90 FR 109 pgs. 24228-24231 - Certain Existing Chemicals; Request To Submit Unpublished Health and Safety Data Under the Toxic Substances Control Act (TSCA); Extension of Submission Deadline
Type: RULEVolume: 90Number: 109Pages: 24228 - 24231
Pages: 24228, 24229, 24230, 24231Docket number: [EPA-HQ-OPPT-2023-0360; FRL-11164.2-02-OCSPP]
FR document: [FR Doc. 2025-10410 Filed 6-6-25; 8:45 am]
Agency: Environmental Protection Agency
Official PDF Version: PDF Version
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 716
[EPA-HQ-OPPT-2023-0360; FRL-11164.2-02-OCSPP]
RIN 2070-AL31
Certain Existing Chemicals; Request To Submit Unpublished Health and Safety Data Under the Toxic Substances Control Act (TSCA); Extension of Submission Deadline
AGENCY:
Environmental Protection Agency (EPA).
ACTION:
Final rule.
SUMMARY:
The Environmental Protection Agency (EPA or Agency) is amending the deadline for reporting pursuant to the Toxic Substances Control Act (TSCA) Health and Safety Data Reporting rule, which requires manufacturers (including importers) of 16 specified chemical substances to submit lists and copies of certain unpublished health and safety studies to the EPA. Specifically, the EPA is amending the reporting deadline for all 16 chemical substances subject to the rule to May 22, 2026, through final action.
DATES:
This rule is effective on June 9, 2025.
ADDRESSES:
The docket for this action, identified by docket identification (ID) number EPA-HQ-OPPT-2023-0360, is available online at https://www.regulations.gov. Additional information about dockets generally, along with instructions for visiting the docket in-person, is available at https://www.epa.gov/dockets.
FOR FURTHER INFORMATION CONTACT:
For technical information: Stephanie Griffin, Data Gathering, Management, and Policy Division (7406M), Office of Pollution Prevention and Toxics, Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460-0001; telephone number: (202) 564-1463; email address: griffin.stephanie@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. Does this action apply to me?
You may be potentially affected by this action if you manufacture (including import) any of the chemical substances that are listed in 40 CFR 716.120(d) of the regulatory text of this document. The following list of North American Industrial Classification System (NAICS) codes affected by this rule are those that align with these activities:
• Chemical manufacturers (including importers), (NAICS code 325); and
• Petroleum refineries (NAICS code 324110).
This action applies to manufacturers in these NAICS codes who are currently manufacturing (including importing) a listed chemical substance (or will do so during the chemical's reporting period) or who have manufactured (including imported) or proposed to manufacture (including import) a listed chemical substance within the last 10 years.
This action may also affect manufacturers of substances for commercial purposes that coincidentally produce the substance during the manufacture, processing, use, or disposal of another substance or mixture, including byproducts and impurities. Such byproducts and impurities may, or may not, in themselves have commercial value. They are nonetheless produced for the purpose of obtaining a commercial advantage because they are part of the manufacture of a chemical product for a commercial purpose.
B. What action is the Agency taking?
The EPA is amending the data submission period for the TSCA section 8(d) rule by changing the reporting deadline for all 16 chemical substances to May 22, 2026.
C. Why is the Agency taking this action?
[top] The EPA promulgated a final rule in the Federal Register of December 13, 2024 (89 FR 100756 (FRL-11164-02-OCSPP)), to require manufacturers (including importers) of 16 specific chemical substances to submit copies and lists of certain unpublished health and safety studies to the EPA. The 16 chemical substances were added to 40 CFR 716.120 to support ongoing and upcoming activities under TSCA section 6. On March 13, 2025, the EPA modified the submission deadlines from March
The Agency is taking this action for several reasons. First, the EPA needs additional time to provide guidance on particular implementation problems that entities subject to the rule have raised to the Agency as described in the EPA's previous March 13, 2025, final rule to modify the reporting deadlines for the chemical substances subject to this rule. Despite best efforts to act expeditiously, the Agency has not yet finalized this guidance, which will address topics such as submitting harmonized templates, which are required for submissions containing Confidential Business Information. In this action, however, the EPA is not reopening or reconsidering provisions of the underlying rule other than the submission deadline.
