Biobased Chemicals and Biofuels
Biobased chemicals and biofuels are steadily taking root thanks to both popular appeal and political support. The consumer and political goals of reducing America’s dependence on foreign oil, enhancing national security, and greening the economy converge in biobased chemicals and advanced biofuels, the promising technology of producing commercial chemicals and fuels from renewable resources. With Congress’s commitment to advanced biofuels found in the 2007 Energy Independence and Security Act, compelling incentives to invest in and support growth of biotechnologies has spurred record production. Some estimate biobased chemicals' share of the global chemical industry will grow from 2 percent to 22 percent by 2025.
Much of the growth in biofuels technology development has been driven by the fuel-blending requirements set in the U.S. Environmental Protection Agency's (EPA) Renewable Fuel Standard (RFS). But the RFS, along with other statutory incentives, is still tentative as biotechnology limitations have hampered a seamless adoption of advanced biofuels.
Companies investing in biobased products need continued legislative support to ensure their ability to flourish. At the same time, it is imperative that these companies recognize -- and work with -- regulatory standards that impact biobased products. Biotechnology companies have Bergeson & Campbell, P.C. (B&C®) to turn to for expertise on the legislative, regulatory, and scientific fronts.
B&C's team of professionals is well-versed to guide clients in navigating the challenging legal issues and policy advocacy opportunities that are unique to this emerging technology. The enormous enthusiasm that supports the rapid commercialization of biobased chemicals has eclipsed a solid understanding of the application of the Toxic Substances Control Act (TSCA) to them. While there is no doubt TSCA applies, there is a lack of clarity on how TSCA applies, to what commercial operations, and why failure to acknowledge this fact can inspire commercial havoc in otherwise well-planned business operations. B&C professionals can assist in this area and many more specific to biobased chemicals. Similar policy and regulatory issues confront biofuels legislative and regulatory actions, the management and resolution of which B&C government relations professionals are well-suited.
Lynn Bergeson has been working on industrial and agricultural chemical policy issues for over 20 years. She has worked extensively on TSCA reform, emerging technologies, including nanotechnology, biotechnology, and synthetic biology, and the application of legal and governance systems to these emerging technologies. Ms. Bergeson's work has brought her to Capitol Hill, the Organization for Economic Cooperation and Development (OECD), and other governance and standard-setting bodies on chemical policy and management issues.
James Aidala has over 30 years of experience in the field of pesticide legislation, policy, and implementation. His work experience has included senior positions on Capitol Hill and at EPA where he has been responsible for both implementing and legislating our nation's pesticide and toxic chemical laws. He is a former Assistant Administrator for EPA's Office of Prevention, Pesticides, and Toxic Substances (OPPTS) (now the Office of Chemical Safety and Pollution Prevention (OCSPP)), and held other senior political positions at EPA during the Clinton Administration. Among other responsibilities at EPA, Mr. Aidala was responsible for leading the EPA team that drafted the Food Quality Protection Act (FQPA).
Kathleen Roberts, Vice President of B&C Consortia Management, L.L.C. and Executive Director of the Biobased and Renewable Products Advocacy Group (BRAG®), is a recognized expert in chemical control regulations under TSCA and the unique and somewhat complicated ways in which these rules apply to biobased and renewable chemicals and their derivatives. Ms. Roberts has lead successful advocacy efforts for clients making new biobased chemicals and fuels to achieve regulatory parity with comparable existing petroleum based products.
Richard Engler, Ph.D., is a Senior Policy Advisor and a 17-year veteran of EPA. He is one of the most widely recognized experts in the field of green chemistry, having served as senior staff scientist in EPA's Office of Pollution Prevention and Toxics (OPPT) and leader of EPA's Green Chemistry Program. He has participated in thousands of TSCA substance reviews at EPA, as well as pre-notice and post-review meetings with submitters to resolve complex or difficult cases, and he draws upon this invaluable experience to assist B&C clients as they develop and commercialize novel chemistries.
David Peveler, Ph.D., has over 15 years of regulatory experience, including a broad range of TSCA and U.S. Food and Drug Administration (FDA) issues. Dr. Peveler has provided regulatory support based on bio-sourced feedstocks and has significant experience navigating the complex nomenclature and naming conventions applicable to natural source raw materials arising in connection with listings under the TSCA Inventory.
Joseph Plamondon, Ph.D., has spent decades consulting with chemical companies on a broad range of TSCA issues and has written extensively on chemical regulatory matters.
Molly Blessing is an Assistant Regulatory Chemist and veteran of EPA’s Green Chemistry Program, with experience analyzing applications of TSCA to biobased chemistry. Ms. Blessing determines chemical identity for Substances of Unknown or Variable Composition, Complex Reaction Products, or Biological Materials (UVCB) and other complex chemical intermediates and products.
Lauren Graham, Ph.D., leads advocacy efforts for clients producing new biobased chemicals and fuels and creates a weekly news and policy report for Biobased and Renewable Products Advocacy Group (BRAG®) members and other interested members of the biobased industry.
Oscar Hernandez, Ph.D., former Director of the Risk Assessment Division (RAD) in EPA’s OPPT, offers expert scientific support and understanding of Agency processes for chemicals being reviewed pursuant to TSCA and other federal, state, and international chemical control authorities.
What We Do:
B&C professionals assist clients on a wide range of areas, from legislative authorization and rulemaking to TSCA naming conventions, TSCA Inventory identification, and general compliance measures.
Regulatory areas in which we advise clients include the following:
- Chemical Product Approval and Review --
- Assist in the approval and regulation of industrial biobased chemical products, including those enabled by biotechnology
- Assist with reporting obligations for new and existing chemicals
- Specific Regulatory Reviews --
- Assist clients' adherence to:
- Premanufacture Notification (PMN)/Microbial Commercial Activity Notice (MCAN) requirements
- PMN requirements pertinent to biobased chemical products
- Section 5 Significant New Use Rules (SNUR)
- Recordkeeping and Reporting Assistance --
- Assist clients with their Section 8(a), (d), and (e) recordkeeping and reporting requirements, Standard Operating Procedures (SOP), and systems development issues
- Additional Sample Matters --
- Export issues
- Inventory issues
- Assist clients' adherence to:
Advocacy areas in which we represent clients include efforts to support Congressional appropriations for and reauthorization of existing bioenergy programs, efforts to influence rulemaking to implement bioenergy programs, and efforts to secure financing for construction of biofuel production facilities.
- Representing biobased chemical producers, we have tackled unique questions of first impression before EPA regarding application of TSCA obligations to biobased chemicals and have assisted with how the issues are framed and resolved.
- We have prepared and obtained approvals for microbial chemical substances under EPA's MCAN program.
- We have assisted large chemical producers with assessing their naming conventions under TSCA of chemical substances procured from naturally-occurring substances.
- We are a proud sponsor of the BIO World Congress, and presented a workshop on TSCA's application to biobased chemicals.
- Our government relations professionals have assisted large and small chemical, biotechnology, and biofuel clients advance their bioenergy policy objectives before Congress, the U.S. Department of Energy (DOE), U.S. Department of Agriculture (USDA), and EPA.
- We have organized and managed a coalition of clients to advance Congressional appropriations and authorizing legislation supporting production of nonfood bioenergy crops.