Significant New Use Rules on Certain Chemical Substances (25-2.5e)
EPA is proposing significant new use rules (SNURs) under the Toxic Substances Control Act (TSCA) for certain chemical substances that were the subject of premanufacture notices ...
EPA is proposing significant new use rules (SNURs) under the Toxic Substances Control Act (TSCA) for certain chemical substances that were the subject of premanufacture notices (PMNs) and are also subject to an Order issued by EPA pursuant to TSCA. 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 rulemaking to notify EPA at least 90 days before commencing that activity. The required notification initiates EPA's evaluation of the conditions of that 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 December 3, 2025.
ADDRESSES:
Submit your comments, identified by docket identification (ID) number EPA-HQ-OPPT-2025-0314, online 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:
Punam Tyagi, New Chemicals Division (7405M), Office of Pollution Prevention and Toxics, Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460-0001; telephone number: (202) 566-1176; email address:
tyagi.punam@epa.gov.
For general information on SNURs:
William Wysong, New Chemicals Division (7405M), Office of Pollution Prevention and Toxics, Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460-0001; telephone number: (202) 564-4163; email address:
wysong.william@epa.gov.
For general information on TSCA:
The TSCA Assistance Information Service Hotline, Goodwill Vision Enterprises, 422 South Clinton Ave., Rochester, NY 14620; telephone number: (800) 471-7127 or (202) 554-1404; email address:
TSCA-Hotline@epa.gov.
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 contained in this proposed rule. The following list of North American Industrial Classification System (NAICS) codes is not intended to be exhaustive, but rather provides a guide to help readers determine whether this document applies to them. Potentially affected entities may include:
Manufacturers or processors of one or more subject chemical substances (NAICS codes 325 and 324110),e.g.,
chemical manufacturing and petroleum refineries.
Chemical importers are subject to TSCA section 13 (15 U.S.C. 2612), the requirements in 19 CFR 12.118 through 12.127, 19 CFR 127.28, and 40 CFR part 707, subpart B. Importers of chemical substances in bulk form, as part of a mixture, or as part of an article (if required by rule) 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, any persons who export or intend to export a chemical substance that is the subject of this proposed rule on or after December 3, 2025 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 $45,496 per SNUN submission for large business submitters and $14,976 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)). 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
( printed page 49181)
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?
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 listed in this unit and discussed in Unit III.
These proposed SNURs include PMN substances that are subject to Orders issued under TSCA section 5(e)(1)(A), as required by the determinations made under TSCA section 5(a)(3)(B). 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 PMNs submitted that are subject to these proposed SNURs, EPA concluded that regulation was warranted under TSCA section 5(e), pending the development of information sufficient to make reasoned evaluations of the health or environmental effects of the chemical substances. Based on the findings outlined in Unit III., TSCA section 5(e) Orders requiring the use of appropriate exposure controls were negotiated with the PMN submitters. As a general matter, EPA believes it is necessary to follow 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 has determined it is appropriate:
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 parts 2 and 703. Absent a final determination or other disposition of the confidentiality claim under these regulations, 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 ask EPA to identify the confidential significant new use subject to the SNUR. The manufacturer or processor must show that it has a
bona fide
intent to manufacture or process the chemical substance. If EPA concludes that the person has shown a
bona fide
intent to manufacture or process the chemical substance, EPA will identify the confidential significant new use to that person. Since most of the chemical identities of the chemical substances subject to these SNURs are also CBI, manufacturers and processors can combine the
bona fide
submission
( printed page 49182)
under the procedure in 40 CFR 721.11 into a single step.
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 significant new use of the chemical substance is not likely to present an unreasonable risk, EPA is required under TSCA section 5(g) to make public, and submit for publication in the
Federal Register
, a statement of EPA's findings.
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 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 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.
EPA recognizes that TSCA section 5 does not require development of any particular new information (
e.g.,
generating test data) before submission of a SNUN. There is an exception: If a person is required to submit information for a chemical substance pursuant to a rule, order or consent agreement under TSCA section 4, then TSCA section 5(b)(1)(A) requires such information to be submitted to EPA at the time of submission of the SNUN.
In the absence of a rule, 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 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 as 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. may not be the only means of providing information to evaluate the chemical substance associated with the significant new uses. However, submitting a SNUN without any test data may increase the likelihood that EPA will take action under TSCA sections 5(e) or 5(f). EPA recommends that potential SNUN submitters contact EPA early enough so that they will be able to conduct the appropriate tests.
SNUN submitters should be aware that EPA will be better able to evaluate SNUNs that provide detailed information about 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 November 3, 2025 as the cutoff date for determining whether the new use is ongoing. This designation is explained in more detail in Unit II.E.
( printed page 49183)
B. What information is provided for each chemical substance?
For each chemical substance identified in Unit III.C., EPA provides the following information:
PMN number (the proposed CFR citation assigned in the regulatory text section of the proposed rule).
Chemical name (generic name, if the specific name is claimed as CBI).
Chemical Abstracts Service Registry Number (CASRN) or Accession Number (if assigned for confidential chemical identities).
Basis for the SNUR (e.g.,
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 SNURs include PMN substances that are subject to Orders issued under TSCA section 5(e)(1)(A), as required by the determinations made under TSCA section 5(a)(3)(B). Those TSCA Orders require protective measures to limit exposures or otherwise mitigate the potential unreasonable risk. The 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 these proposed SNURs?
The substances subject to the proposed SNURs in this document are as follows, listed by PMN number and with the proposed CFR citation:
Basis for TSCA Order:
The PMN states that the use will be as a halogen-free flame retardant for use in thermoplastic polymers. Based on the PMN substance meeting the criteria of being insoluble in water and being non-reactive, respirable, and a high molecular weight polymer, EPA has identified concerns for lung effects (lung overload). 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 of the PMN substance only by import into the United States (i.e.,
no domestic manufacture) and only if the concentration of the PMN substance in formulation does not exceed the confidential percentage by weight listed in the Order;
Use of the PMN substance only as a halogen-free flame retardant for use in thermoplastic polymers;
Use of a NIOSH-certified respirator with an APF of at least 1,000 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 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.
Basis for TSCA Order:
The PMN states that the generic (non-confidential) use will be as a specialty additive. Based on submitted test data on the PMN substance, EPA has identified concerns for systemic effects, immunotoxicity, portal-of-entry effects, and reproduction and developmental toxicity. Based on comparison to analogous chemical substances, EPA has also identified concerns for skin and eye corrosion, portal-of-entry effects, systemic effects, and neurotoxicity for the incineration and hydrolysis products. Based on potential oral toxicity for systemic effects, EPA identified a drinking water equivalent level (DWEL) of 554 ppb. Based on submitted test data on the PMN substance and comparison to analogous esters, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 670 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 other than in an enclosed process;
Use of personal protective equipment where there is a potential for dermal exposure;
No release of the PMN substance, or any waste stream containing the PMN substance, resulting in surface water concentrations that exceed 554 ppb; and
Establishment of a hazard communication program, including human health and environmental 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 occupational/workplace exposure monitoring may be potentially useful to characterize the exposure 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.
Chemical Name:
Heterocyclic epoxide polymer with mixed substituted glycols and acid anhydride (generic).
CASRN or Accession No.:
Not available.
Effective Date of TSCA Order:
April 28, 2025.
Basis for TSCA Order:
The PMN states that the generic (non-confidential) use will be as a molding compound. Based on comparison to analogous chemical substances and test data for feedstock residuals, EPA has identified concerns
( printed page 49184)
for acute toxicity, acute neurotoxicity, skin, eye, and respiratory tract irritation, eye corrosion, skin sensitization, mortality, systemic effects, respiratory tract effects, local irritation effects (stomach), reproductive/developmental effects, and genotoxicity for the low molecular weight fractions of the PMN substance and the feedstock residuals. Based on the weight of evidence, EPA has also identified concerns for respiratory sensitization. Based on OncoLogic results, EPA has also identified concerns for carcinogenicity for the low molecular weight fractions and
a
feedstock residual. Based on comparison to analogous polyepoxides and esters, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 7 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;
Use of a NIOSH-certified respirator with an APF of at least 1,000 where there is a potential for inhalation exposure;
No manufacture of the PMN substance as a solid without the use of a fume hood, dust collector, or other engineering controls with at least 25% combined capture and removal efficiency of aggregate releases of the total process, unless in an enclosed process;
No processing or use of the PMN substance as a solid without the use of a fume hood, dust collector, or other engineering controls with at least 25% combined capture and removal efficiency, unless in an enclosed process;
No release of the PMN substance, or any waste stream containing the PMN substance, to water;
No disposal of the PMN substance, or waste streams containing the PMN substance, other than by incineration or hazardous waste landfill in compliance with RCRA subtitle C; and
Establishment of a hazard communication program, including human health and environmental 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 developmental toxicity, reproductive toxicity, neurotoxicity, 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.
Chemical Name:
Pyridinium, 3-carboxy-1-methyl-, inner salt.
CASRN:
535-83-1.
Effective Date of TSCA Order:
January 22, 2025.
Basis for TSCA Order:
The PMN states that the use will be as a primarily aqueous alkaline electroplating solution that produces a nominal zinc (Zn)-nickel (Ni) alloy deposit on iron bearing substrates (this deposit improves the corrosion resistance of the iron bearing substrates that it is applied to; the PMN substance is a secondary brightening additive that is used in instances where the inherent specularity of the plating deposit is unsatisfactory). Based on comparison to analogous chemical substances, EPA has identified concerns for eye and respiratory tract irritation, clinical signs (niacin flush), systemic effects, and reproductive/developmental effects. Based on comparison to analogous chemical substances, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 770 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 processing for use or 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, resulting in surface water concentrations that exceed 770 ppb; and
Establishment of a hazard communication program, including human health and environmental 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, reproductive effects, developmental toxicity, serious eye damage, 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.
Chemical Names:
Polyol allyl ether, homopolymer terpene ether and polyol allyl ether, homopolymer, alkyl ethers (generic) (P-22-60 and P-22-61).
CASRNs or Accession Nos.:
Not available.
Effective Date of TSCA Order:
July 19, 2024.