When the EPA previously extended the reporting deadlines for the 16 chemical substances subject to this rule, the Agency bifurcated the deadlines such that the modified deadline for vinyl chloride was June 11, 2025, and the modified deadline for the remaining 15 chemical substances was September 9, 2025 (90 FR 11899, March 13, 2025 (11164.1-02-OCSPP)). In the final rule to modify these deadlines, the EPA explained that it anticipated that companies were more likely to have already reviewed their records for studies of vinyl chloride, as compared with the other chemical substances subject to this rule, because the Agency published a draft scope for the TSCA risk evaluation of vinyl chloride for public comment on January 16, 2025 (90 FR 4738 (FRL-12439-01-OCSPP)). Accordingly, the EPA expected that companies with unpublished health and safety studies on vinyl chloride would likely have prioritized this chemical substance in terms of searching for records to support commenting on the draft scope.
However, the EPA has been unable as yet to resolve the issues for which additional guidance is needed and continues to have substantial concerns that the scope of the reporting required will be difficult for companies to provide. As such, the EPA believes that providing a later reporting deadline for vinyl chloride, as well as for the other chemical substances subject to this rule, will ensure consistency of reporting requirements for all 16 chemical substances subject to this rule as well as provide the EPA sufficient time to incorporate data received in response to this rule for any of the Agency's associated TSCA section 6 responsibilities. Thus, the EPA finds it prudent to delay the deadline for the reporting requirements subject to this rule for all 16 chemical substances.
D. What is the Agency's authority for taking this action?
The Health and Safety Data Reporting rule for these 16 chemical substances is promulgated under TSCA section 8(d) (15 U.S.C. 2607(d)) and codified at 40 CFR part 716. The EPA's statutory authority to modify the deadlines for the final TSCA section 8(d) rule is the same statutory authority relied upon to promulgate the underlying rule. The EPA's authority for the rulemaking procedures used in this direct final rule is Administrative Procedure Act (APA) section 553(b)(B), 5 U.S.C. 553(b)(B), which permits an agency to forego notice and an opportunity for public comment if the agency finds good cause that such procedures are impracticable, unnecessary, or contrary to the public interest.
The EPA finds that notice and public comment is impracticable here because there is insufficient time for notice and comment on an extension to the deadline prior to the reporting deadline for vinyl chloride of June 11, 2025. Though more time is available ahead of the September 9, 2025 deadline for the other 15 chemical substances, it is nonetheless a limited period in which to conduct a notice and comment rulemaking. Relatedly, notice and public comment would be contrary to the public interest because if notice and comment timeframes prevented the Agency from extending the reporting deadline, many TSCA section 8(d) submissions might be provided without sufficient time or guidance to properly prepare them, impairing the ability of the Agency to carry out its prioritization and risk evaluation requirements and defeating the purpose of the rule, which is to effectuate the public interest by providing the EPA with sound data to analyze risk and protect human health and the environment. The EPA further notes that extending the submission period avoids the risk of covered entities collecting irresponsive materials that may not be required or may be required in a different format once the Agency issues related guidance on issues such as the use of harmonized templates.
This final rule is effective immediately upon publication. APA section 553(d)(1), 5 U.S.C. 553(d)(3), provides that agencies may make a final rule effective immediately "for good cause found and published with the rule." The EPA finds that the good cause discussed above applies equally to having an immediately effective date for this rule, especially considering the imminent reporting deadline for vinyl chloride. The EPA notes that the volume of reporting required means that covered entities require significant lead time prior to the compliance date to collect, process, and format the necessary information, meaning that an immediate effective date is appropriate for the 15 additional chemical substances as well.
II. Statutory and Executive Order Reviews
Additional information about these statutes and Executive orders can be found at https://www.epa.gov/laws-regulations/and-executive-orders.
