[Federal Register Volume 89, Number 161 (Tuesday, August 20, 2024)]
[Proposed Rules]
[Pages 67368-67394]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-18259]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Parts 721 and 725
[EPA-HQ-OPPT-2024-0074; FRL-11916-01-OCSPP]
RIN 2070-AB27
Significant New Use Rules on Certain Chemical Substances (24-
1.5e)
AGENCY: Environmental Protection Agency (EPA).
ACTION: Proposed rule.
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SUMMARY: EPA is proposing significant new use rules (SNURs) under the
Toxic Substances Control Act (TSCA) for chemical substances that were
the subject of premanufacture notices (PMNs) and a Microbial Commercial
Activity Notice (MCAN) and are also subject to a TSCA Order. 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 proposed 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 conditions of
use for that chemical substance. In addition, the manufacture or
processing for the significant new use may not commence until EPA has
conducted a review of the required notification, made an appropriate
determination regarding that notification, and taken such actions as
required by that determination.
DATES: Comments must be received on or before September 19, 2024.
ADDRESSES: Submit your comments, identified by docket identification
(ID) number EPA-HQ-OPPT-2024-0074, at https://www.regulations.gov.
Follow the online instructions for submitting comments. Do not submit
electronically any information you consider to be Confidential Business
Information (CBI) or other information whose disclosure is restricted
by statute. Additional instructions on commenting and visiting the
docket, along with more information about dockets generally, is
available at https://www.epa.gov/dockets.
FOR FURTHER INFORMATION CONTACT:
For technical information contact: William Wysong, New Chemicals
Division (7405M), Office of Pollution Prevention and Toxics,
Environmental
[[Page 67369]]
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. Executive Summary
A. 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 factors in TSCA section 5(a)(2) (see
also the discussion in Unit II.).
B. What action is the Agency taking?
EPA is proposing SNURs for the chemical substances discussed in
Unit III. These SNURs, if finalized as proposed, would require persons
who intend to manufacture or process any of these chemical substances
for an activity that is designated as a significant new use to notify
EPA at least 90 days before commencing that activity.
C. Does this action apply to me?
1. General Applicability
This action applies to you if you manufacture, process, or use the
chemical substances identified in Unit III. This may include entities
in North American Industrial Classification System (NAICS) codes 325
and 324110, e.g., chemical manufacturing and petroleum refineries.
2. Applicability to Importers and Exporters
This action may also apply to certain entities through pre-existing
import certification and export notification requirements under TSCA
(https://www.epa.gov/tsca-import-export-requirements).
Chemical importers are subject to TSCA section 13 (15 U.S.C. 2612),
the requirements promulgated at 19 CFR 12.118 through 12.127 (see also
19 CFR 127.28), and the EPA policy in support of import certification
at 40 CFR part 707, subpart B. Chemical importers must certify that the
shipment of the chemical substance complies with all applicable rules
and orders under TSCA, including regulations issued under TSCA sections
5, 6, 7 and Title IV.
Pursuant to 40 CFR 721.20, or 40 CFR 725.920 (for the
microorganism), any persons who export or intend to export a chemical
substance that is the subject of this proposed rule on or after
September 19, 2024 are subject to TSCA section 12(b) (15 U.S.C.
2611(b)) and must comply with the export notification requirements in
40 CFR part 707, subpart D.
D. What are the incremental economic impacts of this action?
EPA has evaluated the potential costs of establishing SNUN
reporting requirements for potential manufacturers (including
importers) and processors of the chemical substances subject to these
proposed SNURs. This analysis, which is available in the docket, is
briefly summarized here.
1. Estimated Costs for SNUN Submissions
If a SNUN is submitted, costs are an estimated $45,000 per SNUN
submission for large business submitters and $14,500 for small business
submitters. These estimates include the cost to prepare and submit the
SNUN (including registration for EPA's Central Data Exchange (CDX)),
and the payment of a user fee. Businesses that submit a SNUN would be
subject to either a $37,000 user fee required by 40 CFR
700.45(c)(2)(ii) and (d), or, if they are a small business as defined
at 13 CFR 121.201, a reduced user fee of $6,480 (40 CFR
700.45(c)(1)(ii) and (d)) per fiscal year 2022. The costs of submission
for SNUNs will not be incurred by any company unless a company decides
to pursue a significant new use as defined in these SNURs.
Additionally, these estimates reflect the costs and fees as they are
known at the time of this rulemaking.
2. Estimated Costs for Export Notifications
EPA has also evaluated the potential costs associated with the
export notification requirements under TSCA section 12(b) and the
implementing regulations at 40 CFR part 707, subpart D. For persons
exporting a substance that is the subject of a SNUR, a one-time notice
to EPA must be provided for the first export or intended export to a
particular country. The total costs of export notification will vary by
chemical, depending on the number of required notifications (i.e., the
number of countries to which the chemical is exported). While EPA is
unable to make any estimate of the likely number of export
notifications for the chemical substances covered by these SNURs, as
stated in the accompanying economic analysis, the estimated cost of the
export notification requirement on a per unit basis is approximately
$106.
E. What should I consider as I prepare my comments for EPA?
1. Submitting CBI
Do not submit CBI to EPA through email or https://www.regulations.gov. If you wish to include CBI in your comment, please
follow the applicable instructions at https://www.epa.gov/dockets/commenting-epa-dockets#rules and clearly mark the information that you
claim to be CBI. Information so marked will not be disclosed except in
accordance with procedures set forth in 40 CFR parts 2 and 703.
2. Tips for Preparing Your Comments
When preparing and submitting your comments, see the commenting
tips at https://www.epa.gov/dockets/commenting-epa-dockets.
II. Background
This unit provides general information about SNURs. For additional
information about EPA's new chemical program go to https://www.epa.gov/reviewing-new-chemicals-under-toxic-substances-control-act-tsca.
A. Significant New Use Determination Factors
TSCA section 5(a)(2) states that EPA's determination that a use of
a chemical substance is a significant new use must be made after
consideration of all relevant factors, including:
The projected volume of manufacturing and processing of a
chemical substance.
The extent to which a use changes the type or form of
exposure of human beings or the environment to a chemical substance.
The extent to which a use increases the magnitude and
duration of exposure of human beings or the environment to a chemical
substance.
The reasonably anticipated manner and methods of
manufacturing, processing, distribution in commerce, and disposal of a
chemical substance.
In determining what would constitute a significant new use for the
chemical substances that are the subject of these SNURs, EPA considered
relevant information about the toxicity of the chemical substances, and
potential human exposures and environmental releases that may be
associated with the substances, in the context of the four bulleted
TSCA section 5(a)(2) factors
[[Page 67370]]
listed in this unit and discussed in Unit III.
These proposed SNURs include PMN and MCAN 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). The TSCA Orders
require protective measures to limit exposures or otherwise mitigate
the potential unreasonable risk. The proposed 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).
B. Rationale and Objectives of the SNURs
1. Rationale
Under TSCA, no person may manufacture a new chemical substance or
manufacture or process a chemical substance for a significant new use
until EPA makes a determination as described in TSCA section 5(a) and
takes any required action. The issuance of a SNUR is not a risk
determination itself, only a notification requirement for ``significant
new uses,'' so that the Agency has the opportunity to review the SNUN
for the significant new use and make a TSCA section 5(a)(3) risk
determination.
During review of the PMN/MCAN submitted for these chemical
substances, 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 these
chemical substances. The basis for such findings is outlined in Unit
IV. Based on these findings, TSCA Orders requiring the use of
appropriate exposure controls were negotiated with the PMN/MCAN
submitters. As a general matter, EPA believes it is necessary to follow
the 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.
2. Objectives
EPA is proposing these SNURs because the Agency wants:
To 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).
To have an opportunity to review and evaluate data
submitted in a SNUN before the submitter begins manufacturing or
processing a listed chemical substance for the described significant
new use.
To be obligated to make a determination under TSCA section
5(a)(3) regarding the use described in the SNUN, under the conditions
of use. The Agency will either determine under TSCA section 5(a)(3)(C)
that the significant new use is not likely to present an unreasonable
risk, including an unreasonable risk to a potentially exposed or
susceptible subpopulation identified as relevant by the Administrator
under the conditions of use, or make a determination under TSCA section
5(a)(3)(A) or (B) and take the required regulatory action associated
with the determination, before manufacture or processing for the
significant new use of the chemical substance can occur.
Issuance of a proposed 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 at https://www.epa.gov/tsca-inventory.
C. Significant New Uses Claimed as CBI
EPA is proposing to establish certain significant new uses which
have been claimed as CBI subject to Agency confidentiality regulations
at 40 CFR part 2, 40 CFR part 720, subpart E. Absent a final
determination or other disposition of the confidentiality claim under
40 CFR part 2 procedures, EPA is required to keep this information
confidential. EPA promulgated a procedure at 40 CFR 721.11 to deal with
the situation where a specific significant new use is CBI.
Under these procedures, a manufacturer or processor may request EPA
to determine whether a specific use would be a significant new use
under the rule. The manufacturer or processor must show that it has a
bona fide intent to manufacture or process the chemical substance and
must identify the specific use for which it intends to manufacture or
process the chemical substance. If EPA concludes that the person has
shown a bona fide intent to manufacture or process the chemical
substance, EPA will tell the person whether the use identified in the
bona fide submission would be a significant new use under the rule.
Since most of the chemical identities of the chemical substances
subject to these SNURs are also CBI, manufacturers and processors can
request if a substance is subject to a SNUR and whether a specific use
would be a significant new use under the rule in a single bona fide
submission.
If EPA determines that the use identified in the bona fide
submission would not be a significant new use, i.e., the use does not
meet the criteria specified in the rule for a significant new use, that
person can manufacture or process the chemical substance so long as the
significant new use trigger is not met. In the case of a production
volume trigger, this means that the aggregate annual production volume
does not exceed that identified in the bona fide submission to EPA.
Because of confidentiality concerns, EPA does not typically disclose
the actual production volume that constitutes the use trigger. Thus, if
the person later intends to exceed that volume, a new bona fide
submission would be necessary to determine whether that higher volume
would be a significant new use.
D. Applicability of General Provisions
General provisions for SNURs appear in 40 CFR part 721, subpart A.
These provisions describe persons subject to SNURs, recordkeeping
requirements, exemptions to reporting requirements, and applicability
of the rule to uses occurring before the effective date of the rule.
Pursuant to 40 CFR 721.1(c), persons subject to SNURs must comply with
the same requirements and EPA regulatory procedures as submitters of
PMNs under TSCA section 5(a)(1)(A). In particular, these requirements
include the information submission requirements of TSCA sections 5(b)
and 5(d)(1), the exemptions authorized by TSCA sections 5(h)(1),
5(h)(2), 5(h)(3), and 5(h)(5) and the regulations at 40 CFR part 720.
In addition, provisions relating to user fees appear at 40 CFR part
700.
Once EPA receives a SNUN, EPA must either determine that the
significant new use is not likely to present an unreasonable risk of
injury under the conditions of use for the chemical substance or take
such regulatory action as is associated with an alternative
determination under TSCA section 5 before the manufacture (including
import) or processing for the significant new use can commence. If EPA
determines that the conditions of use of the chemical substance is not
likely to present an unreasonable risk, EPA is required under TSCA
section 5(g) to publish a statement of EPA's findings in the Federal
Register.
As discussed in Unit I.C.2., persons who export or intend to export
a chemical substance identified in a proposed or final SNUR are subject
to the export notification provisions of
[[Page 67371]]
TSCA section 12(b), and persons who import a chemical substance
identified in a final SNUR are subject to the TSCA section 13 import
certification requirements. See also https://www.epa.gov/tsca-import-export-requirements.
E. Applicability of the Proposed SNURs to Uses Occurring Before the
Effective Date of the Final Rule
To establish a significant new use, EPA must determine that the use
is not ongoing. The chemical substances subject to this proposed rule
have undergone premanufacture review and received determinations under
TSCA section 5(a)(3)(C). TSCA Orders have been issued for these
chemical substances and the PMN/MCAN submitters are required by the
TSCA Orders to submit a SNUN before undertaking activities that would
be designated as significant new uses in these SNURs. Additionally, the
identities of many of the chemical substances subject to this proposed
rule have been claimed as confidential per 40 CFR 720.85, further
reducing the likelihood that another party would manufacture or process
the substances for an activity that would be designated as a
significant new use. Based on this, the Agency believes that it is
highly unlikely that any of the significant new uses identified in Unit
III. are ongoing.
When the chemical substances identified in Unit III. 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. Persons who begin manufacture or processing of the
chemical substances for a significant new use identified on or after
the designated cutoff date specified in Unit III.A. would have to cease
any such activity upon the effective date of the final rule. To resume
their activities, these persons would have to first comply with all
applicable SNUR notification requirements and EPA would have to take
action under TSCA section 5 allowing manufacture or processing to
proceed.
F. Important Information About SNUN Submissions
1. SNUN Submissions
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 at https://www.epa.gov/reviewing-new-chemicals-under-toxic-substances-control-act-tsca.
2. Development and Submission of Information.
EPA recognizes that TSCA section 5 does not require development of
any particular new information (e.g., generating test data) before
submission of a SNUN. There is an exception: If a person is required to
submit information for a chemical substance pursuant to a rule, order
or consent agreement under TSCA section 4, then TSCA section 5(b)(1)(A)
requires such information 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 or reasonably ascertainable by
them (see 40 CFR 720.50). However, upon review of PMNs/MCANs and SNUNs,
the Agency has the authority to require appropriate testing. To assist
with EPA's analysis of the SNUN, submitters are encouraged, but not
required, to provide the potentially useful information identified for
the chemical substance in Unit III.C. EPA strongly encourages persons,
before performing any testing, to consult with the Agency pertaining to
protocol selection. Furthermore, pursuant to TSCA section 4(h), which
pertains to reduction of testing in vertebrate animals, EPA encourages
consultation with the Agency on the use of alternative test methods and
strategies (also called New Approach Methodologies, or NAMs), if
available, to generate the recommended test data. EPA encourages dialog
with Agency representatives to help determine how best the submitter
can meet both the data needs and the objective of TSCA section 4(h).