Basis for TSCA Order:
The PMNs state that the generic (non-confidential) uses will be as intermediates. Based on comparison to analogous chemical substances, EPA has identified concerns for carcinogenicity, genetic toxicity, portal-of-entry (oral) effects, acute toxicity, corrosion to all tissues, skin sensitization, and systemic effects. Based on the pH of the chemical substances, EPA has also identified concerns for irritation to skin, eyes, and respiratory tract. Based on potential activation of the terminal allyl moieties to yield DNA-reactive metabolites, EPA has also identified concerns for genetic toxicity and carcinogenicity. Based on the potential for epoxidation of terminal double bonds and subsequent formation of functional reactive groups capable of binding carrier proteins, EPA has also identified concerns for skin and respiratory sensitization. Based on information in the SDS, EPA has also identified concerns for acute toxicity and skin sensitization. Based on comparison to analogous chemical substances, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 18 ppb (P-22-60) and 2 ppb (P-22-61). The Order was issued under TSCA sections
( printed page 49185)
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 to the PMN substances;
No processing for use or use of the PMN substances in a consumer product formulation;
Disposal of the PMN substances, or waste streams containing the PMN substances, only by incineration;
No release of the PMN substances, or any waste stream containing the PMN substances, to water;
Use of personal protective equipment where there is a potential for dermal exposure; and
Establishment of a hazard communication program, including human health and environmental 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 toxicokinetics, acute toxicity, skin irritation/corrosion, eye irritation/corrosion, skin sensitization, specific target organ toxicity, pulmonary effects, genetic toxicity, carcinogenicity, 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.
Chemical Names:
Polyol allyl ether, polymer with alkylene oxides, terpene ether and polyol allyl ether, polymer with alkylene oxides, alkyl ethers (generic) (P-22-64 and P-22-65).
CASRNs or Accession Nos.:
Not available.
Effective Date of TSCA Order:
July 19, 2024.
Basis for TSCA Order:
The PMNs state that the generic (non-confidential) uses will be as intermediates. Based on comparison to analogous chemical substances, EPA has identified concerns for carcinogenicity, genetic toxicity, portal-of-entry (oral) effects, acute toxicity, corrosion to all tissues, skin sensitization, and systemic effects. Based on the pH of the chemical substances, EPA has also identified concerns for irritation to skin, eyes, and respiratory tract. Based on potential activation of the terminal allyl moieties to yield DNA-reactive metabolites, EPA has also identified concerns for genetic toxicity and carcinogenicity. Based on the potential for epoxidation of terminal double bonds and subsequent formation of functional reactive groups capable of binding carrier proteins, EPA has also identified concerns for skin and respiratory sensitization. Based on comparison to analogous nonionic surfactants, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 101 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 to the PMN substances;
No processing for use or use of the PMN substances in a consumer product formulation;
Disposal of the PMN substances, or waste streams containing the PMN substances, only by incineration;
No release of the PMN substances, or any waste stream containing the PMN substances, to water;
Use of personal protective equipment where there is a potential for dermal exposure; and
Establishment of a hazard communication program, including human health and environmental 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 toxicokinetics, acute toxicity, skin irritation/corrosion, eye irritation/corrosion, skin sensitization, specific target organ toxicity, pulmonary effects, genetic toxicity, carcinogenicity, 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.
Chemical Names:
Polyol allyl ether, polymer with alkylene oxides, terpene ether sulfate, ammonium salt and polyol allyl ether, polymer with alkylene oxides, alkyl ether sulfate, ammonium salts (generic) (P-22-66 and P-22-67).
CASRNs or Accession Nos.:
Not available.
Effective Date of TSCA Order:
July 19, 2024.
Basis for TSCA Order:
The PMNs state that the generic (non-confidential) uses will be as additives for adhesives and coatings. Based on comparison to analogous chemical substances, EPA has identified concerns for acute toxicity, corrosion to all tissues, skin sensitization, portal-of-entry (oral) effects, systemic effects, and genetic toxicity. Based on structure, comparison to analogous chemical substances, and the intended use as a surfactant, EPA has also identified concerns for carcinogenicity, respiratory sensitization, and lung effects. Based on comparison to analogous
chemical substances,
EPA predicts that
one
substance (P-22-66) is expected to have low environmental hazard and that toxicity to aquatic organisms may occur at concentrations that exceed 98 ppb for the other substance (P-22-67). 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 to the PMN substances;
No processing for use or use of the PMN substances in a consumer product formulation;
Disposal of the PMN substances, or waste streams containing the PMN substances, only by incineration;
No release of the PMN substances, or any waste stream containing the PMN substances, to water;
( printed page 49186)
Use of personal protective equipment where there is a potential for dermal exposure; and
Establishment of a hazard communication program, including human health and environmental 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 toxicokinetics, skin corrosion, eye corrosion, skin sensitization, specific target organ toxicity, pulmonary effects, genetic toxicity, carcinogenicity, acute 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.
Chemical Name:
2-Propenoic acid, 2-methyl-, 2-hydroxyethyl ester, reaction products with 2-oxepanone homopolymer 2-[(2-methyl-1-oxo-2-propen-1-yl)oxy]ethyl] ester and phosphorous oxide (P2O5).
CASRN:
2548699-72-3.
Effective Date of TSCA Order:
March 7, 2025.
Basis for TSCA Order:
The PMN states that the use will be as an adhesion promoter in a resin used for adhesives and/or sealants in industrial assembly or manufacturing operations and in outdoor repair operations for windmill blades. Based on comparison to analogous acrylates/methacrylates, EPA has identified concerns for irritation to the skin, eyes, and respiratory tract and skin and respiratory tract sensitization. Based on comparison to analogous chemical substances, EPA has also identified concerns for skin irritation, systemic effects, neurotoxicity, and carcinogenicity. Based on the presence of methacrylates, skin and/or respiratory sensitization alerts in the OECD QSAR Toolbox, and the weight of the scientific evidence, EPA has also identified concerns for skin and respiratory sensitization for the low molecular weight fractions. Based on data for a residual/hydrolysis product, EPA has also identified concerns for neurotoxicity, skin irritation, eye irritation/corrosion, skin sensitization, and systemic effects. Based on a structural alert for phosphate esters, EPA has also identified concerns for delayed neurotoxicity and genetic toxicity. Based on comparison to analogous esters, methacrylates, and inorganic phosphate, 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:
Use of personal protective equipment where there is a potential for dermal exposure;
No processing for use or 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 to the PMN substance;
No release of the PMN substance, or any waste stream containing the PMN substance, resulting in surface water concentrations that exceed 3 ppb; and
Establishment of a hazard communication program, including human health and environmental 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 carcinogenicity, genetic toxicity, skin sensitization, skin irritation, respiratory irritation, eye irritation/corrosion, neurotoxicity, 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.
Chemical Name:
Alkyl acid, 2-hydroxy-, methyl substituted alkyl ester (generic).
CASRN or Accession No.:
Not available.
Effective Date of TSCA Order:
January 13, 2025.
Basis for TSCA Order:
The PMN states that the generic (non-confidential) use will be as an industrial process chemical. Based on comparison to analogous chemical substances and data for hydrolysis products and a metabolite of the chemical substance, EPA has identified concerns for lung toxicity (surfactancy), eye corrosion, respiratory tract irritation, clinical signs, neurotoxicity, systemic effects, reproductive and developmental effects, and carcinogenicity. Based on comparison to analogous chemical substances, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 231 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;
Use of a NIOSH-certified respirator with an APF of at least 1,000 where there is a potential for inhalation exposure;
No processing for use or use of the PMN substance other than for the confidential use listed in the Order;
No release of the PMN substance, or any waste stream containing the PMN substance, resulting in surface water concentrations that exceed 231 ppb; and
Establishment of a hazard communication program, including human health and environmental 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 carcinogenicity, developmental toxicity, eye irritation/corrosion, neurotoxicity, pulmonary effects, 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
( printed page 49187)
restrictions remain in effect until the Order is modified or revoked by EPA based on submission of this or other relevant information.
Chemical Names:
Cysteine, cyclic alkyl, ethyl ester; alkylthio ketone (P-23-9 and P-23-10) (generic).
CASRNs or Accession Nos.:
Not available.
Effective Date of TSCA Order:
October 4, 2024.
Basis for TSCA Order:
The PMNs state that the generic (non-confidential) uses will be as fragrance ingredients for use in laundry applications. Based on submitted test data on the PMN substances, EPA has identified concerns for skin sensitization. Based on test data for a stereoisomer, EPA has also identified concerns for skin irritation for the degradation product for the P-23-9 substance. Based on comparison to analogous chemical substances, EPA has also identified concerns for systemic effects. Based on test data on the degradation products, EPA has also identified concerns for acute toxicity, skin, eye, and respiratory tract irritation, systemic effects (body weight, liver, kidney, and lungs) and reproductive effects for the P-23-10 substance. Based on submitted test data on the PMN substances and comparison to analogous chemical substances, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 0.1 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 or processing of the PMN substances in any manner that results in inhalation exposure to the PMN substances;
No processing for use or use of the PMN substances in a consumer product unless the concentration of the PMN substances does not exceed 0.1% (P-23-9) or 1% (P-23-10) by weight in the consumer product;
No land application of the PMN substances, or waste streams containing the PMN substances, to agricultural lands;
Use of personal protective equipment where there is a potential for dermal exposure;
No release of the PMN substances, or any waste stream containing the PMN substances, to water; and
Establishment of a hazard communication program, including human health and environmental 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 and specific target organ 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.
Chemical Name:
1,3-Propanediol, polymer with 1,3-diisocyanatomethylbenzene.
CASRN:
67517-96-8.
Effective Date of TSCA Order:
June 13, 2024.
Basis for TSCA Order:
The PMN states that the use will be as a prepolymer in industrial belting, no-crush wheels, and a general replacement for polytetramethylene ether glycol (PTMEG)-based cast urethane parts. Based on comparison to analogous diisocyanates, EPA has identified concerns for skin sensitization and lung toxicity. Based on test data for a residual, EPA has also identified concerns for acute toxicity, skin and respiratory sensitization, lung toxicity, systemic effects, reproductive/developmental effects, genotoxicity, and carcinogenicity. 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 manufacture, processing, or use of the PMN substance in any manner that results in inhalation exposure to the PMN substance;
No processing for use or use of the PMN substance in a consumer product; 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, skin sensitization, pulmonary effects, specific target organ toxicity, reproductive toxicity, developmental toxicity, genetic toxicity, and carcinogenicity 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.
Chemical Name:
Glycerides from fermentation of genetically modified microorganism, ethoxylated, reaction products with ethanol, polycyclic isocyanate (generic).
CASRN or Accession No.:
Not available.
Effective Date of TSCA Order:
March 4, 2025.
Basis for TSCA Order:
The PMN states that the generic (non-confidential) use will be as a reactant. Based on comparison to analogous diisocyanates, EPA has identified concerns for skin and respiratory sensitization, skin, eye, and respiratory tract irritation, and pulmonary 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 for use or use of the PMN substance in a consumer product;
No manufacture, processing, use, or disposal of the PMN substance in any manner that results in inhalation exposure to the PMN substance;
Manufacture of the PMN substance in a formulation only where the percentage of the unreacted confidential substance listed in the Order does not
( printed page 49188)
exceed the confidential percentage by weight listed in the Order;
No disposal of the PMN substance, or waste streams containing the PMN substance, other than by hazardous waste incineration and the disposal must be at a facility that is in compliance with RCRA subtitle C; 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, pulmonary effects, skin irritation, 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.
