Rule2022-25807
Significant New Use Rules on Certain Chemical Substances (21-1.5e)
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
December 2, 2022
Effective
January 31, 2023
Issuing agencies
Environmental Protection Agency
Abstract
EPA is issuing significant new use rules (SNURs) under the Toxic Substances Control Act (TSCA) for chemical substances that were the subject of premanufacture notices (PMNs) and a Microbial Commercial Activity Notice (MCAN). The SNURs require persons who intend to manufacture (defined by statute to include import) or process any of these chemical substances for an activity that is designated as a significant new use by this rule to notify EPA at least 90 days before commencing that activity. The required notification initiates EPA's evaluation of the use, under the conditions of use for that chemical substance, within the applicable review period. Persons may not commence manufacture or processing for the significant new use until EPA has conducted a review of the notice, made an appropriate determination on the notice, and has taken such actions as are required by that determination.
Full Text
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<title>Federal Register, Volume 87 Issue 231 (Friday, December 2, 2022)</title>
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[Federal Register Volume 87, Number 231 (Friday, December 2, 2022)]
[Rules and Regulations]
[Pages 73941-73955]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2022-25807]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Parts 9, 721, and 725
[EPA-HQ-OPPT-2020-0588; FRL-8582-01-OCSPP]
RIN 2070-AB27
Significant New Use Rules on Certain Chemical Substances (21-
1.5e)
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: EPA is issuing significant new use rules (SNURs) under the
Toxic Substances Control Act (TSCA) for chemical substances that were
the subject of premanufacture notices (PMNs) and a Microbial Commercial
Activity Notice (MCAN). The SNURs require persons who intend to
manufacture (defined by statute to include import) or process any of
these chemical substances for an activity that is designated as a
significant new use by this rule to notify EPA at least 90 days before
commencing that activity. The required notification initiates EPA's
evaluation of the use, under the conditions of use for that chemical
substance, within the applicable review period. Persons may not
commence manufacture or processing for the significant new use until
EPA has conducted a review of the notice, made an appropriate
determination on the
[[Page 73942]]
notice, and has taken such actions as are required by that
determination.
DATES: This rule is effective on January 31, 2023. For purposes of
judicial review, this rule shall be promulgated at 1 p.m. (e.s.t.) on
December 16, 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#6d1a141e02030a431a040101040c002d081d0c430a021b"><span class="__cf_email__" data-cfemail="1b6c626874757c356c727777727a765b7e6b7a357c746d">[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#92c6c1d1d3bfdafde6fefbfcf7d2f7e2f3bcf5fde4"><span class="__cf_email__" data-cfemail="3c686f7f7d11745348505552597c594c5d125b534a">[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 promulgated at 19 CFR 12.118 through 12.127 and 19 CFR
127.28. Chemical importers must certify that the shipment of the
chemical substance complies with all applicable rules and Orders under
TSCA, which would include the SNUR requirements. The EPA policy in
support of import certification appears at 40 CFR part 707, subpart B.
In addition, any persons who export or intend to export a chemical
substance that is the subject of this rule are subject to the export
notification provisions of TSCA section 12(b) (15 U.S.C. 2611(b)) (see
40 CFR 721.20 or 40 CFR 725.920 for the microorganism), and must comply
with the export notification requirements in 40 CFR part 707, subpart
D.
B. How can I access the dockets?
The dockets include information considered by the Agency in
developing the proposed and final rules. The docket for this action,
identified by docket identification (ID) number EPA-HQ-OPPT-2020-0588,
is available online at <a href="https://www.regulations.gov">https://www.regulations.gov</a> and in-person at the
Office of Pollution Prevention and Toxics Docket (OPPT Docket),
Environmental Protection Agency Docket Center (EPA/DC), West William
Jefferson Clinton Bldg., Rm. 3334, 1301 Constitution Ave. NW,
Washington, DC. The Public Reading Room is open from 8:30 a.m. to 4:30
p.m., Monday through Friday, excluding legal holidays. The telephone
number for the Public Reading Room is (202) 566-1744, and the telephone
number for the OPPT Docket is (202) 566-0280. Additional instructions
on commenting and visiting the docket, along with more information
about dockets generally, is 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 certain
chemical substances which were the subject of PMNs and an MCAN.
Previously, in the Federal Register of June 11, 2021 (86 FR 31239)
(FRL-10022-56), EPA proposed SNURs for these chemical substances and
established the record for these SNURs in the docket under docket ID
number EPA-HQ-OPPT-2020-0588. That docket includes information
considered by the Agency in developing the proposed and final rules,
including public comments and EPA's responses to the public comments
received.
B. What is the Agency's authority for taking this action?
TSCA section 5(a)(2) (15 U.S.C. 2604(a)(2)) authorizes EPA to
determine that a use of a chemical substance is a ``significant new
use.'' EPA must make this determination by rule after considering all
relevant factors, including the four bulleted TSCA section 5(a)(2)
factors listed in Unit III.
C. Applicability of General Provisions
General provisions for SNURs appear in 40 CFR part 721, subpart A.
These provisions describe persons subject to the rule, recordkeeping
requirements, exemptions to reporting requirements, and applicability
of the rule to uses occurring before the effective date of the rule.
Provisions relating to user fees appear at 40 CFR part 700. Pursuant to
40 CFR 721.1(c), persons subject to these SNURs must comply with the
significant new use notice (SNUN) requirements and EPA regulatory
procedures as submitters of PMNs under TSCA section 5(a)(1)(A). in
particular, these requirements include the information submission
requirements of TSCA sections 5(b) and 5(d)(1), the exemptions
authorized by TSCA sections 5(h)(1), (h)(2), (h)(3), and (h)(5), and
the regulations at 40 CFR part 720. Once EPA receives a SNUN and before
the manufacture or processing for the significant new use can commence,
EPA must either determine that the significant new use is not likely to
present an unreasonable risk of injury or take such regulatory action
as is associated with an alternative determination. If EPA determines
that the significant new use is not likely to present an unreasonable
risk, EPA is required under TSCA section 5(g) to make public, and
submit for publication in the Federal Register, a statement of EPA's
findings.
III. Significant New Use Determination
A. Considerations for Significant New Use Determinations
When the Agency issues an order under TSCA section 5(e), section
5(f)(4) requires that the Agency consider whether to promulgate a SNUR
for any use not conforming to the restrictions of the TSCA Order or
publish a statement describing the reasons for not initiating the
rulemaking. TSCA section 5(a)(2) states that EPA's determination that a
use of a chemical substance is a significant new use must be made after
consideration of all relevant factors, including:
<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 possible uses of these chemical substances, in the
context of the four
[[Page 73943]]
bulleted TSCA section 5(a)(2) factors listed in this unit.
B. Procedures for Significant New Uses Claimed as CBI
By this rule, EPA is establishing certain significant new uses
which have been claimed as CBI subject to Agency confidentiality
regulations at 40 CFR part 2 and 40 CFR part 720, subpart E. Absent a
final determination or other disposition of the confidentiality claim
under 40 CFR part 2 procedures, EPA is required to keep this
information confidential. When this rule was proposed on June 11, 2021
(86 FR 31239) (FRL-10022-56), EPA cross referenced 40 CFR
721.1725(b)(1), the procedures to deal with the situation where a
specific significant new use is CBI, in order to apply it other SNURs
where certain significant new uses have been claimed as CBI. Since the
proposed rule, however, EPA has finalized amendments to 40 CFR 721.11
(87 FR 39756, July 5, 2022), which now provides a means by which bona
fide submitters can determine whether their substance is subject to the
SNUR and for EPA to disclose the confidential significant new use
designations to a manufacturer or processor who has established a bona
fide intent to manufacture or process a particular chemical substance.
As such, EPA has removed the proposed references to 40 CFR
721.1725(b)(1) for SNURs that certain significant new uses have been
claimed as CBI because the procedure in 40 CFR 721.11 now applies to
all SNURs containing any CBI, including the significant new use.
Under these procedures a manufacturer or processor may request EPA
to determine whether a specific use would be a significant new use
under the rule. The manufacturer or processor must show that it has a
bona fide intent to manufacture or process the chemical substance and
must identify the specific use for which it intends to manufacture or
process the chemical substance. If EPA concludes that the person has
shown a bona fide intent to manufacture or process the chemical
substance, EPA will tell the person whether the use identified in the
bona fide submission would be a significant new use under the rule.
Since most of the chemical identities of the chemical substances
subject to these SNURs are also CBI, manufacturers and processors can
combine the bona fide submission under the procedure in 40 CFR 721.11
into a single step to identify if a chemical substance is subject to
part 721 and if a specific use would be a significant new use under the
rule.