For more information on alternative test methods and strategies to
reduce vertebrate animal testing, visit https://www.epa.gov/assessing-and-managing-chemicals-under-tsca/alternative-test-methods-and-strategies-reduce.
The potentially useful information described in Unit III.C. for
these chemical substances may not be the only means of providing
information to evaluate the chemical substance associated with the
significant new uses. However, submitting a SNUN without any
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 to provide useful information with their
SNUN submission.
SNUN submitters should be aware that EPA will be better able to
evaluate SNUNs which provide detailed information on the following:
Human exposure and environmental release that may result
from the significant new use of the chemical substances.
III. Chemical Substances Subject to These Proposed SNURs
A. What is the designated cutoff date for ongoing uses?
EPA designates August 20, 2024, as the cutoff date for determining
whether the new use is ongoing. This designation is explained in more
detail in Unit II.E.
B. What information is provided for each chemical substance?
For each chemical substance identified in Unit III.C., EPA provides
the following information:
PMN or MCAN number (the proposed CFR citation assigned in
the regulatory text section of this document).
Chemical name (generic name, if the specific name is
claimed as CBI).
Chemical Abstracts Service Registry Number (CASRN) (if
assigned for non-confidential chemical identities).
Effective date of and basis for the TSCA Order.
Potentially useful information.
The regulatory text section of the proposed rule specifies the
activities designated as significant new uses. Certain new uses,
including production volume limits and other uses designated in the
proposed rules, may be claimed as CBI.
These proposed rules include PMN and MCAN 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 proposed 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).
C. Which chemical substances are subject to this proposed rule?
The substances subject to the proposed rules in this document are
as follows:
[[Page 67372]]
PMN Numbers: P-18-356 (40 CFR 721.11894) and P-18-357 (40 CFR
721.11895)
Chemical Names: Sulfonated phenolic resin salt, polymer with
acetone-phenol reaction products, formaldehyde and phenol, sodium salt
(generic) (P-18-356) and Sulfonated phenolic resin salt, polymer with
acetone-phenol reaction products, formaldehyde and phenol, potassium
salt (generic) (P-18-357).
CASRN: Not available.
Effective Date of TSCA Order: May 2, 2023.
Basis for TSCA Order: The PMNs state that the generic (non-
confidential) uses will be as adhesives. Based on comparison to
analogous chemical substances, EPA has identified concerns for
reproductive and developmental effects, systemic effects, and corrosion
to the eyes, skin, and respiratory tract. Based on comparison to
analogous polyanionic polymers and monomers, EPA predicts toxicity to
aquatic organisms may occur at concentrations that exceed 6 ppb. The
Order was issued under TSCA sections 5(a)(3)(B)(ii)(I) and
5(e)(1)(A)(ii)(I), based on a finding that in the absence of sufficient
information to permit a reasoned evaluation, the substances may present
an unreasonable risk of injury to human health and the environment. To
protect against these risks, the Order requires:
No manufacture, processing, or use of the PMN substances
in any manner that results in inhalation exposure;
No processing for use or use of the PMN substances in
consumer products;
No release of the PMN substances, or any waste stream
containing the PMN substances, in surface water concentrations that
exceed 6 ppb;
Use of personal protective equipment where there is a
potential for dermal exposure; and
Establishment of a hazard communication program, including
human health precautionary statements on each label and in the SDS.
The proposed SNUR would designate as a ``significant new use'' the
absence of these protective measures.
Potentially Useful Information: EPA has determined that certain
information may be potentially useful in support of a request by the
PMN submitter to modify the Order, or if a manufacturer or processor is
considering submitting a SNUN for a significant new use that will be
designated by this SNUR. EPA has determined that the results of skin
corrosion, eye damage, specific target organ toxicity, reproductive
toxicity, developmental toxicity, and aquatic toxicity testing may be
potentially useful to characterize the health and environmental effects
of the PMN substances. Although the Order does not require these tests,
the Order's restrictions remain in effect until the Order is modified
or revoked by EPA based on submission of this or other relevant
information.
PMN Number: P-19-188 (40 CFR 721.11896)
Chemical Name: Octadecanamide, N,N-dialkyl, salts (generic).
CASRN: Not available.
Effective Date of TSCA Order: December 5, 2022.
Basis for TSCA Order: The PMN states that the use will be as a
wetting agent and lubricant. Based on the surfactant properties of the
PMN substance, EPA has identified concerns for irritation and lung
effects (surfactancy). Based on amines, EPA has also identified
concerns for irritation to the skin, eyes, and respiratory tract. Based
on submitted test data on the PMN substance, EPA has also identified
concerns for severe skin and eye irritation, skin corrosion, and
scabbing. Based on submitted test data on the PMN substance, EPA
predicts toxicity to aquatic organisms may occur at concentrations that
exceed 34 ppb. The Order was issued under TSCA sections
5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on a finding that in the
absence of sufficient information to permit a reasoned evaluation, the
substance may present an unreasonable risk of injury to human health
and the environment. To protect against these risks, the Order
requires:
Use of personal protective equipment where there is a
potential for dermal exposure;
No use of the PMN substance in a consumer product;
No manufacture, processing, or use of the PMN substance in
any manner that results in inhalation exposure;
No release of the PMN substance, or any waste stream
containing the PMN substance, in surface water concentrations that
exceed 34 ppb; and
Establishment of a hazard communication program, including
human health precautionary statements on each label and in the SDS.
The proposed SNUR would designate as a ``significant new use'' the
absence of these protective measures.
Potentially Useful Information: EPA has determined that certain
information may be potentially useful in support of a request by the
PMN submitter to modify the Order, or if a manufacturer or processor is
considering submitting a SNUN for a significant new use that will be
designated by this SNUR. EPA has determined that the results of
specific target organ toxicity, pulmonary effects, and aquatic toxicity
testing may be potentially useful to characterize the health and
environmental effects of the PMN substance. Although the Order does not
require these tests, the Order's restrictions remain in effect until
the Order is modified or revoked by EPA based on submission of this or
other relevant information.
PMN Numbers: P-20-175 (40 CFR 721.11897), P-20-176 (40 CFR 721.11898),
and P-20-178 (40 CFR 721.11899)
Chemical Names: Acid N-[4-(4-diarylalkyl]-, carbopolycyclic
alkenyl, methyl ester (generic) (P-20-175); Acid N-(diarylalkyl)-,
carbopolycyclic alkenyl, methyl ester (generic) (P-20-176); and
Carbopolycyclic alkenyl, 2-carboxylic acid, 2-
[[[(diarylalkyl)]carbonyl]oxy]ethyl ester (generic) (P-20-178).
CASRNs: Not available.
Effective Date of TSCA Order: May 15, 2023.
Basis for TSCA Order: The PMNs state that the generic (non-
confidential) uses will be as proprietary additive for formulations.
Based on the structure alert for isocyanates, EPA has identified
concerns for irritation to the eyes, skin, and respiratory tract. Based
on comparison to analogous chemical substances, EPA has also identified
concerns for respiratory effects and skin and respiratory sensitization
for the residual. For the hydrolysis product of the residual, EPA has
also identified concerns for systemic effects and cancer. Based on
comparison to analogous chemical substances, EPA predicts toxicity to
aquatic organisms may occur at concentrations that exceed 0.1 ppb for
P-20-175 and P-20-176 and 0.2 ppb for P-20-178. The Order was issued
under TSCA sections 5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on a
finding that in the absence of sufficient information to permit a
reasoned evaluation, the substances may present an unreasonable risk of
injury to human health and the environment. To protect against these
risks, the Order requires:
No manufacture, processing, or use of the PMN substances
in any manner that results in inhalation exposure;
No release of the PMN substances, or any waste stream
containing the PMN substances, in surface water concentrations that
exceed 0.1 ppb for P-20-175 and P-20-176 and 0.2 ppb for P-20-178;
No use of the PMN substances in consumer products;
[[Page 67373]]
Use of personal protective equipment where there is a
potential for dermal exposure; and
Establishment of a hazard communication program, including
human health precautionary statements on each label and in the SDS.
The proposed SNUR would designate as a ``significant new use'' the
absence of these protective measures.
Potentially Useful Information: EPA has determined that certain
information may be potentially useful in support of a request by the
PMN submitter to modify the Order, or if a manufacturer or processor is
considering submitting a SNUN for a significant new use that will be
designated by this SNUR. EPA has determined that the results of aquatic
toxicity testing may be potentially useful to characterize the
environmental effects of the PMN substances. Although the Order does
not require these tests, the Order's restrictions remain in effect
until the Order is modified or revoked by EPA based on submission of
this or other relevant information.
PMN Number: P-21-15 (40 CFR 721.11900)
Chemical Name: Amines, C36-alkylenedi-, polymers with 5,5'-[(1-
methylethylidene)bis(4,1-phenyleneoxy)]bis[1,3-isobenzofurandione] and
4,4'-[2,2,2-trifluoro-1-(trifluoromethyl)ethylidene]bis[2-aminophenol].
CASRN: 2419899-87-7.
Effective Date of TSCA Order: May 19, 2021.
Basis for TSCA Order: The PMN states that the use will be as a raw
material in a temporary bonding adhesive formulation. The adhesive is
used to bond completed semiconductor wafers to a backing substrate to
facilitate mechanical grinding of the wafer to reduce its thickness.
Based on the high molecular weight and low water solubility of the PMN
substance, EPA has identified concerns for lung effects (lung
overload). Based on test data for the potential incineration product,
EPA has also identified concerns for portal-of-entry effects (lesions
in the upper respiratory tract and lungs), liver effects, kidney
effects, body weight loss, and neurotoxicity.
The Order was issued under TSCA sections 5(a)(3)(B)(ii)(I) and
5(e)(1)(A)(ii)(I), based on a finding that in the absence of sufficient
information to permit a reasoned evaluation, the substance may present
an unreasonable risk of injury to human health. To protect against
these risks, the Order requires:
No use of the PMN substance other than as a raw material
in a temporary bonding adhesive formulation. The adhesive is used to
bond completed semiconductor wafers to a backing substrate to
facilitate mechanical grinding of the wafer to reduce its thickness;
No manufacture, processing, or use of the PMN substance in
any manner that results in worker inhalation exposure; and
Establishment of a hazard communication program, including
human health precautionary statements on each label and in the SDS.
The proposed SNUR would designate as a ``significant new use'' the
absence of these protective measures.
Potentially Useful Information: EPA has determined that certain
information may be potentially useful in support of a request by the
PMN submitter to modify the Order, or if a manufacturer or processor is
considering submitting a SNUN for a significant new use that will be
designated by this SNUR. EPA has determined that the results of
specific target organ toxicity, pulmonary effects, and neurotoxicity
testing may be potentially useful to characterize the health effects of
the PMN substance. Although the Order does not require these tests, the
Order's restrictions remain in effect until the Order is modified or
revoked by EPA based on submission of this or other relevant
information.
PMN Numbers: P-21-32 (40 CFR 721.11901) and P-21-33 (40 CFR 721.11902)
Chemical Names: Poly[oxy(methyl-1,2-ethanediyl)], .alpha.-(3-
aminopropyl)-.omega.-(1-methylethoxy)- (P-21-32) and Poly[oxy(methyl-
1,2-ethanediyl)], .alpha.-(3-aminopropyl)-.omega.-butoxy- (P-21-33).
CASRNs: 2304726-48-3 (P-21-32) and 2304726-50-7 (P-21-33).
Effective Date of TSCA Order: April 27, 2023.
Basis for TSCA Order: The PMNs state that the uses will be as
chemical intermediates for an asphalt emulsified (20%) and ore
flotation (80%). Based on comparison to analogous chemical substances,
EPA has identified concerns for acute toxicity, skin and eye corrosion,
skin sensitization, systemic effects, and lung effects. Based on
comparison to analogous polycationic polymers and aliphatic amines, EPA
predicts toxicity to aquatic organisms may occur at concentrations that
exceed 220 ppb (P-21-32) and 110 ppb (P-21-33). The Order was issued
under TSCA sections 5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on a
finding that in the absence of sufficient information to permit a
reasoned evaluation, the substance may present an unreasonable risk of
injury to human health and the environment. To protect against these
risks, the Order requires:
No processing or use of the PMN substances in a
formulation containing the PMN substances at greater than 4%;
No processing or use of the PMN substances in consumer
products;
No release of the PMN substances, or any waste stream
containing the PMN substances, in surface water concentrations that
exceed 110 ppb of the PMN substances combined;
Use of personal protective equipment where there is a
potential for dermal exposure; and
Establishment of a hazard communication program, including
human health precautionary statements on each label and in the SDS.
The proposed SNUR would designate as a ``significant new use'' the
absence of these protective measures.
Potentially Useful Information: EPA has determined that certain
information may be potentially useful in support of a request by the
PMN submitter to modify the Order, or if a manufacturer or processor is
considering submitting a SNUN for a significant new use that will be
designated by this SNUR. EPA has determined that the results of skin
corrosion, eye damage, skin sensitization, specific target organ
toxicity, pulmonary effects, and aquatic toxicity testing may be
potentially useful to characterize the health and environmental effects
of the PMN substances. Although the Order does not require these tests,
the Order's restrictions remain in effect until the Order is modified
or revoked by EPA based on submission of this or other relevant
information.
PMN Number: P-21-75 (40 CFR 721.11903)
Chemical Name: Alkanoic acid, hydroxy-(hydroxyalkyl)-alkyl-,
polymer with .alpha.-[(hydroxyalkyl)alkyl]-.omega.-alkoxypoly(oxy-
alkanediyl), dialkyl carbonate, alkanediol, alkylene[isocyanato-
carbomonocycle] and [oxybis(alkylene)]bis[alkyl-alkanediole] alkenoate,
compd. with dialkyalkanamine (generic).
CASRN: Not available.
Effective Date of TSCA Order: May 24, 2023.
