Rule2021-17388
Significant New Use Rules on Certain Chemical Substances (19-2.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
August 18, 2021
Effective
October 18, 2021
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
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<title>Federal Register, Volume 86 Issue 157 (Wednesday, August 18, 2021)</title>
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[Federal Register Volume 86, Number 157 (Wednesday, August 18, 2021)]
[Rules and Regulations]
[Pages 46123-46133]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2021-17388]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Parts 9 and 721
[EPA-HQ-OPPT-2019-0359; FRL-7486-01-OCSPP]
RIN 2070-AB27
Significant New Use Rules on Certain Chemical Substances (19-2.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 October 18, 2021. For purposes of
judicial review, this rule shall be promulgated at 1 p.m. (e.s.t.) on
September 1, 2021.
FOR FURTHER INFORMATION CONTACT:
For technical information contact: William Wysong, New Chemicals
Division (7405M), Office of Pollution Prevention and Toxics,
Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington,
DC 20460-0001; telephone number: (202) 564-4163; email address:
<a href="/cdn-cgi/l/email-protection#ec9b959f83828bc29b858080858d81ac899c8dc28b839a"><span class="__cf_email__" data-cfemail="592e202a36373e772e303535303834193c2938773e362f">[email protected]</span></a>.
For general information contact: The TSCA-Hotline, ABVI-Goodwill,
422 South Clinton Ave., Rochester, NY
[[Page 46124]]
14620; telephone number: (202) 554-1404; email address: <a href="/cdn-cgi/l/email-protection#21757262600c694e554d484f44614451400f464e57"><span class="__cf_email__" data-cfemail="a2f6f1e1e38feacdd6cecbccc7e2c7d2c38cc5cdd4">[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. The EPA policy in 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-2019-0359,
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>.
Due to the public health emergency, the EPA Docket Center (EPA/DC)
and Reading Room is closed to visitors with limited exceptions. The
staff continues to provide remote customer service via email, phone,
and webform. For the latest status information on EPA/DC services and
docket access, visit <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-16-400, P-17-119, P-17-191,
P-17-220, P-17-387, P-17-388, P-18-7, P-18-8, P-18-77, P-18-85, P-18-
101, P-18-107, P-18-118, P-18-119, P-18-152, P-18-169, P-18-238, P-18-
307, P-18-312, P-19-8, P-19-9, P-19-26, P-19-27, and P-19-45. 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 August 6, 2019 (84 FR 38159)
(FRL-9996-62), EPA proposed SNURs for the chemical substances being
finalized in this Federal Register document, in addition to proposing
SNURs for other chemical substances, which will be addressed in a
subsequent Federal Register document. 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.
[[Page 46125]]
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 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.
EPA made changes to two of the proposed rules based on these comments,
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 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 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:
<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
[[Page 46126]]
unlikely that any of the significant new uses described in the
regulatory text of this rule are ongoing.
EPA designated August 6, 2019 (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 <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
[[Page 46127]]
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)
In addition, 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: August 9, 2021.
Tala Henry,
Deputy Director, Office of Pollution Prevention and Toxics.
Therefore, for the reasons stated in the preamble, 40 CFR chapter I
is amended as follows:
PART 9--OMB APPROVALS UNDER THE PAPERWORK REDUCTION ACT
0
1. The authority citation for part 9 continues to read as follows:
Authority: 7 U.S.C. 135 et seq., 136-136y; 15 U.S.C. 2001, 2003,
2005, 2006, 2601-2671; 21 U.S.C. 331j, 346a; 31 U.S.C. 9701; 33
U.S.C. 1251 et seq., 1311, 1313d, 1314, 1318, 1321, 1326, 1330,
1342, 1344, 1345 (d) and (e), 1361; E.O. 11735, 38 FR 21243, 3 CFR,
1971-1975 Comp. p. 973; 42 U.S.C. 241, 242b, 243, 246, 300f, 300g,
300g-1, 300g-2, 300g-3, 300g-4, 300g-5, 300g-6, 300j-1, 300j-2,
300j-3, 300j-4, 300j-9, 1857 et seq., 6901-6992k, 7401-7671q, 7542,
9601-9657, 11023, 11048.