IV. Public Comments on Proposed Rule and EPA Responses
EPA received public comments from three identifying entities on the
proposed rules. The Agency's responses are presented in the Response to
Public Comments document that is available in the public docket for
this rulemaking. EPA made a change to one of the proposed rules as
described in the response to comments.
EPA made additional changes to the proposed rules because it
inadvertently proposed incorrect terms in several SNURs. The revised
language better reflects the language used in the underlying TSCA
Orders for these chemical substances and these changes make the SNUR
requirements consistent with those TSCA Orders. EPA received no
comments on these requirements. For the SNURs for P-18-327 at
721.11588, P-18-218 at 721.11581, P-18-217 at 721.11580, and P-18-178
at 721.11579, EPA changed the language in paragraph (a)(1) exempting
SNUR requirements from ``completely reacted (cured)'' to ``completely
entrained,'' which more accurately reflects the exemption language in
the underlying TSCA Orders. For the SNURs for P-16-424 at 721.11574 and
P-20-42 at 721.11601, EPA removed the proposed reporting requirement
specified at 721.72(g)(2)(iv). This would have required the inclusion
of the term ``use respiratory protection'' in hazard communication
materials; however, this requirement was not in the underlying TSCA
Orders for these two chemical substances. For the SNUR for P-20-42 at
721.11601, EPA added the reporting requirement specified at 721.72(f).
This allows persons subject to the SNUR to use any existing hazard
communication program that meets the requirements of the SNUR. The
underlying TSCA Order for this chemical substance contains this
requirement.
V. Substances Subject to This Rule
EPA is establishing significant new use and recordkeeping
requirements for chemical substances in 40 CFR part 721, subpart E. In
Unit IV. of the proposed SNURs, EPA provided the following information
for each chemical substance:
<bullet> PMN number.
<bullet> Chemical name (generic name, if the specific name is
claimed as confidential business information (CBI)).
<bullet> Chemical Abstracts Service (CAS) Registry number (if
assigned for non-confidential chemical identities).
<bullet> Effective date of and basis for the TSCA Order.
<bullet> Potentially Useful Information. This is information
identified by EPA that would help characterize the potential health
and/or environmental effects of the chemical substances if a
manufacturer or processor is considering submitting a SNUN for a
significant new use designated by the SNUR.
<bullet> CFR citation assigned in the regulatory text section of
these rules.
The regulatory text section of these rules specifies the activities
designated as significant new uses. Certain new uses, including
production volume limits and other uses designated in the rules, may be
claimed as CBI.
These final rules include PMN substances that are subject to orders
issued under TSCA section 5(e)(1)(A), as required by the determinations
made under TSCA section 5(a)(3)(B). Those TSCA Orders require
protective measures to limit exposures or otherwise mitigate the
potential unreasonable risk. The final SNURs identify as significant
new uses any manufacturing, processing, use, distribution in commerce,
or disposal that does not conform to the restrictions imposed by the
underlying TSCA Orders, consistent with TSCA section 5(f)(4).
Where EPA determined that the PMN substance may present an
unreasonable risk of injury to human health via inhalation exposure,
the underlying TSCA Order usually requires that potentially exposed
employees wear specified respirators unless actual measurements of the
workplace air show that air-borne concentrations of the PMN substance
are below a New Chemical Exposure Limit (NCEL). The comprehensive NCELs
provisions in TSCA Orders include requirements addressing performance
criteria for sampling and analytical methods, periodic monitoring,
respiratory protection, and recordkeeping. No comparable NCEL
provisions currently exist in 40 CFR part 721, subpart B, for SNURs.
Therefore, for these cases, the individual SNURs in 40 CFR part 721,
subpart E, will state that persons subject to the SNUR who wish to
pursue NCELs as an alternative to the 40 CFR 721.63 respirator
requirements may request to do so under 40 CFR 721.30. EPA expects that
persons whose 40 CFR 721.30 requests to use the NCELs approach for
SNURs that are approved by EPA will be required to comply with NCELs
provisions that are comparable to those contained in the corresponding
TSCA Order.
[[Page 73944]]
VI. Rationale and Objectives of the Rule
A. Rationale
During review of the PMNs submitted for the chemical substances
that are subject to these SNURs and as further discussed in Unit IV of
the proposed rules, EPA concluded that regulation was warranted under
TSCA section 5(e), pending the development of information sufficient to
make reasoned evaluations of the health or environmental effects of the
chemical substances. Based on such findings, TSCA Orders requiring the
use of appropriate exposure controls were negotiated with the PMN
submitters. As a general matter, EPA believes it is necessary to follow
TSCA Orders with a SNUR that identifies the absence of those protective
measures as significant new uses to ensure that all manufacturers and
processors--not just the original submitter--are held to the same
standard.
B. Objectives
EPA is issuing these SNURs because the Agency wants to
<bullet> Receive notice of any person's intent to manufacture or
process a listed chemical substance for the described significant new
use before that activity begins.
<bullet> Have an opportunity to review and evaluate data submitted
in a SNUN before the notice submitter begins manufacturing or
processing a listed chemical substance for the described significant
new use; and
<bullet> Be obligated to make a determination under TSCA section
5(a)(3) regarding the use described in the SNUN, under the conditions
of use. The Agency will either determine under TSCA section 5(a)(3)(C)
that significant new use is not likely to present an unreasonable risk,
including an unreasonable risk to a potentially exposed or susceptible
subpopulation identified as relevant by the Administrator under the
conditions of use, or make a determination under TSCA section
5(a)(3)(A) or (B) and take the required regulatory action associated
with the determination, before manufacture or processing for the
significant new use of the chemical substance can occur.
Issuance of a SNUR for a chemical substance does not signify that
the chemical substance is listed on the TSCA Chemical Substance
Inventory (TSCA Inventory). Guidance on how to determine if a chemical
substance is on the TSCA Inventory is available on the internet at
<a href="https://www.epa.gov/tsca-inventory">https://www.epa.gov/tsca-inventory</a>.
VII. Applicability of the Significant New Use Designation
To establish a significant new use, EPA must determine that the use
is not ongoing. The chemical substances subject to this rule have
undergone premanufacture review. In cases where EPA has not received a
notice of commencement (NOC) and the chemical substance has not been
added to the TSCA Inventory, no person may commence such activities
without first submitting a PMN. Therefore, for chemical substances for
which an NOC has not been submitted, EPA concludes that the designated
significant new uses are not ongoing.
When chemical substances identified in this rule are added to the
TSCA Inventory, EPA recognizes that, before the rule is effective,
other persons might engage in a use that has been identified as a
significant new use. However, TSCA Orders have been issued for all the
chemical substances that are the subject of this rule, and the PMN
submitters are prohibited by the TSCA Orders from undertaking
activities which will be designated as significant new uses. The
identities of many of the chemical substances subject to this rule have
been claimed as confidential (per 40 CFR 720.85). Based on this, the
Agency believes that it is highly unlikely that any of the significant
new uses described in the regulatory text of this rule are ongoing.
Furthermore, EPA designated the publication dates of the proposed
rules (see Unit II.) as the cutoff dates for determining whether the
new uses are ongoing. The objective of EPA's approach has been to
ensure that a person could not defeat a SNUR by initiating a
significant new use before the effective date of the final rule.
In the unlikely event that a person began commercial manufacture or
processing of the chemical substances for a significant new use
identified as of the abovementioned dates, that person will have to
cease any such activity upon the effective date of the final rule. To
resume their activities, that person would have to first comply with
all applicable SNUR notification requirements and wait until EPA has
conducted a review of the notice, made an appropriate determination on
the notice, and has taken such actions as are required with that
determination.
VIII. Development and Submission of Information
EPA recognizes that TSCA section 5 does not require development of
any particular new information (e.g., generating test data) before
submission of a SNUN. There is an exception: If a person is required to
submit information for a chemical substance pursuant to a rule, TSCA
Order or consent agreement under TSCA section 4, then TSCA section
5(b)(1)(A) requires such information to be submitted to EPA at the time
of submission of the SNUN.
In the absence of a rule, TSCA Order, or consent agreement under
TSCA section 4 covering the chemical substance, persons are required
only to submit information in their possession or control and to
describe any other information known to them or reasonably
ascertainable by them (see 40 CFR 720.50). However, upon review of PMNs
and SNUNs, the Agency has the authority to require appropriate testing.
