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

Plant Protection Act, 7 U.S.C. §§ 7701-7772

Plant Variety Protection Act, 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

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

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

CRS Subject(s):

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

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

Agricultural Marketing Service (AMS)

BE Disclosure & Labeling

 Environmental Protection Agency (EPA)

Plant-Incorporated ProtectantsFcenter
Regulating Biopesticides

Food and Drug Administration (FDA)

Guidance for Industry: Voluntary Labeling Indicating Whether Foods Have or Have Not Been Derived from Genetically Engineered Plants
Consumer Info about Food from Geneticlly Engineered Plants
Foods Derived From Plants Produced Using Genome Editing
Food From Genetically Engineered Plants
Labeling of Foods Derived from Genetically Engineered Plants
Center for Food Safety and Applied Nutrition
Animal and Veterinary Product Regulation (Center for Veterinary Medicine)

National Agricultural Library (NAL)

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

Patent and Trademark Office

Manual of Patent Examining Procedure: 2400 Biotechnology
Plant Patent Application

Publications

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 Regulations (Food Policy, 2018)
Implementing the National Bioengineered Food Disclosure Standard   (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)