90 FR 3 pgs. 567-573 - Significant New Use Rules on Certain Chemical Substances (19-5.F)
Type: RULEVolume: 90Number: 3Pages: 567 - 573
Pages: 567, 568, 569, 570, 571, 572, 573Docket number: [EPA-HQ-OPPT-2019-0530; FRL-7645-02-OCSPP]
FR document: [FR Doc. 2024-30964 Filed 1-3-25; 8:45 am]
Agency: Environmental Protection Agency
Official PDF Version: PDF Version
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Parts 9 and 721
[EPA-HQ-OPPT-2019-0530; FRL-7645-02-OCSPP]
RIN 2070-AB27
Significant New Use Rules on Certain Chemical Substances (19-5.F)
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). The SNURs require persons to notify EPA at least 90 days before commencing manufacture (defined by statute to include import) or processing of any of these chemical substances for an activity that is designated as a significant new use in the SNUR. The required notification initiates EPA's evaluation of the use, under the conditions of use for that chemical substance, within the applicable review period. Persons may not commence manufacture or processing for the significant new use until they have submitted a Significant New Use Notice (SNUN), and EPA has conducted a review of the notice, made an appropriate determination on the notice, and has taken any risk management actions as are required as a result of that determination.
DATES:
This rule is effective on March 7, 2025. For purposes of judicial review, this rule shall be promulgated at 1 p.m. (EST) on January 21, 2025.
ADDRESSES:
[top] The docket for this action, identified under docket identification (ID) number EPA-HQ-OPPT-2019-0530, 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
FOR FURTHER INFORMATION CONTACT:
For technical information: James Yan, New Chemicals Division (7405M), Office of Pollution Prevention and Toxics, Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460-0001; telephone number: (202) 564-2138; email address: yan.james@epa.gov.
For technical information: 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: 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) (see also the discussion in Unit II.).
B. What action is the Agency taking?
EPA is finalizing SNURs under TSCA section 5(a)(2) for chemical substances that were the subject of PMNs P-16-541, P-17-299, P-18-172, P-19-99, P-19-118, and P-19-120. The SNURs require persons who intend to manufacture or process any of these chemical substances for an activity that is designated as a significant new use in the SNURs to notify EPA at least 90 days before commencing that activity.
Previously, in the Federal Register of December 6, 2019 (84 FR 66855) (FRL-10001-48), EPA proposed SNURs for these chemical substances along with nineteen other SNURs. EPA finalized the proposed SNURs for P-17-393, P-19-86, P-19-87, P-19-89, P-19-90, P-19-91, P-19-92, P-19-93, P-19-97, P-19-100, P-19-101, P-19-102, P-19-103, P-19-104, P-19-105, P-19-106, P-19-107, P-19-108, and P-19-110 in a previous Federal Register notice of August 18, 2021 (86 FR 46133) (FRL-8000-02-OCSPP). EPA is not currently finalizing the SNURs for the chemical substances which were the subject of PMNs P-18-387 and P-18-388 and will address these SNURs in a future notice in order to consider new information about exposures. More information on the specific chemical substances subject to this final rule can be found in the Federal Register document proposing the SNURs. The docket includes information considered by the Agency in developing the proposed and final rules, including the public comments received on the proposed rules that are described in Unit II.
C. Does this action apply to me?
1. General Applicability
This action may apply to you if you manufacture (defined by statute to include import), process, or use the chemical substances addressed in this Federal Register 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 affect certain entities through pre-existing import certification and export notification requirements under TSCA. Chemical importers are subject to TSCA section 13 (15 U.S.C. 2612), the import provisions promulgated at 19 CFR 12.118 through 12.127 (see also 19 CFR 127.28), and the EPA policy in support of import certification at 40 CFR part 707, subpart B. 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.
In addition, 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)) (see 40 CFR 721.20), and must comply with the export notification requirements in 40 CFR part 707, subpart D.
D. What are the estimated incremental impacts of this action?
EPA has evaluated the potential costs of establishing SNUN reporting requirements for potential manufacturers (including importers) and processors of the chemical substances included in these SNURs. This analysis, which is available in the docket, is briefly summarized here.
