Significant New Use Rules on Certain Chemical Substances (21-2.F), 21480-21490 [2023-07458]

Agencies

• ENVIRONMENTAL PROTECTION AGENCY

[Federal Register Volume 88, Number 69 (Tuesday, April 11, 2023)]
[Rules and Regulations]
[Pages 21480-21490]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-07458]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Parts 9 and 721

[EPA-HQ-OPPT-2021-0227; FRL-8985-02-OCSPP]
RIN 2070-AB27


Significant New Use Rules on Certain Chemical Substances (21-2.F)

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 which were 
the subject of premanufacture notices (PMNs). This action requires 
persons to notify EPA at least 90 days before commencing manufacture 
(defined by statute to include import) or processing of any of these 
chemical substances for an activity that is designated as a significant 
new use by this rule. This action further requires that persons not 
commence manufacture or processing for the significant new use until 
they have submitted a Significant New Use Notice (SNUN), and EPA has 
conducted a review of the notice, made an appropriate determination on 
the notice, and has taken any risk management actions as are required 
as a result of that determination.

DATES: This rule is effective on June 12, 2023. For purposes of 
judicial review, this rule shall be promulgated at 1 p.m. (e.s.t.) on 
April 25, 2023.

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;

[[Page 21481]]

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?

1. General Applicability
    This action may apply to you if you manufacture (import), 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.
2. Applicability to Importers and Exporters
    This action may also apply to certain entities through pre-existing 
import certification and export notification rules under TSCA. Chemical 
importers are subject to the import provisions of TSCA section 13 (15 
U.S.C. 2612), the requirements promulgated at 19 CFR 12.118 through 
12.127 (see also 19 CFR 127.28), and the EPA policy in support of 
import certification at 40 CFR part 707, subpart B. Chemical importers 
must certify that the shipment of the chemical substance complies with 
all applicable rules and orders under TSCA, including regulations 
issued under TSCA sections 5, 6, 7 and Title IV.
    In addition, pursuant to 40 CFR 721.20, this action may also apply 
to 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)), and must comply 
with the export notification requirements in 40 CFR part 707, subpart 
D.

B. How can I access the docket?

    The docket includes information considered by the Agency in 
developing the proposed and final rules. The docket for this action, 
identified by docket identification (ID) number EPA-HQ-OPPT-2021-0227, 
is available online at https://www.regulations.gov and in person 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. Please review the visitor 
instructions and additional information about the docket available at 
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. These SNURs require 
persons who intend to manufacture or process any of these chemical 
substances for an activity that is designated as a significant new use 
to notify EPA at least 90 days before commencing that activity.
    Previously, in the Federal Register of November 17, 2021 (86 FR 
64115 (FRL-8985-01-OCSPP)), EPA proposed SNURs for these chemical 
substances. More information on the specific chemical substances 
subject to this final rule can be found in the Federal Register 
document proposing the SNURs. The docket includes information 
considered by the Agency in developing the proposed and final rules, 
including the public comments received on the proposed rules that are 
described in Unit IV.

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 TSCA section 5(a)(2) factors 
listed in Unit III.

C. Do the SNUR general provisions apply?

    General provisions for SNURs appear in 40 CFR part 721, subpart A. 
These provisions describe persons subject to the rule, recordkeeping 
requirements, exemptions to reporting requirements, and applicability 
of the rule to uses occurring before the effective date of the rule. 
Provisions relating to user fees appear at 40 CFR part 700. Pursuant to 
40 CFR 721.1(c), persons subject to these SNURs must comply with the 
same SNUN requirements and EPA regulatory procedures as submitters of 
PMNs under TSCA section 5(a)(1)(A). In particular, these requirements 
include the information submission requirements of TSCA sections 5(b) 
and 5(d)(1), the exemptions authorized by TSCA sections 5(h)(1), 
5(h)(2), 5(h)(3), and 5(h)(5) and the regulations at 40 CFR part 720. 
Once EPA receives a SNUN, 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 before manufacture or processing for the 
significant new use can commence. 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. Determination Factors

    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 the substances, in the context of the four bulleted 
TSCA section 5(a)(2) factors listed in this unit.
    During its review of the chemical substances that are the subjects 
of these SNURs and as further discussed in Unit VI., EPA identified 
potential risk concerns associated with other circumstances of use 
that, while not intended or reasonably foreseen, may occur in the 
future. EPA is designating

[[Page 21482]]

those other circumstances of use as significant new uses.

