['Toxic Substances Control Act - EPA']
['Toxic Subtances Control Act - EPA']
12/19/2023
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[EPA–HQ–OPPT–2022–0462; FRL–10183–03–OCSPP]
RIN 2070–AB27
Significant New Use Rules on Certain Chemical Substances (22–2.5e)
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 who intend to manufacture (defined by statute to include import) or process any of these chemical substances for an activity that is designated as a significant new use by this rule to notify EPA at least 90 days before commencing that activity. The required notification initiates EPA's evaluation of the use, under the conditions of use for that chemical substance, within the applicable review period. Persons may not commence manufacture or processing for the significant new use until 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 such actions as are required by that determination.
DATES: This rule is effective on February 16, 2024. For purposes of judicial review, this rule shall be promulgated at 1 p.m. (EST) on January 2, 2024.
ADDRESSES: The docket for this action, identified under docket identification (ID) number EPA–HQ–OPPT–2022–0462, 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 contact: William Wysong, New Chemicals Division (7405M), Office of Pollution Prevention and Toxics, Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460–0001; telephone number: (202) 564–4163; email address: wysong.william@epa.gov.
For general information contact: 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 four TSCA section 5(a)(2) factors listed in Unit II.A.1.
B. What action is the Agency taking?
EPA is finalizing these SNURs under TSCA section 5(a)(2) for certain chemical substances that were the subject of PMNs. This document addresses final rules for PMN substances that are subject to orders issued under TSCA section 5(e)(1)(A), as required by the determinations made under TSCA section 5(a)(3)(B). Those TSCA Orders require protective measures to limit exposures or otherwise mitigate the potential unreasonable risk. The final SNURs identify as significant new uses any manufacturing, processing, use, distribution in commerce, or disposal that does not conform to the restrictions imposed by the underlying TSCA Orders, consistent with TSCA section 5(f)(4).
Previously, EPA proposed SNURs for these chemical substances in the Federal Register of October 31, 2022 (87 FR 65548) (FRL–10183–02–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 public comments received. The proposed SNURs for certain chemical substances not included in this Federal Register document will be addressed in a future Federal Register document.
C. Why is the Agency taking this action?
The Agency is issuing these SNURs to ensure that EPA receives timely advanced notice of any future manufacturing (including importing) or processing of the chemical substances subject to these proposed SNURs for uses identified as significant new uses, and to ensure that an appropriate determination (relevant to the potential risks associated with such manufacturing (including importing), processing, distribution in commerce, use and disposal) has been issued prior to the commencement of such manufacturing (including importing) or processing. The SNURs are necessary to ensure that manufacturing (including import) or processing for significant new uses cannot proceed until EPA has responded to the planned new use circumstances by taking the required actions under TSCA sections 5(e) or 5(f) in the event that EPA determines that:
(1) The significant new use presents an unreasonable risk under the conditions of use (without consideration of costs or other non-risk factors, and including an unreasonable risk to a potentially exposed or susceptible subpopulation (PESS) identified as relevant by EPA);
(2) The information available to EPA is insufficient to permit a reasoned evaluation of the health and environmental effects of the significant new use;
(3) In the absence of sufficient information, the manufacturing (including importing), processing, distribution in commerce, use, or disposal of the substance, or any combination of such activities, may present an unreasonable risk (without consideration of costs or other non-risk factors, and including an unreasonable risk to a PESS identified as relevant by EPA); or
(4) There is substantial production and sufficient potential for environmental release or human exposure (as defined in TSCA section 5(a)(3)(B)(ii)(II)).
For manufacturing (including importing) or processing for the significant new use to proceed after EPA has made one of these four determinations, EPA must take actions under TSCA sections 5(e) or 5(f) to protect health and the environment. However, EPA may also determine that the significant new use is not likely to present an unreasonable risk under TSCA section 5(a)(3)(C), after which manufacturing (including importing) or processing for the significant new use may proceed.
The rationale and objectives for this SNUR are further explained in Unit II.B.
D. 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 rules under TSCA. Chemical importers are subject to the TSCA section 13 (15 U.S.C. 2612), 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. Chemical importers must certify that the shipment of the chemical substance complies with all applicable rules and Orders under TSCA, including regulations issued under TSCA sections 5, 6, 7 and Title IV.
In addition, pursuant to 40 CFR 721.20, this action may also apply to any persons who export or intend to export a chemical substance identified in this document is 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.
E. What are the estimated incremental impacts of this action?
EPA has evaluated the potential costs of establishing SNUR 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 $26,700 per SNUN submission for large business submitters and $11,000 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 $19,020 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 $3,300 (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
A. Significant New Use Determination
1. Determination Factors
TSCA section 5(a)(2) states that EPA's determination that a use of a chemical substance is a significant new use must be made after consideration of all relevant factors, including:
• The projected volume of manufacturing and processing of a chemical substance.
• The extent to which a use changes the type or form of exposure of human beings or the environment to a chemical substance.
• The extent to which a use increases the magnitude and duration of exposure of human beings or the environment to a chemical substance.
• The reasonably anticipated manner and methods of manufacturing, processing, distribution in commerce, and disposal of a chemical substance.
In addition to the factors enumerated in TSCA section 5(a)(2), the statute authorizes EPA to consider any other relevant factors.
2. Scientific Standards, Evidence, and Available Information
EPA has used reasonably available information, as well as technical procedures, measures, methods, protocols, methodologies, and models consistent with the best available science, as applicable. These information sources supply information relevant to whether a particular use would be a significant new use, based on relevant factors including those listed under TSCA section 5(a)(2).
The clarity and completeness of the data, assumptions, methods, quality assurance, and analyses employed in EPA's decision are documented, as applicable and to the extent necessary for purposes of the proposed SNURs, in the references cited throughout the preamble of this proposed rule. The extent to which the various information, procedures, measures, methods, protocols, methodologies or models used in EPA's decision have been subject to independent verification or peer review is adequate to justify their use, collectively, in the record for a significant new use rule.
