Rule2022-13338
Significant New Use Rules on Certain Chemical Substances (19-4.F)
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
June 27, 2022
Effective
August 26, 2022
Issuing agencies
Environmental Protection Agency
Abstract
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.
Full Text
<html>
<head>
<title>Federal Register, Volume 87 Issue 122 (Monday, June 27, 2022)</title>
</head>
<body><pre>
[Federal Register Volume 87, Number 122 (Monday, June 27, 2022)]
[Rules and Regulations]
[Pages 37999-38008]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2022-13338]
=======================================================================
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Parts 9 and 721
[EPA-HQ-OPPT-2019-0494; FRL-7584-01-OCSPP]
RIN 2070-AB27
Significant New Use Rules on Certain Chemical Substances (19-4.F)
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: EPA is issuing significant new use rules (SNURs) under the
Toxic Substances Control Act (TSCA) for chemical substances 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 August 26, 2022. For purposes of
judicial review, this rule shall be promulgated at 1 p.m. (e.s.t.) on
July 11, 2022.
FOR FURTHER INFORMATION CONTACT: For technical information contact:
William Wysong, New Chemicals Division (7405M), Office of Pollution
Prevention and Toxics, Environmental Protection Agency, 1200
Pennsylvania Ave. NW, Washington, DC 20460-0001; telephone number:
(202) 564-4163; email address: <a href="/cdn-cgi/l/email-protection#14636d677b7a733a637d78787d7579547164753a737b62"><span class="__cf_email__" data-cfemail="3e49474d5150591049575252575f537e5b4e5f10595148">[email protected]</span></a>.
For general information contact: The TSCA-Hotline, ABVI-Goodwill,
422 South Clinton Ave., Rochester, NY 14620; telephone number: (202)
554-1404; email address: <a href="/cdn-cgi/l/email-protection#5e0a0d1d1f7316312a3237303b1e3b2e3f70393128"><span class="__cf_email__" data-cfemail="c89c9b8b89e580a7bca4a1a6ad88adb8a9e6afa7be">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this action apply to me?
You may be potentially affected by this action if you manufacture,
process, or use the chemical substances contained in this rule. The
following list of North American Industrial Classification System
(NAICS) codes is not intended to be exhaustive, but rather provides a
guide to help readers determine whether this document applies to them.
Potentially affected entities may include:
<bullet> Manufacturers or processors of one or more subject
chemical substances (NAICS codes 325 and 324110), e.g., chemical
manufacturing and petroleum refineries.
This action may also affect certain entities through pre-existing
import certification and export notification rules under TSCA. Chemical
importers are subject to the TSCA section 13 (15 U.S.C. 2612) import
provisions. This action may also affect certain entities through pre-
existing import certification and export notification rules under TSCA,
which would include the SNUR requirements. The EPA policy in
[[Page 38000]]
support of import certification appears at 40 CFR part 707, subpart B.
In addition, pursuant to 40 CFR 721.20, 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-2019-0494,
is available at <a href="https://www.regulations.gov">https://www.regulations.gov</a> and at the Office of
Pollution Prevention and Toxics Docket (OPPT Docket), Environmental
Protection Agency Docket Center (EPA/DC), West William Jefferson
Clinton Bldg., Rm. 3334, 1301 Constitution Ave. NW, Washington, DC. The
Public Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through
Friday, excluding legal holidays. The telephone number for the Public
Reading Room is (202) 566-1744, and the telephone number for the OPPT
Docket is (202) 566-0280. Please review the visitor instructions and
additional information about the docket available at <a href="https://www.epa.gov/dockets">https://www.epa.gov/dockets</a>.
II. Background
A. What action is the Agency taking?
EPA is finalizing SNURs under TSCA section 5(a)(2) for chemical
substances which were the subject of PMNs P-17-312, P-17-313, P-17-314,
P-17-315, P-17-316, P-17-317, P-18-9, P-18-11, P-18-170, P-18-185, P-
18-190, P-18-191, P-18-223, P-18-285, P-18-300, P-18-394, P-18-404, P-
19-12, P-19-31, and P-19-72. 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. EPA is not currently finalizing
the SNUR for the substance which was the subject of PMN P-19-71 because
the Agency has received new data on the substance. EPA will review the
new data and address this proposed SNUR in a future notice.