B. Procedures for Significant New Uses Claimed as Confidential Business 
Information (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. When this rule was proposed in 2021, EPA 
cross referenced 40 CFR 721.1725(b)(1), the procedures to deal with the 
situation where a specific significant new use is CBI, in order to 
apply it other SNURs where certain significant new uses have been 
claimed as CBI. Since the proposed rule, however, EPA has finalized 
amendments to 40 CFR 721.11 (87 FR 39756, July 5, 2022 (FRL-5605-02-
OCSPP)), which now provides a means by which bona fide submitters can 
determine whether their substance is subject to the SNUR and for EPA to 
disclose the confidential significant new use designations to a 
manufacturer or processor who has established a bona fide intent to 
manufacture or process a particular chemical substance. As such, EPA 
has removed the proposed references to 40 CFR 721.1725(b)(1) for SNURs 
that certain significant new uses have been claimed as CBI because the 
procedure in 40 CFR 721.11 now applies to all SNURs containing any CBI, 
including the significant new use.
    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 721.11 
into a single step to identify if a chemical substance is subject to 
part 721 and if a specific use would be a significant new use under the 
rule.

IV. Public Comments

    EPA received public comments from two identifying entities on the 
proposed rules. The Agency's responses are presented in the Response to 
Public Comments document that is available in the docket for this 
rulemaking. EPA did not make any changes to the requirements presented 
in 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 CBI).
     Chemical Abstracts Service (CAS) Registry number (if 
assigned for non-confidential chemical identities).
     Basis for the SNUR.
     Potentially useful information.
     CFR citation assigned in the regulatory text section of 
this final rule.
    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.

VI. Rationale and Objectives of the Rule

A. Rationale

    The chemical substances that are the subjects of these SNURs 
received ``not likely to present an unreasonable risk'' determinations 
under TSCA section 5(a)(3)(C) based on EPA's review of the intended, 
known, and reasonably foreseen conditions of use. However, EPA has 
identified other circumstances that, should they occur in the future, 
even if not reasonably foreseen, may present risk concerns. 
Specifically, EPA has determined that deviations from the protective 
measures identified in the PMN submissions could result in changes in 
the type or form of exposure to the chemical substances, increased 
exposures to the chemical substances, and/or changes in the reasonably 
anticipated manner and methods of manufacturing, processing, 
distribution in commerce, and disposal of the chemical substances. 
These SNURs identify as a significant new use manufacturing, 
processing, use, distribution in commerce, or disposal that does not 
conform to the protective measures identified in the submissions. As a 
result, those significant new uses cannot occur without first going 
through a separate, subsequent EPA review and determination process 
associated with a SNUN.

B. Objectives

    EPA is issuing these SNURs because the Agency wants:
     To have an opportunity to review and evaluate data 
submitted in a SNUN before the notice submitter begins manufacturing or 
processing a listed chemical substance for the described significant 
new use.
     To be 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 section 5(a)(3)(C) that 
the significant new use is not likely to present an unreasonable risk, 
including an unreasonable risk to a potentially exposed or susceptible 
subpopulation identified as relevant by the Administrator under the 
conditions of use, or make a determination under 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.
     To be able to complete its review and determination on 
each of the PMN substances, while deferring analysis on the significant 
new uses proposed in these rules unless and until the Agency receives a 
SNUN.
    Issuance of a SNUR for a chemical substance does not signify that 
the chemical substance is listed on the 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 Rules to Uses Occurring Before the Effective 
Date of the Final Rule

    To establish a significant new use, EPA must determine that the use 
is not ongoing. The chemical substances subject to this rule have 
undergone premanufacture review. In cases where EPA has not received a 
notice of commencement (NOC) and the chemical substance has not been 
added to the TSCA Inventory, no person may commence such activities 
without first submitting a PMN. Therefore, for chemical substances for 
which an NOC has not been submitted, EPA concludes that the designated 
significant new uses are not ongoing.
    When the chemical substances identified in this rule are added to 
the TSCA Inventory, EPA recognizes that, before the rule is effective, 
other persons

[[Page 21483]]

might engage in a use that has been identified as a significant new 
use. However, 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.
    EPA designated October 12, 2021 (the date of FR publication of the 
proposed rule) as the cutoff date for determining whether the new use 
is ongoing. The objective of EPA's approach is to ensure that a person 
cannot defeat a SNUR by initiating a significant new use before the 
effective date of the final rule.
    Persons who began commercial manufacture or processing of the 
chemical substances for a significant new use identified on or after 
that date will have to cease any such activity upon the effective date 
of the final rule. To resume their activities, these persons would have 
to first comply with all applicable SNUR notification requirements and 
EPA would have to take action under section 5 allowing manufacture or 
processing to proceed.