Unit IV. of the proposed rule lists potentially useful information for
all SNURs listed in this document. Descriptions are provided for
informational purposes. The information identified in Unit IV. of the
proposed rule will be potentially useful to EPA's evaluation in the
event that someone submits a SNUN for the significant new use.
Companies who are considering submitting a SNUN are encouraged, but not
required, to develop the information on the substance.
EPA strongly encourages persons, before performing any testing, to
consult with the Agency. Furthermore, pursuant to TSCA section 4(h),
which pertains to reduction of testing in vertebrate animals, EPA
encourages consultation with the Agency on the use of alternative test
methods and strategies (also called New Approach Methodologies, or
NAMs), if available, to generate the recommended test data. EPA
encourages dialog with Agency representatives to help determine how
best the submitter can meet both the data needs and the objective of
TSCA section 4(h). For more information on alternative test methods and
strategies to reduce vertebrate animal testing, visit <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 identified in Unit IV. of the
proposed rule may not be the only means of addressing the potential
risks of the chemical substance associated with the designated
significant new uses. However, submitting a SNUN without any test data
or other information may increase the likelihood that EPA will take
action under TSCA sections 5(e) or 5(f). EPA recommends that potential
SNUN submitters contact EPA early enough so that they will be able to
conduct the appropriate tests.
[[Page 73945]]
SNUN submitters should be aware that EPA will be better able to
evaluate SNUNs that provide detailed information on the following:
<bullet> Human exposure and environmental release that may result
from the significant new use of the chemical substances.
<bullet> Information on risks posed by the chemical substances
compared to risks posed by potential substitutes.
IX. SNUN Submissions
According to 40 CFR 721.1(c), persons submitting a SNUN must comply
with the same notification requirements and EPA regulatory procedures
as persons submitting a PMN, including submission of test data on
health and environmental effects as described in 40 CFR 720.50. SNUNs
must be submitted on EPA Form No. 7710-25, generated using e-PMN
software, and submitted to the Agency in accordance with the procedures
set forth in 40 CFR 720.40 and 721.25. E-PMN software is available
electronically at <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 analyses are
available in each docket listed in Unit II.
XI. Statutory and Executive Order Reviews
Additional information about these statutes and Executive Orders
can be found at <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 several new chemical substances
that were the subject of PMNs. The Office of Management and Budget
(OMB) has exempted these types of actions from review under Executive
Orders 12866 (58 FR 51735, October 4, 1993) and 13563 (76 FR 3821,
January 21, 2011).
B. Paperwork Reduction Act (PRA)
According to the PRA (44 U.S.C. 3501 et seq.), an agency may not
conduct or sponsor, and a person is not required to respond to a
collection of information that requires OMB approval under PRA, unless
it has been approved by OMB and displays a currently valid OMB control
number. The information collection requirements associated with SNURs
have already been approved by OMB pursuant to the PRA under OMB control
number 2070-0012 (EPA ICR No. 574). This rule does not impose any
burden requiring additional OMB approval.
The OMB control numbers for EPA's regulations in title 40 of the
CFR, after appearing in the Federal Register, are listed in 40 CFR part
9, and included on the related collection instrument or form, if
applicable. EPA is amending the table in 40 CFR part 9 to list the OMB
approval number for the information collection requirements contained
in this action. This listing of the OMB control numbers and their
subsequent codification in the CFR satisfies the display requirements
of PRA and OMB's implementing regulations at 5 CFR part 1320. The
Information Collection Request (ICR) covering the SNUR activities was
previously subject to public notice and comment prior to OMB approval,
and given the technical nature of the table, EPA finds that further
notice and comment to amend it is unnecessary. As a result, EPA finds
that there is ``good cause'' under section 553(b)(3)(B) of the
Administrative Procedure Act (5 U.S.C. 553(b)(3)(B)) to amend this
table without further notice and comment.
If an entity were to submit a SNUN to the Agency, the annual burden
is estimated to average between 30 and 170 hours per response. This
burden estimate includes the time needed to review instructions, search
existing data sources, gather and maintain the data needed, and
complete, review, and submit the required SNUN.
C. Regulatory Flexibility Act (RFA)
Pursuant to the RFA section 605(b) (5 U.S.C. 601 et seq.), the
Agency hereby certifies that promulgation of these SNURs would not have
a significant adverse economic impact on a substantial number of small
entities. The requirement to submit a SNUN applies to any person
(including small or large entities) who intends to engage in any
activity described in the final rule as a ``significant new use.''
Because these uses are ``new,'' based on all information currently
available to EPA, EPA has concluded that no small or large entities
presently engage in such activities. A SNUR requires that any person
who intends to engage in such activity in the future must first notify
EPA by submitting a SNUN. Although some small entities may decide to
pursue a significant new use in the future, EPA cannot presently
determine how many, if any, there may be. However, EPA's experience to
date is that, in response to the promulgation of SNURs covering over
1,000 chemicals, the Agency receives only a small number of notices per
year. For example, the number of SNUNs received was 10 in Federal
fiscal year (FY) FY2016, 14 in FY2017, 16 in FY2018, five in FY2019,
seven in FY2020, and 13 in FY2021, 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
$19,020 to $3,330. This lower fee reduces the total reporting and
recordkeeping of cost of submitting a SNUN to about $11,164 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 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
Tribe Governments
This action does not have Tribal implications because it is not
expected to have substantial direct effects on Indian Tribes. This
action does not significantly nor uniquely affect the communities of
Indian Tribal
[[Page 73946]]
governments, nor does it involve or impose any requirements that affect
Indian Tribes. Accordingly, the requirements of Executive Order 13175
(65 FR 67249, November 9, 2000), do not apply to this action.
G. Executive Order 13045: Protection of Children From Environmental
Health Risks and Safety Risks
This action is not subject to Executive Order 13045 (62 FR 19885,
April 23, 1997), because this is not an economically significant
regulatory action as defined by Executive Order 12866, and this action
does not address environmental health or safety risks
disproportionately affecting children. EPA interprets Executive Order
13045 as applying only to those regulatory actions that concern
environmental health or safety risks that EPA has reason to believe may
disproportionately affect children, per the definition of ``covered
regulatory action'' in section 2-202 of the Executive Order.
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 expected to affect energy
supply, distribution, or use and 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 subject to NTTAA section 12(d) (15 U.S.C. 272 note).
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
Administrative practice and procedure, Chemicals, Environmental
protection, Hazardous substances, Reporting and recordkeeping
requirements.
40 CFR Part 725
Administrative practice and procedure, Biologics, Chemicals,
Environmental protection, Hazardous substances, Imports, Labeling,
Microorganisms, Occupational safety and health, Reporting and
recordkeeping requirements.
Dated: November 17, 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 in numerical order entries
for Sec. Sec. 721.11571 through 721.11602 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
------------------------------------------------------------------------
* * * * *
721.11571.................................................. 2070-0012
721.11572.................................................. 2070-0012
721.11573.................................................. 2070-0012
721.11574.................................................. 2070-0012
721.11575.................................................. 2070-0012
721.11576.................................................. 2070-0012
721.11577.................................................. 2070-0012
721.11578.................................................. 2070-0012
721.11579.................................................. 2070-0012
721.11580.................................................. 2070-0012
721.11581.................................................. 2070-0012
721.11582.................................................. 2070-0012
721.11583.................................................. 2070-0012
721.11584.................................................. 2070-0012
721.11585.................................................. 2070-0012
721.11586.................................................. 2070-0012
721.11587.................................................. 2070-0012
721.11588.................................................. 2070-0012
721.11589.................................................. 2070-0012
721.11590.................................................. 2070-0012
721.11591.................................................. 2070-0012
721.11592.................................................. 2070-0012
721.11593.................................................. 2070-0012
721.11594.................................................. 2070-0012
721.11595.................................................. 2070-0012
721.11596.................................................. 2070-0012
721.11597.................................................. 2070-0012
721.11598.................................................. 2070-0012
721.11599.................................................. 2070-0012
721.11600.................................................. 2070-0012
721.11601.................................................. 2070-0012
721.11602.................................................. 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. 721.11571 through 721.11602 in numerical order to
subpart E to read as follows:
Sec.
* * * * *
721.11571 Hindered amine alkyl ester compounds (generic).
721.11572 N-alkyl-dialkylpiperidine (generic).
721.11573 Tetraalkylpiperidinium halide (generic).
721.11574 Tetraalkylpiperidinium hydroxide (generic).
721.11575 Amidoamino quaternary ammonium salt (generic).
721.11576 Tri alkyl, mono alkoxy, fatty acid ester, ammonium salt
(generic).
