Don't Ask, Don't Know: The Biotech Regulatory Vacuum

by Ben Lilliston

Biotech industry supporters such as Senator Kit Bond, R-Missouri, claim that most people in the United States have already accepted genetically engineered crops because of widespread confidence in the government's ability to regulate the introduction of these new foods.

"In the United States, we have a system in place that has been developed for decades to evaluate new products and protect the public," Bond stated at a news conference during the WTO meeting in Seattle. "The system involves several agencies; it is rigorous, it is science-based and it has the confidence of the American people."

But the very agencies that Bond and others point to as the handlers of the government's "collective commitment to food safety" are being criticized from without and within.

A growing legion of biotech critics are contending that key U.S. food safety and environmental regulatory agencies have allowed the introduction of genetically engineered crops into the food supply and the environment without sufficient precautionary testing.

Evidence is mounting, they say, that this reckless action is putting people and ecosystems at risk -- and consumers in the United States in increasing numbers are joining those in Europe and elsewhere in endorsing this view by objecting to the sale of genetically engineered foods.

Opening the Floodgates for GE Food

In 1992, the Food and Drug Administration (FDA) issued a remarkable "Statement of Policy" that would forever change the food supply. Touted by then-Vice President Dan Quayle as a deregulatory initiative, the FDA determined that genetically engineered foods were "substantially similar" to conventional crops, and thus were not required to be labeled or undergo special safety testing before they entered the marketplace.

The 1992 FDA policy opened the floodgates for nearly 50 different genetically engineered crops and foods to enter the U.S. market. More than half of all soybeans and a third of the corn crop in the United States are now grown from genetically engineered seed. Other engineered crops that are rapidly gaining acreage include canola, cotton, potatoes, tomatoes and sweet peppers.

The FDA's policy was a godsend for the biotech industry, which had invested billions of dollars developing a variety of genetically engineered products -- all spliced with foreign genes creating crops never before released into the environment or eaten by humans. If the industry's new products were required to undergo a battery of tests to prove their safety -- similar to what is required for a new drug or food additive -- it would set them back years, perhaps even decades.

Now, more than seven years later, and despite a growing body of new scientific evidence of potential environmental and human health risks of genetically engineered foods, the U.S. regulatory system continues to give this radical new technology a free ride. All three agencies currently regulating genetically engineered products -- the FDA (regulating food), Environmental Protection Agency (EPA, regulating the environment) and Department of Agriculture (regulating the farm) -- utilize statutes that were designed to regulate other products. And Congress still hasn't passed a regulatory statute that deals specifically with the unique threats posed by genetically engineered crops and foods.

"This is a mess," says Jean Halloran of Consumers Union. "This fragmented system is never going to succeed."

The evidence that biotech foods and crops require more stringent regulatory oversight is mounting. Earlier this year, the British Medical Association, akin to the American Medical Association, called for an immediate moratorium on genetically engineered foods because of potential human health risks including possible allergenic reactions, and increased exposure to antibiotic resistance genes (which are spliced into every genetically engineered food). Renowned gene scientist Arpad Puztai reported in the prestigious medical journal Lancet in October 1999 that a specific genetically engineered potato was causing rats to suffer substantial health effects, including weakened immune systems and changes in the development of their hearts, livers, kidneys and brains. Another study, published in the Journal of Medicinal Food last summer, found that a genetically modified soybean had less nutritional value because of lower levels of the beneficial phytoestrogen compounds thought to protect against heart disease and cancer.

Three recent studies indicate that genetically engineered crops react differently than conventional crops in the environment. In the Spring of 1999, Cornell researchers found that pollen from genetically engineered Bt corn was toxic to the Monarch butterfly. In November, University of Georgia researchers reported that Monsanto's genetically engineered Roundup Ready soybeans were splitting open in heat at a much higher rate than conventional soybeans because of their unique metabolic structure. And in December, New York University researchers reported in the journal Nature that roots from common genetically engineered Bt corn exude the Bt pesticide into the soil, where it binds with soil particles and remains active for 243 days.

Health Testing Takes Back Seat

The FDA's 1992 policy statement determined that genetically engineered foods were in most cases "the same as or substantially similar to substances commonly found in food" and thus are not required to undergo specific safety tests prior to entering the market. While food additives are subjected to a rigorous round of testing, and must meet the standard of "a reasonable certainty of no harm," the FDA has determined that the genetically engineered foods currently on the market are not additives. And the FDA has designated all genetically engineered foods as "Generally Regarded As Safe" (GRAS) -- making the new foods exempt from mandatory pre-market review.

After a genetically engineered crop is designated as GRAS, the corporate owner is "encouraged" to participate in the FDA's "voluntary" consultation process. James Maryanski, the FDA's biotechnology coordinator, explained at the FDA's public hearing in December that "the consultations have been established so that companies have an opportunity to make sure that they are meeting all of the safety provisions and labeling requirements of the Food Drug and Cosmetic Act before the product goes to market." Every company that has placed a genetically engineered food product on the market has participated in the consultation process.