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, 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, Order, or consent agreement under TSCA 
section 4 covering the chemical substance, persons are required only to 
submit information in their possession or control and to describe any 
other information known to or reasonably ascertainable by them (see 40 
CFR 720.50). However, upon review of PMNs and SNUNs, the Agency has the 
authority to require appropriate testing. Unit IV. of the proposed rule 
lists potentially useful information for all SNURs listed here. 
Descriptions are provided for informational purposes. The potentially 
useful information identified in Unit IV. of the proposed rule will be 
useful to EPA's evaluation in the event that someone submits a SNUN for 
the significant new use. Companies who are considering submitting a 
SNUN are encouraged, but not required, to develop the information on 
the substance, which may assist with EPA's analysis of the SNUN.
    EPA strongly encourages persons, before performing any testing, to 
consult with the Agency pertaining to protocol election. 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.
    The potentially useful information described in Unit IV. of the 
proposed rule may not be the only means of providing information to 
evaluate the chemical substance associated with the significant new 
uses. However, submitting a SNUN without any test data 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 which provide detailed information on the following:
     Human exposure and environmental release that may result 
from the significant new use of the chemical substances.

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 analysis is 
available in the docket for this rulemaking.

XI. Statutory and Executive Order Reviews

    Additional information about these statutes and Executive orders 
can be found at https://www.epa.gov/laws-regulations/laws-and-executive-orders.

A. Executive Order 12866: Regulatory Planning and Review and Executive 
Order 13563: Improving Regulations and Regulatory Review

    This action establishes SNURs for 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. Paperwork Reduction Act (PRA)

    This action does not impose any new information collection burden 
under the PRA, 44 U.S.C. 3501 et seq. OMB has previously approved the 
information collection activities contained in the existing SNUR 
regulations under OMB Control No. 2070-0038 (EPA ICR No. 1188.13). If 
an entity were to submit a SNUN to the Agency, the annual burden is 
estimated to be less than 100 hours per response, and the estimated 
burden for export notifications is less than 1.5 hours per 
notification. In both cases, if the firm submitting either a SNUN or 
export notification is already registered in CDX, the burden would be 
lower than the presented estimates.
    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 the PRA, unless it has been approved by OMB and displays a 
currently valid OMB control number. The OMB control numbers for EPA's 
regulations in title 40 of the CFR, after appearing in the Federal 
Register, are listed in 40 CFR part 9, and included on the related 
collection instrument or form, if applicable.
    EPA is amending the table in 40 CFR part 9 to list the OMB approval 
number for the information collection requirements contained in this 
action. This listing of the OMB control numbers and their subsequent 
codification in the CFR satisfies the display requirements of PRA and 
OMB's implementing regulations at 5 CFR part 1320. The Information 
Collection Request (ICR) covering the SNUR activities was previously 
subject to public notice and comment prior to OMB approval, and

[[Page 21484]]

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.

C. Regulatory Flexibility Act (RFA)

    Pursuant to RFA section 605(b), 5 U.S.C. 601 et seq., I hereby 
certify that promulgation of this SNUR 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, it 
appears that no small or large entities presently engage in such 
activities. A SNUR requires that any person who intends to engage in 
such activity in the future must first notify EPA by submitting a SNUN. 
Although some small entities may decide to pursue a significant new use 
in the future, EPA cannot presently determine how many, if any, there 
may be. However, EPA's experience to date is that, in response to the 
promulgation of SNURs covering over 1,000 chemicals, the Agency 
receives only a small number of notices per year. For example, the 
number of SNUNs received was seven in Federal fiscal year (FY) 2013, 13 
in FY2014, six in FY2015, 12 in FY2016, 13 in FY2017, and 11 in FY2018. 
Only a fraction of these were from small businesses. In addition, the 
Agency currently offers relief to qualifying small businesses by 
reducing the SNUN submission fee from $16,000 to $2,800. This lower fee 
reduces the total reporting and recordkeeping of cost of submitting a 
SNUN to about $10,116 for qualifying small firms. Therefore, the 
potential economic impacts of complying with this SNUR are not expected 
to be significant or adversely impact a substantial number of small 
entities. In a SNUR that published in the Federal Register of June 2, 
1997 (62 FR 29684) (FRL-5597-1), the Agency presented its general 
determination that final SNURs are not expected to have a significant 
economic impact on a substantial number of small entities, which was 
provided to the Chief Counsel for Advocacy of the Small Business 
Administration.

D. Unfunded Mandates Reform Act (UMRA)

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

E. Executive Order 13132: Federalism

    This action will not have federalism implications because it is not 
expected to 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).

F. Executive Order 13175: Consultation and Coordination With Indian 
Tribal Governments

    This action will not have Tribal implications because it is not 
expected to have substantial direct effects on Indian Tribes, 
significantly or uniquely affect the communities of Indian Tribal 
governments, and does not 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.