Previously, in the Federal Register of November 4, 2019 (84 FR
59335) (FRL-10000-54), EPA proposed SNURs for these chemical substances
and five other SNURs. EPA finalized the proposed SNURs for P-16-548, P-
17-398, P-17-399, P-18-1, and P-18-28 in a previous Federal Register
notice of August 18, 2021 (86 FR 46133) (FRL-8000-02-OCSPP). 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:
<bullet> The projected volume of manufacturing and processing of a
chemical substance.
<bullet> The extent to which a use changes the type or form of
exposure of human beings or the environment to a chemical substance.
<bullet> The extent to which a use increases the magnitude and
duration of exposure of human beings or the environment to a chemical
substance.
<bullet> 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 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. EPA promulgated a procedure to deal with the
situation where a specific significant new use is CBI, at 40 CFR
721.1725(b)(1) and has referenced it to apply to other SNURs.
Under these procedures a manufacturer or processor may request EPA
to determine whether a specific use would be a significant new use
under the rule. The manufacturer or processor must show that it has a
bona fide intent to manufacture or process the chemical substance and
must identify the specific use for which it intends to manufacture or
process the chemical substance. If EPA concludes that the person has
shown a bona fide intent to manufacture or process the chemical
substance, EPA
[[Page 38001]]
will tell the person whether the use identified in the bona fide
submission would be a significant new use under the rule. Since most of
the chemical identities of the chemical substances subject to these
SNURs are also CBI, manufacturers and processors can combine the bona
fide submission under the procedure in 40 CFR 721.1725(b)(1) with that
under 40 CFR 721.11 into a single step.
If EPA determines that the use identified in the bona fide
submission would not be a significant new use, i.e., the use does not
meet the criteria specified in the rule for a significant new use, that
person can manufacture or process the chemical substance so long as the
significant new use trigger is not met. In the case of a production
volume trigger, this means that the aggregate annual production volume
does not exceed that identified in the bona fide submission to EPA.
Because of confidentiality concerns, EPA does not typically disclose
the actual production volume that constitutes the use trigger. Thus, if
the person later intends to exceed that volume, a new bona fide
submission would be necessary to determine whether that higher volume
would be a significant new use.
IV. Public Comments
EPA received public comments from three identifying entities on the
proposed rule. The Agency's responses are presented in the Response to
Public Comments document that is available in the docket for this rule.
Based on these comments EPA made a change to the SNUR for P-17-312
regarding calculation of surface water concentrations as described in
the response to comments document.
V. Substances Subject to This Rule
EPA is establishing significant new use and recordkeeping
requirements for chemical substances in 40 CFR part 721, subpart E. In
Unit IV. of the proposed SNUR, EPA provided the following information
for each chemical substance:
<bullet> PMN number.
<bullet> Chemical name (generic name, if the specific name is
claimed as CBI).
<bullet> Chemical Abstracts Service (CAS) Registry number (if
assigned for non-confidential chemical identities).
<bullet> Basis for the SNUR.
<bullet> Potentially useful information.
<bullet> CFR citation proposed to be assigned in the regulatory
text section. This final rule makes the final assignment to set the CFR
citation for the chemical substance.
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:
<bullet> 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.
<bullet> 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.
<bullet> 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 <a href="https://www.epa.gov/tsca-inventory">https://www.epa.gov/tsca-inventory</a>.
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 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 November 4, 2019 (the date of publication of the
proposed rule in the Federal Register) 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 TSCA section 5 allowing manufacture
or processing to proceed.
[[Page 38002]]
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. 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 <a href="https://www.epa.gov/assessing-and-managing-chemicals-under-tsca/alternative-test-methods-and-strategies-reduce">https://www.epa.gov/assessing-and-managing-chemicals-under-tsca/alternative-test-methods-and-strategies-reduce</a>.
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:
<bullet> 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 <a href="https://www.epa.gov/reviewing-new-chemicals-under-toxic-substances-control-act-tsca">https://www.epa.gov/reviewing-new-chemicals-under-toxic-substances-control-act-tsca</a>.
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 <a href="https://www.epa.gov/laws-regulations-and-executive-orders">https://www.epa.gov/laws-regulations-and-executive-orders</a>.
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)
According to PRA, 44 U.S.C. 3501 et seq., an agency may not conduct
or sponsor, and a person is not required to respond to a collection of
information that requires OMB approval under PRA, unless it has been
approved by OMB and displays a currently valid OMB control number. The
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.