Basis for TSCA Order: The PMN states that the use will be as a
curable resin for aqueous coatings. Based on the presence of acrylates,
EPA has identified concerns for irritation to the skin, eyes, and
respiratory tract and skin and respiratory sensitization. Based on
[[Page 67374]]
data for the counter ion of the PMN substance, EPA has also identified
concerns for skin and eye corrosion, acute toxicity, systemic effects,
male reproductive effects, and respiratory tract effects. Based on data
for an analogue of the counter ion, EPA also identified concerns for
neurotoxicity. The Order was issued under TSCA sections
5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on a finding that in the
absence of sufficient information to permit a reasoned evaluation, the
substance may present an unreasonable risk of injury to human health.
To protect against these risks, the Order requires:
No use of the PMN substance in consumer products;
Use of a NIOSH-certified respirator with an APF of at
least 50 where there is a potential for inhalation exposure, or 1000 if
spray applied;
Use of personal protective equipment where there is a
potential for dermal exposure; and
Establishment of a hazard communication program, including
human health precautionary statements on each label and in the SDS.
The proposed SNUR would designate as a ``significant new use'' the
absence of these protective measures.
Potentially Useful Information: EPA has determined that certain
information may be potentially useful in support of a request by the
PMN submitter to modify the Order, or if a manufacturer or processor is
considering submitting a SNUN for a significant new use that will be
designated by this SNUR. EPA has determined that the results of acute
toxicity, specific toxic organ toxicity, pulmonary effects, skin
sensitization, and reproductive/developmental toxicity testing may be
potentially useful to characterize the health effects of the PMN
substance. Although the Order does not require these tests, the Order's
restrictions remain in effect until the Order is modified or revoked by
EPA based on submission of this or other relevant information.
PMN Number: P-21-80 (40 CFR 721.11904)
Chemical Name: Alkanedioic acid, polymers with alkanoic acid-
dipentaerythritol reaction products, alkanedioc acid dihydrazide,
hydroxy-(hydroxyalkyl)-alkylalkanoic acid, isocyanato-
(isocyanatoalkyl)-alkyl substituted carbomonocycle, dialkylalkanediol
and polyalkylene glycol(hydroxyalkyl)alkyl alkyl ether (generic).
CASRN: Not available.
Effective Date of TSCA Order: May 24, 2023.
Basis for TSCA Order: The PMN states that the use will be as a
binder for UV curable coating resin. Based on a structural alert for
acrylates and information provided in the SDS, EPA has identified
concerns for irritation to the skin, eyes, and respiratory tract. Based
on a structural alert for acrylates for the LMW fraction, EPA has also
identified concerns for skin and respiratory sensitization. Based on
multifunctional reactive groups, EPA has also identified concerns for
respiratory sensitization. Based on comparison to analogous chemical
substances, EPA has also identified concerns for skin irritation,
clinical signs, systemic effects (decreased body weight and body weight
gains, reduced food consumption, blood, adrenal, thymus, and brain
effects), and irritation in the GI tract (stomach, cecum, colon,
duodenum, ileum, and/or jejunum). The Order was issued under TSCA
sections 5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on a finding
that in the absence of sufficient information to permit a reasoned
evaluation, the substance may present an unreasonable risk of injury to
human health. To protect against these risks, the Order requires:
No use of the PMN substance in consumer products;
Use of a NIOSH-certified respirator with an APF of at
least 50 where there is a potential for inhalation exposure, or 1000 if
spray applied;
Use of personal protective equipment where there is a
potential for dermal exposure; and
Establishment of a hazard communication program, including
human health precautionary statements on each label and in the SDS.
The proposed SNUR would designate as a ``significant new use'' the
absence of these protective measures.
Potentially Useful Information: EPA has determined that certain
information may be potentially useful in support of a request by the
PMN submitter to modify the Order, or if a manufacturer or processor is
considering submitting a SNUN for a significant new use that will be
designated by this SNUR. EPA has determined that the results of skin
irritation, specific toxic organ toxicity, eye damage, and skin
sensitization testing may be potentially useful to characterize the
health effects of the PMN substance. Although the Order does not
require these tests, the Order's restrictions remain in effect until
the Order is modified or revoked by EPA based on submission of this or
other relevant information.
PMN Number: P-21-96 (40 CFR 721.11905)
Chemical Name: Phenol, 4,4'-(1-methylethylidene)bis-, polymer with
2,2'-[(1-methylethylidene) bis (4,1-phenyleneoxymethylene)] bis
[heteromonocycle], bis(2-methyl-2-propenoate) (generic).
CASRN: Not available.
Effective Date of TSCA Order: May 17, 2023.
Basis for TSCA Order: The PMN states that the generic (non-
confidential) use will be as a component in thermoset composites. Based
on comparison to analogous chemical substances, EPA has identified
concerns for dermal, respiratory, and eye irritation, skin
sensitization, systemic effects, and reproductive and developmental
effects. Based on the presence of methacrylates, EPA has also
identified concerns for respiratory sensitization. Based on comparison
to analogous acrylates/methacrylates, EPA predicts toxicity to aquatic
organisms may occur at concentrations that exceed 2 ppb. The Order was
issued under TSCA sections 5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I),
based on a finding that in the absence of sufficient information to
permit a reasoned evaluation, the substance may present an unreasonable
risk of injury to human health and the environment. To protect against
these risks, the Order requires:
No manufacture, processing, or use of the PMN substance in
any manner that results in inhalation exposure;
No release of the PMN substance, or any waste stream
containing the PMN substance, in surface water concentrations that
exceed 2 ppb;
Use of personal protective equipment where there is a
potential for dermal exposure; and
Establishment of a hazard communication program, including
human health precautionary statements on each label and in the SDS.
The proposed SNUR would designate as a ``significant new use'' the
absence of these protective measures.
Potentially Useful Information: EPA has determined that certain
information may be potentially useful in support of a request by the
PMN submitter to modify the Order, or if a manufacturer or processor is
considering submitting a SNUN for a significant new use that will be
designated by this SNUR. EPA has determined that the results of skin
sensitization, neurotoxicity, specific target organ toxicity,
developmental toxicity, reproductive toxicity, and aquatic toxicity
testing may be potentially useful to characterize the health and
environmental effects of the
[[Page 67375]]
PMN substance. Although the Order does not require these tests, the
Order's restrictions remain in effect until the Order is modified or
revoked by EPA based on submission of this or other relevant
information.
PMN Number: P-21-98 (40 CFR 721.11906)
Chemical Name: Poly(oxy-1,2-ethanediyl), .alpha.-hydro-.omega.-
[2(or 3)-[[substituted benzoyl]oxy]hydroxypropoxyl]-, .alpha.,
.alpha.', .alpha.'' -ether with 2-ethyl-2-(hydroxymethyl)-1,3-
propanediol (3:1) (generic).
CASRN: Not available
Effective Date of TSCA Order: May 10, 2023.
Basis for TSCA Order: The PMN states that the use will be as a co-
initiator for the curing of UV printing inks. Based on comparison to
analogous chemical substances, EPA has identified concerns for skin
sensitization and reproductive and systemic effects. Based on the
surfactant properties of the PMN substance, EPA also identified
concerns for lung effects and irritation to the skin, eyes, and
respiratory tract. Based on comparison to analogous esters, EPA
predicts toxicity to aquatic organisms may occur at concentrations that
exceed 12 ppb. The Order was issued under TSCA sections
5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on a finding that in the
absence of sufficient information to permit a reasoned evaluation, the
substance may present an unreasonable risk of injury to human health
and the environment. To protect against these risks, the Order
requires:
No use of the PMN substance in consumer products;
No manufacture or processing of the PMN substance in any
manner that results in inhalation exposure;
No use of the PMN substance in formulations at
concentrations greater than 4%;
No release of the PMN substance, or any waste stream
containing the PMN substance, in surface water concentrations that
exceed 12 ppb;
Use of a NIOSH-certified combination particulate and gas/
vapor respirator with an APF of at least 10 where there is a potential
for inhalation exposure;
Use of personal protective equipment where there is a
potential for dermal exposure; and
Establishment of a hazard communication program, including
human health precautionary statements on each label and in the SDS.
The proposed SNUR would designate as a ``significant new use'' the
absence of these protective measures.
Potentially Useful Information: EPA has determined that certain
information may be potentially useful in support of a request by the
PMN submitter to modify the Order, or if a manufacturer or processor is
considering submitting a SNUN for a significant new use that will be
designated by this SNUR. EPA has determined that the results of aquatic
toxicity, skin sensitization, skin irritation/corrosion, eye
irritation/corrosion, pulmonary effects, reproductive toxicity, and
specific target organ toxicity testing may be potentially useful to
characterize the health and environmental effects of the PMN substance.
Although the Order does not require these tests, the Order's
restrictions remain in effect until the Order is modified or revoked by
EPA based on submission of this or other relevant information.
PMN Number: P-21-126 (40 CFR 721.11907)
Chemical Name: Substituted heteromonocycle, polymer with haloalkyl
substituted heteromonocycle, dialkyl-alkanediamine, (alkylalkylidene)
bis [hydroxycarbomonocycle] and oxybls[alkanol], reaction products with
metal oxide and dialkanolamine (generic).
CASRN: Not available.
Effective Date of TSCA Order: May 1, 2023.
Basis for TSCA Order: The PMN states that the use will be as a
component in several coating resin products that are only applied by
cathodic electrodeposition and used as additives for corrosion
protection. Based on submitted test data, EPA predicts toxicity to
aquatic organisms may occur at concentrations that exceed 230 ppb. The
Order was issued under TSCA sections 5(a)(3)(B)(ii)(I) and
5(e)(1)(A)(ii)(I), based on a finding that in the absence of sufficient
information to permit a reasoned evaluation, the substance may present
an unreasonable risk of injury to the environment. To protect against
these risks, the Order requires:
No release of the PMN substance, or any waste stream
containing the PMN substance, in surface water concentrations that
exceed 230 ppb; and
Establishment of a hazard communication program, including
human health precautionary statements on each label and in the SDS.
The proposed SNUR would designate as a ``significant new use'' the
absence of these protective measures.
Potentially Useful Information: EPA has determined that certain
information may be potentially useful in support of a request by the
PMN submitter to modify the Order, or if a manufacturer or processor is
considering submitting a SNUN for a significant new use that will be
designated by this SNUR. EPA has determined that the results of aquatic
toxicity testing may be potentially useful to characterize the
environmental effects of the PMN substance. Although the Order does not
require these tests, the Order's restrictions remain in effect until
the Order is modified or revoked by EPA based on submission of this or
other relevant information.
PMN Number: P-21-175 (40 CFR 721.11908)
Chemical Name: Carbonic acid, diphenyl ester, polymer with 1,4-
butanediol and 1,10-decanediol.
CASRN: 1615685-41-0.
Effective Date of TSCA Order: March 1, 2023.
Basis for TSCA Order: The PMN states that the generic (non-
confidential) use of the PMN substance will be as a raw material of
polyurethane. Based on comparison to analogous esters and test data on
the PMN substance, EPA predicts toxicity to aquatic organisms may occur
at concentrations that exceed 22 ppb. The Order was issued under TSCA
sections 5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on a finding
that in the absence of sufficient information to permit a reasoned
evaluation, the substance may present an unreasonable risk of injury to
the environment. To protect against these risks, the Order requires:
No release of the PMN substance resulting in surface water
concentrations that exceed 22 ppb; and
Establishment of a hazard communication program, including
precautionary statements on each label and in the SDS.
The proposed SNUR would designate as a ``significant new use'' the
absence of these protective measures.
Potentially Useful Information: EPA has determined that certain
information may be potentially useful in support of a request by the
PMN submitter to modify the Order, or if a manufacturer or processor is
considering submitting a SNUN for a significant new use that will be
designated by this SNUR. EPA has determined that the results of chronic
aquatic toxicity testing may be potentially useful to characterize the
environmental effects of the PMN substance. Although the Order does not
require these tests, the Order's restrictions remain in effect until
the Order is modified or revoked by EPA based on submission of this or
other relevant information.
[[Page 67376]]
PMN Number: P-22-7 (40 CFR 721.11909)
Chemical Name: 3,5,8-Trioxa-4-silaalkanoic acid, 4-ethenyl-4-(2-
alkoxy-1-alkyl-2-oxoethoxy)-2,6-dialkyl-7-oxo-, alkyl ester (generic).
CASRN: Not available.
Effective Date of TSCA Order: February 3, 2023.
Basis for TSCA Order: The PMN states that the use will be as a
crosslinker in formulating general purpose sealants and adhesives for
use in consumer and professional markets. Based on test data on the PMN
substance, EPA has identified concerns for eye irritation. Based on
comparison to analogous chemical substances, EPA has also identified
concerns for systemic effects. Based on test data for hydrolysis
products of the PMN substance, EPA has also identified concerns for
respiratory tract irritation and reproductive and developmental
effects. The Order was issued under TSCA sections 5(a)(3)(B)(ii)(I) and
5(e)(1)(A)(ii)(I), based on a finding that in the absence of sufficient
information to permit a reasoned evaluation, the substance may present
an unreasonable risk of injury to human health. To protect against
these risks, the Order requires:
Use of personal protective equipment where there is a
potential for dermal exposure;
No processing or use of the PMN substance other than as a
crosslinker in formulating general purpose sealants and adhesives;
No processing for use or use of the PMN substance where
the concentration of the PMN substance exceeds 6% by weight in consumer
products;
No processing for use or use of the PMN substance in
consumer products other than in the form of a paste;
No manufacture, processing, or use of the PMN substance in
any manner that results in inhalation exposure; and
Establishment of a hazard communication program, including
human health precautionary statements on each label and in the SDS.
The proposed SNUR would designate as a ``significant new use'' the
absence of these protective measures.
