FDA Proposes Regulations, Not Labeling for Genetically Engineered FoodSep 22, 2008 | Parker Waichman LLP
As the U.S. moves closer to eating genetically created animal foods, regulators say the onus on safety remains with the producers of these animals. The U.S. Food and Drug Administration (FDA) said it was proposing new guidelines for such animals that detail the FDA’s position on its authority to regulate this growing industry and its requirements and recommendations to the producers of these animals. There’s a catch, the only labeling the FDA requires is related to health claims producers make about their genetically engineered food.
Such engineering refers to recombinant DNA techniques, which introduce new characteristics or traits, often adding a trait from one animal to another. Those who back these practices say these techniques result in animals that can grow faster, produce healthier foods such as heart-healthy eggs, or be resistant to certain diseases, such as mad cow disease; opponents say genetic engineering can lead to unintended, unplanned results when traditional genetic structures are corrupted.
Some believe techniques could help animals resist diseases and are also being developed to decrease their environmental impact by decreasing harmful substances in their manure. Randall Lutter, deputy commissioner for policy at the FDA, said the U.S. Food, Drug, and Cosmetics Act gives the FDA the authority to regulate these animals. "Genetically engineered animals that contain a recombinant DNA segment that is intended to alter the structure or function of the animal are considered to contain a new animal drug," he said. "Genetically engineered animals will, therefore, require pre-market approval by FDA prior to their introduction into the marketplace."
Dr. Larisa Rudenko, senior adviser for biotechnology at the FDA's Center for Veterinary Medicine, said the safety of genetically engineered animals intended as food will be decided individually. "Attention will be paid to particular risks posed by each line of animal, although the basic test will be the same for all animals," Rudenko said. "If the animal is intended to be used for food or feed, we will have to do a full evaluation of food and feed safety. We will also perform an environmental assessment." Producers will have to prove new genetic traits perform as claimed, Rudenko said. "We will also ask producers to provide a plan for how they will monitor these animals to ensure that the genetically engineered animals entering commerce in the future are equivalent to those we have approved," she said.
Consumers Union, Consumer Reports magazine nonprofit publisher was deeply troubled saying through Jean Halloran, director of food policy initiatives there, "It is incomprehensible to us that FDA does not view these animals as different from their counterparts, and therefore something that under law is required to be labeled,” adding, "In our view, consumers have a right to know if the ham, bacon, or pork … they are buying come from pigs that have been engineered with mouse genes." Jaydee Hanson, a policy analyst on cloning and genetics at the Center for Food Safety, agreed, saying, "It's bad, because the FDA does not require labeling of genetically engineered animal products. It's bad, because the process is entirely confidential. It's bad because the new animal drug system is only intended to look at toxicity of chemicals in the human body. It's not really intended to look at the biology of a new gene introduced into every cell in an animal.