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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).

Adding to the complexity faced by biotechnology companies is that requirements across federal agencies are often inconsistent. Fortunately, Bergeson & Campbell, P.C. (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 Aidala and Charles Auer were significantly engaged in the development of EPA regulations covering biotechnology pesticide and industrial chemical products.

B&C professionals, including Lynn Bergeson, Lisa Campbell, and Sheryl Dolan, 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.

Richard 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.

Jason Johnston, M.S., holds two Master of Science degrees in Chemical Engineering Practice and in Technology and Policy from the Massachusetts Institute of Technology. He has more than 25 years of experience in the field of risk assessment and has served as the project manager and/or senior scientist for a diverse range of risk assessments required under TSCA and FIFRA.

Joseph Plamondon, Ph.D., with a Ph.D. in organic chemistry, has spent decades consulting with chemical companies on a broad range of TSCA issues and has written extensively on chemical regulatory matters.

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.

Brian Xu, M.D., Ph.D., DABT® has over 15 years of industry experience as a senior toxicologist and scientist at major chemical companies. He assists clients in designing safety testing, risk assessment, product safety, and regulatory compliance programs. Dr. Xu has extensive working experience in safety assessment of biotechnology-derived pharmaceuticals, including recombinant proteins, enzymes and monoclonal antibodies, and antisense oligonucleotides.

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 requirement
  • 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.

 
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