Biotechnology Practice
Several U.S. Government agencies have substantial regulatory jurisdiction over the use of biotechnology to produce new products and the introduction of these new products into commerce. The U.S. Environmental Protection Agency (EPA) has authority over a large segment of the biotechnology industry under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and the Toxic Substances Control Act (TSCA). The U.S. Food and Drug Administration (FDA) has authority under the Federal Food, Drug, and Cosmetic Act (FFDCA) over new drugs, foods, and cosmetics that incorporate products of biotechnology. The U.S. Department of Agriculture (USDA) has authority over genetically engineered plants, as well as other products of biotechnology that may be classified as a plant pest, under the Plant Protection Act (PPA). Bergeson & Campbell, P.C. (B&C) personnel had substantial direct involvement in the development of some of these regulatory programs, and have substantial experience counseling clients on matters in each of these areas.
Under the 1989 Coordinated Framework, the government-wide template of respective agency responsibilities, EPA’s Office of Prevention, Pesticides, and Toxic Substances (OPPTS) (now Office of Chemical Safety and Pollution Prevention) issued regulations covering biotechnology pesticide and industrial chemical products during the 1990’s. These regulations were developed and issued by OPPTS during a period when current B&C professional staff held senior positions. Jim Aidala and Charlie Auer (an affiliate of B&C) were both significantly engaged with the development of these rules.
EPA has been especially active with respect to pesticide products and crops designed to be pesticide tolerant and developed with the assistance of biotechnology. Many such products have achieved significant market penetration (e.g., reports indicate that over 90% of U.S. cotton acreage is planted with biotechnology cotton seed). As part of his past EPA experience, Jim Aidala was extensively involved in the issues of insect resistance management, impacts on non-target species such as Monarch butterflies, and the Starlink corn contamination incident. These issues are on-going as EPA continues to evaluate the impacts of biotechnology products on weed resistance, the potential for genetically modified organism (GMO) pollen drift (e.g., impacts on “conventional” growers involved in organic food production), and possible health consequences such as allergenic responses from novel proteins in the diet.
B&C has substantial experience in assisting clients on a wide array of biotechnology issues arising under TSCA. Lisa Campbell, Sheryl Dolan, and other B&C professionals work with clients to prepare and submit Microbial Commercial Activity Notices (MCAN) under TSCA Section 5 for intergeneric microorganisms that were not covered by the exemptions to the requirements. B&C helped clients with some of the first MCANs successfully filed. B&C also assists clients in working with EPA to determine whether particular microorganisms are covered by exemptions to the MCAN requirements and with EPA in addressing issues not clearly addressed by the regulations. B&C has worked extensively with clients to assist with often thorny and complicated compliance issues arising in terms of both MCAN submission and exemption requirements. B&C has assisted clients with import, shipping, and confidentiality issues directly related to MCANs and exemptions from the MCAN requirements.
B&C has counseled clients and has substantial expertise concerning review of GMOs by USDA’s Animal and Plant Health Inspection Service (APHIS) under the PPA. Regulations issued by APHIS prohibit the introduction into the environment of any GMO that is or may be a “plant pest,” unless the party seeking to introduce the material first obtains a permit from APHIS or successfully petitions APHIS to deregulate the organism. Because a bacterium that is classified as a “plant pest” is normally used by biotechnology researchers as a vector to introduce new sequences into the genome of plants, APHIS construes new plant varieties produced in this manner to be “plant pests” that must be reviewed for potential impact on the agricultural economy and the environment prior to introduction. This includes any genetically modified plant that has been created for resistance to a particular pesticide, resistance to a particular disease, or for any other purpose. The issues that are often considered by APHIS typically will include the possibility that new traits will be transferred by pollination to other varieties of beneficial plants or to weed species.
The future of biotech products remains both bright and uncertain. Novel features of products under development will continue to present vast potential as significant improvements to current production methods (e.g., addition of more genetic modifications (stacked genes) to address multiple pest complexes to increase crop productivity). As such, novel traits will continue to present regulatory officials with unique challenges stretching both current science and law (e.g., which agency is best suited, scientifically or legally, to evaluate and regulate the potential environmental impact of a GMO cloned animal?).
As with all regulatory arenas, the arrival of the Obama Administration for many raises either the hope or specter of additional regulatory scrutiny, especially in areas such as biotechnology. To date, officials at the involved agencies have not indicated any significant shift from past policies. At the same time, as the biotechnology industry continues to develop new products which almost certainly will result in new regulatory issues, the current Administration’s approach to biotechnology should become more evident.