[Federal Register Volume 88, Number 43 (Monday, March 6, 2023)]
[Rules and Regulations]
[Pages 13696-13713]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-04157]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Parts 9 and 721
[EPA-HQ-OPPT-2021-0568; FRL-9779-02-OCSPP]
RIN 2070-AB27
Significant New Use Rules on Certain Chemical Substances (21-
3.5e)
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). 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.
DATES: This rule is effective on May 5, 2023. For purposes of judicial
review, this rule shall be promulgated at 1 p.m. (e.s.t.) on March 20,
2023.
FOR FURTHER INFORMATION CONTACT:
For technical information contact: William Wysong, New Chemicals
Division (7405M), Office of Pollution Prevention and Toxics,
Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington,
DC 20460-0001; telephone number: (202) 564-4163; email address:
[email protected].
For general information contact: The TSCA-Hotline, ABVI-Goodwill,
422 South Clinton Ave., Rochester, NY 14620; telephone number: (202)
554-1404; email address: [email protected].
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this action apply to me?
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:
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
[[Page 13697]]
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), 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-2021-0568,
is available at https://www.regulations.gov and at the Office of
Pollution Prevention and Toxics Docket (OPPT Docket), Environmental
Protection Agency Docket Center (EPA/DC), West William Jefferson
Clinton Bldg., Rm. 3334, 1301 Constitution Ave. NW, Washington, DC. The
Public Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through
Friday, excluding legal holidays. The telephone number for the Public
Reading Room is (202) 566-1744, and the telephone number for the OPPT
Docket is (202) 566-0280. Please review the visitor instructions and
additional information about the docket available at https://www.epa.gov/dockets.
II. Background
A. What action is the Agency taking?
EPA is finalizing SNURs under TSCA section 5(a)(2) for certain
chemical substances which were the subject of PMNs. Previously, EPA
proposed SNURs for these chemical substances and established the record
for these SNURs in the following Federal Register and docket ID number:
June 24, 2022 (87 FR 37783) (FRL-9779-01-OCSPP); Docket ID
No. EPA-HQ-OPPT-2021-0568.
EPA will address finalizing the proposed SNURs for certain chemical
substances not included in this final rule in a future Federal Register
document. The 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:
The projected volume of manufacturing and processing of a
chemical substance.
The extent to which a use changes the type or form of
exposure of human beings or the environment to a chemical substance.
The extent to which a use increases the magnitude and
duration of exposure of human beings or the environment to a chemical
substance.
The reasonably anticipated manner and methods of
manufacturing, processing, distribution in commerce, and disposal of a
chemical substance.
In determining what would constitute a significant new use for the
chemical substances that are the subject of these SNURs, EPA considered
relevant information about the toxicity of the chemical substances, and
potential human exposures and environmental releases that may be
associated with possible uses of these chemical substances, in the
context of the four 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.
Under the procedures in 40 CFR part 721.11 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 identify any confidential
significant new use designations 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 40 CFR part 721 and if a
specific use would be a significant new use under the rule.
In the proposed SNURs, EPA referenced 40 CFR 721.1725(b)(1) each
time the agency proposed issuing a SNUR containing a significant new
use
[[Page 13698]]
designation containing CBI. Since, EPA has modified the bona fide
procedure in 40 CFR 721.11 of subpart A so that it applies to all SNURs
containing any CBI, including the significant new use (87 FR 39764,
July 5, 2022 (FRL-5605-02-OCSPP)). EPA has revised the regulatory text
in the final rule and removed the reference to 40 CFR 721.1725(b)(1)
each time the agency issued a final SNUR containing a significant new
use designation containing CBI.
IV. Public Comments on Proposed Rule and EPA Responses
EPA received public comments from two identifying entities on the
proposed rules. The Agency's responses are presented in the Response to
Public Comments document that is available in the public docket for
this rulemaking. EPA updated the chemical IDs in the SNURs for P-19-98,
P-20-58, and P-21-63 as described in the response to comments.
V. Substances Subject to This Rule
EPA is establishing significant new use and recordkeeping
requirements for chemical substances in 40 CFR part 721, subpart E. In
Unit IV. of the proposed SNURs, EPA provided the following information
for each chemical substance:
PMN number.
Chemical name (generic name, if the specific name is
claimed as confidential business information (CBI)).
Chemical Abstracts Service (CAS) Registry number (if
assigned for non-confidential chemical identities).
Effective date of and basis for the TSCA Order.
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.
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).
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
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.
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
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
https://www.epa.gov/tsca-inventory.
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.
[[Page 13699]]
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 https://www.epa.gov/assessing-and-managing-chemicals-under-tsca/alternative-test-methods-and-strategies-reduce.
In some of the TSCA Orders for the chemical substances identified
in this rule, EPA has established production volume and time limits in
view of the lack of data on the potential health and environmental
risks that may be posed by the significant new uses or increased
exposure to the chemical substances. These limits cannot be exceeded
unless the PMN submitter first submits the results of specified tests
that would permit a reasoned evaluation of the potential risks posed by
these chemical substances. The SNURs contain the same limits as the
TSCA Orders. Exceeding these production limits is defined as a
significant new use. Persons who intend to exceed the production limit
must notify the Agency by submitting a SNUN at least 90 days in advance
of commencement of non-exempt commercial manufacture or processing.
Any request by EPA for the triggered and pended testing described
in the TSCA Orders was made based on EPA's consideration of available
screening-level data, if any, as well as other available information on
appropriate testing for the PMN substances. Further, any such testing
request on the part of EPA that includes testing on vertebrates was
made after consideration of available toxicity information,
computational toxicology and bioinformatics, and high-throughput
screening methods and their prediction models.
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.
SNUN submitters should be aware that EPA will be better able to
evaluate SNUNs that provide detailed information on the following:
Human exposure and environmental release that may result
from the significant new use of the chemical substances.
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 https://www.epa.gov/reviewing-new-chemicals-under-toxic-substances-control-act-tsca.
X. Economic Analysis
EPA has evaluated the potential costs of establishing SNUN
requirements for potential manufacturers and processors of the chemical
substances subject to this rule. EPA's complete economic analysis is
available in the docket listed in Unit II.
XI. Statutory and Executive Order Reviews
Additional information about these statutes and Executive Orders
can be found at https://www.epa.gov/laws-regulations-and-executive-orders.
A. Executive Order 12866: Regulatory Planning and Review and Executive
Order 13563: Improving Regulations and Regulatory Review
This action establishes SNURs for 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. Executive Order 13771: Reducing Regulations and Controlling
Regulatory Costs
This action is not subject to Executive Order 13771 (82 FR 9339,
February 3, 2017), because this action is not a significant regulatory
action under Executive Order 12866.
