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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. §§ 174.1-174.485
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
Note: Recently summarized cases are listed and linked in Recent Postings.
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
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
Reference Resources
USDA
USDA Agricultural Biotechnology Website
Plant Variety Protection Office (Agricultural Marketing Service)
Biotechnology Regulatory Services (Animal and Plant Health Inspection Service)
Biotechnology and U.S. Agricultural Trade (Foreign Agricultural Service)
Economic Research Service - ERS
Key Topic: Biotechnology (Research and Productivity)
Data: Adoption of Genetically Modified Crops in the U.S.
Key Topic: Biotechnology
Briefing Room: Agricultural Biotechnology
Publications: Biotechnology
National Agricultural Library - NAL
Research and Technology: Biotechnology
Plants and Crops: Biotechnology, Genetics and Breeding
Other Congressional Resources
Seeds of Opportunity: Plant Genomics and Agricultural Biotechnology (U.S. House Committee)
Reports on Biotechnology (Government Accountability Office)
Other Federal Resources
Department of State
Economic Issues: Agricultural Biotechnology
Agricultural Biotechnology
Environmental Protection Agency
Biotechnology Team
Biotechnology Program Under Toxic Substances Control Act
Plant-Incorporated Protectant Rules
Regulating Biopesticides
Food and Drug Administration
Genetic Engineering: The Future of Foods? (FDA Consumer, Nov.-Dec. 2003)
Bioengineered Foods
Center for Food Safety and Applied Nutrition
Biotechnology in Animals and Feeds (Center for Veterinary Medicine)
Agricultural Biotechnology
(U.S. Trade Representative)
U.S.-EU Biotech Issues
U.S. Regulatory Agencies Biotechnology Website
Other Congressional Resources
Plant Biotechnology Research and Development In Africa: Challenges and Opportunities
(U. S. House of Representatives Subcommittee Hearing, June 12, 2003)
Other Federal Resources
National Institute of Health and National Library of Medicine
National Center for Biotechnology Information
Genetically Engineered Foods (MedLine Plus Medical Encyclopedia)
Patent and Trademark Office
Manual of Patent Examining Procedure: 2400 Biotechnology
Plant Patent Application
Biotechnology (USAID)
The President's Council on Bioethics
Publications
If Your Farm Is Organic, Must It Be GMO-Free? Organic Farmers, Genetically Modified Organisms,
and the Law (FLAG, 2007)
Farmers' Guide to GMOs (FLAG, 2004)
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)
Biotechnology and the Law (Mehta, 2004)
Crop Biotechnology: Feeds for Livestock (Van Deynze, et al., 2004)
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)
Genetically Modified Food and International Law: The Biosafety Protocol and
Regulations in Europe (Nanda, 2000)
Finding a Compromise in the Debate over Genetically Modified Food: An Introduction
to a Model State Consumer Right-to-Know Act (Robertson, 2003)
Farmers' Rights (Haapala, 2004)
Intellectual Property Rights in Plant Varieties: International Legal Regimes and
Policy Options for National Governments (Helfer, 2004)
Biodiversity and Biotechnology: A Misunderstood Relation (Chen, 2005)
An Efficient Way to Improve Patent Quality for Plant Varieties (White, 2004)
Current Status of Access and Availability of Plant Genetic Resources (Shands, 2004)
Applying World Trade Organization Rules to Labeling of Genetically Modified Food
(Compton, 2002)
The History of FDA Regulation of Biotechnology in the Twentieth Century(Stepp, 1999)
U.S. Regulation of Biotechnology: An Overview (Belson, 2000)
Agricultural Biotechnology, Politics, Ethics, and Policy (Kinderlerer & Adcock, 2003)
Consumers and the Future of Biotech Foods in the United States (Shoemaker et al., 2003)
Genetically Modified Organisms, Food Safety and the Environment
(Food and Agriculture Organization of the United Nations - FAO, 2001)
Transgenic Plants and World Agriculture (National Academy Press, 2000)
Biotechnology in Food and Agriculture Documents (FAO)
Additional Resources
What are Genetically Modified (GM) Foods? (Oak Ridge National Laboratory)
Biotechnology (International Portal on Food Safety, Animal & Plant Health)
Agricultural Biotechnology (Purdue U.)
A Primer on GMOs (OR Dept. of Ag)
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)
Agricultural Biotechnology (AgNIC, U. MD, NAL)
Annotated Database of WWW Sites (Info. Systems for Biotechnology - ISB)
Biotechnology Law Resources (LSU)
Biotechnology Assessment Program (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)
Biotechnology Subject Guide (FAO)
Genetic Resources, Biotechnology and Intellectual Property Rights
(International Food Policy Research Institute)
International Plant Protection Convention
Biotechnology (Organization for Economic Cooperation and Development)
Biotechnology - GM Food (World Health Organization)
Biotechnology (World Bank Group)
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