Potentially Useful Information: EPA has determined that certain
information may be potentially useful in support of a request by the
PMN submitter to modify the Order, or if a manufacturer or processor is
considering submitting a SNUN for a significant new use that will be
designated by this SNUR. EPA has determined that the results of
specific target organ toxicity, pulmonary effects, reproductive
toxicity, and developmental toxicity testing may be potentially useful
to characterize the health effects of the PMN substance. Although the
Order does not require these tests, the Order's restrictions remain in
effect until the Order is modified or revoked by EPA based on
submission of this or other relevant information.
PMN Number: P-22-8 (40 CFR 721.11910)
Chemical Name: .beta.-N-Acetylhexosaminidase (expressed in
genetically modified Bacillus licheniformis strain ATJI0138).
CASRN: 9012-33-3.
Effective Date of TSCA Order: March 3, 2023.
Basis for TSCA Order: The PMN states that the generic (non-
confidential) use will be as a biocatalyst used in a variety of
products. Based on comparison to analogous chemical substances, EPA has
identified concerns for skin irritation, eye irritation, respiratory
irritation, skin sensitization, respiratory sensitization, portal-of-
entry (oral) effects, and systemic effects. Based on comparison to
analogous polyamphoteric polymers and test data on the PMN substance,
EPA predicts toxicity to aquatic organisms may occur at concentrations
that exceed 1,000 ppb. The Order was issued under TSCA sections
5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on a finding that in the
absence of sufficient information to permit a reasoned evaluation, the
substance may present an unreasonable risk of injury to human health
and the environment. To protect against these risks, the Order
requires:
No manufacture, processing, or use of the PMN substance in
any manner that results in inhalation exposure;
No processing of the PMN substance to greater than 1% in
formulation for use in a consumer product;
Use of personal protective equipment where there is a
potential for dermal exposure; and
Establishment of a hazard communication program, including
human health precautionary statements on each label and in the SDS.
The proposed SNUR would designate as a ``significant new use'' the
absence of these protective measures.
Potentially Useful Information: EPA has determined that certain
information may be potentially useful in support of a request by the
PMN submitter to modify the Order, or if a manufacturer or processor is
considering submitting a SNUN for a significant new use that will be
designated by this SNUR. EPA has determined that the results of eye
irritation, skin irritation, skin sensitization, and pulmonary effects
testing may be potentially useful to characterize the health effects of
the PMN substance. Although the Order does not require these tests, the
Order's restrictions remain in effect until the Order is modified or
revoked by EPA based on submission of this or other relevant
information.
PMN Number: P-22-9 (40 CFR 721.11911)
Chemical Name: Alkanes, C4-9-branched and linear.
CASRN: 2577172-51-9.
Effective Date of TSCA Order: January 24, 2023.
Basis for TSCA Order: The PMN states that the use will be as a
gasoline blending component to reduce the average carbon intensity and
subsequent CO2 emissions of fuel. Based on comparison to analogous
chemical mixtures, EPA has identified concerns for respiratory tract
irritation, carcinogenicity, neurotoxicity, ototoxicity, portal-of-
entry (inhalation and oral), systemic (body weight, liver, kidney,
blood, adrenal, and spleen) toxicity, developmental effects,
reproductive effects, acute toxicity, skin irritation, eye irritation,
and aspiration hazard. Based on the chemical composition (petroleum)
and n-nonane, EPA also identified concerns for hydrocarbon pneumonia
and aspiration hazard. Based on comparison to analogous neutral organic
chemicals, EPA predicts toxicity to aquatic organisms may occur at
concentrations that exceed 3 ppb. The Order was issued under TSCA
sections 5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on a finding
that in the absence of sufficient information to permit a reasoned
evaluation, the substance may present an unreasonable risk of injury to
human health and the environment. To protect against these risks, the
Order requires:
Manufacture, processing, and use of the PMN substance only
as a fuel, refinery feedstock, a chemical feedstock, or a fuel blending
additive or component;
Use of personal protective equipment where there is a
potential for dermal exposure; and
Establishment of a hazard communication program, including
human health precautionary statements on each label and in the SDS.
The proposed SNUR would designate as a ``significant new use'' the
absence of these protective measures.
Potentially Useful Information: EPA has determined that certain
information may be potentially useful in support of a request by the
PMN submitter to
[[Page 67377]]
modify the Order, or if a manufacturer or processor is considering
submitting a SNUN for a significant new use that will be designated by
this SNUR. EPA has determined that the results of aquatic toxicity,
skin irritation, eye irritation, respiratory depression/irritation,
hydrocarbon pneumonia/aspiration hazard, reproductive/developmental
toxicity, systemic toxicity, genetic toxicity, carcinogenicity, and
consumer inhalation exposures at gas stations testing may be
potentially useful to characterize the health and environmental effects
of the PMN substance. Although the Order does not require these tests,
the Order's restrictions remain in effect until the Order is modified
or revoked by EPA based on submission of this or other relevant
information.
PMN Number: P-22-10 (40 CFR 721.11912)
Chemical Name: Amino alkanoic acid, N-[3-(trimethoxysilyl)propyl]-,
3-(trimethoxysilyl)propyl ester (generic).
CASRN: Not available.
Effective Date of TSCA Order: March 16, 2023.
Basis for TSCA Order: The PMN states that the use will be as part
of an industrial adhesive. Based on comparison to analogous
alkoxysilanes, EPA has identified concerns for lung pathology and
systemic effects. Based on comparison to analogous chemical substances,
EPA has also identified concerns for mortality, skin irritation, eye
corrosion, respiratory irritation, portal-of-entry, neurotoxicity,
systemic, and reproductive effects. Based on a hydrolysis product, EPA
has also identified concerns for systemic, neurotoxicity, and
developmental effects. Based on comparison to analogous alkoxysilanes
and aliphatic amines, EPA predicts toxicity to aquatic organisms may
occur at concentrations that exceed 80 ppb. The Order was issued under
TSCA sections 5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on a
finding that in the absence of sufficient information to permit a
reasoned evaluation, the substance may present an unreasonable risk of
injury to human health and the environment. To protect against these
risks, the Order requires:
No use of the PMN substance in consumer products;
No manufacture, processing, or use of the PMN substance in
any manner that results in inhalation exposure;
No release of the PMN substance, or any waste stream
containing the PMN substance, in surface water concentrations that
exceed 80 ppb;
Use of personal protective equipment where there is a
potential for dermal exposure;
Establishment of a hazard communication program, including
human health precautionary statements on each label and in the SDS.
The proposed SNUR would designate as a ``significant new use'' the
absence of these protective measures.
Potentially Useful Information: EPA has determined that certain
information may be potentially useful in support of a request by the
PMN submitter to modify the Order, or if a manufacturer or processor is
considering submitting a SNUN for a significant new use that will be
designated by this SNUR. EPA has determined that the results of aquatic
toxicity testing may be potentially useful to characterize the
environmental effects of the PMN substance. Although the Order does not
require these tests, the Order's restrictions remain in effect until
the Order is modified or revoked by EPA based on submission of this or
other relevant information.
PMN Number: P-22-13 (40 CFR 721.11913)
Chemical Name: 2-Pyridinecarboxylic acid, 3-halo-4-nitrogen-
substituted-5-halo-6-halo, aryl ester (generic).
CASRN: Not available.
Effective Date of TSCA Order: March 2, 2023.
Basis for TSCA Order: The PMN states that the use will be as a raw
material/intermediate, site-limited, destructive use. Based on test
data for the ester hydrolysis products, EPA has identified concerns for
skin sensitization, eye irritation, and systemic and neurotoxicity
effects. Based on comparison to analogous anilines and esters, EPA
predicts toxicity to aquatic organisms may occur at concentrations that
exceed 4 ppb. The Order was issued under TSCA sections
5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on a finding that in the
absence of sufficient information to permit a reasoned evaluation, the
substance may present an unreasonable risk of injury to human health
and the environment. To protect against these risks, the Order
requires:
Manufacture, processing, and use of the PMN substance only
in a solid form when using a dust collection system with a capture and
control efficiency of at least 32% to control dust exposure;
No use of the PMN substance other than as an intermediate;
No release of the PMN substance, or any waste stream
containing the PMN substance, into waters of the United States;
Use of personal protective equipment where there is a
potential for dermal exposure;
Use of a NIOSH-certified respirator with an APF of at
least 50 where there is a potential for inhalation exposure;
Establishment of a hazard communication program, including
human health precautionary statements on each label and in the SDS.
The proposed SNUR would designate as a ``significant new use'' the
absence of these protective measures.
Potentially Useful Information: EPA has determined that certain
information may be potentially useful in support of a request by the
PMN submitter to modify the Order, or if a manufacturer or processor is
considering submitting a SNUN for a significant new use that will be
designated by this SNUR. EPA has determined that the results of aquatic
toxicity, neurotoxicity, eye irritation/corrosion, skin sensitization,
specific target organ toxicity, and persistence and bioaccumulation
testing may be potentially useful to characterize the health,
environmental, and fate effects of the PMN substance. Although the
Order does not require these tests, the Order's restrictions remain in
effect until the Order is modified or revoked by EPA based on
submission of this or other relevant information.
PMN Number: P-22-15 (40 CFR 721.11914)
Chemical Name: 2-Pyridinecarboxylic acid, 3-halo-4-nitrogen-
substituted-5-halo-6-halo (generic).
CASRN: Not available.
Effective Date of TSCA Order: March 6, 2023.
Basis for TSCA Order: The PMN states that the use will be as a raw
material/intermediate, site-limited, destructive use. Based on
comparison to analogous chemical substances, EPA has identified
concerns for eye irritation and systemic effects. Based on comparison
to analogous anilines, EPA predicts toxicity to aquatic organisms may
occur at concentrations that exceed 14 ppb. The Order was issued under
TSCA sections 5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on a
finding that in the absence of sufficient information to permit a
reasoned evaluation, the substance may present an unreasonable risk of
injury to human health and the environment. To protect against these
risks, the Order requires:
Manufacture, processing, and use of the PMN substance only
in a solid form when using a dust collection system with a capture and
control efficiency of at least 32% to control dust exposure;
No use of the PMN substance other than as an intermediate;
[[Page 67378]]
No release of the PMN substance, or any waste stream
containing the PMN substance, into waters of the United States;
Use of personal protective equipment where there is a
potential for dermal exposure;
Use of a NIOSH-certified respirator with an APF of at
least 50 where there is a potential for inhalation exposure;
Establishment of a hazard communication program, including
human health precautionary statements on each label and in the SDS.
The proposed SNUR would designate as a ``significant new use'' the
absence of these protective measures.
Potentially Useful Information: EPA has determined that certain
information may be potentially useful in support of a request by the
PMN submitter to modify the Order, or if a manufacturer or processor is
considering submitting a SNUN for a significant new use that will be
designated by this SNUR. EPA has determined that the results of aquatic
toxicity, eye irritation, specific target organ toxicity, and
persistence and bioaccumulation testing may be potentially useful to
characterize the health, environmental, and fate effects of the PMN
substance. Although the Order does not require these tests, the Order's
restrictions remain in effect until the Order is modified or revoked by
EPA based on submission of this or other relevant information.
PMN Number: P-22-37 (40 CFR 721.11915)
Chemical Name: Polyphosphoric acids, esters with heteromonocycle
homopolymer (generic).
CASRN: Not available.
Effective Date of TSCA Order: April 3, 2023.
Basis for TSCA Order: The PMN states that the use will be as an
adhesion promoter used in coatings for better adhesion to metals under
high humidity conditions. Based on comparison to analogous chemical
substances, EPA has identified concerns for irritation/corrosion to the
skin, eyes, and respiratory tract, clinical signs, and systemic
effects. Based on the surfactant-like properties of the PMN substance,
EPA has also identified concerns for lung effects (surfactancy). Based
on comparison to analogous phosphates--inorganic and polyanionic
polymers (& monomers) and the standard toxicity profile for inorganic
phosphate, EPA predicts toxicity to aquatic organisms may occur at
concentrations that exceed 2 ppb. The Order was issued under TSCA
sections 5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on a finding
that in the absence of sufficient information to permit a reasoned
evaluation, the substance may present an unreasonable risk of injury to
human health and the environment. To protect against these risks, the
Order requires:
No processing of the PMN substance to greater than 1% in
formulation;
No use of the PMN substance in a formulation containing
the PMN substance at a concentration greater than 1%;
No processing for use or use of the PMN substance in
consumer products;
No release of the PMN substance, or any waste stream
containing the PMN substance, in surface water concentrations that
exceed 2 ppb;
Use of personal protective equipment where there is a
potential for dermal exposure;
Use of a NIOSH-certified combination particulate and gas/
vapor respirator with an APF of at least 50 where there is a potential
for inhalation exposure; and
Establishment of a hazard communication program, including
human health precautionary statements on each label and in the SDS.
The proposed SNUR would designate as a ``significant new use'' the
absence of these protective measures.
Potentially Useful Information: EPA has determined that certain
information may be potentially useful in support of a request by the
PMN submitter to modify the Order, or if a manufacturer or processor is
considering submitting a SNUN for a significant new use that will be
designated by this SNUR. EPA has determined that the results of
specific target organ toxicity, pulmonary effects, skin corrosion, eye
irritation/corrosion, and aquatic toxicity testing may be potentially
useful to characterize the health and environmental effects of the PMN
substance. Although the Order does not require these tests, the Order's
restrictions remain in effect until the Order is modified or revoked by
EPA based on submission of this or other relevant information.
PMN Number: P-22-44 (40 CFR 721.11916)
Chemical Name: Silica gel, reaction products with alkyl metal salt
(generic).
CASRN: Not available.
Effective Date of TSCA Order: February 16, 2023.