Chemical Name:
Alkenal, 9-(acetyloxy)-, (E)- (generic).
Accession No.:
302751.
Effective Date of TSCA Order:
June 11, 2024.
Basis for TSCA Order:
The PMN states that the generic (non-confidential) use will be for a destructive use. Based on comparison to analogous chemical substances, EPA has identified concerns for skin and respiratory tract irritation, and systemic, reproductive, and developmental effects for the PMN substance and the alcohol ester hydrolysis product. Based on comparison to analogous chemical substances and potential oxidation that is expected to produce bifunctional reactive groups, EPA has also identified concerns for respiratory sensitization for the alcohol ester hydrolysis product. Based on comparison to analogous aldehydes and esters, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 7 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 or the environment. To protect against these risks, the Order requires:
No processing for use or use of the PMN substance in a consumer product;
Use of a NIOSH-certified gas/vapor respirator with an APF of at least 50 where there is a potential for inhalation exposure;
Use of personal protective equipment where there is a potential for dermal exposure;
Disposal of the PMN substance, or waste streams containing the PMN substance, only by incineration;
No release of the PMN substance, or any waste stream containing the PMN substance, to water; 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, skin sensitization, pulmonary effects, specific target organ toxicity, developmental 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.
Chemical Name:
Cellulose, alkoxyalkyl ether, alkali metal salt (generic).
Accession No.:
303061.
Effective Date of TSCA Order:
January 10, 2025.
Basis for TSCA Order:
The PMN states that the generic (non-confidential) use will be as a component used in battery manufacturing. Based on test data for the cation, EPA has identified concerns for systemic effects, neurotoxicity, reproductive effects, and developmental effects. Based on comparison to analogous chemical substances, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 120 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;
Use of a NIOSH-certified respirator with an APF of at least 10 where there is a potential for inhalation exposure;
No use of the PMN substance other than for the confidential use listed in the Order;
No release of the PMN substance, or any waste stream containing the PMN substance, resulting in surface water concentrations that exceed 120 ppb; and
Establishment of a hazard communication program, including human health and environmental 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, reproductive 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.
Chemical Name:
Benzoylated amino acid salt (generic).
CASRN or Accession No.:
Not available.
Effective Date of TSCA Order:
April 28, 2025.
Basis for TSCA Order:
The PMN states that the generic (non-confidential) use will be as a plastic production aid. Based on comparison to analogous chemical substances, EPA has identified concerns for systemic effects. Based on comparison to analogous chemical substances and information provided in the SDS, EPA has also identified concerns for eye irritation. 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
( printed page 49189)
human health. To protect against these risks, the Order requires:
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 10 where there is a potential for inhalation exposure;
Manufacture of the PMN substance only below the confidential annual production volume listed in the Order;
No processing for use or use of the PMN substance other than for the confidential use listed in the Order; 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, reproductive toxicity, developmental toxicity, 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.
Basis for TSCA Order:
The PMN states that the generic (non-confidential) use will be as a fuel additive. 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 1999) 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 5,000. Based on comparison to analogous chemical substances, EPA has identified concerns for systemic effects. Based on comparison to analogous imides, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 0.036 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;
Use of the PMN substance only for the confidential use listed in the Order;
Manufacture, processing, and disposal of the PMN substance only in a manner that does not result in inhalation exposure to the PMN substance;
No release of the PMN substance, or waste streams containing the PMN substance, to water;
No disposal of the PMN substance, or waste streams containing the PMN substance, other than by hazardous waste incineration in compliance with RCRA, including RCRA subtitle C; and
Establishment of a hazard communication program, including human health and environmental 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 bioaccumulation, persistence, specific target organ toxicity, sediment toxicity, and aquatic toxicity 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.
Chemical Name:
2-Propenoic acid, 3-bromo-2,2-bis(bromomethyl)propyl ester.
CASRN:
3217-37-6.
Effective Date of TSCA Order:
May 13, 2025.
Basis for TSCA Order:
The PMN states that the generic (non-confidential) use will be as an additive used in 3D printing ink formulations. Based on comparison to analogous acrylates and OECD QSAR toolbox results, EPA has identified concerns for irritation and sensitization. Based on the OECD QSAR Toolbox alert for Michael Addition and comparison to analogous acrylates, EPA has also identified concerns for respiratory sensitization. Based on comparison to analogous chemical substances, EPA has also identified concerns for skin irritation, eye irritation, and genetic toxicity. Based on comparison to analogous chemical substances of the pentaerythritol tribromide hydrolysis product, EPA has also identified concerns for acute toxicity, eye irritation, genetic toxicity, systemic effects, reproductive/developmental effects, and carcinogenicity. Based on test data for the acrylic acid hydrolysis product, EPA has also identified concerns for skin corrosion, serious eye damage, respiratory tract corrosion, systemic effects, and developmental effects. Based on comparison to analogous acrylates, 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:
Use of personal protective equipment where there is a potential for dermal exposure;
Manufacture of the PMN substance only by import into the United States in ink cartridges (i.e.,
no domestic manufacture);
No processing, use, or disposal of the PMN substance in any manner that results in inhalation exposure to the PMN substance;
No processing for use or use of the PMN substance in a consumer product;
The PMN substance, or cartridges or waste streams containing the PMN substance, must be disposed of by hazardous waste incineration in compliance with RCRA;
No release of the PMN substance, or any waste stream containing the PMN substance, to water; and
Establishment of a hazard communication program, including human health and environmental 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
( printed page 49190)
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, acute toxicity, carcinogenicity, serious eye damage, reproductive toxicity, skin corrosion, skin sensitization, 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.
Chemical Name:
Siloxanes and Silicones, di-Me, 3-[[[[4-[(4-isocyanantocyclohexyl)methyl]cyclohexyl]amino]carbonyl]oxy] propyl group-terminated.
CASRN:
1411848-76-4.
Effective Date of TSCA Order:
March 3, 2025.
Basis for TSCA Order:
The PMN states that the use will be as a curative for polyurethane sealant. Based on comparison to analogous diisocyanates, EPA has identified concerns for acute toxicity (inhalation), irritation to the skin, eyes, and respiratory tract, skin and respiratory sensitization, and pulmonary toxicity. 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, or use of the PMN substance only in a manner that does not result in inhalation exposure to the PMN substance;
No processing for use or use of the PMN substance 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 acute toxicity, eye irritation, pulmonary effects, skin irritation, 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.
Chemical Names:
Polyester polymer with polyether polymer and 1,1′-methylenebis(4-isocyanatobenzene) (generic) (P-24-102) and polyester polymer with polyether polymer and 1,1′-methylenebis(isocyanatobenzene) (generic) (P-24-103).
CASRNs or Accession Nos.:
Not available.
Effective Date of TSCA Order:
January 28, 2025.
Basis for TSCA Order:
The PMNs state that the uses will be as industrial adhesives. Based on the structure of the PMN substances and comparison to analogous diisocyanates, EPA has identified concerns for skin and respiratory sensitization and 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 substances in a consumer product;
No manufacture, processing, or use of the PMN substances in any manner that results in inhalation exposure to the PMN substances;
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, pulmonary effects, skin irritation, and skin sensitization testing may be potentially useful to characterize the health 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.
Chemical Name:
Alkanoic acid, mercapto-, ((((mercapto-oxoalkoxy)-(mercapto-oxoalkoxy)alkyl)alkoxy)alkyl)-((mercapto-oxoalkoxy)alkyl)-alkanediyl ester (generic).
CASRN or Accession No.:
Not available.
Effective Date of TSCA Order:
April 7, 2025.
Basis for TSCA Order:
The PMN states that the generic (non-confidential) use will be as a monomer. Based on comparison to analogous chemical substances, EPA has identified concerns for acute toxicity, skin sensitization, and systemic and developmental effects. Based on OECD QSAR Toolbox results, EPA has also identified concerns for respiratory sensitization. Based on comparison to analogous thiols and mercaptans, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 1.6 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 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 manufacture, processing, or use of the PMN substance in any manner that results in inhalation exposure to the PMN substance;
No processing for use or use of the PMN substance in a consumer product;
No release of the PMN substance, or any waste stream containing the PMN substance, resulting in surface water concentrations that exceed 1.6 ppb; and
Establishment of a hazard communication program, including human health and environmental 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
( printed page 49191)
be designated by this SNUR. EPA has determined that the results of skin sensitization, acute toxicity, pulmonary effects, developmental toxicity, specific target organ toxicity, toxicokinetics, 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.
Chemical Names:
Sulfonium, triphenyl-, salt with fluorosulfoalkyl-fluoroalkyl substituted-heterotricycloalkane-carboxylate (1:1) (generic) (P-24-185) and heteroonium, tri(substitutedaromatichydrocarbon)-, nitrate (1:1) (generic) (P-25-28).
CASRNs or Accession Nos.:
Not available.
Effective Date of TSCA Order:
March 5, 2025.
Basis for TSCA Order:
The PMNs state that the generic (non-confidential) uses of the PMN substances will be for contained use 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) and in the absence of data, the PMN substances and photolysis products 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 that their potential to bioaccumulate is unknown. EPA estimates that the photolysis products 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 comparison to analogous compounds, EPA has identified concerns for acute toxicity, irritation to the skin and respiratory tract, eye corrosion, neurological effects, and systemic effects for the cations of the PMN substances. Based on the photoreactivity of the PMN substances, EPA has also identified concerns for photosensitization. Based on comparison to analogous chemical substances, EPA also identified concerns for genetic toxicity. Based on the OECD QSAR Toolbox alert, EPA has also identified concerns for skin sensitization for the anion of P-24-185. Based on test data of an analogue, EPA has also identified concerns for carcinogenicity, genetic toxicity, blood toxicity (methemoglobinemia), and systemic, reproductive, and developmental effects for the anion of P-25-28. Based on insufficient information, the PMN substances have unknown toxicity to aquatic organisms. 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 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 and environmental precautionary statements on each label and in the SDS;
No processing of the PMN substances in any way that generates a dust, mist, or aerosol in a non-enclosed process;
Use of the PMN substances only for the confidential use listed in the Order;
No domestic manufacture of the PMN substances (i.e.,
import only);
Import of the PMN substances only in solution, unless 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.
Chemical Name:
Alkyl transition metal alkoxide (generic).