G. Executive Order 13045: Protection of Children From Environmental 
Health 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.

H. 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 a significant regulatory 
action under Executive Order 12866.

I. National Technology Transfer and Advancement Act (NTTAA)

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

J. Executive Order 12898: 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).

K. 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: April 3, 2023.
Denise Keehner,
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.  
721.11604 through 721.11634 in numerical order under the undesignated 
center heading ``Significant New Uses of Chemical Substances'' to read 
as follows:

[[Page 21485]]

Sec.  9.1  OMB approvals under the Paperwork Reduction Act.

* * * * *

------------------------------------------------------------------------
                                                             OMB control
                      40 CFR citation                            No.
------------------------------------------------------------------------
 
                                * * * * *
        Significant New Uses of Chemical Substances
 
                                * * * * *
721.11659..................................................    2070-0038
721.11660..................................................    2070-0038
721.11661..................................................    2070-0038
721.11662..................................................    2070-0038
721.11663..................................................    2070-0038
721.11664..................................................    2070-0038
721.11665..................................................    2070-0038
721.11666..................................................    2070-0038
721.11667..................................................    2070-0038
721.11668..................................................    2070-0038
721.11669..................................................    2070-0038
721.11670..................................................    2070-0038
721.11671..................................................    2070-0038
721.11672..................................................    2070-0038
721.11673..................................................    2070-0038
721.11674..................................................    2070-0038
721.11675..................................................    2070-0038
721.11676..................................................    2070-0038
721.11677..................................................    2070-0038
721.11678..................................................    2070-0038
721.11679..................................................    2070-0038
721.11680..................................................    2070-0038
721.11681..................................................    2070-0038
721.11682..................................................    2070-0038
721.11683..................................................    2070-0038
721.11684..................................................    2070-0038
721.11685..................................................    2070-0038
721.11686..................................................    2070-0038
 
                                * * * * *
------------------------------------------------------------------------

* * * * *

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.  721.11659 through 721.11686 to subpart E to read as 
follows:
* * * * *
Sec.
721.11659 Mixed amine salt (generic).
721.11660 Oxyalkylene modified polyalkyl amine alkyl diacid polymer 
with 2-(chloromethyl)oxirane (generic).
721.11661 Formaldehyde, homopolymer, reaction products with N-
propyl-1-propanamine.
721.11662 2-Propenoic acid, polymer with 2-methyl-2-[(1-oxo-2-
propen-1-yl)amino]-1-propanesulfonic acid.
721.11663 Benzoic acid, alkyl derivs. (generic).
721.11664 Aminoalkylated imidazole (generic).
721.11665 Fatty acids and fatty acid unsatd., reaction products with 
ethyleneamines and maleic anhydride (generic).
721.11666 Aromatic anhydride polymer with bisalkylbiphenylbisamine 
compound with alkylamino acrylate ester (generic).
721.11667 Propanoic acid, hydroxyl- (hydroxyalkyl)-alkyl-, polymer 
with 1,6-diisocyanatoalkane and poly[oxy(alkyl-alkanediyl)] ether 
with alkyl (hydroxyalkyl)- alkanediol, 2-propenoate (ester), lithium 
salt, glycerol monoacrylate 1-neodecanoate- and alkylene glycol 
monoacrylate-blocked (generic).
721.11668 Polyol adduct of bisaldehyde (generic).
721.11669 2,5-Furandione, polymer with ethenylbenzene, 4-hydroxy-
substituted butyl amide, sodium salts (generic).
721.11670 2,5-Furandione, polymer with ethenylbenzene, 4-hydroxy- 
substituted butyl[3-[2-[1-[[(2-methoxyphenyl)amino]carbonyl]-2-
oxopropyl]diazenyl]phenyl]substituted, sodium salts (generic).
721.11671 Butanamide, 2-[2-[(substituted phenyl)diazenyl]-N-(2-
methoxyphenyl)-3-oxo- (generic).
721.11672 Polycyclic substituted alkane, polymer with 
cyclicalkylamine, epoxide, and polycyclic epoxide ether, reaction 
products with dialkylamine substituted alkyl amine (generic).
721.11673 Polycyclic alkane, polymer with monocyclic amine, 
polycyclic epoxide ether, reaction products with dialkylamine alkyl 
amine (generic).
721.11674 Polycyclic substituted alkane, polymer with epoxide, 
reaction products with cyclicalkylamine and dialkylamine substituted 
alkyl amine (generic).
721.11675 Substituted carbopolycyclic dicarboxylic acid dialkyl 
ester, polymer with alkanediol and carbopolycyclic bis(substituted 
carbopolycycle) bisalkanol (generic).
721.11676 D-Glucopyranose, oligomeric, Bu glycosides, polymers with 
epichlorohydrin, 2-hydroxy-3-sulfopropyl ethers, sodium salts.
721.11677 Alkyl polyoxyethylene ethers, carboxymethylated (generic).
721.11678 Iron, complexes with ethylenediamine-4-
hydroxycarbomonocycle hetero-acid-2-oxoacetic acid reaction 
products, potassium salts (generic).
721.11679 Iron, complexes with ethylenediamine-4-
hydroxycarbomonocycle hetero-acid potassium salt (1:1)-potassium 2-
oxoacetate (1:1) reaction products, potassium salts (generic).
721.11680 Iron, complexes with ethylenediamine-4-
hydroxycarbomonocycle hetero-acid-2-oxoacetic acid reaction 
products, sodium salts (generic).
721.11681 Iron, complexes with ethylenediamine-4-
hydroxycarbomonocycle hetero-acid sodium salt (1:1)-sodium 2-
oxoacetate (1:1) reaction products, sodium salts (generic).
721.11682 Alkaneic acid, dialkyl ester polymer with alkanediol, 
(isocyanatocarbomonocycle) alkyl)carbomonocycle) carbamate 
(generic).
721.11683 Amides, from C8-18 and C18-unsatd. glycerides and 
diethylenetriamine, ethoxylated.
721.11684 Amides, from diethylenetriamine and palm kernel-oil, 
ethoxylated.
721.11685 Amides, from coconut oil and diethylenetriamine, 
ethoxylated.
721.11686 Phenol-formaldehyde polymer with amino-oxirane copolymer 
and benzoates (generic).


