3)(i) and (ii), and (g)(5). For
purposes of § 721.72(e), the
concentration is set at 1.0%. For
purposes of § 721.72(g)(1), this
substance may cause: Acute toxicity;
skin sensitization; serious eye damage;
specific target organ toxicity;
neurotoxicity; genetic toxicity;
reproductive toxicity. 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(f), (k), and (t). It is
a significant new use to import the
substance in any physical state other
than in solution, unless in sealed
containers weighing 5 kilograms or less.
It is a significant new use to process the
substance in any way that generates a
dust, mist, or aerosol in a non-enclosed
process. It is a significant new use to
manufacture the substance longer than
18 months.
(b) Specific requirements. The
provisions of subpart A of this part
apply to this section except as modified
by this paragraph (b).
(1) Recordkeeping. Recordkeeping
requirements as specified in
§ 721.125(a) through (i) are applicable to
manufacturers and processors of this
substance.
(2) Limitation 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.
§ 721.11540 Triarylsulfonium
alkylestersulfonate (generic).
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified
generically as triarylsulfonium
alkylestersulfonate (PMN P–19–166) 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 or
adhered (during the photolithographic
process) onto a semiconductor wafer
surface or similar manufactured article
used in the production of
semiconductor technologies.
(2) The significant new uses are:
(i) Protection in the workplace.
Requirements as specified in
§ 721.63(a)(1), (a)(2)(i) and (iii), (a)(3),
and (c). When determining which
persons are reasonably likely to be
exposed as required for § 721.63(a)(1),
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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 (e), (g)(1), (g)(2)(i) through (iii)
and (v), (g)(3)(i) and (ii), and (g)(5). For
purposes of § 721.72(e), the
concentration is set at 1.0%. For
purposes of § 721.72(g)(1), this
substance may cause: Acute toxicity;
skin sensitization; serious eye damage;
specific target organ toxicity;
neurotoxicity; genetic toxicity;
reproductive toxicity.
(iii) Industrial, commercial, and
consumer activities. Requirements as
specified in § 721.80(f), (k), and (t). It is
a significant new use to import the
substance in any physical state other
than in solution, unless in sealed
containers weighing 5 kilograms or less.
It is a significant new use to use or
process the substance in any way that
generates a dust, mist, or aerosol in a
non-enclosed process. It is a significant
new use to manufacture the substance
longer than 18 months.
(b) Specific requirements. The
provisions of subpart A of this part
apply to this section except as modified
by this paragraph (b).
(1) Recordkeeping. Recordkeeping
requirements as specified in
§ 721.125(a) through (i) are applicable to
manufacturers and processors of this
substance.
(2) Limitation 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.
jspears on DSK121TN23PROD with RULES1
§ 721.11541 Halogenated alkylbenzoic acid
(generic) (P–19–168).
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified
generically as halogenated alkylbenzoic
acid (PMN P–19–168) 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), (a)(2)(i), (iii), and (iv),
(a)(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.,
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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 10. For purposes of
§ 721.63(a)(6), the airborne form(s) of
the substance include particulate, gas/
vapor (all substances in the gas form),
combination gas/vapor and particulate
(gas and liquid/solid physical states are
present; a good example is paint spray
mist, which contains both liquid
droplets and vapor). For purposes of
§ 721.63(b), the concentration is set at
1.0%.
(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 Order for this substance.
The NCEL is 0.0195 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 that are approved by
EPA will be required to follow NCELs
provisions comparable to those
contained in the corresponding TSCA
Order.
(B) [Reserved]
(ii) Hazard communication.
Requirements as specified in § 721.72(a)
through (f) and (g)(1), (2), and (5). For
purposes of § 721.72(e), the
concentration is set at 1.0%. For
purposes of § 721.72(g)(1), this
substance may cause: Skin irritation;
eye irritation; respiratory complications;
central nervous system effects; internal
organ effects; reproductive effects;
developmental effects. For purposes of
§ 721.72(g)(2), when using this
substance: Avoid skin contact; avoid
breathing the substance; avoid
ingestion; use respiratory protection or
maintain workplace airborne
concentrations at or below an 8-hour
time-weighted average of 0.0195 mg/m3;
use skin protection. 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), (q), and (t). It is
a significant new use to manufacture or
process the substance without
implementing the engineering controls/
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70403
processes described in the TSCA Order
for the substance.
(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) Limitation 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.
§ 721.11542 Halogenated alkylbenzoic acid
(generic) (P–19–169).
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified
generically as halogenated alkylbenzoic
acid (PMN P–19–169) 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), (a)(2)(i), (iii), and (iv),
(a)(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 10. For purposes of
§ 721.63(a)(6), the airborne form(s) of
the substance include particulate, gas/
vapor (all substances in the gas form),
combination gas/vapor and particulate
(gas and liquid/solid physical states are
present; a good example is paint spray
mist, which contains both liquid
droplets and vapor). For purposes of
§ 721.63(b), the concentration is set at
1.0%.
(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 Order for this substance.
The NCEL is 0.0195 mg/m3 as an 8-hour
time weighted average. Persons who
wish to pursue NCELs as an alternative
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to § 721.63 respirator requirements may
request to do so under § 721.30. Persons
whose § 721.30 requests to use the
NCELs approach that are approved by
EPA will be required to follow NCELs
provisions comparable to those
contained in the corresponding TSCA
Order.
(B) [Reserved]
(ii) Hazard communication.
Requirements as specified in § 721.72(a)
through (f) and (g)(1), (2), and (5). For
purposes of § 721.72(e), the
concentration is set at 1.0%. For
purposes of § 721.72(g)(1), this
substance may cause: Skin irritation;
eye irritation; respiratory complications;
central nervous system effects; internal
organ effects; reproductive effects;
developmental effects. For purposes of
§ 721.72(g)(2), when using this
substance: Avoid skin contact; avoid
breathing the substance; avoid
ingestion; use respiratory protection or
maintain workplace airborne
concentrations at or below an 8-hour
time-weighted average of 0.0195 mg/m3;
use skin protection. 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), (q), and (t). It is
a significant new use to manufacture or
process the substance without
implementing the engineering controls/
processes described in the TSCA Order
for the substance.
(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) Limitation 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.
jspears on DSK121TN23PROD with RULES1
§ 721.11543 Halogenated benzoic acid
(generic) (P–19–171).
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified
generically as halogenated benzoic acid
(PMN P–19–171) 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) Protection in the workplace.
Requirements as specified in
§ 721.63(a)(1), (a)(2)(i), (iii), and (iv),
(a)(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 10. For purposes of
§ 721.63(a)(6), the airborne form(s) of
the substance include particulate, gas/
vapor (all substances in the gas form),
combination gas/vapor and particulate
(gas and liquid/solid physical states are
present; a good example is paint spray
mist, which contains both liquid
droplets and vapor). For purposes of
§ 721.63(b), the concentration is set at
1.0%.