Basis for TSCA Order: The PMN states that the generic (non-
confidential) use will be as a site-limited intermediate. Based on the
reactivity of the parent substance, EPA has identified concerns for eye
irritation, skin irritation, and respiratory tract irritation. Based on
test data for analogues of the hydrolysis products, EPA has also
identified concerns for lung, systemic, reproductive, and developmental
effects. The Order was issued under TSCA sections 5(a)(3)(B)(ii)(I) and
5(e)(1)(A)(ii)(I), based on a finding that in the absence of sufficient
information to permit a reasoned evaluation, the substance may present
an unreasonable risk of injury to human health. To protect against
these risks, the Order requires:
Manufacture, processing, and use of the PMN substance only
in an enclosed process;
Use of personal protective equipment where there is a
potential for dermal exposure;
Use of a NIOSH-certified respirator with an APF of at
least 50 where there is a potential for inhalation exposure; and
Establishment of a hazard communication program, including
human health precautionary statements on each label and in the SDS.
The proposed SNUR would designate as a ``significant new use'' the
absence of these protective measures.
Potentially Useful Information: EPA has determined that certain
information may be potentially useful in support of a request by the
PMN submitter to modify the Order, or if a manufacturer or processor is
considering submitting a SNUN for a significant new use that will be
designated by this SNUR. EPA has determined that the results of eye
irritation, skin irritation, and specific target organ toxicity testing
may be potentially useful to characterize the health effects of the PMN
substance. Although the Order does not require these tests, the Order's
restrictions remain in effect until the Order is modified or revoked by
EPA based on submission of this or other relevant information.
PMN Number: P-22-54 (40 CFR 721.11917)
Chemical Name: Graphene nanoplatelets (generic).
CASRN: Not available.
Effective Date of TSCA Order: March 17, 2023.
Basis for TSCA Order: The PMN states that the generic (non-
confidential) use will be as an additive for paint coatings. Based on
comparison to analogous chemical substances, EPA has identified
concerns for lung effects and systemic effects. The Order was issued
under TSCA sections 5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on a
finding that in the absence of sufficient information to permit a
reasoned evaluation, the substance may present an unreasonable
[[Page 67379]]
risk of injury to human health and the environment. To protect against
these risks, the Order requires:
No manufacture of the PMN substance other than by import
into the United States in the form of a solution (i.e., no domestic
manufacture);
No processing of the PMN substance in any manner that
results in inhalation exposure;
No processing or use of the PMN substance other than in a
liquid formulation;
No use of the PMN substance other than for the
confidential use listed in the Order;
No use of the PMN substance in an application method where
the concentration of the PMN substance in the formulation exceeds the
confidential concentration listed in the Order;
No release of the PMN substance, or any waste stream
containing the PMN substance, into waters of the United States;
Use of personal protective equipment where there is a
potential for dermal exposure;
Use of a NIOSH-certified combination particulate and gas/
vapor respirator with an APF of at least 50 where there is a potential
for inhalation exposure; and
Establishment of a hazard communication program, including
human health precautionary statements on each label and in the SDS.
The proposed SNUR would designate as a ``significant new use'' the
absence of these protective measures.
Potentially Useful Information: EPA has determined that certain
information may be potentially useful in support of a request by the
PMN submitter to modify the Order, or if a manufacturer or processor is
considering submitting a SNUN for a significant new use that will be
designated by this SNUR. EPA has determined that the results of
specific target organ toxicity, pulmonary effects, sediment toxicity,
and aquatic toxicity testing may be potentially useful to characterize
the health and environmental effects of the PMN substance. Although the
Order does not require these tests, the Order's restrictions remain in
effect until the Order is modified or revoked by EPA based on
submission of this or other relevant information.
PMN Numbers: P-22-86 (40 CFR 721.11918), P-22-122 (40 CFR 721.11919),
P-22-179 (40 CFR 721.11920), and P-22-180 (40 CFR 721.11921)
Chemical Names: Phenoxathiinium, 10-phenyl-, 5-alkyl-2-alkyl-4-
(2,4,6-substituted tri-carbopolycycle, hetero-acid)benzenesulfonate
(1:1) (generic) (P-22-86), Heterotrisubstituted-bile acid, 1-
(difluorosulfomethyl)-2,2,2-trifluoroethyl ester, ion(1-), (5)-, 5-
phenyldibenzothiophenium (1:1) (generic) (P-22-122), Sulfonium,
(alkylsubstitutedphenyl)diphenyl-, salt with 1-
(heterosubstitutedalkyl)-2,2,2-triheterosubstitutedalkyl
trisubstitutedbenzoate (1:1) (generic) (P-22-179), and
Dibenzothiophenium, 5-phenyl-, 4-[1-(heterosubstitutedalkyl)-2,2,2-
triheterosubstitutedalkoxy]-4-oxoalkyl trisubstitutedbenzoate (1:1)
(generic) (P-22-180).
CASRNs: Not available.
Effective Date of TSCA Order: January 24, 2023.
Basis for TSCA Order: The PMNs state that the generic (non-
confidential) use of the PMN substances will be for contained used for
microlithography for electronic device manufacturing. Based on the
physical/chemical properties of the PMN substances (as described in the
New Chemical Program's PBT category at 64 FR 60194; November 1999), the
PMN substances are potentially persistent, bioaccumulative, and toxic
(PBT) chemicals. EPA estimates that the PMN substances will persist in
the environment for more than two months and estimates a
bioaccumulation factor of greater than or equal to 1,000. Based on the
reactivity of the PMN substances, EPA has identified concerns for
photosensitization and irritation to the skin, eyes, and respiratory
tract. Based on information provided in the SDS, EPA has also
identified concerns for acute toxicity and irritation to the skin,
eyes, and respiratory tract. Based on confidential analogous compounds,
EPA has also identified concerns for acute toxicity, irritation to the
skin, eyes, and respiratory tract, eye corrosion, ocular lethality,
neurological effects, and systemic effects for the confidential cation
of the PMN substances. Based on comparison to analogous substances, EPA
has also identified concerns for mutagenicity. Based on a potential
incineration by-product, EPA has also identified concerns for local,
neurotoxic, and systemic effects for P-22-122, P-22-179, and P-22-180.
Based on OECD QSAR Toolbox results, EPA has also identified hazards for
skin sensitization and carcinogenicity for the anion for P-22-179 and
P-22-180. The Order was issued under TSCA sections 5(a)(3)(B)(ii)(I)
and 5(e)(1)(A)(ii)(I), based on a finding that in the absence of
sufficient information to permit a reasoned evaluation, the substances
may present an unreasonable risk of injury to human health or the
environment.
To protect against these risks, the Order requires:
No manufacture of any of the PMN substances beyond the
time limits specified in the Order without submittal to EPA the results
of certain testing described in the Testing section of the Order;
Use of personal protective equipment where there is a
potential for dermal exposure;
Establishment of a hazard communication program, including
human health precautionary statements on each label and in the SDS;
No processing or use of the PMN substances in any way that
generates a vapor, dust, mist, or aerosol in a non-enclosed process;
Use of the PMN substances only for the confidential use
stated in the Order;
No domestic manufacture of the PMN substances (i.e.,
import only);
Import of the PMN substances only in solution, or in any
form in sealed containers weighing 5 kilograms or less; and
No exceedance of the confidential annual importation
volumes listed the Order.
The proposed SNUR would designate as a ``significant new use'' the
absence of these protective measures.
Potentially Useful Information: EPA has determined that certain
information about the physical/chemical properties, fate,
bioaccumulation, environmental hazard, and human health effects of the
PMN substances may be potentially useful in support of a request by the
PMN submitter to modify the Order, or if a manufacturer or processor is
considering submitting a SNUN for a significant new use that will be
designated by this SNUR. The submitter has agreed not to exceed the
time limits specified in the Order without performing the required Tier
I and Tier II testing outlined in the Testing section of the Order.
PMN Number: P-22-115 (40 CFR 721.11922)
Chemical Name: .beta.-cyclodextrin, polymer with 2,3,5,6-
tetrafluoro-1,4-benzenedicarbonitrile, hydrolyzed, 2-
(trimethylammonio)ethyl ethers, chlorides.
CASRN: 2683011-63-2.
Effective Date of TSCA Order: May 9, 2023.
Basis for TSCA Order: The PMN states that the uses will be as a
filter media integrated and encapsulated in block filter articles for
consumer, industrial, and commercial applications, filter media
integrated and encapsulated in filter articles for consumer
applications, and filter media integrated and encapsulated in packed
bed filters for industrial and commercial applications.
[[Page 67380]]
Based on the high molecular weight polymer and low water solubility,
EPA has identified concerns for lung effects (lung overload). Based on
amine content, EPA has also identified concerns for irritation to the
skin, eyes, and respiratory tract. The Order was issued under TSCA
sections 5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on a finding
that in the absence of sufficient information to permit a reasoned
evaluation, the substance may present an unreasonable risk of injury to
human health. To protect against these risks, the Order requires:
No processing for use or use of the PMN substance in
consumer products except when incorporated into an article;
No manufacture, processing, or use of the PMN substance
with a particle size less than 20 microns;
Use of personal protective equipment where there is a
potential for dermal exposure;
Use of a NIOSH-certified particulate respirator with an
APF of at least 10 where there is a potential for inhalation exposure;
and
Establishment of a hazard communication program, including
human health precautionary statements on each label and in the SDS.
The proposed SNUR would designate as a ``significant new use'' the
absence of these protective measures.
Potentially Useful Information: EPA has determined that certain
information may be potentially useful in support of a request by the
PMN submitter to modify the Order, or if a manufacturer or processor is
considering submitting a SNUN for a significant new use that will be
designated by this SNUR. EPA has determined that the results of
pulmonary effects, skin irritation, and eye irritation testing may be
potentially useful to characterize the health effects of the PMN
substance. Although the Order does not require these tests, the Order's
restrictions remain in effect until the Order is modified or revoked by
EPA based on submission of this or other relevant information.
PMN Number: P-22-129 (40 CFR 721.11923)
Chemical Name: Substituted heterocyclic onium compound, salt with
heteropolysubstitutedalkyl substitutedtricycloalkane carboxylate (1:1),
polymer with 1-alkenyl-4-[(alkylcycloalkyl)oxy]carbomonocycle, 5-
ethyloctahydro-4,7-methano-1H-inden-5-yl 2-methyl-2-propenoate,
hexahydro-5-oxo-2,6-methanofuro[3,2-b]furan-3-yl 2-methyl-2-propenoate
and 4-hydroxyphenyl 2-methyl-2-propenoate (generic).
CASRN: Not available.
Effective Date of TSCA Order: April 24, 2023.
Basis for TSCA Order: The PMN states that the generic (non-
confidential) use of the PMN substance will be for contained use for
microlithography for electronic device manufacturing. Based on the
physical/chemical properties of the PMN substance (as described in the
New Chemical Program's PBT category at 64 FR 60194, November 4, 1999
(FRL-6097-7)), the PMN substance is a potentially persistent,
bioaccumulative, and toxic (PBT) chemical. EPA estimates that the PMN
substance will persist in the environment for more than six months and
estimates a bioaccumulation factor of greater than or equal to 1,000.
Based on the reactivity of the PMN substance, EPA has identified
concerns for photosensitization, and irritation to the skin, eyes, and
respiratory tract. Based on the cation of the PMN substance and
information provided in the SDS, EPA has also identified concerns for
acute toxicity, irritation to the skin, eyes, and respiratory tract,
eye corrosion, ocular lethality, neurological effects, and systemic
effects. Based on comparison to analogous chemical substances, EPA has
also identified concerns for mutagenicity. Based on a potential
incineration by-product, EPA has also identified concerns for local,
neurotoxic, and systemic effects. The Order was issued under TSCA
sections 5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on a finding
that in the absence of sufficient information to permit a reasoned
evaluation, the substance may present an unreasonable risk of injury to
human health or the environment. To protect against these risks, the
Order requires:
No manufacture of the PMN substance beyond the time limits
specified in the Order without submittal to EPA the results of certain
testing described in the Testing section of the Order;
Use of personal protective equipment where there is a
potential for dermal exposure;
Establishment of a hazard communication program, including
human health precautionary statements on each label and in the SDS;
No modification of the processing or use of the PMN
substance in any way that generates a vapor, dust, mist, or aerosol in
a non-enclosed process;
Use of the PMN substance only for the confidential use
listed in the Order;
No domestic manufacture of the PMN substance (i.e., import
only);
Import of the PMN substance only in solution, or in any
form in sealed containers weighing 5 kilograms or less; and
No exceedance of the confidential annual importation
volume listed the Order.
The proposed SNUR would designate as a ``significant new use'' the
absence of these protective measures.
Potentially Useful Information: EPA has determined that certain
information about the physical/chemical properties, fate,
bioaccumulation, environmental hazard, and human health effects of the
PMN substance may be potentially useful in support of a request by the
PMN submitter to modify the Order, or if a manufacturer or processor is
considering submitting a SNUN for a significant new use that will be
designated by this SNUR. The submitter has agreed not to exceed the
time limits specified in the Order without performing the required Tier
I and Tier II testing outlined in the Testing section of the Order.
PMN Number: P-22-162 (40 CFR 721.11924)
Chemical Name: Haloalkylfurancarboxaldehyde (generic).
CASRN: Not available.
Effective Date of TSCA Order: May 8, 2023.
Basis for TSCA Order: The PMN states that the use will be as a
chemical intermediate used in the production of para-xylene and in
production of FDCA/PET and other specialty chemicals. Based on
submitted test data on the PMN substance and comparison to analogous
chemical substances, EPA has identified concerns for acute toxicity,
skin and respiratory tract irritation, serious eye damage, skin
sensitization, systemic effects, developmental effects, and
genotoxicity. Based on comparison to analogous aldehydes and submitted
acute toxicity data on the PMN substance, EPA predicts toxicity to
aquatic organisms may occur at concentrations that exceed 540 ppb. The
Order was issued under TSCA sections 5(a)(3)(B)(ii)(I) and
5(e)(1)(A)(ii)(I), based on a finding that in the absence of sufficient
information to permit a reasoned evaluation, the substance may present
an unreasonable risk of injury to human health and the environment. To
protect against these risks, the Order requires:
No processing or use of the PMN substance in consumer
products;
No manufacture, processing, or use of the substance in any
manner that results in inhalation exposure;
No release of the PMN substance, or any waste stream
containing the PMN
[[Page 67381]]
substance, in surface water concentrations that exceed 540 ppb;
Use of personal protective equipment where there is a
potential for dermal exposure;
Disposal of the PMN substance, or any waste steams
containing the PMN substance, only by hazardous waste incineration
achieving at least 99.99% destruction of the PMN substance;
Manufacture, processing, or use of the PMN substance only
in an enclosed process; and
Establishment of a hazard communication program, including
human health precautionary statements on each label and in the SDS.