Sec.  721.11659  Mixed amine salt (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as mixed 
amine salt (PMN P-15-632) 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(y)(1) and (2).
    (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.


Sec.  721.11660  Oxyalkylene modified polyalkyl amine alkyl diacid 
polymer with 2-(chloromethyl)oxirane (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 
oxyalkylene modified polyalkyl amine alkyl diacid polymer with 2-
(chloromethyl)oxirane (PMN P-17-233) is subject to reporting under this 
section for the significant new uses described in paragraph (a)(2) of 
this section.
    (2) The significant new uses are:
    (i) Industrial, commercial, and consumer activities. It is a 
significant new use to manufacture, process, or use the PMN substance 
in any manner that results in inhalation exposure.
    (ii) Release to water. Requirements as specified in Sec.  
721.90(a)(4), (b)(4), and (c)(4), where N=20.
    (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

[[Page 21486]]

Sec.  721.125(a) through (c), (i), and (k) 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.


Sec.  721.11661  Formaldehyde, homopolymer, reaction products with N-
propyl-1-propanamine.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified as formaldehyde, 
homopolymer, reaction products with N-propyl-1-propanamine (PMN P-17-
298; CAS No. 1374859-50-3) is subject to reporting under this section 
for the significant new uses described in paragraph (a)(2) of this 
section.
    (2) The significant new uses are:
    (i) Industrial, commercial, and consumer activities. It is a 
significant new use to use the PMN substance other than as a hydrogen 
sulfide scavenger used in controlling hydrogen sulfide in the vapor 
space of fuel storage, shipping vessels, and pipelines.
    (ii) Release to water. Requirements as specified in Sec.  
721.90(a)(4), (b)(4), and (c)(4), where N=3.
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph (b).
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125(a) through (c), (i), and (k) 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.


Sec.  721.11662  2-Propenoic acid, polymer with 2-methyl-2-[(1-oxo-2-
propen-1-yl)amino]-1-propanesulfonic acid.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified as 2-propenoic acid, 
polymer with 2-methyl-2-[(1-oxo-2-propen-1-yl)amino]-1-propanesulfonic 
acid (PMN P-17-325; CAS No. 40623-75-4) is subject to reporting under 
this section for the significant new uses described in paragraph (a)(2) 
of this section.
    (2) The significant new uses are:
    (i) Release to water. Requirements as specified in Sec.  
721.90(a)(4), (b)(4), and (c)(4), where N = 50.
    (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 (k) 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.


Sec.  721.11663  Benzoic acid, alkyl derivs. (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as benzoic 
acid, alkyl derivs. (PMN P-17-355) is subject to reporting under this 
section for the significant new uses described in paragraph (a)(2) of 
this section.
    (2) The significant new uses are:
    (i) Industrial, commercial, and consumer activities. It is a 
significant new use to manufacture, process, or use the PMN substance 
in any manner that results in inhalation exposure.
    (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.