(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 Order for this substance.
The NCEL is 0.0195 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 that are approved by
EPA will be required to follow NCELs
provisions comparable to those
contained in the corresponding TSCA
Order.
(B) [Reserved]
(ii) Hazard communication.
Requirements as specified in § 721.72(a)
through (f) and (g)(1), (2), and (5). For
purposes of § 721.72(e), the
concentration is set at 1.0%. For
purposes of § 721.72(g)(1), this
substance may cause: Skin irritation;
eye irritation; respiratory complications;
central nervous system effects; internal
organ effects; reproductive effects;
developmental effects. For purposes of
§ 721.72(g)(2), when using this
substance: Avoid skin contact; avoid
breathing the substance; avoid
ingestion; use respiratory protection or
maintain workplace airborne
concentrations at or below an 8-hour
time-weighted average of 0.0195 mg/m3;
use skin protection. Alternative hazard
and warning statements that meet the
criteria of the Globally Harmonized
PO 00000
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Fmt 4700
Sfmt 4700
System and OSHA Hazard
Communication Standard may be used.
(iii) Industrial, commercial, and
consumer activities. Requirements as
specified in § 721.80(k), (q), and (t). It is
a significant new use to manufacture or
process the substance without
implementing the engineering controls/
processes described in the TSCA Order
for the substance.
(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) Limitation 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.
§ 721.11544 Halogenated benzoic acid
(generic) (P–19–172).
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified
generically as halogenated benzoic acid
(PMN P–19–172) 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), (a)(2)(i), (iii), and (iv),
(a)(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 10. For purposes of
§ 721.63(a)(6), the airborne form(s) of
the substance include particulate, gas/
vapor (all substances in the gas form),
combination gas/vapor and particulate
(gas and liquid/solid physical states are
present; a good example is paint spray
mist, which contains both liquid
droplets and vapor). For purposes of
§ 721.63(b), the concentration is set at
1.0%.
E:\FR\FM\10DER1.SGM
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Federal Register / Vol. 86, No. 235 / Friday, December 10, 2021 / Rules and Regulations
(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 Order for this substance.
The NCEL is 0.0195 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 that are approved by
EPA will be required to follow NCELs
provisions comparable to those
contained in the corresponding TSCA
Order.
(B) [Reserved]
(ii) Hazard communication.
Requirements as specified in § 721.72(a)
through (f) and (g)(1), (2), and (5). For
purposes of § 721.72(e), the
concentration is set at 1.0%. For
purposes of § 721.72(g)(1), this
substance may cause: Skin irritation;
eye irritation; respiratory complications;
central nervous system effects; internal
organ effects; reproductive effects;
developmental effects. For purposes of
§ 721.72(g)(2), when using this
substance: Avoid skin contact; avoid
breathing the substance; avoid
ingestion; use respiratory protection or
maintain workplace airborne
concentrations at or below an 8-hour
time-weighted average of 0.0195 mg/m3;
use skin protection. 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), (q), and (t). It is
a significant new use to manufacture or
process the substance without
implementing the engineering controls/
processes described in the TSCA Order
for the substance.
(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) Limitation 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.
VerDate Sep<11>2014
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Jkt 256001
§ 721.11545 Halogenated benzoic acid
(generic) (P–19–173).
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified
generically as halogenated benzoic acid
(PMN P–19–173) 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), (a)(2)(i), (iii), and (iv),
(a)(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 10. For purposes of
§ 721.63(a)(6), the airborne form(s) of
the substance include particulate, gas/
vapor (all substances in the gas form),
combination gas/vapor and particulate
(gas and liquid/solid physical states are
present; a good example is paint spray
mist, which contains both liquid
droplets and vapor). For purposes of
§ 721.63(b), the concentration is set at
1.0%.
(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 Order for this substance.
The NCEL is 0.0195 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 that are approved by
EPA will be required to follow NCELs
provisions comparable to those
contained in the corresponding TSCA
Order.
(B) [Reserved]
(ii) Hazard communication.
Requirements as specified in § 721.72(a)
through (f) and (g)(1), (2), and (5). For
purposes of § 721.72(e), the
concentration is set at 1.0%. For
purposes of § 721.72(g)(1), this
substance may cause: Skin irritation;
eye irritation; respiratory complications;
central nervous system effects; internal
organ effects; reproductive effects;
developmental effects. For purposes of
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Fmt 4700
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70405
§ 721.72(g)(2), when using this
substance: Avoid skin contact; avoid
breathing the substance; avoid
ingestion; use respiratory protection or
maintain workplace airborne
concentrations at or below an 8-hour
time-weighted average of 0.0195 mg/m3;
use skin protection. 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), (q), and (t). It is
a significant new use to manufacture or
process the substance without
implementing the engineering controls/
processes described in the TSCA Order
for the substance.
(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) Limitation 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.
§ 721.11546 Halogenated alkylbenzoic acid
(generic) (P–19–175).
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified
generically as halogenated alkylbenzoic
acid (PMN P–19–175) 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), (a)(2)(i), (iii), and (iv),
(a)(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 10. For purposes of
§ 721.63(a)(6), the airborne form(s) of
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the substance include particulate, gas/
vapor (all substances in the gas form),
combination gas/vapor and particulate
(gas and liquid/solid physical states are
present; a good example is paint spray
mist, which contains both liquid
droplets and vapor). For purposes of
§ 721.63(b), the concentration is set at
1.0%.
(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 Order for this substance.
The NCEL is 0.0195 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 that are approved by
EPA will be required to follow NCELs
provisions comparable to those
contained in the corresponding TSCA
Order.
(B) [Reserved]
(ii) Hazard communication.
Requirements as specified in § 721.72(a)
through (f) and (g)(1), (2), and (5). For
purposes of § 721.72(e), the
concentration is set at 1.0%. For
purposes of § 721.72(g)(1), this
substance may cause: Skin irritation;
eye irritation; respiratory complications;
central nervous system effects; internal
organ effects; reproductive effects;
developmental effects. For purposes of
§ 721.72(g)(2), when using this
substance: Avoid skin contact; avoid
breathing the substance; avoid
ingestion; use respiratory protection or
maintain workplace airborne
concentrations at or below an 8-hour
time-weighted average of 0.0195 mg/m3;
use skin protection. 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), (q), and (t). It is
a significant new use to manufacture or
process the substance without
implementing the engineering controls/
processes described in the TSCA Order
for the substance.
(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) Limitation or revocation of certain
notification requirements. The
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15:55 Dec 09, 2021
Jkt 256001
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.
