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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
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
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
Center published Federal Register Digest
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
Reference Resources
Economic Research Service (ERS)
Key Topic: Biotechnology (Research and Productivity)
Data: Adoption of Genetically Modified Crops in the U.S.
Key Topic: Biotechnology (Food Sector)
Briefing Room: Agricultural Biotechnology
Key Topic: Farm Practices Management
Key Topic: Trade & International Markets
Environmental Protection Agency (EPA)
Biotechnology Team
Biotechnology Program Under Toxic Substances Control Act
Plant-Incorporated Protectant Rules
Regulating Biopesticides
Food and Drug Administration (FDA)
Bioengineered Foods
Center for Food Safety and Applied Nutrition
Biotechnology in Animals and Feeds (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
Department of State
Congressional Resources
Reports on Biotechnology (Government Accountability Office)
Plant Biotechnology Research and Development In Africa: Challenges and Opportunities
(U. S. House of Representatives Subcommittee Hearing, June 12, 2003)
Other Federal Resources
USDA Agricultural Biotechnology Website
Plant Variety Protection Office (Agricultural Marketing Service)
Biotechnology Regulatory Services (Animal and Plant Health Inspection Service)
U.S. Regulatory Agencies Biotechnology Website
National Institute of Health and National Library of Medicine
National Center for Biotechnology Information
Genetically Engineered Foods (MedLine Plus Medical Encyclopedia)
Biotechnology (USAID)
The President's Council on Bioethics
Biotechnology and U.S. Agricultural Trade (Foreign Agricultural Service)
International Resources
U.S.-EU Biotech Issues (U.S. Mission to the European Union)
Publications
Farmers' Guide to GMOs, Second Ed. (FLAG, 2009)
If Your Farm Is Organic, Must It Be GMO-Free? Organic Farmers, Genetically Modified Organisms,
and the Law (FLAG, 2007)
Biodiversity and Biotechnology: A Misunderstood Relation (Chen, 2005)
Biotechnology and the Law (Mehta, 2004)
Crop Biotechnology: Feeds for Livestock (Van Deynze, et al., 2004)
Farmers' Rights (Haapala, 2004)
Intellectual Property Rights in Plant Varieties: International Legal Regimes and
Policy Options for National Governments (Helfer, 2004)
An Efficient Way to Improve Patent Quality for Plant Varieties (White, 2004)
Current Status of Access and Availability of Plant Genetic Resources (Shands, 2004)
Finding a Compromise in the Debate over Genetically Modified Food: An Introduction
to a Model State Consumer Right-to-Know Act (Robertson, 2003)
Consumers and the Future of Biotech Foods in the United States (Shoemaker et al., 2003)
Applying World Trade Organization Rules to Labeling of Genetically Modified Food
(Compton, 2002)
GMO Liability Threats for Farmers, Legal Issues Surround the Planting of Genetically Modified Crops
(FLAG, 2001)
State GMO Restrictions and the Dormant Commerce Clause (FLAG, 2001)
Genetically Modified Organisms, Food Safety and the Environment
(Food and Agriculture Organization of the United Nations - FAO, 2001)
Taking Consumers Seriously: The Swiss Regulatory Approach to Genetically Modified
Food (Perrez, 2000)
A Statement on Biotechnology: A Discussion of Four Important Issues in the
Biotechnology Debate (Loy, 2000)
Transgenic Plants and World Agriculture (National Academy Press, 2000)
U.S. Regulation of Biotechnology: An Overview (Belson, 2000)
The History of FDA Regulation of Biotechnology in the Twentieth Century (Stepp, 1999)
Biotechnology in Food and Agriculture Documents (FAO)
Additional Resources
Biotechnology Posts (United States Agricultural & Food Law and Policy Blog)
Journal of Agrobiotechnology Management and Economics (AgBioForum)
What are Genetically Modified (GM) Foods? (Oak Ridge National Laboratory)
Agricultural Biotechnology (Purdue U.)
Seed Protection: Rights and Responsibilities (AR Plant Board)
International Union for the Protection of New Varieties of Plants
Genetic Engineering (Union of Concerned Scientists)
GMOs and Biotechnology (FoodLaw.org)
Glossary of Biotechnology for Food and Agriculture (Zaid et al., FAO)
Annotated Database of WWW Sites (Info. Systems for Biotechnology - ISB)
Biotechnology Law Resources (LSU)
Biotech Derived Crops (National Center for Food & Agricultural Policy)
Food Safety from the Farm to the Fork: Genetically Modified Organisms (European Commission)
Pew Initiative on Food and Biotechnology
Commisson on Genetic Resources for Food and Agriculture
EU Biotechnology Programme
Biotechnology and Food Safety (FAO)
Biotechnology in Food and Agriculture (FAO)
International Plant Protection Convention
Biotechnology (Organization for Economic Cooperation and Development)
Biotechnology (GM foods) and Nanotechnology (World Health Organization)
Biotechnology and Genetic Resource Policies (World Bank Group)
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