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.