90 FR 135 pgs. 33283-33299 - Significant New Use Rules on Certain Chemical Substances (24-3.5e)
Type: RULEVolume: 90Number: 135Pages: 33283 - 33299
Pages: 33283, 33284, 33285, 33286, 33287, 33288, 33289, 33290, 33291, 33292, 33293, 33294, 33295, 33296, 33297, 33298, 33299Docket number: [EPA-HQ-OPPT-2024-0079; FRL-12386-02-OCSPP]
FR document: [FR Doc. 2025-13363 Filed 7-16-25; 8:45 am]
Agency: Environmental Protection Agency
Official PDF Version: PDF Version
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 721
[EPA-HQ-OPPT-2024-0079; FRL-12386-02-OCSPP]
RIN 2070-AB27
Significant New Use Rules on Certain Chemical Substances (24-3.5e)
AGENCY:
Environmental Protection Agency (EPA).
ACTION:
Final rule.
SUMMARY:
EPA is issuing 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 to notify EPA at least 90 days before commencing the manufacture (defined by statute to include import) or processing of any of these chemical substances for an activity that is designated as a significant new use in the SNUR. 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:
This rule is effective on September 15, 2025. For purposes of judicial review, this rule shall be promulgated at 1 p.m. (EST) on July 31, 2025.
ADDRESSES:
The docket for this action, identified under docket identification (ID) number EPA-HQ-OPPT-2024-0079, is available online at https://www.regulations.gov or in person at the Office of Pollution Prevention and Toxics Docket (OPPT Docket) in the Environmental Protection Agency Docket Center (EPA/DC). Please review the visitor instructions and additional information about the docket available at https://www.epa.gov/dockets.
FOR FURTHER INFORMATION CONTACT:
For technical information: Jordan Garbin, New Chemicals Division (7405M), Office of Pollution Prevention and Toxics, Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460-0001; telephone number: (202) 564-4156; email address: garbin.jordan@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-Hotline, ABVI-Goodwill, 422 South Clinton Ave., Rochester, NY 14620; telephone number: (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).
B. What action is the Agency taking?
[top] EPA is finalizing SNURs under TSCA section 5(a)(2) for the chemical substances identified in this document. These chemical substances were the
Previously, EPA proposed SNURs for these chemical substances in the Federal Register of December 17, 2024 (89 FR 102046 (FRL-12386-01-OCSPP)). The docket includes information considered by the Agency in developing the proposed and final rules, including public comments and EPA's responses to the comments received as discussed in Unit II.D.
C. Does this action apply to me?
1. General Applicability
This action applies to you if you manufacture, process, or use the chemical substances identified in this document. 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.
2. Applicability to Importers and Exporters
This action may also apply to certain entities through pre-existing import certification and export notification requirements under TSCA ( https://www.epa.gov/tsca-import-export-requirements ).
Chemical importers are subject to TSCA section 13 (15 U.S.C. 2612), the requirements 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 identified in this document are subject to the export notification provisions of TSCA section 12(b) (15 U.S.C. 2611(b)) and must comply with the export notification requirements in 40 CFR part 707, subpart D.
D. What are the incremental economic impacts of this action?
EPA has evaluated the potential costs of establishing SNUN reporting requirements for potential manufacturers and processors of the chemical substances identified in this document. This analysis, which is available in the docket, is briefly summarized here.
1. Estimated Costs for SNUN Submissions
A SNUR requires that any person who intends to engage in such activity in the future must first notify EPA by submitting a SNUN. If a SNUN is submitted, costs are an estimated $45,000 per SNUN submission for large business submitters and $14,500 for small business submitters. These estimates include the cost to prepare and submit the SNUN (including registration for EPA's Central Data Exchange (CDX)), and the payment of a user fee. Businesses that submit a SNUN would be subject to either a $37,000 user fee required by 40 CFR 700.45(c)(2)(ii) and (d), or, if they are a small business as defined at 13 CFR 121.201, a reduced user fee of $6,480 (40 CFR 700.45(c)(1)(ii) and (d)). 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 pre-existing export notification requirements under TSCA section 12(b) and the implementing regulations at 40 CFR part 707, subpart D. For persons exporting a substance that is the subject of a SNUR, a one-time notice to EPA must be provided for the first export or intended export to a particular country. The total costs of export notification will vary by chemical, depending on the number of required notifications ( i.e., the number of countries to which the chemical is exported). While EPA is unable to make any estimate of the likely number of export notifications for the chemical substances covered by these SNURs, as stated in the accompanying economic analysis, the estimated cost of the export notification requirement on a per unit basis is approximately $106.
II. Background
A. General Information About SNURs
Unit II. of the proposed rule provides general information about SNURs, and additional information about EPA's new chemical program is available at https://www.epa.gov/reviewing-new-chemicals-under-toxic-substances-control-act-tsca.
B. Applicability of the Significant New Use Designation
To establish a significant new use, EPA must determine that the use is not ongoing. As discussed in Unit II.E. of the proposed rule, EPA concluded that the proposed significant new uses were not ongoing. If EPA subsequently determines that such a use was ongoing as of the date of publication of the proposed rule and did not cease prior to issuance of the final rule, EPA will not designate that use as a significant new use in the final rule. EPA has no information to suggest that any of the significant new uses identified in this rule meet this criterion.