0
2. In Sec. 9.1, amend the table by adding entries for Sec. Sec.
721.11300 through 721.11304, 721.11306, 721.11307, 721.11309 through
721.11314, 721.11317, 721.11318, and 721.11322 through 721.11329 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
------------------------------------------------------------------------
* * * * *
721.11300............................................... 2070-0012
[[Page 46128]]
721.11301............................................... 2070-0012
721.11302............................................... 2070-0012
721.11303............................................... 2070-0012
721.11304............................................... 2070-0012
* * * * *
721.11306............................................... 2070-0012
721.11307............................................... 2070-0012
* * * * *
721.11309............................................... 2070-0012
721.11310............................................... 2070-0012
721.11311............................................... 2070-0012
721.11312............................................... 2070-0012
721.11313............................................... 2070-0012
721.11314............................................... 2070-0012
* * * * *
721.11317............................................... 2070-0012
721.11318............................................... 2070-0012
* * * * *
721.11322............................................... 2070-0012
721.11323............................................... 2070-0012
721.11324............................................... 2070-0012
721.11325............................................... 2070-0012
721.11326............................................... 2070-0012
721.11327............................................... 2070-0012
721.11328............................................... 2070-0012
721.11329............................................... 2070-0012
* * * * *
------------------------------------------------------------------------
* * * * *
PART 721--SIGNIFICANT NEW USES OF CHEMICAL SUBSTANCES
0
3. The authority citation for part 721 continues to read as follows:
Authority: 15 U.S.C. 2604, 2607, and 2625(c).
Subpart E--Significant New Uses for Specific Chemical Substances
0
4. Add Sec. Sec. 721.11300 through 721.11304 to read as follows:
Sec.
* * * * *
721.11300 Alkanes, C11-16-branched and linear.
721.11301 Alkyl alkenoic acid, alkoxyalkyl ester, polymer with alkyl
alkenoate, alkyl alkyl alkenoate and tris alkyl silyl alkyl
alkenoate (generic).
721.11302 Alkyldiamine, aminoalkyl dimethylaminoalkyl dimethyl-,
reaction products with propylene oxide (generic).
721.11303 2-oxepanone, reaction products with alkylenediamine-
alkyleneimine polymer, 2-[[(2-alkyl)oxy]alkyl]oxirane and
tetrahydro-2H-pyran-2-one (generic).
721.11304 Dicarboxylic acids, polymers with alkanoic acid,
alkanediol, substituted-alkylalkanoic acid, substituted alkyl
carbomonocycle, alkanedioic acid and alkanediol, alkanolamine
blocked, compds. with alkanolamine (generic).
* * * * *
Sec. 721.11300 Alkanes, C11-16-branched and linear.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as alkanes, C11-16-
branched and linear (PMN P-16-400; CAS No. 1809170-78-2) 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 use the
substance other than as a chemical intermediate, in cured coatings,
cleaning fluids, metalworking fluids/rolling oils, and in
agrochemicals.
(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. 721.11301 Alkyl alkenoic acid, alkoxyalkyl ester, polymer with
alkyl alkenoate, alkyl alkyl alkenoate and tris alkyl silyl alkyl
alkenoate (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as alkyl
alkenoic acid, alkoxyalkyl ester, polymer with alkyl alkenoate, alkyl
alkyl alkenoate and tris alkyl silyl alkyl alkenoate (PMN P-17-119) 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 use the
substance other than as a chemical intermediate, in cured coatings,
cleaning fluids, metalworking fluids/rolling oils, and in
agrochemicals.
(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. 721.11301 Alkyl alkenoic acid, alkoxyalkyl ester, polymer with
alkyl alkenoate, alkyl alkyl alkenoate and tris alkyl silyl alkyl
alkenoate (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as alkyl
alkenoic acid, alkoxyalkyl ester, polymer with alkyl alkenoate, alkyl
alkyl alkenoate and tris alkyl silyl alkyl alkenoate (PMN P-17-119) 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). It is a significant new use to
manufacture, process, or use the PMN substance in any manner that
results in inhalation exposures.
(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. 721.11302 Alkyldiamine, aminoalkyl dimethylaminoalkyl dimethyl-
, reaction products with propylene oxide (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
alkyldiamine, aminoalkyl dimethylaminoalkyl dimethyl-, reaction
products with propylene oxide (PMN P-17-191) 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 manufacture, process, or use the PMN substance
in any manner that generates a spray, mist, or aerosol.
(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
[[Page 46129]]
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. 721.11303 2-oxepanone, reaction products with alkylenediamine-
alkyleneimine polymer, 2-[[(2-alkyl)oxy]alkyl]oxirane and tetrahydro-
2H-pyran-2-one (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as 2-
oxepanone, reaction products with alkylenediamine-alkyleneimine
polymer, 2-[[(2-alkyl)oxy]alkyl]oxirane and tetrahydro-2H-pyran-2-one
(PMN P-17-220) 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). It is a significant new use to
manufacture or import the PMN substance other than in liquid form.