§ 721.11547 Halogenated alkylbenzoic acid
(generic) (P–19–176).
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified
generically as halogenated alkylbenzoic
acid (PMN P–19–176) 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), (a)(2)(i), (iii), and (iv),
(a)(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 10. For purposes of
§ 721.63(a)(6), the airborne form(s) of
the substance include particulate, gas/
vapor (all substances in the gas form),
combination gas/vapor and particulate.
For purposes of § 721.63(b), the
concentration is set at 1.0%.
(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 Order for this substance.
The NCEL is 0.0195 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 that are approved by
EPA will be required to follow NCELs
provisions comparable to those
contained in the corresponding TSCA
Order.
(B) [Reserved]
(ii) Hazard communication.
Requirements as specified in § 721.72(a)
through (f) and (g)(1), (2), and (5). For
purposes of § 721.72(e), the
concentration is set at 1.0%. For
purposes of § 721.72(g)(1), this
substance may cause: Respiratory
complications; central nervous system
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Fmt 4700
Sfmt 4700
effects; internal organ effects; skin
irritation; eye irritation; acute toxicity;
skin sensitization; serious eye damage;
specific target organ toxicity;
neurotoxicity; genetic toxicity;
reproductive toxicity. For purposes of
§ 721.72(g)(2), when using this
substance: Avoid skin contact; avoid
breathing substance; avoid ingestion;
use skin protection; use respiratory
protection or maintain workplace
airborne concentrations at or below an
8-hour time-weighted average of 0.0195
mg/m3; use skin protection. 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), (q), and (t). It is
a significant new use to manufacture or
process the substance without
implementing the engineering controls/
processes described in the TSCA Order
for the substance.
(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) Limitation 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.
§ 721.11548 Halogenated alkylbenzoic acid
(generic) (P–19–177).
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified
generically as halogenated alkylbenzoic
acid (PMN P–19–177) 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), (a)(2)(i), (iii), and (iv),
(a)(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
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jspears on DSK121TN23PROD with RULES1
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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 10. For purposes of
§ 721.63(a)(6), the airborne form(s) of
the substance include particulate, gas/
vapor (all substances in the gas form),
combination gas/vapor and particulate
(gas and liquid/solid physical states are
present; a good example is paint spray
mist, which contains both liquid
droplets and vapor). For purposes of
§ 721.63(b), the concentration is set at
1.0%.
(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 Order for this substance.
The NCEL is 0.0195 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 that are approved by
EPA will be required to follow NCELs
provisions comparable to those
contained in the corresponding TSCA
Order.
(B) [Reserved]
(ii) Hazard communication.
Requirements as specified in § 721.72(a)
through (f) and (g)(1), (2), and (5). For
purposes of § 721.72(e), the
concentration is set at 1.0%. For
purposes of § 721.72(g)(1), this
substance may cause: Skin irritation;
eye irritation; respiratory complications;
central nervous system effects; internal
organ effects; reproductive effects;
developmental effects. For purposes of
§ 721.72(g)(2), when using this
substance: Avoid skin contact; avoid
breathing the substance; avoid
ingestion; use respiratory protection or
maintain workplace airborne
concentrations at or below an 8-hour
time-weighted average of 0.0195 mg/m3;
use skin protection. 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), (q), and (t). It is
a significant new use to manufacture or
process the substance without
implementing the engineering controls/
processes described in the TSCA Order
for the substance.
(b) Specific requirements. The
provisions of subpart A of this part
apply to this section except as modified
by this paragraph (b).
VerDate Sep<11>2014
15:55 Dec 09, 2021
Jkt 256001
(1) Recordkeeping. Recordkeeping
requirements as specified in
§ 721.125(a) through (i) are applicable to
manufacturers and processors of this
substance.
(2) Limitation 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.
§ 721.11549 Halogenated alkylbenzoic acid
(generic) (P–19–178).
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified
generically as halogenated alkylbenzoic
acid (PMN P–19–178) 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), (a)(2)(i), (iii), and (iv),
(a)(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 10. For purposes of
§ 721.63(a)(6), the airborne form(s) of
the substance include particulate, gas/
vapor (all substances in the gas form),
combination gas/vapor and particulate
(gas and liquid/solid physical states are
present; a good example is paint spray
mist, which contains both liquid
droplets and vapor). For purposes of
§ 721.63(b), the concentration is set at
1.0%.
(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 Order for this substance.
The NCEL is 0.0195 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 that are approved by
EPA will be required to follow NCELs
provisions comparable to those
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Fmt 4700
Sfmt 4700
70407
contained in the corresponding TSCA
Order.
(B) [Reserved]
(ii) Hazard communication.
Requirements as specified in § 721.72(a)
through (f) and (g)(1), (2), and (5). For
purposes of § 721.72(e), the
concentration is set at 1.0%. For
purposes of § 721.72(g)(1), this
substance may cause: Skin irritation;
eye irritation; respiratory complications;
central nervous system effects; internal
organ effects; reproductive effects;
developmental effects. For purposes of
§ 721.72(g)(2), when using this
substance: Avoid skin contact; avoid
breathing the substance; avoid
ingestion; use respiratory protection or
maintain workplace airborne
concentrations at or below an 8-hour
time-weighted average of 0.0195 mg/m3;
use skin protection. 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), (q), and (t). It is
a significant new use to manufacture or
process the substance without
implementing the engineering controls/
processes described in the TSCA Order
for the substance.
(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) Limitation 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.
§ 721.11550 Halogenated alkylbenzoic acid
(generic) (P–19–179).
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified
generically as halogenated alkylbenzoic
acid (PMN P–19–179) 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), (a)(2)(i), (iii), and (iv),
(a)(3) through (6), (b), and (c). When
determining which persons are
reasonably likely to be exposed as
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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 10. For purposes of
§ 721.63(a)(6), the airborne form(s) of
the substance include particulate, gas/
vapor (all substances in the gas form),
combination gas/vapor and particulate
(gas and liquid/solid physical states are
present; a good example is paint spray
mist, which contains both liquid
droplets and vapor). For purposes of
§ 721.63(b), the concentration is set at
1.0%.
(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 Order for this substance.
The NCEL is 0.0195 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 that are approved by
EPA will be required to follow NCELs
provisions comparable to those
contained in the corresponding TSCA
Order.
(B) [Reserved]
(ii) Hazard communication.