C. 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
[[Page 13700]]
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.
Send any comments about the accuracy of the burden estimate, and
any suggested methods for minimizing respondent burden, including
through the use of automated collection techniques, to the Director,
Regulatory Support Division, Office of Mission Support (2822T),
Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington,
DC 20460-0001. Please remember to include the OMB control number in any
correspondence, but do not submit any completed forms to this address.
D. 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, and 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 she 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.
E. 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.).
F. 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).
G. 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 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.
H. 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.
I. 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.
J. 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).
K. 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).
L. 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.
[[Page 13701]]
40 CFR Part 721
Environmental protection, Chemicals, Hazardous substances,
Reporting and recordkeeping requirements.
Dated: February 23, 2023.
Denise Keehner,
Director, Office of Pollution Prevention and Toxics.
Therefore, for the reasons stated in the preamble, 40 CFR chapter I
is amended as follows:
PART 9--OMB APPROVALS UNDER THE PAPERWORK REDUCTION ACT
0
1. The authority citation for part 9 continues to read as follows:
Authority: 7 U.S.C. 135 et seq., 136-136y; 15 U.S.C. 2001,
2003, 2005, 2006, 2601-2671; 21 U.S.C. 331j, 346a; 31 U.S.C. 9701;
33 U.S.C. 1251 et seq., 1311, 1313d, 1314, 1318, 1321, 1326, 1330,
1342, 1344, 1345 (d) and (e), 1361; E.O. 11735, 38 FR 21243, 3 CFR,
1971-1975 Comp. p. 973; 42 U.S.C. 241, 242b, 243, 246, 300f, 300g,
300g-1, 300g-2, 300g-3, 300g-4, 300g-5, 300g-6, 300j-1, 300j-2,
300j-3, 300j-4, 300j-9, 1857 et seq., 6901-6992k, 7401-7671q, 7542,
9601-9657, 11023, 11048.
0
2. In Sec. 9.1, amend the table by adding entries for Sec. Sec.
721.11687 through 721.11715 in numerical order under the undesignated
center heading ``Significant New Uses of Chemical Substances'' to read
as follows:
Sec. 9.1 OMB approvals under the Paperwork Reduction Act.
* * * * *
------------------------------------------------------------------------
40 CFR citation OMB control No.
------------------------------------------------------------------------
* * * * *
------------------------------------------------------------------------
Significant New Uses of Chemical Substances
------------------------------------------------------------------------
* * * * *
721.11687................................. 2070-0012
721.11688................................. 2070-0012
721.11689................................. 2070-0012
721.11690................................. 2070-0012
721.11691................................. 2070-0012
721.11692................................. 2070-0012
721.11693................................. 2070-0012
721.11694................................. 2070-0012
721.11695................................. 2070-0012
721.11696................................. 2070-0012
721.11697................................. 2070-0012
721.11698................................. 2070-0012
721.11699................................. 2070-0012
721.11700................................. 2070-0012
721.11701................................. 2070-0012
721.11702................................. 2070-0012
721.11703................................. 2070-0012
721.11704................................. 2070-0012
721.11705................................. 2070-0012
721.11706................................. 2070-0012
721.11707................................. 2070-0012
721.11708................................. 2070-0012
721.11709................................. 2070-0012
721.11710................................. 2070-0012
721.11711................................. 2070-0012
721.11712................................. 2070-0012
721.11713................................. 2070-0012
721.11714................................. 2070-0012
721.11715................................. 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. 721.11687 through 721.11715 in numerical order to
subpart E to read as follows:
Sec.
* * * * *
721.11687 Fatty acids, tall-oil polymers with aminoalkyl, dialkyl
alkane diamine, polyalkylene polyamine alkanepolyamine fraction, and
tris-[(alkylamino) alkyl] phenol (generic).
721.11688 Isocyanic acid, polyalkylenepolycycloalkylene ester, 2-
alkoxy alkanol and 1-alkoxy alkanol and alkylene diol blocked
(generic).
721.11689 1,4-Cyclohexanedicarboxylic acid, 1,4-bis(2-ethylhexyl)
ester.
721.11690 Carbomonocylic-oxazolidine (generic).
721.11691 Propoxylated, ethoxylated alkoxyalkyl ether (generic).
721.11692 Phosphoric acid, polymer with 2,2-bis(hydroxymethyl)-1,3-
propanediol and 1,2-ethanediol.
721.11693 2-Propenoic acid, 2-(hydrogenated animal-based nitrogen-
substituted)ethyl ester (generic).
721.11694 2-Propenoic acid, nitrogen-substituted alkyl, N-C16-18-
acyl derivs. (generic).
721.11695 Modified graphene (generic).
721.11696 Maltodextrin, polymer with 2-propenoic acid and N,N,N-
trimethyl-2-[(2-methyl-1-oxo-2-propen-1-yl)oxy]ethanaminium chloride
(1:1), sodium salt, peroxydisulfuric acid ([(HO)S(O)2]2O2) sodium
salt (1:2)-initiated.
721.11697 Ashes (residues), reactions products with dicarboxylic
acid, silicic acid (H4SiO4) tetra-Et ester and 2-[[3-
(trialkoxysilyl)alkoxy]methyl]oxirane (generic) (P-20-112)
721.11698 Ashes (residues), reactions products with substituted
tricarboxylic acid, silicic acid (H4SiO4) tetra-Et ester and 2-[[3-
(trialkoxysilyl)alkoxy]methyl]oxirane (generic) (P-20-113)
721.11699 Ashes (residues), reactions products with dicarboxylic
acid, silicic acid (H4SiO4) tetra-Et ester and 2-[[3-
(trialkoxysilyl)alkoxy]methyl]oxirane (generic) (P-20-114)
721.11700 Ashes (residues), reactions products with substituted
tricarboxylic acid, silicic acid (H4SiO4) tetra-Et ester and 2-[[3-
(trialkoxysilyl)alkoxy]methyl]oxirane (generic) (P-20-115)
721.11701 Ashes (residues), reactions products with dicarboxylic
acid, silicic acid (H4SiO4) tetra-Et ester and 2-[[3-
(trialkoxysilyl)alkoxy]methyl]oxirane (generic) (P-20-116)
721.11702 Ashes (residues), reactions products with dicarboxylic
acid, silicic acid (H4SiO4) tetra-Et ester and 2-[[3-
(trialkoxysilyl)alkoxy]methyl]oxirane (generic) (P-20-117)
721.11703 Silsesquioxanes, alkyl, alkoxy- and hydroxy- terminated
(generic).