3. Determination for These Chemical Substances
In determining what would constitute a significant new use for the chemical substances that are the subject of these SNURs, EPA considered relevant information about the toxicity of the chemical substances and potential human exposures and environmental releases that may be associated with possible uses of these chemical substances, in the context of the four TSCA section 5(a)(2) factors listed in Unit II.A.1.
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). The TSCA Orders require protective measures to limit exposures or otherwise mitigate the potential unreasonable risk. The SNURs identify significant new uses as any manufacturing, processing, use, distribution in commerce, or disposal that does not conform to the restrictions imposed by the underlying TSCA Orders, consistent with TSCA section 5(f)(4).
B. Rationale and Objectives
1. Rationale
During review of the PMNs submitted for the chemical substances that are subject to these SNURs, EPA concluded that regulation was warranted under TSCA section 5(e), pending the development of information sufficient to make reasoned evaluations of the health or environmental effects of the chemical substances. The basis for such findings is outlined in Unit V. of the proposed rule for each chemical. Based on these findings, TSCA section 5(e) Orders requiring the use of appropriate exposure controls were negotiated with the PMN submitters. As a general matter, EPA believes it is necessary to follow the TSCA Orders with a SNUR that identifies the absence of those protective measures as significant new uses to ensure that all manufacturers and processors—not just the original submitter—are held to the same standard.
2. Objectives
EPA is issuing these SNURs because the Agency wants to
• Receive notice of any person's intent to manufacture or process a listed chemical substance for the described significant new use before that activity begins.
• Have an opportunity to review and evaluate data submitted in a SNUN before the notice submitter begins manufacturing or processing a listed chemical substance for the described significant new use; and
• To make a determination under TSCA section 5(a)(3) regarding the use described in the SNUN, under the conditions of use. The Agency will either determine under TSCA section 5(a)(3)(C) that significant new use is not likely to present an unreasonable risk, including an unreasonable risk to a potentially exposed or susceptible subpopulation identified as relevant by the Administrator under the conditions of use, or make a determination under TSCA section 5(a)(3)(A) or (B) and take the required regulatory action associated with the determination, before manufacture or processing for the significant new use of the chemical substance can occur.
C. Applicability of General Provisions
General provisions for SNURs appear in 40 CFR part 721, subpart A. These provisions describe persons required to submit a Significant New Use Notice (SNUN), recordkeeping requirements, and exemptions to reporting requirements, among other things.
Provisions relating to user fees appear at 40 CFR part 700. Pursuant to 40 CFR 721.1(c), persons submitting a SNUN are subject to the same requirements and regulatory procedures as submitters of PMNs under TSCA section 5(a)(1)(A). These include the information submission requirements of TSCA sections 5(b) and 5(d)(1), the exemptions authorized by TSCA sections 5(h)(1), (h)(2), (h)(3), and (h)(5), and the regulations at 40 CFR part 720, except where modified in part 721.
Once EPA receives a SNUN, and before the manufacture or processing for the significant new use can commence, EPA must either determine that the use addressed in the SNUN is not likely to present an unreasonable risk of injury under the conditions of use for the chemical substance or take such regulatory action as is associated with an alternative determination. If EPA determines that the use is not likely to present an unreasonable risk, EPA is required under TSCA section 5(g) to make public, and submit for publication in the Federal Register , a statement of EPA's findings.
D. 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 are ongoing.
Under the procedures in 40 CFR 721.11 a manufacturer or processor may request EPA to determine whether a specific use would be a significant new use under the rule. The manufacturer or processor must show that it has a bona fide intent to manufacture or process the chemical substance and must identify the specific use for which it intends to manufacture or process the chemical substance. If EPA concludes that the person has shown a bona fide intent to manufacture or process the chemical substance, EPA will identify any confidential significant new use designations under the rule. Since most of the chemical identities of the chemical substances subject to these SNURs are also CBI, manufacturers and processors can combine the bona fide submission under the procedure in 40 CFR 721.11 into a single step to identify if a chemical substance is subject to 40 CFR part 721 and if a specific use would be a significant new use under the rule.
The chemical substances subject to this rule have undergone premanufacture review. In cases where EPA has not received a notice of commencement (NOC) and the chemical substance is not on the TSCA Inventory, no person may commence any activities without first submitting a PMN. Therefore, when EPA has received a PMN for a chemical substance but has not received a NOC for that same substance, the fact that a NOC has not been received is evidence that no manufacturing or processing of the chemical substance is occuring in the United States. When chemical substances identified in this rule are added to the TSCA Inventory, EPA recognizes that, before the rule is effective, other persons might engage in a use that has been identified as a significant new use. However, TSCA Orders have been issued for these chemical substances, and the PMN submitters are prohibited by the TSCA Orders from undertaking activities which would be designated as significant new uses. The identities of many of the chemical substances subject to these SNURs have been claimed as confidential per 40 CFR 720.85.
As discussed in the Federal Register of April 24, 1990 (55 FR 17376 (FRL–3658–5)), EPA has decided 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.
E. Important Information About SNUN Submissions
1. SNUN Submissions
According to 40 CFR 721.1(c), persons submitting a SNUN must comply with the same notification requirements and EPA regulatory procedures as persons submitting a PMN, including submission of test data on health and environmental effects as described in 40 CFR 720.50. SNUNs must be submitted on EPA Form No. 7710–25, generated using e-PMN software, and submitted to the Agency in accordance with the procedures set forth in 40 CFR 720.40. 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 With the SNUN
EPA recognizes that TSCA section 5 does not require developing any particular new information ( e.g., generating test data) before submission of a SNUN. There is an exception: If a person is otherwise required to submit information for a chemical substance subject to the SNUR pursuant to a rule, TSCA Order or consent agreement under TSCA section 4, then TSCA section 5(b)(1)(A) requires such information to be submitted to EPA at the time of submission of the SNUN.
