Biotechnology
Overview
A uniformly accepted definition of biotechnology does not exist. Under the broadest definition, the use of biological sciences to develop products, conventional plant and animal breeding techniques, conducted since the dawn of civilization, fall under biotechnology. In the popular press, biotechnology generally refers to newly developed scientific methods used to create products by altering the genetic makeup of organisms and producing unique individuals or traits that are not easily obtained through conventional breeding techniques. These products are often referred to as transgenic, bioengineered, or genetically modified because they contain foreign genetic material. Agriculture is one of the first industries radically affected by this new technology on both a fundamental production level and a legal level. Read the full overview.
Note: Recently added resources are posted at the top of the applicable sections.
Major Statutes
National Bioengineered Food Disclosure Standard, 7 U.S.C. §§ 1639-1639g
Labeling of Certain Food, 7 U.S.C. §§ 1639i-1639j
Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. §§ 301-399h
Toxic Substances Control Act (TSCA),15 U.S.C. §§ 2601-2629
Animal Health Protection Act, 7 U.S.C. §§ 8301-8322
Federal Insecticide, Fungicide, and Rodenticide Act, 7 U.S.C §§ 136-136y
Virus-Serum-Toxin Act,21 U.S.C. §§ 151-159
Plant Protection Act (PPA), 7 U.S.C. §§ 7701-7786
Plant Variety Protection Act (PVPA), 7 U.S.C. §§ 2321-2582
Plant Patent Act, 35 U.S.C. §§ 161-164
Uniform Food, Drug, and Cosmetic Act, C.G.S. §§ 21a-91-125
Labeling of Food Produced with Genetic Engineering, 9 V.S.A. §§ 3041-3048
Regulations
National Bioengineered Food Disclosure Standard, 7 C.F.R. §§ 66.1-66.406
Movement of Organisms Modified or Produced Through Genetic Engineering Regulations, 7 C.F.R. §§ 340.1-340.8
Procedures and Requirements for Plant-Incorporated Protectants, 40 C.F.R. §§ 174.1-174.705
Plant Variety and Protection Regulations, 7 C.F.R. §§ 97.1-97.900
Federal Register Rules Open for Comment
Case Law
Case Law Index for Biotechnology
Administrative Law Decisions
USDA Office of the Administrative Law Judges
USDA National Appeals Division
FDA Dockets Management
EPA Office of Administrative Law Judges
EPA Environmental Appeals Board
USDA Judicial Officer’s Decisions (NALC published)
Center Research Publications
The Bioengineered Food Disclosure Standard (Caracciolo, 2022)
The Regulation of “Cell-Cultured Meat” (Rollins and R. Rumley, 2019)
Non-GMO Labeling (E. and R. Rumley, 2012)
Nation-Specific Risk Tolerance in the WTO: US-Continued Suspension of Obligations in the EC-Hormones Dispute (Peck, 2009)
Plant Biotechnology Law After Geertson Seed Farms: Potential Impacts on Regulation, Liability, and Coexistence Measures (Peck, 2008)
International Legal Issues Concerning Animal Cloning and Nanotechnology — More of the Same or Are “The Times They Are A-Changin'”? (Roberts, 2008)
Summary of the WTO Interim Report in EC-Biotech (Peck, 2006)
Revising Seed Purity Laws to Account for the Adventitious Presence of Genetically Modified Varieties: A First Step Towards Coexistence (Endres, 2005)
Farmers’ Guide to GMOs (Moeller and Sligh, 2005)
The War on GMOs: A Report from the Front (Harbison, 2004)
Jack and the Beanstalk: Property Rights in Genetically Modified Plants (Busch, 2004)
J.E.M. Ag Supply v. Pioneer Hi-Bred Int’l: Its Meaning and Significance (Roberts, 2002)
Legal Liability in Biotechnology (Kershen, 2002)
Congressional Research Service Reports
Reports– published and made available by CRS beginning in 2017
Subjects- published by CRS and made available by NALC until 2018:
Agricultural Law Bibliography
Introduction | Keyword Search | Browse Categories
Legal publications on Biotechnology:
Agribusiness Corporations
Biotechnology
Environmental Issues
Food and Drug Law
