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Advocating for Biobased Chemicals and Biofuels

Overview:

Biobased chemicals and advanced biofuels are promising technologies sought worldwide by countries hoping to achieve greater energy independence and greener economies. According to one estimate, biobased chemicals’ share of the global chemical industry is expected to 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 by the U.S. Environmental Protection Agency’s (EPA) and the European Commission’s (EC) renewable fuel standards, established in 2007 and 2009, and the funding and tax incentives provided to this industry in recent years. As renewable energy and advanced biofuels become commercial realities, emerging conversion technologies are producing business opportunities for a growing list of biobased products. The growth opportunities buttressed by governmental supports provide ample opportunities for stakeholders -- both in the market and in the policy-making process.

Our Experience:

The Acta Group (Acta®) team of professionals is well-versed to assist clients in navigating the challenging regulatory issues and policy advocacy opportunities that are unique to this emerging technology.

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 was  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)).

Lynn Bergeson has been working on industrial and agricultural chemical policy issues for over 20 years. She has worked extensively on Toxic Substances Control Act (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.

Richard Engler, Ph.D., is Senior Chemist with Acta and a former 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 Bergeson & Campbell, P.C. (B&C®) clients as they develop and commercialize novel chemistries.

Dr. 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.

Dr. 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:

Acta professionals manage regulatory, legislative, and policy issues critical to evolving biobased technologies, including bioenergy, biofuels, and biobased chemical production. We assist clients in a wide range of areas, from legislative authorization to rulemaking.

Regulatory areas in which we advise clients include the following:

  • Strategic Planning to Identify the Most Efficient and Effective Regulatory Pathways
  • 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

Advocacy areas in which we represent clients include efforts to support governmental appropriations for and reauthorization of existing bioenergy and biomass production programs, influence rulemaking to implement bioenergy and biomass production programs, and help clients secure financing for construction of biofuel production facilities.

Representative Engagements:

  • We assist biobased chemical producers to assess and comply with regulatory obligations as they relate to biobased chemicals. In this regard, we have tackled unique questions of first impression before EPA, 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 to advance their bioenergy policy objectives before the U.S. Congress, 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 for programs supporting production of non-food bioenergy crops.

 
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