721.11704 1,3-Benzenedicarboxylic acid, polymer with 2,2-dimethyl-
1,3-propanediol, 1,2-ethanediol, 2-ethyl-2-(hydroxymethyl)-1,3-
propanediol, hexanedioic acid, 1,6-hexanediol and 1,3-
isobenzofurandione, N-[[1,3,3-trimethyl-5-[[[2-[(1-oxo-2- propen-1-
yl)oxy]ethoxy]carbonyl]amino]cyclohexyl]methyl]carbamate N-[3,3,5-
trimethyl-5-[[[[2-[(1-oxo-2-propen-1-
yl)oxy]ethoxy]carbonyl]amino]methyl]cyclohexyl]carbamate.
721.11705 Methyl phenylethyl cyclopropanemethanol (generic).
721.11706 [(Substituted-carbomonocyclic)amino] oxoalkenoic acid,
inorganic salt (generic).
721.11707 Sulfonium, triphenyl-, heterocyclic compound-carboxylate
(1:1) (generic).
721.11708 Sulfonium, carbocyclic-, salt with 1-(alkyl) 2-[4-
[polyhydro-2-carbomonocyclic-5-(polyfluoro-2-sulfoalkyl)-4,7-
methano-1,3-benzodioxol-2-yl]carbomonocyclic oxy]acetate (1:1)
(generic).
721.11709 Sulfonium, triphenyl-, polyfluoro-polyhydrospiro[9H-
carbopolycyclic-9,2'-[4,7]methano[1,3]benzodioxole]-5'-
alkenesulfonic acid (1:1) (generic).
721.11710 Heteropolycyclic, trihaloalkyl carbomonocycle-, hydroxy
carbomonocyclic salt (generic).
721.11711 Sulfonium, tricarbocyclic-, 2-heteroatom-substituted-4-
(alkyl)carbomonocyclic carboxylate (1:1) (generic).
721.11712 2-Propenoic acid, 2-methyl-, aminoalkyl ester, polymer
with hydroxyalkyl alkenoate and octadecyl alkenoate, acetate (salts)
(generic).
721.11713 Pyrazole-polycarboxylic acid, polyhaloaryl-polyhydro-
alkyl-polyalkyl ester (generic).
721.11714 Alkenoic acid, reaction products with alkylamine-
alkanediyl diacrylate polymer and [oxybis(alkylene)]bis[alkyl-
alkanediol] (generic).
721.11715 Nonane, branched.
* * * * *
[[Page 13702]]
Sec. 721.11687 Fatty acids, tall-oil polymers with aminoalkyl,
dialkyl alkane diamine, polyalkylene polyamine alkanepolyamine
fraction, and tris-[(alkylamino)alkyl] phenol (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as fatty
acids, tall-oil polymers with aminoalkyl, dialkyl alkane diamine,
polyalkylene polyamine alkanepolyamine fraction, and tris-[(alkylamino)
alkyl] phenol (PMN P-18-143) 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 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).
(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 notification requirements.
The provisions of Sec. 721.185 apply to this section.
Sec. 721.11688 Isocyanic acid, polyalkylenepolycycloalkylene ester,
2-alkoxy alkanol and 1-alkoxy alkanol and alkylene diol blocked
(generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
isocyanic acid, polyalkylenepolycycloalkylene ester, 2-alkoxy alkanol
and 1-alkoxy alkanol and alkylene diol blocked (PMN P-18-154) 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) 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 (d), (f), and (g)(1), (3), and (5). For purposes of
Sec. 721.72(g)(1), this substance may cause: skin sensitization;
respiratory sensitization; germ cell mutagenicity. For purposes of
Sec. 721.72(g)(3), this substance may be: toxic to aquatic life.
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(o). It is a significant new use to
manufacture, process, or use the substance in any manner that results
in inhalation exposure.
(iv) 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 (i), and (k) are applicable to manufacturers,
importers, and processors of this substance.
(2) Limitation or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
Sec. 721.11689 1,4-Cyclohexanedicarboxylic acid, 1,4-bis(2-
ethylhexyl) ester.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as 1,4-
cyclohexanedicarboxylic acid, 1,4-bis(2-ethylhexyl) ester (PMN P-18-
273; CAS No. 84731-70-4) 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), (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 1.0%.
(ii) Hazard communication. Requirements as specified in Sec.
721.72(a) through (f) and (g)(1) and (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.
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) and (k).
(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, importers, and
processors of this substance.
(2) Limitation or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
Sec. 721.11690 Carbomonocylic-oxazolidine (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
carbomonocylic-oxazolidine (PMN P-18-290) 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) through (5), (a)(6)(v) and (vi), (b), and (c).
When determining which persons are reasonably likely to be exposed as
required for Sec. 721.63(a)(1) and (4), engineering control measures
(e.g., enclosure or confinement of the operation, general and local
ventilation) or administrative control measures (e.g., workplace
policies and procedures) shall be considered and implemented to prevent
exposure, where feasible. For purposes of Sec. 721.63(a)(5),
respirators must provide a National Institute for Occupational Safety
and Health (NIOSH) assigned protection factor (APF) of at least 10. 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) and (g)(1), (3), and (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; specific target
organ toxicity. For
[[Page 13703]]
purposes of Sec. 721.72(g)(3), this substance may be: toxic to aquatic
life. 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=285.
(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,
importers, and processors of this substance.
(2) Limitation or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
Sec. 721.11691 Propoxylated, ethoxylated alkoxyalkyl ether (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
propoxylated, ethoxylated alkoxyalkyl ether (PMN P-19-73) 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) through (6) and (c). When determining which
persons are reasonably likely to be exposed as required for Sec.
721.63(a)(1) and (4), engineering control measures (e.g., enclosure or
confinement of the operation, general and local ventilation) or
administrative control measures (e.g., workplace policies and
procedures) shall be considered and implemented to prevent exposure,
where feasible. For purposes of Sec. 721.63(a)(5), respirators must
provide a National Institute for Occupational Safety and Health (NIOSH)
assigned protection factor (APF) of at least 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) Hazard communication. Requirements as specified in Sec.
721.72(a) through (d), (f), and (g)(1), (3), and (5). For purposes of
Sec. 721.72(g)(1), this substance may cause: skin irritation; serious
eye damage; specific target organ toxicity. For purposes of Sec.
721.72(g)(3), this substance may be: toxic to aquatic life. 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. It is a
significant new use to process the substance for use in a consumer
product where the concentration of the substance is 1% or greater in
the consumer product formulation.
(iv) Release to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4), and (c)(4), where N=24.
(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,
importers, and processors of this substance.