As discussed in the Federal Register of April 24, 1990 (55 FR 17376 (FRL-3658-5)), EPA believes that the intent of TSCA section 5(a)(1)(B) is best served by designating a use as a significant new use as of the date of publication of the proposed rule rather than as of the effective date of the final rule. The objective of EPA's approach is to ensure that a person cannot impede finalization of a SNUR by initiating a significant new use after publication of the proposed rule but before the effective date of the final rule. Uses arising after the publication of the proposed rule are distinguished from uses that are identified in the final rule as having been ongoing on the date of publication of the proposed rule. The former would be new uses, the latter ongoing uses, except that uses that are identified as ongoing as of the publication of the proposed rule would not be considered ongoing uses if they have ceased by the date of issuance of a final rule.
[top] In the unlikely event that before a final rule becomes effective a person begins commercial manufacturing (including importing) or processing of the chemical substances for a use that is designated as a significant new use in that final rule, such a person 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 wait until all TSCA
Issuance of a SNUR for a chemical substance does not signify that the chemical substance is listed on the TSCA Chemical Substance Inventory (TSCA Inventory). Guidance on how to determine if a chemical substance is on the TSCA Inventory is available on the internet at https://www.epa.gov/tsca-inventory .
C. Important Information About SNUN Submissions
1. SNUN Submissions
SNUNs must be submitted on EPA Form No. 7710-25, generated using e-PMN software, and submitted to the Agency in accordance with the procedures set forth in 40 CFR 720.40 and 721.25. E-PMN software is available electronically at https://www.epa.gov/reviewing-new-chemicals-under-toxic-substances-control-act-tsca .
2. Development and Submission of Information
EPA recognizes that TSCA section 5 does not require development of any particular new information ( e.g., generating test data) before submission of a SNUN. There is an exception: If a person is required to submit information for a chemical substance pursuant to a rule, order or consent agreement under TSCA section 4, then TSCA section 5(b)(1)(A) requires such information 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. of the proposed rule.
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. of the proposed rule may not be the only means of providing information to evaluate the chemical substance associated with the significant new uses. However, submitting a SNUN without any test data may increase the likelihood that EPA will take action under TSCA sections 5(e) or 5(f). EPA recommends that potential SNUN submitters contact EPA early enough so that they will be able to conduct the appropriate tests.
SNUN submitters should be aware that EPA will be better able to evaluate SNUNs which provide detailed information about human exposure and environmental release that may result from the significant new use of the chemical substances.
D. Public Comments on Proposed Rule and EPA Responses
EPA received public comments on the proposed SNURs and prepared a Response to Comment document that provides the Agency responses. The comments and the Response to Comment document are available in the docket. As described in the Response to Comment document, EPA is finalizing these SNURs with the following changes (listed by PMN Number and proposed 40 CFR citation):
• For P-23-37 (40 CFR 721.12069), P-23-44 (40 CFR 721.12070), P-23-80 (40 CFR 721.12071), P-23-93 (40 CFR 721.12072), and P-23-172 (40 CFR 721.12076), EPA incorporated the requirements of 40 CFR 721.72(e) to include a de minimis provision of 1.0% for consistency with the underlying Orders for these substances. EPA also corrected the significant new use regarding the manner in which the substance is imported. The significant new use now reads "It is a significant new use to import the substance other than in solution, unless in sealed containers weighing 5 kilograms or less."
In addition to the changes to respond to comments, EPA identified the need to revise the following proposed SNURs (listed by PMN Number and proposed 40 CFR citation):
• For P-21-170 (40 CFR 721.12048), EPA addressed an inadvertent omission in the industrial, commercial, and consumer activities paragraph of the regulatory text by including processing for use or use of the substance where the concentration of the substance in the final product exceeds 0.008% as a significant new use. In the Federal Register of December 17, 2024 (89 FR 102051), EPA proposed to designate this use as a significant new use, but inadvertently omitted it from the proposed regulatory text appearing on page 102064.
• For P-21-170 (40 CFR 721.12048), P-22-58 (40 CFR 721.12058), P-22-75 (40 CFR 721.12059), P-22-78 (40 CFR 721.12060), P-23-36 (40 CFR 721.12068), and P-23-64 (40 CFR 721.12073), EPA made minor edits to the language in the industrial, commercial, and consumer activities paragraph to be consistent with previous SNURs that had similar requirements.
• For P-18-325 (40 CFR 721.12044), P-21-170 (40 CFR 721.12048), P-21-184 (40 CFR 721.12049), P-22-25 (40 CFR 721.12055), P-22-58 (40 CFR 721.12058), P-22-75 (40 CFR 721.12059), P-22-78 (40 CFR 721.12060), and P-22-82 (40 CFR 721.12062) EPA simplified the requirements in the industrial, commercial, and consumer activities paragraph by removing inadvertent duplication of certain significant new uses.
• For P-18-127 (40 CFR 721.12043), P-18-325 (40 CFR 721.12044), P-20-14 (40 CFR 721.12045), P-21-164 (40 CFR 721.12047), P-21-170 (40 CFR 721.12048), P-21-184 (40 CFR 721.12049), P-22-3 (40 CFR 721.12050), P-22-4 (40 CFR 721.12051), P-22-5 (40 CFR 721.12052), P-22-6 (40 CFR 721.12053), P-22-49 (40 CFR 721.12056). P-22-50 (40 CFR 721.12057), P-22-58 (40 CFR 721.12058), P-22-75 (40 CFR 721.12059), P-22-78 (40 CFR 721.12060), P-22-80 (40 CFR 721.12061), P-22-121 (40 CFR 721.12063), P-22-145 (40 CFR 721.12064), P-22-175 (40 CFR 721.12065), P-22-30 (40 CFR 721.12067), P-23-36 (40 CFR 721.12068), and P-23-72 (40 CFR 721.12074), EPA simplified the requirements in the hazard communication paragraph by referencing 40 CFR 721.72(g)(3)(iii) rather than referencing 721.72(g)(3) and writing out the required environmental hazard statement.
