The Agricultural Biotechnology industry is expanding at an exciting and brisk pace—and for very good reasons. Like no other industry today, biotechnology offers the market potential for highly attractive products that have economical and well as environmental benefits. Biotechnology is poised to reduce the use of pesticides; lessen our dependence on the petrochemical industry through plant–based plastics and films; increase revenue for farmers through crop-derived inks, lubricants, and synthetics; and improve the nutritional qualities of food.

At the same time, this flourishing industry is also evolving. As biotechnology companies prepare to bring their products to market, they must first deal with a number of issues related to the complexities of regulatory compliance. Naturally associated with genetically modified plants and animals are concerns that plant and animal ecosystems could become disrupted, that through unintended gene flow other plant species might become contaminated or that resistance by crop pests to GMO traits could accelerate.

Although multifaceted and demanding, regulatory compliance policies are also designed to help companies avoid the potential of financial risks and liabilities. When buying, growing or transporting genetically engineered products, biotechnology companies face basic economic problems and potential public relations difficulties. Just a few of these possible problems include adverse consumer reactions to GMO food sources, errors resulting in midstream storage, inadvertent flaws in processing systems and mistakes made with improper shipment methods.

To succeed in the biotechnology industry, companies must develop a sophisticated strategy that allows them to integrate strict compliance policies into their handling systems. Before commercialization, genetically engineered plants and organisms must conform to standards set by state and federal marketing statues such as State seed certification laws; the Federal Food, Drug, and Cosmetic Act (FFDCA); or the Toxic Substances Control Act (TSCA). Furthermore, because products are regulated according to their intended use, it is critical that biotechnology companies become familiar with the agencies primarily responsible for regulating the biotechnology industry, agencies such as the U.S Department of Agriculture (USDA), the Environmental Protection Agency (EPA) and the Food and Drug Administration (FDA).

With some products being regulated under more than one agency, it is equally important for biotechnology companies to become familiar with pertinent compliance policies. For instance, within the USDA some regulations require a permit or notification prior to introducing a regulated product into the environment. Also, the EPA, which works to ensure the safety of chemical and biological pesticides, regulates the distribution, sale, use and testing of plants and microbes that generate pesticidal substances. And, the FDA bases its regulatory work on existing food law, requiring that genetically engineered foods meet the same meticulous safety standards required of all other foods.

In the dynamic yet ever changing world of biotechnology, companies must work strategically to incorporate the appropriate purchasing, handling, processing, storage and shipment of GMO products. Understanding the challenges, developing sound relationships with the regulatory agencies, and learning the relevant policies associated with a particular application will substantially help biotechnology companies capitalize on this explosive market.