1. Estimated Costs for SNUN Submissions
If a SNUN is submitted, costs are an estimated $45,000 per SNUN submission for large business submitters and $14,500 for small business submitters. These estimates include the cost to prepare and submit the SNUN (including registration for EPA's Central Data Exchange (CDX)), and the payment of a user fee. Businesses that submit a SNUN would be subject to either a $37,000 user fee required by 40 CFR 700.45(c)(2)(ii) and (d), or, if they are a small business as defined at 13 CFR 121.201, a reduced user fee of $6,480 (40 CFR 700.45(c)(1)(ii) and (d)) per fiscal year 2022. The costs of submission for SNUNs will not be incurred by any company unless a company decides to pursue a significant new use as defined in these SNURs. Additionally, these estimates reflect the costs and fees as they are known at the time of this rulemaking.
2. Estimated Costs for Export Notifications
EPA has also evaluated the potential costs associated with the export notification requirements under TSCA section 12(b) and the implementing regulations at 40 CFR part 707, subpart D. For persons exporting a substance that is the subject of a SNUR, a one-time notice to EPA must be provided for the first export or intended export to a particular country. The total costs of export notification will vary by chemical, depending on the number of required notifications ( i.e., the number of countries to which the chemical is exported). While EPA is unable to make any estimate of the likely number of export notifications for the chemical substances covered by these SNURs, as stated in the accompanying economic analysis, the estimated cost of the export notification requirement on a per unit basis is approximately $106.
II. Background
[top] 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.
A. Significant New Uses Claimed as Confidential Business Information (CBI)
EPA is establishing certain significant new uses which have been claimed as CBI subject to Agency confidentiality regulations at 40 CFR part 2 and 40 CFR part 703. Absent a final determination or other disposition of the confidentiality claim under these regulations, EPA is required to keep this information confidential. EPA promulgated a procedure at 40 CFR 721.11 to deal with the situation where a specific significant new use is CBI.
Under these procedures a manufacturer or processor may request EPA to identify the confidential significant new use under the rule. The manufacturer or processor must show that it has a bona fide intent to manufacture or process the chemical substance. If EPA concludes that the person has shown a bona fide intent to manufacture or process the chemical substance, EPA will identify the confidential significant new use to that person. Since most of the chemical identities of the chemical substances subject to these SNURs are also CBI, manufacturers and processors can combine the bona fide submission under the procedure in 40 CFR 721.11 into a single step.
B. Applicability of the Significant New Use Designation
Any use that EPA determines in the final rule was ongoing as of the date of publication of the proposal and did not cease prior to issuance of the final rule, will not be designated 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 those criteria.
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.
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 prerequisites for the commencement of manufacture or processing have been satisfied.
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 identified for the chemical substance in Unit IV 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 IV 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 on the following:
• 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
[top] EPA received public comments from two identifying entities and two confidential entities pertaining to the SNURs that the Agency is finalizing with this rule. One comment was generally critical of the rule but did not identify specific changes or issues with the rule requirements; therefore, no response is required. Two of the comments identified ongoing uses of two different chemical substances in the proposed rule. As a result, EPA is issuing a modified final rule for those chemical substances that do not designate the ongoing uses as significant new uses. Specifically, for the chemical substance that was the subject of P-17-299, EPA will no longer designate as a
III. Chemical Substances Subject to These SNURs
A. What is the designated cutoff date for determining whether the new use is ongoing for these chemical substances?
EPA designates December 6, 2019, as the cutoff date for determining whether the new use is ongoing. This designation is explained in more detail in Unit VI of the proposed rule.
B. What information is provided for each chemical substance?
In Unit IV. 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) (if assigned for non-confidential chemical identities).
• Potentially useful information.
The regulatory text section specifies the activities designated as significant new uses. Certain new uses, including exceeding production volume limits and other uses designated in the proposed rules, may be claimed as CBI.
In addition, as discussed in Unit V.A. of the proposed rule, for the chemical substances that have undergone premanufacture review, EPA has identified certain conditions of use and other circumstances of use apart from those intended by the PMN submitter as significant new uses. All uses identified as significant new uses in this rule cannot occur without first going through a separate EPA review and determination process associated with a SNUN.
IV. Statutory and Executive Order Reviews
Additional information about these statutes and Executive orders can be found at https://www.epa.gov/laws-regulations-and-executive-orders.
A. Executive Order 12866: Regulatory Planning and Review and Executive Order 14094: Modernizing Regulatory Review
This action 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), as amended by Executive Order 14094 (88 FR 21879, April 11, 2023).
B. Paperwork Reduction Act (PRA)
According to 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 associated with SNURs have already been approved by OMB pursuant to the PRA under OMB control number 2070-0038 (EPA ICR No. 1188.13). This action does not impose any burden requiring additional OMB approval. If an entity were to submit a SNUN to the Agency, the annual burden is estimated to average between 30 and 170 hours per submission. This burden estimate includes the time needed to review instructions, search existing data sources, gather and maintain the data needed, and complete, review, and submit the required SNUN.