[top] • For P-22-3 (40 CFR 721.12050), P-22-4 (40 CFR 721.12051), P-22-5 (40 CFR 721.12052), and P-22-6 (40 CFR
• For P-22-58 (40 CFR 721.12058) and P-23-36 (40 CFR 721.12068), EPA made minor changes to the language in the industrial, commercial, and consumer activities paragraph to more closely align the significant new uses with the terms of the underlying TSCA Orders for these substances.
• For P-22-121 (40 CFR 721.12063) and P-22-175 (40 CFR 721.12065), EPA replaced the generic chemical name with the specific chemical name and CASRN because the CBI claim for this information has been relinquished by the PMN submitter.
• For P-23-72 (40 CFR 721.12074), EPA modified the language in the industrial, commercial, and consumer activities paragraph to clarify that "40% by weight" is referring to the concentration of the substance in the final formulation.
III. Chemical Substances Subject to These SNURs
A. What is the designated cutoff date for ongoing uses?
EPA designates the date of publication of the proposed rule as the cutoff date for determining whether the new use is ongoing, i.e., December 17, 2024 (89 FR 102046 (FRL-12386-01-OCSPP)). This designation is explained in more detail in Unit II.B.
B. What information was provided for each chemical substance?
In Unit III.C. of the proposed rule, EPA provided the following information for each chemical substance subject to these SNURs:
• PMN number (the CFR citation assigned in the regulatory text section of this document).
• Chemical name (generic name, if the specific name is claimed as CBI).
• Chemical Abstracts Service Registry Number (CASRN) 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 this document specifies the chemical substances and activities designated as significant new uses. Certain new uses, including production volume limits and other uses designated, may be claimed as CBI, as discussed in more detail in Unit II.C. of the proposed rule.
In addition, as discussed in Unit III.B. of the proposed rule, these 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. As such, the 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).
IV. Statutory and Executive Order Reviews
Additional information about these statutes and Executive orders can be found at https://www.epa.gov/laws-regulations-and-executive-orders.
A. Executive Order 12866: Regulatory Planning and Review
This action establishes SNURs for new chemical substances that were the subject of PMNs. The Office of Management and Budget (OMB) has exempted these types of actions from review under Executive Order 12866 (58 FR 51735, October 4, 1993).
B. Executive Order 14192: Unleashing Prosperity Through Deregulation
Executive Order 14192 (90 FR 9065, February 6, 2025) does not apply because a significant new use rule for a new chemical under TSCA section 5 is exempt from review under Executive Order 12866.
C. Paperwork Reduction Act (PRA)
According to the PRA (44 U.S.C. 3501 et seq. ), an agency may not conduct or sponsor, and a person is not required to respond to a collection of information that requires OMB approval under PRA, unless it has been approved by OMB and displays a currently valid OMB control number. The 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.
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. 601 et seq. ). The requirement to submit a SNUN applies to any person (including small or large entities) who intends to engage in any activity described in the final rule as a "significant new use." Because these uses are "new," based on all information currently available to EPA, EPA has concluded that no small or large entities presently engage in such activities.
A SNUR requires that any person who intends to engage in such activity in the future must first notify EPA by submitting a SNUN. Although some small entities may decide to pursue a significant new use in the future, EPA cannot presently determine how many, if any, there may be. However, EPA's experience to date is that, in response to the promulgation of SNURs covering over 1,000 chemicals, the Agency receives only a small number of notices per year. For example, the number of SNUNs received was 7 in Federal fiscal year (FY) 2020, 9 in FY2021, 9 in 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 $14,500 per SNUN submission for qualifying small firms. Therefore, the potential economic impacts of complying with these proposed SNURs are not expected to be significant or adversely impact a substantial number of small entities. In a SNUR that published in the Federal Register of June 2, 1997 (62 FR 29684 (FRL-5597-1)), the Agency presented its general determination that SNURs are not expected to have a significant economic impact on a substantial number of small entities, which was provided to the Chief Counsel for Advocacy of the Small Business Administration.
E. Unfunded Mandates Reform Act (UMRA)
[top] 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
F. Executive Order 13132: Federalism
This action will not have federalism implications as specified in Executive Order 13132 (64 FR 43255, August 10, 1999), because it is not expected to have a substantial direct effect on States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government. Accordingly, the requirements of Executive Order 13132 do not apply to this action.
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).
K. Congressional Review Act (CRA)
This action is subject to the CRA (5 U.S.C. 801 et seq. ), and EPA will submit a rule report to each House of the Congress and to the Comptroller General of the United States. This action is not a "major rule" as defined by 5 U.S.C. 804(2).
List of Subjects in 40 CFR Part 721
Environmental protection, Chemicals, Hazardous substances, Reporting and recordkeeping requirements.
Dated: July 14, 2025.
Mary Elissa Reaves,
Director, Office of Pollution Prevention and Toxics.
