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

White House Office of Science and Technology Policy The Office of Science and Technology Policy (OSTP) is a department of the United States government, part of the Executive Office of the President (EOP), established by United States Congress on May 11, 1976, with a broad mandate to advise the pr ...

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

biotechnology Biotechnology is a multidisciplinary field that involves the integration of natural sciences and Engineering Science, engineering sciences in order to achieve the application of organisms and parts thereof for products and services. Specialists ...

.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, 1911 – June 5, 2004) was an American politician and actor who served as the 40th president of the United States from 1981 to 1989. He was a member of the Republican Party and became an important figure in ...

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 union, supranational political union, political and economic union of Member state of the European Union, member states that are Geography of the European Union, located primarily in Europe. The u ...

Japan Japan is an island country in East Asia. Located in the Pacific Ocean off the northeast coast of the Asia, Asian mainland, it is bordered on the west by the Sea of Japan and extends from the Sea of Okhotsk in the north to the East China Sea ...

South Korea South Korea, officially the Republic of Korea (ROK), is a country in East Asia. It constitutes the southern half of the Korea, Korean Peninsula and borders North Korea along the Korean Demilitarized Zone, with the Yellow Sea to the west and t ...

China China, officially the People's Republic of China (PRC), is a country in East Asia. With population of China, a population exceeding 1.4 billion, it is the list of countries by population (United Nations), second-most populous country after ...

Australia Australia, officially the Commonwealth of Australia, is a country comprising mainland Australia, the mainland of the Australia (continent), Australian continent, the island of Tasmania and list of islands of Australia, numerous smaller isl ...

and

New Zealand New Zealand () is an island country in the southwestern Pacific Ocean. It consists of two main landmasses—the North Island () and the South Island ()—and List of islands of New Zealand, over 600 smaller islands. It is the List of isla ...

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, such as vinegar ( pickling), salt ( salting), smoke (smoking) and sugar (crystallization), have been used for ...

subject to existing food additive regulation, under which that material may be considered either

generally recognized as safe Generally recognized as safe (GRAS) is a United States Food and Drug Administration (FDA) designation that a chemical or substance added to food is considered safe by experts under the conditions of its intended use. An ingredient with a GRAS d ...

(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 an United States federal executive departments, executive department of the Federal government of the United States, United States federal government that aims to meet the needs of commerc ...

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 o ...

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