Requirements as specified in § 721.72(a)
through (f) and (g)(1), (2), and (5). For
purposes of § 721.72(e), the
concentration is set at 1.0%. For
purposes of § 721.72(g)(1), this
substance may cause: Skin irritation;
eye irritation; respiratory complications;
central nervous system effects; internal
organ effects; reproductive effects;
developmental effects. For purposes of
§ 721.72(g)(2), when using this
substance: Avoid skin contact; avoid
breathing the substance; avoid
ingestion; use respiratory protection or
maintain workplace airborne
concentrations at or below an 8-hour
time-weighted average of 0.0195 mg/m3;
use skin protection. 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), (q), and (t). It is
a significant new use to manufacture or
process the substance without
VerDate Sep<11>2014
15:55 Dec 09, 2021
Jkt 256001
implementing the engineering controls/
processes described in the TSCA Order
for the substance.
(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) Limitation 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.
§ 721.11551 Halogenated sodium benzoate
(generic) (P–19–180).
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified
generically as halogenated sodium
benzoate (PMN P–19–180) is subject to
reporting under this section for the
significant new uses described in
paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Hazard communication.
Requirements as specified in § 721.72(a)
through (f), (g)(1), (g)(2)(i) through (iii),
and (g)(5). For purposes of § 721.72(e),
the concentration is set at 1.0%. For
purposes of § 721.72(g)(1), this
substance may cause: Skin irritation;
eye irritation; respiratory complications;
central nervous system effects; internal
organ effects; reproductive effects;
developmental effects. Alternative
hazard and warning statements that
meet the criteria of the Globally
Harmonized System and OSHA Hazard
Communication Standard may be used.
(ii) Industrial, commercial, and
consumer activities. Requirements as
specified in § 721.80(k) and (q). It is a
significant new use to manufacture or
process the substance without
implementing the engineering controls/
processes described in the TSCA Order
for the substance. It is a significant new
use to manufacture or use the substance
other than in liquid formulations.
(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 (f) through
(i) are applicable to manufacturers and
processors of this substance.
(2) Limitation or revocation of certain
notification requirements. The
PO 00000
Frm 00060
Fmt 4700
Sfmt 4700
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.
§ 721.11552 Halogenated sodium benzoate
(generic) (P–19–181).
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified
generically as halogenated sodium
benzoate (PMN P–19–181) is subject to
reporting under this section for the
significant new uses described in
paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Hazard communication.
Requirements as specified in § 721.72(a)
through (f), (g)(1), (g)(2)(i) through (iii),
and (g)(5). For purposes of § 721.72(e),
the concentration is set at 1.0%. For
purposes of § 721.72(g)(1), this
substance may cause: Skin irritation;
eye irritation; respiratory complications;
central nervous system effects; internal
organ effects; reproductive effects;
developmental effects. Alternative
hazard and warning statements that
meet the criteria of the Globally
Harmonized System and OSHA Hazard
Communication Standard may be used.
(ii) Industrial, commercial, and
consumer activities. Requirements as
specified in § 721.80(k) and (q). It is a
significant new use to manufacture or
process the substance without
implementing the engineering controls/
processes described in the TSCA Order
for the substance. It is a significant new
use to manufacture or use the substance
other than in liquid formulations.
(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 (f) through
(i) are applicable to manufacturers and
processors of this substance.
(2) Limitation 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.
§ 721.11553 Halogenated sodium benzoate
(generic) (P–19–182).
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified
generically as halogenated sodium
benzoate (PMN P–19–182) is subject to
reporting under this section for the
E:\FR\FM\10DER1.SGM
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Federal Register / Vol. 86, No. 235 / Friday, December 10, 2021 / Rules and Regulations
significant new uses described in
paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Hazard communication.
Requirements as specified in § 721.72(a)
through (f), (g)(1), (g)(2)(i) through (iii),
and (g)(5). For purposes of § 721.72(e),
the concentration is set at 1.0%. For
purposes of § 721.72(g)(1), this
substance may cause: Skin irritation;
eye irritation; respiratory complications;
central nervous system effects; internal
organ effects; reproductive effects;
developmental effects. Alternative
hazard and warning statements that
meet the criteria of the Globally
Harmonized System and OSHA Hazard
Communication Standard may be used.
(ii) Industrial, commercial, and
consumer activities. Requirements as
specified in § 721.80(k) and (q). It is a
significant new use to manufacture or
process the substance without
implementing the engineering controls/
processes described in the TSCA Order
for the substance. It is a significant new
use to manufacture or use the substance
other than in liquid formulations.
(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 (f) through
(i) are applicable to manufacturers and
processors of this substance.
(2) Limitation 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.
jspears on DSK121TN23PROD with RULES1
§ 721.11554 Halogenated sodium
alkylbenzoate (generic) (P–19–184).
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified
generically as halogenated sodium
alkylbenzoate (PMN P–19–184) is
subject to reporting under this section
for the significant new uses described in
paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Hazard communication.
Requirements as specified in § 721.72(a)
through (f), (g)(1), (g)(2)(i) through (iii),
and (g)(5). For purposes of § 721.72(e),
the concentration is set at 1.0%. For
purposes of § 721.72(g)(1), this
substance may cause: Skin irritation;
eye irritation; respiratory complications;
central nervous system effects; internal
organ effects; reproductive effects;
developmental effects. Alternative
hazard and warning statements that
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15:55 Dec 09, 2021
Jkt 256001
meet the criteria of the Globally
Harmonized System and OSHA Hazard
Communication Standard may be used.
(ii) Industrial, commercial, and
consumer activities. Requirements as
specified in § 721.80(k) and (q). It is a
significant new use to manufacture or
process the substance without
implementing the engineering controls/
processes described in the TSCA Order
for the substance. It is a significant new
use to manufacture or use the substance
other than in liquid formulations.
(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 (f) through
(i) are applicable to manufacturers and
processors of this substance.
(2) Limitation 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.
§ 721.11555 Halogenated sodium
alkylbenzoate (generic) (P–19–187).
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified
generically as halogenated sodium
alkylbenzoate (PMN P–19–187) is
subject to reporting under this section
for the significant new uses described in
paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Hazard communication.
Requirements as specified in § 721.72(a)
through (f), (g)(1), (g)(2)(i) through (iii),
and (g)(5). For purposes of § 721.72(e),
the concentration is set at 1.0%. For
purposes of § 721.72(g)(1), this
substance may cause: Skin irritation;
eye irritation; respiratory complications;
central nervous system effects; internal
organ effects; reproductive effects;
developmental effects. Alternative
hazard and warning statements that
meet the criteria of the Globally
Harmonized System and OSHA Hazard
Communication Standard may be used.
(ii) Industrial, commercial, and
consumer activities. Requirements as
specified in § 721.80(k) and (q). It is a
significant new use to manufacture or
process the substance without
implementing the engineering controls/
processes described in the TSCA Order
for the substance. It is a significant new
use to manufacture or use the substance
other than in liquid formulations.