The information collection requirements related to this action have
already been approved by OMB pursuant to PRA under OMB control number
2070-0012 (EPA ICR No. 574). This action does not impose any burden
requiring additional OMB approval. If an entity were to submit a SNUN
to the Agency, the annual burden is estimated to average between 30 and
170 hours per response. This burden estimate includes the time needed
to review instructions, search existing data sources, gather and
maintain the data needed, and complete, review, and submit the required
SNUN.
Send any comments about the accuracy of the burden estimate, and
any suggested methods for minimizing respondent burden, including
through the use of automated collection techniques, to the Director,
Regulatory Support Division, Office of Mission Support (2822T),
Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington,
DC 20460-0001. Please remember to include the OMB control number in any
correspondence, but do not submit any completed forms to this address.
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
[[Page 38003]]
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 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 as specified in
Executive Order 13132 (64 FR 43255, August 10, 1999), 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.
F. Executive Order 13175: Consultation and Coordination With Indian
Tribal Governments
This action will not have Tribal implications as specified under
Executive Order 13175 (65 FR 67249, November 9, 2000), because it is
not expected to have substantial direct effects on Indian Tribes or
significantly or uniquely affect the communities of Indian Tribal
governments, and does not involve or impose any requirements that
affect Indian Tribes.
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)
NTTAA section 12(d), 15 U.S.C. 272 note, does not apply to this
action because this action does not involve any technical standards.
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)
Pursuant to the CRA, 5 U.S.C. 801 et seq., 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: June 15, 2022.
Tala Henry,
Deputy Director, Office of Pollution Prevention and Toxics.
Therefore, for the reasons stated in the preamble, 40 CFR chapter I
is amended as follows:
PART 9--OMB APPROVALS UNDER THE PAPERWORK REDUCTION ACT
0
1. The authority citation for part 9 continues to read as follows:
Authority: 7 U.S.C. 135 et seq., 136-136y; 15 U.S.C. 2001,
2003, 2005, 2006, 2601-2671; 21 U.S.C. 331j, 346a; 31 U.S.C. 9701;
33 U.S.C. 1251 et seq., 1311, 1313d, 1314, 1318, 1321, 1326, 1330,
1342, 1344, 1345 (d) and (e), 1361; E.O. 11735, 38 FR 21243, 3 CFR,
1971-1975 Comp. p. 973; 42 U.S.C. 241, 242b, 243, 246, 300f, 300g,
300g-1, 300g-2, 300g-3, 300g-4, 300g-5, 300g-6, 300j-1, 300j-2,
300j-3, 300j-4, 300j-9, 1857 et seq., 6901-6992k, 7401-7671q, 7542,
9601-9657, 11023, 11048.
0
2. In Sec. 9.1, amend the table by adding entries for Sec. Sec.
721.11384 through 721.11389, 721.11394 through 721.11400, 721.11404
through 721.11410, and 721.11411 in numerical order under the
undesignated center heading ``Significant New Uses of Chemical
Substances'' to read as follows:
Sec. 9.1 OMB approvals under the Paperwork Reduction Act.
* * * * *
------------------------------------------------------------------------
OMB control
40 CFR citation No.
------------------------------------------------------------------------
* * * * *
------------------------------------------------------------------------
Significant New Uses of Chemical Substances
------------------------------------------------------------------------
* * * * *
721.11384............................................... 2070-0012
721.11385............................................... 2070-0012
721.11386............................................... 2070-0012
721.11387............................................... 2070-0012
721.11388............................................... 2070-0012
721.11389............................................... 2070-0012
* * * * *
721.11394............................................... 2070-0012
721.11395............................................... 2070-0012
721.11396............................................... 2070-0012
721.11397............................................... 2070-0012
721.11398............................................... 2070-0012
721.11399............................................... 2070-0012
721.11400............................................... 2070-0012
* * * * *
721.11404............................................... 2070-0012
721.11405............................................... 2070-0012
721.11406............................................... 2070-0012
721.11407............................................... 2070-0012
721.11408............................................... 2070-0012
721.11409............................................... 2070-0012
* * * * *
721.11411............................................... 2070-0012
[[Page 38004]]
* * * * *
------------------------------------------------------------------------
* * * * *
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).
Subpart E--Significant New Uses for Specific Chemical Substances
0
4. Add Sec. Sec. 721.11384 through 721.11389, Sec. Sec. 721.11394
through 721.11400, Sec. Sec. 721.11404 through 721.11409, and Sec.