EPA always welcomes your feedback on the burden estimate. Send any comments about the accuracy of the burden estimate, and any suggested methods for minimizing respondent burden, including through the use of automated collection techniques.
C. Regulatory Flexibility Act (RFA)
I certify that this action will not have a significant economic impact on a substantial number of small entities under the RFA (5 U.S.C. 601 et seq. ). The requirement to submit a SNUN applies to any person (including small or large entities) who intends to engage in any activity described in the final rule as a "significant new use." Because these uses are "new," based on all information currently available to EPA, EPA has concluded that no small or large entities presently engage in such activities.
A SNUR requires that any person who intends to engage in such activity in the future must first notify EPA by submitting a SNUN. Although some small entities may decide to pursue a significant new use in the future, EPA cannot presently determine how many, if any, there may be. However, EPA's experience to date is that, in response to the promulgation of SNURs covering over 1,000 chemicals, the Agency receives only a small number of notices per year. For example, the number of SNUNs received was 16 in Federal fiscal year (FY) FY2018, five in FY2019, seven in FY2020, 13 in FY2021, 11 in FY2022, and 15 in FY2023, and only a fraction of these submissions were from small businesses.
In addition, the Agency currently offers relief to qualifying small businesses by reducing the SNUN submission fee from $37,000 to 6,480. This lower fee reduces the total reporting and recordkeeping cost of submitting a SNUN to about $14,500 per SNUN submission for qualifying small firms. Therefore, the potential economic impacts of complying with these SNURs are not expected to be significant or adversely impact a substantial number of small entities. In a SNUR that published in the Federal Register of June 2, 1997 (62 FR 29684) (FRL-5597-1), the Agency presented its general determination that SNURs are not expected to have a significant economic impact on a substantial number of small entities, which was provided to the Chief Counsel for Advocacy of the Small Business Administration.
D. Unfunded Mandates Reform Act (UMRA)
[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 uniquely affect small governments. Based on EPA's experience with proposing and finalizing SNURs, State, local, and Tribal governments have not been impacted by SNURs, and EPA does not have any reasons to believe that any State, local, or Tribal government will be impacted by these SNURs. In addition, the estimated costs of this action to the private sector do not exceed $183 million or more in any one year (the 1995 dollars are adjusted to 2023 dollars for inflation using the GDP implicit price deflator). The estimated
E. Executive Order 13132: Federalism
This action will not have federalism implications as specified in Executive Order 13132 (64 FR 43255, August 10, 1999), because it is not expected to have a substantial direct effect on States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government. Accordingly, the requirements of Executive Order 13132 do not apply to this action.
F. Executive Order 13175: Consultation and Coordination With Indian Tribal Governments
This action will not have Tribal implications as specified in Executive Order 13175 (65 FR 67249, November 9, 2000), because it is not expected to have substantial direct effects on Indian Tribes or significantly or uniquely affect the communities of Indian Tribal governments and does not involve or impose any requirements that affect Indian Tribes. Accordingly, the requirements of Executive Order 13175 do not apply to this action.
G. Executive Order 13045: Protection of Children From Environmental Health Risks and Safety Risks
This action is not subject to Executive Order 13045 (62 FR 19885, April 23, 1997), because it does not concern an environmental health or safety risk. Since this action does not concern 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 any of these chemical substances for an activity that is designated as a significant new use by this rule. This notification allows EPA to assess the intended uses to identify potential risks and take appropriate actions before the activities commence.
H. Executive Order 13211: Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use
This action is not a "significant energy action" as defined in Executive Order 13211 (66 FR 28355, May 22, 2001), because it is not likely to have a significant adverse effect on the supply, distribution, or use of energy.
I. National Technology Transfer and Advancement Act (NTTAA)
This action does not involve any technical standards subject to NTTAA section 12(d) (15 U.S.C. 272 note).
J. Executive Order 12898: Federal Actions To Address Environmental Justice in Minority Populations and Low-Income Populations and Executive Order 14096: Revitalizing Our Nation's Commitment to Environmental Justice for All
This action does not concern human health or environmental conditions and therefore cannot be evaluated with respect to the potential for disproportionate impacts on non-white and low-income populations in accordance with Executive Order 12898 (59 FR 7629, February 16, 1994) and Executive Order 14096 (88 FR 25251, April 26, 2023). Although this action does not concern human health or environmental conditions, the premanufacture notifications required by these SNURs allow EPA to assess the intended uses to identify potential disproportionate risks and take appropriate actions before the activities commence.
