The Coordinated Framework for Regulation of Biotechnology, proposed in 1984 by the

White House Office of Science and Technology Policy White is the lightest color and is achromatic (having no hue). It is the color of objects such as snow, chalk, and milk, and is the opposite of black. White objects fully reflect and scatter all the visible wavelengths of light. White on ...

and finalized in 1986, spells out the basic federal policy for regulating the development and introduction of products derived from

biotechnology Biotechnology is the integration of natural sciences and engineering sciences in order to achieve the application of organisms, cells, parts thereof and molecular analogues for products and services. The term ''biotechnology'' was first used b ...

.United States Regulatory Agencies Unified Biotechnology Website
web page contains only links to other .gov pages This regulatory policy framework that was developed under

President Ronald Reagan Ronald Wilson Reagan ( ; February 6, 1911June 5, 2004) was an American politician, actor, and union leader who served as the 40th president of the United States from 1981 to 1989. He also served as the 33rd governor of California from 1967 ...

to ensure safety of the public and to ensure the continuing development of the fledgling biotechnology industry without overly burdensome regulation.Emily Marden, Risk and Regulation: U.S. Regulatory Policy on Genetically Modified Food and Agriculture, 44 B.C.L. Rev. 733 (200

/ref> The policy as it developed had three tenets: "(1) U.S. policy would focus on the product of genetic modification (GM) techniques, not the process itself, (2) only regulation grounded in verifiable scientific risks would be tolerated, and (3) GM products are on a continuum with existing products and, therefore, existing statutes are sufficient to review the products." These tenets were first described in the Coordinated Framework for Regulation of Biotechnology, published by the President's Domestic Policy Council Working Group on Biotechnology through the Office of Science and Technology Policy in 1986. The U.S. policy framework contrasts with that of some of its major trading partners: the

European Union The European Union (EU) is a supranational political and economic union of member states that are located primarily in Europe. The union has a total area of and an estimated total population of about 447million. The EU has often been des ...

Japan Japan ( ja, 日本, or , and formally , ''Nihonkoku'') is an island country in East Asia. It is situated in the northwest Pacific Ocean, and is bordered on the west by the Sea of Japan, while extending from the Sea of Okhotsk in the north ...

South Korea South Korea, officially the Republic of Korea (ROK), is a country in East Asia, constituting the southern part of the Korea, Korean Peninsula and sharing a Korean Demilitarized Zone, land border with North Korea. Its western border is formed ...

China China, officially the People's Republic of China (PRC), is a country in East Asia. It is the world's most populous country, with a population exceeding 1.4 billion, slightly ahead of India. China spans the equivalent of five time zones and ...

Australia Australia, officially the Commonwealth of Australia, is a Sovereign state, sovereign country comprising the mainland of the Australia (continent), Australian continent, the island of Tasmania, and numerous List of islands of Australia, sma ...

and

New Zealand New Zealand ( mi, Aotearoa ) is an island country in the southwestern Pacific Ocean. It consists of two main landmasses—the North Island () and the South Island ()—and over 700 smaller islands. It is the sixth-largest island count ...

either have or are establishing separate mandatory labeling requirements for products containing genetically modified organisms. This framework governed specific agency policies. For example, the FDA’s 1992 policy statement on genetically engineered plant foods1992 FDA Policy
treats "transferred genetic material and the intended expression product or products" in food derived from GM crops as

food additives Food additives are substances added to food to preserve flavor or enhance taste, appearance, or other sensory qualities. Some additives have been used for centuries as part of an effort to preserve food, for example vinegar (pickling), salt (sal ...

subject to existing food additive regulation, under which that material may be considered either generally recognized as safe (GRAS) or not, initially at the producer's determination. If the food additive is not GRAS, the producer is required to submit data proving that the food additive does not "adulterate" the food - in other words, that the additive is not injurious to health. With respect to GM food, the FDA retained its ability to take enforcement action any food it found to be "adulterated", which would make its producer "subject to the full range of enforcement measures under the act, including seizure, injunction, and criminal prosecution of those who fail to meet their statutory duty."

USDA The United States Department of Agriculture (USDA) is the federal executive department responsible for developing and executing federal laws related to farming, forestry, rural economic development, and food. It aims to meet the needs of com ...

regulation of

genetically modified crops Genetically modified crops (GM crops) are plants used in agriculture, the DNA of which has been modified using genetic engineering methods. Plant genomes can be engineered by physical methods or by use of ''Agrobacterium'' for the delivery of ...

is based on the

Plant Protection Act The Plant Protection Act (PPA) (part of ) is a US statute relating to plant pests and noxious weeds introduced in 2000. It is currently codified at 7 U.S.C. 7701 ''et seq''. It consolidates related responsibilities that were previously spread ...

and its definition of "plant pest."

References

*{{CRS, article = Report for Congress: Agriculture: A Glossary of Terms, Programs, and Laws, 2005 Edition, url = https://web.archive.org/web/20110810044532/http://ncseonline.org/nle/crsreports/05jun/97-905.pdf, author= Jasper Womach

External links

Coordinated Framework for Regulation of Biotechnology
ACTION: Announcement of policy; notice for public comment. AGENCY: Executive Office of the President, Office of Science and Technology Policy. 51 FR 23302 June 26, 1986 United States Department of Agriculture Regulation of biotechnologies Regulation in the United States