721.11577 Benzenediamine, ar-chloro-ar, ar-diethyl-ar-methyl-.
721.11578 1,4-benzenedicarboxylic acid, 1,4-dipentyl ester, branched
and linear.
721.11579 Dialkyltin dialkylcarboxylate (generic).
[[Page 73947]]
721.11580 Alkyltin dodecylthioester (generic).
721.11581 Alkyltin tetradecylthioester (generic).
721.11582 Undecanol, branched.
721.11583 Hydroxy alkanoic acid, compds. with aminoalkoxyalcohol-
epoxy polymer-alkanolamine reaction products (generic).
721.11584 1,3-propanediol, 2-ethyl-2-(hydroxymethyl)-, polymer with
ethyleneamine, 2-(chloromethyl)oxirane, 2-[[4-(1,1-
dimethylethyl)phenoxy]methyl]oxirane, 2,2'-[1,6-
hexanediylbis(oxymethylene)]bis[oxirane], 4,4'-(1-
methylethylidene)bis[phenol], alkyl ether amine, and 2-[(2-
methylphenoxymethyl]oxirane (generic).
721.11585 Benzenepropanoic acid, 3-(2H-benzotriazol-2-yl)-5-(1,1-
dimethylethyl)-4-hydroxy-, 2,2-bis(hydroxymethyl)butyl ester.
721.11586 1-Octadecanaminium, N,N-dimethyl-N-[3-
(triethoxysilyl)propyl]-, chloride (1:1).
721.11587 2-Propenoic acid, 2-methyl-, 3-methyl-3-buten-1-yl ester.
721.11588 Mixed metal oxide (generic).
721.11589 Amines, polyethylenepoly-, triethylenetetramine fraction,
polymers with guanidine hydrochloride (1:1).
721.11590 Phenol, 4,4'-(1-methylethylidene)bis-, polymer with
3,6,9,12-tetraoxatetradeca-1, 13-diene, glycidyl ether.
721.11591 1,4-Benzenedicarboxylic acid, 1,4-bis(2-phenoxyethyl)
ester.
721.11592 Poly(oxy-1,2-ethanediyl), .alpha.-nonyl-.omega.-hydroxy-,
branched and linear.
721.11593 1-Butanamine, N-butyl-N-[(triethoxysilyl)methyl]-.
721.11594 Alkenylamide (generic).
721.11595 Isoalkylaminium, N-isoalkyl, -N, N-dimethyl chloride
(generic).
721.11596 Aldehyde, polymer with mixed alkane polyamines, 2,2'-[1,4-
alkanediylbis(oxyalkylene)]bis[oxirane], 2-(alkoxyalkyloxirane,
4,4'-(1-alkylidene)bis[phenol], 2,2'-[(1-alkylidene)bis(4,1-
alkyleneoxyalkylene)]bis[oxirane] and 2-(aryloxyalkyl)oxirane,
acetate (salt) (generic).
721.11597 Alkanedioic acid, compds. with substituted arylalkylamine-
arylalcohol disubstituted alkane-the diglycidyl ether of a
arylalcohol disubstituted alkane-epichlorohydrin-aldehyde-2,2'[(1-
alkylidene)bis[4,1-aryleneoxy(alkyl-2,1-
alkanediyl)oxyalkylene]]bis[oxirane]-alkanepolyamine polymer-1-[[2-
[(2-aminoalkyl)amino]alkyl]amino]-3-aryloxy-2-alcohol reaction
products (generic).
721.11598 Polyazaalkane with oxirane and methyloxirane, haloalkane
(generic).
721.11599 Dibromoalkyl ether tetrabromobisphenol A (generic).
721.11600 Octanal, 7(or 8)-formyl-.
721.11601 Sulfonium, trisaryl-, 7,7-dialkyl-2-heteropolycyclic-1-
alkanesulfonate (1:1) (generic).
721.11602 Alkenoic acid, polymer with (alkyl alkenyl) polyether
(generic).
* * * * *
Sec. 721.11571 Hindered amine alkyl ester compounds (generic).
(a) Chemical substance and significant new uses subject to
reporting. The chemical substance generically identified as hindered
amine alkyl ester compounds (PMN P-16-167) 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) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(1), (a)(2)(i) through (iv), (a)(3) through (6), and (c). When
determining which persons are reasonably likely to be exposed as
required for Sec. 721.63(a)(1) and (a)(4), engineering control
measures (e.g., enclosure of 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. For
purposes of Sec. 721.63(a)(6), the airborne form(s) of the substance
include particulate (including solids or liquid droplets), gas/vapor
(all substances in gas form), and combination gas/vapor and particulate
(gas and liquid/solid physical states are present).
(ii) Hazard communication. Requirements as specified in Sec.
721.72(a) through (d), (f), (g)(1), (g)(2)(i) through (v), (g)(3)(i)
and (ii), (g)(4)(i) through (iii), and (g)(5). For purposes of Sec.
721.72(g)(1), this substance may cause: skin irritation; respiratory
complications; central nervous system effects; blood effects.
Alternative hazard and warning statements that meet the criteria of the
Globally Harmonized System and OSHA Hazard Communication Standard may
be used.
(iii) 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 (h), and (k) are applicable to manufacturers and
processors of this substance.
(2) Limitation or revocation of certain modification requirements.
The provisions of Sec. 721.185 apply to this section.
Sec. 721.11572 N-alkyl-dialkylpiperidine (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance generically identified as N-
alkyl-dialkylpiperidine (PMN P-16-419) is subject to reporting under
this section for the significant new uses described in paragraph (a)(2)
of this section. The requirements of this section do not apply to
quantities of the substance after they have been completely reacted
(cured).
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(1), (a)(2)(i) through (iii), (a)(3) through (6), (b), and
(c). When determining which persons are likely to be exposed as
required for Sec. 721.63(a)(1) and (a)(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 10. For
purposes of Sec. 721.63(a)(6), the airborne form(s) of the substance
include gas/vapor (all substances in the gas form). For purposes of
Sec. 721.63(b), the concentration is set at 1.0%.
(ii) Hazard communication. Requirements as specified in Sec.
721.72(a) through (f), (g)(1), (g)(2)(i) through (v), (g)(3)(ii),
(g)(4), and (g)(5). For purposes of Sec. 721.72(e), the concentration
is set at 1.0%. For purposes of Sec. 721.72(g)(1), this substance may
cause: skin corrosion; serious eye damage; acute toxicity; specific
target organ toxicity. For purposes of Sec. 721.72(g)(4), notice to
users: water release restrictions apply. Alternative hazard and warning
statements that meet the criteria of the Globally Harmonized System and
OSHA Hazard Communication Standard may be used.
(iii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(h).
(iv) Release to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4) and (c)(4), where N=286.
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (i), and (k) are applicable to manufacturers and
processors of this substance.
[[Page 73948]]
(2) Limitation or revocation of certain modification requirements.
The provisions of Sec. 721.185 apply to this section.
Sec. 721.11573 Tetraalkylpiperidinium halide (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance generically identified as
tetraalkylpiperidinium halide (PMN P-16-423) is subject to reporting
under this section for the significant new uses described in paragraph
(a)(2) of this section. The requirements of this section do not apply
to quantities of the substance after they have been completely reacted
(cured).
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(1), (a)(2)(i), (a)(3), (b), and (c). When determining which
persons are likely to be exposed as required for Sec. 721.63(a)(1),
engineering control measures (e.g., enclosure or confinement of the
operation, general, and local ventilation) or administrative control
measures (e.g., workplace policies and procedures) shall be considered
and implemented to prevent exposure, where feasible. For purposes of
Sec. 721.63(b), the concentration is set at 1.0%.
(ii) Hazard communication. Requirements as specified in Sec.
721.72(a) through (f), (g)(1), (g)(2)(i) through (iii) and (v),
(g)(3)(ii), (g)(4), and (g)(5). For purposes of Sec. 721.72(e), the
concentration is set at 1.0%. For purposes of Sec. 721.72(g)(1), the
substance may cause: acute toxicity; specific target organ toxicity;
reproductive toxicity. For purposes of Sec. 721.72(g)(4), notice to
users: water release restrictions apply. Alternative hazard and warning
statements that meet the criteria of the Globally Harmonized System and
OSHA Hazard Communication Standard may be used.
(iii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(g).
(iv) Release to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4) and (c)(4), where N = 20.
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (i), and (k) are applicable to manufacturers and
processors of this substance.
(2) Limitation or revocation of certain modification requirements.
The provisions of Sec. 721.185 apply to this section.