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
40 CFR Part 9
Environmental protection, Reporting and recordkeeping requirements.
40 CFR Part 721
Environmental protection, Chemicals, Hazardous substances, Reporting and recordkeeping requirements.
Dated: December 20, 2024.
Mary Elissa Reaves,
Director, Office of Pollution Prevention and Toxics.
Therefore, for the reasons stated in the preamble, 40 CFR chapter I is amended as follows:
PART 9-OMB APPROVALS UNDER THE PAPERWORK REDUCTION ACT
1. The authority citation for part 9 continues to read as follows:
Authority:
7 U.S.C. 135 et seq., 136-136y; 15 U.S.C. 2001, 2003, 2005, 2006, 2601-2671; 21 U.S.C. 331j, 346a; 31 U.S.C. 9701; 33 U.S.C. 1251 et seq., 1311, 1313d, 1314, 1318, 1321, 1326, 1330, 1342, 1344, 1345 (d) and (e), 1361; E.O. 11735, 38 FR 21243, 3 CFR, 1971-1975 Comp. p. 973; 42 U.S.C. 241, 242b, 243, 246, 300f, 300g, 300g-1, 300g-2, 300g-3, 300g-4, 300g-5, 300g-6, 300j-1, 300j-2, 300j-3, 300j-4, 300j-9, 1857 et seq., 6901-6992k, 7401-7671q, 7542, 9601-9657, 11023, 11048.
2. Amend the table in §?9.1, by adding entries for §§?721.11420 and 721.11421, 721.11423, and 721.11444 through 721.11446 in numerical order under the undesignated center heading "Significant New Uses of Chemical Substances" to read as follows:
§?9.1 OMB approvals under the Paperwork Reduction Act.
| 40 CFR citation | OMB control No. |
|---|---|
| * * * * * | |
| Significant New Uses of Chemical Substances | |
| * * * * * | |
| 721.11420 | 2070-0012 |
| 721.11421 | 2070-0012 |
| * * * * * | |
| 721.11423 | 2070-0012 |
| * * * * * | |
| 721.11444 | 2070-0012 |
| 721.11445 | 2070-0012 |
| 721.11446 | 2070-0012 |
| * * * * * | |
PART 721-SIGNIFICANT NEW USES OF CHEMICAL SUBSTANCES
3. The authority citation for part 721 continues to read as follows:
Authority:
15 U.S.C. 2604, 2607, and 2625(c).
Subpart E-Significant New Uses for Specific Chemical Substances
4. Add §§?721.11420, 721.11421, 721.11423, and 721.11444 through 721.11446 to Subpart E to read as follows:
Sec.
* * * * *
721.11420 Soybean meal, reaction products with phosphoric trichloride.
721.11421 2-propenoic acid, alkyl, polymers with alkyl acrylate and polyethylene glycol methacrylate alkyl ether (generic).
[top] * * * * *
721.11423 Calcium, carbonate 2-ethylhexanoate neodecanoate propionate complexes.
* * * * *
721.11444 Propanoic acid, 3-hydroxy-2-(hydroxymethyl)-2-methyl-, polymer with dimethyl carbonate, 1,2-ethanediamine, 2-ethyl-2-(hydroxymethyl)-1,3-propanediol, 1,6-hexanediol and 1,1'-methylenebis[4-isocyanatocyclohexane], compd. with N,N-diethylethanamine.
721.11445 Substituted polyalkylenepoly, reaction products with alkene polymer (generic).
721.11446 Alkenoic acid, polymer with alkanediyl bis substituted alkylene bis heteromonocycle, substituted carbomonocycle and (alkylalkenyl) carbomonocycle, alkali metal salt (generic).
§?721.11420 Soybean meal, reaction products with phosphoric trichloride.
(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as soybean meal, reaction products with phosphoric trichloride (PMN P-16-541, CASRN 1962913-92-3) 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) Release to water. Requirements as specified in §?721.90(a)(4), (b)(4), and (c)(4), where N=22.
(ii) [Reserved]
(b) Specific requirements. The provisions of Subpart A of this part apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in §?721.125(a) through (c), and (k) are applicable to manufacturers and processors of this substance.
(2) Limitation or revocation of certain notification requirements. The provisions of §?721.185 apply to this section.