A. Executive Order 12866: Regulatory Planning and Review
This action is not a significant regulatory action and was therefore not submitted to the Office of Management and Budget (OMB) for review under Executive Order 12866 (58 FR 51735, October 4, 1993).
B. Executive Order 14192: Unleashing Prosperity Through Deregulation
This action is considered an Executive Order 14192 deregulatory action. This final rule provides burden reduction by relieving immediate pressure on manufacturers for rule familiarization, data collection and preparation, and electronic reporting. This longer timeframe will also reduce opportunity costs on affected firms.
C. Paperwork Reduction Act (PRA)
This action does not contain any new information collection burden under the PRA, 44 U.S.C. 3501 et seq. OMB previously approved the information collection activities contained in the existing regulations and assigned OMB control number 2070-0224 (EPA ICR No. 2701.01). This action does not create any new reporting or recordkeeping obligations and does not otherwise change the burden estimates that were approved.
D. Regulatory Flexibility Act (RFA)
[top] This action is not subject to the RFA, 5 U.S.C. 601 et seq. The RFA applies only to rules subject to notice and comment rulemaking requirements under the APA, 5 U.S.C. 553, or any other statute. This rule is not subject to notice and comment requirements under the APA because the Agency has
E. Unfunded Mandates Reform Act (UMRA)
This action does not contain an unfunded mandate of $100 million (in 1995 dollars and adjusted annually for inflation) or more as described in UMRA, 2 U.S.C. 1531-1538, and does not significantly or uniquely affect small governments. The action imposes no enforceable duty on any State, local, or Tribal governments or the private sector.
F. Executive Order 13132: Federalism
This action does not have federalism implications as specified in Executive Order 13132 (64 FR 43255, August 10, 1999) because it will not have substantial direct effects on the 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.
G. Executive Order 13175: Consultation and Coordination With Indian Tribal Governments
This action does not have Tribal implications as specified in Executive Order 13175 (65 FR 67249, November 9, 2000) because it will not have substantial direct effects on Tribal governments, on the relationship between the Federal Government and the Indian Tribes, or on the distribution of power and responsibilities between the Federal Government and Indian Tribes.
H. Executive Order 13045: Protection of Children From Environmental Health Risks and Safety Risks
This action is not subject to Executive Order 13045 (62 FR 19885, April 23, 1997) because it does not address environmental health or safety risks disproportionately affecting children. Because this action does not concern human health, EPA's 2021 Policy on Children's Health also does not apply.
I. Executive Order 13211: Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution or Use
This action is not a "significant energy action" as defined in Executive Order 13211 (66 FR 28355, May 22, 2001) because it is not likely to have any adverse effect on the supply, distribution or use of energy.
J. National Technology Transfer and Advancement Act (NTTAA)
This action does not involve technical standards under the NTTAA section 12(d), 15 U.S.C. 272.
K. Congressional Review Act (CRA)
This action is subject to the CRA, 5 U.S.C. 801 et seq., and EPA will submit a rule report to each House of the Congress and to the Comptroller General of the United States. This action is not a "major rule" as defined by 5 U.S.C. 804(2).
List of Subjects in 40 CFR Part 716
Environmental protection, Chemicals, Hazardous substances, Health and safety, Reporting and recordkeeping requirements.
Dated: June 4, 2025.
Nancy B. Beck,
Principal Deputy Assistant Administrator, Office of Chemical Safety and Pollution Prevention.
Therefore, for the reasons stated in the preamble, EPA is amending 40 CFR chapter I as follows:
PART 716-HEALTH AND SAFETY DATA REPORTING
1. The authority citation for part 716 continues to read as follows:
Authority:
15 U.S.C. 2607(d).
2. Amend §?716.120 in table 3 to paragraph (d), under the heading "OPPT 2024 Chemicals", by revising the entries for "Acetaldehyde", "Acrylonitrile", "2-anilino-5-[(4-methylpentan-2-yl)amino]cyclohexa-2,5-diene-1,4-dione (6PPD-quinone)", "Benzenamine", "Benzene", "Bisphenol A", "Ethylbenzene", "Hydrogen fluoride", "4,4-Methylene bis(2-chloraniline)", "N-(1,3-Dimethylbutyl)-N'-phenyl-p-phenylenediamine (6PPD)", "Naphthalene", "Styrene", "4-tert-octylphenol(4-(1,1,3,3-Tetramethylbutyl)-phenol)", "Tribomomethane (Bromoform)", "Triglycidyl isocyanurate", and "Vinyl chloride" to read as follows:
§?716.120 Substances and listed mixtures to which this subpart applies.
