Resources

Adventitious Presence (AP)

refers to detection of the unintentional presence of biotech crops that have not been approved in any countries on the basis of a food safety assessment according to the relevant Codex guidelines. (From working definition in FAO survey)

Agricultural Biotechnology

See biotechnology

Agricultural value chain

Agricultural value chain, GAABT defines the agricultural value chain as the whole range of goods and services necessary for an agricultural product to move from the farm to the final customer or consumer.

Approval

See Regulatory Review and Approval

Asymmetric approval

Asymmetric approval (also known as an isolated foreign approval) occurs when a cultivating country has approved a biotech crop, but its developer does not seek approval in key importing countries.

Asynchronous approvals

Asynchronous approvals occur when there is a gap of time between the approval of a biotech trait in the country of origin (or exporting country) and an importing country, resulting primarily from dissimilar regulatory regimes with differing statutes and review processes across countries.

Authorization

see Regulatory Review and Approval.

Biosafety system

See Regulatory system.

Biotechnology

According to GMOanswers.com, biotechnology is “a set of tools that uses living organisms (or parts of organisms) to make or modify a product,  improve plants, trees or animals, or develop microorganisms for specific uses. Examples of biotechnology include traditional applications, such as the making of bread, cheese, wine and beer, and more modern applications to grow or culture cells for research…” Agricultural biotechnology uses techniques of genetic engineering to make biotechnology-derived crops (or genetically modified crops) for food, feed, fuel and fiber.

Biotechnology-derived products, biotech products

According to GMOanswers.com, biotechnology is “a set of tools that uses living organisms (or parts of organisms) to make or modify a product, improve plants, trees or animals, or develop microorganisms for specific uses. Examples of biotechnology include traditional applications, such as the making of bread, cheese, wine and beer, and more modern applications to grow or culture cells for research…” Agricultural biotechnology uses techniques of genetic engineering to make biotechnology-derived crops (or genetically modified crops) for food, feed, fuel and fiber.

Co-mingling

Co-mingling occurs when commodity grain produced in one place mixes with grain produced elsewhere, as in a common storage container or shipment.

Codex Alimentarius Commission

An international body established by the UN to develop “harmonised food standards, guidelines, and codes of practice to protect the health of the consumers and ensure fair practices in the food trade. The Commission also provides the coordination of all food standards work undertaken by international governmental and non-governmental organizations… Codex standards are based on the best available science assisted by independent international risk assessment bodies or ad-hoc consultations organized by FAO and WHO. While being recommendations for voluntary application by members, Codex standards serve in many cases as a basis for national legislation.”

Competent government authority

See National authority.

Event

the insertion of a combination of genes (or ‘construct’) into a plant genome to give it a new trait or characteristic, such as insect resistance. A Stacked Event is the insertion of two or more combinations of genes into the same plant species to give it more than one new characteristic.

Food safety assessment

A food safety assessment for products of ag biotechnology is a special kind of risk assessment which is designed to identify whether a hazard, nutritional or other safety concern is present in foods derived from the new products, and if so, to gather information on its nature and severity. The internationally-recognized Codex “Guideline for the Conduct of Food Safety Assessment of Foods Derived from Recombinant-DNA Plants” follows the ‘principle that the safety of foods derived from new plant varieties, including recombinant-DNA plants, is assessed relative to the conventional counterpart having a history of safe use, taking into account both intended and unintended effects. Rather than trying to identify every hazard associated with a particular food, the intention is to identify new or altered hazards relative to the conventional counterpart.’

Food safety assessment in cases of LLP are informed by Codex Annex guidelines which  recognize that “dietary exposure will be significantly lower than would be considered in a food safety assessment of the recombinant-DNA plant according to the Codex Plant Guideline.  As a result, only certain elements of the Codex Plant Guideline will be relevant and therefore are included in [the] Annex” describing the recommended approach to the food safety assessment in such situations or in advance preparation for such potential circumstances.

See also Risk Assessment.

Genetic Engineering

According to GMOAnswers.com, genetic engineering is ‘the name for certain methods used to introduce new traits or characteristics to an organism typically involving the use of recombinant DNA methods. While these techniques are sometimes referred to as “genetic modification” or “GM”, “genetic engineering” is considered to be a more precise term.’

Genetically Modified Organism (GMO)

According to GMOAnswers.com, the term GMO is “often used to describe organisms developed using the tools of genetic engineering. In plants, GMOs commercially available include corn (field and sweet), soybeans, sugar beets, cotton, alfalfa, papaya, squash and canola. Farmers choose to use GM seeds to reduce crop damage from weeds, diseases and insects, as well as from extreme weather conditions, such as drought.”

Living modified organism (LMO)

According to the Cartagena Protocol on Biosafety, “a Living Modified Organism (LMO) is …any living organism that possesses a novel combination of genetic material obtained through the use of modern biotechnology. … In everyday usage LMOs are usually considered to be the same as GMOs (Genetically Modified Organisms), but definitions and interpretations of the term GMO vary widely.”

Low level presence (LLP)

LLP is referred to by Codex as “low levels of recombinant DNA plant materials that have passed a food safety assessment according to the Codex Guideline for the conduct of Food Safety Assessment of Foods Derived from Recombinant-DNA Plants (CAC/GL 45-2003) (Codex Plant Guideline) in one or more countries that may on occasion be present in food in importing countries in which the food safety of the relevant recombinant-DNA plants has not been determined.”

National authorities

Government regulators with expertise in environmental, food and feed safety who perform and/or review risk assessments of biotechnology crops. Also known as ‘competent government authorities’.

Regulatory review and approval

The process a country may use to evaluate the safety of biotechnology crops before they can enter the marketplace. Most countries require risk assessments in line with the Codex guideline, which are conducted and/or reviewed by government regulators with expertise in environmental, food and feed safety.

Regulatory system

collectively, the regulatory and risk assessment frameworks, processes, structures and authorities that evaluate and make approval decisions to enable research, development and commercialization of agriculture biotechnology crops and their use in food feed, fuel and fiber. Also known as ‘biosafety system’.

Risk assessment

According to the World Health Organisation (WHO), “Risk assessment is the scientific evaluation of known or potential adverse health effects resulting from human exposure to foodborne hazards.” In general, the process consists of the following steps:

• Hazard identification of known or potential health effects associated with a specific food
• Hazard characterization: evaluation of the adverse effects
• Exposure assessment: evaluation of the degree of intake likely to occur
• Risk characterization: Integration of the above evaluations into an estimation of the adverse effects likely to occur.

The Codex Alimentarius Commission has developed principles for risk assessment of ag biotechnology product. See also food safety assessment.

Synchronized approvals

when importing countries review and complete their approval decisions for new biotech products in step with review and approval timelines in exporting countries, ideally within 24 months from the date of submission.

Threshold

a maximum acceptable level of non-standard material that can be present in a product. In the context of agricultural trade, according to GMO Compass, ‘the maximum level (in percent) of unintentional, technically unavoidable GMO content in seed, food, or feed that does not [legally] need to be labelled.’  A Marketing Threshold may be even lower and set by a business in order to market a product with even less or no GMO content.

Trade disruptions

when a commodity shipment or other product is returned, recalled or destroyed due to detection of GM products that have not been approved in the destination country, often incurring additional scrutiny, delays and costs for similar shipments or products.

Zero tolerance (threshold) policy

A policy making it illegal to sell or distribute a product known to contain any amount of a biotech product not approved for food, feed or processing use in that country, even if a very small percentage of the unapproved product is found in a shipment of biotech grain or seed products that have been approved.