The FDA is always claiming science for their decisions, whether it is generous science to uphold drug approvals or so called lack of sufficient science to stamp out raw milk producers. Yet when it comes to adamant warnings from their own scientists about GMO safety, they purposely turn and look the other way.
The FDA's own science department waved cautionary flags as early as 1991! They noted profound differences between GM crops and regular ones, warned about foreseeable hazards, and worried about the lack of testing. One doctor accused the agency of forcing a square peg into a round hole and believing what they wanted to suit themselves. That's just what they did while running over science; their own science!
Internal US Food and Drug Administration (FDA) documents reveal that the agency's own scientists expressed doubts about its policy toward labeling genetically modified foods, while raising questions about the foods' safety.
The FDA's policy toward genetically modified foods has been that they are "substantially equivalent" to conventional foods and therefore don't require special labels-unlike most other industrialized nations that require labeling.
"Profound difference" between GM and conventional foods
FDA's policy, established in 1992, states, "The agency is not aware of any information showing that foods derived by these new (genetic engineering) methods differ from other foods in any meaningful or uniform way, or that, as a class, foods developed by the new technologies present any different or greater safety concern than foods developed by traditional plant breeding."
But FDA internal documents released in the late 1990s during a lawsuit against the agency show that the FDA's own scientists had serious doubts about GM foods when the policy was being established.
In a February 1992 memo, Louis J. Pribyl, Ph.D., a scientist in the FDA's Microbiology Group, critiqued a draft of the policy by writing, "There is a profound difference between the types of unexpected effects from traditional breeding and genetic engineering which is just glanced over in this document." Dr. Pribyl added that "several aspects of gene insertion may be more hazardous than traditional plant crossbreeding."
Linda Kahl, Ph.D., an FDA compliance officer, objected that the agency was, "trying to fit a square peg into a round hole [by] trying to force an ultimate conclusion that there is no difference between foods modified by genetic engineering and foods modified by traditional breeding practices." She continued, "The processes of genetic engineering and traditional breeding are different, and according to the technical experts in the agency, they lead to different risks."
E.J. Matthews, Ph.D., of the FDA's Toxicology group warned in an October 1991 memo, "genetically modified plants could also contain unexpected high concentrations of plant toxicants."
In a November 1991 memo to James Maryanski, Ph.D., the agency's Biotechnology Coordinator, FDA's Division of Food Chemistry and Technology cautioned, "it would be necessary to demonstrate that edible seed and oils produced from genetically engineered plants do not contain unintended potentially harmful substances at levels that would cause concern."
GM foods on the market illegally
According to Steven M. Druker, an attorney and executive director of the Alliance for Bio-Integrity, "Numerous agency experts protested that drafts of the statement of policy were ignoring the recognized potential for bioengineering to produce unexpected toxins and allergens."
Druker coordinated the lawsuit against the FDA's GM food policy in 1998, which aimed to force the agency to establish mandatory labeling and safety testing of GM foods.
The plaintiffs argued that FDA violated the US Food, Drug, and Cosmetic Act, which mandates that new food additives be established safe through testing prior to marketing. The FDA claims that GM foods are exempt from testing because they are "generally recognized as safe" (GRAS in FDA shorthand). According to the Food, Drug, and Cosmetic Act, foods can only be recognized as safe on the basis of tests that establish their harmlessness. Druker claims no such tests exist for GM foods.
Several FDA scientists emphasized the lack of scientific data to recognize the safety of GM foods. In her response to the draft of the policy statement, Kahl wrote, "Are we asking the scientific experts to generate the basis for this policy statement in the absence of any data?" She continued, "There is no data that could quantify risk."
According to Druker, "The FDA is using the GRAS exemption to circumvent testing and to approve substances based largely on conjecture that is dubious in the eyes of its own and many experts. Consequently, every genetically engineered food in the US is on the market illegally and should be recalled for vigorous safety testing."
"If Americans want progress, they'll have to be guinea pigs"
Philip J. Regal, emeritus professor of ecology, evolution, and behavior at the University of Minnesota and a plaintiff in the lawsuit, said he knew several FDA scientists who were "disgusted" with the policy.
During the early 1980s, Regal was asked to help the government establish a system of regulating genetically modified foods. He said policy development favored biotech companies.
"The bureaucrats were under pressure from the White House to help the biotech industry, which was against regulation and thought it would be too expensive," Regal said. "The result was no regulatory system, just a sham."
According to Regal, FDA knew about the risks of GM foods before they drafted policy guidelines, but decided it was up to the industry to deal with them. He said a common phrase heard at the time was, "if Americans want progress, they'll have to be the guinea pigs."
When he saw GM foods appearing on the market, Regal said, "it was all I could take," and became a plaintiff in the lawsuit.
In 2000 a US District Court ruled against the plaintiffs and upheld FDA's policy, which remains in effect today.
Druker believes the labeling issue is secondary to the fact that GM foods are on the market illegally. "By merely demanding labeling, it amplifies the impression that these products are legally on the market. As I see it, that's taking a weaker approach than the facts support and warrant; and it surrenders a lot of leverage."