In the absence of a rule, 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 or reasonably ascertainable (see 40 CFR 720.50). However, upon review of PMNs and SNUNs, the Agency may determine under TSCA section 5(e) that it is necessary to require appropriate testing. Unit IV. of the proposed rule lists potentially useful information for the SNURs listed in this document. Descriptions of this information is provided for informational purposes. The potentially useful information identified in Unit IV. of the proposed rule will be useful to EPA's evaluation in the event that someone submits a SNUN for the significant new use.
EPA strongly encourages persons to consult with the Agency before performing any testing. Furthermore, pursuant to TSCA section 4(h), which pertains to reduction of testing in vertebrate animals, EPA encourages dialog 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 listed in Unit IV. of the proposed rule may not be the only means of addressing the potential risks of the chemical substance. However, submitting a SNUN without any test data or other information may increase the likelihood that EPA will take action under TSCA sections 5(e) or 5(f). EPA recommends that potential SNUN submitters contact EPA early enough so that they will be able to conduct the appropriate tests.
SNUN submitters should be aware that EPA will be better able to evaluate SNUNs which provide detailed information on the following:
• Human exposure and environmental release that may result from the significant new use of the chemical substances.
• Information on risks posed by the chemical substances compared to risks posed by potential substitutes.
III. Public Comments on Proposed Rule and EPA Responses
EPA received public comments on the proposed rules from seven identifying entities. The Agency's responses are presented in the Response to Public Comments document that is available in the docket for this rulemaking. EPA is not finalizing the SNUR applicable to PMN P–20–0105, which was proposed as 40 CFR 721.11764. As described in the response to comments EPA will re-propose and finalize that SNUR in a future action.
IV. Substances Subject to This Rule
EPA is establishing significant new use and recordkeeping requirements for certain chemical substances in 40 CFR part 721, subpart E. In Unit V. of the proposed SNURs, EPA provided the following information for each chemical substance:
• PMN number.
• Chemical name (generic name, if the specific name is claimed as confidential business information (CBI)).
• Chemical Abstracts Service Registry Number (CAS RN) (if assigned for non-confidential chemical identities).
• Effective date of and basis for the TSCA Order.
• Potentially Useful Information. This is information identified by EPA that would help characterize the potential health and/or environmental effects of the chemical substances if a manufacturer or processor is considering submitting a SNUN for a significant new use designated by the SNUR.
• CFR citation assigned in the regulatory text section of these rules. The regulatory text specifies the activities designated as significant new uses. Certain new uses, including production volume limits and other uses designated in the rules, may be claimed as CBI. In cases where the rules establish certain significant new uses which have been claimed as CBI subject to Agency confidentiality regulations at 40 CFR part 2 and 40 CFR part 720, subpart E, absent a final determination or other disposition of the confidentiality claim under 40 CFR part 2 procedures, EPA is required to keep this information confidential.
V. 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 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 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 response. This burden estimate includes the time needed to review instructions, search existing data sources, gather and maintain the data needed, and complete, review, and submit the required SNUN.
EPA is amending the table in 40 CFR part 9 to list the SNURs and OMB approval number for the information collection activities contained in this action. This listing of the OMB control numbers and their subsequent codification in the CFR satisfies the display requirements of PRA and OMB's implementing regulations at 5 CFR part 1320. The Information Collection Request (ICR) covering the SNUR activities was previously subject to public notice and comment prior to OMB approval, and given the technical nature of the table, EPA finds that further notice and comment to amend it is unnecessary. As a result, EPA finds that there is “good cause” under section 553(b)(3)(B) of the Administrative Procedure Act (5 U.S.C. 553(b)(3)(B)) to amend this table without further notice and comment.
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, to the Director, Regulatory Support Division, Office of Mission Support (2822T), Environmental Protection Agency, 1200 Pennsylvania Ave., NW, Washington, DC 20460–0001. Please remember to include the OMB control number in any correspondence, but do not submit any completed forms to this address.
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 SNUNs per year. For example, the number of SNUNs received was 10 in Federal fiscal year (FY) FY2016, 14 in FY2017, 16 in FY2018, five in FY2019, seven in FY2020, and 13 in FY2021, and only a fraction of these were from small businesses.
In addition, the Agency currently offers relief to qualifying small businesses by reducing the SNUN submission fee from $19,020 to $3,330. This lower fee reduces the total reporting and recordkeeping cost of submitting a SNUN to about $11,164 per SNUN submission for qualifying small firms. Therefore, the potential economic impacts of complying with this SNUR are not expected to be significant or adversely impact a substantial number of small entities. In a SNUR that published in the Federal Register of June 2, 1997 (62 FR 29684) (FRL–5597–1), the Agency presented its general determination that 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)
Based on EPA's experience with proposing and finalizing SNURs, State, local, and Tribal governments have not been impacted by these rulemakings, and EPA does not have any reasons to believe that any State, local, or Tribal government will be impacted by this action. As such, EPA has determined that this action does not impose any enforceable duty, contain any unfunded mandate, or otherwise have any effect on small governments subject to the requirements of UMRA sections 202, 203, 204, or 205 (2 U.S.C. 1501 et seq. ).
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 Tribe Governments
This action does not have Tribal implications as specified in Executive Order 13175 (65 FR 67249, November 9, 2000), because it is not expected to have substantial direct effects on Indian Tribes, significantly or uniquely affect the communities of Indian Tribal governments, and does not involve or impose any requirements that affect Indian Tribes. Accordingly, the requirements of Executive Order 13175 do not apply to this action.
G. Executive Order 13045: Protection of Children From Environmental Health Risks and Safety Risks
This action is not subject to Executive Order 13045 (62 FR 19885, April 23, 1997), because it does not concern an environmental health or safety risk. Since this action does not concern human health, EPA's 2021 Policy on Children's Health also does not apply. Although the establishment of these SNURs do not address an existing children's environmental health concern because the chemical uses involved are not ongoing uses, SNURs require that persons notify EPA at least 90 days before commencing manufacture (defined by statute to include import) or processing of any of these chemical substances for an activity that is designated as a significant new use by this rule. This notification allows EPA to assess the 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 allows 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 12, 2023.