721.11411 to read as follows:
Sec.
* * * * *
721.11384 Organic acid, compds. with bisphenol A-epichlorohydrin-
polypropylene glycol diglycidyl ether polymer-disubstituted amine-
disubstituted polypropylene glycol reaction products (generic).
721.11385 Phenol, 4,4'-(1-methylethylidene)bis-, polymer with 2-
(chloromethyl)oxirane and .alpha.-(2-oxiranylmethyl)-.omega.-(2-
oxiranylmethoxy)poly[oxy(methyl-1,2-ethanediyl)], reaction products
with disubstituted amine and disubstituted polypropylene glycol,
organic acid salts (generic)
Sec. 721.11386 Organic acid, 2-substituted-, compds. with bisphenol
A-epichlorohydrin-polypropylene glycol diglycidyl ether polymer-
disubstituted amine-disubstituted polypropylene glycol reaction
products (generic).
Sec. 721.11387 Phenol, 4,4'-(1-methylethylidene)bis-, polymer with
.alpha.-(2-substituted-methylethyl)-.omega.-(2-substituted-
methylethoxy)poly[oxy(methyl-1,2-ethanediyl)], 2-
(chloromethyl)oxirane and .alpha.-(2-oxiranylmethyl)-.omega.-(2-
oxiranylmethoxy)poly[oxy(methyl-1,2-ethanediyl)], alkylphenyl
ethers, reaction products with disubstituted amine, organic acid
salts (generic).
Sec. 721.11388 Organic acid, compds. with bisphenol A-
epichlorohydrin-disubstituted polypropylene glycol-polypropylene
glycol diglycidyl ether polymer alkylphenyl ethers-disubstituted
amine reaction products (generic).
Sec. 721.11389 Organic acid, compds. with bisphenol A-
epichlorohydrin-polypropylene glycol diglycidyl ether polymer-
disubstituted polypropylene glycol reaction products (generic).
* * * * *
Sec. 721.11394 Phosphonic acid, dimethyl ester, polymer with alkyl
diols (generic).
Sec. 721.11395 1H-Imidazole, 1,2,4,5-tetramethyl-.
Sec. 721.11396 1-Propanaminium, N,N'-(oxydi-2,1-ethanediyl)bis[3-
chloro-2-hydroxy-N,N-dimethyl-, chloride (1:2).
Sec. 721.11397 Fatty acid, polymer with alkanedioic acid dialkyl
ester, hydroxyl alkyl substituted alkanediol, substituted
carbomonocycle and alkylol substituted alkane (generic).
Sec. 721.11398 2,5-Furandione, polymer with ethenylbenzene, 4-
hydroxy-substituted butyl amide, polymers with epichlorohydrin and
trimethylolpropane, sodium salts (generic)
Sec. 721.11399 2,5-Furandione, polymer with ethenylbenzene, 4-
hydroxy-substitutedbutyl [3-[2-[1-
[[(substitutedphenyl)amino]carbonyl]-2-
oxopropyl]diazenyl]phenyl]methyl amide, polymers with
epichlorohydrin and trimethylolpropane, sodium salts (generic)
Sec. 721.11400 Alkane, bis(alkoxymethyl)-dimethyl- (generic).
* * * * *
Sec. 721.11404 Butanedioic acid, 2-methylene-, polymer with 2-
methyl-2-[(1-oxo-2-propen-1-yl)amino]-1-propanesulfonic acid, sodium
zinc salt.
Sec. 721.11405 Heteromonocycle, alkenoic 1:1 salt, polymer with
.alpha.-(2-methyl-1-oxo-2-propen-1-yl)-.omega.-methoxypoly(oxy-1,2-
ethanediyl) and methyl-alkenoic acid (generic).
Sec. 721.11406 Substituted benzylic ether polyethylene glycol alkyl
ether derivative (generic).
Sec. 721.11407 Alkylmultiheteroatom, 2-functionalisedalkyl-2-
hydroxyalkyl-, polymer with alkylheteroatom-multialkylfunctionalised
carbomonocycleheteroatom and multiglycidylether difunctionalised
polyalkylene glycol (generic).
Sec. 721.11408 Benzenedicarboxylic acid, reaction products with
isobenzofurandione and diethylene glycol (generic).