CASRN or Accession No.:
Not available.
Effective Date of TSCA Order:
January 14, 2025.
Basis for TSCA Order:
The PMN states that the generic (non-confidential) use will be as a chemical intermediate. Based on reactivity and comparison to analogous chemical substances, EPA has identified concerns for skin, eye, and respiratory tract corrosion. Based on test data for hydrolysis products, EPA has also identified concerns for systemic effects, neurological effects, developmental effects, and lung toxicity. Based on comparison to analogous chemical substances, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 1 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 other than for the confidential use listed in the Order;
No manufacture, processing, or use of the PMN substance in any manner that generates a vapor, mist, dust, or aerosol outside of a fully enclosed system containing the PMN substance;
No release of the PMN substance, or any waste stream containing the PMN substance, to water; and
Establishment of a hazard communication program, including human health and environmental 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, skin irritation/corrosion, eye irritation/corrosion, neurotoxicity, developmental 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
( printed page 49192)
based on submission of this or other relevant information.
Chemical Name:
Silsesquioxanes, alkyl Ph alkoxy(halosubstitutedphenyl), polymers with silicic acid (H4SiO4) tetra-Me ester, hydroxy-terminated (generic).
CASRN or Accession No.:
Not available.
Effective Date of TSCA Order:
December 16, 2024.
Basis for TSCA Order:
The PMN states that the generic (non-confidential) use will be for contained use for microlithography for electronic device manufacturing. Based on comparison to analogous chemical substances, EPA has identified concerns for acute inhalation toxicity and lung 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:
No manufacture, processing, or use of the PMN substance in any manner that results in inhalation exposure to the PMN substance;
Use of the PMN substance only for the confidential use listed in the Order; 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 and pulmonary 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.
Chemical Names:
Phenoxathiinium, 10-phenyl-, tricycloalkylcarbomonocyclesulfonate (1:1) (generic) (P-25-3) and sulfonium, triphenyl-, heteropolyclyclecarboxylate (1:1) (generic) (P-25-4).
CASRNs or Accession Nos.:
Not available.
Effective Date of TSCA Order:
February 11, 2025.
Basis for TSCA Order:
The PMNs state that the generic (non-confidential) uses of the PMN substances will be for contained use 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) and in the absence of data, the anion, cation, and cation photodegradation product of the P-25-3 substance and the anion and cation photodegradation product of the P-25-4 substance are potentially persistent, bioaccumulative, and toxic (PBT) chemicals. EPA estimates that the anion and cation of P-25-3 will persist in the environment for more than six months and that their potential to bioaccumulate is unknown. EPA estimates that the anion of P-25-4 will persist in the environment for more than six months and that its potential to bioaccumulate is unknown. EPA estimates that the cation photodegradation products of P-25-3 and P-25-4 will persist in the environment for more than six months and estimates a bioaccumulation factor greater than 5,000. Based on comparison to analogous sulfonium compounds, EPA has identified concerns for acute toxicity, irritation to the skin and respiratory tract, eye corrosion, neurological effects, and systemic effects for the sulfonium cations of the PMN substances. Based on the photoreactivity of the cations of the PMN substances, EPA has also identified concerns for photosensitization. Based on comparison to analogous chemical substances, EPA has also identified concerns for genetic toxicity. Based on insufficient information, the anions of the PMN substances have unknown toxicity. Based on insufficient information, the PMN substances have unknown toxicity to aquatic organisms. 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 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 and environmental precautionary statements on each label and in the SDS;
No processing of the PMN substances in any way that generates a dust, mist, or aerosol in a non-enclosed process;
Use of the PMN substances only for the confidential use listed in the Order;
No domestic manufacture of the PMN substances (i.e.,
import only);
Import of the PMN substances only in solution, unless 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 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.
Chemical Name:
Trihaloaromatmic iodonium dicyclo salt with polyhaloalkyl carbomonocycle hetero-acid (generic).
CASRN or Accession No.:
Not available.
Effective Date of TSCA Order:
April 2, 2025.
Basis for TSCA Order:
The PMN states that the generic (non-confidential) use of the PMN substance will be for photoacid generator use at customer sites. 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 1999) and in the absence of data, the cation and anion of the PMN substance, and the cation photolysis product are potentially persistent, bioaccumulative, and toxic (PBT) chemicals. EPA estimates that the anion and cation will persist in the
( printed page 49193)
environment for more than six months and that the potential to bioaccumulate is unknown. EPA estimates that the cation photolysis product will persist in the environment for more than six months and estimates a bioaccumulation factor of greater than or equal to 5,000. Based on comparison to analogous chemical substances, EPA has identified concerns for acute toxicity, skin irritation, and systemic and reproductive (developmental) toxicity for the anion. Based on OECD QSAR Toolbox alerts, EPA has also identified concerns for skin and respiratory sensitization for the anion. Based on OECD QSAR Toolbox alerts and Oncologic results, EPA has also identified concerns for carcinogenicity for the anion. Due to insufficient information, EPA was unable to estimate the hazards of the cation. Based on the photoreactivity of the PMN substance, EPA has also identified concerns for photosensitization. Based on comparison to analogous chemical substances, EPA also identified concerns for genetic toxicity. Due to insufficient information, EPA was unable to estimate the environmental hazard of the PMN substance. 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 and environmental precautionary statements on each label and in the SDS;
No processing of the PMN substance in any way that generates a 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, unless 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.
Chemical Names:
Sulfonium, triphenyl-, salt with heterosubstituteddifluorosubstitutedalkyl substitutedalkyl trihalosubstitutedcarbomonocycle carboxylate (1:1) (generic) (P-25-20) and sulfonium, tri(halosubstitutedphenyl)-, salt with heterosubstituteddifluorosubstitutedalkyl substitutedalkyl trihalosubstitutedcarbomonocycle carboxylate (1:1) (generic) (P-25-21).
CASRNs or Accession Nos.:
Not available.
Effective Date of TSCA Order:
February 4, 2025.
Basis for TSCA Order:
The PMNs state that the generic (non-confidential) uses of the PMN substances will be for contained use 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) and test data on structurally similar substances, the anion and the cation photodegradation product of the P-25-20 substance and the cation, anion, and cation photodegradation product of the P-25-21 substance are potentially persistent, bioaccumulative, and toxic (PBT) chemicals. EPA estimates that the anion of P-25-20 and the anion and cation of P-25-21 will persist in the environment for more than six months and that their potential to bioaccumulate is unknown. EPA estimates that the cation photodegradation products of P-25-20 and P-25-21 will persist in the environment for more than six months and estimates a bioaccumulation factor greater than 5,000. Based on comparison to analogous sulfonium compounds, EPA has identified concerns for acute toxicity, irritation to the skin, eyes, and respiratory tract, eye corrosion, neurological, and systemic effects for the sulfonium cations of the PMN substances. Based on the photoreactivity of the PMN substances, EPA has also identified concerns for photosensitization. Based on comparison to analogous chemical substances, EPA also identified concerns for genetic toxicity for the cations of the PMN substances. Based on OECD Toolbox results, EPA has also identified concerns for skin sensitization for the anion. Due to insufficient information, EPA was unable to estimate the environmental hazard of the PMN substances. 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 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 of the PMN substances in any way that generates dust, mist, or aerosol in a non-enclosed process;
Use of the PMN substances only for the confidential use listed in the Order;
No domestic manufacture of the PMN substances (i.e.,
import only);
Import of the PMN substances only in solution unless 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 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
( printed page 49194)
specified in the Order without performing the required Tier I and Tier II testing outlined in the Testing section of the Order.
Chemical Name:
Sulfonium, bis(dihalo carbomonocycle)carbomonocycle-, salt with trihalobenzoate (generic).
CASRN or Accession No.:
Not available.
Effective Date of TSCA Order:
May 19, 2025.
Basis for TSCA Order:
The PMN states that the generic (non-confidential) use of the PMN substance will be as an ingredient used in the manufacture of photoresist. 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 1999) and in the absence of data, the cation and anion of the PMN substance, and the cation photodegradation product are potentially persistent, bioaccumulative, and toxic (PBT) chemicals. EPA estimates that the anion and cation of the PMN substance will persist in the environment for more than six months and that their potential to bioaccumulate is unknown. EPA estimates that the cation photodegradation product will persist in the environment for more than six months and estimates a bioaccumulation factor of greater than or equal to 5,000. Based on comparison to analogous sulfonium compounds, EPA has identified concerns for acute toxicity, irritation to the skin, eyes, and respiratory tract, eye corrosion, neurological, and systemic effects for the sulfonium cation. Based on photoreactivity, EPA has also identified concerns for photosensitization. Based on comparison to analogous chemical substances, EPA has also identified concerns for genetic toxicity for the cation of the PMN substance. Based on OECD Toolbox results, EPA has also identified concerns for skin sensitization for the anion of the PMN substance. Due to insufficient information, EPA was unable to estimate the environmental hazard of the PMN substance. 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 and environmental precautionary statements on each label and in the SDS;
No processing of the PMN substance in any way that generates 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 unless 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.
This action proposes to establish SNURs for new chemical substances that were the subject of PMNs. The Office of Management and Budget (OMB) has exempted these types of actions from review under Executive Order 12866 (58 FR 51735, October 4, 1993).
According to the PRA (44 U.S.C. 3501et 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. When submitting comments on these proposed SNURs, include comments about the accuracy of the 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.
D. 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. 601et 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,
( printed page 49195)
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 9 in fiscal year (FY) FY2022, 23 in FY2023, and 7 in FY2024, 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 $14,967 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.
E. 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, and EPA does not have any reasons to believe that any State, local, or Tribal government will be impacted by these 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.
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.
G. 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.
H. Executive Order 13045: Protection of Children From Environmental Health Risks and Safety Risks
This action is not subject to Executive Order 13045 (62 FR 19885, April 23, 1997), because it does not concern an environmental health or safety risk. Since this action does not concern a human health risk, 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 the identified chemical substances for an activity that is designated as a significant new use by the SNUR. This notification allows EPA to assess the intended uses to identify potential risks and take appropriate actions before the activities commence.
I. 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.
J. 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).
(a)
Chemical substance and significant new uses subject to reporting.
(1) The chemical substance identified generically as heteroaromatic substituted alkanoic acid, [2,2-bis[[(1-oxo-2-propen-1-yl)oxy]methyl]- 1,3-propanediyl] ester, dioxide homopolymer (PMN P-18-104) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section. The requirements of this section do not apply to quantities of the substance after they have been entrained in the plastic article.
(2) The significant new uses are:
(i)
Protection in the workplace.