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 §§721.11752 through 721.11763 and 721.11765 through 721.11776 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.
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|---|---|
| * * * * * | |
| Significant New Uses of Chemical Substances | |
| * * * * * | |
| 721.11752 | 2070–0038 |
| 721.11753 | 2070–0038 |
| 721.11754 | 2070–0038 |
| 721.11755 | 2070–0038 |
| 721.11756 | 2070–0038 |
| 721.11757 | 2070–0038 |
| 721.11758 | 2070–0038 |
| 721.11759 | 2070–0038 |
| 721.11760 | 2070–0038 |
| 721.11761 | 2070–0038 |
| 721.11762 | 2070–0038 |
| 721.11763 | 2070–0038 |
| 721.11765 | 2070–0038 |
| 721.11766 | 2070–0038 |
| 721.11767 | 2070–0038 |
| 721.11768 | 2070–0038 |
| 721.11769 | 2070–0038 |
| 721.11770 | 2070–0038 |
| 721.11771 | 2070–0038 |
| 721.11772 | 2070–0038 |
| 721.11773 | 2070–0038 |
| 721.11774 | 2070–0038 |
| 721.11775 | 2070–0038 |
| 721.11776 | 2070–0038 |
| * * * * * |
* * * * *
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 §§721.11752 through 721.11763 and 721.11765 through 721.11776 in numerical order to subpart E to read as follows:
Sec
* * * * *
721.11752 Quaternary ammonium salt of polyisobutene succinic acid (generic).
721.11753 2-Propenoic acid, 2-alkyl-, 2-(dialkylamino)alkyl ester, polymer with .alpha.-(2-alkyl-1-oxo-2-alken-1-yl)-.omega.-methoxypoly(oxy-1,2-alkanediyl) (generic).
721.11754 Alkanedioic acid, polymer with cycloalkyl dimethanol, alkyl and cycloalkyl diisocyanates, dimethyl-alkanediol, dihydroxyalkanoic acid methylenebis[isocyanatocyclohexane], hydroxyethyl acrylate- and polyalkyl glycol monoalkyl ether blocked (generic).
721.11755 Poly(oxy-1,4-butanediyl), .alpha.-hydro-.omega.-hydroxy-, polymer with 1,1′-methylenebis[4-isocyanatobenzene], caprolactam-blocked.
721.11756 Tall-oil pitch, fraction, sterol-low (generic).
721.11757 Carboxylic acid, reaction products with metal hydroxide, inorganic dioxide and metal (generic).
721.11758 Multi-walled carbon nanotubes; closed; 4.4–12.8 nm diameter; bundle length 10.6–211.1 µm; Grade: Jenotube 6.
721.11759 Multi-walled carbon nanotubes; closed; 5.1–11.6 nm diameter; bundle length 1.9–552.0 µm; Grade: Jenotube 8.
721.11760 Multi-walled carbon nanotubes; closed; 7.9–14.2 nm diameter; bundle length 9.4–106.4 µm; Grade: Jenotube 10.
721.11761 Multi-walled carbon nanotubes; closed; 17.0–34.7 nm diameter; globular shape; Grade: Jenotube 20.
721.11762 Nonanamide, N,N-dimethyl-.
721.11763 2-Propenoic acid, 2-methyl, 2-(dimethylamino)ethyl ester, polymers with 2-(C16–18-acylamino)ethyl acrylate and hydroxyalkyl acrylate, acetates (generic).
721.11765 2H-Pyran, tetrahydro-4-methyl.
721.11766 Organic acid ester, polymer with aliphatic diols and 1,1′-methylenebis[4-isocyanatobenzene] (generic).
721.11767 4,4-Methylenebis (2,6-dimethyl phenol) polymer with 2-(chloromethyl)oxirane, 1,4-benzenediol, 2-methyl-2-propenoic acid, mixed alkyl substituted 2-methyl 2-propenoate, and ethyl 2-propenoate, reaction products with 2-(dimethylamino) ethanol (generic).
721.11768 Phenol, methylethylidene, polymer chloromethyl epoxide and methylethylidene bis-oxy, bis-amine (generic).
721.11769 Amine, methylethylidenebis(oxy) (generic).
721.11770 Carbamic acid, N-[3-(trialkoxysilyl)propyl]-, C,C′-[2,2,4(or 2,4,4)-trimethyl-1,6-hexanediyl] ester (generic).
721.11771 Arylfurandione, [bis(trihaloalkyl)alkylidene]bis-, polymer with alkanediamine (generic).
721.11772 Phosphonic acid, dimethyl ester, reaction products with alkyl-alkyl-alkanediol and alkanediol (generic).
721.11773 Silane, halogenated (generic).
721.11774 Heteromonocycle, polymer, substituted aliphatic carbamate, [2-[(1-oxo-2-propen-1-yl)oxy]alkyl]ester (generic).
721.11775 Alkanes, C4-8-branched and linear.
721.11776 5H-1,2-Oxathiole, 2,2-dioxide.
* * * * *
§721.11752 Quaternary ammonium salt of polyisobutene succinic acid (generic).
(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as quaternary ammonium salt of polyisobutene succinic acid (PMN P–16–349) 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)(3), (6)(vii) and (7), (b) and (c). 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)(ix), (2)(i) and (v), and (5). For purposes of §721.72(e), the concentration is set at 1.0%. 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 in inhalation exposure. It is a significant new use to use the substance in any consumer product to be added to gasoline or diesel fuels by the consumer.
(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 and processors of this substance.
(2) Limitation or revocation of certain notification requirements. The provisions of §721.185 apply to this section.
§721.11753 2-Propenoic acid, 2-alkyl-, 2-(dialkylamino)alkyl ester, polymer with .alpha.-(2-alkyl-1-oxo-2-alken-1-yl)-.omega.-methoxypoly(oxy-1,2-alkanediyl) (generic).
