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NIST Bioeconomy Lexicon
Summary
As directed in the Executive Order on Advancing Biotechnology and Biomanufacturing Innovation for a Sustainable, Safe, and Secure American Bioeconomy, and as part of NIST’s roles within the National Biotechnology and Biomanufacturing Initiative, NIST led the development of a lexicon to help support measurements and risk assessments of the bioeconomy.
Biotechnology and biomanufacturing are increasingly vital to the global economy, including in the health care, food and agriculture, and energy sectors. Accordingly, there is a need for standardized terms and definitions to ensure a common understanding of the concepts, data, technical developments, and workforce opportunities as the bioeconomy grows both domestically and internationally.
This initial lexicon was developed by NIST in consultation with an interagency working group consisting of several U.S. government departments and agencies as directed in the Executive Order noted above, and reflects consideration of relevant domestic and international definitions as well as those from private sector stakeholders. The lexicon harmonizes a base set of terms and definitions with the goal of helping to enable the development of measurements and measurement methods for the bioeconomy that support uses such as economic measurement, risk assessments, and the application of machine learning and other artificial intelligence tools. This lexicon is intended to be a living document, and NIST intends to periodically engage with government and private sector stakeholders to inform future updates to the lexicon terms and definitions as appropriate.
If you have questions or comments about this resource, please contact bioeconomylexicon [at] nist.gov (bioeconomylexicon[at]nist[dot]gov).
DESCRIPTION AND ORGANIZATION OF THE LEXICON
Terms are listed alphabetically, with revision dates for each definition, and scope notes are provided to give context for definitions when appropriate.
Note: The bioeconomy is rapidly developing and evolving, with a possibility that some terms and definitions may change over time, and that more sector-specific or technology-specific terms and definitions will be needed as fields mature. In certain circumstances, terms may have more than one definition based on sector, technical field, and/or domestic vs. international use. In those cases, scope notes are added to provide context; those scope notes or the definitions themselves can be edited to provide clarity if increased harmonization becomes possible.
ABBREVIATED TERMS
CBRN – chemical, biological, radiological, nuclear (threats)
C.F.R. – Code of Federal Regulations
DNA – deoxyribonucleic acid
FDA – U.S. Food and Drug Administration
GWAS – genome-wide association studies
PHS – Public Health Service (Act)
RNA – ribonucleic acid
SNP – single nucleotide polymorphism
USDA – U.S. Department of Agriculture
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food technology-based alternatives (including field-grown or facility-produced) to protein harvested or obtained directly from animals
Version date: December 8, 2022
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a product determined by the Secretary of Agriculture to be a commercial or industrial product (other than food or feed) that is (A) composed, in whole or in significant part, of biological products, including renewable domestic agricultural materials and forestry materials, or (B) an intermediate ingredient or feedstock; see also "bioproduct"
Scope Note: The use of “biological product” within this definition generally refers to biomass and is outside the scope of its use referring to medical products regulated by the U.S. Food and Drug Administration (FDA) in 21 C.F.R. § 600.3(h) and by the U.S. Department of Agriculture (USDA) in 9 C.F.R. § 101.2. The separate FDA and USDA regulatory definitions of “biological product” do not affect the definition of “biobased product” herein and as defined in 7 U.S.C. § 8101(4). See also “biological product (human medical use)” and “biological product (veterinary medical use)” in this lexicon for further information.
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a biomolecule, such as an enzyme, that increases the rate of a chemical reaction
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a process using organisms, cells, or cellular components to transform a starting material
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a process by which organisms, cells, or cellular components break down an organic material
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economic activity derived from the life sciences, particularly in the areas of biotechnology and biomanufacturing, including industries, products, services, and the workforce
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energy derived in whole or in significant part from biomass
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certain food produced with biotechnology and subject to labeling under the National Bioengineered Food Disclosure Standard. As noted therein, a food is bioengineered if it contains detectable genetic material that has been modified through in vitro recombinant DNA techniques, and for which the modification could not otherwise be obtained through conventional breeding or found in nature.
