Biotechnology

Overview:

Industrial and agricultural biotechnology offer tremendous tools to diminish pollution, improve efficiencies, and enhance manufacturing output. The road to commercialization is complicated, however, and biotechnology companies, whether industrial or agricultural, must navigate a variety of regulations from agencies, including the U.S. Environmental Protection Agency (EPA), the U.S. Food and Drug Administration (FDA), and the U.S. Department of Agriculture (USDA). Relevant laws impacting biotechnology companies include, among others, the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), the Toxic Substances Control Act (TSCA), and the Plant Protection Act (PPA). A report authored by Bergeson & Campbell, P.C. (B&C^®) professionals, “The DNA of the U.S. Regulatory System: Are We Getting It Right for Synthetic Biology?,” and published in the Woodrow Wilson International Center for Scholars Synthetic Biology Project Report, reviews current regulatory oversight of synthetic biology in the United States through the lens of different products. 

Adding to the complexity faced by biotechnology companies is that requirements across federal agencies are often inconsistent. Fortunately, B&C professionals have extensive knowledge of the regulatory landscape -- with direct involvement in the development of many of the regulatory programs -- and are able effectively to counsel clients on commercializing products incorporating biotechnology.

Our Experience:

B&C professionals have been at the helm of regulatory development and compliance. Possessing both scientific and regulatory backgrounds, B&C professionals are uniquely able to address science-based legal issues.

James V. Aidala was significantly engaged in the development of EPA regulations covering biotechnology pesticide and industrial chemical products.

B&C professionals, including Lynn L. Bergeson and Lisa M. Campbell, assisted in some of the first successfully filed Microbial Commercial Activity Notices (MCAN), the EPA notification required under TSCA for certain microorganisms. Lynn Bergeson serves on the Editorial Board of Industrial Biotechnology and is a frequent contributor to the publication.

Scott J. Burya, Ph.D., a Regulatory Chemist with a Ph.D. in analytical chemistry, assists with the preparation of biotechnology notices (e.g., MCANs) under TSCA. 

Heather F. Collins, M.S., Regulatory Consultant, monitors new developments in policies and regulations impacting biotechnology and provides expertise in pesticide compliance strategies under FIFRA. 

Richard E. Engler, Ph.D., holds a Ph.D. in physical organic chemistry and is a 17-year veteran of EPA, where he served as a senior staff scientist in EPA's Office of Pollution Prevention and Toxics (OPPT). At EPA he participated in numerous TSCA reviews, including MCAN, and other biotechnology notices. He also participated in the development of guidance relating to how much an organism reported via MCAN can be changed before again being considered "new" and requiring an additional MCAN.

R. David Peveler, Ph.D., with a Ph.D. in organic chemistry, has over 15 years of regulatory experience, including a broad range of TSCA and 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.

What We Do:

B&C professionals are highly experienced in legal and regulatory issues impacting biotechnology products. We assist clients on a wide range of areas, including product registration, approval, and compliance. Areas in which we advise clients include the following:

• TSCA Matters -
  • Prepare and submit MCANs
  • Work with EPA to determine whether a client satisfies MCAN exemptions
  • Comply with MCAN submission and exemption requirements
  • Handle importing, shipping, and confidentiality issues directly related to MCANs and exemptions from the MCAN requirements
• PPA Compliance -
  • Navigate USDA's review of Genetically Modified Organisms (GMO)
• FIFRA Issues -
  • Track and evaluate the latest regulations, policies, and decisions made by EPA on biotechnology matters
  • Interact regularly with the regulatory division at EPA that handles biotechnology approvals

Representative Engagements:

• B&C assisted a major agricultural biotechnology company in tracking the latest regulatory developments in the area of weed resistance to the biotechnology platform.
• B&C assisted a global biotechnology company with developing TSCA nomenclature procedures and templates to assure consistent naming conventions.
• B&C regularly submits applications on behalf of clients to EPA's Biopesticide and Pollution Prevention Division (BPPD) (the group of EPA review scientists and regulatory staff who are responsible for approving biopesticide and biotechnology pesticide products).
• B&C regularly prepares and procures MCANs with EPA's OPPT.
• B&C’s consulting affiliate, B&C^® Consortia Management, L.L.C. (BCCM), managed the now sunsetted Biobased and Renewable Products Advocacy Group (BRAG^®), a consortium focused on addressing the unique challenges that biobased chemicals face under TSCA.