(2) Limitation or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
Sec. 721.11692 Phosphoric acid, polymer with 2,2-bis(hydroxymethyl)-
1,3-propanediol and 1,2-ethanediol.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as phosphoric acid,
polymer with 2,2-bis(hydroxymethyl)-1,3-propanediol and 1,2-ethanediol
(PMN P-19-98; CAS No. 2248116-55-2) 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 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) through (6), (b), and (c). When determining which
persons are reasonably likely to be exposed as required for Sec.
721.63(a)(1) and (4), engineering control measures (e.g., enclosure or
confinement of the operation, general and local ventilation) or
administrative control measures (e.g., workplace policies and
procedures) shall be considered and implemented to prevent exposure,
where feasible. For purposes of Sec. 721.63(a)(5), respirators must
provide a National Institute for Occupational Safety and Health (NIOSH)
assigned protection factor (APF) of at least 50. For purposes of Sec.
721.63(b), the concentration is set at 1.0%. For purposes of Sec.
721.63(a)(6), the airborne form(s) of the substance include:
particulate (including solids or liquid droplets).
(ii) Hazard communication. Requirements as specified in Sec.
721.72(a) through (f), and (g)(1) and (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; severe eye
damage; 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) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(o). It is a significant new use to use the
substance other than as a flame retardant additive for intumescent
coatings.
(iv) Release to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4), and (c)(4), where N=500.
(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,
importers, and processors of this substance.
(2) Limitation or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
Sec. 721.11693 2-Propenoic acid, 2-(hydrogenated animal-based
nitrogen-substituted)ethyl ester (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as 2-
propenoic acid, 2-(hydrogenated animal-based nitrogen-substituted)ethyl
ester (PMN P-19-122) 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) through (6) and (c). When determining which
persons are reasonably likely to be exposed as required for Sec.
721.63(a)(1) and (4), engineering control measures (e.g., enclosure or
confinement of the operation, general and local ventilation) or
administrative control measures (e.g., workplace policies and
procedures) shall be considered and implemented to prevent exposure,
where feasible. For purposes of Sec. 721.63(a)(5), respirators must
provide a National Institute for
[[Page 13704]]
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).
(ii) Hazard communication. Requirements as specified in Sec.
721.72(a) through (d), (f), and (g)(1), (3), and (5). For purposes of
Sec. 721.72(g)(1), this substance may cause: skin corrosion; serious
eye damage; skin sensitization; reproductive toxicity; specific target
organ toxicity. For purposes of Sec. 721.72(g)(3), this substance may
be: toxic to aquatic life. 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). It is a significant new use to use the
substance in consumer applications.
(iv) 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 (i), and (k) are applicable to manufacturers,
importers, and processors of this substance.
(2) Limitation or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
Sec. 721.11694 2-Propenoic acid, nitrogen-substituted alkyl, N-C16-
18-acyl derivs. (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as 2-
propenoic acid, nitrogen-substituted alkyl, N-C16-18-acyl derivs. (PMN
P-20-83) 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) through (6) and (c). When determining which
persons are reasonably likely to be exposed as required for Sec.
721.63(a)(1) and (4), engineering control measures (e.g., enclosure or
confinement of the operation, general and local ventilation) or
administrative control measures (e.g., workplace policies and
procedures) shall be considered and implemented to prevent exposure,
where feasible. For purposes of Sec. 721.63(a)(5), respirators must
provide a National Institute for Occupational Safety and Health (NIOSH)
assigned protection factor (APF) of at least 50. For purposes of Sec.
721.63(a)(6), the airborne form(s) of the substance include:
particulate (including solids or liquid droplets).
(ii) Hazard communication. Requirements as specified in Sec.
721.72(a) through (d), (f), and (g)(1), (3), and (5). For purposes of
Sec. 721.72(g)(1), this substance may cause: skin corrosion, serious
eye damage, skin sensitization, reproductive toxicity, and specific
target organ toxicity. For purposes of Sec. 721.72(g)(3), this
substance may be: toxic to aquatic life. 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). It is a significant new use to use the
substance in consumer applications.
(iv) 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 (i), and (k) are applicable to manufacturers,
importers, and processors of this substance.
(2) Limitation or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
Sec. 721.11695 Modified graphene (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
modified graphene (PMN P-20-5) 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), embedded into a thermoset polymer resin as an intermediate
step before curing, or embedded into a permanent solid polymer form
that is not intended to undergo further processing, except mechanical
processing or physical blending.
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(1) and (3) through (6) and (c). When determining which
persons are reasonably likely to be exposed as required for Sec.
721.63(a)(1) and (4), engineering control measures (e.g., enclosure or
confinement of the operation, general and local ventilation) or
administrative control measures (e.g., workplace policies and
procedures) shall be considered and implemented to prevent exposure,
where feasible. Where workers are reasonably expected to be exposed by
inhalation to dust from the substance, dust controls shall be
implemented that demonstrate an exposure reduction of at least 90%. 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).
(ii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(f) and (k). It is a significant new use to
use the substance in an application method that results in inhalation
exposure to workers.
(iii) Disposal. Requirements as specified in Sec. 721.85(a)(1) and
(2), (b)(1) and (2), and (c)(1) and (2). It is a significant new use to
release the substance directly to air.
(iv) 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) and (i) through (k) are applicable to
manufacturers, importers, and processors of this substance.
(2) Limitation or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
Sec. 721.11696 Maltodextrin, polymer with 2-propenoic acid and N,N,N-
trimethyl-2-[(2-methyl-1-oxo-2-propen-1-yl)oxy]ethanaminium chloride
(1:1), sodium salt, peroxydisulfuric acid ([(HO)S(O)2]2O2) sodium salt
(1:2)-initiated.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as maltodextrin,
polymer with 2-propenoic acid and N,N,N-trimethyl-2-[(2-methyl-1-oxo-2-
propen-1-yl)oxy]ethanaminium chloride (1:1), sodium salt,
peroxydisulfuric acid ([(HO)S(O)2]2O2) sodium salt (1:2)-initiated (PMN
P-20-58; CAS No. 1646857-41-1) is subject to
[[Page 13705]]
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), (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 1.0%.
(ii) Hazard communication. Requirements as specified in Sec.
721.72(a) through (f) and (g)(1), (3), and (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.
For the purposes of Sec. 721.72(g)(3), this substance may be: toxic to
aquatic life. 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=102.
(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,
importers, and processors of this substance.