For the reasons stated in the preamble, 40 CFR chapter I is amended as follows:
PART 721-SIGNIFICANT NEW USES OF CHEMICAL SUBSTANCES
1. The authority citation for part 721 continues to read as follows:
Authority:
15 U.S.C. 2604, 2607, and 2625(c).
2. Add §§?721.12043 through 721.12076 to Subpart E to read as follows:
Subpart E-Significant New Uses for Specific Chemical Substances
[top] Sec. 721.12043 Heptane, 2-methoxy-2-methyl-.721.12044 Benzenesulfonic acid, alkyl-, compd. with 1,1'-iminobis[2-propanol] (1:1) (generic).721.12045 Sugars, polymer with alkanetriamine (generic).721.12046 Isooctadecanamide, N,N-bis(2-ethylhexyl)-.721.12047 2-Butanone, oxime, reaction products with trimethoxymethylsilane.721.12048 2,6-Bis(dialkyl)-4-[2-(1-alkyl-4(1H)-pyridinylidene)alkylidene]-2,5-cycloalkyladien-1-one (generic).721.12049 Fatty acids, soya, reaction products with ammonia-ethanolamine reaction by-products.721.12050 1,5-Pentanediamine, 2-methyl-, hydrochloride (1:2).721.12051 1,5-Pentanediamine, 2-methyl-, hydrochloride (1:1).721.12052 Formic acid, compd. with 2-methyl-1,5- pentanediamine (2:1).721.12053 Formic acid, compd. with 2-methyl-1,5-pentanediamine (1:1).721.12054 Alkadiene, homopolymer, hydroxy-terminated, bis[N-[2-[(1-oxo-2-propen-1-yl)oxylethyl]carbamates] (generic).721.12055 Oxirane, 2-(chloromethyl)-, homopolymer, ether with dialkyl-alkanediol (2:1) (generic).721.12056 Aryl, polymer with formaldehyde, glycidyl ether, reaction products with amino alkyl-alkane diamine, cyclohexanediamine and alkylene (alkylcyclohexanamine) (generic).721.12057 Alkene, alkoxy-, polymer with alkoxyalkene (generic).721.12058 Methanesulfonamide, l,l,l-trifluoro-N-[(trifluoromethyl)sulfonyl]-, sodium salt (1:1).721.12059 1H-Isoindole-1,3(2H)-dione, 3a,4,7,7a-tetrahydro-2-(2-hydroxyethyl)-.721.12060 Oxirane, 2-methyl-, polymer with oxirane, mono-isoalkyl ethers, phosphates, salt (generic).721.12061 Poly(oxy-1,2-ethanediyl), .alpha.-(2-aminoethyl)-.omega.-(2-aminoethoxy)- and Poly(oxy-1,2-ethanediyl), .alpha.,.alpha.',-(iminodi-2,1- ethanediyl)bis[.omega.-(2-aminoethoxy)-.721.12062 Alkenoic acid, alkyl, carbopolycyclic alkyl ester, polymer with trihalo (trihaloalkyl) alkyl alkyl alkenoate (generic).721.12063 1-Propene, 1,1,3,3-tetrachloro-.721.12064 Alkanoic acid, trialkyl-, diester with carbomonocycle bis(alkyleneoxy)]bis[alkanediol] (generic).721.12065 Silsesquioxanes, Me vinyl, hydroxy and methoxy and [(trimethylsilyl)oxy]- terminated.721.12066 Vegetable oil, polymer with pimelin ketone, oxymethylene and polymethylenepolyphenylene isocyanate (generic).721.12067 Silsesquioxanes, 3-mercaptopropyl, polymers with silicic acid (H4SiO4) tetra-Et ester, [(trimethylsilyl)oxy]-terminated.721.12068 Castor oil, polymer with dicyclopentadiene, maleic anhydride, 2-methyl-1,3-propanediol, 3a,4,7,7a-tetrahydro-2-(2-hydroxyethyl)-1H-isoindole-1,3(2H)-dione and triethylene glycol.721.12069 Monoaromatic cyclic alkylene sulfonium fluoroalkyl sulfonic acid salt (generic).721.12070 Monoaromatic cyclic alkylene sulfonium fluoroalkyl sulfonic acid salt (generic).721.12071 Aromatic sulfonium tricyclo fluoroalkyl sulfonic acid salt (generic).
§?721.12043 Heptane, 2-methoxy-2-methyl-.
(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as heptane, 2-methoxy-2-methyl- (PMN P-18-127; CASRN 76589-16-7) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in §?721.63(a)(1) and (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 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). It is a significant new use to manufacture the substance unless by import into the United States in a solution of no greater than 5% by weight ( i.e., no domestic manufacture). It is a significant new use to process the substance unless in a solution of no greater than 5% by weight of the substance. It is a significant new use to process for use or use the substance in consumer products unless the concentration of the substance is less than 1% by weight.
(iv) Release to water. Requirements as specified in §?721.90(a)(4), (b)(4), and (c)(4), where N=210.
(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.
§?721.12044 Benzenesulfonic acid, alkyl-, compd. with 1,1'-iminobis[2-propanol] (1:1) (generic).
(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as benzenesulfonic acid, alkyl-, compd. with 1,1'-iminobis[2-propanol] (1:1) (PMN P-18-325) 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) and (3), (b), 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. For purposes of §?721.63(b), the concentration is set at 1.0%.
(ii) Hazard communication. Requirements as specified in §?721.72(a) through (f), and (g)(1), (g)(3)(iii) 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: skin irritation, 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. 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 process for use or use the substance other than as an industrial cross-linking catalyst.
(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.
§?721.12045 Sugars, polymer with alkanetriamine (generic).
(a) Chemical substance and significant new uses subject to reporting.
(1) The chemical substance identified generically as sugars, polymer with alkanetriamine (PMN P-20-14) 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) and (3), (b), 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. For purposes of §?721.63(b), the concentration is set at 1.0%.
