C.I. Pigment Violet 29 (PV29); Regulation Under the Toxic Substances Control Act (TSCA)

ENVIRONMENTAL PROTECTION AGENCY <CFR>40 CFR Part 751</CFR> <DEPDOC>[EPA-HQ-OPPT-2021-0277; FRL-8331-02-OCSPP]</DEPDOC> <RIN>RIN 2070-AK87</RIN> <SUBJECT>C.I. Pigment Violet 29 (PV29); Regulation Under the Toxic Substances Control Act (TSCA)</SUBJECT> <HD SOURCE="HED">AGENCY:</HD> Environmental Protection Agency (EPA). <HD SOURCE="HED">ACTION:</HD> Proposed rule. <SUM> <HD SOURCE="HED">SUMMARY:</HD> The Environmental Protection Agency (EPA or Agency) is proposing to address the unreasonable risk of injury to human health presented by C.I. Pigment Violet 29 (CASRN 81-33-4, also known as PV29), under its conditions of use as documented in EPA's January 2021 Risk Evaluation for PV29 and the September 2022 Revised Risk Determination for PV29 prepared under TSCA. TSCA requires that EPA address by rule any unreasonable risk of injury to health or the environment identified in a TSCA risk evaluation and apply requirements to the extent necessary so the chemical no longer presents unreasonable risk. To address the identified unreasonable risk, EPA is proposing requirements to protect workers from the unreasonable risk of PV29 during manufacturing and processing, certain industrial and commercial uses of the chemical, and disposal, while also allowing for a reasonable transition period prior to enforcement of said requirements. </SUM> <EFFDATE> <HD SOURCE="HED">DATES:</HD> Comments must be received on or before February 28, 2025. Under the Paperwork Reduction Act (PRA), comments on the information collection provisions are best assured of consideration if the Office of Management and Budget (OMB) receives a copy of your comments on or before February 13, 2025. </EFFDATE> <HD SOURCE="HED">ADDRESSES:</HD> Submit your comments, identified by docket identification (ID) number EPA-HQ-OPPT-2021-0277, online at <E T="03">https://www.regulations.gov.</E> Follow the online instructions for submitting comments. Do not submit electronically any information you consider to be Confidential Business Information (CBI) or other information whose disclosure is restricted by statute. Additional instructions on commenting or visiting the docket, along with more information about dockets generally, is available at <E T="03">https://www.epa.gov/dockets.</E> <FURINF> <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD> <E T="03">For technical information:</E> Carolyn Mottley, Existing Chemicals Risk Management Division (7404M), Office of Pollution Prevention and Toxics, Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460-0001; telephone number (202) 566-1955; email address: <E T="03">mottley.carolyn@epa.gov.</E> <E T="03">For general information:</E> The TSCA-Hotline, ABVI-Goodwill, 422 South Clinton Ave., Rochester, NY 14620; telephone number: (202) 554-1404; email address: <E T="03">TSCA-Hotline@epa.gov.</E> </FURINF> <SUPLINF> <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD> <HD SOURCE="HD1">I. Executive Summary</HD> <HD SOURCE="HD2">A. Does this action apply to me?</HD> You may be potentially affected by this action if you manufacture (defined under TSCA to include import), process, distribute in commerce, use, or dispose of PV29. 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 include: • Synthetic Dye and Pigment Manufacturing (NAICS code 325130); • Plastics Material and Resin Manufacturing (NAICS code 325211); • Other Basic Inorganic Chemical Manufacturing (NAICS code 325180); • Paint and Coating Manufacturing (NAICS code 325510); • Custom Compounding of Purchased Resins (NAICS code 325991); • Automobile and Light Duty Motor Vehicle Manufacturing (NAICS code 336110); • Motor Vehicle Body Manufacturing (NAICS code 336211); • Automotive Body, Paint, and Interior Repair and Maintenance (NAICS code 811121); • Printing Ink Manufacturing (NAICS code 325910); • Motor Vehicle Parts (Used) Merchant Wholesalers (NAICS code 423140); • Recyclable Material Merchant Wholesalers (NAICS code 423930); • Carpet and Rug Mills (NAICS code 314110); • All Other Miscellaneous Textile Product Mills (NAICS code 314999); • Artificial and Synthetic Fibers and Filaments Manufacturing (NAICS code 325220); • Floor Covering Retailers (NAICS code 449121); • Materials Recovery Facilities (NAICS code 562920); • Sewage Treatment Facilities (NAICS code 221320); • Solid Waste Collection (NAICS code 562111); • Solid Waste Landfill (NAICS code 562212; • Solid Waste Combustors and Incinerators (NAICS code 562213); and • Other Nonhazardous Waste Treatment and Disposal (NAICS code 562219). This action may also affect certain entities subject to import certification and export notification rules under TSCA ( <E T="03">https://www.epa.gov/tsca-import-export-requirements</E> ). Persons who import any chemical substance in bulk form, as part of a mixture, or as part of an article (if required by rule) are subject to the TSCA section 