Allele One of the variant forms of a gene at a particular location (that is, locus) on a chromosome. Different alleles produce variation in inherited characteristics, such as blood type.
Bioeconomy Research and innovation in the biological sciences used to create economic activity and public benefit.
Biotechnology A number of methods other than selective breeding and sexually crossing organisms to endow new characteristics in organisms.
Biotechnology product A product developed through genetic engineering (including products where the engineered DNA molecule is itself the “product,” as in an engineered molecule used as a DNA storage medium) or the targeted or in vitro manipulation of genetic information of organisms, including plants, animals, and microbes. The term also covers some products produced by such plants, animals, and microbes or their derived products.
Comparator A known nonbiotechnology organism that is similar to the engineered organism except for the engineered trait.
CRISPR (clustered regularly interspaced short palindromic repeat) A naturally occurring mechanism of immunity to viruses found in bacteria that involves identification and degradation of foreign DNA. This natural mechanism has been manipulated by researchers to develop genome-editing techniques.
De novo genome sequencing Determination of the DNA sequence of the genome (full genetic complement) of an organism.
Dimensionality The spatial and temporal scales of a risk assessment.
Epigenome The physical factors affecting the expression of genes without affecting the actual DNA sequence of the genome.
Expression The result of a gene being transcribed into RNA, translated into a protein, and ultimately conferring a trait.
Gene drive A system of biased inheritance in which the ability of a genetic element to pass from a parent to its offspring through sexual reproduction is enhanced. Thus, the result of a gene drive is the preferential increase of a specific genotype, the genetic makeup of an organism that determines a specific phenotype (trait), from one generation to the next, and potentially throughout the population.
Genetic engineering Introduction or change of DNA, RNA, or proteins by human manipulation to effect a change in an organism’s genome or epigenome.
Genome The complete sequence of the DNA in an organism.
Genome editing Specific modification of the DNA of an organism to create mutations or introduce new alleles or new genes; used interchangeably with the term gene editing.
Genome engineering The use of tools that allow rapid and precise changes directly across chromosomes of living cells instead of limiting modifications at single genes.
Genomics The study of the genome which typically involves sequencing the genome and identifying genes and their functions.
Genotype The genetic identity of an individual. Genotype often is evident by outward characteristics.
Governance A set of values, norms, processes, and institutions through which society manages technology development and deployment and resolves conflict formally or informally. Governance includes oversight, which is defined more narrowly as watchful and responsible care or regulatory supervision.
Horizon scanning A technique for detecting early signs of potentially important developments through a systematic examination of potential threats and opportunities, with emphasis on new technology and its effects on the issue at hand.
Interested and affected parties People, groups, or organizations that decide to become informed about and involved in a risk characterization or decision-making process. Interested parties may or may not be affected parties, who are people, groups, or organizations that may experience benefit or harm as the results of a hazard or of the processing leading to a decision about risk.
Mesocosm A bounded and partially enclosed outdoor experimental unit that closely simulates the natural environment.
Metabolomics Systematic global analysis of nonpeptide small molecules, such as vitamins, sugars, hormones, fatty acids, and other metabolites. It is distinct from traditional analyses that target only individual metabolites or pathways.
Nontarget effects Unintended, short- or long-term consequences for one or more organisms other than the organism intended to be affected by an action or intervention. Concern about nontarget effects typically centers around unforeseen harms to other species or environments, but nontarget effects can also be neutral or beneficial.
Off-target effects Unintended, short- or long-term consequences of an intervention on the genome of the organism in which the intended effect was incorporated.
Oversight See Governance.
Phenotype/Phenotypic The visible and/or measurable characteristics of an organism (i.e., how it appears outwardly and physiologically) as opposed to its genotype, or genetic characteristics.
Problem formulation The scoping phase of a risk assessment, in which the characteristics and use pattern of the product to be assessed are documented, as are the ecosystem or human population potentially at risk and the endpoints that will be the focus of the assessment.
Reagent Generally a chemical used in a science experiment; in the context of genome editing, a chemical that is used to modify DNA.
Recombinant DNA A novel DNA sequence created by joining DNA molecules that are not found together in nature.
Regulation A subcategory of oversight and governance that represents an authoritative rule dealing with details or procedure or a rule or order issued by an executive authority or regulatory agency of a government and having the force of law.
Regulatory science The development and implementation of risk-analysis methods and the maximization the utility of risk analyses to inform regulatory decisions for biotechnology products, consistent with human health and environmental risk–benefit standards provided in relevant government statutes. Regulatory science includes establishment of information and data quality standards, study guidelines, and generation of data and information to support risk analyses. It can include the development of risk-mitigation measures as well as the development and implementation of safety training and certification programs to help ensure the intended benefits of products are realized and risks to workers, users, and the environment are minimized. Individuals in government, industry, academia, and nongovernmental organizations that contribute to the advancement of regulatory science have degrees across disciplines in the natural, socioeconomic, and computational sciences, engineering, and public policy.
Risk analysis Risk assessment, risk communication, risk management, and policy relating to risk to human health and the environment, in the context of risks of concern to individuals; to public, private, and nongovernmental organizations; and to society at a local, regional, national, or global level.
Risk-assessment endpoint Societal, human health, or environmental values that need to be managed or protected.
RNA interference (RNAi) A natural mechanism found in nearly all organisms in which the levels of transcripts are reduced or suppressed and can be exploited with biotechnology to modify an organism.
Stressor Any agent or actor with the potential to alter a component of the ecosystem.
Synthetic biology The application of engineering principles to reduce genetics into DNA “parts” so that those parts can be understood in terms of how they can be combined to build desired functions in living cells. Through this process, it is possible to assemble new organisms from parts of DNA from more than one source organism or to build synthetic DNA from molecules.
Trait A genetically determined characteristic or condition.
Transcriptomics The study of transcripts including the number, type, and modification, many of which can impact phenotype.
Transgene Any gene transferred into an organism by genetic engineering.
Transgenic organism An organism that has had genes that contain sequences from another species or synthetic sequences introduced into its genome by genetic engineering.