Scope note: For more specific information, see U.S. Department of Agriculture (USDA) regulations within 7 C.F.R. 66.1
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the application of engineering principles and practices (including from chemical, mechanical, and electrical engineering disciplines) to the life sciences; see also "biological engineering"
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the study of ethical, social, and/or legal issues that arise in the life sciences and biotechnology
Scope note: The field of bioethics is evolving, with some entities additionally including aspects of "enviromental" and/or "economic" issues within scope. If use of these additional issues becomes more commonplace, the definition will be updated
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solid, liquid, or gaseous fuel produced from biomass or through biomanufacturing
Scope note: 1) This definition does not supersede the biofuel regulations by the U.S. Environmental Protection Agency (EPA) under the Renewable Fuel Standard (RFS) program; 2) The field of biofuels is evolving; in some circumstances, biofuels can include fuels blended from multiple biomass sources, fuels blended from a mixture of biomass and other sources, and fuels from emerging biomanufacturing technologies
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the application of computational approaches for the processing and analysis of biological data to make biological discoveries and/or predictions. Bioinformatics may encompass computer science, biology, statistics, mathematics and/or engineering to interpret biological data
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a synthetic material that is designed to exhibit one or more attributes of a biological material
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the information, including associated descriptors, derived from the structure, function, or process of a biological system(s) that is either measured, collected, or aggregated for analysis
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synonym that may be used interchangeably with bioengineering
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biomass intended for use as a starting material or an intermediate ingredient to be converted to another material through biomanufacturing or other manufacturing process
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any substance in whole or in part, derived or obtained, from a human, animal, plant, or other organism(s) or cell(s)
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a virus, therapeutic serum, toxin, antitoxin, vaccine, blood, blood component or derivative, allergenic product, protein, or analogous product, or arsphenamine or derivative of arsphenamine (or any other trivalent organic arsenic compound), applicable to the prevention, treatment, or cure of a disease or condition of human beings
Scope note: This definition refers to human medical uses regulated by the U.S. Food and Drug Administration (FDA) within 21 C.F.R. § 600.3(h), where the statutory definition of "biological product" applies only to section 351(i) of the Public Health Service (PHS) Act. The FDA’s regulatory definition of "biological product" does not affect the definition of "biological product" for veterinary medical uses as regulated by the U.S. Department of Agriculture (USDA) within 9 C.F.R. § 101.2, nor does it affect the definition of "biobased product" within 7 U.S.C. § 8101(4). See also "biological product (veterinary medical use)" and "biobased product" in this lexicon for further information
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all viruses, serums, toxins (excluding substances that are selectively toxic to microorganisms, such as antibiotics), or analogous products at any stage of production, shipment, distribution, or sale which are intended for use in the treatment of animals and which act primarily through the direct stimulation, supplementation, enhancement, or modulation of the immune system or immune response
Scope note: This definition refers to veterinary medical uses regulated by the U.S. Department of Agriculture (USDA) within 9 C.F.R. § 101.2. The USDA’s definition of "biological product" does not affect the definition of "biological product" for human medical uses as regulated by the U.S. Food and Drug Administration (FDA) within 21 C.F.R. § 600.3(h), nor does it affect the definition of "biobased product" within 7 U.S.C. § 8101(4). See also "biological product (human medical use)"and "biobased product" in this lexicon for further information
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the use of biological systems to produce goods and services at commercial scale
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any material of biological origin that is available on a renewable or recurring basis. Examples of biomass include plants, trees, algae, and waste material such as crop residue, wood waste, animal waste and byproducts, food waste, and yard waste
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a plastic, in whole or in significant part, derived from and/or composed of biomass; see also "biobased polymer"
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synonym that may be used interchangeably with biobased product
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a vessel used for bioconversion, biosynthesis, cell expansion, or other cell manipulation
Scope note: This definition does not contain an exhaustive list of processes that can occur within a bioreactor, including any process within scope of the definitions for "bioconversion" and "biosynthesis" elsewhere in this lexicon
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a process whereby organisms, cells, or cellular components are used for environmental decontamination
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the effect of uncertainty expressed by the combination of the consequences and the associated likelihood of occurrence that a biological event will adversely affect the health of humans, nonhuman animals, and/or the environment. A biological event may include naturally occurring disease, accidental infection or release, unexpected discovery, loss, theft, misuse, diversion, or intentional unauthorized release of a biological agent or biological material
