Practice/Industry Group Overview
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.
Articles Authored by Lawyers at this office:
FDA Finalizes Rule Prohibiting Certain Nutrient Content Claims for Omega-3 Fatty Acids
Melvin S. Drozen,Alissa D. Jijon,Leslie T. Krasny,Richard F. Mann,Evangelia C. Pelonis, May 06, 2014
On April 28, 2014, the Food and Drug Administration (FDA) published a final rule that will prohibit certain nutrient content claims for foods and dietary supplements containing the omega-3 fatty acids docosahexaenoic acid (DHA), eicosapentaenoic acid (EPA), and alpha-linolenic acid (ALA). As...
Notable Provisions of H.B. 112
Melvin S. Drozen,Leslie T. Krasny,Eric S.C. Lindstrom,Richard F. Mann,Frederick A. Stearns, April 30, 2014
Section 3403 sets forth the GMO labeling requirements in Vermont. Foods that are produced entirely or partially with genetic engineering must be labeled as follows:
FSMA Update: FDA Seeks Input on Reportable Food Registry Requirements
Melvin S. Drozen,Alissa D. Jijon,Evangelia C. Pelonis, April 01, 2014
FDA has issued an Advanced Notice of Proposed Rulemaking (ANPRM) to seek comments, data, and information from stakeholders that will assist the Agency with implementing amendments to the Reportable Food Registry (RFR) requirements that were enacted as part of the FDA Food Safety Modernization Act...
FDA Announces Major Revisions to the Nutrition and Supplement Facts Labels
Melvin S. Drozen,Leslie T. Krasny,Eric S.C. Lindstrom,Richard F. Mann,Frederick A. Stearns, March 05, 2014
Today, the Food and Drug Administration (FDA) announced the availability of three proposed rules that would revise the Nutrition Facts label requirements. These proposals will be published in the Federal Register on Monday, March 3.
A Brief History and Overview of Country of Origin Labeling Requirements
Melvin S. Drozen,Alissa D. Jijon, January 06, 2014
Country of Origin Labeling (COOL) laws and regulations require retailers to notify their customers of the country of origin of covered commodities, which include beef, veal, lamb, chicken, fish and shellfish, goat, pork, perishable agricultural commodities, macadamia nuts, pecans, ginseng, and...
FDA Tentatively Determines Trans Fats Not GRAS
Melvin S. Drozen,Evangelia C. Pelonis, November 11, 2013
On November 7, FDA announced that it has tentatively determined that partially hydrogenated oils (PHOs) are not generally recognized as safe (GRAS) under any condition of use in food and therefore are food additives that, unlike GRAS substances, require pre-market approval by FDA before they can be...
OSHA Proposes Revisions to Crystalline Silica Standard
Lawrence P. Halprin,Manesh K. Rath,David G. Sarvadi, November 05, 2013
On September 12, 2013, the Occupational Safety and Health Administration (OSHA) issued a proposed rule to establish comprehensive, substance-specific health standards for occupational exposure to respirable crystalline silica (RCS) for General Industry, Maritime, and Construction activities.
OSHA's Proposed Silica Health Standard: A Summary of Key Elements
Lawrence P. Halprin,Manesh K. Rath,David G. Sarvadi, October 11, 2013
On September 12, 2013, the Occupational Safety and Health Administration (OSHA) issued a proposed rule to establish comprehensive, substance-specific health standards for occupational exposure to respirable crystalline silica (RCS) for General Industry, Maritime, and Construction activities. The...
FDA Issues Revised Draft Guidance on "Medical Foods"
Melvin S. Drozen,Frederick A. Stearns,Laura Venker, August 19, 2013
On August 13, the Food and Drug Administration (FDA) announced the availability of a draft guidance entitled “Frequently Asked Questions About Medical Foods; Second Edition.” The draft guidance updates and expands a previous draft issued in May 2007 regarding the definition, labeling,...
"Gluten-Free" Claims - FDA Publishes Final Rule
Evangelia C. Pelonis,Laura Venker, August 07, 2013
The Food and Drug Administration (FDA) has published a final rule that defines the term “gluten-free” and deems misbranded any use of such a claim or related claims on foods that do not meet the definition. The final rule creates new 21 CFR 101.91 in Subpart F—Specific...