The proposed SNUR would designate as a ``significant new use'' the
absence of these protective measures.
Potentially Useful Information: EPA has determined that certain
information may be potentially useful in support of a request by the
PMN submitter to modify the Order, or if a manufacturer or processor is
considering submitting a SNUN for a significant new use that will be
designated by this SNUR. EPA has determined that the results of
reproductive toxicity, specific target organ toxicity, and aquatic
toxicity testing may be potentially useful to characterize the health
and environmental effects of the PMN substance. Although the Order does
not require these tests, the Order's restrictions remain in effect
until the Order is modified or revoked by EPA based on submission of
this or other relevant information.
MCAN Number: J-23-3 (40 CFR 725.1082)
Chemical Name: Microorganism expressing enzymes (generic).
CASRN: Not available.
Effective Date of TSCA Order: April 21, 2023.
Basis for TSCA Order: The MCAN states that the generic (non-
confidential) use of the microorganism will be for production of an
enzyme mixture. EPA determined that certain fermentation conditions,
other than the typical submerged standard industrial fermentation
process for enzyme production, could result in increased exposures.
Specifically, EPA is concerned that where growth on plant material or
on solid substrates occur, the MCAN microorganism has been shown to
produce a secondary metabolite known as paracelsin, which is associated
with a variety of toxic effects to mammalian and bacterial cells. The
Order was issued under TSCA sections 5(a)(3)(B)(ii)(I) and
5(e)(1)(A)(ii)(I), based on a finding that in the absence of sufficient
information to permit a reasoned evaluation, the microorganism may
present an unreasonable risk of injury to human health and the
environment. To protect against these risks, the Order requires:
No manufacture, processing, or use of the microorganism
other than in a fermentation system that meets all of the following
conditions:
(1) Enzyme production is conducted under conditions of submerged
fermentation (i.e., growth of the microorganism occurs beneath the
surface of the liquid growth medium); and
(2) Any fermentation of solid plant material or insoluble
substrate, to which the fermentation broth is added after the submerged
standard industrial fermentation operations used for enzyme production
is completed, may be initiated only after the inactivation of the
microorganism as delineated in 40 CFR 725.422(d).
The proposed SNUR would designate as a ``significant new use'' the
absence of these protective measures.
Potentially Useful Information: EPA has determined that the results
of the following studies would help characterize any potential human
health and environmental effects of the MCAN microorganism if a
manufacturer or processor is considering submitting a SNUN for a
significant new use that would be designated by this SNUR:
Investigation of whether paracelsin will be produced, and
at what levels if the MCAN microorganism is grown on various plant
biomass materials for different durations under various fermentation
conditions in cellulosic biomass facilities.
If paracelsin is produced, a study of whether paracelsin
would be denatured/inactivated during production and processing.
If paracelsin is released from the facility, a study of
whether paracelsin would be degraded/inactivated during wastewater
treatment.
If released to the environment, studies on the
persistence, stability, dissemination, accumulation, and the potential
resulting biological activity of paracelsin with exposure to aquatic
and terrestrial organisms in the environment.
Studies to determine the ability of the MCAN microorganism
to survive in the environment relative to the survival of the
unmodified parent or recipient strain, and to assess its
competitiveness with other fungi in the environment. This study may
require some supplementation with one or more carbon sources and the
use of various soil types.
A study to determine survival of the MCAN microorganism
during an anaerobic fermentation for production of ethanol by an
ethanologen, and survival of the MCAN microorganism during ethanol
distillation or at the distillation temperature for ethanol.
Although the Order does not require these tests, the Order's
restrictions remain in effect until the Order is modified or revoked by
EPA based on submission of this or other relevant information.
IV. 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 14094: Modernizing Regulatory Review
This action proposes to establish SNURs for new chemical substances
that were the subject of PMNs or MCANs. The Office of Management and
Budget (OMB) has exempted these types of actions from review under
Executive Order 12866 (58 FR 51735, October 4, 1993), as amended by
Executive Order 14094 (88 FR 21879, April 11, 2023).
B. Paperwork Reduction Act (PRA)
According to the PRA (44 U.S.C. 3501 et seq.), an agency may not
conduct or sponsor, and a person is not required to respond to a
collection of information that requires OMB approval under PRA, unless
it has been approved by OMB and displays a currently valid OMB control
number. The OMB control numbers for EPA's regulations in title 40 of
the CFR, after appearing in the Federal Register, are listed in 40 CFR
part 9, and included on the related collection instrument or form, if
applicable.
The information collection requirements related to SNURs have
already been approved by OMB pursuant to PRA under OMB control number
2070-0038 (EPA ICR No. 1188). This action does not impose any burden
requiring additional OMB approval. If an entity were to submit a SNUN
to the Agency, the annual burden is estimated to average between 30 and
170 hours per submission. 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.
EPA always welcomes your feedback on the burden estimates. Send any
comments about the accuracy of the
[[Page 67382]]
burden estimate, and any suggested methods for improving the collection
instruments or instruction or minimizing respondent burden, including
through the use of automated collection techniques.
C. Regulatory Flexibility Act (RFA)
I certify that this action will not have a significant economic
impact on a substantial number of small entities under the RFA (5
U.S.C. 601 et seq.). 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 16 in Federal fiscal year (FY) FY2018,
five in FY2019, seven in FY2020, 13 in FY2021, 11 in FY2022, and 15 in
FY2023, and only a fraction of these submissions were from small
businesses.
In addition, the Agency currently offers relief to qualifying small
businesses by reducing the SNUN submission fee from $37,000 to $6,480.
This lower fee reduces the total reporting and recordkeeping cost of
submitting a SNUN to about $14,500 per SNUN submission for qualifying
small firms. Therefore, the potential economic impacts of complying
with these proposed SNURs 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 SNURs are
not expected to have a significant economic impact on a substantial
number of small entities, which was provided to the Chief Counsel for
Advocacy of the Small Business Administration.
D. Unfunded Mandates Reform Act (UMRA)
This action does not contain an unfunded mandate of $100 million or
more (in 1995 dollars) in any one year as described in UMRA, 2 U.S.C.
1531-1538, and does not significantly or uniquely affect small
governments. Based on EPA's experience with proposing and finalizing
SNURs, State, local, and Tribal governments have not been impacted by
SNURs. In addition, the estimated costs of this action to the private
sector do not exceed $183 million or more in any one year (the 1995
dollars are adjusted to 2023 dollars for inflation using the GDP
implicit price deflator). The estimated costs for this action are
discussed in Unit I.D.
E. Executive Order 13132: Federalism
This action will not have federalism implications as specified in
Executive Order 13132 (64 FR 43255, August 10, 1999), because it is not
expected to have a substantial direct effect on States, on the
relationship between the national government and the States, or on the
distribution of power and responsibilities among the various levels of
government. Accordingly, the requirements of Executive Order 13132 do
not apply to this action.
F. Executive Order 13175: Consultation and Coordination With Indian
Tribal Governments
This action will not have Tribal implications as specified in
Executive Order 13175 (65 FR 67249, November 9, 2000), because it is
not expected to have substantial direct effects on Indian Tribes,
significantly or uniquely affect the communities of Indian Tribal
governments and does not involve or impose any requirements that affect
Indian Tribes. Accordingly, the requirements of Executive Order 13175
do not apply to this action.
G. Executive Order 13045: Protection of Children from Environmental
Health Risks and Safety Risks
This action is not subject to Executive Order 13045 (62 FR 19885,
April 23, 1997), because it does not concern an environmental health or
safety risk. Since this action does not concern human health, EPA's
2021 Policy on Children's Health also does not apply. Although the
establishment of these SNURs do not address an existing children's
environmental health concern because the chemical uses involved are not
ongoing uses, SNURs require that persons notify EPA at least 90 days
before commencing manufacture (defined by statute to include import) or
processing of any of these chemical substances for an activity that is
designated as a significant new use by this rule. This notification
allows EPA to assess the conditions of use to identify potential risks
and take appropriate actions before the activities commence.
H. Executive Order 13211: Actions Concerning Regulations That
Significantly Affect Energy Supply, Distribution, or Use
This action is not a ``significant energy action'' as defined in
Executive Order 13211 (66 FR 28355, May 22, 2001), because it is not
likely to have a significant adverse effect on the supply,
distribution, or use of energy.
I. National Technology Transfer and Advancement Act (NTTAA)
This action does not involve any technical standards subject to
NTTAA section 12(d) (15 U.S.C. 272 note).
J. Executive Order 12898: Federal Actions to Address Environmental
Justice in Minority Populations and Low-Income Populations and
Executive Order 14096: Revitalizing Our Nation's Commitment to
Environmental Justice for All
This action does not concern human health or environmental
conditions and therefore cannot be evaluated with respect to the
potential for disproportionate impacts on non-white and low-income
populations in accordance with Executive Order 12898 (59 FR 7629,
February 16, 1994) and Executive Order 14096 (88 FR 25251, April 26,
2023). Although this action does not concern human health or
environmental conditions, the premanufacture notifications required by
these SNURs allow EPA to assess the conditions of use to identify
potential disproportionate risks and take appropriate actions before
the activities commence.
List of Subjects in 40 CFR Part 721 and 725
Environmental protection, Chemicals, Hazardous substances,
Reporting and recordkeeping requirements.
Dated: August 9, 2024.
Mark Hartman,
Deputy Director, Office of Pollution Prevention and Toxics.
Therefore, for the reasons stated in the preamble, EPA proposes to
amend 40 CFR chapter I as follows:
PART 721-SIGNIFICANT NEW USES OF CHEMICAL SUBSTANCES
0
1. The authority citation for part 721 continues to read as follows:
Authority: 15 U.S.C. 2604, 2607, and 2625(c).
[[Page 67383]]
0
2. Add Sec. Sec. 721.11894 through 721.11924 to subpart E to read as
follows:
Subpart E--Significant New Uses for Specific Chemical Substances
* * * * *
Sec.
721.11894 Sulfonated phenolic resin salt, polymer with acetone-
phenol reaction products, formaldehyde and phenol, sodium salt
(generic).
721.11895 Sulfonated phenolic resin salt, polymer with acetone-
phenol reaction products, formaldehyde and phenol, potassium salt
(generic).
721.11896 Octadecanamide, N,N-dialkyl, salts (generic).
721.11897 Acid N-[4-(4-diarylalkyl]-, carbopolycyclic alkenyl,
methyl ester (generic).
721.11898 Acid N-(diarylalkyl)-, carbopolycyclic alkenyl, methyl
ester (generic).
721.11899 Carbopolycyclic alkenyl, 2-carboxylic acid, 2-
[[[(diarylalkyl)]carbonyl]oxy]ethyl ester (generic).
721.11900 Amines, C36-alkylenedi-, polymers with 5,5'-[(1-
methylethylidene)bis(4,1-phenyleneoxy)]bis[1,3-isobenzofurandione]
and 4,4'-[2,2,2-trifluoro-1-(trifluoromethyl)ethylidene]bis[2-
aminophenol].
721.11901 Poly[oxy(methyl-1,2-ethanediyl)], .alpha.-(3-
aminopropyl)-.omega.-(1-methylethoxy)-.
721.11902 Poly[oxy(methyl-1,2-ethanediyl)], .alpha.-(3-
aminopropyl)-.omega.-butoxy-.
721.11903 Alkanoic acid, hydroxy-(hydroxyalkyl)-alkyl-, polymer with
.alpha.-[(hydroxyalkyl)alkyl]-.omega.-alkoxypoly(oxy-alkanediyl),
dialkyl carbonate, alkanediol, alkylene[isocyanato-carbomonocycle]
and [oxybis(alkylene)]bis[alkyl-alkanediole] alkenoate, compd. with
dialkyalkanamine (generic).
721.11904 Alkanedioic acid, polymers with alkanoic acid-
dipentaerythritol reaction products, alkanedioc acid dihydrazide,
hydroxy-(hydroxyalkyl)-alkylalkanoic acid, isocyanato-
(isocyanatoalkyl)-alkyl substituted carbomonocycle,
dialkylalkanediol and polyalkylene glycol(hydroxyalkyl)alkyl alkyl
ether (generic).
721.11905 Phenol, 4,4'-(1-methylethylidene)bis-, polymer with 2,2'-
[(1-methylethylidene)bis(4,1-phenyleneoxymethylene)] bis
[heteromonocycle], bis(2-methyl-2-propenoate) (generic).
721.11906 Poly(oxy-1,2-ethanediyl), .alpha.-hydro-.omega.-[2(or 3)-
[[substituted benzoyl]oxy]hydroxypropoxyl]-, .alpha., .alpha.',
.alpha.'' -ether with 2-ethyl-2-(hydroxymethyl)-1,3-propanediol
(3:1) (generic).
721.11907 Substituted heteromonocycle, polymer with haloalkyl
substituted heteromonocycle, dialkyl-alkanediamine,
(alkylalkylidene)bis[hydroxy-carbomonocycle] and oxybis[alkanol],
reaction products with metal oxide and dialkanolamine (generic).
721.11908 Carbonic acid, diphenyl ester, polymer with 1,4-butanediol
and 1,10-decanediol.
721.11909 3,5,8-Trioxa-4-silaalkanoic acid, 4-ethenyl-4-(2-alkoxy-1-
alkyl-2-oxoethoxy)-2,6-dialkyl-7-oxo-, alkyl ester (generic).
721.11910 .beta.-N-Acetylhexosaminidase (expressed in genetically
modified Bacillus licheniformis strain ATJI0138).