(2) Limitation or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
Sec. 721.11697 Ashes (residues), reactions products with dicarboxylic
acid, silicic acid (H4SiO4) tetra-Et ester and 2-[[3-
(trialkoxysilyl)alkoxy]methyl]oxirane (generic) (P-20-112).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as ashes
(residues), reactions products with dicarboxylic acid, silicic acid
(H4SiO4) tetra-Et ester and 2-[[3-(trialkoxysilyl)alkoxy]methyl]oxirane
(PMN P-20-112) 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 incorporated into a polymer
matrix.
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(4) through (6), (b), and (c). When determining which persons
are reasonably likely to be exposed as required for Sec. 721.63(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). For purposes of Sec. 721.63(b), the concentration is
set at 0.1%.
(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 Order for this substance. The NCEL is 0.05 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 under Sec. 721.30. Persons whose Sec. 721.30 requests to use the
NCEL approach are approved by EPA will be required to follow NCEL
provisions comparable to those contained in the corresponding TSCA
Order.
(B) [Reserved]
(ii) Hazard communication. Requirements as specified in Sec.
721.72(a) through (f), (g)(1)(ii) through (ix), and (g)(2) and (5). For
purposes of Sec. 721.72(e), the concentration is set at 0.1%. For
purposes of Sec. 721.72(g)(2), 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 0.05 mg/m\3\; use skin protection. 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). It is a significant new use to
manufacture the substances without sampling and analyzing the immediate
precursor used to manufacture the substances according to the terms
specified in the TSCA Order for the following elements: arsenic,
barium, beryllium, cadmium, chromium, cobalt, copper, lead, manganese,
mercury, nickel, selenium, silver, vanadium, and zinc. It is a
significant new use to manufacture the substances at facilities other
than those equipped with pollution controls, such as a bag house, that
remove particulates from the air at 99% or greater efficiency. It is a
significant new use to process the substances other than in an enclosed
system that does not allow for the release of particulates or at
facilities equipped with pollution controls, such as a bag house, that
remove particulates from the air at 99% or greater efficiency.
(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 (d) and (f) through (i) are applicable to
manufacturers, importers, and processors of this substance.
(2) Limitation or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
Sec. 721.11698 Ashes (residues), reactions products with substituted
tricarboxylic acid, silicic acid (H4SiO4) tetra-Et ester and 2-[[3-
(trialkoxysilyl)alkoxy]methyl] oxirane (generic) (P-20-113).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as ashes
(residues), reactions products with substituted tricarboxylic acid,
silicic acid (H4SiO4) tetra-Et ester and 2-[[3-
(trialkoxysilyl)alkoxy]methyl] oxirane (PMN P-20-113) 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 incorporated into a polymer matrix.
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(4) through (6), (b), and (c). When determining which persons
are reasonably likely to be exposed as required for Sec. 721.63(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
[[Page 13706]]
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). For purposes of Sec. 721.63(b), the concentration is
set at 0.1%.
(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 Order for this substance. The NCEL is 0.05 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 under Sec. 721.30. Persons whose Sec. 721.30 requests to use the
NCEL approach are approved by EPA will be required to follow NCEL
provisions comparable to those contained in the corresponding TSCA
Order.
(B) [Reserved]
(ii) Hazard communication. Requirements as specified in Sec.
721.72(a) through (f), (g)(1)(ii) through (ix), and (g)(2) and (5). For
purposes of Sec. 721.72(e), the concentration is set at 0.1%. For
purposes of Sec. 721.72(g)(2), 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 0.05 mg/m\3\; use skin protection. 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). It is a significant new use to
manufacture the substances without sampling and analyzing the immediate
precursor used to manufacture the substances according to the terms
specified in the TSCA Order for the following elements: arsenic,
barium, beryllium, cadmium, chromium, cobalt, copper, lead, manganese,
mercury, nickel, selenium, silver, vanadium, and zinc. It is a
significant new use to manufacture the substances at facilities other
than those equipped with pollution controls, such as a bag house, that
remove particulates from the air at 99% or greater efficiency. It is a
significant new use to process the substances other than in an enclosed
system that does not allow for the release of particulates or at
facilities equipped with pollution controls, such as a bag house, that
remove particulates from the air at 99% or greater efficiency.
(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 (d) and (f) through (i) are applicable to
manufacturers, importers, and processors of this substance.
(2) Limitation or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
Sec. 721.11699 Ashes (residues), reactions products with dicarboxylic
acid, silicic acid (H4SiO4) tetra-Et ester and 2-[[3-
(trialkoxysilyl)alkoxy]methyl]oxirane (generic) (P-20-114).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as ashes
(residues), reactions products with dicarboxylic acid, silicic acid
(H4SiO4) tetra-Et ester and 2-[[3-(trialkoxysilyl)alkoxy]methyl]oxirane
(PMN P-20-114) 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 incorporated into a polymer
matrix.
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in Sec.
721.63 (a)(4) 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 50. 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 0.1%.
(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 Order for this substance. The NCEL is 0.05 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 under Sec. 721.30. Persons whose Sec. 721.30 requests to use the
NCEL approach are approved by EPA will be required to follow NCEL
provisions comparable to those contained in the corresponding TSCA
Order.
(B) [Reserved]
(ii) Hazard communication. Requirements as specified in Sec.
721.72(a) through (f), (g)(1)(ii) through (ix), (g)(2) and (g)(5). For
purposes of Sec. 721.72(e), the concentration is set at 0.1%. For
purposes of Sec. 721.72(g)(2), 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 0.05 mg/m\3\; use skin protection. 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). It is a significant new use to
manufacture the substances without sampling and analyzing the immediate
precursor used to manufacture the substances according to the terms
specified in the TSCA Order for the following elements: arsenic,
barium, beryllium, cadmium, chromium, cobalt, copper, lead, manganese,
mercury, nickel, selenium, silver, vanadium, and zinc. It is a
significant new use to manufacture the substances at facilities other
than those equipped with pollution controls, such as a bag house, that
remove particulates from the air at 99% or greater efficiency. It is a
significant new use to process the substances other than in an enclosed
system that does not allow for the release of particulates or at
facilities equipped with pollution controls, such as a bag house, that
remove particulates from the air at 99% or greater efficiency.
(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 (d) and (f) through (i) are applicable to
manufacturers, importers, and processors of this substance.
(2) Limitation or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
[[Page 13707]]
Sec. 721.11700 Ashes (residues), reactions products with substituted
tricarboxylic acid, silicic acid (H4SiO4) tetra-Et ester and 2-[[3-
(trialkoxysilyl)alkoxy]methyl] oxirane (generic) (P-20-115).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as ashes
(residues), reactions products with substituted tricarboxylic acid,
silicic acid (H4SiO4) tetra-Et ester and 2-[[3-
(trialkoxysilyl)alkoxy]methyl] oxirane (PMN P-20-115) 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 incorporated into a polymer matrix.
