Coordinated Framework for Regulation of Biotechnology

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The Coordinated Framework for Regulation of Biotechnology, proposed in 1984 by the White House Office of Science and Technology Policy and finalized in 1986, spells out the basic federal policy for regulating the development and introduction of products derived from biotechnology. [1]

This regulatory policy framework that was developed under President Ronald Reagan to ensure safety of the public and to ensure the continuing development of the fledgling biotechnology industry without overly burdensome regulation. [2] 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." [2] 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. [1] The U.S. policy framework contrasts with that of some of its major trading partners: the European Union, Japan, South Korea, China, Australia and New Zealand 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 foods [3] treats "transferred genetic material and the intended expression product or products" in food derived from GM crops as food additives 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. [3] 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. [3] 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." [3]

USDA regulation of genetically modified crops is based on the Plant Protection Act and its definition of "plant pest."

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Biotechnology Use of living systems and organisms to develop or make useful products

Biotechnology is a broad area of biology, involving the use of living systems and organisms to develop or make products. Depending on the tools and applications, it often overlaps with related scientific fields. In the late 20th and early 21st centuries, biotechnology has expanded to include new and diverse sciences, such as genomics, recombinant gene techniques, applied immunology, and development of pharmaceutical therapies and diagnostic tests. The term biotechnology was first used by Karl Ereky in 1919, meaning the production of products from raw materials with the aid of living organisms.

Genetically modified organism Organisms whose genetic material has been altered using genetic engineering methods

A genetically modified organism (GMO) is any organism whose genetic material has been altered using genetic engineering techniques. The exact definition of a genetically modified organism and what constitutes genetic engineering varies, with the most common being an organism altered in a way that "does not occur naturally by mating and/or natural recombination". A wide variety of organisms have been genetically modified (GM), from animals to plants and microorganisms. Genes have been transferred within the same species, across species, and even across kingdoms. New genes can be introduced, or endogenous genes can be enhanced, altered, or knocked out.

Genetic engineering Direct manipulation of an organisms genome using biotechnology

Genetic engineering, also called genetic modification or genetic manipulation, is the direct manipulation of an organism's genes using biotechnology. It is a set of technologies used to change the genetic makeup of cells, including the transfer of genes within and across species boundaries to produce improved or novel organisms. New DNA is obtained by either isolating and copying the genetic material of interest using recombinant DNA methods or by artificially synthesising the DNA. A construct is usually created and used to insert this DNA into the host organism. The first recombinant DNA molecule was made by Paul Berg in 1972 by combining DNA from the monkey virus SV40 with the lambda virus. As well as inserting genes, the process can be used to remove, or "knock out", genes. The new DNA can be inserted randomly, or targeted to a specific part of the genome.

Genetically modified food Foods produced from organisms that have had changes introduced into their DNA

Genetically modified foods, also known as genetically engineered foods, or bioengineered foods are foods produced from organisms that have had changes introduced into their DNA using the methods of genetic engineering. Genetic engineering techniques allow for the introduction of new traits as well as greater control over traits when compared to previous methods, such as selective breeding and mutation breeding.

In food safety, the concept of substantial equivalence holds that the safety of a new food, particularly one that has been genetically modified (GM), may be assessed by comparing it with a similar traditional food that has proven safe in normal use over time. It was first formulated as a food safety policy in 1993, by the Organisation for Economic Co-operation and Development (OECD).

Pharming, a portmanteau of "farming" and "pharmaceutical", refers to the use of genetic engineering to insert genes that code for useful pharmaceuticals into host animals or plants that would otherwise not express those genes, thus creating a genetically modified organism (GMO). Pharming is also known as molecular farming, molecular pharming or biopharming.

Since the advent of genetic engineering in the 1970s, concerns have been raised about the dangers of the technology. Laws, regulations, and treaties were created in the years following to contain genetically modified organisms and prevent their escape. Nevertheless, there are several examples of failure to keep GM crops separate from conventional ones.

Genetically modified food controversies Controversies over GMO food

Genetically modified food controversies are disputes over the use of foods and other goods derived from genetically modified crops instead of conventional crops, and other uses of genetic engineering in food production. The disputes involve consumers, farmers, biotechnology companies, governmental regulators, non-governmental organizations, and scientists. The key areas of controversy related to genetically modified food are whether such food should be labeled, the role of government regulators, the objectivity of scientific research and publication, the effect of genetically modified crops on health and the environment, the effect on pesticide resistance, the impact of such crops for farmers, and the role of the crops in feeding the world population. In addition, products derived from GMO organisms play a role in the production of ethanol fuels and pharmaceuticals.

The Center for Food Safety and Applied Nutrition is the branch of the United States Food and Drug Administration (FDA) that regulates food, dietary supplements, cosmetics, drugs, biologics, medical devices, and radiological products.