721.11911 Alkanes, C4-9-branched and linear.
721.11912 Amino alkanoic acid, N-[3-(trimethoxysilyl)propyl]-, 3-
(trimethoxysilyl)propyl ester (generic).
721.11913 2-Pyridinecarboxylic acid, 3-halo-4-nitrogen-substituted-
5-halo-6-halo, aryl ester (generic).
721.11914 2-Pyridinecarboxylic acid, 3-halo-4-nitrogen-substituted-
5-halo-6-halo- (generic).
721.11915 Polyphosphoric acids, esters with heteromonocycle
homopolymer (generic).
721.11916 Silica gel, reaction products with alkyl metal salt
(generic).
721.11917 Graphene nanoplatelets (generic)
721.11918 Phenoxathiinium, 10-phenyl-, 5-alkyl-2-alkyl-4-(2,4,6-
substituted tri-carbopolycycle, hetero-acid)benzenesulfonate (1:1)
(generic).
721.11919 Heterotrisubstituted-bile acid, 1-(difluorosulfomethyl)-
2,2,2-trifluoroethyl ester, ion(1-), (5)-, 5-
phenyldibenzothiophenium (1:1) (generic).
721.11920 Sulfonium, (alkylsubstitutedphenyl)diphenyl-, salt with 1-
(heterosubstitutedalkyl)-2,2,2-triheterosubstitutedalkyl
trisubstitutedbenzoate (1:1) (generic).
721.11921 Dibenzothiophenium, 5-phenyl-, 4-[1-
(heterosubstitutedalkyl)-2,2,2-triheterosubstitutedalkoxy]-4-
oxoalkyl trisubstitutedbenzoate (1:1) (generic).
721.11922 .beta.-cyclodextrin, polymer with 2,3,5,6-tetrafluoro-1,4-
benzenedicarbonitrile, hydrolyzed, 2-(trimethylammonio)ethyl ethers,
chlorides.
721.11923 Substituted heterocyclic onium compound, salt with
heteropolysubstitutedalkyl substitutedtricycloalkane carboxylate
(1:1), polymer with 1-alkenyl-4-
[(alkylcycloalkyl)oxy]carbomonocycle, 5-ethyloctahydro-4,7-methano-
1H-inden-5-yl 2-methyl-2-propenoate, hexahydro-5-oxo-2,6-
methanofuro[3,2-b]furan-3-yl 2-methyl-2-propenoate and 4-
hydroxyphenyl 2-methyl-2-propenoate (generic).
721.11924 Haloalkylfurancarboxaldehyde (generic).
Sec. 721.11894 Sulfonated phenolic resin salt, polymer with acetone-
phenol reaction products, formaldehyde and phenol, sodium salt
(generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
sulfonated phenolic resin salt, polymer with acetone-phenol reaction
products, formaldehyde and phenol, sodium salt (PMN P-18-356) 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 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: skin corrosion; serious eye
damage; 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). 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=6.
(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.
[[Page 67384]]
Sec. 721.11895 Sulfonated phenolic resin salt, polymer with acetone-
phenol reaction products, formaldehyde and phenol, potassium salt
(generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
sulfonated phenolic resin salt, polymer with acetone-phenol reaction
products, formaldehyde and phenol, potassium salt (PMN P-18-357) 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 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: skin corrosion; serious eye
damage; 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). 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=6.
(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. 721.11896 Octadecanamide, N,N-dialkyl, salts (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
octadecanamide, N,N-dialkyl, salts (PMN P-19-188) 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; eye
irritation; specific target organ toxicity; serious eye damage. 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=34.
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (i), and (k) are applicable to manufacturers,
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. 721.11897 Acid N-[4-(4-diarylalkyl]-, carbopolycyclic alkenyl,
methyl ester (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as acid N-
[4-(4-diarylalkyl]-, carbopolycyclic alkenyl, methyl ester (PMN P-20-
175) 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 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), (g)(1), (3), and (5). For purposes of Sec.
721.72(g)(1), this substance may cause: skin irritation; eye
irritation; respiratory sensitization; skin sensitization;
carcinogenicity; 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). 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=0.1.
(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.
[[Page 67385]]
Sec. 721.11898 Acid N-(diarylalkyl)-, carbopolycyclic alkenyl, methyl
ester (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as acid N-
(diarylalkyl)-, carbopolycyclic alkenyl, methyl ester (PMN P-20-176) 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 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), (3) and (5). For purposes of
Sec. 721.72(g)(1), this substance may cause: skin irritation; eye
irritation; respiratory sensitization; skin sensitization;
carcinogenicity; 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). 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=0.1.
(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. 721.11899 Carbopolycyclic alkenyl, 2-carboxylic acid, 2-
[[[(diarylalkyl)] carbonyl]oxy] ethyl ester (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
carbopolycyclic alkenyl, 2-carboxylic acid, 2-
[[[(diarylalkyl)]carbonyl]oxy]ethyl ester (PMN P-20-178) is subject to
reporting under this section for the significant new uses described in
paragraph (a)(2) of this section. The requirements of this section do
not apply to quantities of the substance after they have been
completely reacted or 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), (3) and (5). For purposes of
Sec. 721.72(g)(1), this substance may cause: skin irritation; eye
irritation; respiratory sensitization; skin sensitization;
carcinogenicity; 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). 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=0.2.
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (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. 721.11900 Amines, C36-alkylenedi-, polymers with 5,5'-[(1-
methylethylidene)bis(4,1-phenyleneoxy)]bis[1,3-isobenzofurandione] and
4,4'-[2,2,2-trifluoro-1-(trifluoromethyl)ethylidene]bis[2-aminophenol].
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as amines, C36-
alkylenedi-, polymers with 5,5'-[(1-methylethylidene)bis(4,1-
phenyleneoxy)]bis[1,3-isobenzofurandione] and 4,4'-[2,2,2-trifluoro-1-
(trifluoromethyl)ethylidene]bis[2-aminophenol] (PMN P-21-15; CASRN
2419899-87-7) is subject to reporting under this section for the
significant new uses described in paragraph (a)(2) of this section. The
requirements of this section do not apply to quantities of the
substance after they have been completely reacted (cured).
(2) The significant new uses are:
(i) Hazard communication. Requirements as specified in Sec.
721.72(a) through (f), 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.
(ii) Industrial, commercial, and consumer activities. It is a
significant new use to use the substance other than as a raw material
in a temporary bonding adhesive formulation. The adhesive is used to
bond completed semiconductor wafers to a backing substrate to
facilitate mechanical grinding of the wafer to reduce its thickness. It
is a significant new use to manufacture, process, or use the substance
in any manner that results in worker 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 (c), 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. 721.11901 Poly[oxy(methyl-1,2-ethanediyl)], .alpha.-(3-
aminopropyl)-.omega.-(1-methylethoxy)-.
(a) Chemical substance and significant new uses subject to
reporting.
[[Page 67386]]
(1) The chemical substance identified as poly[oxy(methyl-1,2-
ethanediyl)], .alpha.-(3-aminopropyl)-.omega.-(1-methylethoxy)- (PMN P-
21-32; CASRN 2304726-48-3) is subject to reporting under this section
for the significant new uses described in paragraph (a)(2) of this
section. The requirements of this section do not apply to quantities of
the substance after they have been completely reacted or destroyed.
(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), (g)(1), (3), and (5). For purposes of Sec.
721.72(g)(1), this substance may cause: acute toxicity; skin corrosion;
serious eye damage; skin sensitization; 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). It is a significant new use to process
or use the substance in any manner in formulation containing the
substance at greater than 4%.
(iv) Release to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4), and (c)(4), where N=110. Whenever the substance
is released together with poly[oxy(methyl-1,2-ethanediyl)], .alpha.-(3-
aminopropyl)-.omega.-butoxy- (PMN P-21-33; CASRN 2304726-50-7), N
should be calculated using the combined number of kilograms of both
substances released per site per day.
(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. 721.11902 Poly[oxy(methyl-1,2-ethanediyl)], .alpha.-(3-
aminopropyl)-.omega.-butoxy-.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as poly[oxy(methyl-
1,2-ethanediyl)], .alpha.-(3-aminopropyl)-.omega.-butoxy- (PMN P-21-33;
CASRN 2304726-50-7) is subject to reporting under this section for the
significant new uses described in paragraph (a)(2) of this section. The
requirements of this section do not apply to quantities of the
substance after they have been completely reacted or destroyed.
(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: acute toxicity; skin
corrosion; serious eye damage; skin sensitization; 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). It is a significant new use to process
or use the substance in any manner in formulation containing the
substance at greater than 4%.
(iv) Release to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4), and (c)(4), where N=110. Whenever the substance
is released together with poly[oxy(methyl-1,2-ethanediyl)], .alpha.-(3-
aminopropyl)-.omega.-(1-methylethoxy)- (PMN P-21-32; CASRN 2304726-48-
3), N should be calculated using the combined number of kilograms of
both substances released per site per day.
(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. 721.11903 Alkanoic acid, hydroxy-(hydroxyalkyl)-alkyl-, polymer
with .alpha.-[(hydroxyalkyl)alkyl]-.omega.-alkoxypoly(oxy-alkanediyl),
dialkyl carbonate, alkanediol, alkylene[isocyanato-carbomonocycle] and
[oxybis(alkylene)]bis[alkyl-alkanediole] alkenoate, compd. with
dialkyalkanamine (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
alkanoic acid, hydroxy-(hydroxyalkyl)-alkyl-, polymer with .alpha.-
[(hydroxyalkyl)alkyl]-.omega.-alkoxypoly(oxy-alkanediyl), dialkyl
carbonate, alkanediol, alkylene[isocyanato-carbomonocycle] and
[oxybis(alkylene)]bis[alkyl-alkanediole] alkenoate, compd. with
dialkyalkanamine (PMN P-21-75) 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
cured.
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(1), (3) through (5), 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, or 1000 if spray applied.
(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: acute toxicity; skin corrosion;
skin irritation; serious eye damage; eye irritation; respiratory
sensitization; 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.
[[Page 67387]]
(iii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(o).
(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. 721.11904 Alkanedioic acid, polymers with alkanoic acid-
dipentaerythritol reaction products, alkanedioc acid dihydrazide,
hydroxy-(hydroxyalkyl)-alkylalkanoic acid, isocyanato-
(isocyanatoalkyl)-alkyl substituted carbomonocycle, dialkylalkanediol
and polyalkylene glycol(hydroxyalkyl)alkyl alkyl ether (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
alkanedioic acid, polymers with alkanoic acid-dipentaerythritol
reaction products, alkanedioc acid dihydrazide, hydroxy-(hydroxyalkyl)-
alkylalkanoic acid, isocyanato-(isocyanatoalkyl)-alkyl substituted
carbomonocycle, dialkylalkanediol and polyalkylene
glycol(hydroxyalkyl)alkyl alkyl ether (PMN P-21-80) 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 cured.
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(1), (3) through (5), 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, or 1000 if spray applied.
(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; respiratory sensitization; 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(o).
(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. 721.11905 Phenol, 4,4'-(1-methylethylidene) bis-, polymer with
2,2'-[(1-methylethylidene) bis (4,1-phenyleneoxymethylene)] bis
[heteromonocycle], bis (2-methyl-2-propenoate) (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as phenol,
4,4'-(1-methylethylidene)bis-, polymer with 2,2'-[(1-
methylethylidene)bis(4,1-phenyleneoxymethylene)] bis [heteromonocycle],
bis (2-methyl-2-propenoate) (PMN P-21-96) 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
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), (3) and (5). For purposes of
Sec. 721.72(g)(1), this substance may cause: skin irritation; eye
irritation; respiratory sensitization; 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. 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=2.
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (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. 721.11906 Poly(oxy-1,2-ethanediyl), .alpha.-hydro-.omega.-[2(or
3)-[[substituted benzoyl]oxy]hydroxypropoxyl]-, .alpha., .alpha.',
.alpha.'' -ether with 2-ethyl-2-(hydroxymethyl)-1,3-propanediol (3:1)
(generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
poly(oxy-1,2-ethanediyl), .alpha.-hydro-.omega.-[2(or 3)-[[substituted
benzoyl]oxy]hydroxypropoxyl]-, .alpha., .alpha.', .alpha.'' -ether with
2-ethyl-2-(hydroxymethyl)-1,3-propanediol (3:1) (PMN P-21-98) 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 cured.
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(1), (3) through (5), 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.
[[Page 67388]]
(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; eye
irritation; skin sensitization; specific target organ toxicity;
reproductive 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). It is a significant new use to
manufacture or process the substance in any manner or method that
results in inhalation exposure. It is a significant new use to use the
substance in formulations at concentrations greater than 4%.
(iv) Release to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4), and (c)(4), where N=12.
(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. 721.11907 Substituted heteromonocycle, polymer with haloalkyl
substituted heteromonocycle, dialkyl-alkanediamine,
(alkylalkylidene)bis[hydroxy-carbomonocycle] and oxybis[alkanol],
reaction products with metal oxide and dialkanolamine (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
substituted heteromonocycle, polymer with haloalkyl substituted
heteromonocycle, dialkyl-alkanediamine, (alkylalkylidene)bis[hydroxy-
carbomonocycle] and oxybis[alkanol], reaction products with metal oxide
and dialkanolamine (PMN P-21-126) 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 destroyed.
(2) The significant new uses are:
(i) Hazard communication. Requirements as specified in Sec.
721.72(a) through (f), and (g)(3) and (5). For purposes of Sec.
721.72(e), the concentration is set at 1.0%. 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.
(ii) Release to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4), and (c)(4), where N=230.
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (c), (f) through (h), 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. 721.11908 Carbonic acid, diphenyl ester, polymer with 1,4-
butanediol and 1,10-decanediol.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as carbonic acid,
diphenyl ester, polymer with 1,4-butanediol and 1,10-decanediol (PMN P-
21-175; CASRN 1615685-41-0) 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 destroyed.
(2) The significant new uses are:
(i) Hazard communication. Requirements as specified in Sec.
721.72(a) through (f), and (g)(3) and (5). For purposes of Sec.