(b) Specific requirements. The
provisions of subpart A of this part
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70409
apply to this section except as modified
by this paragraph (b).
(1) Recordkeeping. Recordkeeping
requirements as specified in
§ 721.125(a) through (c) and (f) through
(i) are applicable to manufacturers and
processors of this substance.
(2) Limitation 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.
*
*
*
*
*
[FR Doc. 2021–26683 Filed 12–9–21; 8:45 am]
BILLING CODE 6560–50–P
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 52
[EPA–R01–OAR–2021–0580; FRL–8967–02–
R1]
Air Plan Approval; Rhode Island; 2015
Ozone NAAQS Interstate Transport
Requirements
Environmental Protection
Agency (EPA).
ACTION: Final rule.
AGENCY:
The Environmental Protection
Agency (EPA) is approving a State
Implementation Plan (SIP) revision
submitted by the State of Rhode Island
as meeting the Clean Air Act (CAA)
requirement that each State’s SIP
contain adequate provisions to prohibit
emissions that will significantly
contribute to nonattainment or interfere
with maintenance of the 2015 8-hour
ozone national ambient air quality
standards (NAAQS) in any other state.
This action is being taken in accordance
with the CAA.
DATES: This rule is effective on January
10, 2022.
ADDRESSES: EPA has established a
docket for this action under Docket
Identification No. EPA–R01–OAR–
2021–0580. All documents in the docket
are listed on the https://
www.regulations.gov website. Although
listed in the index, some information is
not publicly available, i.e., confidential
business information (CBI) or other
information whose disclosure is
restricted by statute. Certain other
material, such as copyrighted material,
is not placed on the internet and will be
publicly available only in hard copy
form. Publicly available docket
materials are available at https://
www.regulations.gov or at the U.S.
SUMMARY:
E:\FR\FM\10DER1.SGM
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Agencies
[Federal Register Volume 86, Number 235 (Friday, December 10, 2021)]
[Rules and Regulations]
[Pages 70385-70409]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-26683]
=======================================================================
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Parts 9 and 721
[EPA-HQ-OPPT-2020-0131; FRL-7842-02-OCSPP]
RIN 2070-AB27
Significant New Use Rules on Certain Chemical Substances (20-
2.5e)
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). The SNURs require persons
who intend to manufacture (defined by statute to include import) or
process any of these chemical substances for an activity that is
designated as a significant new use by this rule to notify EPA at least
90 days before commencing that activity. The required notification
initiates EPA's evaluation of the use, under the conditions of use for
that chemical substance, within the applicable review period. Persons
may not commence manufacture or processing for the significant new use
until EPA has conducted a review of the notice, made an appropriate
determination on the notice, and has taken such actions as are required
by that determination.
DATES: This rule is effective on February 8, 2022. For purposes of
judicial review, this rule shall be promulgated at 1 p.m. (e.s.t.) on
December 27, 2021.
FOR FURTHER INFORMATION CONTACT: For technical information contact:
William Wysong, New Chemicals 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: [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
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
[[Page 70386]]
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 dockets?
The dockets include 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-2020-0131,
is available at https://www.regulations.gov and 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) for certain
chemical substances which were the subject of PMNs. EPA will address
the other proposed SNURs in future FR notices.
Previously, EPA proposed SNURs for these chemical substances and
established the record for these SNURs in the following Federal
Register and docket ID number:
October 9, 2020 (85 FR 64280) (FRL-10011-86); Docket ID
No. EPA-HQ-OPPT-2020-0131.
The dockets include 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, 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
A. Considerations for Significant New Use Determinations
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.
B. Procedures for Significant New Uses Claimed as CBI
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) and has referenced it to apply to other SNURs.
Under these procedures a manufacturer or processor may request EPA
to determine whether a specific 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
[[Page 70387]]
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.
IV. Public Comments on Proposed Rule and EPA Responses
EPA received public comments from three identifying entities on the
proposed rules. The Agency's responses are presented in the Response to
Public Comments document that is available in the public docket for
this rulemaking. In addition, EPA received three anonymous comments.
The anonymous comments were either general in nature and did not
pertain to the proposed rule or were broadly supportive of the rule and
requested no changes to the rule itself; therefore, no response is
required. EPA made changes to 27 of the proposed rules as described in
the response to 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 SNURs, 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 rules, 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 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 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 TSCA section
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.
[[Page 70388]]
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 many of the 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 the publication dates of the proposed
rules (see Unit II.) as the cutoff dates for determining whether the
new uses are 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 the abovementioned dates, 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 them 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). For more information on alternative test methods and
strategies to reduce vertebrate animal testing, visit https://www.epa.gov/assessing-and-managing-chemicals-under-tsca/alternative-test-methods-and-strategies-reduce.
In some of the TSCA Orders for the chemical substances identified
in this rule, EPA has established production volume and time 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 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:
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. 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.
X. 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 analyses are
available in each docket listed in Unit II.
XI. 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.
[[Page 70389]]
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 the 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 pursuant to 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 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
[[Page 70390]]
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)
In addition, since 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).
L. Congressional Review Act (CRA)
This action is subject to the CRA, 5 U.S.C. 801 et seq., and EPA
will submit a rule report containing this rule and other required
information 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: December 3, 2021.
Tala Henry,
Deputy Director, Office of Pollution Prevention and Toxics.
Therefore, for the reasons stated in the preamble, 40 CFR chapter I
is amended as follows:
PART 9--OMB APPROVALS UNDER THE PAPERWORK REDUCTION ACT
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; 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, amend the table by adding entries for Sec. Sec.
721.11401 through 721.11403 and Sec. Sec. 721.11514 through 721.11555
in numerical order under the undesignated center heading ``Significant
New Uses of Chemical Substances'' to read as follows:
Sec. 9.1 OMB approvals under the Paperwork Reduction Act.