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practices, controls, and containment infrastructure that reduce the risk of unintentional exposure to, contamination with, release of, or harm from pathogens, toxins, and biological materials
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security measures designed to prevent the loss, theft, misuse, diversion, unauthorized possession or material introduction, or intentional release of pathogens, toxins, biological materials, and related information and/or technology
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the production of a material by organisms, cells, or cellular components
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technology that applies to and/or is enabled by life sciences innovation or product development
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economic activity derived from the life sciences, particularly in the areas of biotechnology and biomanufacturing, that focuses on the sustainable and/or resource-efficient valorization of biomass
Scope note: The circular bioeconomy is a subset of the larger bioeconomy
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design, construction, and/or assembly of the components of living systems (including genetic circuits, enzymes, metabolic pathways, etc.) to achieve an intended function or outcome
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a process by which foreign nucleic acid is introduced to host cells through mechanical, chemical, or biological approaches
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a naturally occurring process or genetic engineering technology whereby the probability of a gene or suite of genes propagating throughout a population is altered to bias inheritance of the gene(s) in each generation
Scope note: The biased inheritance related to a gene drive is generally a substantial deviation from what would be expected from natural selection, either in the positive or negative direction
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techniques for genome engineering that involve nucleic acid damage, repair mechanisms, replication, and/or recombination for incorporating site-specific modification(s) into a gene or genes
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therapeutic product that mediates its effect by the expression of transferred genetic material(s), or by specifically altering a target genome
Scope note: The expression referred to in a gene therapy product can occur via transcription or translation, and the target genome is not limited to human cells
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selective, deliberate alteration of genes (genetic material) by means of recombinant DNA technology
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nucleic acid sequences and associated information pertaining to their structure and/or function
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techniques for genome engineering that involve nucleic acid damage, repair mechanisms, replication, and/or recombination for incorporating site-specific modification(s) into a genome
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process of introducing intentional changes to genomic nucleic acid, including through genome editing or genetic engineering
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data pertaining to all or part of the genetic or epigenetic sequence information of organisms and their functions, including genome-wide association studies (GWAS), single nucleotide polymorphism (SNP) arrays, and genome sequence, transcriptomic, metagenomic, epigenomic, and gene expression data
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the study of all or a significant portion of nucleic acids and their function(s) in an organism
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the study or use of living organisms, viruses, or their products, including all disciplines, methodologies, and applications of biology (including biotechnology, genomics, proteomics, bioinformatics, and pharmaceutical and biomedical research and techniques)
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medicines and medical supplies that can be used to diagnose, prevent, protect from, or treat conditions or diseases related to chemical, biological, radiological, or nuclear (CBRN) threats
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the study of all or a significant portion of metabolites within an organism or biological material
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the study of nucleic acids and their function(s) from all or a significant portion of the organisms within a collection
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refers to combined information derived from data, analysis, and interpretation of multiple omics measurement technologies to identify or analyze the roles, relationships, and functions of biomolecules (including nucleic acids, proteins, metabolites) that make up a cell or cellular system. Omics are disciplines in biology that include genomics, transcriptomics, proteomics, and metabolomics
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the study of all or a significant portion of proteins produced and/or modified by an organism
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treatments used to alleviate or prevent specific diseases or medical conditions
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the study of all or a significant portion of RNA transcripts, including coding and non-coding, that are produced within an organism or biological material
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a preparation that is used to stimulate the body’s immune response against a specific disease or set of diseases
Version date: December 8, 2022
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