Glossary of Biotechnology Regulation and Compliance Terminology

Experimental Use Permit (EUP): The U.S. Environmental Protection Agency (EPA) requires, pursuant to its authority under the Federal Insecticde, Fungicide, and Rodenticide Act (FIFRA) an EUP for field trials larger than 10 acres (or one acre in aquatic systems) of certain regulated articles, including plants containing pest control characteristics derived through biotechnology.

Federal Seed Act: The U.S. Federal Seed Act is essentially a truth-in-labeling law covering the sale of seed in interstate commerce and seed imported into the United States. The law requires seed to be labeled with information, allowing buyers to make informed choices. It also helps promote uniformity among state laws and fair competition within the seed trade.

Gene: The fundamental physical and functional unit of heredity. A gene is typically a sequence of DNA that encodes a specific functional product (such as a protein or RNA molecule).

Genetic engineering: Manipulation of an organism's genes by introducing, deleting, or rearranging specific genes or DNA sequences using the methods of modern molecular biology, particularly those referred to as recombinant DNA techniques.

Herbicide-tolerant crops: Crops that have been developed to survive application(s) of particular herbicides by the incorporation of certain gene(s) either through genetic engineering or traditional breeding methods. The genes enable crops to survive the application of certain herbicides to provide effective weed control without damaging the crop itself.

Insect Resistance Management (IRM): A set of strategies designed to reduce the frequency and slow the evolution of resistance to control measures by insect pests. Unlike with any other crops, growers of insect protected biotech crops have from their first plantings used a variety of resistance management measures. These have included the widespread use of refugia - the setting aside of a certain area of untreated crops to provide a haven for insect pests to reduce the pressure on them to adapt to the control measures employed.

Introgression: The common phenomenon in which genes move from one population to another, usually via pollen carried by wind, or animal pollinators such as birds or insects.

Investigative and Enforcement Services (IES): A serious incident or a history of lesser incidents may prompt APHIS-BRS CIB to refer a situation to another APHIS office, IES, for further investigation. BRS also works closely with state departments of agriculture and other federal agencies, including the FDA, EPA and the Department of Justice to ensure compliance with APHIS regulations. The Plant Protection Act provides for substantial penalties for serious infractions, including fines up to $500,000 and the possibility of criminal prosecution.

ISO Certification: ISO refers to the International Organization for Standardization, based in Geneva, Switzerland, a non-governmental body that sets voluntary international standards for a variety of scientific, industrial, manufacturing and commercial purposes to help ensure quality and consistency. A process that is ISO certified has been executed in compliance with relevant ISO approved protocols and standards.

Notifications: Introductions of most crop varieties improved through biotechnology are authorized by APHIS under a notification procedure. This is a streamlined alternative to the full-blown permit process. The notification requires less paperwork and is accomplished in less time than the permit procedure (30 as opposed to 120 days). Notifications are reserved for crops improved through biotechnology with which APHIS has extensive experience and solid confidence in their safety.

Organization for Economic Co-operation and Development (OECD): The OECD is a voluntary association of member countries that cooperate to produce internationally agreed instruments, decisions and recommendations in areas where international cooperation is required to enable countries to profit from being integrated into global markets. One such instrument is the OECD seed schemes, through which more than 55 countries cooperate to establish international best practices and standards for the production of seed of uniform high quality. The OECD annual list of products includes about 37,000 varieties of 191 species.

Permits: Applicants must obtain permits for all introductions of new plant varieties or plant associated microbes produced through biotechnology that APHIS believes or has reason to believe may present a plant pest risk. These are termed "regulated articles." In making a decision on a request for a permit, USDA scientists evaluate any potential plant pest risks and environmental impacts posed by the introduction of the regulated article.

Petitions: Developers and researchers may petition APHIS for a determination of regulatory status of a regulated article. Successful petitions result in the removal of the regulated organism from further USDA oversight (though regulation can be re-instated if new data indicate a need). For food safety review, FDA consultations may also be needed. For plant incorporated protectants (PIPs) or for other organisms that involve new herbicide uses, EPA registration may be needed.

Plant-Made Pharmaceuticals (PMPs): An innovative application of biotechnology, whereby plants are modified to enable them to produce proteins useful as pharmaceutical substances for new therapeutics that can treat diseases and save lives. Such plant derived proteins can serve as essential building blocks for drugs that may treat and cure such widespread diseases as cancer, HIV, heart disease, diabetes, Alzheimer's and others. FDA regulates the evaluation, production and distribution of pharmaceutical products.