13 (15 U.S.C. 2612) import certification requirements and the corresponding regulations at 19 CFR 12.118 through 12.127; see also 19 CFR 127.28. Those persons must certify that the shipment of the chemical substance complies with all applicable rules and orders under TSCA. The EPA policy in support of import certification appears at 40 CFR part 707, subpart B. In addition, any persons who export or intend to export a chemical substance that is the subject of this proposed rule are subject to the export notification provisions of TSCA section 12(b) (15 U.S.C. 2611(b)) and must comply with the export notification requirements in 40 CFR part 707, subpart D. If you have any questions regarding the applicability of this proposed action to a particular entity, consult the technical information contact listed under <E T="02">FOR FURTHER INFORMATION CONTACT</E> . <HD SOURCE="HD2">B. What is the Agency's authority for taking this action?</HD> Under TSCA section 6(a) (15 U.S.C. 2605(a)), if EPA determines through a TSCA section 6(b) risk evaluation that a chemical substance presents an unreasonable risk of injury to health or the environment, EPA must by rule apply one or more requirements listed in TSCA section 6(a) to the extent necessary so that the chemical substance or mixture no longer presents such risk. <HD SOURCE="HD2">C. What action is the Agency taking?</HD> Pursuant to TSCA section 6(b), EPA determined that PV29 presents an unreasonable risk of injury to health, without consideration of costs or other nonrisk factors, including an unreasonable risk to potentially exposed or susceptible subpopulations (PESS) identified as relevant to the Risk Evaluation for C.I. Pigment Violet 29 (2021 Risk Evaluation for PV29), under the conditions of use (Refs. 1, 2). The term “conditions of use” is defined in TSCA section 3(4) (15 U.S.C. 2602(4)) to mean the circumstances under which a chemical substance is intended, known, or reasonably foreseen to be manufactured, processed, distributed in commerce, used, or disposed of. A detailed description of the conditions of use that contribute to EPA's determination that PV29 presents an unreasonable risk is provided in Unit III.B. Accordingly, to address the unreasonable risk, EPA is proposing, under TSCA section 6(a) to: (i) Require use of assigned protection factor (APF) 50 respirators and equipment and area cleaning to address the risk from inhalation exposure to dry powder PV29 (also referred to as regulated PV29), where dry powder PV29 is expected to be present, for the following conditions of use, as outlined in Unit IV.A.1: • Domestic manufacture; • Import; • Incorporation into formulation, mixture or reaction products in paints and coatings; • Incorporation into formulation, mixture or reaction products in plastic and rubber products; and • Intermediate in the creation or adjustment of color of other perylene pigments; • Recycling; • Industrial and commercial use in automobile (original equipment manufacturer (OEM) and refinishing) paints and coatings; • Industrial and commercial use in coatings and basecoats paints and coatings; • Industrial and commercial use in merchant ink for commercial printing; and • Disposal. (ii) Require manufacturers (including importers), processors, and distributors in commerce of regulated PV29 to provide downstream notification of the requirements, as outlined in Unit IV.A.2. (iii) Require recordkeeping, as outlined in Unit IV.A.2. EPA notes that not all TSCA conditions of use of PV29 are subject to this proposal. As described in the 2021 Risk Evaluation for C.I. Pigment Violet 29 (Ref. 1) and the September 2022 revised unreasonable risk determination (Ref. 2), four conditions of use of PV29 do not contribute to the unreasonable risk: distribution in commerce; industrial/commercial use in plastic and rubber products—automobile plastics; industrial/commercial use in plastic and rubber products—industrial carpeting; and consumer use in professional quality watercolor and acrylic artist paint. Consumer use in professional quality watercolor and acrylic artist paint was the only consumer condition of use evaluated as part of the 2021 PV29 Risk Evaluation. EPA is requesting public comment on all aspects of this proposal. <HD SOURCE="HD2">D. Why is the Agency taking this action?</HD> Under TSCA section 6(a), “[i]f the Administrator determines in accordance with subsection (b)(4)(A) that the manufacture, processing, distribution in commerce, use or disposal of a chemical substance or mixture, or that any combination of such activities, presents an unreasonable risk of injury to health or the environment, the Administrator shall by rule . . . apply one or more of the [section 6(a)] requirements ━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━ Preview showing 10k of 173k characters. Full document text is stored and available for version comparison. ━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━