Sec. 721.11409 Formaldehyde, polymer with N1-(2-aminoethyl)-
alkanediamine, 5-amino-1,3,3-trimethylcyclohexanemethanamine, 2-
(chloromethyl)oxirane, 4,4'-(1-methylethylidene)bis[phenol] and
.alpha.-hydro-.omega.-hydroxypoly(oxy-1,2-ethanediyl) (generic).
* * * * *
Sec. 721.11411 1-Butanol, reaction products with 2-[(2-propen-1-
yloxy)methyl]oxirane.
* * * * *
Sec. 721.11384 Organic acid, compds. with bisphenol A-
epichlorohydrin-polypropylene glycol diglycidyl ether polymer-
disubstituted amine-disubstituted polypropylene glycol reaction
products (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as organic
acid, compds. with bisphenol A-epichlorohydrin-polypropylene glycol
diglycidyl ether polymer-disubstituted amine-disubstituted
polypropylene glycol reaction products (PMN P-17-312) 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 substance in a
manner that results in the generation of a dust, mist, or aerosol.
(ii) Release to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4), and (c)(4), where N=78. When making the
computation of estimated surface water concentrations calculation under
Sec. 721.91 for this substance, you may subtract 90% from the highest
expected daily release if the substance is subject to primary and
secondary wastewater treatment as defined in 40 CFR part 133.
(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. 721.11385 Phenol, 4,4'-(1-methylethylidene)bis-, polymer with 2-
(chloromethyl)oxirane and .alpha.-(2-oxiranylmethyl)-.omega.-(2-
oxiranylmethoxy)poly[oxy(methyl-1,2-ethanediyl)], reaction products
with disubstituted amine and disubstituted polypropylene glycol,
organic acid salts (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as phenol,
4,4'-(1-methylethylidene)bis-, polymer with 2-(chloromethyl)oxirane and
.alpha.-(2-oxiranylmethyl)-.omega.-(2-oxiranylmethoxy)poly[oxy(methyl-
1,2-ethanediyl)], reaction products with disubstituted amine and
disubstituted polypropylene glycol, organic acid salts (PMN P-17-313)
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 substance in a
manner that results in the generation of a dust, mist, or aerosol.
(ii) Release to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4), and (c)(4), where N=78.
[[Page 38005]]
(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. 721.11386 Organic acid, 2-substituted-, compds. with bisphenol
A-epichlorohydrin-polypropylene glycol diglycidyl ether polymer-
disubstituted amine-disubstituted polypropylene glycol reaction
products (generic).
(a) Chemical substance and significant new uses subject to
reporting.
(1) The chemical substance identified generically as organic acid,
2-substituted-, compds. with bisphenol A-epichlorohydrin-polypropylene
glycol diglycidyl ether polymer-disubstituted amine-disubstituted
polypropylene glycol reaction products (PMN P-17-314) 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 substance in a
manner that results in the generation of a dust, mist, or aerosol.
(ii) Release to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4), and (c)(4), where N=78.
(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. 721.11387 Phenol, 4,4'-(1-methylethylidene)bis-, polymer with
.alpha.-(2-substituted-methylethyl)-.omega.-(2-substituted-
methylethoxy)poly[oxy(methyl-1,2-ethanediyl)], 2-(chloromethyl)oxirane
and .alpha.-(2-oxiranylmethyl)-.omega.-(2-
oxiranylmethoxy)poly[oxy(methyl-1,2-ethanediyl)], alkylphenyl ethers,
reaction products with disubstituted amine, organic acid salts
(generic).
(a) Chemical substance and significant new uses subject to
reporting.
(1) The chemical substance identified generically as phenol, 4,4'-
(1-methylethylidene)bis-, polymer with .alpha.-(2-substituted-
methylethyl)-.omega.-(2-substituted-methylethoxy)poly[oxy(methyl-1,2-
ethanediyl)], 2-(chloromethyl)oxirane and .alpha.-(2-
oxiranylmethyl)-.omega.-(2-oxiranylmethoxy)poly[oxy(methyl-1,2-
ethanediyl)], alkylphenyl ethers, reaction products with disubstituted
amine, organic acid salts (PMN P-17-315) 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 substance in a
manner that results in the generation of a dust, mist, or aerosol.
(ii) Release to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4), and (c)(4), where N = 78.
(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. 721.11388 Organic acid, compds. with bisphenol A-
epichlorohydrin-disubstituted polypropylene glycol-polypropylene glycol
diglycidyl ether polymer alkylphenyl ethers-disubstituted amine
reaction products (generic).