§?721.11421 2-propenoic acid, alkyl, polymers with alkyl acrylate and polyethylene glycol methacrylate alkyl ether (generic).
(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as 2-propenoic acid, alkyl, polymers with alkyl acrylate and polyethylene glycol methacrylate alkyl ether (PMN P-17-299) 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)(4) through (6), and (c). When determining which persons are reasonably likely to be exposed as required for §?721.63(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) Industrial, commercial, and consumer activities. Requirements as specified in §?721.80(f). It is a significant new use to use the substance other than as a thickener in paint. It is a significant new use to use the substance in concentrations greater than 1% in formulated products.
(b) Specific requirements. The provisions of Subpart A of this part apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in §?721.125(a) through (c), and (i) are applicable to manufacturers and processors of this substance.
(2) Limitation or revocation of certain notification requirements. The provisions of §?721.185 apply to this section.
§?721.11423 Calcium, carbonate 2-ethylhexanoate neodecanoate propionate complexes.
(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as calcium, carbonate 2-ethylhexanoate neodecanoate propionate complexes (PMN P-18-172) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Industrial, commercial, and consumer activities. It is a significant new use to use the substance in a consumer product except for use in architectural coatings. It is a significant new use to use the substance other than as an auxiliary drier for architectural paints, industrial coatings and stains.
(ii) [Reserved]
(b) Specific requirements. The provisions of Subpart A of this part apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in §?721.125(a) through (c), and (i) are applicable to manufacturers and processors of this substance.
(2) Limitation or revocation of certain notification requirements. The provisions of §?721.185 apply to this section.
§?721.11444 Propanoic acid, 3-hydroxy-2-(hydroxymethyl)-2-methyl-, polymer with dimethyl carbonate, 1,2-ethanediamine, 2-ethyl-2-(hydroxymethyl)-1,3-propanediol, 1,6-hexanediol and 1,1'-methylenebis[4-isocyanatocyclohexane], compd. with N,N-diethylethanamine.
(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as propanoic acid, 3-hydroxy-2-(hydroxymethyl)-2-methyl-, polymer with dimethyl carbonate, 1,2-ethanediamine, 2-ethyl-2-(hydroxymethyl)-1,3-propanediol, 1,6-hexanediol and 1,1'-methylenebis[4-isocyanatocyclohexane], compd. with N,N-diethylethanamine (PMN P-19-99, CASRN 1178511-46-0) 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) Industrial, commercial, and consumer activities. Requirements as specified in §?721.80(o). It is a significant new use to use the substance other than as a clear coat for wood.
(ii) [Reserved]
(b) Specific requirements. The provisions of Subpart A of this part apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in §?721.125(a) through (c), and (i) are applicable to manufacturers and processors of this substance.
(2) Limitation or revocation of certain notification requirements. The provisions of §?721.185 apply to this section.
§?721.11445 Substituted polyalkylenepoly, reaction products with alkene polymer (generic).
(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as substituted polyalkylenepoly, reaction products with alkene polymer (PMN P-19-118) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section. (2) The significant new uses are:
(i) Industrial, commercial, and consumer activities. It is a significant new use to manufacture, process, or use the substance in any manner that results in inhalation exposure.
(ii) [Reserved]
[top] (b) Specific requirements. The provisions of subpart A of this part
(1) Recordkeeping. Recordkeeping requirements as specified in §?721.125(a) through (c), and (i) are applicable to manufacturers and processors of this substance.
(2) Limitation or revocation of certain notification requirements. The provisions of §?721.185 apply to this section.
§?721.11446 Alkenoic acid, polymer with alkanediyl bis substituted alkylene bis heteromonocycle, substituted carbomonocycle and (alkylalkenyl) carbomonocycle, alkali metal salt (generic).
(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as alkenoic acid, polymer with alkanediyl bis substituted alkylene bis heteromonocycle, substituted carbomonocycle and (alkylalkenyl) carbomonocycle, alkali metal salt (PMN P-19-120) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section. (2) The significant new uses are:
(i) Release to water. Requirements as specified in §?721.90(a)(4), (b)(4), and (c)(4) where N=78.
(ii) [Reserved]
(b) Specific requirements. The provisions of Subpart A of this part apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in §?721.125(a) through (c), and (k) are applicable to manufacturers and processors of this substance.
(2) Limitation or revocation of certain notification requirements. The provisions of §?721.185 apply to this section.
[FR Doc. 2024-30964 Filed 1-3-25; 8:45 am]
BILLING CODE 6560-50-P