Maryanski,+James

Maryanski, James H. "Genetically Engineered Foods." //U S Food and Drug Administration Home Page//. 06 Sept. 2009. Web. 08 Sept. 2010. [].
 o two decades FDA has been studying genetic modification techniques for drug-biologic development, as well as the development of new foods, and the Agency has carefully developed policies to accommodate the changing and evolving world of biotechnology.  o Many of the foods that are already common in our diet are obtained from plant varieties that were developed using conventional genetic techniques of breeding and selection.  o Food products produced through modern methods of biotechnology such as recombinant DNA techniques and cell fusion are emerging from research and development into the marketplace.  o First, they can be used with greater precision and allow for more complete characterization and, therefore, greater predictability about the qualities of the new variety  o Second, today's techniques give breeders the power to cross biological boundaries that could not be crossed by traditional breeding.  o Although study of the final product ultimately holds the answer to whether or not a product is safe to eat, knowing the techniques used to create the product helps in understanding what questions to ask in reviewing the product's safety.  o Turning now to FDA's legal authority over genetically engineered foods, FDA has authority under the Federal Food, Drug, and Cosmetic (FD&C or the Act) Act to ensure the safety of all domestic and imported foods for man or other animals in the United States market, except meat, poultry and egg products which are regulated by the United States Department of Agriculture (USDA).  o Bioengineered foods and food ingredients (including food additives) must adhere to the same standards of safety under the Act that apply to their conventional counterparts. This means that these products must be as safe as the traditional foods in the market. o FDA relies primarily on two sections of the Act to ensure the safety of foods and food ingredients: (1) The adulteration provisions of section 402(a)(1). Under this postmarket authority, FDA has the power to remove a food from the market (or sanction those marketing the food) if the food poses a risk to public health. It is important to note that the Act places a legal duty on developers to ensure that the foods they market to consumers are safe and comply with all legal requirements. (2) The food additive provisions (section 409). Under this section, substances that are intentionally added to food are food additives, unless the substance is generally recognized as safe (GRAS) or is otherwise exempt (e.g., a pesticide, the safety of which is overseen by EPA).  o The FD&C Act requires premarket approval of any food additive -- regardless of the technique used to add it to food.  o Under FDA policy on foods derived from new plant varieties, a substance that would be a food additive if it were added during traditional food manufacture is also treated as a food additive if it is introduced into food through genetic modification of a food crop.  o The substances intentionally added to food via biotechnology to date have been well-characterized proteins, fats, and carbohydrates, and are functionally very similar to other proteins, fats, and carbohydrates that are commonly and safely consumed in the diet and so will be presumptively generally recognized as safe. o FDA's authority under current law, both pre- and postmarket provisions, is sufficient to ensure the safety in the marketplace of foods derived from new plant varieties. o Because FDA determined that bioengineered foods should be regulated like their conventional counterparts, FDA has not to date established any regulations specific to bioengineered food. o We also considered scientific principles for assessing safety that had been developed and agreed upon by several prestigious scientific groups, including the National Academy of Sciences (NAS), the Food and Agriculture Organization (FAO), the World Health Organization (WHO), and the Organization for Economic Cooperation and Development (OECD) in developing FDA's policy. o (1) Recombinant DNA techniques are being used to introduce copies of one or a limited number of well-characterized genes into a desired food crop. (2) In most cases, these genes produce proteins, or proteins that modify fatty acids or carbohydrates in the plant, in other words, common food substances (3) The proteins, fatty acids, and carbohydrates introduced into food crops are well- characterized and not known to be toxic and they would be digested to normal metabolites in the same manner that the body handles the thousands of different proteins, fat and carbohydrates that make up our diet today. o procedures industry follows to get a biotech food product to market. o conducted a comprehensive scientific review of Calgene's data on the Flavr SavrTM tomato and the use of kanamycin resistance marker gene, and also held a public meeting of our Food Advisory Committee (the Committee) to examine applicability of the 1992 policy to products such as the Flavr SavrTM tomato. o FDA requests that firms submit a summary of their assessment to the Agency. o The goal of FDA's evaluation is to ensure that human food and animal feed safety issues or other regulatory issues (e.g. labeling) have been addressed prior to commercial distribution. o When a firm has accumulated the information that it believes is adequate to ensure that the product complies with the relevant provisions of the FD&C Act, the Agency recommends that the developer inform FDA about the bioengineered foods intended to be introduced into commercial distribution by providing a summary of the company's safety and nutritional assessment which Agency scientists review for unresolved safety or regulatory issues. o The safety and nutritional assessment summary should normally contain sufficient information for Agency scientists to understand the approach the firm has followed in identifying and addressing relevant issues. Some examples of this information would include:  o The name of the food and the crop from which it is derived;  o The uses of the food, including both human food and animal feed uses;  o The sources, identities, and functions of introduced genetic material;  o The purpose or intended technical effect of the modification and its expected effect on the composition or characteristic properties of the food or feed;  o The identity and function of any new products encoded by the introduced genetic material, including an estimate of its concentration; <span style="margin: 0in 0in 0pt 1in; mso-list: l0 level2 lfo1; mso-margin-bottom-alt: auto; mso-margin-top-alt: auto; tab-stops: list 1.0in; text-indent: -0.25in;"> o Comparison of the composition or characteristics of the bioengineered food to that of food derived from the parental variety or other commonly consumed varieties with special emphasis on important nutrients, anti-nutrients, and toxicants that occur naturally in the food; <span style="margin: 0in 0in 0pt 1in; mso-list: l0 level2 lfo1; mso-margin-bottom-alt: auto; mso-margin-top-alt: auto; tab-stops: list 1.0in; text-indent: -0.25in;"> o Information on whether the genetic modification altered the potential for the bioengineered food to induce an allergic response; and, <span style="margin: 0in 0in 0pt 1in; mso-list: l0 level2 lfo1; mso-margin-bottom-alt: auto; mso-margin-top-alt: auto; tab-stops: list 1.0in; text-indent: -0.25in;"> o Other information relevant to the safety and nutritional assessment of the bioengineered food.