Requirements as specified in § 721.63(a)(1), (a)(3) through (6), and (c). When determining which persons are reasonably likely to be exposed as required for § 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 § 721.63(a)(5), respirators must provide a National Institute for Occupational Safety and Health (NIOSH) assigned protection factor (APF) of at least 1,000.
(ii)
Hazard communication.
Requirements as specified in § 721.72(a) through (d), (f), (g)(1), and (g)(5). For purposes of § 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
( printed page 49196)
System and OSHA Hazard Communication Standard may be used.
(iii)
Industrial, commercial, and consumer activities.
It is a significant new use to manufacture the substance other than by import into the United States (
i.e.,
no domestic manufacture) and only if the concentration of the substance in formulation does not exceed the confidential percentage by weight listed in the Order. It is a significant new use to use the substance other than as a halogen-free flame retardant for use in thermoplastic polymers.
(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 § 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 § 721.185 apply to this section.
(a)
Chemical substance and significant new uses subject to reporting.
(1) The chemical substance identified as ethanol, 2,2-difluoro-, 1-acetate (PMN P-18-413; CASRN: 1550-44-3) 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 chemical substance after they have been completely entrained in a sealed battery or sealed supercapacitor, unless or until the article has been shredded or processed such that exposure to the chemical substance occurs.
(2) The significant new uses are:
(i)
Protection in the workplace.
Requirements as specified in § 721.63(a)(1), (a)(3), and (c). When determining which persons are reasonably likely to be exposed as required for § 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 § 721.72(a) through (d), (f), (g)(1), (g)(3)(iii), and (g)(5). For purposes of § 721.72(g)(1), this substance may cause: reproductive toxicity, specific target organ toxicity, skin corrosion, and serious eye damage. 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 § 721.80(a) through (c).
(iv)
Release to water.
Requirements as specified in § 721.90(a)(4), (b)(4), and (c)(4) where N=554.
(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 § 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 § 721.185 apply to this section.
Heterocyclic epoxide polymer with mixed substituted glycols and acid anhydride (generic).
(a)
Chemical substance and significant new uses subject to reporting.
(1) The chemical substance identified generically as heterocyclic epoxide polymer with mixed substituted glycols and acid anhydride (PMN P-21-88) 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 (
i.e.,
the substance has been reacted or cured to the extent that no release of the substance can be detected).
(2) The significant new uses are:
(i)
Protection in the workplace.
Requirements as specified in § 721.63(a)(1), (a)(3) through (6), and (c). When determining which persons are reasonably likely to be exposed as required for § 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 § 721.63(a)(5), respirators must provide a National Institute for Occupational Safety and Health (NIOSH) assigned protection factor (APF) of at least 1,000.
(ii)
Hazard communication.
Requirements as specified in § 721.72(a) through (d), (f), (g)(1), (g)(3)(iii), and (g)(5). For purposes of § 721.72(g)(1), this substance may cause: acute toxicity, skin irritation, serious eye damage, eye irritation, respiratory sensitization, skin sensitization, genetic toxicity, reproductive toxicity, and 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 the substance as a solid without the use of a fume hood, dust collector, or other engineering controls with at least 25% combined capture and removal efficiency of aggregate releases of the total process, unless in an enclosed process. It is a significant new use to process or use the substance as a solid without the use of a fume hood, dust collector, or other engineering controls with at least 25% combined capture and removal efficiency, unless in an enclosed process.
(iv)
Disposal.
It is a significant new use to dispose of the substance or waste streams containing the substance other than by incineration or hazardous waste landfill in compliance with RCRA subtitle C.
(v)
Release to water.
Requirements as specified in § 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 § 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 § 721.185 apply to this section.
(a)
Chemical substance and significant new uses subject to reporting.
(1) The chemical substance identified as pyridinium, 3-carboxy-1-methyl-, inner salt (PMN P-21-215; CASRN 535-83-1) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section. The requirements of this section do not apply to quantities of the substance after they have been completely destroyed.
(2) The significant new uses are:
(i)
Protection in the workplace.
Requirements as specified in § 721.63(a)(1), (a)(3), and (c). When determining which persons are reasonably likely to be exposed as required for § 721.63(a)(1), engineering control measures (
e.g.,
enclosure or confinement of the operation, general and local ventilation) or administrative
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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 § 721.72(a) through (d), (f), (g)(1), (g)(3)(iii), and (g)(5). For purposes of § 721.72(g)(1), this substance may cause: eye irritation, reproductive toxicity, and 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 § 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 § 721.90(a)(4), (b)(4), and (c)(4) where N=770.
(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 § 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 § 721.185 apply to this section.
(a)
Chemical substance and significant new uses subject to reporting.
(1) The chemical substance identified generically as polyol allyl ether, homopolymer terpene ether and polyol allyl ether, homopolymer, alkyl ethers (PMN P-22-60) 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 when completely reacted, cured, or incorporated into a polymer matrix.
(2) The significant new uses are:
(i)
Protection in the workplace.
Requirements as specified in § 721.63(a)(1), (a)(3), and (c). When determining which persons are reasonably likely to be exposed as required for § 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 § 721.72(a) through (d), (f), (g)(1), (g)(3)(iii), and (g)(5). For purposes of § 721.72(g)(1), this substance may cause: acute toxicity, skin corrosion, skin irritation, serious eye damage, eye irritation, respiratory sensitization, skin sensitization, genetic toxicity, carcinogenicity, and 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 § 721.80(o). It is a significant new use to manufacture, process, or use the substance in any manner that results in inhalation exposure to the substance.
(iv)
Disposal.
Requirements as specified in § 721.85(a)(1), (b)(1), and (c)(1).
(v)
Release to water.
Requirements as specified in § 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 § 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 § 721.185 apply to this section.
(a)
Chemical substance and significant new uses subject to reporting.
(1) The chemical substance identified generically as polyol allyl ether, homopolymer terpene ether and polyol allyl ether, homopolymer, alkyl ethers (PMN P-22-61) 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 when completely reacted, cured, or incorporated into a polymer matrix.
(2) The significant new uses are:
(i)
Protection in the workplace.
Requirements as specified in § 721.63(a)(1), (a)(3), and (c). When determining which persons are reasonably likely to be exposed as required for § 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 § 721.72(a) through (d), (f), (g)(1), (g)(3)(iii), and (g)(5). For purposes of § 721.72(g)(1), this substance may cause: acute toxicity, skin corrosion, skin irritation, serious eye damage, eye irritation, respiratory sensitization, skin sensitization, genetic toxicity, carcinogenicity, and 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 activitie
s. Requirements as specified in § 721.80(o). It is a significant new use to manufacture, process, or use the substance in any manner that results in inhalation exposure to the substance.
(iv)
Disposal.
Requirements as specified in § 721.85(a)(1), (b)(1), and (c)(1).
(v)
Release to water.
Requirements as specified in § 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 § 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 § 721.185 apply to this section.
Polyol allyl ether, polymer with alkylene oxides, terpene ether and Polyol allyl ether, polymer with alkylene oxides, alkyl ethers (generic) (P-22-64).
(a)
Chemical substance and significant new uses subject to reporting.
(1) The chemical substance identified generically as polyol allyl ether, polymer with alkylene oxides, terpene ether and polyol allyl ether, polymer with alkylene oxides, alkyl ethers (PMN P-22-64) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section. The requirements of this section do not apply to quantities of the substance when completely reacted, cured, or incorporated into a polymer matrix.
(2) The significant new uses are:
(i)
Protection in the workplace.
Requirements as specified in § 721.63(a)(1), (a)(3), and (c). When
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determining which persons are reasonably likely to be exposed as required for § 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 § 721.72(a) through (d), (f), (g)(1), (g)(3)(iii), and (g)(5). For purposes of § 721.72(g)(1), this substance may cause: acute toxicity, skin corrosion, skin irritation, serious eye damage, eye irritation, respiratory sensitization, skin sensitization, genetic toxicity, carcinogenicity, and 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 § 721.80(o). It is a significant new use to manufacture, process, or use the substance in any manner that results in inhalation exposure to the substance.
(iv)
Disposal.
Requirements as specified in § 721.85(a)(1), (b)(1), and (c)(1).
(v)
Release to water.
Requirements as specified in § 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 § 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 § 721.185 apply to this section.
Polyol allyl ether, polymer with alkylene oxides, terpene ether and Polyol allyl ether, polymer with alkylene oxides, alkyl ethers (generic) (P-22-65).
(a)
Chemical substance and significant new uses subject to reporting.
(1) The chemical substance identified generically as polyol allyl ether, polymer with alkylene oxides, terpene ether and polyol allyl ether, polymer with alkylene oxides, alkyl ethers (PMN P-22-65) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section. The requirements of this section do not apply to quantities of the substance when completely reacted, cured, or incorporated into a polymer matrix.
(2) The significant new uses are:
(i)
Protection in the workplace.
Requirements as specified in § 721.63(a)(1), (a)(3), and (c). When determining which persons are reasonably likely to be exposed as required for § 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 § 721.72(a) through (d), (f), (g)(1), (g)(3)(iii), and (g)(5). For purposes of § 721.72(g)(1), this substance may cause: acute toxicity, skin corrosion, skin irritation, serious eye damage, eye irritation, respiratory sensitization, skin sensitization, genetic toxicity, carcinogenicity, and 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 § 721.80(o). It is a significant new use to manufacture, process, or use the substance in any manner that results in inhalation exposure to the substance.
(iv)
Disposal.
Requirements as specified in § 721.85(a)(1), (b)(1), and (c)(1).
(v)
Release to water.
Requirements as specified in § 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 § 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 § 721.185 apply to this section.
Polyol allyl ether, polymer with alkylene oxides, terpene ether sulfate, ammonium salt and Polyol allyl ether, polymer with alkylene oxides, alkyl ether sulfate, ammonium salts (generic) (P-22-66).
(a)
Chemical substance and significant new uses subject to reporting.
(1) The chemical substance identified generically as polyol allyl ether, polymer with alkylene oxides, terpene ether sulfate, ammonium salt and polyol allyl ether, polymer with alkylene oxides, alkyl ether sulfate, ammonium salts (PMN P-22-66) 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 when completely reacted, cured, or incorporated into a polymer matrix.
(2) The significant new uses are:
(i)
Protection in the workplace.
Requirements as specified in § 721.63(a)(1), (a)(3), and (c). When determining which persons are reasonably likely to be exposed as required for § 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 § 721.72(a) through (d), (f), (g)(1), (g)(3)(iii), and (g)(5). For purposes of § 721.72(g)(1), this substance may cause: acute toxicity, skin corrosion, serious eye damage, respiratory sensitization, skin sensitization, genetic toxicity, carcinogenicity, and 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 § 721.80(o). It is a significant new use to manufacture, process, or use the substance in any manner that results in inhalation exposure to the substance.