(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. 721.11304 Dicarboxylic acids, polymers with alkanoic acid,
alkanediol, substituted-alkylalkanoic acid, substituted alkyl
carbomonocycle, alkanedioic acid and alkanediol, alkanolamine blocked,
compds. with alkanolamine (generic).
(a) Chemical substances and significant new uses subject to
reporting. (1) The chemical substances identified generically as
dicarboxylic acids, polymers with alkanoic acid, alkanediol,
substituted-alkylalkanoic acid, substituted alkyl carbomonocycle,
alkanedioic acid and alkanediol, alkanolamine blocked, compds. with
alkanolamine (PMNs P-17-387 and P-17-388) are 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 substances
such that the proportion of amine counterions is greater than 4% by
weight, isocyanate residuals are present at greater than 0.1% by
weight, or the proportion of the acid group is greater than 20% by
weight. It is a significant new use to manufacture, process, or use the
PMN substances such that the average molecular weight is less than the
confidential molecular weight specified in the PMNs, or such that the
proportion of the low molecular weight species is greater than the
confidential values specified in the PMNs for the 500 and 1000 Dalton
species.
(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.
(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.
0
5. Add Sec. 721.11306 to read as follows:
Sec. 721.11306 Glycerides, soya mono- and di-, epoxidized, acetates.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as glycerides, soya
mono- and di-, epoxidized, acetates (PMN P-18-7; CAS No. 2097734-14-8)
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 generates a dust containing the substance. It is a
significant new use to manufacture or process the substance at greater
than 20% by weight in consumer products.
(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.
0
6. Add Sec. 721.11307 to read as follows:
Sec. 721.11307 Glycerides, C16-18 and C18-unsatd. mono- and di-,
epoxidized, acetates.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as glycerides, C16-18
and C18-unsatd. mono- and di-, epoxidized, acetates (PMN P-18-8; CAS
No. 2097734-15-9) 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 the substance in
any manner that generates a dust containing the substance. It is a
significant new use to manufacture or process the substance at greater
than 20% by weight in consumer products.
(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.
0
7. Add Sec. Sec. 721.11309 through 721.11314 to read as follows:
Sec.
* * * * *
721.11309 Urea, reaction products with N-butylphosphorothioic
triamide and formaldehyde.
721.11310 Fatty acids reaction products with ethyleneamines and
dialkyl ester (generic).
721.11311 Pentaerythritol, mixed esters with linear and branched
fatty acids (generic).
721.11312 Alcohol capped polycarbodiimide from
diethyldiisocyanatobenzene (generic).
721.11313 Oxirane, 2-methyl-, polymer with methoxirane homopolymer,
1,1'-methylenebis[4-isocyanatobenzene], and glycerolpropylene oxide
polymer (generic).
721.11314 Oxirane, 2-methyl-, polymer with methoxirane homopolymer,
1,1'-methylenebis[isocyanatobenzene], and glycerol-propylene oxide
polymer (generic).
* * * * *
[[Page 46130]]
Sec. 721.11309 Urea, reaction products with N-butylphosphorothioic
triamide and formaldehyde.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as urea, reaction
products with N-butylphosphorothioic triamide and formaldehyde (PMN P-
18-77; CAS No. 2093385-47-6) 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 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 (f) 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. 721.11310 Fatty acids reaction products with ethyleneamines and
dialkyl ester (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as fatty
acids reaction products with ethyleneamines and dialkyl ester (PMN P-
18-85) is subject to reporting under this section for the significant
new use 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
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. 721.11311 Pentaerythritol, mixed esters with linear and branched
fatty acids (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
pentaerythritol, mixed esters with linear and branched fatty acids (PMN
P-18-101) 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. 721.11312 Alcohol capped polycarbodiimide from
diethyldiisocyanatobenzene (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as alcohol
capped polycarbodiimide from diethyldiisocyanatobenzene (PMN P-18-107)
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 the substance to contain greater
than 0.1% residual isocyanate by weight.
(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. 721.11313 Oxirane, 2-methyl-, polymer with methoxirane
homopolymer, 1,1'-methylenebis[4-isocyanatobenzene], and
glycerolpropylene oxide polymer (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
oxirane, 2-methyl-, polymer with methoxirane homopolymer, 1,1'-
methylenebis[4-isocyanatobenzene], and glycerolpropylene oxide polymer
(PMN P-18-118) 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 substance in any manner that results
in inhalation exposure. It is a significant new use to manufacture,
process, or use the substance with greater than 0.1% residual
isocyanate by weight.