(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as 2-propenoic acid, 2-alkyl-, 2-(dialkylamino)alkyl ester, polymer with .alpha.-(2-alkyl-1-oxo-2-alken-1-yl)-.omega.-methoxypoly(oxy-1,2-alkanediyl) (PMN P–18–27) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section. The requirements of this section do not apply to quantities of the substance after they have been completely reacted (cured) or when present as an impurity at less than 1% by weight.
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in §721.63(a)(3) and (5) through (8), and (c). 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 or of at least 1,000 during spray applications.
(ii) Hazard communication. Requirements as specified in §721.72(a) through (d), (f), and (g)(1) and (5). For purposes of §721.72(g)(1), this substance may cause: specific target organ toxicity; skin irritation; eye irritation; 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 use the substance in formulations at greater than 0.1% for spray applications.
(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.
§721.11754 Alkanedioic acid, polymer with cycloalkyl dimethanol, alkyl and cycloalkyl diisocyanates, dimethyl-alkanediol, dihydroxyalkanoic acid methylenebis[isocyanatocyclohexane], hydroxyethyl acrylate- and polyalkyl glycol monoalkyl ether blocked (generic).
(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as alkanedioic acid, polymer with cycloalkyl dimethanol, alkyl and cycloalkyl diisocyanates, dimethyl-alkanediol, dihydroxyalkanoic acid methylenebis[isocyanatocyclohexane], hydroxyethyl acrylate- and polyalkyl glycol monoalkyl ether blocked (PMN P–18–301) 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)(3) and (7), and (c).
(ii) Hazard communication. Requirements as specified in §721.72(a) through (d), (f), and (g)(1) and (5). For purposes of §721.72(g)(1), this substance may cause: skin irritation; skin sensitization; eye irritation; respiratory sensitization. Alternative hazard and warning statements that meet the criteria of the Globally Harmonized System and OSHA Hazard Communication Standard may be used.
(iii) Industrial, commercial, and consumer activities. Requirements as specified in §721.80(o).
(b) Specific requirements. The provisions of subpart A of this part apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in §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.
§721.11755 Poly(oxy-1,4-butanediyl), .alpha.-hydro-.omega.-hydroxy-, polymer with 1,1′-methylenebis[4-isocyanatobenzene], caprolactam-blocked.
(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as poly(oxy-1,4-butanediyl), .alpha.-hydro-.omega.-hydroxy-, polymer with 1,1′-methylenebis[4-isocyanatobenzene], caprolactam-blocked (P–18–340; CAS RN 2247074–17–3) 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 (cured).
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in §721.63(a)(3) and (7), and (c).
(ii) Hazard communication. Requirements as specified in §721.72(a) through (d), (f), and (g)(1) and (5). For purposes of §721.72(g)(1), this substance may cause: respiratory sensitization; skin sensitization; reproductive toxicity; specific target organ toxicity. Alternative hazard and warning statements that meet the criteria of the Globally Harmonized System and OSHA Hazard Communication Standard may be used.
(iii) Industrial, commercial, and consumer activities. Requirements as specified in §721.80(o). It is a significant new use to use the substance other than for one component thermoset elastomer manufacture. It is a significant new use to manufacture, process, or use the substance in any manner that results in inhalation exposure. It is a significant new use to manufacture the substance without the use of a packed tower scrubber that removes at least 95 percent of the substance prior to release.
(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.
§721.11756 Tall-oil pitch, fraction, sterol-low (generic).
(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as tall-oil pitch, fraction, sterol-low (PMN P–19–165) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section. The requirements of this section do not apply to quantities of the substance after they have been completely reacted (cured).
(2) The significant new uses are:
(i) 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 (c), 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.
§721.11757 Carboxylic acid, reaction products with metal hydroxide, inorganic dioxide and metal (generic).
(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as carboxylic acid, reaction products with metal hydroxide, inorganic dioxide and metal (PMN P–20–10) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section. The requirements of this section do not apply to quantities of the substance after they have been completely reacted (cured).
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in §721.63(a)(3), (5), (6)(vii), (7) and (8), and (c). 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, or an APF of 50 if dust controls are implemented that demonstrate an exposure reduction of at least 30%.
(ii) Hazard communication. Requirements as specified in §721.72(a) through (d), (f), and (g)(1), (3)(iii) and (5). For purposes of §721.72(g)(1), this substance may cause: skin sensitization; genetic toxicity; reproductive toxicity; specific target organ toxicity. Alternative hazard and warning statements that meet the criteria of the Globally Harmonized System and OSHA Hazard Communication Standard may be used.
(iii) Release to water. Requirements as specified in §721.90(a)(4), (b)(4), and (c)(4), where N=11.
(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 (h), 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.
§721.11758 Multi-walled carbon nanotubes; closed; 4.4–12.8 nm diameter; bundle length 10.6–211.1 µm; Grade: Jenotube 6.
(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as multi-walled carbon nanotubes; closed; 4.4–12.8 nm diameter; bundle length 10.6–211.1 µm; Grade: Jenotube 6 (PMN P–20–62) 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 or incorporated into an article.
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in §721.63(a)(3), (5), (6)(vii), (7) and (8), and (c). 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), and (g)(1), (3)(iii) and (5). For purposes of §721.72(g)(1), this substance may cause: skin sensitization; eye irritation; respiratory sensitization; carcinogenicity; specific target organ toxicity. Alternative hazard and warning statements that meet the criteria of the Globally Harmonized System and OSHA Hazard Communication Standard may be used.
(iii) Industrial, commercial, and consumer activities. Requirements as specified in §721.80(f). It is a significant new use to manufacture the substance with a maximum weight percent of cobalt oxide impurity in excess of 2.1%. It is a significant new use to process or use the substance other than as an electrically conductive material, a heat dissipation material, a heat generation material, an additive for weight reduction, an additive to improve physical or mechanical properties, an additive in batteries, energy storage, and electrode applications, or an additive in field emission applications. It is a significant new use to process or use the substance in application methods that do not generate a vapor, mist, dust, or aerosol unless such an application method occurs in an enclosed process.
(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.
§721.11759 Multi-walled carbon nanotubes; closed; 5.1–11.6 nm diameter; bundle length 1.9–552.0 µm; Grade: Jenotube 8.