(ii) Hazard communication. Requirements as specified in §?721.72(a) through (f), (g)(1), (g)(3)(iii), 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: 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) Release to water. Requirements as specified in §?721.90(a)(4), (b)(4), and (c)(4), where N=191.
[top] (b) Specific requirements. The provisions of Subpart A of this part
(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.
§?721.12046 Isooctadecanamide, N,N-bis(2-ethylhexyl)-.
(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as isooctadecanamide, N,N-bis(2-ethylhexyl)- (PMN P-21-86; CASRN 1616494-50-8) 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 entrained in a polymer.
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in §?721.63(a)(1) and (3), (b), 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. For purposes of §?721.63(b), the concentration is set at 1.0%.
(ii) Hazard communication. Requirements as specified in §?721.72(a) through (f), (g)(1), and (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: specific target organ toxicity. Alternative hazard and warning statements that meet the criteria of the Globally Harmonized System and OSHA Hazard Communication Standard may be used.
(iii) Industrial, commercial, and consumer activities. It is a significant new use to process the substance for use in a consumer product where the concentration of the substance in the consumer product formulation exceeds the confidential percentage listed in the Order. It is a significant new use to use the substance in a consumer product where the concentration of the substance exceeds the confidential percentage listed in the Order.
(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.
§?721.12047 2-Butanone, oxime, reaction products with trimethoxymethylsilane.
(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as 2-butanone, oxime, reaction products with trimethoxymethylsilane (PMN P-21-164; CASRN 2639393-45-4) 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.
(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: acute toxicity, carcinogenicity, serious eye damage, reproductive toxicity, 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. It is a significant new use to load or unload the substance for manufacture, processing, or use in any manner unless under a gas ( e.g., nitrogen) blanket. It is a significant new use to use the substance unless at 4% or less by weight in formulation. It is a significant new use to apply the substance for use unless by roll, brush, or dip coating.
(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.
§?721.12048 2,6-Bis(dialkyl)-4-[2-(1-alkyl-4(1H)-pyridinylidene)alkylidene]-2,5-cycloalkyladien-1-one (generic).
(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as 2,6-bis(dialkyl)-4-[2-(1-alkyl-4(1H)-pyridinylidene)alkylidene]-2,5-cycloalkyladien-1-one (generic) (PMN P-21-170) 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 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: acute toxicity, skin irritation, eye irritation, 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.
[top] (iii) Industrial, commercial, and consumer activities. It is a significant new use to manufacture 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.
§?721.12049 Fatty acids, soya, reaction products with ammonia-ethanolamine reaction by-products.
(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as fatty acids, soya, reaction products with ammonia-ethanolamine reaction by-products (PMN P-21-184; CASRN 2378512-59-3) 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: acute toxicity, skin corrosion, skin irritation, serious eye damage, eye 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 the generation of vapor, mist, aerosol, or dust.
(iv) Release to water. Requirements as specified in §?721.90(a)(4), (b)(4), and (c)(4), where N=2.
(b) Specific requirements. The provisions of Subpart A of this part apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in §?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.
§?721.12050 1,5-Pentanediamine, 2-methyl-, hydrochloride (1:2).
(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as 1,5-pentanediamine, 2-methyl-, hydrochloride (1:2) (PMN P-22-3; CASRN 34813-63-3) 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) and (3), (b), 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. For purposes of §?721.63(b), the concentration is set at 1.0%.
(ii) Hazard communication. Requirements as specified in §?721.72(a) through (f), (g)(1), (g)(3)(iii), 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, and eye irritation. 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=570 in aggregate of P-22-3, P-22-4, P-22-5, and P-22-6.
(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.
§?721.12051 1,5-Pentanediamine, 2-methyl-, hydrochloride (1:1).
(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as 1,5-pentanediamine, 2-methyl-, hydrochloride (1:1) (PMN P-22-4; CASRN 1840915-04-9) 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) and (3), (b), 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. For purposes of §?721.63(b), the concentration is set at 1.0%.
(ii) Hazard communication. Requirements as specified in §?721.72(a) through (f), (g)(1), (g)(3)(iii), 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, eye irritation, serious eye damage, skin corrosion, 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.
[top] (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
(iv) Release to water. Requirements as specified in §?721.90(a)(4), (b)(4), and (c)(4), where N=570 in aggregate of P-22-3, P-22-4, P-22-5, and P-22-6.
(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.
§?721.12052 Formic acid, compd. with 2-methyl-1,5-pentanediamine (2:1).
(a) Chemical substance and significant new uses subject to reporting.
(1) The chemical substance identified as formic acid, compd. with 2-methyl-1,5-pentanediamine (2:1) (PMN P-22-5; CASRN 1836131-73-7) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in §?721.63(a)(1) and (3), (b), 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. For purposes of §?721.63(b), the concentration is set at 1.0%.
(ii) Hazard communication. Requirements as specified in §?721.72(a) through (f), (g)(1), (g)(3)(iii), 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, 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(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=570 in aggregate of P-22-3, P-22-4, P-22-5, and P-22-6.
(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.
§?721.12053 Formic acid, compd. with 2-methyl-1,5-pentanediamine (1:1)
(a) Chemical substance and significant new uses subject to reporting.
(1) The chemical substance identified as formic acid, compd. with 2-methyl-1,5-pentanediamine (1:1) (PMN P-22-6; CASRN 1836131-75-9) 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) and (3), (b), 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. For purposes of §?721.63(b), the concentration is set at 1.0%.