(a) Chemical substance and significant new uses subject to
reporting.
(1) The chemical substance identified generically as organic acid,
compds. with bisphenol A-epichlorohydrin-disubstituted polypropylene
glycol-polypropylene glycol diglycidyl ether polymer alkylphenyl
ethers-disubstituted amine reaction products (PMN P-17-316) 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 substance in a
manner that results in the generation of a dust, mist, or aerosol.
(ii) Release to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4), and (c)(4), where N=78.
(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. 721.11389 Organic acid, compds. with bisphenol A-
epichlorohydrin-polypropylene glycol diglycidyl ether polymer-
disubstituted polypropylene glycol reaction products (generic).
(a) Chemical substance and significant new uses subject to
reporting.
(1) The chemical substance identified generically as organic acid,
compds. with bisphenol A-epichlorohydrin-polypropylene glycol
diglycidyl ether polymer-disubstituted polypropylene glycol reaction
products (PMN P-17-317) 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 substance in a
manner that results in the generation of a dust, mist, or aerosol.
(ii) Release to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4), and (c)(4), where N=78.
(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. 721.11394 Phosphonic acid, dimethyl ester, polymer with alkyl
diols (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
phosphonic acid, dimethyl ester, polymer with alkyl diols (PMN P-18-9)
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
[[Page 38006]]
the substance in a manner that generates a dust, mist, or aerosol.
(ii) Release to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4), and (c)(4), where N=300.
(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. 721.11395 1H-Imidazole, 1,2,4,5-tetramethyl-.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as 1H-imidazole,
1,2,4,5-tetramethyl- (PMN P-18-11; CAS No. 1739-83-9) 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 (g).
(ii) Release to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4), and (c)(4), where N=7.
(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. 721.11396 1-Propanaminium, N,N'-(oxydi-2,1-ethanediyl)bis[3-
chloro-2-hydroxy-N,N-dimethyl-, chloride (1:2).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as 1-propanaminium,
N,N'-(oxydi-2,1-ethanediyl)bis[3-chloro-2-hydroxy-N,N-dimethyl-,
chloride (1:2) (PMN P-18-170; CAS No. 96320-92-2) 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. It is a
significant new use to manufacture, process, or use the substance in
any manner that results in inhalation exposures.
(ii) Release to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4), and (c)(4), where N=164.
(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. 721.11397 Fatty acid, polymer with alkanedioic acid dialkyl
ester, hydroxyl alkyl substituted alkanediol, substituted
carbomonocycle and alkylol substituted alkane (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as fatty
acid, polymer with alkanedioic acid dialkyl ester, hydroxyl alkyl
substituted alkanediol, substituted carbomonocycle and alkylol
substituted alkane (PMN P-18-185) 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).
(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. 721.11398 2,5-Furandione, polymer with ethenylbenzene, 4-
hydroxy-substituted butyl amide, polymers with epichlorohydrin and
trimethylolpropane, 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, polymers with epichlorohydrin and trimethylolpropane, sodium
salts (PMN P-18-190) 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 substance other than as a pigment
dispersing aid for pigments in inkjet printing inks.
(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 these substances.
(2) Limitation or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
Sec. 721.11399 2,5-Furandione, polymer with ethenylbenzene, 4-
hydroxy-substitutedbutyl [3-[2-[1-[[(substitutedphenyl)amino]carbonyl]-
2-oxopropyl]diazenyl]phenyl]methyl amide, polymers with epichlorohydrin
and trimethylolpropane, 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-substitutedbutyl [3-
[2-[1-[[(substitutedphenyl)amino]carbonyl]-2-
oxopropyl]diazenyl]phenyl]methyl amide, polymers with epichlorohydrin
and trimethylolpropane, sodium salts (PMN P-18-191) 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 substance other than as a pigment
dispersing aid for pigments in inkjet printing inks.
(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 these substances.
(2) Limitation or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
Sec. 721.11400 Alkane, bis(alkoxymethyl)-dimethyl- (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as alkane,
bis(alkoxymethyl)-dimethyl- (PMN P-18-223) is subject to reporting
under
[[Page 38007]]
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 the substance beyond the
confidential annual production volume specified in 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.
(3) Determining whether a specific use is subject to this section.
The provisions of Sec. 721.1725(b)(1) apply to paragraph (a)(2)(i) of
this section.