(iv)
Disposal.
Requirements as specified in § 721.85(a)(1), (b)(1), and (c)(1).
(v)
Release to water.
Requirements as specified in § 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 § 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 § 721.185 apply to this section.
Polyol allyl ether, polymer with alkylene oxides, terpene ether sulfate, ammonium salt and Polyol allyl ether, polymer with alkylene oxides, alkyl ether sulfate, ammonium salts (generic) (P-22-67).
(a)
Chemical substance and significant new uses subject to reporting.
(1) The chemical substance identified generically as polyol allyl ether, polymer with alkylene oxides, terpene ether sulfate, ammonium salt and polyol allyl ether, polymer with alkylene oxides, alkyl ether sulfate, ammonium salts (PMN P-22-67) 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 when completely reacted, cured, or incorporated into a polymer matrix.
(2) The significant new uses are:
(i)
Protection in the workplace.
Requirements as specified in § 721.63(a)(1), (a)(3), and (c). When determining which persons are reasonably likely to be exposed as required for § 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 § 721.72(a) through (d), (f), (g)(1), (g)(3)(iii), and (g)(5). For purposes of § 721.72(g)(1), this substance may cause: acute toxicity, skin corrosion, serious eye damage, respiratory sensitization, skin sensitization, genetic toxicity, carcinogenicity, and 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 § 721.80(o). It is a significant new use to manufacture, process, or use the substance in any manner that results in inhalation exposure to the substance.
(iv)
Disposal.
Requirements as specified in § 721.85(a)(1), (b)(1), and (c)(1).
(v)
Release to water.
Requirements as specified in § 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 § 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 § 721.185 apply to this section.
2-Propenoic acid, 2-methyl-, 2-hydroxyethyl ester, reaction products with 2-oxepanone homopolymer 2-[(2-methyl-1-oxo-2-propen-1-yl)oxy]ethyl] ester and phosphorous oxide (P2O5).
(a)
Chemical substance and significant new uses subject to reporting.
(1) The chemical substance identified as 2-propenoic acid, 2-methyl-, 2-hydroxyethyl ester, reaction products with 2-oxepanone homopolymer 2-[(2-methyl-1-oxo-2-propen-1-yl)oxy]ethyl] ester and phosphorous oxide (P2O5) (PMN P-22-153; CASRN 2548699-72-3) 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 § 721.63(a)(1), (a)(3), and (c). When determining which persons are reasonably likely to be exposed as required for § 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 § 721.72(a) through (d), (f), (g)(1), (g)(3)(iii), and (g)(5). For purposes of § 721.72(g)(1), this substance may cause: skin irritation, serious eye damage, respiratory sensitization, skin sensitization, carcinogenicity, genetic toxicity, and 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 § 721.80(o). It is a significant new use to manufacture, process, or use the substance in any manner that results in inhalation exposure to the substance.
(iv)
Release to water.
Requirements as specified in § 721.90(a)(4), (b)(4), and (c)(4) where N=3.
(b)
Specific requirements.
The provisions of subpart A of this part apply to this section except as modified by this paragraph (b).
(1)
Recordkeeping.
Recordkeeping requirements as specified in § 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 § 721.185 apply to this section.
(a)
Chemical substance and significant new uses subject to reporting.
(1) The chemical substance identified generically as alkyl acid, 2-hydroxy-, methyl substituted alkyl ester (PMN P-22-165) 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 § 721.63(a)(1), (a)(3) through (6), and (c). When determining which persons are reasonably likely to be exposed as required for § 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 § 721.63(a)(5), respirators must provide a National Institute for Occupational Safety and Health (NIOSH) assigned protection factor (APF) of at least 1,000.
(ii)
Hazard communication.
Requirements as specified in § 721.72(a) through (d), (f), (g)(1), (g)(3)(iii), and (g)(5). For purposes of § 721.72(g)(1), this substance may cause: serious eye damage, carcinogenicity, reproductive toxicity, and 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 § 721.80(k).
(iv)
Release to water.
Requirements as specified in § 721.90(a)(4), (b)(4), and (c)(4) where N=231.
(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 § 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 § 721.185 apply to this section.
(a)
Chemical substance and significant new uses subject to reporting.
(1) The chemical substance identified generically as cysteine, cyclic alkyl, ethyl ester; alkylthio ketone (PMN P-23-9) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section.
(2) The significant new uses are:
(i)
Protection in the workplace.
Requirements as specified in § 721.63(a)(1), (a)(3), and (c). When determining which persons are reasonably likely to be exposed as required for § 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 § 721.72(a) through (d), (f), (g)(1), (g)(3)(iii), and (g)(5). For purposes of § 721.72(g)(1), this substance may cause: skin irritation (degradation product), skin sensitization, and 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 or process the substance in any manner that results in inhalation exposure to the substance. It is a significant new use to process for use or use the substance in a consumer product unless the concentration does not exceed 0.1% by weight in the consumer product.
(iv)
Disposal.
It is a significant new use to land apply the substance, or waste streams containing the substance, to agricultural lands.
(v)
Release to water.
Requirements as specified in § 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 § 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 § 721.185 apply to this section.
(a)
Chemical substance and significant new uses subject to reporting.
(1) The chemical substance identified generically as cysteine, cyclic alkyl, ethyl ester; alkylthio ketone (PMN P-23-10) 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 § 721.63(a)(1), (a)(3), and (c). When determining which persons are reasonably likely to be exposed as required for § 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 § 721.72(a) through (d), (f), (g)(1), (g)(3)(iii), and (g)(5). For purposes of § 721.72(g)(1), this substance may cause: acute toxicity (degradation product), skin irritation (degradation product), eye irritation (degradation product), skin sensitization, reproductive toxicity (degradation product), and 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 or process the substance in any manner that results in inhalation exposure to the substance. It is a significant new use to process for use or use the substance in a consumer product unless the concentration does not exceed 1% by weight in the consumer product.
(iv)
Disposal.
It is a significant new use to land apply the substance, or waste streams containing the substance, to agricultural lands.
(v)
Release to water.
Requirements as specified in § 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 § 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 § 721.185 apply to this section.
1,3-Propanediol, polymer with 1,3-diisocyanatomethylbenzene.
(a)
Chemical substance and significant new uses subject to reporting.
(1) The chemical substance identified as 1,3-propanediol, polymer with 1,3-diisocyanatomethylbenzene (PMN P-23-32; CASRN 67517-96-8) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section. The requirements of this section do not apply to quantities of the substance after they have been completely reacted or cured.
(2) The significant new uses are:
(i)
Protection in the workplace.
Requirements as specified in § 721.63(a)(1), (a)(3), and (c). When determining which persons are reasonably likely to be exposed as required for § 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 § 721.72(a) through (d), (f), (g)(1), and (g)(5). For purposes of § 721.72(g)(1), this substance may cause: acute toxicity, respiratory sensitization, skin sensitization, genetic toxicity, carcinogenicity, reproductive toxicity, and 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 § 721.80(o). It is a significant new use to manufacture, process, or use the substance in any manner that results in inhalation exposure to the substance.
(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 § 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 § 721.185 apply to this section.
Glycerides from fermentation of genetically modified microorganism, ethoxylated, reaction products with ethanol, polycyclic isocyanate (generic).
(a)
Chemical substance and significant new uses subject to reporting.
(1) The chemical substance identified generically as glycerides from fermentation of genetically modified microorganism, ethoxylated, reaction products with ethanol, polycyclic isocyanate (PMN P-23-118) 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 (
i.e.,
the substance has been reacted or cured to the extent that no release of the substance can be detected).
(2) The significant new uses are:
(i)
Protection in the workplace.
Requirements as specified in § 721.63(a)(1), (a)(3), and (c). When determining which persons are reasonably likely to be exposed as required for § 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 § 721.72(a) through (d), (f), (g)(1), and (g)(5). For purposes of § 721.72(g)(1), this substance may cause: eye irritation, respiratory sensitization, skin irritation, skin sensitization, and 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 § 721.80(o). It is a significant new use to manufacture, process, or use the substance in any manner that results in inhalation exposure to the substance. It is a significant new use to manufacture the substance in a formulation unless the percentage of the confidential unreacted substance listed in the Order does not exceed the confidential percentage by weight listed in the Order.
(iv)
Disposal.
It is a significant new use to dispose of the substance in any manner that results in inhalation exposure to the substance. It is a significant new use to dispose of the substance other than by hazardous waste incineration and the disposal must be at a facility that is in compliance with RCRA subtitle 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 § 721.125(a) through (j) are applicable to manufacturers, importers, and processors of this substance.
(2)
Limitation or revocation of certain notification requirements.
The provisions of § 721.185 apply to this section.
(a)
Chemical substance and significant new uses subject to reporting.
(1) The chemical substance identified generically as alkenal, 9-(acetyloxy)-, (E)- (PMN P-23-142; Accession No. 302751) 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 § 721.63(a)(1), (a)(3) through (6), and (c). When determining which persons are reasonably likely to be exposed as required for § 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 § 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 § 721.72(a) through (d), (f), (g)(1), (g)(3)(iii), and (g)(5). For purposes of § 721.72(g)(1), this substance may cause: skin irritation, respiratory sensitization, skin sensitization, reproductive toxicity, and 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 § 721.80(o).
(iv)
Disposal.
Requirements as specified in § 721.85(a)(1), (b)(1), and (c)(1).
(v)
Release to water.
Requirements as specified in § 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 § 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 § 721.185 apply to this section.
Cellulose, alkoxyalkyl ether, alkali metal salt (generic).
(a)
Chemical substance and significant new uses subject to reporting.
(1) The chemical substance identified generically as cellulose, alkoxyalkyl ether, alkali metal salt (PMN P-23-173; Accession No. 303061) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section. The requirements of this section do not apply to quantities of the substance after they have been incorporated into an article as defined at 40 CFR 720.3 or when the substance is embedded in or cured in a matrix.
(2) The significant new uses are:
(i)
Protection in the workplace.
Requirements as specified in § 721.63(a)(1), (a)(3) through (6), and (c). When determining which persons are reasonably likely to be exposed as required for § 721.63(a)(1) and (a)(4), engineering control measures (
e.g.,
enclosure or confinement of the operation, general and local ventilation) or administrative control measures (
e.g.,
workplace policies and procedures) shall be considered and implemented to prevent exposure, where feasible. For purposes of § 721.63(a)(5), respirators must provide a National Institute for Occupational Safety and Health (NIOSH) assigned protection factor (APF) of at least 10.
(ii)
Hazard communication.