(ii) Hazard communication. Requirements as specified in §?721.72(a) through (f), (g)(1), (g)(3)(iii), 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 corrosion, skin irritation, serious eye damage, 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(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=570 in aggregate of P-22-3, P-22-4, P-22-5, and P-22-6.
(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.
§?721.12054 Alkadiene, homopolymer, hydroxy-terminated, bis[N-[2-[(1-oxo-2-propen-1- yl)oxylethyl]carbamates] (generic).
(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as alkadiene, homopolymer, hydroxy-terminated, bis[N-[2-[(1-oxo-2-propen-1- yl)oxylethyl]carbamates] (PMN P-22-11) 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) and (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 sensitization, 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.
(b) Specific requirements. The provisions of Subpart A of this part apply to this section except as modified by this paragraph (b).
[top] (1) Recordkeeping. Recordkeeping requirements as specified in
(2) Limitation or revocation of certain notification requirements. The provisions of §?721.185 apply to this section.
§?721.12055 Oxirane, 2-(chloromethyl)-, homopolymer, ether with dialkyl-alkanediol (2:1) (generic).
(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically?as?oxirane,?2-(chloromethyl)-, homopolymer, ether with dialkyl-alkanediol (2:1) (PMN P-22-25) 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) and (3), (b), 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. For purposes of §?721.63(b), the concentration is set at 0.1%.
(ii) Hazard communication. Requirements as specified in §?721.72(a) through (f), (g)(1), 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, eye irritation, 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(g) and (t). It is a significant new use to manufacture, process, or use the substance in any manner that generates a vapor, mist, aerosol, or dust.
(iv) Disposal. It is a significant new use to dispose of the substance, or waste streams containing the substance, other than by hazardous waste incineration.
(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.
§?721.12056 Aryl, polymer with formaldehyde, glycidyl ether, reaction products with amino alkyl-alkane diamine, cyclohexanediamine and alkylene (alkylcyclohexanamine) (generic).
(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as aryl, polymer with formaldehyde, glycidyl ether, reaction products with amino alkyl-alkane diamine, cyclohexanediamine and alkylene (alkylcyclohexanamine) (PMN P-22-49) 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) and (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, eye irritation, skin corrosion, serious eye damage, 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. Requirements as specified in §?721.80(o).
(iv) Release to water. Requirements as specified in §?721.90(a)(4), (b)(4), and (c)(4), where N=2.
(b) Specific requirements. The provisions of Subpart A of this part apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in §?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.
§?721.12057 Alkene, alkoxy-, polymer with alkoxyalkene (generic).
(a) Chemical substance and significant new uses subject to reporting.
(1) The chemical substance identified generically as alkene, alkoxy-, polymer with alkoxyalkene (PMN P-22-50) 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) and (a)(3), (b), 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. For purposes of §?721.63(b), the concentration is set at 1.0%.
(ii) Hazard communication. Requirements as specified in §?721.72(a) through (f), (g)(1), (g)(3)(iii), 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: skin irritation, 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 (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)(1), (b)(1), and (c)(1).
[top] (b) Specific requirements. The provisions of Subpart A of this part
(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.
§?721.12058 Methanesulfonamide, l,l,l-trifluoro-N-[(trifluoromethyl)sulfonyl]-, sodium salt (1:1).
(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as Methanesulfonamide, l,l,l-trifluoro-N-[(trifluoromethyl)sulfonyl]-, sodium salt (1:1) (PMN P-22-58; CASRN 91742-21-1) 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 incorporated into an article.
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in §?721.63(a)(1), (a)(3) through (6), (b), 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. For purposes of §?721.63(b), the concentration is set at 1.0%.
(ii) Hazard communication. Requirements as specified in §?721.72(a) through (f), (g)(1), (g)(3)(iii), 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, serious eye damage, skin 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(b) and (k). It is a significant new use to process the substance in any manner that generates a vapor, mist, aerosol, or dust that results in inhalation to workers. It is a significant new use to use the substance in an application method that generates a vapor, mist, aerosol, or dust that results in inhalation to workers. It is a significant new use to use the substance other than in the form of a liquid.
(iv) Release to water. Requirements as specified in §?721.90(a)(4), (b)(4), and (c)(4), where N=100.
(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.
§?721.12059 H-Isoindole-1,3(2H)-dione, 3a,4,7,7a-tetrahydro-2-(2-hydroxyethyl)-.
(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as 1H-isoindole-1,3(2H)-dione, 3a,4,7,7a-tetrahydro-2-(2-hydroxyethyl)- (PMN P-22-75; CASRN 15458-48-7) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section. The requirements of this section do not apply to quantities of the substance after they have been completely reacted or cured.
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in §?721.63(a)(1) and (3), (b), 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. For purposes of §?721.63(b), the concentration is set at 1.0%.
(ii) Hazard communication. Requirements as specified in §?721.72(a) through (f), (g)(1), (g)(3)(iii), 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, 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(f). It is a significant new use to manufacture the substance beyond an annual production volume of 3,000 kilograms. It is a significant new use to use the substance other than as a monomer used to produce an unsaturated polyester resin.
(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.
§?721.12060 Oxirane, 2-methyl-, polymer with oxirane, mono-isoalkyl ethers, phosphates, salt (generic).
(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as oxirane, 2-methyl-, polymer with oxirane, mono-isoalkyl ethers, phosphates, salt (PMN P-22-78) 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) and (3), (b), 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. For purposes of §?721.63(b), the concentration is set at 1.0%.
(ii) Hazard communication. Requirements as specified in §?721.72(a) through (f), (g)(1), (g)(3)(iii), 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: skin 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.
