TSCA Section 8(a) Preliminary Assessment Information Rule (PAIR) (Renewal)

EPA promulgated the generic Preliminary Assessment Information Rule (PAIR) (40 CFR part 712) under section 8(a) of the Toxic Substances Control Act (TSCA). The Frank R. Lautenberg Chemical Safety for the 21st Century Act amending TSCA was enacted on June 22, 2016; however, the authority for a TSCA section 8(a) PAIR rule was not modified. EPA uses PAIR, using the Manufacturer’s Report Preliminary Assessment Information Form, to collect information to help identify, assess, and manage human health and environmental risks from chemical substances, mixtures and categories. PAIR requires chemical manufacturers and importers to complete and submit standardized information about production, use, or exposure-related data to help evaluate the potential for human health and environmental risks caused by the manufacture or importation of identified chemical substances, mixtures or categories. EPA or other federal agencies can identify chemicals for a TSCA section 8(a) PAIR expediated rulemaking that have a justifiable need for production, use, or exposure-related data. This ICR also covers certain specific chemical testing and reporting requirements under Subpart B of 40 CFR part 766 that are very similar to the PAIR requirements. The Agency rarely receives submissions of the information required by 40 CFR 766. The dibenzo-para-dioxin/dibenzofuran regulations at 40 CFR part 766 require that any person who manufactures, imports, or processes a chemical substance listed at 40 CFR 766.25 test that chemical substance and submit appropriate information to EPA. Persons who commence manufacture, import, or processing of a chemical substance listed at 40 CFR 766.25, must submit a letter of intent to test or an exemption application within 60-days of starting any of those activities. Each person who is manufacturing or processing a chemical listed in 40 CFR 766.25, must submit a protocol for testing. Persons who manufacture or import a chemical substance listed under 40 CFR 766.25 must report positive test results, using the Dioxin/Furan Report Form, of all existing test data that show that chemical substance has been tested for the presence of halogenated dibenzodioxins/halogenated dibenzofurans (HDDs/HDFs), as well as any health and safety studies for the chemical substance, as defined in the regulation, no later than 90 days after the date of submission of the positive test result. Additionally, any manufacturer or importer of a chemical substance listed in 40 CFR 766.25 in possession of unpublished health and safety studies on HDDs/HDFs is required to submit copies of such studies to EPA, in accordance with provisions of 40 CFR 716, no later than 90 days after the person first manufactures or imports the chemical substance.

The latest form for TSCA Section 8(a) Preliminary Assessment Information Rule (PAIR) (Renewal) expires 2023-01-31 and can be found here.