(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. 721.11314 Oxirane, 2-methyl-, polymer with methoxirane
homopolymer, 1,1'-methylenebis[isocyanatobenzene], and glycerol-
propylene oxide polymer (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
oxirane, 2-methyl-, polymer with methoxirane homopolymer, 1,1'-
methylenebis[isocyanatobenzene], and glycerol-propylene oxide polymer
(PMN P-18-119) 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 substance in any manner that results
in inhalation exposures. It is a significant new use to manufacture,
process, or use the substance with greater than 0.1% residual
isocyanate by weight.
[[Page 46131]]
(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.
0
8. Add Sec. 721.11317 to read as follows:
Sec. 721.11317 Hydrolyzed functionalized di-amino silanol polymer
(generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
hydrolyzed functionalized di-amino silanol polymer (PMN P-18-52) 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=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.
0
9. Add Sec. 721.11318 to read as follows:
Sec. 721.11318 Propanoic acid, 3-hydroxy-2-(hydroxymethyl)-2-methyl-,
polymer with dimethyl carbonate, 1,6-hexanediol, diamine and 1,1'-
methylenebis[4-isocyanatocyclohexane], pentaerythritol triacrylate-
blocked, compds. with triethylamine (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
propanoic acid, 3-hydroxy-2-(hydroxymethyl)-2-methyl-, polymer with
dimethyl carbonate, 1,6-hexanediol, diamine and 1,1'-methylenebis[4-
isocyanatocyclohexane], pentaerythritol triacrylate-blocked, compds.
with triethylamine (PMN P-18-169) is subject to reporting under this
section for the significant new uses described in paragraph (a)(2) of
this section.
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(2)(i) and (a)(3) through (5). When determining which persons
are reasonably likely to be exposed as required for Sec. 721.63(a)(1)
and (4), engineering control measures (e.g., enclosure or confinement
of the operation, general and local ventilation) or administrative
control measures (e.g., workplace policies and procedures) shall be
considered and implemented to prevent exposure, where feasible. For
purposes of Sec. 721.63(a)(5), respirators must provide a National
Institute for Occupational Safety and Health (NIOSH) assigned
protection factor (APF) of at least 50, or at least 1000 if the
substance is spray-applied.
(ii) Industrial, commercial, and consumer activities. It is a
significant new use to manufacture (including import) the PMN substance
with a triethylamine concentration greater than the confidential
concentration stated in the PMN.
(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 (e) 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)(ii) of
this section.
0
10. Add Sec. Sec. 721.11322 through 721.11329 to read as follows:
Sec.
* * * * *
721.11322 Saccharide reaction products with acid anhydride,
etherified (generic).
721.11323 Alkyl alkenoic acid, alkyl ester, telomer with alkyl
alkenoate, substituted alkyl alkyl alkenoate, alkylthiol,
substituted carbomonocycle, hydroxyalkyl alkyl alkenoate and alkyl
alkyl alkenoate (generic).
721.11324 Formaldehyde, polymer with 2-phenoxyalkanol and .alpha.-
phenyl-.omega.-hydroxypoly(oxy-1,2-alkylenediyl), dihydrogen
phosphate 2-phenoxyalkyl hydrogen phosphate, alkaline salt
(generic).
721.11325 Substituted polyalkylenepolycarbomonocycle ester, polymer
with dialkanolamine, [(hydroxyalkoxy)carbonyl] derivs.,
(alkoxyalkoxy)alkanol-blocked (generic).
721.11326 Carbomonocycles, polymer with haloalkyl-substituted
heteromonocycle and hydro-hydroxypoly[oxy(alkyl-alkanediyl)],
dialkyl-alkanediamine-terminated, hydroxyalkylated acetates (salts)
(generic).
721.11327 Alkanoic acid, compds. with substituted carbomonocycle-
dialkyl-alkanediamine-halosubstitued heteromonocycle-polyalkylene
glycol polymer dialkanolamine reaction products (generic).
721.11328 Substituted carbomoncycle, polymer with haloalkyl
substituted heteromonocycle, dialkyl-alkanediamine and hydro-
hydroxypoly[oxy(alkylalkanediyl)], reaction products with metal
oxide and dialkanolamine, acetates (salts) (generic).
721.11329 Non-metal tetrakis (hydroxyalkyl)-, halide, polymer with
amide oxidized (generic).