(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as multi-walled carbon nanotubes; closed; 5.1–11.6 nm diameter; bundle length 1.9–552.0 µm; Grade: Jenotube 8 (PMN P–20–63) 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 or incorporated into an article.
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in §721.63(a)(3), (5), (6)(vii), (7) and (8), and (c). 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), and (g)(1), (3)(iii) and (5). For purposes of §721.72(g)(1), this substance may cause: skin sensitization; eye irritation; respiratory sensitization; carcinogenicity; specific target organ toxicity. Alternative hazard and warning statements that meet the criteria of the Globally Harmonized System and OSHA Hazard Communication Standard may be used.
(iii) Industrial, commercial, and consumer activities. Requirements as specified in §721.80(f). It is a significant new use to manufacture the substance with a maximum weight percentage of cobalt oxide impurity in excess of 2.1%. It is a significant new use to process or use the substance other than as an electrically conductive material, a heat dissipation material, a heat generation material, an additive for weight reduction, an additive to improve physical or mechanical properties, an additive in batteries, energy storage, and electrode applications, or an additive in field emission applications. It is a significant new use to process or use the substance in application methods that do not generate a vapor, mist, dust, or aerosol unless such an application method occurs in an enclosed process.
(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.
§721.11760 Multi-walled carbon nanotubes; closed; 7.9–14.2 nm diameter; bundle length 9.4–106.4 µm; Grade: Jenotube 10.
(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as multi-walled carbon nanotubes; closed; 7.9–14.2 nm diameter; bundle length 9.4–106.4 µm; Grade: Jenotube 10 (PMN P–20–64) 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 or incorporated into an article.
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in §721.63(a)(3), (5), (6)(vii), (7) and (8), and (c). 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), and (g)(1), (3)(iii) and (5). For purposes of §721.72(g)(1), this substance may cause: skin sensitization; eye irritation; respiratory sensitization; carcinogenicity; specific target organ toxicity. Alternative hazard and warning statements that meet the criteria of the Globally Harmonized System and OSHA Hazard Communication Standard may be used.
(iii) Industrial, commercial, and consumer activities. Requirements as specified in §721.80(f). It is a significant new use to manufacture the substance with a maximum weight percentage of cobalt oxide impurity in excess of 2.1%. It is a significant new use to process or use the substance other than as an electrically conductive material, a heat dissipation material, a heat generation material, an additive for weight reduction, an additive to improve physical or mechanical properties, an additive in batteries, energy storage, and electrode applications, or an additive in field emission applications. It is a significant new use to process or use the substance in application methods that do not generate a vapor, mist, dust, or aerosol unless such an application method occurs in an enclosed process.
(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.
§721.11761 Multi-walled carbon nanotubes; closed; 17.0–34.7 nm diameter; globular shape; Grade: Jenotube 20.
(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as multi-walled carbon nanotubes; closed; 17.0–34.7 nm diameter; globular shape; Grade: Jenotube 20 (PMN P–20–65) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section. The requirements of this section do not apply to quantities of the substance after they have been completely reacted or cured or incorporated into an article.
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in §721.63(a)(3), (5), (6)(vii), (7) and (8), and (c). 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), and (g)(1), (3)(iii) and (5). For purposes of §721.72(g)(1), this substance may cause: skin sensitization; eye irritation; respiratory sensitization; carcinogenicity; specific target organ toxicity. Alternative hazard and warning statements that meet the criteria of the Globally Harmonized System and OSHA Hazard Communication Standard may be used.
(iii) Industrial, commercial, and consumer activities. Requirements as specified in §721.80(f). It is a significant new use to manufacture the substance with a maximum weight percentage of cobalt oxide impurity in excess of 2.1%. It is a significant new use to process or use the substance other than as an electrically conductive material, a heat dissipation material, a heat generation material, an additive for weight reduction, an additive to improve physical or mechanical properties, an additive in batteries, energy storage, and electrode applications, or an additive in field emission applications. It is a significant new use to process or use the substance in application methods that do not generate a vapor, mist, dust, or aerosol unless such an application method occurs in an enclosed process.
(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.
§721.11762 Nonanamide, N,N-dimethyl-.
(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as nonanamide, N,N-dimethyl- (PMN P–20–70; CAS RN 6225–08–7) 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)(3), (5), (6)(v) and (vi), (7) and (8), (b), and (c). For purposes of §721.63(b), the concentration is set at 1.0%. 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 (f), and (g)(1), (3)(iii) 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: skin irritation; eye irritation; specific target organ toxicity; reproductive toxicity; aspiration hazard. Alternative hazard and warning statements that meet the criteria of the Globally Harmonized System and OSHA Hazard Communication Standard may be used.
(iii) Industrial, commercial, and consumer activities. It is a significant new use to use the substance other than as a solvent for use in formulated pesticide products. It is a significant new use to manufacture the substance other than by import into the United States ( i.e., no domestic manufacture) using 20,000 kg International Organization for Standardization tank containers (ISOtainers) or 1,000 kg intermediate bulk containers (IBCs).
(iv) Release to water. Requirements as specified in §721.90(a)(4), (b)(4), and (c)(4), where N=96.
(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.
§721.11763 2-Propenoic acid, 2-methyl, 2-(dimethylamino)ethyl ester, polymers with 2-(C16–18-acylamino)ethyl acrylate and hydroxyalkyl acrylate, acetates (generic).
(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as 2-propenoic acid, 2-methyl, 2-(dimethylamino)ethyl ester, polymers with 2-(C16–18-acylamino)ethyl acrylate and hydroxyalkyl acrylate, acetates (PMN P–20–84) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section. The requirements of this section do not apply to quantities of the substance after they have been completely reacted (cured).
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in §721.63(a)(3) and (7), (b), and (c). 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) 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: skin irritation; eye irritation; specific target organ toxicity. Alternative hazard and warning statements that meet the criteria of the Globally Harmonized System and OSHA Hazard Communication Standard may be used.
