Significant New Use Rules on Certain Chemical Substances (20-2.5e), 70385-70409 [2021-26683]

Agencies

• ENVIRONMENTAL PROTECTION AGENCY

[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]


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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.

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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