Fuels and Fuel Additives: Health-Effects Research Requirements for Manufacturers (40 CFR part 79, subpart F) (Renewal)

In accordance with the regulations at 40 CFR 79, Subparts A, B, C, and D, Registration of Fuels and Fuel Additives, (including importers) of motor-vehicle gasoline, motor-vehicle diesel fuel, and additives for those fuels, are required to have these products registered by the EPA prior to their introduction into commerce. Registration involves providing a chemical description of the fuel or additive, and certain technical, marketing, and health-effects information. The development of health-effects data, as required by 40 CFR 79, Subpart F, is the subject of this ICR. The information collection requirements for Subparts A through D, and the supplemental notification requirements of Subpart F (including how the manufacturer will satisfy the health-effects data requirements) are covered by a separate ICR (EPS ICR Number 309.15, OMB Control Number 2060-0150). The health-effects data will be used to determine if there are any products which have evaporative or combustion emissions that may pose an unreasonable risk to public health, thus meriting further investigation and potential regulation. This information is required for specific groups of fuels and additives as defined in the regulations. For example, gasoline and gasoline additives which consist of only carbon, hydrogen, oxygen, nitrogen, and/or sulfur, and which involve a gasoline oxygen content of less than 1.5 weight percent, fall into a" baseline" group. Oxygenated additives, such as ethanol, when used in gasoline at an oxygen level of at least 1.5 weight percent, define separate "non-baseline" groups for each oxygenate. Additives which contain elements other than carbon, hydrogen, oxygen, nitrogen, and sulfur fall into separate "atypical" groups. There are similar grouping requirements for diesel fuel and diesel fuel additives.

The latest form for Fuels and Fuel Additives: Health-Effects Research Requirements for Manufacturers (40 CFR part 79, subpart F) (Renewal) expires 2026-04-30 and can be found here.

Fuels and Fuel Additives: Health-Effects Research Requirements for Manufacturers (Tier 1 Testing)

Federal Enterprise Architecture: Environmental Management - Pollution Prevention and Control