Sec. 721.11574 Tetraalkylpiperidinium hydroxide (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance generically identified as
tetraalkylpiperidinium hydroxide (PMN P-16-424) is subject to reporting
under this section for the significant new uses described in paragraph
(a)(2) of this section. The requirements of this section do not apply
to quantities of the substance after they have been completely reacted
(cured).
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(1), (a)(2)(i) through (iii), (a)(3), (b), and (c). When
determining which persons are likely to be exposed as required for
Sec. 721.63(a)(1), engineering control measures (e.g., enclosure or
confinement of the operation, general, and local ventilation) or
administrative control measures (e.g., workplace policies and
procedures) shall be considered and implemented to prevent exposure,
where feasible. For purposes of Sec. 721.63(b), the concentration is
set at 1.0%.
(ii) Hazard communication. Requirements as specified in Sec.
721.72(a) through (f), (g)(1), (g)(2)(i) through (iii) and (v),
(g)(3)(ii), (g)(4), and (g)(5). For purposes of Sec. 721.72(e), the
concentration is set at 1.0%. For purposes of Sec. 721.72(g)(1), this
substance may cause: skin corrosion; serious eye damage; acute
toxicity; specific target organ toxicity; reproductive toxicity. For
purposes of Sec. 721.72(g)(4), notice to users: water release
restrictions apply. Alternative hazard and warning statements that meet
the criteria of the Globally Harmonized System and OSHA Hazard
Communication Standard may be used.
(iii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(k).
(iv) Release to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4) and (c)(4), where N=20.
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (i), and (k) are applicable to manufacturers and
processors of this substance.
(2) Limitation or revocation of certain modification requirements.
The provisions of Sec. 721.185 apply to this section.
Sec. 721.11575 Amidoamino quaternary ammonium salt (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance generically identified as
amidoamino quaternary ammonium salt (PMN P-17-235) 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. Requirements
as specified in Sec. 721.80(k).
(ii) Release to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4) and (c)(4), where N = 44.
(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 modification requirements.
The provisions of Sec. 721.185 apply to this section.
Sec. 721.11576 Tri alkyl, mono alkoxy, fatty acid ester, ammonium
salt (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance generically identified as tri
alkyl, mono alkoxy, fatty acid ester, ammonium salt (PMN P-18-226) 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(k).
(ii) Release to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4) and (c)(4), where N = 44.
(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 modification requirements.
The provisions of Sec. 721.185 apply to this section.
Sec. 721.11577 Benzenediamine, ar-chloro-ar, ar-diethyl-ar-methyl-.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as benzenediamine, ar-
chloro-ar, ar-
[[Page 73949]]
diethyl-ar-methyl- (PMN P-17-259; CAS No. 1616795-05-1) is subject to
reporting under this section for the significant new uses described in
paragraph (a)(2) of this section. The requirements of this section do
not apply to quantities of the PMN substance after they have been
completely reacted (cured).
(2) The significant new uses are:
(i) Release to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4) and (c)(4), where N = 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 (k) are applicable to manufacturers and
processors of this substance.
(2) Limitation or revocation of certain modification requirements.
The provisions of Sec. 721.185 apply to this section.
Sec. 721.11578 1,4-benzenedicarboxylic acid, 1,4-dipentyl ester,
branched and linear.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as 1,4-
benzenedicarboxylic acid, 1,4-dipentyl ester, branched and linear (PMN
P-18-43; CAS No. 2097734-13-7) is subject to reporting under this
section for the significant new uses described in paragraph (a)(2) of
this section. The requirements of this section do not apply to
quantities of the PMN substance after they have been completely reacted
(cured).
(2) The significant new uses are:
(i) Release to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4) and (c)(4), where N=2.
(ii) [Reserved]
(b) Specific requirements. The provision 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 modification requirements.
The provisions of Sec. 721.185 apply to this section.
Sec. 721.11579 Dialkyltin dialkylcarboxylate (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance generically identified as
dialkyltin dialkylcarboxylate (PMN P-18-178) is subject to reporting
under this section for the significant new uses described in paragraph
(a)(2) of this section. The requirements of this section do not apply
to quantities of the substance after they have been completely
entrained.
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(1), (a)(3) through (6), and (c). When determining which
persons are likely to be exposed as required for Sec. 721.63(a)(1) and
(a)(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 10. For purposes of Sec.
721.63(a)(6), the airborne form(s) of the substance include particulate
(including solids or liquid droplets).
(ii) Industrial, commercial, and consumer activities. It is a
significant new use to use the substance other than as a stabilizer for
PVC compounds.
(iii) 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 (e), (i), and (k) are applicable to manufacturers
and processors of this substance.
(2) Limitation or revocation of certain modification requirements.
The provisions of Sec. 721.185 apply to this section.
Sec. 721.11580 Alkyltin dodecylthioester (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance generically identified as
alkyltin dodecylthioester (PMN P-18-217) is subject to reporting under
this section for the significant new uses described in paragraph (a)(2)
of this section. The requirements of this section do not apply to
quantities of the substance after they have been completely entrained.
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(1), (a)(3), and (c). When determining which persons are
likely to be exposed as required for Sec. 721.63(a)(1), engineering
control measures (e.g., enclosure or confinement of the operation,
general, and local ventilation) or administrative control measures
(e.g., workplace policies and procedures) shall be considered and
implemented to prevent exposure, where feasible.
(ii) Industrial, commercial, and consumer activities. It is a
significant new use to use the substance other than as a stabilizer for
PVC compounds.
(iii) 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 (e), (i), and (k) are applicable to manufacturers
and processors of this substance.
(2) Limitation or revocation of certain modification requirements.
The provisions of Sec. 721.185 apply to this section
Sec. 721.11581 Alkyltin tetradecylthioester (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance generically identified as
alkyltin tetradecylthioester (PMN P-18-218) is subject to reporting
under this section for the significant new uses described in paragraph
(a)(2) of this section. The requirements of this section do not apply
to quantities of the substance after they have been completely
entrained.
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(1), (a)(3), and (c). When determining which persons are
likely to be exposed as required for Sec. 721.63(a)(1), engineering
control measures (e.g., enclosure or confinement of the operation,
general, and local ventilation) or administrative control measures
(e.g., workplace policies and procedures) shall be considered and
implemented to prevent exposure, where feasible.
(ii) Industrial, commercial, and consumer activities. It is a
significant new use to use the substance other than as a stabilizer for
PVC compounds.
(iii) 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 (e), (i), and (k) are
[[Page 73950]]
applicable to manufacturers and processors of this substance.
(2) Limitation or revocation of certain modification requirements.
The provisions of Sec. 721.185 apply to this section
Sec. 721.11582 Undecanol, branched.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as undecanol, branched
(PMN P-18-256; CAS No. 203743-00-4) is subject to reporting under this
section for the significant new use described in paragraph (a)(2) of
this section. The requirements of this section do not apply to
quantities of the PMN substance after they have been completely reacted
(cured).
(2) The significant new uses are:
(i) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(g).
(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 modification requirements.
The provisions of Sec. 721.185 apply to this section.
Sec. 721.11583 Hydroxy alkanoic acid, compds. with
aminoalkoxyalcohol-epoxy polymer-alkanolamine reaction products
(generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance generically identified as hydroxy
alkanoic acid, compds. with aminoalkoxyalcohol-epoxy polymer-
alkanolamine reaction products (PMN P-18-283) 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)(1), (a)(2)(i) through (iii), (a)(3), and (c). When
determining which persons are reasonably likely to be exposed as
required for Sec. 721.63(a)(1), engineering control measures (e.g.,
enclosure or confinement of the operation, general and local
ventilation) or administrative control measures (e.g., workplace
policies and procedures) shall be considered and implemented to prevent
exposure, where feasible.
(ii) Hazard communication. Requirements as specified in Sec.
721.72(a) through (f), (g)(1), (g)(2)(i) and (v), (g)(3)(ii),
(g)(4)(iii), and (g)(5). For purposes of Sec. 721.72(e), the
concentration is set at 1%. For purposes of Sec. 721.72(g)(1), this
substance may cause: skin irritation; skin sensitization; eye
irritation; specific target organ toxicity; reproductive toxicity.
Alternative hazard and warning statements that meet the criteria of the
Globally Harmonized System and OSHA Hazard Communication Standard may
be used.
(iii) 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 (h), and (k) are applicable to manufacturers and
processors of this substance.
(2) Limitation or revocation of certain modification requirements.
The provisions of Sec. 721.185 apply to this section.
