Keller and Heckman's biotechnology practice provides creative and streamlined regulatory strategies to help clients navigate the entire product lifecycle, from scientific research to product development and manufacturing to global marketing and distribution.
As a leader in the use of interdisciplinary approaches to assist clients, we understand the science and technology in the rapidly advancing field of biotechnology. Our attorneys—many of whom have scientific backgrounds—are assisted by a scientific staff to provide comprehensive legal and regulatory advice for biotechnology clients with a diverse range of products. Our scientists have expertise in a wide array of specialties, ranging from molecular biology and toxicology to genetic engineering and polymer chemistry.
Keller and Heckman attorneys counsels clients on regulatory requirements for the full range of biotechnology products, including genetically engineered microorganisms and plants, biobased chemicals, biopesticides, veterinary biologics, biobased plastics used for food packaging, human food and animal feed ingredients, and biofuels. 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). For example, USDA-APHIS Veterinary Services inspects biologics production establishments and licenses veterinary biological substances, including animal vaccines that are products of biotechnology. We assist 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" letters from FDA, prepare Food Additive Petitions (FAPs), and issue GRAS self-determination opinions. 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 and the microbial strains used to produce them, we regularly advise clients on requirements under the Toxic Substances Control Act (TSCA). Our attorneys also have extensive experience with compliance issues for the three major classes of biopesticides (biochemical pesticides, microbial pesticides, and plant-incorporated protectants), including regulatory requirements for conducting clinical studies and field tests, and preparation of environmental assessments.
Our clients—ranging from established companies to cutting-edge start-ups—benefit from our expertise in regulatory compliance; international trade and import/export requirements; technology transfer; corporate transactions, including ones involving intellectual property (IP) rights; litigation; and employment and labor law. We assist start-up companies with negotiating venture capital and vendor financing. We also assist companies with Occupational Safety and Health Administration (OSHA) hazard assessments and workplace compliance matters.