Patents and Other Intellectual Property Rights in Agriculture
Sustainable and Organic Farming
Torts, Insurance
Congressional Resources
Reports on Biotechnology (Government Accountability Office)
USDA Needs to Enhance Oversight and Better Understand Impacts of Unintended Mixing with Other Crops (GAO-16–241)
FDA and USDA Could Strengthen Existing Efforts to Prepare for Oversight of Cell-Cultured Meat (GAO-20-325)
Reference Resources
Unified Website for Biotechnology Regulation
About
Frequently Asked Questions
Modernizing the Regulatory System for Biotechnology Products: Final Version of the 2017 Update to the Coordinated Framework for the Regulation of Biotechnology
Department of Agriculture (USDA)
Bioeconomy
How the Federal Government Regulates Biotech Plants
Biotechnology Frequently Asked Questions
Biotechnology Glossary
Roles of USDA Agencies in Biotechnology
Advisory Committee on Biotechnology & 21st Century Agricultural
Biotechnology and Climate Change
Agricultural Marketing Service (AMS)
BE Disclosure
BE Symbols
Disclosure Determination Tool
Information for Regulated Entities
Information for Consumers
Detectability Testing
Guidance on Testing Methods
Frequently Asked Question – Testing Methods
Guidance on ValidationFrequently Asked Questions – Refining Process Validation
List of Bioengineered Foods
Frequently Asked Questions – General
BE Frequently Asked Questions – For Manufacturers
BE Frequently Asked Questions – Retailers and Importers
BE Frequently Asked Questions – Disclosure and Voluntary Disclosure
BE Frequently Asked Questions – Compliance and Enforcement
Rulemaking Documents
What is a Bioengineered Food? (Fact Sheet)
National Bioengineered Food Disclosure Standard (Fact Sheet)
Economic Research Service (ERS)
Data: Adoption of Genetically Modified Crops in the U.S.
Key Topic: Biotechnology
Food Safety and Inspection Service (FSIS)
Guideline for Label Approval
Labeling Guideline on Statements That Bioengineered or Genetically Modified Ingredients or Animal Feed Were Not Used in Meat, Poultry, or Egg Products
Human Food Made with Cultured Animal Cells
Labeling of Meat or Poultry Products Comprised of or Containing Cultured Animal Cells
FSIS Responsibilities in Establishments Producing Cell-Cultured Meat and Poultry Food Products
Environmental Protection Agency (EPA)
Biotechnology and Emerging Technology
Overview of Plant Incorporated Protectants
Overview of Emerging Mosquito Control Technologies
Overview of GMO Foods and the Feed Your Mind Initiative
Managing Biotechnology Pest Resistance
Insect Resistance Management for Bt Plant-Incorporated Protectants
Framework to Delay Corn Rootworm Resistance
Biotechnology and Emerging Technology Regulation
National Strategy for Modernizing the Regulatory System for Biotechnology Products
Regulation of Genetically Engineered Microorganisms under FIFRA, FFDCA, and TSCA
Biotechnology Under TSCA
Overview of Biotechnology Under TSCA
TSCA Biotechnology Regulations
Filing a Biotechnology Submission Under TSCA
Status of TSCA Biotechnology Cases Reviewed after June 22, 2016
Biotechnology under FIFRA
Introduction to Biotechnology Regulation for Pesticides
Regulation of Biotechnology for Pest Management
Biopesticide Science Advisory (SAP) Meetings
Biotechnology Webinars
Biotechnology Seminars
Food and Drug Administration (FDA)
Consultation Programs on Food from New Plant Varieties
Guidance for Industry: Voluntary Labeling Indicating Whether Foods Have or Have Not Been Derived from Genetically Engineered Plants
Draft Guidance for Industry: Voluntary Labeling Indicating Whether Food Has or Has Not Been Derived from Genetically Engineered Atlantic Salmon
Consumer Info about Food from Genetically Engineered Plants
Foods Derived From Plants Produced Using Genome Editing
Food From New Plant Varieties
Center for Food Safety and Applied Nutrition (CFSAN)