Sec. 721.11584 1,3-propanediol, 2-ethyl-2-(hydroxymethyl)-, polymer
with ethyleneamine, 2-(chloromethyl)oxirane, 2-[[4-(1,1-
dimethylethyl)phenoxy]methyl]oxirane, 2,2'-[1,6-
hexanediylbis(oxymethylene)]bis[oxirane], 4,4'-(1-
methylethylidene)bis[phenol], alkyl ether amine, and 2-[(2-
methylphenoxy methyl]oxirane (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance generically identified as 1,3-
propanediol, 2-ethyl-2-(hydroxymethyl)-, polymer with ethyleneamine, 2-
(chloromethyl)oxirane, 2-[[4-(1,1-dimethylethyl)phenoxy]methyl]oxirane,
2,2'-[1,6-hexanediylbis(oxymethylene)]bis[oxirane], 4,4'-(1-
methylethylidene)bis[phenol], alkyl ether amine, and 2-[(2-
methylphenoxy methyl]oxirane (PMN P-18-298) is subject to reporting
under this section for the significant new uses described in paragraph
(a)(2) of this section. The requirements of this section do not apply
to quantities of the PMN substance after they have been completely
reacted (cured).
(2) The significant new uses are:
(i) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(o). It is a significant new use to
manufacture, process, or use the PMN substance for an application
method 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=50.
(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 modification requirements.
The provisions of Sec. 721.185 apply to this section.
Sec. 721.11585 Benzenepropanoic acid, 3-(2H-benzotriazol-2-yl)-5-
(1,1-dimethylethyl)-4-hydroxy-, 2,2-bis(hydroxymethyl)butyl ester.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as benzenepropanoic
acid, 3-(2H-benzotriazol-2-yl)-5-(1,1-dimethylethyl)-4-hydroxy-, 2,2-
bis(hydroxymethyl)butyl ester (PMN P-18-310; CAS No. 2101609-93-0) is
subject to reporting under this section for the significant new use
described in paragraph (a)(2) of this section. The requirements of this
section do not apply to quantities of the PMN substance after they have
been completely reacted (cured).
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(1), (a)(2)(i) through (iii), (a)(3) through (6), and (c).
When determining which persons are reasonably likely to be exposed as
required for Sec. 721.63(a)(1) and (a)(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 1,000.
For purposes of Sec. 721.63(a)(6), the airborne form(s) of the
substance include gas/vapor and particulate.
(A) As an alternative to the respirator requirements in paragraph
(a)(2)(i) of this section, a manufacturer or processor may choose to
follow the new chemical exposure limit (NCEL) provision listed in the
TSCA section 5(e) consent order for this substance. The NCEL is 0.16
mg/m\3\ as an 8-hour time-weighted average. Persons who wish to pursue
NCELs as an alternative to Sec. 721.63 respirator
[[Page 73951]]
requirements may request to do so under Sec. 721.30. Persons whose
Sec. 721.30 requests to use the NCELs approach are approved by EPA
will be required to follow NCELs provisions comparable to those
contained in the corresponding TSCA section 5(e) consent order.
(B) [Reserved]
(ii) Hazard communication. Requirements as specified in Sec.
721.72(a) through (f), (g)(1), (g)(3)(ii), and (g)(5). For purposes of
Sec. 721.72(e), the concentration is set at 1.0%. For purposes of
Sec. 721.72(g)(1), this substance may cause: specific target organ
toxicity; reproductive toxicity. Alternative hazard and warning
statements that meet the criteria of the Globally Harmonized System and
OSHA Hazard Communication Standard may be used.
(iii) 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 (h), and (k) are applicable to manufacturers and
processors of this substance.
(2) Limitation or revocation of certain modification requirements.
The provisions of Sec. 721.185 apply to this section.
Sec. 721.11586 1-Octadecanaminium, N,N-dimethyl-N-[3-
(triethoxysilyl)propyl]-, chloride (1:1).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as 1-octadecanaminium,
N,N-dimethyl-N-[3-(triethoxysilyl)propyl]-, chloride (1:1) (PMN P-18-
318; CAS No. 62117-57-1) 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) Hazard communication. Requirements as specified in Sec.
721.72(a) through (f), (g)(1), (g)(3)(ii), and (g)(5). For purposes of
Sec. 721.72(g)(1), this substance may cause: skin irritation; eye
irritation; specific target organ toxicity. For purposes of Sec.
721.72(e), the concentration is set at 1.0%. Alternative hazard and
warning statements that meet the criteria of the Globally Harmonized
System and OSHA Hazard Communication Standard may be used.
(ii) Industrial, commercial, and consumer activities. It is a
significant new use to use the substance other than as a surface
treatment for added lubricity and anti-static properties. It is a
significant new use to use the substance in an application method that
results in inhalation exposure to workers.
(iii) 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), (f) through (i), and (k) are applicable to
manufacturers and processors of this substance.
(2) Limitation or revocation of certain modification requirements.
The provisions of Sec. 721.185 apply to this section.
Sec. 721.11587 2-Propenoic acid, 2-methyl-, 3-methyl-3-buten-1-yl
ester.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as 2-propenoic acid,
2-methyl-, 3-methyl-3-buten-1-yl ester (PMN P-18-323; CAS No. 156291-
88-2) is subject to reporting under this section for the significant
new uses described in paragraph (a)(2) of this section. The
requirements of this section do not apply to quantities of the PMN
substance after they have been completely reacted (cured).
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(1), (a)(2)(i) through (iii), (a)(3) through (6), and (c).
When determining which persons are reasonably likely to be exposed as
required for Sec. 721.63(a)(1) and (a)(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. For
purposes of Sec. 721.63(a)(6), the airborne form(s) of the substance
include particulate (including solids or liquid droplets) and gas/vapor
(all substances in the gas form).
(ii) Hazard communication. Requirements as specified in Sec.
721.72(a) through (d), (f), (g)(1), (g)(2)(i) through (v), (g)(3)(i)
and (ii), (g)(4)(i) through (iii), and (g)(5). For purposes of Sec.
721.72(g)(1), this substance may cause: skin irritation; developmental
effects; systemic effects; respiratory effects; skin sensitization;
respiratory sensitization. Alternative hazard and warning statements
that meet the criteria of the Globally Harmonized System and Hazard
Communication Standard may be used.
(iii) Industrial, commercial, and consumer use. Requirements as
specified in Sec. 721.80(k).
(iv) Release to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4) and (c)(4), where N = 98.
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (i), 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. 721.11588 Mixed metal oxide (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance generically identified as mixed
metal oxide (PMN P-18-327) is subject to reporting under this section
for the significant new uses described in paragraph (a)(2) of this
section. The requirements of this section do not apply to quantities of
the substance after they have been completely entrained.
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(1), (a)(3) through (6), and (c). When determining which
persons are reasonably likely to be exposed as required for Sec.
721.63(a)(1) and (a)(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 1,000. For purposes of
Sec. 721.63(a)(6), the airborne form(s) of the substance include
particulate (including solids or liquid droplets).
(A) As an alternative to the respirator requirements in paragraph
(a)(2)(i) of this section, a manufacturer or processor may choose to
follow the new chemical exposure limit (NCEL) provision listed in the
TSCA section 5(e) consent order for this substance. The NCEL is 0.1 mg/
m\3\ as an 8-hour time-weighted average. Persons who wish to pursue
NCELs as an alternative to Sec. 721.63 respirator requirements may
request to do so
[[Page 73952]]
under Sec. 721.30. Persons whose Sec. 721.30 requests to use NCELs
approach are approved by EPA will be required to follow NCELs
provisions comparable to those contained in the corresponding TSCA
section 5(e) consent order.
(B) [Reserved]
(ii) Hazard communication. Requirements as specified in Sec.
721.72(a) through (d), (f), (g)(1), (g)(2), and (g)(5). For purposes of
Sec. 721.72(g)(1), this substance may cause: cancer; skin
sensitization; respiratory sensitization; specific target organ
toxicity. Alternative hazard and warning statements that meet the
criteria of the Globally Harmonized System and OSHA Hazard
Communication Standard may be used. For purposes of Sec. 721.72(g)(2),
when using this substance: avoid skin contact, avoid breathing
substance, avoid ingestion, use respiratory protection or maintain
workplace airborne concentrations at or below an 8-hour time-weighted
average of 0.1 mg/m\3\, and use skin protection.
(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 (h) are applicable to manufacturers and processors
of this substance.
(2) Limitation or revocation of certain modification requirements.
The provisions of Sec. 721.185 apply to this section.