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(4) through (6), (b), and (c). When determining which persons
are reasonably likely to be exposed as required for Sec. 721.63(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). For purposes of Sec. 721.63(b), the concentration is
set at 0.1%.
(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 Order for this substance. The NCEL is 0.05 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 under Sec. 721.30. Persons whose Sec. 721.30 requests to use the
NCEL approach are approved by EPA will be required to follow NCEL
provisions comparable to those contained in the corresponding TSCA
Order.
(B) [Reserved]
(ii) Hazard communication. Requirements as specified in Sec.
721.72(a) through (f), (g)(1)(ii) through (ix), and (g)(2) and (5). For
purposes of Sec. 721.72(e), the concentration is set at 0.1%. For
purposes of Sec. 721.72(g)(2), 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 0.05 mg/m\3\; use skin protection. 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). It is a significant new use to
manufacture the substances without sampling and analyzing the immediate
precursor used to manufacture the substances according to the terms
specified in the TSCA Order for the following elements: arsenic,
barium, beryllium, cadmium, chromium, cobalt, copper, lead, manganese,
mercury, nickel, selenium, silver, vanadium, and zinc. It is a
significant new use to manufacture the substances at facilities other
than those equipped with pollution controls, such as a bag house, that
remove particulates from the air at 99% or greater efficiency. It is a
significant new use to process the substances other than in an enclosed
system that does not allow for the release of particulates or at
facilities equipped with pollution controls, such as a bag house, that
remove particulates from the air at 99% or greater efficiency.
(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 (d) and (f) through (i) are applicable to
manufacturers, importers, and processors of this substance.
(2) Limitation or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
Sec. 721.11701 Ashes (residues), reactions products with dicarboxylic
acid, silicic acid (H4SiO4) tetra-Et ester and 2-[[3-
(trialkoxysilyl)alkoxy]methyl]oxirane (generic) (P-20-116).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as ashes
(residues), reactions products with dicarboxylic acid, silicic acid
(H4SiO4) tetra-Et ester and 2-[[3-(trialkoxysilyl)alkoxy]methyl]oxirane
(PMN P-20-116) 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 incorporated into a polymer
matrix.
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(4) through (6), (b), and (c). When determining which persons
are reasonably likely to be exposed as required for Sec. 721.63(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. For purposes of Sec. 721.63(b), the
concentration is set at 0.1%.
(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 Order for this substance. The NCEL is 0.05 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 under Sec. 721.30. Persons whose Sec. 721.30 requests to use the
NCEL approach are approved by EPA will be required to follow NCEL
provisions comparable to those contained in the corresponding TSCA
Order.
(B) [Reserved]
(ii) Hazard communication. Requirements as specified in Sec.
721.72(a) through (f), (g)(1)(ii) through (ix), and (g)(2) and (5). For
purposes of Sec. 721.72(e), the concentration is set at 0.1%. For
purposes of Sec. 721.72(g)(2), 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 0.05 mg/m\3\; use skin protection. 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). It is a significant new use to
manufacture the substances without sampling and analyzing the immediate
precursor used to manufacture the substances according to the terms
specified in the TSCA Order for the following elements:
[[Page 13708]]
arsenic, barium, beryllium, cadmium, chromium, cobalt, copper, lead,
manganese, mercury, nickel, selenium, silver, vanadium, and zinc. It is
a significant new use to manufacture the substances at facilities other
than those equipped with pollution controls, such as a bag house, that
remove particulates from the air at 99% or greater efficiency. It is a
significant new use to process the substances other than in an enclosed
system that does not allow for the release of particulates or at
facilities equipped with pollution controls, such as a bag house, that
remove particulates from the air at 99% or greater efficiency.
(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 (d) and (f) through (i) are applicable to
manufacturers, importers, and processors of this substance.
(2) Limitation or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
Sec. 721.11702 Ashes (residues), reactions products with dicarboxylic
acid, silicic acid (H4SiO4) tetra-Et ester and 2-[[3-
(trialkoxysilyl)alkoxy]methyl]oxirane (generic) (P-20-117).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as ashes
(residues), reactions products with dicarboxylic acid, silicic acid
(H4SiO4) tetra-Et ester and 2-[[3-(trialkoxysilyl)alkoxy]methyl]oxirane
(PMN P-20-117) 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 incorporated into a polymer
matrix.
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(4) through (6), (b), and (c). When determining which persons
are reasonably likely to be exposed as required for Sec. 721.63(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). For purposes of Sec. 721.63(b), the concentration is
set at 0.1%.
(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 Order for this substance. The NCEL is 0.05 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 under Sec. 721.30. Persons whose Sec. 721.30 requests to use the
NCEL approach are approved by EPA will be required to follow NCEL
provisions comparable to those contained in the corresponding TSCA
Order.
(B) [Reserved]
(ii) Hazard communication. Requirements as specified in Sec.
721.72(a) through (f), (g)(1)(ii) through (ix), (g)(2) and (g)(5). For
purposes of Sec. 721.72(e), the concentration is set at 0.1%. For
purposes of Sec. 721.72(g)(2), 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 0.05 mg/m\3\; use skin protection. 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). It is a significant new use to
manufacture the substances without sampling and analyzing the immediate
precursor used to manufacture the substances according to the terms
specified in the TSCA Order for the following elements: arsenic,
barium, beryllium, cadmium, chromium, cobalt, copper, lead, manganese,
mercury, nickel, selenium, silver, vanadium, and zinc. It is a
significant new use to manufacture the substances at facilities other
than those equipped with pollution controls, such as a bag house, that
remove particulates from the air at 99% or greater efficiency. It is a
significant new use to process the substances other than in an enclosed
system that does not allow for the release of particulates or at
facilities equipped with pollution controls, such as a bag house, that
remove particulates from the air at 99% or greater efficiency.
(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 (d) and (f) through (i) are applicable to
manufacturers, importers, and processors of this substance.
(2) Limitation or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
Sec. 721.11703 Silsesquioxanes, alkyl, alkoxy- and hydroxy-
terminated (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
silsesquioxanes, alkyl, alkoxy- and hydroxy- terminated (PMN P-20-173)
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) through (6), (b), and (c). When determining which
persons are reasonably likely to be exposed as required for Sec.
721.63(a)(1) and (4), engineering control measures (e.g., enclosure or
confinement of the operation, general and local ventilation) or
administrative control measures (e.g., workplace policies and
procedures) shall be considered and implemented to prevent exposure,
where feasible. For purposes of Sec. 721.63(a)(5), respirators must
provide a National Institute for Occupational Safety and Health (NIOSH)
assigned protection factor (APF) of at least 10. For purposes of Sec.
