Definitions and Glossary
Unintentional and incidental presence of trace amounts of one or more biotechnology-derived traits in seed, grain or food product.
An approval, clearance, or other grant of authority that comes from a responsible governmental entity and covers a particular article, product or activity. This may include authorization to transport plant material between states, conduct confined field trials, and release biotechnology-derived plants for the purpose of cultivation.
Materials produced at a single stage of production.
Per the Convention on Biological Diversity, biotechnology is the application of a) in-vitro nucleic acid techniques, including recombinant deoxyribonucleic acid (DNA) and direct injection of nucleic acid into cells or organelles; or b) fusion of cells beyond the taxonomic family, that overcome natural physiological reproductive or recombination barriers and that are not techniques used in traditional breeding and selection.
Biotechnology Quality Management System Program
A voluntary program developed by the U.S. Department of Agriculture that is intended to assist organizations involved in biotechnology research and development (including small businesses and academic researchers), analyze the critical control points within their management systems to better maintain compliance with the APHIS regulations (7 CFR part 340) for the import, interstate movement, and field release of regulated, genetically engineered organisms.
Seed or vegetative propagating material, increased by the originating, sponsoring plant breeder or institution, used as the first source for further seed increase.
a. Seed of a cultivar that has been verified for its genetic identity and purity by visual inspection by an official seed-certifying agency — classes of certified seed are breeder, foundation, registered, and certified; or
b. Class of certified seed that generally is produced from a planting of registered seed, but which also may be produced from foundation or certified seed.
The control of viable seed or vegetative propagating material planted in the field in a manner that mitigates the spread of pollen or other propagative plant parts out of the confined trial area.
An engineered chimeric DNA designed to be transferred into a cell or tissue; may be synonymous with vector fragment or vector. Typically, the construct comprises the gene or genes of interest, a marker gene, and appropriate control sequences as a single package.
The control of viable seed, pollen or vegetative propagating material in a manner that mitigates their release outside of their controlled development in the laboratory, greenhouse, seed conditioning or storage facilities.
Any facility designed to limit access by unauthorized personnel as well as egress of controlled plant materials.
Critical Control Point
Specific to the Guide for Maintaining Plant Product Integrity, a step at which control can be applied and is essential to prevent, eliminate, or reduce risks to an acceptable level from an activity that may compromise plant product integrity.
Plants within a species bred for distinct characteristics, sometimes called a variety.
The act or means of settlement of (i.e., what was done with) plant material (e.g., planted, devitalized, buried or stored).
Recorded information such as specifications, quality manuals, quality plans, records, and procedure documents.
Plant materials of proven genetic utility, including existing germplasm in commerce or in an advanced stage of development.
A genotype produced from a single transformation of a plant species using a specific genetic construct. For example, two lines of the same plant species that are transformed with the same or different constructs constitute two events.
Sites that are contiguous, under common control by a company or individual, and have a grouping of equipment or individuals engaged in a common process.
Seed stocks increased from breeder seed or foundation seed, handled to maintain specific genetic identity and purity. Foundation seed is the source of certified seed, either directly or through registered seed.
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).
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.
The genetic makeup or genome of an individual, group of individuals, or a clone representing a genotype, variety, species, or culture, held in an in situ or ex situ collection.
Good Manufacturing Practice (GMP)
Good Manufacturing Practice (GMP) is a term that is recognized worldwide for the management and quality control of product manufacturing. GMP regulations and guidance are designed to ensure that products are consistently produced and controlled to quality standards. Most countries have promulgated regulations and guidelines defining GMPs and require that manufacturers comply with their own GMP guidelines.
The plant receiving the genetic elements of the construct or the genotype receiving the genetic elements of the construct.
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.
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.
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.
A group of individuals derived by descent from a single individual within a species.
Low level presence
Unintentional, trace amounts of biotechnology-derived trait(s) in a seed, grain or food product approved in one or more countries, but not yet approved in the country of import.
Organisation 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.
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.
Plant product integrity
Specific to the Guide for Maintaining Plant Product Integrity, plant product integrity (PPI) is the specific identity of a plant and purity of populations of the plant that are established and maintained using appropriate measures.
Removal of authorized commercial biotechnology-derived products that have reached the end of their commercial life cycle from the market by the technology owner and not as part of a product recall or withdrawal.
The introduction of an authorized biotechnology-derived plant product into commerce.
Recovery of a product from the supply chain and/or commerce.
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.
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.
The process of growing plant cells or an entire plant from a single cell or group of cells.
Seed increased from breeder seed and handled so as to closely maintain the genetic identity and purity of a variety used to render commercial seed.
Standard Operating Procedure (SOP)
An established, written method or set of methods that describes how to routinely perform a given task.
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.
The ability to follow the movement of a biotechnology-derived plant through specified stage(s) of development, production, and distribution of seeds or plants to growers.
A genetically determined characteristic.
A measure of the extent to which the intended trait(s) is present and unintended traits are absent in a population of plants.
A cell, cell culture or a first generation of a regenerated plant into which foreign DNA has been introduced.
The process of incorporating DNA into an organism’s genome. There are several methods to do this in plants. The most commonly used methods for plant transformation are Agrobacterium-mediated transformation and biolistic transformation.
An organism that has had genes from another organism added to its genome through recombinant DNA techniques.
A measure of the extent to which the intended transgene(s) is present and unintended transgenes are absent in plant material.
Biotechnology-derived plant material that has not been authorized by the relevant competent authority for release into the environment for purpose of cultivation or for use in the food and feed chains.
Any release of unauthorized plant material in the environment, human food, or livestock feed chains.
Subdivision of a species for taxonomic classification. Used interchangeably with the term cultivar to denote a uniform, stable group of individuals that is genetically and possibly morphologically distinct from other groups of individuals in the species.
A small self-replicating DNA molecule (plasmid, virus, bacteriophage, or artificial DNA molecule) that can be used to deliver DNA into a cell, bulk up specific DNA to be used in biolistic transformation, or maintain a construct for archival reasons.