Significant New Use Rules on Certain Chemical Substances (19-5.F)
Published Date: 1/6/2025
Rule
Summary
The EPA is rolling out new rules that make companies tell them 90 days before starting new uses of certain chemicals. This gives the EPA time to check if the new use is safe before it happens. These rules kick in on March 7, 2025, and could affect anyone making or importing these chemicals, so plan ahead to avoid surprises or delays!
Analyzed Economic Effects
12 provisions identified: 0 benefits, 12 costs, 0 mixed.
90-Day Notice Before New Uses
If you plan to start manufacturing (including importing) or processing any of the listed chemicals for a use the rule calls a “significant new use,” you must notify EPA at least 90 days before starting. You may not begin that activity until EPA reviews your Significant New Use Notice (SNUN), makes a determination, and takes any required risk management actions.
Estimated SNUN Submission Costs
If you submit a SNUN, EPA estimates the total cost per submission at about $45,000 for large businesses and about $14,500 for qualifying small businesses. The estimate includes registration costs and a user fee of $37,000 (standard) or a reduced user fee of $6,480 for qualifying small businesses (FY2022 fee levels).
SNUN Paperwork Time Burden
EPA estimates the annual paperwork burden for submitting a SNUN averages between 30 and 170 hours per submission. This includes time to review instructions, gather data, and complete the SNUN form.
Workplace Controls and High-Protection Respirators
For the chemical identified by PMN P-17-299, EPA designates workplace protection measures as a significant new use and requires that engineering or administrative controls be considered and implemented where feasible. When respirators are used, they must provide a NIOSH assigned protection factor (APF) of at least 1,000.
P-17-299 Use and Concentration Limits
For PMN P-17-299, it is a significant new use to use the substance other than as a thickener in paint or to use it in concentrations greater than 1% in formulated products; such uses trigger the SNUN requirement and EPA review.
P-18-172 Consumer Product and Use Limits
For PMN P-18-172 (calcium carbonate complexes), EPA designates as a significant new use: using the substance in consumer products except for architectural coatings, and using it other than as an auxiliary drier for architectural paints, industrial coatings, and stains. Those uses require submission of a SNUN before commencing.
Inhalation Exposure Triggers SNUN (P-19-118)
For PMN P-19-118 (a substituted polyalkylenepoly generic), it is a significant new use to manufacture, process, or use the substance in any manner that results in inhalation exposure. Such activities require a SNUN before commencing.
Export Notification Cost Per Country
If you export a substance covered by these SNURs, you must give a one-time export notice to EPA for the first export or intended export to each country. EPA estimates the per-notification cost is about $106 (one-time per country).
Release-to-Water Designation (P-16-541)
For PMN P-16-541 (soybean meal reaction product), EPA designates release to water as a significant new use and applies the requirements specified in 40 CFR 721.90(a)(4), (b)(4), and (c)(4) with N=22. Those activities require a SNUN before starting.
Release-to-Water Designation (P-19-120)
For PMN P-19-120 (a generic alkenoic acid polymer alkali metal salt), EPA designates release to water as a significant new use and applies the requirements in 40 CFR 721.90(a)(4), (b)(4), and (c)(4) with N=78. Such releases require a SNUN before commencing.
Recordkeeping Requirements for Manufacturers
Manufacturers and processors of the listed substances must comply with recordkeeping requirements specified in 40 CFR 721.125(a) through (c) and additional subsections referenced for each chemical (for example, (i) or (k)). These records must be maintained as part of compliance if you manufacture or process the substance.
Compliance Start Date and Judicial Promulgation
The rule is effective March 7, 2025, and for purposes of judicial review it was promulgated at 1 p.m. (EST) on January 21, 2025. Businesses should plan for the March 7, 2025 effective date when scheduling activities that could be designated significant new uses.
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