Keller and Heckman biotechnology attorneys counsel clients on regulatory requirements for the full range of biotechnology products, including genetically modified microorganisms and plants, biobased chemicals, biopesticides, veterinary biologics, biobased plastics used for food packaging, human food and animal feed ingredients, and biofuels. Our attorneys, many of whom have scientific backgrounds, and our in-house scientists, with expertise in molecular biology, toxicology, genetic engineering, and polymer chemistry, provide clients with creative and streamlined regulatory strategies to navigate the entire product lifecycle, from scientific research to product development and manufacturing to global marketing and distribution.
Keller and Heckman’s multifaceted legal and regulatory practice is well positioned to help clients get their agricultural products, biobased chemicals, biobased fuels, and biopesticides products to the market and remain on the market. Regulatory oversight for these products is divided between multiple federal agencies under the Coordinated Framework for the Regulation of Biotechnology.
Depending on the specific product, agricultural biotechnology products may be regulated by the U.S. Department of Agriculture's (USDA) Animal and Plant Health Inspection Service (APHIS) or the Food and Drug Administration (FDA). We assist agricultural biotechnology clients in determining the legal status of human food and animal feed components developed through biotechnology and, when necessary, in obtaining regulatory clearance for the components. In particular, we help companies obtain "Generally Recognized As Safe" (GRAS) letters from FDA, prepare Food Additive Petitions (FAPs), and issue GRAS self-determination opinions. Where necessary we also arrange for pre-submission consultations with the appropriate regulators. We also counsel clients on submitting the required information for an ingredient to be listed in the Official Publication of the American Feed Control Officials (AFCO).
In the area of biobased chemicals and fuels, including the microbial strains used to produce them, we advise clients on requirements under the Toxic Substances Control Act (TSCA). We assist clients in preparing Microbial Commercial Activity Notices (MCANs), Premanufacture Notices (PMNs), TSCA Environmental Release Applications (TERAs), and Tier I and Tier II exemption determinations and notices. With our in-house scientists, our attorneys counsel clients on the nuanced TSCA nomenclature rules that determine whether a chemical alternative produced by a microorganism is a new chemical needing approval or an existing chemical that can go straight to market.
We have extensive experience with compliance issues for the three major classes of biopesticides (biochemical pesticides, microbial pesticides, and plant-incorporated protectants) arising under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) in the U.S., as well as products regulated under the Biocidal Products Regulation in the EU. Our experience includes advising clients on the regulatory requirements for conducting clinical studies and field tests and preparing environmental assessments and registration applications.
Biotechnology product clients, ranging from established companies to cutting-edge start-ups, benefit from the full range of our legal and regulatory practices, including Environmental, Food and Drug, Employment and Labor, Litigation, and Workplace and Safety. With our expertise in food, chemical, and pesticides law, we are uniquely positioned to advise companies on the nexus of FDA and EPA regulatory authority. In addition, we have in-depth knowledge of international trade and import/export requirements; technology transfer; and corporate transactions, including ones involving intellectual property (IP) rights, as well as the ability to assist start-up companies with negotiating venture capital and vendor financing.
- Negotiated consolidated Microbial Commercial Activity Notice (MCAN) approach with EPA, providing flexibility in genetically modified strain selection for biobased chemical production
- Advised research group on field trials of genetically modified, blight-tolerant tree under FIFRA
- Assisted client with food regulatory matters for cell-based meat
- Guided company through Class-1 and Class-2 TSCA nomenclature issues for commercial development of biofuels from algal oils
- Prepared and successfully submitted GRAS Notices for genetically modified human food ingredients to FDA
- Prepared and successfully submitted a GRAS Notice for a genetically modified animal feed ingredient to FDA’s Center for Veterinary Medicine
- Counseled company on successful TSCA Experimental Release Application (TERA) for genetically modified algae
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Areas of Focus
Counseling clients on regulatory requirements for the full range of biotechnology products, including genetically modified microorganisms and plants, biobased chemicals, biopesticides, veterinary biologics, biobased plastics used for food packaging, human food and animal feed ingredients, and biofuels
Assisting clients in determining legal status of human food and animal feed components developed through biotechnology and in obtaining regulatory clearance for the components
Preparing and submitting GRAS Notices to FDA and successfully obtaining the desired close out letters from the agency
Preparing Food Additive Petitions
Preparing and issuing GRAS self-determination opinions
Advising clients on requirements for genetically modified strains and the biobased chemical and fuels they produce, under TSCA
Counseling clients on all regulatory requirements for conducting clinical studies and field tests and assisting with preparation of environmental assessments