Sec. 721.11589 Amines, polyethylenepoly-, triethylenetetramine
fraction, polymers with guanidine hydrochloride (1:1).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as amines,
polyethylenepoly-, triethylenetetramine fraction, polymers with
guanidine hydrochloride (1:1) (PMN P-18-347; CAS No. 1902936-67-7) 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) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(1) and (3), (b), and (c). When determining which persons are
reasonably likely to be exposed as required for Sec. 721.63(a)(1),
engineering control measures (e.g., enclosure or confinement of the
operation, general and local ventilation) or administrative control
measures (e.g., workplace policies and procedures) shall be considered
and implemented to prevent exposure, where feasible. For purposes of
Sec. 721.63(b), the concentration is set at 1%.
(ii) Hazard communication. Requirements as specified in Sec.
721.72(a) through (f), (g)(1), (g)(2)(i) and (v), (g)(3)(i) and (ii),
(g)(4)(i), and (g)(5). For purposes of Sec. 721.72(e), the
concentration is set at 1%. For purposes of Sec. 721.72(g)(1), this
substance may cause: acute toxicity; skin sensitization; specific
target organ toxicity. Alternative hazard and warning statements that
meet the criteria of the Globally Harmonized System and OSHA Hazard
Communication Standard may be used.
(iii) Release to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4) and (c)(4), where N = 2.
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (h), 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. 721.11590 Phenol, 4,4'-(1-methylethylidene)bis-, polymer with
3,6,9,12-tetraoxatetradeca-1, 13-diene, glycidyl ether.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as phenol, 4,4'-(1-
methylethylidene)bis-, polymer with 3,6,9,12-tetraoxatetradeca-1, 13-
diene, glycidyl ether (PMN P-18-405; CAS No. 647028-24-8) is subject to
reporting under this section for the significant new uses described in
paragraph (a)(2) of this section. The requirements of this section do
not apply to quantities of the PMN substance after they have been
completely reacted (cured).
(2) The significant new uses are:
(i) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(o). It is a significant new use to
manufacture, process, or use the PMN substance in a 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,
importers, and processors of this substance.
(2) Limitation or revocation of certain modification requirements.
The provisions of Sec. 721.185 apply to this section.
Sec. 721.11591 1,4-Benzenedicarboxylic acid, 1,4-bis(2-phenoxyethyl)
ester.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as 1,4-
benzenedicarboxylic acid, 1,4-bis(2-phenoxyethyl) ester (PMN P-19-36;
CAS No. 25900-07-6) is subject to reporting under this section for the
significant new uses described in paragraph (a)(2) of this section. The
requirements of this section do not apply to quantities of the PMN
substance after they have been completely reacted (cured).
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(1), (a)(2)(i), (a)(3) through (6), and (c). When determining
which persons are reasonably likely to be exposed as required for Sec.
721.63(a)(1) and (a)(4), engineering control measures (e.g., enclosure
of 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 1,000. For purposes of
Sec. 721.63(a)(6), the airborne form(s) of the substance include
particulate (including solids or liquid droplets).
(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
may 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 (k) are applicable to manufacturers and
processors of this substance.
(2) Limitation or revocation of certain modification requirements.
The provisions of Sec. 721.185 apply to this section.
Sec. 721.11592 Poly(oxy-1,2-ethanediyl), .alpha.-nonyl-.omega.-
hydroxy-, branched and linear.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as poly(oxy-1,2-
ethanediyl), .alpha.-nonyl-.omega.-hydroxy-, branched and linear
[[Page 73953]]
(PMN P-19-52; CAS No. 2242406-13-7) 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) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(1), (a)(2)(i) through (iii), (a)(3) through (6), (b), and
(c). When determining which persons are reasonably likely to be exposed
as required for Sec. 721.63(a)(1) and (a)(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 1,000.
For purposes of Sec. 721.63(a)(6), the airborne form(s) of the
substance include particulate (including solids or liquid droplets).
For purposes of Sec. 721.63(b), the concentration is set at 1%.
(ii) Hazard communication. Requirements as specified in Sec.
721.72(a) through (f), (g)(1), (g)(2)(i) through (v), (g)(3)(i) and
(ii), and (g)(5). For purposes of Sec. 721.72(e), the concentration is
set at 1%. For purposes of Sec. 721.72(g)(1), this substance may
cause: skin irritation; respiratory complications; internal organ
effects; eye corrosion. Alternative hazard and warning statements that
meet the criteria of the Globally Harmonized System and OSHA Hazard
Communication Standard may be used.
(iii) Industrial, commercial, and consumer use. It is a significant
new use to use the substance where the concentration of the substance
in the product formulation intended for distribution in commerce
exceeds 1% by weight.
(iv) Release to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4) and (c)(4), where N = 34.
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (i), and (k) are applicable to manufacturers and
processors of this substance.
(2) Limitation or revocation of certain modification requirements.
The provisions of Sec. 721.185 apply to this section.
Sec. 721.11593 1-Butanamine, N-butyl-N-[(triethoxysilyl)methyl]-.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as 1-butanamine, N-
butyl-N-[(triethoxysilyl)methyl]- (PMN P-19-53; CAS No. 35501-23-6) is
subject to reporting under this section for the significant new uses
described in paragraph (a)(2) of this section. The requirements of this
section do not apply to quantities of the substance after they have
been completely reacted (cured).
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(1) and (3), and (c). When determining which persons are
reasonably likely to be exposed as required for Sec. 721.63(a)(1),
engineering control measures (e.g., enclosure or confinement of the
operation, general, and local ventilation) or administrative control
measures (e.g., workplace policies and procedures) shall be considered
and implemented to prevent exposure, where feasible.
(ii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(f) and (o). It is a significant new use to
process and use the substance other than in a liquid formulation.
(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 modification requirements.
The provisions of Sec. 721.185 apply to this section.
Sec. 721.11594 Alkenylamide (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance generically identified as
alkenylamide (PMN P-19-77) 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(k).
(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. 721.11595 Isoalkylaminium, N-isoalkyl, -N, N-dimethyl chloride
(generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance generically identified as
isoalkylaminium, N-isoalkyl, -N, N-dimethyl chloride (PMN P-19-131) is
subject to reporting under this section for the significant new uses
described in paragraph (a)(2) of this section. The requirements of this
section do not apply to quantities of the substance after they have
been completely reacted or destroyed (e.g., reacted to bind with clay).
(2) The significant new uses are:
(i) Hazard communication. Requirements as specified in Sec.
721.72(a) through (f), (g)(1), (g)(3)(ii), and (g)(5). For purposes of
Sec. 721.72(e), the concentration is set at 1.0%. For purposes of
Sec. 721.72(g)(1), this substance may cause: skin irritation; eye
irritation; specific target organ toxicity. Alternative hazard and
warning statements that meet the criteria of the Globally Harmonized
System and OSHA Hazard Communication Standard may be used.
(ii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(o). It is significant new use to
manufacture, process, or use the PMN substance in a manner that results
in inhalation exposure.
(iii) 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), (f) through (i), and (k) are applicable to
manufacturers and processors of this substance.
(2) Limitation or revocation of certain modification requirements.
The provisions of Sec. 721.185 apply to this section.
[[Page 73954]]
Sec. 721.11596 Aldehyde, polymer with mixed alkane polyamines, 2,2'-
[1,4-alkanediylbis(oxyalkylene)]bis[oxirane], 2-(alkoxyalkyloxirane,
4,4'-(1-alkylidene)bis[phenol], 2,2'-[(1-alkylidene)bis(4,1-
alkyleneoxyalkylene)]bis[oxirane] and 2-(aryloxyalkyl)oxirane, acetate
(salt) (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance generically identified as
aldehyde, polymer with mixed alkane polyamines, 2,2'-[1,4-
alkanediylbis(oxyalkylene)]bis[oxirane], 2-(alkoxyalkyloxirane, 4,4'-
(1-alkylidene)bis[phenol], 2,2'-[(1-alkylidene)bis(4,1-
alkyleneoxyalkylene)]bis[oxirane] and 2-(aryloxyalkyl)oxirane, acetate
(salt) (PMN P-19-143) is subject to reporting under this section for
the significant new uses described in paragraph (a)(2) of this section.
The requirements of this section do not apply to quantities of the PMN
substance after they have been completely reacted (cured) or destroyed.
(2) The significant new uses are:
(i) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(o). It is a significant new use to
manufacture, process, or use the PMN substance in a manner that results
in inhalation exposure to either the PMN substance or to formaldehyde.
(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 modification requirements.
The provisions of Sec. 721.185 apply to this section.
