Biotechnology

 

OverviewAA049627

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

Regulations

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
Center published USDA Judicial Officer’s Decisions

Center Research Publications

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, 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:

Biotechnology

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)

Reference Resources

Unified Website for Biotechnology Regulation

Frequently Asked Questions

Department of Agriculture (USDA)

Biotechnology

Agricultural Marketing Service (AMS)

BE Disclosure & Labeling
BE Frequently Asked Questions
BE Information for Consumers
List of Bioengineered Foods
Detectability Testing
Decision Tool – Do I Need to Make a Bioengineered Food Disclosure?
Animal and Plant Health Inspection Service (APHIS)
Am I Regulated?
Biotechnology Regulatory Services (BRS)
Permitting and the Regulatory Process
SECURE Rule (updating regulations regarding the movement and release of bioengineered organisms) – effective August 2020

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)

Labeling Guideline on Statements That Bioengineered or Genetically-Modified Ingredients or Animal Feed Were Not Used in Meat, Poultry, or Egg Products

 Environmental Protection Agency (EPA)

Plant-Incorporated Protectants
Regulating Biopesticides
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 

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

Publications

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)