(d) * * *
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| Category | CASRN | Special exemptions | Effective date | Sunset date |
|---|---|---|---|---|
| * * * * * * * | ||||
| OPPT 2024 Chemicals: | ||||
| Acetaldehyde | 75-07-0 | §?716.21(a)(11) applies; §?716.20(a)(9) does not apply | January 13, 2025 | May 22, 2026. |
| Acrylonitrile | 107-13-1 | §?716.21(a)(11) applies; §?716.20(a)(9) does not apply | January 13, 2025 | May 22, 2026. |
| 2-anilino-5-[(4-methylpentan-2-yl)amino]cyclohexa-2,5-diene-1,4-dione (6PPD-quinone) | 2754428-18-5 | §?716.21(a)(11) applies; §?716.20(a)(9) does not apply | January 13, 2025 | May 22, 2026. |
| Benzenamine | 62-53-3 | §?716.21(a)(11) applies; §?716.20(a)(9) does not apply applies; §?716.20(a)(9) does not apply | January 13, 2025 | May 22, 2026. |
| Benzene | 71-43-2 | §?716.21(a)(11) applies; §?716.20(a)(9) does not apply | January 13, 2025 | May 22, 2026. |
| Bisphenol A | 80-05-7 | §?716.21(a)(11) applies; §?716.20(a)(9) does not apply | January 13, 2025 | May 22, 2026. |
| Ethylbenzene | 100-41-4 | §?716.21(a)(11) applies; §?716.20(a)(9) does not apply | January 13, 2025 | May 22, 2026. |
| Hydrogen fluoride | 7664-39-3 | §?716.21(a)(11) applies; §§?716.20, 716.20(a)(9) does not apply | January 13, 2025 | May 22, 2026. |
| 4,4-Methylene bis(2-chloraniline) | 101-14-4 | §?716.21(a)(11) applies; §?716.20, 716.20(a)(9) does not apply | January 13, 2025 | May 22, 2026. |
| N-(1,3-Dimethylbutyl)-N'-phenyl-p-phenylenediamine (6PPD) | 793-24-8 | §?716.21(a)(11) applies; §?716.20(a)(9) does not apply | January 13, 2025 | May 22, 2026. |
| Naphthalene | 91-20-3 | §?716.21(a)(11) applies; §?716.20(a)(9) does not apply | January 13, 2025 | May 22, 2026. |
| Styrene | 100-42-5 | §?716.21(a)(11) applies; §?716.20(a)(9) does not apply | January 13, 2025 | May 22, 2026. |
| 4-tert-octylphenol(4-(1,1,3,3-Tetramethylbutyl)-phenol) | 140-66-9 | §?716.21(a)(11) applies; §?716.20, 716.20(a)(9) does not apply | January 13, 2025 | May 22, 2026. |
| Tribomomethane (Bromoform) | 75-25-2 | §?716.21(a)(11) applies; §?716.20(a)(9) does not apply | January 13, 2025 | May 22, 2026. |
| Triglycidyl isocyanurate | 2451-62-9 | §?716.21(a)(11) applies; §?716.20(a)(9) does not apply | January 13, 2025 | May 22, 2026. |
| Vinyl chloride | 75-01-4 | §?716.21(a)(11) applies; §?716.20(a)(9) does not apply | January 13, 2025 | May 22, 2026. |
| * * * * * * * | ||||
[FR Doc. 2025-10410 Filed 6-6-25; 8:45 am]
BILLING CODE 6560-50-P