Requirements as specified in § 721.72(a) through (d), (f), (g)(1), (g)(3)(iii), and (g)(5). For purposes of § 721.72(g)(1), this substance may cause: specific target organ toxicity and reproductive toxicity. Alternative hazard and warning statements that meet the criteria of the Globally Harmonized System and OSHA Hazard Communication Standard may be used.
(iii)
Industrial, commercial, and consumer activities.
Requirements as specified in § 721.80(k).
(iv)
Release to water.
Requirements as specified in § 721.90(a)(4), (b)(4), and (c)(4) where N=120.
(b)
Specific requirements.
The provisions of subpart A of this part
( printed page 49202)
apply to this section except as modified by this paragraph (b).
(1)
Recordkeeping.
Recordkeeping requirements as specified in § 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 § 721.185 apply to this section.
(a)
Chemical substance and significant new uses subject to reporting.
(1) The chemical substance identified generically as benzoylated amino acid salt (PMN P-24-4) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section. The requirements of this section do not apply to quantities of the substance after they have been completely reacted or cured (
i.e.,
the substance has been reacted or cured to the extent that no release of the substance can be detected).
(2) The significant new uses are:
(i)
Protection in the workplace.
Requirements as specified in § 721.63(a)(1), (a)(3) through (6), and (c). When determining which persons are reasonably likely to be exposed as required for § 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 § 721.63(a)(5), respirators must provide a National Institute for Occupational Safety and Health (NIOSH) assigned protection factor (APF) of at least 10.
(ii)
Hazard communication.
Requirements as specified in § 721.72(a) through (d), (f), (g)(1), and (g)(5). For purposes of § 721.72(g)(1), this substance may cause: eye irritation and 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 § 721.80(k) and (t).
(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 § 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 § 721.185 apply to this section.
(a)
Chemical substance and significant new uses subject to reporting.
(1) The chemical substance identified generically as alkylated succinimide (PMN P-24-79) 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 § 721.63(a)(1), (a)(3), and (c). When determining which persons are reasonably likely to be exposed as required for § 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 § 721.72(a) through (d), (f), (g)(1), (g)(3)(iii), and (g)(5). For purposes of § 721.72(g)(1), this substance may cause: specific target organ toxicity. Alternative hazard and warning statements that meet the criteria of the Globally Harmonized System and OSHA Hazard Communication Standard may be used.
(iii) Industrial, commercial, and consumer activities. Requirements as specified in § 721.80(k). It is a significant new use to manufacture or process the substance in any manner that results in inhalation exposure to the substance.
(iv)
Disposal.
It is a significant new use to dispose of the substance in any manner that results in inhalation exposure to the substance. It is a significant new use to dispose of the substance, or waste streams containing the substance, other than by hazardous waste incineration in compliance with RCRA, including RCRA subtitle C.
(v)
Release to water.
Requirements as specified in § 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 § 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 § 721.185 apply to this section.
(a)
Chemical substance and significant new uses subject to reporting.
(1) The chemical substance identified as 2-propenoic acid, 3-bromo-2,2-bis(bromomethyl)propyl ester (PMN P-24-82; CASRN 3217-37-6) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section. The requirements of this section do not apply to quantities of the substances when completely reacted or cured (
i.e.,
the substance has been reacted or cured to the extent that no release of the substance can be detected).
(2) The significant new uses are:
(i)
Protection in the workplace.
Requirements as specified in § 721.63(a)(1), (a)(3), and (c). When determining which persons are reasonably likely to be exposed as required for § 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 § 721.72(a) through (d), (f), (g)(1), (g)(3)(iii), and (g)(5). For purposes of § 721.72(g)(1), this substance may cause: acute toxicity, respiratory sensitization, skin corrosion, skin sensitization, serious eye damage, genetic toxicity, carcinogenicity, reproductive toxicity, and 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 § 721.80(o). It is a significant new use to manufacture the substance other than by import into the United States in ink cartridges (
i.e.,
no domestic manufacture). It is a significant new use to process or use the substance in any manner that results in inhalation exposure to the substance.
(iv)
Disposal.
It is a significant new use to dispose of the substance, or cartridges or waste steams containing the substance, other than by hazardous waste incineration in compliance with RCRA. It is a significant new use to dispose of the substance in any manner that results in inhalation exposure to the substance.
( printed page 49203)
(v)
Release to water.
Requirements as specified in § 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 § 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 § 721.185 apply to this section.
Siloxanes and Silicones, di-Me, 3-[[[[4-[(4-isocyanantocyclohexyl)methyl]cyclohexyl]amino]carbonyl]oxy] propyl group-terminated.
(a)
Chemical substance and significant new uses subject to reporting.
(1) The chemical substance identified as siloxanes and silicones, di-Me, 3-[[[[4-[(4-isocyanantocyclohexyl)methyl]cyclohexyl]amino]carbonyl]oxy] propyl group-terminated (PMN P-24-85; CASRN 1411848-76-4) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section. The requirements of this section do not apply to quantities of the substance after they have been completely reacted or cured (
i.e.,
the substance has been reacted or cured to the extent that no release of the substance can be detected).
(2) The significant new uses are:
(i)
Protection in the workplace.
Requirements as specified in § 721.63(a)(1), (a)(3), and (c). When determining which persons are reasonably likely to be exposed as required for § 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 § 721.72(a) through (d), (f), (g)(1), and (g)(5). For purposes of § 721.72(g)(1), this substance may cause: acute toxicity, eye irritation, respiratory sensitization, skin irritation, skin sensitization, and 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 § 721.80(o). It is a significant new use to manufacture, process, or use the substance in any manner that results in inhalation exposure to the substance.
(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 § 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 § 721.185 apply to this section.
Polyester polymer with polyether polymer and 1,1′-methylenebis(4-isocyanatobenzene) (generic).
(a)
Chemical substance and significant new uses subject to reporting.
(1) The chemical substance identified generically as polyester polymer with polyether polymer and 1,1′-methylenebis(4-isocyanatobenzene) (PMN P-24-102) 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 (
i.e.,
the substance has been reacted or cured to the extent that no release of the substance can be detected).
(2) The significant new uses are:
(i)
Protection in the workplace.
Requirements as specified in § 721.63(a)(1), (a)(3), and (c). When determining which persons are reasonably likely to be exposed as required for § 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 § 721.72(a) through (d), (f), (g)(1), and (g)(5). For purposes of § 721.72(g)(1), this substance may cause: skin irritation, eye irritation, respiratory sensitization, skin sensitization, and 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 § 721.80(o). It is a significant new use to manufacture, process, or use the substance in any manner that results in inhalation exposure to the substance.
(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 § 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 § 721.185 apply to this section.
Polyester polymer with polyether polymer and 1,1′-methylenebis(isocyanatobenzene) (generic).
(a)
Chemical substance and significant new uses subject to reporting.
(1) The chemical substance identified generically as polyester polymer with polyether polymer and 1,1′-methylenebis(isocyanatobenzene) (PMN P-24-103) 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 (
i.e.,
the substance has been reacted or cured to the extent that no release of the substance can be detected).
(2) The significant new uses are:
(i)
Protection in the workplace.
Requirements as specified in § 721.63(a)(1), (a)(3), and (c). When determining which persons are reasonably likely to be exposed as required for § 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 § 721.72(a) through (d), (f), (g)(1), and (g)(5). For purposes of § 721.72(g)(1), this substance may cause: skin irritation, eye irritation, respiratory sensitization, skin sensitization, and 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 § 721.80(o). It is a significant new use to manufacture, process, or use the substance in any manner that results in inhalation exposure to the substance.
( printed page 49204)
(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 § 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 § 721.185 apply to this section.
(a)
Chemical substance and significant new uses subject to reporting.
(1) The chemical substance identified generically as alkanoic acid, mercapto-, ((((mercapto-oxoalkoxy)-(mercapto-oxoalkoxy)alkyl)alkoxy)alkyl)-((mercapto-oxoalkoxy)alkyl)-alkanediyl ester (PMN P-24-129) 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 cured (
i.e.,
the substance has been reacted or cured to the extent that no release of the substance can be detected).
(2) The significant new uses are:
(i)
Protection in the workplace.
Requirements as specified in § 721.63(a)(1), (a)(3), and (c). When determining which persons are reasonably likely to be exposed as required for § 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 § 721.72(a) through (d), (f), (g)(1), (g)(3)(iii), and (g)(5). For purposes of § 721.72(g)(1), this substance may cause: skin sensitization, acute toxicity, respiratory sensitization, reproductive toxicity, and 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 § 721.80(o). It is a significant new use to manufacture, process, or use the substance in any manner that results in inhalation exposure to the substance.
(iv) Release to water. Requirements as specified in § 721.90(a)(4), (b)(4), and (c)(4) where N=1.6.
(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 § 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 § 721.185 apply to this section.
Sulfonium, triphenyl-, salt with fluorosulfoalkyl-fluoroalkyl substituted-heterotricycloalkane-carboxylate (1:1) (generic).
(a)
Chemical substance and significant new uses subject to reporting.
(1) The chemical substance identified generically as sulfonium, triphenyl-, salt with fluorosulfoalkyl-fluoroalkyl substituted-heterotricycloalkane-carboxylate (1:1) (PMN P-24-185) 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 § 721.63(a)(1), (a)(2)(i) and (a)(2)(iii), (a)(3), and (c). When determining which persons are reasonably likely to be exposed as required for § 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 § 721.72(a) through (f), (g)(1), (g)(2)(i) through (iii) and (g)(2)(v), (g)(3)(i) and (ii), and (g)(5). For purposes of § 721.72(e), the concentration is set at 1.0%. For purposes of § 721.72(g)(1), this substance may cause: acute toxicity, genetic toxicity, skin irritation, skin sensitization, serious eye damage, and 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 § 721.80(f), (k), and (t). It is a significant new use to import the substance other than in solution, unless in sealed containers weighing 5 kilograms or less. It is a significant new use to process the substance in any way that generates dust, mist, or aerosol in a non-enclosed process. It is a significant new use to manufacture the substance longer than 18 months.
(b)
Specific requirements.
The provisions of subpart A of this part apply to this section except as modified by this paragraph (b).
(1)
Recordkeeping.
Recordkeeping requirements as specified in § 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 § 721.185 apply to this section.
(a)
Chemical substance and significant new uses subject to reporting.