The United States is the largest grower of commercial crops that have been genetically engineered in the world, but not without domestic and international opposition.

Adulteration is a legal term meaning that a food product fails to meet the legal standards. One form of adulteration is an addition of another substance to a food item in order to increase the quantity of the food item in raw form or prepared form, which results in the loss of actual quality of food item. These substances may be either available food items or non-food items. Among meat and meat products some of the items used to adulterate are water or ice, carcasses, or carcasses of animals other than the animal meant to be consumed.

The Non-GMO Project

The Non-GMO Project is a 501(c)(3) non-profit organization focusing on genetically modified organisms. The organization began as an initiative of independent natural foods retailers in the U.S. and Canada, with the stated aim to label products produced in compliance with their Non-GMO Project Standard, which aims to prevent genetically modified foodstuffs from being present in retail food products. The organization is headquartered in Bellingham, Washington. The Non-GMO label began use in 2012 with Numi Organic Tea products.

Michael R. Taylor American politician

Michael R. Taylor is an American lawyer who has played leadership roles on public health and food safety in government, academia, and the private sector, with a major focus on modernizing the U.S. food safety system to prevent foodborne illness. From 2010 to 2016, he was the Deputy Commissioner for Foods and Veterinary Medicine at the United States Food and Drug Administration (FDA) and currently co-chairs the board of STOP Foodborne Illness, a non-profit that supports victims of serious illness and their families in efforts to strengthen food safety culture and practices in government and industry.

Genetically modified canola is a genetically modified crop. The first strain, Roundup Ready canola, was developed by Monsanto for tolerance to glyphosate, the active ingredient in the commonly used herbicide Roundup.

Regulation of genetic engineering Overview of the regulation of genetic engineering

The regulation of genetic engineering varies widely by country. Countries such as the United States, Canada, Lebanon and Egypt use substantial equivalence as the starting point when assessing safety, while many countries such as those in the European Union, Brazil and China authorize GMO cultivation on a case-by-case basis. Many countries allow the import of GM food with authorization, but either do not allow its cultivation or have provisions for cultivation, but no GM products are yet produced. Most countries that do not allow for GMO cultivation do permit research. Most (85%) of the world's GMO crops are grown in the Americas. One of the key issues concerning regulators is whether GM products should be labeled. Labeling of GMO products in the marketplace is required in 64 countries. Labeling can be mandatory up to a threshold GM content level or voluntary. A study investigating voluntary labeling in South Africa found that 31% of products labeled as GMO-free had a GM content above 1.0%. In Canada and the USA labeling of GM food is voluntary, while in Europe all food or feed which contains greater than 0.9% of approved GMOs must be labelled.

Genetically modified food in the European Union Overview of genetically modified food in the European Union

Genetic engineering in the European Union has varying degrees of regulation.

Fisheries law

Fisheries law is an emerging and specialized area of law. Fisheries law is the study and analysis of different fisheries management approaches such as catch shares e.g. Individual Transferable Quotas; TURFs; and others. The study of fisheries law is important in order to craft policy guidelines that maximize sustainability and legal enforcement. This specific legal area is rarely taught at law schools around the world, which leaves a vacuum of advocacy and research. Fisheries law also takes into account international treaties and industry norms in order to analyze fisheries management regulations. In addition, fisheries law includes access to justice for small-scale fisheries and coastal and aboriginal communities and labor issues such as child labor laws, employment law, and family law.

New Breeding Techniques (NBT), also named New Plant Engineering Techniques, are a suite of methods that could increase and accelerate the development of new traits in plant breeding. These new techniques, often involve 'genome editing' whose intention is to modify DNA at specific locations within the plants' genes so that new traits and properties are produced in crop plants.

India and China are the two largest producers of genetically modified products in Asia. India currently only grows GM cotton, while China produces GM varieties of cotton, poplar, petunia, tomato, papaya and sweet pepper. Cost of enforcement of regulations in India are generally higher, possibly due to the greater influence farmers and small seed firms have on policy makers, while the enforcement of regulations was more effective in China. Other Asian countries that grew GM crops in 2011 were Pakistan, the Philippines and Myanmar. GM crops were approved for commercialisation in Bangladesh in 2013 and in Vietnam and Indonesia in 2014.

Genetic engineering in North America is any genetic engineering activities in North America

References

  1. 1 2 United States Regulatory Agencies Unified Biotechnology Website Archived 2012-11-17 at the Wayback Machine web page contains only links to other .gov pages
  2. 1 2 Emily Marden, Risk and Regulation: U.S. Regulatory Policy on Genetically Modified Food and Agriculture, 44 B.C.L. Rev. 733 (2003)
  3. 1 2 3 4 1992 FDA Policy