[top] (iii) Industrial, commercial, and consumer activities. It is a significant new use to manufacture or process the substance in any manner that generates a vapor, mist, aerosol, or dust. It is a
(iv) Release to water. Requirements as specified in §?721.90(a)(4), (b)(4), and (c)(4), where N=23.
(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.
§?721.12061 Poly(oxy-1,2-ethanediyl), .alpha.-(2-aminoethyl)-.omega.-(2-aminoethoxy)- and Poly(oxy-1,2-ethanediyl), .alpha.,.alpha.',-(iminodi-2,1- ethanediyl)bis[.omega.-(2-aminoethoxy)-.
(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as poly(oxy-1,2-ethanediyl), .alpha.-(2-aminoethyl)-.omega.-(2-aminoethoxy)- and poly(oxy-1,2-ethanediyl), .alpha.,.alpha.',-(iminodi-2,1- ethanediyl)bis[.omega.-(2-aminoethoxy)- (PMN P-22-80; CAS Nos. 24991-53-5 and 90350-34-8) 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 destroyed.
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in §?721.63(a)(1) and (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, and skin sensitization. Alternative hazard and warning statements that meet the criteria of the Globally Harmonized System and OSHA Hazard Communication Standard may be used.
(iii) Industrial, commercial, and consumer activities. 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=0.7.
(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.
§?721.12062 Alkenoic acid, alkyl, carbopolycyclic alkyl ester, polymer with trihalo (trihaloalkyl) alkyl alkyl alkenoate (generic).
(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as alkenoic acid, alkyl, carbopolycyclic alkyl ester, polymer with trihalo (trihaloalkyl) alkyl alkyl alkenoate (PMN P-22-82) 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 dried photoresist.
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in §?721.63(a)(1) and (3), (b), 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. For purposes of §?721.63(b), the concentration is set at 1.0%.
(ii) Hazard communication. Requirements as specified in §?721.72(a) through (f), (g)(1), 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: 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), (v)(1), (2) and (4), (w)(1), (2) and (4), and (x)(1), (2) and (4). It is a significant new use to manufacture the substance other than by import into the United States ( i.e., no domestic manufacture) in a liquid formulation.
(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.
§?721.12063 1-Propene, 1,1,3,3-tetrachloro-.
(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as 1-propene, 1,1,3,3-tetrachloro- (PMN P-22-121; CASRN 18611-43-3) 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.
(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.
[top] (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, skin sensitization, genetic toxicity, carcinogenicity, and specific target organ toxicity. Alternative hazard and warning statements that meet the
(iii) Industrial, commercial, and consumer activities. Requirements as specified in §?721.80(f) and (k). It is a significant new use to process, use, load, or unload the substance unless under a gas ( e.g., nitrogen) blanket or in a closed system except that sampling may occur outside the closed system resulting in exposures.
(iv) Release to water. Requirements as specified in §?721.90(a)(4), (b)(4), and (c)(4), where N=0.15.
(b) Specific requirements. The provisions of Subpart A of this part apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in §?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.
§?721.12064 Alkanoic acid, trialkyl-, diester with carbomonocycle bis(alkyleneoxy)]bis[alkanediol] (generic).
(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as alkanoic acid, trialkyl-, diester with carbomonocycle bis(alkyleneoxy)]bis[alkanediol] (PMN P-22-145) 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) and (3), (b), 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. For purposes of §?721.63(b), the concentration is set at 1.0%.
(ii) Hazard communication. Requirements as specified in §?721.72(a) through (f), (g)(1), (g)(3)(iii), 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, 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 use the substance in any manner that may generate a spray, mist, vapor, or aerosol containing the substance unless the concentration of the substance is less than 5.7% by weight.
(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.
§?721.12065 Silsesquioxanes, Me vinyl, hydroxy and methoxy and [(trimethylsilyl)oxy]-terminated.
(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as silsesquioxanes, Me vinyl, hydroxy and methoxy and [(trimethylsilyl)oxy]- terminated (PMN P-22-175; CASRN 2450324-50-0) 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), (b), 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. For purposes of §?721.63(b), the concentration is set at 1.0%.
(ii) Hazard communication. Requirements as specified in §?721.72(a) through (f), (g)(1), (g)(3)(iii), 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: skin irritation, 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(f). It is a significant new use to use the substance unless the concentration of the substance does not exceed 10% by weight in formulation.
(iv) Release to water. Requirements as specified in §?721.90(a)(4), (b)(4), and (c)(4), where N=7.
(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.
§?721.12066 Vegetable oil, polymer with pimelin ketone, oxymethylene and polymethylenepolyphenylene isocyanate (generic).
(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as vegetable oil, polymer with pimelin ketone, oxymethylene and polymethylenepolyphenylene isocyanate (PMN P-23-18) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section. The requirements of this section do not apply to quantities of the substance after they have been completely reacted or cured.
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in §?721.63(a)(1) and (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.
[top] (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,
(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.
§?721.12067 Silsesquioxanes, 3-mercaptopropyl, polymers with silicic acid (H4SiO4) tetra-Et ester, [(trimethylsilyl)oxy]-terminated.
(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as silsesquioxanes, 3-mercaptopropyl, polymers with silicic acid (H4SiO4) tetra-Et ester, [(trimethylsilyl)oxy]-terminated (PMN P-23-20; CASRN 2796383-42-9) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section. The requirements of this section do not apply to quantities of the substance after they have been completely reacted or cured.
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in §?721.63(a)(1) and (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 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 results inhalation exposure.
(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.
