In the U.S., three federal agencies are charged with ensuring the safety of genetically engineered food sold in the United States: the U.S. Food and Drug Administration, the U.S. Environmental Protection Agency and the U.S. Department of Agriculture. But a close look shows that federal regulations are contradictory and uncoordinated between agencies, are almost entirely voluntary, and are full of loopholes – leaving genetically engineered foods on the U.S. market without independent testing for risks to human health or the environment.
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.
Herbicide tolerant varieties make up about 70% of the genetically engineered crop acreage in the United States. Yet, the U.S. government agency charged with environmental protection does not evaluate the environmental risks of these varieties. The EPA’s role in regulating these crops, such as Monsanto’s Roundup Ready brand soybeans, is limited to approving herbicide for use on the new crop.
In addition to allowing higher residue levels of Monsanto’s Roundup brand herbicide on foods, the EPA has approved the use of bromoxynal on cotton, despite a cancer risk calculated at nearly twice the legal standard. The EPA does regulate the other main variety of biotech crop grown widely in the U.S., the so-called “Bt plant pesticides.” However, the agency’s 1995 proposed policy showed that the EPA intended from the outset to exempt the majority of Bt plants from insecticide or food regulation. Since allowing Bt crops on the market, the agency has heard from three scientific panels on the issue of insect resistance. The scientists warned the EPA that near perfect compliance is required to forestall the development of insect resistance. However, the EPA has made only minor adjustments in resistance management recommendations – even though, as the Associated Press reported on January 31, 2001, an EPA survey of farmers showed that nearly 30% were not complying with insect resistance management rules.
In September 2000, food testing by environmental watchdogs showed the presence of StarLink corn in store-bought taco shells. StarLink is a genetically engineered variety of Bt corn that the EPA approved only for animal feed, due to scientists’ concerns that the corn could trigger dangerous allergies in some people. The discovery of StarLink in the human food supply prompted the recall of nearly 300 supermarket and restaurant foods. Aventis, the biotech firm that developed StarLink, petitioned the agency to retroactively approve the corn for human food, but pressure from consumers and environmentalists forced the agency to withhold approval, and StarLink was forced off the market.
To this day, the agency remains unwilling to impose effective regulatory oversight, and another, possibly even more serious, release of food not safe for human consumption is almost an eventual certainty.
USDA biotech oversight is even less stringent than the FDA’s. As noted by The New York Times, and acknowledged by the agency, the USDA has not denied a single one of over 5,000 applications for genetically engineered crop field trials submitted by industry. The USDA claims that its review process, “evaluates agricultural and environmental safety issues,” but scientists outside the agency have pointed out that the agency virtually abandoned its permit process in the mid-1990′s, in favor of mere notifications that do not require any risk assessment or specific environmental review. In this system, “Ninety-nine percent of all field trials can be undertaken without [USDA] review. Developers need send only a brief notice to USDA along with a promise to conduct the tests safely.”
Meanwhile, the USDA actively encourages and even partners with industry in developing some of the worst genetically engineered crop technologies. For example, the agency has spent over $200,000 of taxpayer’s money to develop “terminator technology,” a genetic engineering technique intended to make it impossible for farmers to save seed for replanting. Part of the USDA’s mission is to support American farmers – yet this technology is a direct assault on farmers’ long-held right to save seed. Despite worldwide outrage about terminator, the USDA continues to pursue the technology with its industry partners.
For international regulations, please see our World Map of GE Crop Regulations
For state regulations, please see our State Initiatives section, or our report A New View of U.S. Agriculture