721.63(b), the concentration is set at 1.0%. For purposes of Sec.
721.63(a)(6), the airborne form(s) of the substance include:
particulate (including solids or liquid droplets).
(ii) Hazard communication. Requirements as specified in Sec.
721.72(a) through (f) and (g)(1), (3), and (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; serious eye damage; specific target organ toxicity. For
purposes of Sec. 721.72(g)(3), this substance may cause: aquatic
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
[[Page 13709]]
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,
importers, and processors of this substance.
(2) Limitation or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
Sec. 721.11704 1,3-Benzenedicarboxylic acid, polymer with 2,2-
dimethyl-1,3-propanediol, 1,2-ethanediol, 2-ethyl-2-(hydroxymethyl)-
1,3-propanediol, hexanedioic acid, 1,6-hexanediol and 1,3-
isobenzofurandione, N-[[1,3,3-trimethyl-5-[[[2-[(1-oxo-2- propen-1-
yl)oxy]ethoxy]carbonyl]amino]cyclohexyl]methyl]carbamate N-[3,3,5-
trimethyl-5-[[[[2-[(1-oxo-2-propen-1-
yl)oxy]ethoxy]carbonyl]amino]methyl]cyclohexyl]carbamate.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as 1,3-
benzenedicarboxylic acid, polymer with 2,2-dimethyl-1,3-propanediol,
1,2-ethanediol, 2-ethyl-2-(hydroxymethyl)-1,3-propanediol, hexanedioic
acid, 1,6-hexanediol and 1,3-isobenzofurandione, N-[[1,3,3-trimethyl-5-
[[[2-[(1-oxo-2-propen-1-
yl)oxy]ethoxy]carbonyl]amino]cyclohexyl]methyl]carbamate N-[3,3,5-
trimethyl-5-[[[[2-[(1-oxo-2-propen-1-
yl)oxy]ethoxy]carbonyl]amino]methyl]cyclohexyl]carbamate (PMN P-21-10;
CAS No. 2460376-09-2) 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
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) Hazard communication. Requirements as specified in Sec.
721.72(a) through (d), (f), and (g)(1) and (5). For purposes of Sec.
721.72(g)(1), this substance may cause: skin irritation, eye
irritation, skin sensitization, and respiratory sensitization.
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(o). It is a significant new use to
manufacture, process, or use the substance in any manner that results
in inhalation exposure.
(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, importers, and
processors of this substance.
(2) Limitation or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
Sec. 721.11705 Methyl phenylethyl cyclopropanemethanol (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as methyl
phenylethyl cyclopropanemethanol (PMN P-21-13) 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) through (5), (a)(6)(v) and (vi), and (c). When
determining which persons are reasonably likely to be exposed as
required for Sec. 721.63(a)(1) and (4), engineering control measures
(e.g., enclosure or confinement of the operation, general and local
ventilation) or administrative control measures (e.g., workplace
policies and procedures) shall be considered and implemented to prevent
exposure, where feasible. For purposes of Sec. 721.63(a)(5),
respirators must provide a National Institute for Occupational Safety
and Health (NIOSH) assigned protection factor (APF) of at least 50.
(ii) Hazard communication. Requirements as specified in Sec.
721.72(a) through (d), (f), and (g)(1), (3), and (5). For purposes of
Sec. 721.72(g)(1), this substance may cause: eye irritation; skin
sensitization. For purposes of Sec. 721.72(g)(3), this substance may
be: toxic to aquatic life. 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. It is a
significant new use to use the substance in consumer products unless
the concentration of the substance is less than 1%.
(iv) 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 (i) and (k) are applicable to manufacturers,
importers, and processors of this substance.
(2) Limitation or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
Sec. 721.11706 [(Substituted-carbomonocyclic)amino] oxoalkenoic acid,
inorganic salt (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
[(substituted-carbomonocyclic)amino] oxoalkenoic acid, inorganic salt
(PMN P-21-17) 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) through (6), and (c). When determining which
persons are reasonably likely to be exposed as required for Sec.
721.63(a)(1) and (4), engineering control measures (e.g., enclosure or
confinement of the operation, general and local ventilation) or
administrative control measures (e.g., workplace policies and
procedures) shall be considered and implemented to prevent exposure,
where feasible. For purposes of Sec. 721.63(a)(5), respirators must
provide a National Institute for Occupational Safety and Health (NIOSH)
assigned protection factor (APF) of at least 50. For purposes of Sec.
721.63(a)(6), the airborne form(s) of the substance include:
particulate (including solids or liquid droplets).
(ii) Hazard communication. Requirements as specified in Sec.
721.72(a) through (d), (f), and (g)(1) and (5). For purposes of Sec.
721.72(g)(1), this substance may cause: 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) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(f). It is a significant
[[Page 13710]]
new use to use the substance other than as an additive to improve
physical properties in rubber products.
(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, importers, and
processors of this substance.
(2) Limitation or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
Sec. 721.11707 Sulfonium, triphenyl-, heterocyclic compound-
carboxylate (1:1) (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
sulfonium, triphenyl-, heterocyclic compound-carboxylate (1:1) (PMN P-
21-18) 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
photolithographic processes) 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%. 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 substance other than in solution, unless in sealed
containers weighing 5 kilograms or less. It is a significant new use to
process the substance in any way that generates dust, mist, or aerosol
in a non-enclosed process. It is a significant new use to manufacture
the 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, importers, and
processors of this substance.
(2) Limitation or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
Sec. 721.11708 Sulfonium, carbocyclic-, salt with 1-(alkyl) 2-[4-
[polyhydro-2-carbomonocyclic-5-(polyfluoro-2-sulfoalkyl)-4,7-methano-
1,3-benzodioxol-2-yl]carbomonocyclic oxy]acetate (1:1) (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
sulfonium, carbocyclic-, salt with 1-(alkyl) 2-[4-[polyhydro-2-
carbomonocyclic-5-(polyfluoro-2-sulfoalkyl)-4,7-methano-1,3-
benzodioxol-2-yl]carbomonocyclic oxy]acetate (1:1) (PMN P-21-23) 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 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%. 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 substance other than in solution, unless in sealed
containers weighing 5 kilograms or less. It is a significant new use to
process the substance in any way that generates dust, mist, or aerosol
in a non-enclosed process. It is a significant new use to manufacture
the 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, importers, and
processors of this substance.