Sec.  721.11664  Aminoalkylated imidazole (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 
aminoalkylated imidazole (PMN P-17-396) 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) and (o).
    (ii) Release to water. Requirements as specified in Sec.  
721.90(a)(4), (b)(4), and (c)(4), where N = 33.
    (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), (i), and (k) 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.


Sec.  721.11665  Fatty acids and fatty acid unsatd., reaction products 
with ethyleneamines and maleic anhydride (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as fatty 
acids and fatty acid unsatd., reaction products with ethyleneamines and 
maleic anhydride (PMN P-18-29) is subject to reporting under this 
section for the significant new uses described in paragraph (a)(2) of 
this section.
    (2) The significant new uses are:
    (i) Industrial, commercial, and consumer activities. It is a 
significant new use to manufacture, process, or use the PMN substance 
in any manner that results in inhalation exposure.
    (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.


Sec.  721.11666  Aromatic anhydride polymer with 
bisalkylbiphenylbisamine compound with alkylamino acrylate ester 
(generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 
aromatic anhydride polymer with bisalkylbiphenylbisamine compound with 
alkylamino acrylate ester (PMN P-18-108) 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). It is a significant new use to 
manufacture, process, or use the PMN substance in any manner that 
results in inhalation exposure.
    (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 21487]]

Sec.  721.11667  Propanoic acid, hydroxyl- (hydroxyalkyl)-alkyl-, 
polymer with 1,6-diisocyanatoalkane and poly[oxy(alkyl-alkanediyl)] 
ether with alkyl (hydroxyalkyl)- alkanediol, 2-propenoate (ester), 
lithium salt, glycerol monoacrylate 1-neodecanoate- and alkylene glycol 
monoacrylate-blocked (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 
propanoic acid, hydroxyl- (hydroxyalkyl)-alkyl-, polymer with 1,6-
diisocyanatoalkane and poly[oxy(alkyl-alkanediyl)] ether with alkyl 
(hydroxyalkyl)- alkanediol, 2-propenoate (ester), lithium salt, 
glycerol monoacrylate 1-neodecanoate- and alkylene glycol monoacrylate-
blocked (PMN P-18-114) is subject to reporting under this section for 
the significant new uses described in paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Industrial, commercial, and consumer activities. It is a 
significant new use to use the PMN substance in spray applications.
    (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.


Sec.  721.11668  Polyol adduct of bisaldehyde (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as polyol 
adduct of bisaldehyde (PMN P-18-133) 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(y)(1).
    (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.


Sec.  721.11669  2,5-Furandione, polymer with ethenylbenzene, 4-
hydroxy-substituted butyl amide, sodium salts (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 2,5-
furandione, polymer with ethenylbenzene, 4-hydroxy-substituted butyl 
amide, sodium salts (PMN P-18-165) 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(o). It is a significant new use to 
manufacture, process, or use the PMN substance in any manner that 
results in inhalation exposure.
    (ii) Release to water. Requirements as specified in Sec.  
721.90(a)(1), (b)(1), and (c)(1).
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph (b).
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125(a) through (c), (i), and (k) 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.


Sec.  721.11670  2,5-Furandione, polymer with ethenylbenzene, 4-
hydroxy- substituted butyl[3-[2-[1-[[(2-methoxyphenyl)amino]carbonyl]-
2-oxopropyl]diazenyl]phenyl]substituted, sodium salts (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 2,5-
furandione, polymer with ethenylbenzene, 4-hydroxy- substituted 
butyl[3-[2-[1-[[(2-methoxyphenyl)amino]carbonyl]-2-
oxopropyl]diazenyl]phenyl]substituted, sodium salts (PMN P-18-166) 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(o). It is a significant new use to 
manufacture, process, or use the PMN substance in any manner that 
results in inhalation exposure.
    (ii) Release to water. Requirements as specified in Sec.  
721.90(a)(1), (b)(1), and (c)(1).
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph (b).
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125(a) through (c), (i), and (k) 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.


Sec.  721.11671  Butanamide, 2-[2-[(substituted phenyl)diazenyl]-N-(2-
methoxyphenyl)-3-oxo- (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 
butanamide, 2-[2-[(substituted phenyl)diazenyl]-N-(2-methoxyphenyl)-3-
oxo- (PMN P-18-167) 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 (o). It is a significant new use to 
manufacture, process, or use the PMN substance in any manner that 
results in inhalation exposure.
    (ii) Release to water. Requirements as specified in Sec.  
721.90(a)(1), (b)(1), and (c)(1).
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph (b).
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125(a) through (c), (i), and (k) 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.