§?721.12068 Castor oil, polymer with dicyclopentadiene, maleic anhydride, 2-methyl-1,3-propanediol, 3a,4,7,7a-tetrahydro-2-(2-hydroxyethyl)-1H-isoindole-1,3(2H)-dione and triethylene glycol.
(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as castor oil, polymer with dicyclopentadiene, maleic anhydride, 2-methyl-1,3-propanediol, 3a,4,7,7a-tetrahydro-2-(2-hydroxyethyl)-1H-isoindole-1,3(2H)-dione and triethylene glycol (PMN P-23-36; CASRN 2794200-69-2) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section. The requirements of this section do not apply to quantities of the substance after they have been completely reacted or cured.
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in §?721.63(a)(1) and (3), (b), 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. For purposes of §?721.63(b), the concentration is set at 1.0%.
(ii) Hazard communication. Requirements as specified in §?721.72(a) through (f), (g)(1), (g)(3)(iii), 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: skin irritation, 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(o). It is a significant new use to manufacture, process, or use the substance in any manner that generates a vapor, mist, aerosol, or dust.
(iv) Release to water. Requirements as specified in §?721.90(a)(4), (b)(4), and (c)(4), where N=27.
(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.
§?721.12069 Monoaromatic cyclic alkylene sulfonium fluoroalkyl sulfonic acid salt (generic).
(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as monoaromatic cyclic alkylene sulfonium fluoroalkyl sulfonic acid salt (PMN P-23-37) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section. The requirements of this section do not apply to quantities of the substance after they have been completely reacted or 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 (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.
[top] (ii) Hazard communication. Requirements as specified in §?721.72(a) through (f), (g)(1), (g)(2)(i) through (iii)
(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 modify the processing or use of 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.
§?721.12070 Monoaromatic cyclic alkylene sulfonium fluoroalkyl sulfonic acid salt (generic).
(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as monoaromatic cyclic alkylene sulfonium fluoroalkyl sulfonic acid salt (PMN P-23-44) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section. The requirements of this section do not apply to quantities of the substance after they have been completely 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 (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 (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, reproductive toxicity, 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 modify the processing or use of 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.
§?721.12071 Aromatic sulfonium tricyclo fluoroalkyl sulfonic acid salt (generic).
(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as aromatic sulfonium tricyclo fluoroalkyl sulfonic acid salt (PMN P-23-80) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section. The requirements of this section do not apply to quantities of the substance after they have been completely reacted or 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 (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 (v), (g)(3)(i) and (ii), and (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 modify the processing or use of 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.
§?721.12072 Aromatic dibenzothiophenium fluoroalkyl carbopolycycle sulfonic acid salt (generic).
[top] (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as aromatic dibenzothiophenium fluoroalkyl carbopolycycle sulfonic acid salt (PMN P-23-93) 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
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in §?721.63(a)(1), (a)(2)(i) and (iii), (a)(3), and (c). When determining which persons are reasonably likely to be exposed as required for §?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 (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, reproductive toxicity, 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 modify the processing or use of 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.
§?721.12073 Alkanediol, substituted, polymer with diisocyanatoalkane, substituted heterocycle-modified (generic).
(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as alkanediol, substituted, polymer with diisocyanatoalkane, substituted heterocycle-modified (PMN P-23-64) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section. The requirements of this section do not apply to quantities of the substance after they have been completely reacted or cured.
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in §?721.63(a)(1) and (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 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), and (y)(1) and (2). It is a significant new use to manufacture or process the substance in any manner that generates a vapor, mist, aerosol, or dust.
(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.
§?721.12074 Halosubstituted carbopolycycle, polymer with substituted carbomonocycles and oxybis[alkanol] (generic).
(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as halosubstituted carbopolycycle, polymer with substituted carbomonocycles and oxybis[alkanol] (PMN P-23-72) 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) through (6), (b), 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. For purposes of §?721.63(b), the concentration is set at 0.1%.
(ii) Hazard communication. Requirements as specified in §?721.72(a) through (f), (g)(1), (g)(3)(iii), 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: 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 process for use or use the substance other than in an enclosed roll-coating lithographic printing machine. It is a significant new use to process for use or use the substance at a concentration in the final formulation that exceeds 40% by weight for a coating application.
(iv) Disposal. Requirements as specified in §?721.85(a)(2), (b)(2), and (c)(2).
(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.
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(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as polymer of benzenedicarboxylic acid, substituted-benzenedicarboxylic acid, branched-alkyldiol, alkyldiol and triisocyanate (PMN P-23-94) 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) and (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 sensitization, respiratory 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 inhalation exposure.
(b) Specific requirements. The provisions of Subpart A of this part apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in §?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.
§?721.12076 Sulfonium, tricarbocyclic-, alkylcarbomonocyclic-polyfluoro-heteropolycyclic-alkyl sulfonate (1:1), polymer with alkylaryl and carbomonocyclic alkylalkanoate, di-Me 2,2'-(1,2-diazenediyl)bis[2-alkylalkanoate]-initiated (generic).
(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically?as?sulfonium,?tricarbocyclic-, alkylcarbomonocyclic-polyfluoro-heteropolycyclic-alkyl sulfonate (1:1), polymer with alkylaryl and carbomonocyclic alkylalkanoate, di-Me 2,2'-(1,2-diazenediyl)bis[2-alkylalkanoate]-initiated (PMN P-23-172) 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 (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 (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, 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(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 modify the processing of 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.
[FR Doc. 2025-13363 Filed 7-16-25; 8:45 am]
BILLING CODE 6560-50-P