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. §§ 1639-1639c
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. §§ 7701-7772
Plant Variety Protection Act (PVPA), 7 U.S.C. §§ 2321-2583
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


National Bioengineered Food Disclosure Standard, 7 C.F.R. §§ 66.1-66.406
Genetically Engineered Plant Pest Regulations, 7 C.F.R. §§ 340.0-340.9
Plant Incorporated Protectant Regulations, 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)
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)
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
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)

Reference Resources

Unified Website for Biotechnology Regulation

Frequently Asked Questions

Department of Agriculture (USDA)


Agricultural Marketing Service (AMS)

Information for Regulated Entities
BE Disclosure & Labeling
BE Rulemaking and Related Documents
National Bioengineered Food Disclosure Standard (Fact Sheet)
BE Frequently Asked Questions
BE Frequently Asked Questions – Disclosure
BE Frequently Asked Questions – For Manufacturers
BE Information for Consumers
List of Bioengineered Foods
What is a Bioengineered Food? (Fact Sheet)
Detectability Testing
Decision Tool – Do I Need to Make a Bioengineered Food Disclosure?

Economic Research Service (ERS)

Data: Adoption of Genetically Modified Crops in the U.S.
Key Topic: Biotechnology
Key Topic: Farm Practices & Management 
Key Topic: Trade & International Markets

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)

Overview of Plant Incorporated Protectants
Regulating Biopesticides
Regulation of Biotechnology under TSCA and FIFRA
Modernizing the Regulatory System for Biotechnology Products 

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

Animal and Plant Health Inspection Service (APHIS)

Biotechnology Regulatory Services (BRS)
Biotechnology Environmental Documents for Permits
Revised Biotechnology Regulations (Previously SECURE Rule)

National Agricultural Library (NAL)

Research and Technology: Biotechnology
Plants and Crops: Agricultural Biotechnology, Plant Genetics, and Plant Breeding

Patent and Trademark Office(USPTO)

Manual of Patent Examining Procedure: 2400 Biotechnology
Plant Patent Application


USDA’s SECURE Rule to Regulate Agricultural Biotechnology (Bickell, 2023)
Gene-Edited Plants: Regulation and Issues for Congress (Bickell, 2023)
Gene Editing and Agrifood Systems (FAO, 2022)
Agricultural Biotechnology: Overview, Regulation, and Selected Policy Issues (Bickell, 2021)
The National Bioengineered Food Disclosure Standard: Overview and Selected Considerations (Johnson, 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)