* * * * *
Sec. 721.11404 Butanedioic acid, 2-methylene-, polymer with 2-
methyl-2-[(1-oxo-2-propen-1-yl)amino]-1-propanesulfonic acid, sodium
zinc salt.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as butanedioic acid,
2-methylene-, polymer with 2-methyl-2-[(1-oxo-2-propen-1-yl)amino]-1-
propanesulfonic acid, sodium zinc salt (PMN P-18-285; CAS No. 2220235-
78-7) 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) Releases to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4), and (c)(4), where N=143.
(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. 721.11405 Heteromonocycle, alkenoic 1:1 salt, polymer with
.alpha.-(2-methyl-1-oxo-2-propen-1-yl)-.omega.-methoxypoly(oxy-1,2-
ethanediyl) and methyl-alkenoic acid (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
heteromonocycle, alkenoic 1:1 salt, polymer with .alpha.-(2-methyl-1-
oxo-2-propen-1-yl)-.omega.-methoxypoly(oxy-1,2-ethanediyl) and methyl-
alkenoic acid (PMN P-18-300) 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 substance in a
manner that results in particles less than 50 microns. It is a
significant new use to use the substance in a manner that results in
consumer inhalation or dermal exposure. It is a significant new use to
use the substance other than as sealed single-use packets.
(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. 721.11406 Substituted benzylic ether polyethylene glycol alkyl
ether derivative (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
substituted benzylic ether polyethylene glycol alkyl ether derivative
(PMN P-18-394) 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) Release to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4), and (c)(4), where N=4.
(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. 721.11407 Alkylmultiheteroatom, 2-functionalisedalkyl-2-
hydroxyalkyl-, polymer with alkylheteroatom-multialkylfunctionalised
carbomonocycleheteroatom and multiglycidylether difunctionalised
polyalkylene glycol (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
alkylmultiheteroatom, 2-functionalisedalkyl-2-hydroxyalkyl-, polymer
with alkylheteroatom-multialkylfunctionalised carbomonocycleheteroatom
and multiglycidylether difunctionalised polyalkylene glycol (PMN P-18-
404) 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 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. 721.11408 Benzenedicarboxylic acid, reaction products with
isobenzofurandione and diethylene glycol (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
benzenedicarboxylic acid, reaction products with isobenzofurandione and
diethylene glycol (PMN P-19-12) 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 substance in
any manner that results in inhalation exposure.
(ii) [Reserved]
(b) Specific requirements. The provisions of subpart A of this part
[[Page 38008]]
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. 721.11409 Formaldehyde, polymer with N1-(2-aminoethyl)-
alkanediamine, 5-amino-1,3,3-trimethylcyclohexanemethanamine, 2-
(chloromethyl)oxirane, 4,4'-(1-methylethylidene)bis[phenol] and
.alpha.-hydro-.omega.-hydroxypoly(oxy-1,2-ethanediyl) (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
formaldehyde, polymer with N1-(2-aminoethyl)-alkanediamine, 5-amino-
1,3,3-trimethylcyclohexanemethanamine, 2-(chloromethyl)oxirane, 4,4'-
(1-methylethylidene)bis[phenol] and .alpha.-hydro-.omega.-
hydroxypoly(oxy-1,2-ethanediyl) (PMN P-19-31) 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 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=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. 721.11411 1-Butanol, reaction products with 2-[(2-propen-1-
yloxy)methyl]oxirane.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as 1-butanol, reaction
products with 2-[(2-propen-1-yloxy)methyl]oxirane (PMN P-19-72) is
subject to reporting under this section for the significant new uses
described in paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(j).
(ii) [Reserved]
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (c) and (i) are applicable to manufacturers and
processors of this substance.
(2) Limitation or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
(3) Determining whether a specific use is subject to this section.
The provisions of Sec. 721.1725(b)(1) apply to paragraph (a)(2)(i) of
this section.
* * * * *
[FR Doc. 2022-13338 Filed 6-24-22; 8:45 am]
BILLING CODE 6560-50-P
</pre><script data-cfasync="false" src="/cdn-cgi/scripts/5c5dd728/cloudflare-static/email-decode.min.js"></script></body>
</html>Indexed from Federal Register on June 27, 2022.
This is legal information, not legal advice. Laws vary by jurisdiction and change frequently. Always verify current law with official sources and consult a licensed attorney in your jurisdiction for advice on your specific situation.