U.S. Food and Drug Administration (FDA)
Special regulatory attention should be required for genetically engineered food because it contains genetic material never before seen in the diet, and releases life forms that never before existed into the environment. Like a new drug, the effects of the genetic changes are not entirely predictable, and may have unintended consequences. However, the rigorous review process for new drugs contrasts sharply with the near total deregulation of genetically engineered food.
New drug applications submitted to the FDA first go through several stages of required clinical trials that include months or years of experiments. A FDA physician, who also coordinates input from other agency scientists, then reviews the results in detail. Compare this process with the FDA’s biotech policy: “FDA has not found it necessary to conduct comprehensive scientific reviews of foods derived from bioengineered plants [but instead] expects developers to consult with the agency on safety and regulatory questions.” (i)
It is noteworthy that the agency has never formalized its rules for genetically engineered food – they remain as “guidelines” that do not have the force of law. Moreover, the latest proposed FDA policy on genetically engineered food does little to change the voluntary nature of biotech industry reporting on the foods they intend to market. Under the pending proposal, biotech companies would merely be required to notify the agency 120 days before bringing a new genetically engineered food to market. Also, the FDA would still not require health or environmental studies, leaving it to the industry to decide how many and what kinds of tests to conduct.
In short, the FDA’s consultation process for genetically engineered foods has none of the scientific rigor seen in the drug approval process, and is even weaker than FDA standards for other food additives (such as artificial flavors or colors). As Dr. Rebecca Goldburg (a senior scientist at Environmental Defense and a member of USDA’s advisory body on organic agriculture) noted:
Most genetically engineered foods are essentially foods with added substances, usually proteins. FDA’s policy gives manufacturers who use genetic engineering to add substances to food considerably more discretion than manufacturers who use other technologies to add substances to food. FDA’s policy strongly favors food manufacturers at the expense of consumer protection. The FDA’s proposed guidelines also continue to leave genetically engineered foods unlabeled, despite their own public opinion data, which notes that when asked about labels for genetically engineered food, “Virtually all participants said that bioengineered foods should be labeled as such.”
Furthermore, FDA guidelines are designed to make it as difficult as possible for responsible food producers, those that have rejected genetically engineered ingredients, to label their products as “Non-GE” foods. According to the FDA, food producers should not label products as “Non-GE” because, they say, it could be “misleading.” At the same time, the FDA somehow does not find it misleading when genetically engineered food is unlabeled – leaving consumers in the dark about what they are buying.