(iii) Industrial, commercial, and consumer activities. Requirements as specified in §721.80(o). It is a significant new use to process or use the substance in any manner that results in inhalation exposure.
(b) Specific requirements. The provisions of subpart A of this part apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in §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.
§721.11765 2H-Pyran, tetrahydro-4-methyl.
(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as 2H-pyran, tetrahydro-4-methyl (PMN P–20–127; CAS RN 4717–96–8) 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)(3), (5), (6)(v) and (vi), (7) and (8), (b), and (c). 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), and (g)(1), (3)(iii) 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: skin corrosion; serious eye damage; specific target organ toxicity; aspiration hazard. 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=540.
(b) Specific requirements. The provisions of subpart A of this part apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in §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.
§721.11766 Organic acid ester, polymer with aliphatic diols and 1,1′-methylenebis[4-isocyanatobenzene] (generic).
(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as organic acid ester, polymer with aliphatic diols and 1,1′-methylenebis[4-isocyanatobenzene] (PMN P–20–130) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section. The requirements of this section do not apply to quantities of the substance after they have been completely reacted (cured).
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in §721.63(a)(3), (5), (6)(ix), (7) amd (8), and (c). 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), and (g)(1) and (5). For purposes of §721.72(g)(1), this substance may cause: acute toxicity; skin irritation; respiratory sensitization; skin sensitization; genetic toxicity; carcinogenicity; reproductive toxicity; specific target organ toxicity. Alternative hazard and warning statements that meet the criteria of the Globally Harmonized System and OSHA Hazard Communication Standard may be used.
(iii) Industrial, commercial, and consumer use. Requirements as specified in §721.80(o). It is a significant new use to use the substance in any manner or method that involves spray application.
(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.
§721.11767 4,4-Methylenebis (2,6-dimethyl phenol) polymer with 2-(chloromethyl)oxirane, 1,4-benzenediol, 2-methyl-2-propenoic acid, mixed alkyl substituted 2-methyl 2-propenoate, and ethyl 2-propenoate, reaction products with 2-(dimethylamino) ethanol (generic).
(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as 4,4-methylenebis (2,6-dimethyl phenol) polymer with 2-(chloromethyl)oxirane, 1,4-benzenediol, 2-methyl-2-propenoic acid, mixed alkyl substituted 2-methyl 2-propenoate, and ethyl 2-propenoate, reaction products with 2-(dimethylamino) ethanol (PMN P–21–3) 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 (cured).
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in §721.63(a)(3), (5), (6)(vii), (7) and (8), (b), and (c). 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), and (g)(1) and (5). For purposes of §721.72(g)(1), this substance may cause: skin irritation; eye irritation. For purposes of §721.72(e), the concentration is set at 1.0%. 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).
(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.
§721.11768 Phenol, methylethylidene, polymer chloromethyl epoxide and methylethylidene bis-oxy, bis-amine (generic).
(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as phenol, methylethylidene, polymer chloromethyl epoxide and methylethylidene bis-oxy, bis-amine (PMN P–21–28) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section. The requirements of this section do not apply to quantities of the substance after they have been completely reacted.
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in §721.63(a)(3), (5), (6)(vii), (7) and (8), and (c). 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 in non-spray applications and 1,000 in spray applications.
(ii) Hazard communication. Requirements as specified in §721.72(a) through (d), (f) and (g)(1), (3)(iii) and (5). For purposes of §721.72(g)(1), this substance may cause: acute toxicity; skin corrosion; skin irritation; serious eye damage; eye irritation; respiratory sensitization; skin sensitization; 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) 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 (h), 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.
§721.11769 Amine, methylethylidenebis(oxy) (generic).
(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as amine, methylethylidenebis(oxy) (generic) (PMN P–21–29) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section. The requirements of this section do not apply to quantities of the substance after they have been completely reacted (cured).
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in §721.63(a)(3), (5), (6)(vii), (7) and (8), and (c). 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 in non-spray applications and 1,000 in spray applications.
(ii) Hazard communication. Requirements as specified in §721.72(a) through (d), (f), and (g)(1), (3)(iii) and (5). For purposes of §721.72(g)(1), this substance may cause: acute toxicity; skin corrosion; skin irritation; serious eye damage; eye irritation; respiratory sensitization; skin sensitization; 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) Release to water. Requirements as specified in §721.90(a)(4), (b)(4), and (c)(4), where N=840.
(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 (h), 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.
§721.11770 Carbamic acid, N-[3-(trialkoxysilyl)propyl]-, C,C′-[2,2,4(or 2,4,4)-trimethyl-1,6-hexanediyl] ester (generic).
(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as carbamic acid, N-[3-(trialkoxysilyl)propyl]-, C,C′-[2,2,4(or 2,4,4)-trimethyl-1,6-hexanediyl] ester (PMN P–21–34) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section. The requirements of this section do not apply to quantities of the substance after they have been completely reacted (cured).
(2) The significant new uses are:
(i) Hazard communication. Requirements as specified in §721.72(a) through (f), and (g)(1), (3)(iii) 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.
(ii) Release to water. Requirements as specified in §721.90(a)(4), (b)(4), and (c)(4), where N=1.
(b) Specific requirements. The provisions of subpart A of this part apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in §721.125(a) through (c), (f), and (k) are applicable to manufacturers, importers, and processors of this substance.
(2) Limitation or revocation of certain notification requirements. The provisions of §721.185 apply to this section.
§721.11771 Arylfurandione, [bis(trihaloalkyl)alkylidene]bis-, polymer with alkanediamine (generic).
(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as arylfurandione, [bis(trihaloalkyl)alkylidene]bis-, polymer with alkanediamine (PMN P–21–67) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section. The requirements of this section do not apply to quantities of the substance after they have been completely reacted, cured, or formed into an article.
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in §721.63(a)(3) and (7), (b), and (c). 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: skin irritation; eye irritation; specific target organ toxicity. Alternative hazard and warning statements that meet the criteria of the Globally Harmonized System and OSHA Hazard Communication Standard may be used.
