Biotechnologically developed foods are those in which new characteristics have been introduced via recombinant DNA techniques. The DNA may come fro m a wide variety of sources such as bacteria, other plants, or other animals, though for the most part bacterial genes are those which are commonly utilized because of the ease with which these microbes transfer genes. These foods are developed to provide better shelf-life, processing characteristics, flavor, nutritional properties, and other growth characteristics (1). The new technology of recombinant DNA techniques allow scientists to find the gene for the targeted characteristic, clone it, and then place copies into the cells of the recipient organism. This method of introducing genes to an organism is better than the conventional method of cross-hybridization which often lead to the introduction and sometimes the expression of unwanted genes. With recombinant DNA techniques only one or two genes of interest are transferred to the target, whereas in cross-hybridization it is difficult to transfer less than a few thousand genes (1). Though the new techniques are precise incisions of new genes the general public often questions the safety of foods arising from such manipulations. They fear that products containing the new genetic material will yield unintended effects, or result in the production of new allergens not normally found in these foods (3).
The FDA is given the authority to regulate all foods under the Food, Drug, and Cosmetic Act which provides for regulation to ensure the safety of most foods, imported and domestic, with the exceptions of meat and poultry which are regulated by the USDA. The foods resulting from genetic engineering must meet the same qualifications as other foods and food ingredients (1). The FDA has the authority to take legal actions against substances it considers to be a public hazard. The first biotechnologically produced protein to be considered safe by the FDA was chymosin, this was passed before any written regulation or statute existed about transgenic products. Chymosin was passed in 1990, two years before regulations were published, it is commonly known as rennet and is used in the production of cheese and other dairy products. This enzyme was a commonly used protein that was usually extracted from animals, the new method of production provided efficiency and the same protein so it was deemed a generally recognized as safe substance (GRAS). The factors taken into consideration in the regulation of chymosin, which later aided in the formulation of the regulations, included: the genetically engineered product had the same structure and function as that of natural chymosin, there were fewer impurities in the new product, the microorganisms producing it are destroyed in the processing, are non-pathogenic and non-toxigenic, the marker-genes which are antibiotic resistance are destroyed in processing (1).
The Office of Science and Technology Policy (OSTP) published the policy on biotechnologically derived food and food products in February 1992 . This policy intended to make the regulation of biotechnological products based on risk and the degree to which the product could be a risk to the public (2). The FDA concurrently published its policy which focused on providing producers with guidelines by which to develop and test their products. This policy not only covers genetically engineered foods, but also those derived from any other type of manipulations, it was intended to be flexible enough to allow for updating as technological advances are made (1,2). In the 1992 policy the FDA wrote "the key factors in review safety concerns should be the characteristics of the food product rather than the fact that the new methods are used."(2) In keeping with this statement they use sections of the law that have already been written, those used most often are sections 402(a)(1) and 409 of the Federal Food, Drug, and Cosmetic Act to regulate foods (1,2). It is especially difficult to regulated whole fresh foods such as fruits, vegetables, and grains since they are not subject to pre-market approval. the primary tool the FDA uses to ensure the safety of these products is section 402(a)(1) that limits the adulteration of products. This section places the responsibility to ensure the safety of a product on the developer and says they have to make sure their product complies with the law. If foods contain poisonous or deleterious substances that cause the food to be injurious to health or if they contain unusually high amounts of naturally occurring compounds that are not normally injurious they are considered adulterated and therefore illegal (1).
The second section of the Food, Drug, and Cosmetic Act that the FDA relies on heavily in their 1992 policy is section 409 which deals with food additives (1,2). This section dictates that unless they are generally recognized as safe (GRAS), anything added to food is considered a food additive and is subject to review and approval before use. If the product of the new genetic material is the same as or similar to and found in comparable amounts to those found in the original plant it may more easily be determined GRAS. If requested the FDA also reviews the status of GRAS substances. The FDA is much more interested in the new product of the genetic modification rather than the actual genetic material introduced (1,2).
The mainstay of the 1992 policy is a detailed "guidance to industry" which takes into consideration those questions manufacturing firms may have regarding regulatory and scientific issues dealing with the safety of their products (2). The policy provides a "standard of care" for the developers to follow in production of biotechnological goods. Intense analysis of the chemical properties of newly developed foods is not undergone because their safety is generally accepted if their basic composition has not been changed. The history of newly derived plant varieties has been sufficient in proving their safety for public use. The foods from biotechnological backgrounds are compared to the foods which are found on grocery shelves today, if they differ significantly then they may be required to undergo more rigorous testing (1,2).
It is difficult to scientifically assess the safety of a whole food product because of the variety of chemicals they contain when compared to a food additive . Clinical testing is tricky because feeding lab animals solely the food being tested may cause a nutrient deficiency making results difficult to read (1). The methods used preferentially are those pertaining to the stability and safety of newly produced proteins, analysis of new genetic codes, and chemical analysis of nutrients or toxicants that may be introduced or affected (1,2).
The guidance primarily regulates genetic changes that may modify or introduce genes that will code for toxic or harmful substances. It regulates the levels of known toxic compounds found in plants to remain at levels previously determined to be safe, the amount of major nutrients the product normally provides, and the introduction of new compounds (1). The developers must provide detailed flow charts of the origin of genetic material introduced and new substances for which it encodes such as carbohydrates, proteins, and fatty acids. If the newly introduced compounds vary significantly from those in the original product then they are subject to pre-market approval by the FDA (2). If they are similar they are considered GRAS and approval is not required. Particular attention is given to those proteins and other substances that are common allergens. The producer must provide proof in these cases that the allergen is not present, or if it is, provide for proper labeling to warn the consumers. The only condition under which the producer is required to provide labeling is if there are any possibly hazardous changes, such as introduction of allergens, to the composition of the original product. Otherwise the FDA states "FDA believes that the new techniques are extensions at the molecular level of traditional methods and will be used to achieve the same goals as pursued with traditional plant breeding," (2) and therefore does not require labeling of the type of modification. When finally being assessed for safety the five main focuses are:
The 1992 policies and guidelines focus on the fact that there have been many genetically modified products in the United States food marked for many years and, with rare exceptions, have generally been safe. All of the agencies in the government work together to regulate the new food products. For an example of how they work together imagine a transgenically changed animal that is presented to the USDA for inspection by FSIS, the animal would have first been inspected by the EPA and APHIS in order to be released. If the animal contained new proteins or other compounds it would then go to CFSAN to be tested as a food additive or determined to be GRAS (4).
Many people fear that though the FDA is an agency sworn to protect the American public from unsafe foods, they are judging the safety of biotechnological food products to leniently (3). There are also those that criticize the FDA for not considering the economic impacts of biotechnology, without understanding that the FDA holds no jurisdiction in this area. Though a biotechnologically derived food may be determined safe according to scientific study and government regulation, the ultimate test will be public opinion and how the product does on the market (3). The perceived safety of the product which is psychologically defined by a person's social, ethical, and cultural background and will predominate over whether the individual chooses to buy the product.