(2) Limitation or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
Sec. 721.11709 Sulfonium, triphenyl-, polyfluoro-polyhydrospiro[9H-
carbopolycyclic-9,2'-[4,7]methano[1,3]benzodioxole]-5'-alkenesulfonic
acid (1:1) (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
sulfonium, triphenyl-, polyfluoro-polyhydrospiro[9H-carbopolycyclic-
9,2'-[4,7]methano[1,3]benzodioxole]-5'-alkenesulfonic acid (1:1) (PMN
P-21-64) 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 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
[[Page 13711]]
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%. 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 substance other than in solution, unless in sealed
containers weighing 5 kilograms or less. It is a significant new use to
process the substance in any way that generates dust, mist, or aerosol
in a non-enclosed process. It is a significant new use to manufacture
the 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, importers, and
processors of this substance.
(2) Limitation or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
Sec. 721.11710 Heteropolycyclic, trihaloalkyl carbomonocycle-,
hydroxy carbomonocyclic salt (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
heteropolycyclic, trihaloalkyl carbomonocycle-, hydroxy carbomonocyclic
salt (PMN P-21-27) 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
photolithographic processes) 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%. 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 substance other than in solution, unless in sealed
containers weighing 5 kilograms or less. It is a significant new use to
process the substance in any way that generates dust, mist, or aerosol
in a non-enclosed process. It is a significant new use to manufacture
the 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, importers, and
processors of this substance.
(2) Limitation or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
Sec. 721.11711 Sulfonium, tricarbocyclic-, 2-heteroatom-substituted-
4-(alkyl)carbomonocyclic carboxylate (1:1) (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
sulfonium, tricarbocyclic-, 2-heteroatom-substituted-4-
(alkyl)carbomonocyclic carboxylate (1:1) (PMN P-21-42) 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 photolithographic processes) 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%. 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 substance other than in solution, unless in sealed
containers weighing 5 kilograms or less. It is a significant new use to
process the substance in any way that generates dust, mist, or aerosol
in a non-enclosed process. It is a significant new use to manufacture
the 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, importers, and
processors of this substance.
(2) Limitation or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
[[Page 13712]]
Sec. 721.11712 2-Propenoic acid, 2-methyl-, aminoalkyl ester, polymer
with hydroxyalkyl alkenoate and octadecyl alkenoate, acetate (salts)
(generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as 2-
propenoic acid, 2-methyl-, aminoalkyl ester, polymer with hydroxyalkyl
alkenoate and octadecyl alkenoate, acetate (salts) (PMN P-21-54) 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 incorporated into an article as defined at Sec. 720.3(c).
(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 1.0%.
(ii) Hazard communication. Requirements as specified in Sec.
721.72(a) through (f), and (g)(1), (3), and (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; and specific target organ toxicity. For purposes of Sec.
721.72(g)(3), this substance may be: toxic to aquatic life. 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. It is a
significant new use to manufacture or process the substance in any
manner that results in inhalation exposure. It is a significant new use
to use the substance in an application method that results in
inhalation exposure. It is a significant new use to use the substance
in a product that is applied by a consumer.
(iv) Release to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4), and (c)(4), where N=52. Before totaling the
releases of the substance to water from all operations at a site as
described in 40 CFR 721.91(a)(5), you may subtract up to 90 percent for
any releases that will be treated using primary and secondary
wastewater treatment as defined in 40 CFR part 133.
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (i) and (k) are applicable to manufacturers,
importers, and processors of this substance.
(2) Limitation or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
Sec. 721.11713 Pyrazole-polycarboxylic acid, polyhaloaryl-polyhydro-
alkyl-polyalkyl ester (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
pyrazole-polycarboxylic acid, polyhaloaryl-polyhydro-alkyl-polyalkyl
ester (PMN P-21-63) 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 1.0%.
(ii) Hazard communication. Requirements as specified in Sec.
721.72(a) through (f), and (g)(1), (3), and (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; reproductive toxicity; specific target organ toxicity. For
purposes of Sec. 721.72(g)(3), this substance may be: toxic to aquatic
life. 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(o).
(iv) 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 (i) and (k) are applicable to manufacturers,
importers, and processors of this substance.
(2) Limitation or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
Sec. 721.11714 Alkenoic acid, reaction products with alkylamine-
alkanediyl diacrylate polymer and [oxybis(alkylene)]bis[alkyl-
alkanediol] (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
alkenoic acid, reaction products with alkylamine-alkanediyl diacrylate
polymer and [oxybis(alkylene)]bis[alkyl-alkanediol] (PMN P-21-65) 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) through (6) and (c). When determining which
persons are reasonably likely to be exposed as required for Sec.
721.63(a)(1) and (4), engineering control measures (e.g., enclosure or
confinement of the operation, general and local ventilation) or
administrative control measures (e.g., workplace policies and
procedures) shall be considered and implemented to prevent exposure,
where feasible. For purposes of Sec. 721.63(a)(5), respirators must
provide a National Institute for Occupational Safety and Health (NIOSH)
assigned protection factor (APF) of at least 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) Hazard communication. Requirements as specified in Sec.
721.72(a) through (d), (f), and (g)(1) and (5). 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.
(iii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(o). It is a significant new use to use the
substance in a spray application.
(b) Specific requirements. The provisions of subpart A of this part
[[Page 13713]]
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, importers, and
processors of this substance.
(2) Limitation or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
Sec. 721.11715 Nonane, branched.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as nonane, branched
(PMN P-21-125; CAS No. 85408-10-2) is subject to reporting under this
section for the significant new uses described in paragraph (a)(2) of
this section.
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(1) and (3) through (5), (a)(6)(v) and (vi), (b), and (c).
When determining which persons are reasonably likely to be exposed as
required for Sec. 721.63(a)(1) and (4), engineering control measures
(e.g., enclosure or confinement of the operation, general and local
ventilation) or administrative control measures (e.g., workplace
policies and procedures) shall be considered and implemented to prevent
exposure, where feasible. For purposes of Sec. 721.63(a)(5),
respirators must provide a National Institute for Occupational Safety
and Health (NIOSH) assigned protection factor (APF) of at least 50. For
purposes of Sec. 721.63(b), the concentration is set at 1.0%.
(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 Order for this substance. The NCEL is 0.72 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 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
Order.
(B) [Reserved]
(ii) Hazard communication. Requirements as specified in Sec.
721.72(a) through (f), and (g)(1), (3), and (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; reproductive toxicity; specific target organ toxicity;
aspiration hazard. For purposes of Sec. 721.72(g)(3), this substance
may be: toxic to aquatic life. 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)(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 (i) and (k) are applicable to manufacturers,
importers, and processors of this substance.
(2) Limitation or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
[FR Doc. 2023-04157 Filed 3-3-23; 8:45 am]
BILLING CODE 6560-50-P