Glossary of Biotechnology Regulation and Compliance Terminology
Adventitious presence (also known as low-level presence, or LLP): Refers to the unintentional and incidental commingling of trace amounts of one type of seed, grain or food product with another. Adventitious presence (AP) is an unavoidable reality of plant biology, seed production and the distribution of commodity crops. There are a number of factors that contribute to commingling: pollen flow; volunteerism; mixing during harvesting, transport, storage and processing; human error; and accidents can all play a role in adventitious presence. While adventitious presence can be minimized, as a practical matter it cannot be eliminated entirely and is not unique to crops enhanced through biotechnology. Adventitious presence of biotech products does not necessarily compromise food safety.
Agricultural biotechnology: A range of tools, including traditional breeding techniques, which improve domesticated plants, animals, or microbes to enhance their traits with regard to ease or efficiency of production or their end use qualities and characteristics. Modern biotechnology today includes recombinant DNA techniques.
Agricultural Biotechnology Stewardship Technical Committee (ABSTC): A coalition of agricultural biotechnology companies/technology providers that are Bt corn registrants that work together to address scientific issues central to the responsible stewardship of products of plant biotechnology.
Animal and Plant Health Inspection Service (APHIS): "Protecting American agriculture" is the basic charge of the U.S. Department of Agriculture's (USDA) Animal and Plant Health Inspection Service (APHIS). APHIS provides leadership in ensuring the health and care of animals and plants. The agency improves agricultural productivity and competitiveness and contributes to the national economy and the public health.
Association of Official Seed Certifying Agencies (AOSCA): Established in 1919 in the United States, AOSCA has grown to include members from around the world. AOSCA establishes minimum standards for genetic purity and identity and recommends minimum standards for seed quality. Its goal is to standardize certification regulations and procedures internationally so companies compete under one set of standards.
Biotechnology Regulatory Services (BRS): The division within USDA APHIS that oversees the development and introduction (importation, interstate movement and environmental release) of genetically engineered organisms. The work of BRS is coordinated across four program units: policy coordination programs, environmental risk analysis, regulatory operations programs and resource management programs.
cGMP Facility: cGMP refers to Good Manufacturing Practices, a rigorous set of manufacturing guidelines the U.S Food and Drug Administration (FDA) uses to document and ensure the products it regulates are produced safely and consistently.
Code of Federal Regulations: All U.S. federal regulations are published first in the Federal Register then in the Code of Federal Regulations (CFR), a large multi-volume series. Regulations for U.S. agriculture comprise 15 volumes. In 1987, USDA implemented regulations for biotechnology (7 CFR 340, commonly referred to as APHIS Part 340 regulations) under the authorities of the Federal Plant Pest Act and the Plant Quarantine Act.
Containment Analysis and Critical Control Point (CACCP) plan: A rigorous industry protocol to enhance compliance with federal regulations in two key product categories: Plant-Made Pharmaceuticals (PMPs), in which proteins produced in plants are used in medicines; and Plant-Made Industrial Products (PMIPs), in which plant proteins are used in industrial products. The CACCP plan is based on best practices and is endorsed by numerous U.S. government agencies and industry associations. CACCP protocols identify potential hazards and control points, and outline management plans to ensure proper handling.
Compliance and Inspection Branch (CIB): The compliance branch of APHIS BRS, CIB ensures compliance with all relevant provisions of BRS regulations, including authorizations under the permitting and notification procedures. APHIS inspectors and compliance specialists perform targeted inspections of field tests and thoroughly evaluate all potential noncompliance incidents. BRS also evaluates facilities, equipment, records of developers and potential incidents reported by permittees.
Deregulated: The common term used to refer to a biotech crop variety for which APHIS has ruled favorably on an applicant's "petition to determine regulatory status." This is usually the last regulatory step taken by USDA before a product is commercialized (though some products can be, and in fact are intended for commercial growing under permits, such as plants used to manufacture pharmaceutical compounds). It allows the product to be moved and planted freely without the need for notification or permits. A developer may file a petition for deregulation only after a biotech crop has been tested extensively and the developer can show the product does not pose a plant pest risk.
Event (also known as biotech event or transformation event): A specific and unique procedure during which a gene that enables desired characteristics is inserted into the genome of another plant. Biotech plant varieties are developed by inserting the desired gene at different locations within the recipient plant's genome.
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.
Plant Protection Act: A part of the larger Agriculture Risk Protection Act of 2000, a Federal statute under which Congress authorizes various parts of the USDA to regulate specific areas of U.S. agriculture.
Protein: A molecule composed of amino acids in a specific order. Proteins are required for the structure, function, and regulation of metabolic activities in the body's cells, tissues and organs, and each protein has a unique function.
Quality Management: A component of stewardship, which comprises the processes and systems to establish and maintain quality in each phase of the product life cycle.
Recombinant DNA (rDNA): The DNA formed by combining segments of DNA from two different sources.
Regulated: If a crop improved through biotechnology has not gone through the review process for USDA to determine if it can be safely excused from further regulatory oversight, it is commonly referred to as a "regulated article."
Remedial Measures: APHIS has authority under the Plant Protection Act to take or order remedial measures to address any known or suspected plant pest risk. This includes the authority to hold, seize, quarantine, treat, or apply other procedures, to destroy or otherwise dispose of regulated materials, if it is determined that such measures are necessary to prevent the dissemination of a plant pest within or throughout the United States.
Stewardship: Product stewardship is the responsible management of a product from its inception through to its ultimate end and discontinuation. In agricultural biotechnology, stewardship includes careful attention to the safety of products and their market impact is essential for high value products in any industry.
Transgenic: An organism that has had genes from another organism added to its genome through recombinant DNA techniques.