(iii) Industrial, commercial, and consumer activities. It is a significant new use to manufacture or process the substance unless at a particle size of 10 microns or greater.
(iv) Disposal. It is a significant new use to dispose of the substance or waste streams containing the substance by incineration unless such incineration occurs at a minimum temperature of 870 degrees Celsius.
(b) Specific requirements. The provisions of subpart A of this part apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in §721.125(a) through (j) are applicable to manufacturers, importers, and processors of this substance.
(2) Limitation or revocation of certain notification requirements. The provisions of §721.185 apply to this section.
§721.11772 Phosphonic acid, dimethyl ester, reaction products with alkyl-alkyl-alkanediol and alkanediol (generic).
(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as phosphonic acid, dimethyl ester, reaction products with alkyl-alkyl-alkanediol and alkanediol (PMN P–21–93) 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 completely reacted (cured).
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in §721.63(a)(3) and (7), (b), and (c). 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), (3)(iii) 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: skin corrosion; serious eye damage; eye irritation; reproductive toxicity; specific target organ toxicity. Alternative hazard and warning statements that meet the criteria of the Globally Harmonized System and OSHA Hazard Communication Standard may be used.
(iii) Industrial, commercial, and consumer activities. It is a significant new use to manufacture, process, or use the substance in any manner that generates a dust, mist, particulate, or aerosol that results in inhalation exposure. It is a significant new use to use the substance in consumer products where the concentration of the substance equals or exceeds 3%.
(iv) Release to water. Requirements as specified in §721.90(a)(4), (b)(4), and (c)(4), where N=180.
(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.
§721.11773 Silane, halogenated (generic).
(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as silane, halogenated (PMN P–21–94) 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 (cured).
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in §721.63(a)(3), (5), (6)(vii), (7) and (8), (b), and (c). For purposes of §721.63(b), the concentration is set at 1.0%. 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.
(A) As an alternative to the respirator requirements in paragraph (a)(2)(i) of this section, a manufacture or processor may choose to follow the new chemical exposure limit (NCEL) provision listed in the TSCA Order for this substance. The NCEL is 0.05 mg/m 3 as an 8-hour time weighted average. Persons who wish to pursue NCELs as an alternative to §721.63 respirator requirements may request to do so under §721.30. Persons whose §721.30 requests to use the NCELs approach are approved by EPA will be required to follow NCELs provisions comparable to those contained in the corresponding TSCA Order.
(B) [Reserved]
(ii) Hazard communication. Requirements as specified in §721.72(a) through (f), and (g)(1), (3)(iii) 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: skin corrosion; eye damage; specific target organ toxicity; pulmonary effects; developmental neurotoxicity. Alternative hazard and warning statements that meet the criteria of the Globally Harmonized System and OSHA Hazard Communication Standard may be used.
(iii) Industrial, commercial, and consumer activities. It is a significant new use to use the substance other than as a deposition precursor for the manufacture of electronic components.
(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.
§721.11774 Heteromonocycle, polymer, substituted aliphatic carbamate, [2-[(1-oxo-2-propen-1-yl)oxy]alkyl]ester (generic).
(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as heteromonocycle, polymer, substituted aliphatic carbamate, [2-[(1-oxo-2-propen-1-yl)oxy]alkyl]ester (PMN P–21–115) 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)(3), (5), (6)(vii), (7) and (8), and (c). 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 or of at least 1,000 during spray applications.
(ii) Hazard communication. Requirements as specified in §721.72(a) through (d), (f), and (g)(1) and (5). For purposes of §721.72(g)(1), this substance may cause: skin irritation; eye irritation; skin sensitization; respiratory sensitization. Alternative hazard and warning statements that meet the criteria of the Globally Harmonized System and OSHA Hazard Communication Standard may be used.
(iii) Industrial, commercial, and consumer activities. Requirements as specified in §721.80(o).
(b) Specific requirements. The provisions of subpart A of this part apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in §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.
§721.11775 Alkanes, C4–8-branched and linear.
(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as alkanes, C4–8-branched and linear (PMN P–21–141; CAS RN 2529890–37–5) 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)(3) and (7), (b), and (c). For purposes of §721.63(b), the concentration is set at 0.1%.
(ii) Hazard communication. Requirements as specified in §721.72(a).
(iii) Industrial, commercial, and consumer activities. It is a significant new use to manufacture, process, or use the substance other than for use as a transportation fuel, refinery feedstock, or fuel blending additive.
(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.
§721.11776 5H–1,2-Oxathiole, 2,2-dioxide.
(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as 5H–1,2-Oxathiole, 2,2-dioxide (PMN P–21–196; CAS RN 21806–61–1) 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)(3), (5), (6)(v) and (vi), (7) and (8), (b), and (c). 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 1000. For purposes of §721.63(b), the concentration is set at 0.1%.
(ii) Hazard communication. Requirements as specified in §721.72(a) through (d), (f), and (g)(1), (3)(iii) and (5). For purposes of §721.72(g)(1), this substance may cause: carcinogenicity, reproductive toxicity, skin sensitization; respiratory sensitization; genetic toxicity; specific target organ toxicity. Alternative hazard and warning statements that meet the criteria of the Globally Harmonized System and OSHA Hazard Communication Standard may be used.
(iii) Industrial, commercial, and consumer activities. Requirements as specified in §721.80(f). It is a significant new use to process or use the substance other than an enclosed system unless the worker personal protective equipment described in paragraph (a)(2)(i) is used.
(iv) Disposal. Requirements as specified in §721.85(b)(1) and (2), and (c)(1) and (2). It is a significant new use to dispose of the substance by incineration unless the removal efficiency is at least 99.9%.
(b) Specific requirements. The provisions of subpart A of this part apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in §721.125(a) through (j) are applicable to manufacturers, importers, and processors of this substance.
(2) Limitation or revocation of certain notification requirements. The provisions of §721.185 apply to this section.
[FR Doc. 2023–27653 Filed 12–15–23; 8:45 am]
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