Fuel and Fuel Additive Regulation under the Clean Air Act
The press for renewable energy has created a significant demand for novel fuels and fuel additives, while also heightening public interest in their potential health and environmental effects. Although the U.S. Environmental Protection Agency (EPA) registration process for fuels and fuel additives was once relatively simple, it has become more involved over recent years, with increased emphasis on -- and scrutiny of -- fuel products’ potential impact on public health and welfare. Now obtaining and maintaining an EPA registration requires a complex determination of the fuel/fuel additive group in which a fuel or additive may be enrolled and may also require complex testing if a new fuel/fuel additive group must be created.
Bergeson & Campbell, P.C.’s (B&C®) deep and extensive knowledge of EPA’s regulatory process, and its fuel registration requirements under the Clean Air Act (CAA), well serves our clients who are fuel and fuel additive manufacturers. We help these clients navigate the increasing complexities and challenges in obtaining an EPA registration and we continue to work with these manufacturers to assist them in maintaining their registrations.
B&C’s professionals have significant and specialized expertise in the growing area of fuel and fuel additive regulation.
B&C attorney Timothy Backstrom worked extensively on fuel and fuel additive registration and regulation issues during his 25 years with the EPA Office of General Counsel (OGC). Mr. Backstrom was directly involved in the promulgation by EPA in 1994 of new fuel and fuel additive testing regulations, and helped develop the system for classifying fuels and fuel additives and the system for imposing specialized data development requirements for atypical fuel additives. Mr. Backstrom was the EPA attorney who handled extensive litigation concerning the manganese-containing fuel additive MMT, and he argued for EPA in cases involving MMT before the D.C. Circuit Court of Appeals and the Fourth Circuit Court of Appeals.
B&C attorney Lynn Bergeson has considerable experience assisting fuel additive manufacturers in resolving registration issues under CAA Section 211. Ms. Bergeson has worked with manufacturers to satisfy the testing requirements required when an additive is first registered, and to address legal questions presented when the registration is updated or amended.
What We Do:
B&C professionals routinely advise clients on matters involving fuels and fuel additives, including registration, compliance, and defense:
Product Registration –
Counsel clients in registration matters, including:
- Determining the fuel/fuel additive group in which a fuel or additive may be enrolled
- Determining whether particular testing requirements may be waived
- Resolving data generation issues when testing is required
- Cost allocation for data generation
- Public health and welfare impact of fuels
- Efficacy of emission control systems
- Counsel clients in registration matters, including:
- Assist clients in updating fuel or additive registration materials with any changes in composition or supporting information
- Advise clients in responding to regulatory proposals on new regulations or restrictions
- Defend fuel or additive products in enforcement matters
- B&C assisted a manufacturer of a fuel additive product with an unusual composition in securing registration in an existing fuel/fuel additive group, thereby resolving a critical barrier to successful marketing of the product.
- B&C assisted a manufacturer of a novel fuel product in determining the fuel/fuel additive group in which the product should be enrolled, and in evaluating options for waiving or satisfying applicable data requirements.
- B&C routinely assists existing companies and start-ups with monetizing their fuel additive innovations.