Sec. 721.11322 Saccharide reaction products with acid anhydride,
etherified (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
saccharide reaction products with acid anhydride, etherified (PMN P-18-
238) 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
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. 721.11323 Alkyl alkenoic acid, alkyl ester, telomer with alkyl
alkenoate, substituted alkyl alkyl alkenoate, alkylthiol, substituted
carbomonocycle, hydroxyalkyl alkyl alkenoate and alkyl alkyl alkenoate
(generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as alkyl
alkenoic acid, alkyl ester, telomer with alkyl alkenoate, substituted
alkyl alkyl alkenoate, alkylthiol, substituted carbomonocycle,
hydroxyalkyl alkyl alkenoate and alkyl alkyl alkenoate (PMN P-18-307)
is subject to reporting under this section
[[Page 46132]]
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 (including import) the PMN substance
such that the weight percent of low molecular weight species below 1000
Daltons is greater than 5%.
(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. 721.11324 Formaldehyde, polymer with 2-phenoxyalkanol and
.alpha.-phenyl-.omega.-hydroxypoly(oxy-1,2-alkylenediyl), dihydrogen
phosphate 2-phenoxyalkyl hydrogen phosphate, alkaline salt (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
formaldehyde, polymer with 2-phenoxyalkanol and .alpha.-phenyl-.omega.-
hydroxypoly(oxy-1,2-alkylenediyl), dihydrogen phosphate 2-phenoxyalkyl
hydrogen phosphate, alkaline salt (PMN P-18-312) 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
any manner that results in inhalation exposure. It is a significant new
use to manufacture the PMN substance such that the weight percent of
low molecular weight species below 500 Daltons is greater than 20%.
(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. 721.11325 Substituted polyalkylenepolycarbomonocycle ester,
polymer with dialkanolamine, [(hydroxyalkoxy)carbonyl] derivs.,
(alkoxyalkoxy)alkanol-blocked (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
substituted polyalkylenepolycarbomonocycle ester, polymer with
dialkanolamine, [(hydroxyalkoxy)carbonyl] derivs.,
(alkoxyalkoxy)alkanol-blocked (PMN P-19-8) 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(w)(1) and (2), (x)(1) and (2), and (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. 721.11326 Carbomonocycles, polymer with haloalkyl-substituted
heteromonocycle and hydro-hydroxypoly[oxy(alkyl-alkanediyl)], dialkyl-
alkanediamine-terminated, hydroxyalkylated acetates (salts) (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
carbomonocycles, polymer with haloalkyl-substituted heteromonocycle and
hydro-hydroxypoly[oxy(alkyl-alkanediyl)], dialkyl-alkanediamine-
terminated, hydroxyalkylated acetates (salts) (PMN P-19-9) 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 the substance in
any manner that results in inhalation exposure to vapor, particulate,
mist, or aerosols. It is a significant new use to manufacture the PMN
substance beyond an annual production volume of 85,000 kg.
(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. 721.11327 Alkanoic acid, compds. with substituted
carbomonocycle-dialkyl-alkanediamine-halosubstitued heteromonocycle-
polyalkylene glycol polymer dialkanolamine reaction products (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
alkanoic acid, compds. with substituted carbomonocycle-dialkyl-
alkanediamine-halosubstitued heteromonocycle-polyalkylene glycol
polymer dialkanolamine reaction products (PMN P-19-26) 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 to vapor, particulate,
mist, or aerosols.
(ii) Release to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4), and (c)(4) where N=15.
(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. 721.11328 Substituted carbomoncycle, polymer with haloalkyl
substituted heteromonocycle, dialkyl-alkanediamine and hydro-
hydroxypoly[oxy(alkylalkanediyl)], reaction products with metal oxide
and dialkanolamine, acetates (salts) (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
substituted carbomoncycle, polymer with haloalkyl substituted
heteromonocycle, dialkyl-alkanediamine and hydro-hydroxypoly
[oxy(alkylalkanediyl)], reaction products with metal oxide and
[[Page 46133]]
dialkanolamine, acetates (salts) (PMN P-19-27) 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 to vapor,
particulate, mist, or aerosols. It is a significant new use to
manufacture the PMN substance beyond an annual production volume of
95,600 kg.
(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. 721.11329 Non-metal tetrakis (hydroxyalkyl)-, halide, polymer
with amide oxidized (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as non-
metal tetrakis (hydroxyalkyl)-, halide, polymer with amide oxidized
(PMN P-19-45) 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 substance in any manner that results
in inhalation exposure. It is a significant new use to manufacture the
substance to contain greater than 0.1% residual unbound formaldehyde by
weight.
(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. 2021-17388 Filed 8-17-21; 8:45 am]
BILLING CODE 6560-50-P
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