721.72(e), the concentration is set at 1.0%. 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.
(ii) Release to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4), and (c)(4), where N=22.
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (c), (f), 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. 721.11909 3,5,8-Trioxa-4-silaalkanoic acid, 4-ethenyl-4-(2-
alkoxy-1-alkyl-2-oxoethoxy)-2,6-dialkyl-7-oxo-, alkyl ester (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as 3,5,8-
trioxa-4-silaalkanoic acid, 4-ethenyl-4-(2-alkoxy-1-alkyl-2-oxoethoxy)-
2,6-dialkyl-7-oxo-, alkyl ester (PMN P-22-7) is subject to reporting
under this section for the significant new uses described in paragraph
(a)(2) of this section. The requirements of this section do not apply
to quantities of the substance after they have been completely reacted
or destroyed.
(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: eye irritation; 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. It is a
significant new use to process for use or use the substance other than
as a crosslinker in formulating general purpose sealants and adhesives.
It is a significant new use to process for use or use the substance in
consumer products other than in the form of a paste. It is a
significant new use to process for use or use the substance where the
concentration of the substance exceeds 6% by weight in consumer
products. 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
[[Page 67389]]
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. 721.11910 .beta.-N-Acetylhexosaminidase (expressed in
genetically modified Bacillus licheniformis strain ATJI0138).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as .beta.-N-
acetylhexosaminidase (expressed in genetically modified Bacillus
licheniformis strain ATJI0138) (PMN P-22-8; CASRN 9012-33-3) is subject
to reporting under this section for the significant new uses described
in paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) 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; respiratory sensitization; 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. It is a
significant new use to manufacture, process, or use the substance in
any manner that results in inhalation exposure. It is a significant new
use to process the substance to greater than 1% in formulation for use
in a consumer product.
(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. 721.11911 Alkanes, C4-9-branched and linear.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as alkanes, C4-9-
branched and linear (PMN P-22-9; CASRN 2577172-51-9) 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 a fuel or refined or blended into other chemical or
fuel formulations.
(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 0.1%.
(ii) Hazard communication. Requirements as specified in Sec.
721.72(a).
(iii) Industrial, commercial, and consumer activities. It is a
significant new use to manufacture, process, or use the substance other
than as a fuel, a refinery feedstock, a chemical feedstock, or a fuel
blending additive or component.
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (f), and (i) are applicable to manufacturers,
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. 721.11912 Amino alkanoic acid, N-[3-(trimethoxysilyl)propyl]-,
3-(trimethoxysilyl)propyl ester (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as amino
alkanoic acid, N-[3-(trimethoxysilyl)propyl]-, 3-
(trimethoxysilyl)propyl ester (PMN P-22-10) 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 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: skin irritation; serious eye
damage; 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). It is a significant new use to
manufacture, process, or use the substance in any manner that generates
inhalation exposure.
(iv) Release to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4), and (c)(4), where N=80.
(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. 721.11913 2-Pyridinecarboxylic acid, 3-halo-4-nitrogen-
substituted-5-halo-6-halo, aryl ester (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified
[[Page 67390]]
generically as 2-pyridinecarboxylic acid, 3-halo-4-nitrogen-
substituted-5-halo-6-halo, aryl ester (PMN P-22-13) 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), (3) through (5), 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), (g)(1), (3) and (5). For purposes of Sec.
721.72(g)(1), this substance may cause: eye irritation; skin
sensitization; 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(g). It is a significant new use to
manufacture, process, or use the substance unless in solid form when
using a dust collection system with a capture and control efficient of
at least 32%.
(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. 721.11914 2-Pyridinecarboxylic acid, 3-halo-4-nitrogen-
substituted-5-halo-6-halo- (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as 2-
pyridinecarboxylic acid, 3-halo-4-nitrogen-substituted-5-halo-6-halo-
(PMN P-22-15) 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), (3) through (5), (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%.
(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 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(g). It is a significant new use to
manufacture, process, or use the substance unless in solid form when
using a dust collection system with a capture and control efficient of
at least 32%.
(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. 721.11915 Polyphosphoric acids, esters with heteromonocycle
homopolymer (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
polyphosphoric acids, esters with heteromonocycle homopolymer (PMN P-
22-37) 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 cured.
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(1), (3) through (5), (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%.
(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 corrosion; skin
irritation; serious eye damage; eye irritation; 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). It is a significant new use to process
the substance to greater than 1% in formulation. It is a significant
new use to use the substance in a formulation containing the substance
at a concentration greater than 1%.
(iv) Release to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4), and (c)(4), where N=2.
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
[[Page 67391]]
(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. 721.11916 Silica gel, reaction products with alkyl metal salt
(generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as silica
gel, reaction products with alkyl metal salt (PMN P-22-44) 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 destroyed.
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(1), (3) through (5), (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%.
(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: eye irritation; skin
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(a) through (c).
(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. 721.11917 Graphene nanoplatelets (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
graphene nanoplatelets (PMN P-22-54) 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: (i) Completely
reacted or cured; or (ii) 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), (3) through (5), (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%.
(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 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), (v)(3), and (x)(3). It is a
significant new use to manufacture the substance other than by import
into the United States in the form of a solution (i.e., no domestic
manufacture). It is a significant new use to process the substance in
any manner that generates inhalation exposure. It is a significant new
use to use the substance in an application method where the
concentration of the substance in the formulation exceeds the
confidential concentration listed in the Order.
(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. 721.11918 Phenoxathiinium, 10-phenyl-, 5-alkyl-2-alkyl-4-(2,4,6-
substituted tri-carbopolycycle, hetero-acid)benzenesulfonate (1:1)
(generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
phenoxathiinium, 10-phenyl-, 5-alkyl-2-alkyl-4-(2,4,6-substituted tri-
carbopolycycle, hetero-acid)benzenesulfonate (1:1) (PMN P-22-86) 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), (2)(i) and (iii), (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), (2)(i) through (iii), (v),
(3)(i) and (ii), and (5). For purposes of Sec. 721.72(g)(1), this
substance may cause: acute toxicity; skin irritation; serious eye
damage; skin sensitization; genetic toxicity; specific
[[Page 67392]]
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), (k), and (t). It is a significant new
use to import the substance other than in solution or in sealed
containers weighing 5 kilograms or less. It is a significant new use to
process the substance in any way that generates a vapor, dust, mist, or
aerosol in a non-enclosed process. It is a significant new use to
manufacture the substance longer than 9 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. 721.11919 Heterotrisubstituted-bile acid, 1-
(difluorosulfomethyl)-2,2,2-trifluoroethyl ester, ion(1-), (5)-, 5-
phenyldibenzothiophenium (1:1) (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
heterotrisubstituted-bile acid, 1-(difluorosulfomethyl)-2,2,2-
trifluoroethyl ester, ion(1-), (5)-, 5-phenyldibenzothiophenium (1:1)
(PMN P-22-122) 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 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), (2)(i) and (iii), (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), (2)(i) through (iii), (v),
(3)(i) and (ii), and (5). For purposes of Sec. 721.72(g)(1), this
substance may cause: acute toxicity; skin irritation; serious eye
damage; skin sensitization; genetic 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(f), (k), and (t). It is a significant new
use to import the substance other than in solution or in sealed
containers weighing 5 kilograms or less. It is a significant new use to
process the substance in any way that generates a vapor, dust, mist, or
aerosol in a non-enclosed process. It is a significant new use to
manufacture the substance longer than 9 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. 721.11920 Sulfonium, (alkylsubstitutedphenyl)diphenyl-, salt
with 1-(heterosubstitutedalkyl)-2,2,2-triheterosubstitutedalkyl
trisubstitutedbenzoate (1:1) (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
sulfonium, (alkylsubstitutedphenyl)diphenyl-, salt with 1-
(heterosubstitutedalkyl)-2,2,2-triheterosubstitutedalkyl
trisubstitutedbenzoate (1:1) (PMN P-22-179) 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), (2)(i) and (iii), (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), (2)(i) through (iii), (v),
(3)(i) and (ii), and (5). For purposes of Sec. 721.72(g)(1), this
substance may cause: acute toxicity; skin irritation; serious eye
damage; skin sensitization; genetic toxicity; carcinogenicity; 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), (k), and (t). It is a significant new
use to import the substance other than in solution or in sealed
containers weighing 5 kilograms or less. It is a significant new use to
process the substance in any way that generates a vapor, dust, mist, or
aerosol in a non-enclosed process. It is a significant new use to
manufacture the substance longer than 9 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. 721.11921 Dibenzothiophenium, 5-phenyl-, 4-[1-
(heterosubstitutedalkyl)-2,2,2-triheterosubstitutedalkoxy]-4-oxoalkyl
trisubstitutedbenzoate (1:1) (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
dibenzothiophenium, 5-phenyl-, 4-[1-(heterosubstitutedalkyl)-2,2,2-
triheterosubstitutedalkoxy]-4-oxoalkyl trisubstitutedbenzoate (1:1)
(PMN P-22-180) 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
[[Page 67393]]
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), (2)(i) and (iii), (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), (2)(i) through (iii), (v),
(3)(i) and (ii), and (5). For purposes of Sec. 721.72(g)(1), this
substance may cause: acute toxicity; skin irritation; serious eye
damage; skin sensitization; genetic toxicity; carcinogenicity; 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), (k), and (t). It is a significant new
use to import the substance other than in solution or in sealed
containers weighing 5 kilograms or less. It is a significant new use to
process the substance in any way that generates a vapor, dust, mist, or
aerosol in a non-enclosed process. It is a significant new use to
manufacture the substance longer than 9 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. 721.11922 .beta.-cyclodextrin, polymer with 2,3,5,6-tetrafluoro-
1,4-benzenedicarbonitrile, hydrolyzed, 2-(trimethylammonio)ethyl
ethers, chlorides.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as .beta.-
cyclodextrin, polymer with 2,3,5,6-tetrafluoro-1,4-
benzenedicarbonitrile, hydrolyzed, 2-(trimethylammonio)ethyl ethers,
chlorides (PMN P-22-115; CASRN 2683011-63-2) 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 incorporated into
an article.
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(1), (3) through (5), (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) 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; 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. It is a
significant new use to manufacture, process, or use the substance with
particle size less than 20 microns. It is a significant new use to
process for use or use the substance in consumer products except when
incorporated into an article.
(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. 721.11923 Substituted heterocyclic onium compound, salt with
heteropolysubstitutedalkyl substitutedtricycloalkane carboxylate (1:1),
polymer with 1-alkenyl-4-[(alkylcycloalkyl)oxy]carbomonocycle, 5-
ethyloctahydro-4,7-methano-1H-inden-5-yl 2-methyl-2-propenoate,
hexahydro-5-oxo-2,6-methanofuro[3,2-b]furan-3-yl 2-methyl-2-propenoate
and 4-hydroxyphenyl 2-methyl-2-propenoate (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
substituted heterocyclic onium compound, salt with
heteropolysubstitutedalkyl substitutedtricycloalkane carboxylate (1:1),
polymer with 1-alkenyl-4-[(alkylcycloalkyl)oxy]carbomonocycle, 5-
ethyloctahydro-4,7-methano-1H-inden-5-yl 2-methyl-2-propenoate,
hexahydro-5-oxo-2,6-methanofuro[3,2-b]furan-3-yl 2-methyl-2-propenoate
and 4-hydroxyphenyl 2-methyl-2-propenoate (PMN P-22-129) 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), (2)(i) and (iii), (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), (2)(i) through (iii), (v),
(3)(i) and (ii), and (5). For purposes of Sec. 721.72(g)(1), this
substance may cause: acute toxicity; skin irritation; serious eye
damage; skin sensitization; genetic 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(f), (k), and (t). It is a significant new
use to import the substance other than in solution, unless in sealed
containers weighing 5
[[Page 67394]]
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. 721.11924 Haloalkylfurancarboxaldehyde (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
haloalkylfurancarboxaldehyde (PMN P-22-162) 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
(destroyed).
(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: acute toxicity; skin
irritation; serious eye damage; skin sensitization; genetic 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(a) through (c), and (o). It is a
significant new use to manufacture, process, or use the substance in
any manner that results in inhalation exposure.
(iv) Disposal. It is a significant new use to dispose of the
substance, or any waste streams containing the substance, other than by
hazardous waste incineration achieving at least 99.99% destruction of
the substance.
(v) Release to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4), and (c)(4), where N=540.
(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 (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.
PART 725--REPORTING REQUIREMENTS AND REVIEW PROCESSES FOR
MICROORGANISMS
0
3. The authority citation for part 725 continues to read as follows:
Authority: 15 U.S.C. 2604, 2607, 2613, and 2625.
0
4. Add Sec. Sec. 725.1082 to subpart M to read as follows:
Subpart M--Significant New Uses for Specific Microorganisms
* * * * *
Sec. 725.1082 Microorganism expressing enzymes (generic).
(a) Microorganism and significant new uses subject to reporting.
(1) The genetically-modified microorganism identified generically as
microorganism expressing enzymes (MCAN J-23-3) is subject to reporting
under this section for the significant new uses described in paragraph
(a)(2) of this section.
(2) The significant new uses are:
(i) It is a significant new use to manufacture, process, or use the
microorganism other than in a fermentation system that meets all of the
following conditions:
(A) Enzyme production occurs by submerged fermentation (i.e., for
enzyme production, growth of the microorganism occurs beneath the
surface of the liquid growth medium); and
(B) Any fermentation of solid plant material or insoluble substrate
to which the microorganism fermentation broth is added after the
standard industrial fermentation is completed is initiated only after
the inactivation of the microorganism as delineated in Sec.
725.422(d).
(ii) [Reserved]
(b) Specific requirements. The provisions of subpart L of this part
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
725.950(b)(2) through (4) are applicable to manufacturers and
processors of this microorganism.
(2) Modification or revocation of certain notification
requirements. The provisions of Sec. 725.984 apply to this section.
[FR Doc. 2024-18259 Filed 8-19-24; 8:45 am]
BILLING CODE 6560-50-P