(1) The chemical substance identified generically as heteroonium, tri(substitutedaromatichydrocarbon)-, nitrate (1:1) (PMN P-25-28) 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 § 721.63(a)(1), (a)(2)(i) and (a)(2)(iii), (a)(3), and (c). When determining which persons are reasonably likely to be exposed as required for § 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 § 721.72(a) through (f), (g)(1), (g)(2)(i) through (iii) and (g)(2) (v), (g)(3)(i) and (ii), and (g)(5). For purposes of § 721.72(e), the concentration is set at 0.1%. For purposes of § 721.72(g)(1), this
( printed page 49205)
substance may cause: acute toxicity, carcinogenicity, reproductive toxicity, genetic toxicity, skin irritation, skin sensitization, serious eye damage, and 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 § 721.80(f), (k), and (t). It is a significant new use to import the substance other than in solution, unless in sealed containers weighing 5 kilograms or less. It is a significant new use to process the substance in any way that generates dust, mist, or aerosol in a non-enclosed process. It is a significant new use to manufacture the substance longer than 18 months.
(b)
Specific requirements.
The provisions of subpart A of this part apply to this section except as modified by this paragraph (b).
(1)
Recordkeeping.
Recordkeeping requirements as specified in § 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 § 721.185 apply to this section.
(a)
Chemical substance and significant new uses subject to reporting.
(1) The chemical substance identified generically as alkyl transition metal alkoxide (PMN P-24-187) 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 destroyed.
(2) The significant new uses are:
(i)
Protection in the workplace.
Requirements as specified in § 721.63(a)(1), (a)(3), and (c). When determining which persons are reasonably likely to be exposed as required for § 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 § 721.72(a) through (d), (f), (g)(1), (g)(3)(iii), and (g)(5). For purposes of § 721.72(g)(1), this substance may cause: skin corrosion, serious eye damage, reproductive toxicity, and 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 § 721.80(k). It is a significant new use to manufacture, process, or use the substance in any manner that generates a vapor, mist, dust, or aerosol outside of a fully enclosed system containing the substance.
(iv)
Release to water.
Requirements as specified in § 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 § 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 § 721.185 apply to this section.
(a)
Chemical substance and significant new uses subject to reporting.
(1) The chemical substance identified generically as silsesquioxanes, alkyl Ph alkoxy(halosubstitutedphenyl), polymers with silicic acid (H4SiO4) tetra-Me ester, hydroxy-terminated (PMN P-24-189) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section.
(2) The significant new uses are:
(i)
Hazard communication.
Requirements as specified in § 721.72(a) through (d), (f), (g)(1), and (g)(5). For purposes of § 721.72(g)(1), this substance may cause: acute toxicity and specific target organ toxicity. Alternative hazard and warning statements that meet the criteria of the Globally Harmonized System and OSHA Hazard Communication Standard may be used.
(ii)
Industrial, commercial, and consumer activities.
Requirements as specified in § 721.80(k). It is a significant new use to manufacture, process, or use the substance in any manner that results in inhalation exposure to the substance.
(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 § 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 § 721.185 apply to this section.
(a)
Chemical substance and significant new uses subject to reporting.
(1) The chemical substance identified generically as phenoxathiinium, 10-phenyl-, tricycloalkylcarbomonocyclesulfonate (1:1) (PMN P-25-3) 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 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 § 721.63(a)(1), (a)(2)(i) and (a)(2)(iii), (a)(3), and (c). When determining which persons are reasonably likely to be exposed as required for § 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 § 721.72(a) through (f), (g)(1), (g)(2)(i) through (iii) and (g)(2)(v), (g)(3)(i) and (ii), and (g)(5). For purposes of § 721.72(e), the concentration is set at 1.0%. For purposes of § 721.72(g)(1), this substance may cause: acute toxicity, skin irritation, serious eye damage, skin sensitization, genetic toxicity, and 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 § 721.80(f), (k), and (t). It is a significant new use to import the substance other than in solution, unless in sealed containers weighing 5 kilograms or less. It is a significant new
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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 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 § 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 § 721.185 apply to this section.
(a)
Chemical substance and significant new uses subject to reporting.
(1) The chemical substance identified generically as sulfonium, triphenyl-, heteropolyclyclecarboxylate (1:1) (PMN P-25-4) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section. The requirements of this section do not apply to quantities of the substance after they have been completely reacted 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 § 721.63(a)(1), (a)(2)(i) and (a)(2)(iii), (a)(3), and (c). When determining which persons are reasonably likely to be exposed as required for § 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 § 721.72(a) through (f), (g)(1), (g)(2)(i) through (iii) and (g)(2)(v), (g)(3)(i) and (ii), and (g)(5). For purposes of § 721.72(e), the concentration is set at 1.0%. For purposes of § 721.72(g)(1), this substance may cause: acute toxicity, skin irritation, serious eye damage, skin sensitization, genetic toxicity, and 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 § 721.80(f), (k), and (t). It is a significant new use to import the substance other than in solution, unless in sealed containers weighing 5 kilograms or less. It is a significant new use to process the substance in any way that generates dust, mist, or aerosol in a non-enclosed process. It is a significant new use to manufacture the substance longer than 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 § 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 § 721.185 apply to this section.
Trihaloaromatic iodonium dicyclo salt with polyhaloalkyl carbomonocycle hetero-acid (generic).
(a)
Chemical substance and significant new uses subject to reporting.
(1) The chemical substance identified generically as trihaloaromatic iodonium dicyclo salt with polyhaloalkyl carbomonocycle hetero-acid (PMN P-25-16) 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 § 721.63(a)(1), (a)(2)(i) and (a)(2)(iii), (a)(3), and (c). When determining which persons are reasonably likely to be exposed as required for § 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 § 721.72(a) through (f), (g)(1), (g)(2)(i) through (iii) and (g)(2)(v), (g)(3)(i) and (ii), and (g)(5). For purposes of § 721.72(e), the concentration is set at 0.1%. For purposes of § 721.72(g)(1), this substance may cause: acute toxicity, skin irritation, skin sensitization, genetic toxicity, reproductive toxicity, specific target organ toxicity, and carcinogenicity. 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 § 721.80(f), (k), and (t). It is a significant new use to import the substance other than in solution, unless in sealed containers weighing 5 kilograms or less. It is a significant new use to process the substance in any way that generates dust, mist, or aerosol in a non-enclosed process. It is a significant new use to manufacture the substance longer than 18 months.
(b) Specific requirements. The provisions of subpart A of this part apply to this section except as modified by this paragraph (b).
(1)
Recordkeeping.
Recordkeeping requirements as specified in § 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 § 721.185 apply to this section.
Sulfonium, triphenyl-, salt with heterosubstituteddifluorosubstitutedalkyl substitutedalkyl trihalosubstitutedcarbomonocycle carboxylate (1:1) (generic).
(a)
Chemical substance and significant new uses subject to reporting.
(1) The chemical substance identified generically as sulfonium, triphenyl-, salt with heterosubstituteddifluorosubstitutedalkyl substitutedalkyl trihalosubstitutedcarbomonocycle carboxylate (1:1) (PMN P-25-20) 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 § 721.63(a)(1), (a)(2)(i) and (a)(2)(iii), (a)(3), and (c). When determining which persons are reasonably likely to be exposed as required for § 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)
( printed page 49207)
shall be considered and implemented to prevent exposure, where feasible.
(ii)
Hazard communication.
Requirements as specified in § 721.72(a) through (f), (g)(1), (g)(2)(i) through (iii), (g)(2)(v), (g)(3)(i) and (ii), and (g)(5). For purposes of § 721.72(e), the concentration is set at 1.0%. For purposes of § 721.72(g)(1), this substance may cause: acute toxicity, skin irritation, serious eye damage, skin sensitization, genetic toxicity, and 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 § 721.80(f), (k), and (t). It is a significant new use to import the substance other than in solution, unless in sealed containers weighing 5 kilograms or less. It is a significant new use to process the substance in any way that generates dust, mist, or aerosol in a non-enclosed process. It is a significant new use to manufacture the substance longer than 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 § 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 § 721.185 apply to this section.
Sulfonium, tri(halosubstitutedphenyl)-, salt with heterosubstituteddifluorosubstitutedalkyl substitutedalkyl trihalosubstitutedcarbomonocycle carboxylate (1:1) (generic).
(a)
Chemical substance and significant new uses subject to reporting.
(1) The chemical substance identified generically as sulfonium, tri(halosubstitutedphenyl)-, salt with heterosubstituteddifluorosubstitutedalkyl substitutedalkyl trihalosubstitutedcarbomonocycle carboxylate (1:1) (PMN P-25-21) 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 § 721.63(a)(1), (a)(2)(i) and (a)(2)(iii), (a)(3), and (c). When determining which persons are reasonably likely to be exposed as required for § 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 § 721.72(a) through (f), (g)(1), (g)(2)(i) through (iii), (g)(2)(v), (g)(3)(i) and (ii), and (g)(5). For purposes of § 721.72(e), the concentration is set at 1.0%. For purposes of § 721.72(g)(1), this substance may cause: acute toxicity, skin irritation, serious eye damage, skin sensitization, genetic toxicity, and 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 § 721.80(f), (k), and (t). It is a significant new use to import the substance other than in solution, unless in sealed containers weighing 5 kilograms or less. It is a significant new use to process the substance in any way that generates dust, mist, or aerosol in a non-enclosed process. It is a significant new use to manufacture the substance longer than 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 § 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 § 721.185 apply to this section.
Sulfonium, bis(dihalo carbomonocycle)carbomonocycle-, salt with trihalobenzoate (generic).
(a)
Chemical substance and significant new uses subject to reporting.
(1) The chemical substance identified generically as sulfonium, bis(dihalo carbomonocycle)carbomonocycle-, salt with trihalobenzoate (PMN P-25-67) 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 § 721.63(a)(1), (a)(2)(i) and (a)(2)(iii), (a)(3), and (c). When determining which persons are reasonably likely to be exposed as required for § 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 § 721.72(a) through (f), (g)(1), (g)(2)(i) through (iii) and (g)(2)(v), (g)(3)(i) and (ii), and (g)(5). For purposes of § 721.72(e), the concentration is set at 1.0%. For purposes of § 721.72(g)(1), this substance may cause: acute toxicity, skin irritation, serious eye damage, skin sensitization, genetic toxicity, and 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 § 721.80(f), (k), and (t). It is a significant new use to import the substance other than in solution, unless in sealed containers weighing 5 kilograms or less. It is a significant new use to process the substance in any way that generates 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 § 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 § 721.185 apply to this section.
Use this for formal legal and research references to the published document.
90 FR 49180
Web Citation
Suggested Web Citation
Use this when citing the archival web version of the document.
“Significant New Use Rules on Certain Chemical Substances (25-2.5e),” thefederalregister.org (November 3, 2025), https://thefederalregister.org/documents/2025-19757/significant-new-use-rules-on-certain-chemical-substances-25-2-5e.