* * * * *
------------------------------------------------------------------------
40 CFR citation OMB control No.
------------------------------------------------------------------------
* * * * *
------------------------------------------------------------------------
Significant New Uses of Chemical Substances
------------------------------------------------------------------------
* * * * *
721.11401............................................ 2070-0012
721.11402............................................ 2070-0012
721.11403............................................ 2070-0012
* * * * *
721.11514............................................ 2070-0012
721.11515............................................ 2070-0012
721.11516............................................ 2070-0012
721.11517............................................ 2070-0012
721.11518............................................ 2070-0012
721.11519............................................ 2070-0012
721.11520............................................ 2070-0012
721.11521............................................ 2070-0012
721.11522............................................ 2070-0012
721.11523............................................ 2070-0012
721.11524............................................ 2070-0012
721.11525............................................ 2070-0012
721.11526............................................ 2070-0012
721.11527............................................ 2070-0012
721.11528............................................ 2070-0012
721.11529............................................ 2070-0012
721.11530............................................ 2070-0012
721.11531............................................ 2070-0012
721.11532............................................ 2070-0012
721.11533............................................ 2070-0012
721.11534............................................ 2070-0012
721.11535............................................ 2070-0012
721.11536............................................ 2070-0012
721.11537............................................ 2070-0012
721.11538............................................ 2070-0012
721.11539............................................ 2070-0012
721.11540............................................ 2070-0012
721.11541............................................ 2070-0012
721.11542............................................ 2070-0012
721.11543............................................ 2070-0012
721.11544............................................ 2070-0012
721.11545............................................ 2070-0012
721.11546............................................ 2070-0012
721.11547............................................ 2070-0012
721.11548............................................ 2070-0012
721.11549............................................ 2070-0012
721.11550............................................ 2070-0012
721.11551............................................ 2070-0012
721.11552............................................ 2070-0012
721.11553............................................ 2070-0012
721.11554............................................ 2070-0012
721.11555............................................ 2070-0012
721.11443............................................ 2070-0012
* * * * *
------------------------------------------------------------------------
* * * * *
PART 721--SIGNIFICANT NEW USES OF CHEMICAL SUBSTANCES
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. 721.11401 through 721.11403 and Sec. Sec. 721.11514
through 721.11555 in numerical order to subpart E to read as follows:
Subpart E--Significant New Uses for Specific Chemical Substances
Sec.
* * * * *
721.11401 2-Propenoic acid, 2-methyl-, methyl ester, polymer with
ethenylbenzene, ethyl 2-propenoate, 2-oxiranylmethyl 2-methyl-2-
propenoate and 1,2-propanediol mono(2-methyl-2-propenoate), reaction
products with diethanolamine, polymers with substituted-alkyl
acrylate, formats (salts) (generic).
721.11402 2-Propenoic acid, 2-methyl, methyl ester, polymer with
ethenylbenzene, ethyl 2-propenoate, 2-oxiranylmethyl 2-methyl-2-
propenoate and 1,2-propanediol mono(2-methyl-2-propenoate), reaction
products with diethanolamine, polymers with substituted-alkyl
methacrylate, formats (salts) (generic).
721.11403 2-Propenoic acid, 2-methyl-, methyl ester, polymer with
ethenylbenzene, ethyl 2-propenoate, 2-oxrianylmethyl 2-methyl-2-
propenoate, and 1,2-propaneidol mono(2-methyl-2-propenoate),
reaction products with diethanolamine, polymers with alkylene glycol
monoacrylate, formats (salts) (generic).
* * * * *
721.11514 Organic sulfonate compound (generic).
721.11515 Thiophenium, 1-(2,7-disubstituted-1-
naphthalenyl)tetrahydro-, salt with polyfluoro-N-
polyfluoroalkylsulfonyl-1-alkanesulfonamide (1:1) (generic).
721.11516 Sulfonium, triphenyl-, salt with 2,3-bis(substituted) 5-
sulfocarbopolycyclic-2,3-carboxylate derivative (1:1) (generic).
721.11517 Thiophenium, 1-(2,7-disubstituted-1-
naphthalenyl)tetrahydro-, salt with polyfluoro-N-
polyfluoroalkylsulfonyl-1-alkanesulfonamide (1:1) (generic).
[[Page 70391]]
721.11518 Sulfonium, triphenyl-, 5-(alkyl) fluoropentane derivative
(generic).
721.11519 Sulfonium, triphenyl-, salt with substituted-alkyl 4-
substituted-benzoate (generic).
721.11520 Substituted-triphenylsulfonium, inner salt (generic).
721.11521 Sulfonium, triphenyl-, salt with disubstituted-
heterocyclic compound (1:1) (generic).
721.11522 Sulfonium, triphenyl-, salt with 2,4,5-trisubstituted-
benzenesulfonate (1:1) (generic).
721.11523 Substituted heterocyclic onium compound, salt with 2,2,2-
trifluoro-1-(sulfomethyl)-1-(trifluoromethyl)ethyl 3-[(2-methyl-1-
oxo-2-propen-1-yl)oxy]tricyclo[3.3.1.13,7]decane-1-carboxylate
(1:1), polymer with acenaphthylene, 1-ethenyl-4-[(1-
ethylcyclopentyl)oxy]benzene and 4-ethenylphenol, di-Me 2,2'-(1,2-
diazenediyl)bis[2-methylpropanoate]-initiated (generic).
721.11524 Substituted heterocyclic onium compound, salt with 2,2,2-
trifluoro-1-(sulfomethyl)-1-(trifluoromethyl)ethyl 3-[(2-methyl-1-
oxo-2-propen-1-yl)oxy]tricyclo[3.3.1.13,7]decane-1- carboxylate
(1:1), polymer with acenaphthylene, 1-ethenyl-4-[[1-(1-
methylethyl)cyclopentyl]oxy]benzene and 4-ethenylphenol, di-Me 2,2'-
(1,2-diazenediyl)bis[2-methylpropanoate]-initiated (generic).
721.11525 Dibenzothiophenium, aryl substituted trifluoro-hydroxy-
(triheterosubstitutedalkyl)alkanoate (1:1) (generic).
721.11526 Substituted heterocyclic onium compound, salt with 1-
(difluorosulfomethyl)-2,2,2-trifluoroethyl 3-[(2-methyl-1-oxo-2-
propen-1-yl)oxy]tricyclo[3.3.1.13,7]decane-1-carboxylate (1:1),
polymer with 3-ethenylphenol, 1-(1-methylethyl)cyclopentyl 2-methyl-
2-propenoate and 1-(7-oxabicyclo[2.2.1]hept-2-yl)cyclopentyl 2-
methyl-2-propenoate, di-Me 2,2'-(1,2-diazenediyl)bis[2-
methylpropenoate]-initiated (generic).
721.11527 Sulfonium, triphenyl-, trifluoro-hydroxy-
(triheterosubstitutedalkyl)alkanoate (1:1) (generic).
721.11528 Heterotrisubstituted-bile acid, 1-(difluorosulfomethyl)-
2,2,2-trifluoroethyl ester, ion(1-), (5)-, triphenylsulfonium (1:1)
(generic).
721.11529 Aromatic sulfonium tricyclo fluoroalkyl sulfonic acid salt
(generic)
721.11530 Substituted, (alkylaromatic)diaromatic salt with trihalo-
[(trihaloalkyl)substituted]substituted alkaneamide (generic).
721.11531 Triarylsulfonium substituted oxatricycloalkyloxycarbonyl
dihalo alkane sulfonate (generic).
721.11532 Substituted triarylsulfonium carbopolycyclic
heteromonocyclic dihalo sulfoacetate (generic).