Sec. 721.11597 Alkanedioic acid, compds. with substituted
arylalkylamine-arylalcohol disubstituted alkane-the diglycidyl ether of
a arylalcohol disubstituted alkane-epichlorohydrin-aldehyde-2,2'[(1-
alkylidene)bis[4,1-aryleneoxy(alkyl-2,1-
alkanediyl)oxyalkylene]]bis[oxirane]-alkanepolyamine polymer-1-[[2-[(2-
aminoalkyl)amino]alkyl]amino]-3-aryloxy-2-alcohol reaction products
(generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance generically identified as
alkanedioic acid, compds. with substituted arylalkylamine-arylalcohol
disubstituted alkane-the diglycidyl ether of a arylalcohol
disubstituted alkane-epichlorohydrin-aldehyde-2,2'[(1-
alkylidene)bis[4,1-aryleneoxy(alkyl-2,1-
alkanediyl)oxyalkylene]]bis[oxirane]-alkanepolyamine polymer-1-[[2-[(2-
aminoalkyl)amino]alkyl]amino]-3-aryloxy-2-alcohol reaction products
(PMN P-19-144) is subject to reporting under this section for the
significant new uses described in paragraph (a)(2) of this section. The
requirements of this section do not apply to quantities of the
substance after they have been completely reacted (cured) or destroyed.
(2) The significant new uses are:
(i) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(o). It is a significant new use to
manufacture, process, or use the PMN substance in a manner that results
in inhalation exposure to either the PMN substance or to formaldehyde.
(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 modification requirements.
The provisions of Sec. 721.185 apply to this section.
Sec. 721.11598 Polyazaalkane with oxirane and methyloxirane,
haloalkane (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance generically identified as
polyazaalkane with oxirane and methyloxirane, haloalkane (PMN P-19-145)
is subject to reporting under this section for the significant new uses
described in paragraph (a)(2) of this section. The requirements of this
section do not apply to quantities of the substance after they have
been completely reacted (cured).
(2) The significant new uses are:
(i) Hazard communication. Requirements as specified in Sec.
721.72(a) through (f), (g)(1), and (g)(5). For purposes of Sec.
721.72(e), the concentration is set at 1%. For purposes of Sec.
721.72(g)(1), this substance may cause: reproductive toxicity; specific
target organ toxicity. Alternative hazard and warning statements that
meet the criteria of the Globally Harmonized System and OSHA Hazard
Communication Standard may be used.
(ii) Industrial, commercial, and consumer activities. It is a
significant new use to manufacture, process, or use the PMN substance
in a manner that results in inhalation exposure.
(iii) Release to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4) and (c)(4), where N = 26.
(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), (f) through (h), (i) and (k) are applicable to
manufacturers and processors of this substance.
(2) Limitation or revocation of certain modification requirements.
The provisions of Sec. 721.185 apply to this section.
Sec. 721.11599 Dibromoalkyl ether tetrabromobisphenol A (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance generically identified as
dibromoalkyl ether tetrabromobisphenol A (PMN P-19-153) 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)(1), (a)(2)(i) and (iii), (a)(3), and (c). When determining
which persons are reasonably likely to be exposed as required for Sec.
721.63(a)(1), engineering control measures (e.g., enclosure or
confinement of the operation, general and local ventilation) or
administrative control measures (e.g., workplace policies and
procedures) shall be considered and implemented to prevent exposure,
where feasible.
(ii) Hazard communication. Requirements as specified in Sec.
721.72(a) through (f), (g)(1), (g)(3)(ii), and (g)(5). For purposes of
Sec. 721.72(e), the concentration is set at 1.0%. For purposes of
Sec. 721.72(g)(1), this substance may cause: eye irritation;
carcinogenicity; reproductive toxicity; specific target organ toxicity.
Alternative hazard and warning statements that meet the criteria of the
Globally Harmonized System and OSHA Hazard Communication Standard may
be used.
(iii) 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 (h), and (k) are
[[Page 73955]]
applicable to manufacturers and processors of this substance.
(2) Limitation or revocation of certain modification requirements.
The provisions of Sec. 721.185 apply to this section.
Sec. 721.11600 Octanal, 7(or 8)-formyl-.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as octanal, 7(or 8)-
formyl- (PMN P-20-29; CAS No. 1607842-40-9) 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) Release to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4) and (c)(4), where N = 17.
(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 modification requirements.
The provisions of Sec. 721.185 apply to this section.
Sec. 721.11601 Sulfonium, trisaryl-, 7, 7-dialkyl-2-heteropolycyclic-
1-alkanesulfonate (1:1) (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance generically identified as
sulfonium, trisaryl-, 7, 7-dialkyl-2-heteropolycyclic-1-alkanesulfonate
(1:1) (PMN P-20-42) is subject to reporting under this section for the
significant new uses described in paragraph (a)(2) of this section. The
requirements of this section do not apply to quantities of the
substance after they have been completely reacted or adhered (during
the photolithographic process) onto a semiconductor wafer surface or
similar manufactured article used in the production of semiconductor
technologies.
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(1), (a)(2)(i) and (iii), (a)(3), and (c). When determining
which persons are reasonably likely to be exposed as required for Sec.
721.63(a)(1), engineering control measures (e.g., enclosure or
confinement of the operation, general and local ventilation) or
administrative control measures (e.g., workplace policies and
procedures) shall be considered and implemented to prevent exposure,
where feasible.
(ii) Hazard communication. Requirements as specified in Sec.
721.72(a) through (f), (g)(1), (g)(2)(i) through (iii) and (v),
(g)(3)(i) and (ii), and (g)(5). For purposes of Sec. 721.72(e), the
concentration is set at 1.0%. For purposes of Sec. 721.72(g)(1), this
substance may cause: skin irritation; acute toxicity; skin
sensitization; serious eye damage; specific target organ toxicity;
neurotoxicity; genetic toxicity; reproductive toxicity. Alternative
hazard and warning statements that meet the criteria of the Globally
Harmonized System and OSHA Hazard Communication Standard may be used.
(iii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(f), (k), and (t). It is a significant new
use to import the PMN substance other than in solution, unless in
sealed containers weighing 5 kilograms or less. It is a significant new
use to process the PMN substance in any way that generates a dust,
mist, or aerosol in a non-enclosed process. It is a significant new use
to manufacture the PMN substance longer than 18 months.
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (i) are applicable to manufacturers and processors
of this substance.
(2) Limitation or revocation of certain modification requirements.
The provisions of Sec. 721.185 apply to this section.
Sec. 721.11602 Alkenoic acid, polymer with (alkyl alkenyl) polyether
(generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance generically identified as
alkenoic acid, polymer with (alkyl alkenyl) polyether (PMN P-20-104) is
subject to reporting under this section for the significant new uses
described in paragraph (a)(2) of this section. The requirements of this
section do not apply to quantities of the substance after they have
been completely reacted (cured).
(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 a 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 = 75.
(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 modification requirements.
The provisions of Sec. 721.185 apply to this section.
* * * * *
PART 725--REPORTING REQUIREMENTS AND REVIEW PROCESSES FOR
MICROORGANISMS
0
3. The authority citation for part 725 continues to read as follows:
Authority: 15 U.S.C. 2604, 2607, 2613, and 2625.
0
4. Add Sec. 725.1081 to read as follows:
Sec. 725.1081 Trichoderma reesei modified (generic).
(a) Microorganism and significant new uses subject to reporting.
(1) The genetically modified microorganism generically identified as
Trichoderma reesei modified (MCAN J-16-26) is subject to reporting
under this section for the significant new uses described in paragraph
(a)(2) of this section.
(2)(i) It is a significant new use to manufacture, process, or use
the microorganism other than in a fermentation system that meets all of
the following conditions:
(A) Enzyme production occurs by submerged fermentation (i.e., for
enzyme production, growth of the microorganism occurs beneath the
surface of the liquid growth medium); and
(B) Any fermentation of solid plant material or insoluble substrate
to which Trichoderma reesei fermentation broth is added after the
standard industrial fermentation is completed is initiated only after
the inactivation of the microorganism as delineated in Sec.
725.422(d).
(ii) [Reserved]
(b) Specific requirements. The provisions of subpart L of this part
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
725.950(b)(2) through (4) are applicable to manufacturers and
processors of this microorganism.
(2) Modification or revocation of certain notification
requirements. The provisions of Sec. 725.984 apply to this section.
[FR Doc. 2022-25807 Filed 12-1-22; 8:45 am]
BILLING CODE 6560-50-P
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</html>Indexed from Federal Register on December 2, 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.