Animal and Veterinary Product Regulation
Animal Cloning
Animal Cloning: A Risk Assessment
Formal Agreement Between FDA and USDA Regarding Oversight of Human Food Produced Using Animal Cell Technology Derived from Cell Lines of USDA-amenable Species
Overview of FDA and USDA Roles and Responsibilities for Cultured Animal Cell Human and Animal Food Products Webinar
Plant and Animal Biotechnology Innovation Action Plan
Genome Editing in Agricultural Biotechnology
Animal and Plant Health Inspection Service (APHIS)
Biotechnology Regulatory Services (BRS)
Biotechnology Environmental Documents for Permits
Regulatory Status Reviews
Exemptions and Confirmations
Compliance and Inspection
Revised Biotechnology Regulations (Previously SECURE Rule)
Patent and Trademark Office (USPTO)
Manual of Patent Examining Procedure: 2400 Biotechnology
Plant Patent Application
National Security Commission on Emerging Biotechnology
Publications
Merging Nanotechnology and Biotechnology; Transforming Plant Sciences with Nanobiotechological Innovations (Hassan & Siddiqui, International Journal of Applied Machine Learning and Computational Intelligence, 2024)
Biotechnology and Genetic Engineering using AI: A Review (Sreelakshmi, Vishwakarma, Rao, Maqbool, Samal, Saini, & Thakur, International Journal of Intelligent Systems and Applications in Engineering, 2024)
Using Biotechnology and Genetic Engineering to Improve the Quality and Sustainability of Plants and Livestock (Nengsi, Journal of Agro Complex Development Society, 2024)
AI for Life: Trends in Artificial Intelligence for Biotechnology (Holzinger, Keiblinger, Holub, Zatloukal, & Muller, New Biotechnology, 2023)
Cell-Cultivated Meat: An Overview (Benson & Green, CRS Report R47697, 2023)
USDA’s SECURE Rule to Regulate Agricultural Biotechnology (Bickell, 2023)
Gene-Edited Plants: Regulation and Issues for Congress (Bickell, CRS Report R47683, 2023)
Gene Editing and Agrifood Systems (FAO, 2022)
Agricultural Biotechnology: Overview, Regulation, and Selected Policy Issues (Bickell, CRS Report R46737, 2021)
The National Bioengineered Food Disclosure Standard: Overview and Selected Considerations (Bickell, CRS Report R46183, 2020)
How Consumers Use Mandatory Genetic Engineering (GE) Labels: Evidence from Vermont (Kolodinsky, Morris, & Pazuniak, Agriculture and Human Values, 2019)
What Can the Adoption of GM Foods Teach us About the Adoption of Other Food Technologies? (Mohorcich, Sentience Institute, 2018)
Food Processor and Retailer Non-GMO Standards in the US and EU and the Driving Role of Regulation (Castellari, Soregaroli, Venus, & WesselerFood Policy, 2018)
Implementing the National Bioengineered Food Disclosure Standard: Will Consumers Use QR Codes to Check for Genetically Modified (GM) Ingredients in Food Products?(Hallman & Tallapragada, AgBioForum, 2018)
Food Product Labeling Basics (Oklahoma State University Ext. Services, 2017)
Preparing for Future Products of Biotechnology (The National Academies of Sciences, Engineering, & Medicine, 2017)
GMO Litigation (Laney, 2016)
Genetically Engineered Crops: Experiences and Prospects (The National Academies of Sciences, Engineering & Medicine, 2016)
The Future of Biotechnology Litigation and Adjudication (Mandel, Pace Environmental Law Review, 2006)
Biotechnology’s Challenge to the Law of Torts (Davies & Levine, McGeorge Law Review, 2000)
Additional Resources
European Food Safety Authority’s GMO Overview (EFSU, 2024)
China’s embrace of GMO crops gains momentum with new import, planting approvals (Reuters, 2024)
The Landscape of Agricultural Biotechnology (Technology Network Content Piece, 2023)
USDA Approves 1st Ever ‘cell-cultivated meat’ for 2 American Manufacturers (Good Morning America, 2023)
How are GMO Plants Made (FDA Informational Video, 2020)
Journal of Agricultural Biotechnology and Sustainable Development