Sec.  721.11672  Polycyclic substituted alkane, polymer with 
cyclicalkylamine, epoxide, and polycyclic epoxide ether, reaction 
products with dialkylamine substituted alkyl amine (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 
polycyclic substituted alkane, polymer with cyclicalkylamine, epoxide, 
and polycyclic epoxide ether, reaction products with dialkylamine 
substituted alkyl amine (PMN P-18-214) 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:

[[Page 21488]]

    (i) Industrial, commercial, and consumer activities. It is a 
significant new use to use the PMN substance in a spray application 
method other than the method described in the spray analysis report 
submitted with the PMN.
    (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.


Sec.  721.11673  Polycyclic alkane, polymer with monocyclic amine, 
polycyclic epoxide ether, reaction products with dialkylamine alkyl 
amine (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 
polycyclic alkane, polymer with monocyclic amine, polycyclic epoxide 
ether, reaction products with dialkylamine alkyl amine (PMN P-18-215) 
is subject to reporting under this section for the significant new uses 
described in paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Industrial, commercial, and consumer activities. It is a 
significant new use to use the PMN substance in a spray application 
method other than the method described in the spray analysis report 
submitted with the PMN.
    (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.


Sec.  721.11674  Polycyclic substituted alkane, polymer with epoxide, 
reaction products with cyclicalkylamine and dialkylamine substituted 
alkyl amine (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 
polycyclic substituted alkane, polymer with epoxide, reaction products 
with cyclicalkylamine and dialkylamine substituted alkyl amine (PMN P-
18-216) is subject to reporting under this section for the significant 
new uses described in paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Industrial, commercial, and consumer activities. It is a 
significant new use to use the PMN substance in a spray application 
method other than the method described in the spray analysis report 
submitted with the PMN.
    (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.


Sec.  721.11675  Substituted carbopolycyclic dicarboxylic acid dialkyl 
ester, polymer with alkanediol and carbopolycyclic bis(substituted 
carbopolycycle) bisalkanol (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 
substituted carbopolycyclic dicarboxylic acid dialkyl ester, polymer 
with alkanediol and carbopolycyclic bis(substituted carbopolycycle) 
bisalkanol (PMN P-18-329) is subject to reporting under this section 
for the significant new uses described in paragraph (a)(2) of this 
section.
    (2) The significant new uses are:
    (i) Industrial, commercial, and consumer activities. It is a 
significant new use to manufacture, process, or use the PMN substance 
in any manner that results in inhalation exposure.
    (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.


Sec.  721.11676  D-Glucopyranose, oligomeric, Bu glycosides, polymers 
with epichlorohydrin, 2-hydroxy-3-sulfopropyl ethers, sodium salts.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified as D-glucopyranose, 
oligomeric, Bu glycosides, polymers with epichlorohydrin, 2-hydroxy-3-
sulfopropyl ethers, sodium salts (PMN P-18-385; CAS No. 2139271-53-5) 
is subject to reporting under this section for the significant new uses 
described in paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Industrial, commercial, and consumer activities. It is a 
significant new use to manufacture, process, or use the PMN substance 
in any manner that results in inhalation exposure.
    (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.


Sec.  721.11677  Alkyl polyoxyethylene ethers, carboxymethylated 
(generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as alkyl 
polyoxyethylene ethers, carboxymethylated (PMN P-19-135) is subject to 
reporting under this section for the significant new uses described in 
paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Industrial, commercial, and consumer activities. It is a 
significant new use to manufacture, process, or use the PMN substance 
in any manner that results in inhalation exposure.
    (ii) Release to water. Requirements as specified in Sec.  
721.90(a)(4), (b)(4), and (c)(4), where N = 60.
    (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), (i), and (k) 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.


Sec.  721.11678  Iron, complexes with ethylenediamine-4-
hydroxycarbomonocycle hetero-acid-2-oxoacetic acid reaction products, 
potassium salts (generic).

    (a) Chemical substance and significant new uses subject to 
reporting.

[[Page 21489]]

(1) The chemical substance identified generically as iron, complexes 
with ethylenediamine-4-hydroxycarbomonocycle hetero-acid-2-oxoacetic 
acid reaction products, potassium salts (PMN P-19-148) is subject to 
reporting under this section for the significant new uses described in 
paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80(f) and (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.


Sec.  721.11679  Iron, complexes with ethylenediamine-4-
hydroxycarbomonocycle hetero-acid potassium salt (1:1)-potassium 2-
oxoacetate (1:1) reaction products, potassium salts (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as iron, 
complexes with ethylenediamine-4-hydroxycarbomonocycle hetero-acid 
potassium salt (1:1)-potassium 2-oxoacetate (1:1) reaction products, 
potassium salts (PMN P-19-149) is subject to reporting under this 
section for the significant new uses described in paragraph (a)(2) of 
this section.
    (2) The significant new uses are:
    (i) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80(f) and (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.