721.11533 Substituted triarylsulfonium substituted carbopolycyclic
carboxylate (generic).
721.11534 Sulfonium, bis(dihalocarbomonocycle) carbomonocycle, salt
with substituted heteropolycycle dihalo sulfoalkanoate (1:1)
(generic).
721.11535 Heteropolycycle, alkylaromatic-, salt with dihalo-
substituted alkyl carbopolycycle carboxylate (generic).
721.11536 Sulfonium, triaryl-, salt with polyhalo-4-sulfoalkyl
polycarbocyclic alkane-1-carboxylate (1:1) (generic).
721.11537 Sulfonium, bis(dihalocarbomonocycle) carbomonocycle, salt
with dihalo substituted alkyl carbopolycyclic carboxylate (1:1)
(generic).
721.11538 Sulfonium, bis(dihalocarbomonocycle) carbomonocycle,
substituted carbomonocyclic ester (generic).
721.11539 Heteropolycycle, aromatic-, salt with dihalo-substituted
alkyl carbopolycycle carboxylate (1:1) (generic).
721.11540 Triarylsulfonium alkylestersulfonate (generic).
721.11541 Halogenated alkylbenzoic acid (generic) (P-19-168).
721.11542 Halogenated alkylbenzoic acid (generic) (P-19-169).
721.11543 Halogenated benzoic acid (generic) (P-19-171).
721.11544 Halogenated benzoic acid (generic) (P-19-172).
721.11545 Halogenated benzoic acid (generic) (P-19-173).
721.11546 Halogenated alkylbenzoic acid (generic) (P-19-175).
721.11547 Halogenated alkylbenzoic acid (generic) (P-19-176).
721.11548 Halogenated alkylbenzoic acid (generic) (P-19-177).
721.11549 Halogenated alkylbenzoic acid (generic) (P-19-178).
721.11550 Halogenated alkylbenzoic acid (generic) (P-19-179).
721.11551 Halogenated sodium benzoate (generic) (P-19-180).
721.11552 Halogenated sodium benzoate (generic) (P-19-181).
721.11553 Halogenated sodium benzoate (generic) (P-19-182).
721.11554 Halogenated sodium alkylbenzoate (generic) (P-19-184).
721.11555 Halogenated sodium alkylbenzoate (generic) (P-19-187).
* * * * *
Sec. 721.11401 2-Propenoic acid, 2-methyl-, methyl ester, polymer
with ethenylbenzene, ethyl 2-propenoate, 2-oxiranylmethyl 2-methyl-2-
propenoate and 1,2-propanediol mono(2-methyl-2-propenoate), reaction
products with diethanolamine, polymers with substituted-alkyl acrylate,
formats (salts) (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as 2-
propenoic acid, 2-methyl-, methyl ester, polymer with ethenylbenzene,
ethyl 2-propenoate, 2-oxiranylmethyl 2-methyl-2-propenoate and 1,2-
propanediol mono(2-methyl-2-propenoate), reaction products with
diethanolamine, polymers with substituted-alkyl acrylate, formats
(salts) (PMN P-18-241) 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(j).
(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) Limitation 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. 721.11402 2-Propenoic acid, 2-methyl, methyl ester, polymer with
ethenylbenzene, ethyl 2-propenoate, 2-oxiranylmethyl 2-methyl-2-
propenoate and 1,2-propanediol mono(2-methyl-2-propenoate), reaction
products with diethanolamine, polymers with substituted-alkyl
methacrylate, formats (salts) (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as 2-
propenoic acid, 2-methyl, methyl ester, polymer with ethenylbenzene,
ethyl 2-propenoate, 2-oxiranylmethyl 2-methyl-2-propenoate and 1,2-
propanediol mono(2-methyl-2-propenoate), reaction products with
diethanolamine, polymers with substituted-alkyl methacrylate, formats
(salts) (PMN P-18-244) 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(j).
(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) Limitation or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
[[Page 70392]]
(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. 721.11403 2-Propenoic acid, 2-methyl-, methyl ester, polymer
with ethenylbenzene, ethyl 2-propenoate, 2-oxrianylmethyl 2-methyl-2-
propenoate, and 1,2-propaneidol mono(2-methyl-2-propenoate), reaction
products with diethanolamine, polymers with alkylene glycol
monoacrylate, formats (salts) (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as 2-
propenoic acid, 2-methyl-, methyl ester, polymer with ethenylbenzene,
ethyl 2-propenoate, 2-oxrianylmethyl 2-methyl-2-propenoate, and 1,2-
propaneidol mono(2-methyl-2-propenoate), reaction products with
diethanolamine, polymers with alkylene glycol monoacrylate, formats
(salts) (PMN P-18-245) 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(j).
(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) Limitation 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. 721.11514 Organic sulfonate compound (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as organic
sulfonate compound (PMN P-16-539) 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 or
adhered (during the photolithographic process) onto a semiconductor
wafer surface or similar manufactured article used in the production of
semiconductor technologies.
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(1), (a)(2)(i) and (iii), (a)(3), and (c). When determining
which persons are reasonably likely to be exposed as required for Sec.
721.63(a)(1), engineering control measures (e.g., enclosure or
confinement of the operation, general and local ventilation) or
administrative control measures (e.g., workplace policies and
procedures) shall be considered and implemented to prevent exposure,
where feasible.
(ii) Hazard communication. Requirements as specified in Sec.
721.72(a) through (e), (g)(1), (g)(2)(i) through (iii) and (v),
(g)(3)(i) and (ii), and (g)(5). For purposes of Sec. 721.72(e), the
concentration is set at 1.0%. For purposes of Sec. 721.72(g)(1), this
substance may cause: Skin irritation; acute toxicity; skin
sensitization; serious eye damage; specific target organ toxicity;
neurotoxicity; genetic toxicity; reproductive toxicity. 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 Sec. 721.80(f), (k), and (t). It is a significant new
use to import the substance in any physical state other than in
solution, unless in sealed containers weighing 5 kilograms or less. It
is a significant new use to process the substance in any way that
generates a dust, mist, or aerosol in a non-enclosed process. It is a
significant new use to manufacture the substance longer than 18 months.
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (i) are applicable to manufacturers and processors
of this substance.
(2) Limitation 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. 721.11515 Thiophenium, 1-(2,7-disubstituted-1-
naphthalenyl)tetrahydro-, salt with polyfluoro-N-
polyfluoroalkylsulfonyl-1-alkanesulfonamide (1:1) (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
thiophenium, 1-(2,7-disubstituted-1-naphthalenyl)tetrahydro-, salt with
polyfluoro-N-polyfluoroalkylsulfonyl-1-alkanesulfonamide (1:1) (PMN P-
18-157) 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 or adhered (during
the photolithographic process) onto a semiconductor wafer surface or
similar manufactured article used in the production of semiconductor
technologies.
