[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