This final rule establishes new requirements for the registration of designated fuels and fuel additives (F/FAs) as authorized by sections 211(b)(2) and 211(e) of the Clean Air Act (CAA). The registration requirements are organized within a three-tier structure. Tier 1 requires F/FA manufacturers to perform a literature search on the health and welfare effects of F/FA emissions, characterize the emissions, and provide qualitative exposure information. Tier 2 requires biological testing for the examination of subchronic systemic and organ toxicity, as well as the assessment of specific health effects endpoints. When necessary, Tier 3, which includes follow-up studies or other additional tests, may be required. The rule permits adequate existing test data to be submitted in lieu of conducting new duplicative tests. It also includes special provisions for small businesses and certain types of products, and a grouping system which permits manufacturers of similar F/FA products to share the costs of compliance.
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