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(1), (a)(2)(i) and (iii), (a)(3), and (c). When determining
which persons are reasonably likely to be exposed as required for Sec.
721.63(a)(1), engineering control measures (e.g., enclosure or
confinement of the operation, general and local ventilation) or
administrative control measures (e.g., workplace policies and
procedures) shall be considered and implemented to prevent exposure,
where feasible.
(ii) Hazard communication. Requirements as specified in Sec.
721.72(a) through (e), (g)(1), (g)(2)(i) through (iii) and (v),
(g)(3)(i) and (ii), and (g)(5). For purposes of Sec. 721.72(e), the
concentration is set at 1.0%. For purposes of Sec. 721.72(g)(1), this
substance may cause: Acute toxicity; skin sensitization; serious eye
damage; specific target organ toxicity; neurotoxicity; genetic
toxicity; reproductive toxicity. 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 Sec. 721.80(f), (k), and (t). It is a significant new
use to import the substance in any physical state other than in
solution, unless in sealed containers weighing 5 kilograms or less. It
is a significant new use to process the substance in any way that
generates a dust, mist, or aerosol in a non-enclosed process. It is a
significant new use to manufacture the substance longer than 18 months.
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (i) are applicable to manufacturers and processors
of this substance.
[[Page 70393]]
(2) Limitation 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. 721.11516 Sulfonium, triphenyl-, salt with 2,3-bis(substituted)
5-sulfocarbopolycyclic-2,3-carboxylate derivative (1:1) (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
sulfonium, triphenyl-, salt with 2,3-bis(substituted) 5-
sulfocarbopolycyclic-2,3-carboxylate derivative (1:1) (PMN P-18-158),
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 or adhered (during the photolithographic
process) onto a semiconductor wafer surface or similar manufactured
article used in the production of semiconductor technologies.
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(1), (a)(2)(i) and (iii), (a)(3), and (c). When determining
which persons are reasonably likely to be exposed as required for Sec.
721.63(a)(1), engineering control measures (e.g., enclosure or
confinement of the operation, general and local ventilation) or
administrative control measures (e.g., workplace policies and
procedures) shall be considered and implemented to prevent exposure,
where feasible.
(ii) Hazard communication. Requirements as specified in Sec.
721.72(a) through (e), (g)(1), (g)(2)(i) through (iii) and (v),
(g)(3)(i), and (ii), and (g)(5). For purposes of Sec. 721.72(e), the
concentration is set at 1.0%. For purposes of Sec. 721.72(g)(1), this
substance may cause: Acute toxicity; skin sensitization, serious eye
damage; specific target organ toxicity; neurotoxicity; genetic
toxicity; reproductive toxicity. 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 Sec. 721.80(f), (k), and (t). It is a significant new
use to import the substance in any physical state other than in
solution, unless in sealed containers weighing 5 kilograms or less. It
is a significant new use to process the substance in any way that
generates a dust, mist, or aerosol in a non-enclosed process. It is a
significant new use to manufacture the substance longer than 18 months.
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (i) are applicable to manufacturers and processors
of this substance.
(2) Limitation 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. 721.11517 Thiophenium, 1-(2,7-disubstituted-1-
naphthalenyl)tetrahydro-, salt with polyfluoro-N-
polyfluoroalkylsulfonyl-1-alkanesulfonamide (1:1) (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
thiophenium, 1-(2,7-disubstituted-1-naphthalenyl)tetrahydro-, salt with
polyfluoro-N-polyfluoroalkylsulfonyl-1-alkanesulfonamide (1:1) (PMN P-
18-159) 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 or adhered (during
the photolithographic process) onto a semiconductor wafer surface or
similar manufactured article used in the production of semiconductor
technologies.
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(1), (a)(2)(i) and (iii), (a)(3), and (c). When determining
which persons are reasonably likely to be exposed as required for Sec.
721.63(a)(1) engineering control measures (e.g., enclosure or
confinement of the operation, general and local ventilation) or
administrative control measures (e.g., workplace policies and
procedures) shall be considered and implemented to prevent exposure,
where feasible.
(ii) Hazard communication. Requirements as specified in Sec.
721.72(a) through (e), (g)(1), (g)(2)(i) through (iii) and (v),
(g)(3)(i) and (ii), and (g)(5). For purposes of Sec. 721.72(e), the
concentration is set at 1.0%. For purposes of Sec. 721.72(g)(1), this
substance may cause: Acute toxicity; skin sensitization; serious eye
damage; specific target organ toxicity; neurotoxicity; genetic
toxicity; reproductive toxicity. 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 Sec. 721.80(f), (k), and (t). It is a significant new
use to import the substance in any physical state other than in
solution, unless in sealed containers weighing 5 kilograms or less. It
is a significant new use to process the substance in any way that
generates a dust, mist, or aerosol in a non-enclosed process. It is a
significant new use to manufacture the substance longer than 18 months.
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (i) are applicable to manufacturers and processors
of this substance.
(2) Limitation 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. 721.11518 Sulfonium, triphenyl-, 5-(alkyl) fluoropentane
derivative (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
sulfonium, triphenyl-, 5-(alkyl) fluoropentane derivative (PMN P-19-33)
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 or adhered (during the photolithographic
process) onto a semiconductor wafer surface or similar manufactured
article used in the production of semiconductor technologies.
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(1), (a)(2)(i) and (iii), (a)(3), and (c). When determining
which persons are reasonably likely to be exposed as required for Sec.
721.63(a)(1) engineering control measures (e.g., enclosure or
confinement of the operation, general and local ventilation) or
administrative control measures (e.g.,
[[Page 70394]]
workplace policies and procedures) shall be considered and implemented
to prevent exposure, where feasible.
(ii) Hazard communication. Requirements as specified in Sec.
721.72(a) through (e), (g)(1), (a)(2)(i) through (iii) and (v),
(a)(3)(i) and (ii), and (a)(5). For purposes of Sec. 721.72(e), the
concentration is set at 1.0%. For purposes of Sec. 721.72(g)(1), this
substance may cause: Acute toxicity; skin sensitization; serious eye
damage; specific target organ toxicity; neurotoxicity; genetic
toxicity; reproductive toxicity. 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 Sec. 721.80(f), (k), and (t). It is a significant new
use to import the substance in any physical state other than in
solution, unless in sealed containers weighing 5 kilograms or less. It
is a significant new use to process the substance in any way that
generates a dust, mist, or aerosol in a non-enclosed process. It is a
significant new use to manufacture the substance longer than 18 months.
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (i) are applicable to manufacturers and processors
of this substance.
(2) Limitation or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this sec