Sec.  721.11680  Iron, complexes with ethylenediamine-4-
hydroxycarbomonocycle hetero-acid-2-oxoacetic acid reaction products, 
sodium salts (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as iron, 
complexes with ethylenediamine-4-hydroxycarbomonocycle hetero-acid-2-
oxoacetic acid reaction products, sodium salts (PMN P-19-150) is 
subject to reporting under this section for the significant new uses 
described in paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80(f) and (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.


Sec.  721.11681  Iron, complexes with ethylenediamine-4-
hydroxycarbomonocycle hetero-acid sodium salt (1:1)-sodium 2-oxoacetate 
(1:1) reaction products, sodium salts (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as iron, 
complexes with ethylenediamine-4-hydroxycarbomonocycle hetero-acid 
sodium salt (1:1)-sodium 2-oxoacetate (1:1) reaction products, sodium 
salts (PMN P-19-151) is subject to reporting under this section for the 
significant new uses described in paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80(f) and (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.


Sec.  721.11682  Alkaneic acid, dialkyl ester polymer with alkanediol, 
(isocyanatocarbomonocycle) alkyl)carbomonocycle) carbamate (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 
alkaneic acid, dialkyl ester polymer with alkanediol, 
(isocyanatocarbomonocycle) alkyl)carbomonocycle) carbamate (PMN P-19-
152) 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(o). It is a significant new use to 
manufacture the PMN substance with greater than 25.0% residual 
isocyanate by weight. It is a significant new use to manufacture, 
process, or use the PMN substance in any manner that results in 
inhalation exposure.
    (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.


Sec.  721.11683  Amides, from C8-18 and C18-unsatd. glycerides and 
diethylenetriamine, ethoxylated.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified as amides, from C8-18 
and C18-unsatd. glycerides and diethylenetriamine, ethoxylated (PMN P-
19-155; CAS No. 2173332-72-2) is subject to reporting under this 
section for the significant new uses described in paragraph (a)(2) of 
this section.
    (2) The significant new uses are:
    (i) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80(o). It is a significant new use to 
manufacture or process the PMN substance in any manner that results in 
inhalation exposure. It is a significant new use to use the PMN 
substance other than as an adjuvant for industrial herbicide 
agrochemical formulations.
    (ii) Release to water. Requirements as specified in Sec.  
721.90(a)(4), (b)(4), and (c)(4), where N = 2.
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph (b).
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125(a) through (c), (i), and (k) are

[[Page 21490]]

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.


Sec.  721.11684  Amides, from diethylenetriamine and palm kernel-oil, 
ethoxylated.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified as amides, from 
diethylenetriamine and palm kernel-oil, ethoxylated (PMN P-19-156; CAS 
No. 2173332-69-7) is subject to reporting under this section for the 
significant new uses described in paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80(o). It is a significant new use to 
manufacture or process the PMN substance in any manner that results in 
inhalation exposure. It is a significant new use to use the PMN 
substance other than as an adjuvant for industrial herbicide 
agrochemical formulations.
    (ii) Release to water. Requirements as specified in Sec.  
721.90(a)(4), (b)(4), and (c)(4), where N = 2.
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph (b).
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125(a) through (c), (i), and (k) 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.


Sec.  721.11685  Amides, from coconut oil and diethylenetriamine, 
ethoxylated.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified as amides, from 
coconut oil and diethylenetriamine, ethoxylated (PMN P-19-157; CAS No. 
2173332-70-0) 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(o). It is a significant new use to 
manufacture or process the PMN substance in any manner that results in 
inhalation exposure. It is a significant new use to use the PMN 
substance other than as an adjuvant for industrial herbicide 
agrochemical formulations.
    (ii) Release to water. Requirements as specified in Sec.  
721.90(a)(4), (b)(4), and (c)(4), where N = 2.
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph (b).
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125(a) through (c), (i), and (k) 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.


Sec.  721.11686  Phenol-formaldehyde polymer with amino-oxirane 
copolymer and benzoates (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as phenol-
formaldehyde polymer with amino-oxirane copolymer and benzoates (PMN P-
20-24) 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) and (o). It is a significant new use to 
use the PMN substance in final product formulation at a concentration 
greater than 8%.
    (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.

[FR Doc. 2023-07458 Filed 4-10-23; 8:45 am]
BILLING CODE 6560-50-P