"We think that the process, as it's been carried out to date, has done a highly praiseworthy job of ensuring that the products of foods derived from crops improved through modern biotechnology are at least as safe as, if not safer than, those we have hitherto consumed," Val Giddings of the Biotech Industry Organization stated at public FDA hearings held in Chicago in December. "We see no evidence based on science, and no evidence based on experience for any requirement to change this process."

But the consultation process is not mandatory or uniform -- each company submits different types of tests -- and only the summary of the data, not the entire studies, are sent to the FDA. The tests are not peer reviewed or available for public scrutiny. And the testing is largely done by the company seeking guidance from the agency.

Maryanski defended the agency's anti-precautionary policy before a Senate Committee in October: "FDA's 1992 policy statement and our guidance documents make clear that premarket clearance is required if there is scientific uncertainty about the safety of food derived from bioengineered plants." Yet it is the biotech companies that decide whether there is any such "scientific uncertainty."

The FDA's policy is a dramatic shift away from the long-standing requirement that companies prove their product is safe, says Rebecca Goldburg, of the Environmental Defense Fund. "In other words, FDA's policy strongly favors food manufacturers at the expense of consumer protection," Goldburg told the FDA at public hearings in November.

Of specific concern is the potential exposure to food allergens. Although FDA co-sponsored a scientific meeting on food allergies in genetically engineered foods in 1994, the agency has yet to develop and publish guidance to industry on how to assess the allergenic potential of new proteins. A disaster was narrowly avoided in 1996, when University of Nebraska researchers found that inserting the gene from a Brazil Nut into a soybean caused a potentially fatal reaction when consumed by people allergic to Brazil nuts. The Nebraska University test was not required by U.S. regulatory agencies, and took place after animal tests on the Pioneer Hybrid engineered soybean did not indicate it was allergenic.

"Most proteins added to foods via genetic engineering cannot be tested for allergenicity," Goldburg told the FDA panel. "Instead, industry scientists simply screen the biochemical characteristics of proteins to see if they are consistent with the characteristics associated with allergens. It remains to be seen how effective such screening will be in protecting public health."

The lack of toxicity testing is another cause for concern. Puztai's rat study with a strain of genetically engineered potato is one of the few rat studies conducted on genetically engineered foods.

"Currently, there is no toxicity testing requirement to ensure engineered substances are safe," says Halloran of Consumers Union. "We need to see more studies like Dr. Puztai's, as well as other long-term rat studies."

An additional characteristic of genetically engineered food is that all current products include an antibiotic resistant gene. This gene is spliced into the food to serve as a marker. The product is doused with the antibiotic -- and those that survive the antibiotic are considered successfully engineered. The practice of adding antibiotic resistant markers to genetically engineered foods was instrumental in the British Medical Association's decision to call for a moratorium on the introduction of new engineered foods. The British Medical Association's concern, widely shared, is that the widespread, avoidable use of antibiotics for non-essential purposes will intensify the problem of antibiotic resistance, already considered a crisis in the medical community. An estimated $5 billion a year are spent treating antibiotic-resistant infections in the United States alone.

The FDA's oversight is so lax that even pro-biotech groups like the National Food Processors Association and the Grocery Manufacturers Association urged the FDA at its Oakland public hearings to make the consultative process with the FDA mandatory for biotech companies, and that summary data be made available to the public.

Groups like the Council for Responsible Genetics, Center for Food Safety, Union of Concerned Scientists and Consumers Union would like the FDA to require a battery of health tests and detailed scientific studies, and that the FDA share all of the data with the public.

Controversy Within FDA

When the FDA announced its 1992 policy, the agency argued that a clear scientific consensus supported the policy. But as documents uncovered as a result of a recent lawsuit filed by the Center for Food Safety and the Alliance for Bio-Integrity indicate, many of the FDA's own scientists strongly disagreed with the agency's policy.

In a memo to FDA Biotechnology Coordinator James Maryanski in 1992, FDA compliance officer Dr. Linda Kahl argued that genetically engineered crops and traditional crops were not the same. "The process of genetic engineering and traditional breeding are different, and according to the technical experts in the agency, they lead to different risks," Dr. Kahl wrote.

In a separate memo, Dr. Louis Pribyl, an FDA microbiologist, commented that a draft of the FDA policy "read very pro-industry, especially in the area of unintended effects." It is "industry's pet idea that there are no unintended effects that will raise the FDA's level of concern." But, Prybil wrote, "there is no data to back up their contention."

In court filings, the FDA has dismissed the memos as coming from "low-level FDA employees" and said their comments were not part of the formal record on which the agency based its decision. A judge is expected to decide upon the lawsuit against FDA early this year.

EPA: Ignoring Environmental Risks

The U.S. EPA is in charge of protecting the environment from the adverse effects of genetically engineered crops. But critics say the agency has ignored several important environmental statutes and dropped the ball in evaluating risks.

The EPA is currently being sued by Greenpeace, the Center for Food Safety and numerous other environmental groups and organic farmers because of the way it has regulated crops which contain genes from a naturally occurring soil bacterium, Bacillus thuringiensis (Bt). Among several charges, the lawsuit claims that the EPA has ignored the Federal Fungicide, Insecticide and Rodenticide Act (FIFRA) and the National Environmental Policy Act (NEPA) by allowing Bt plants on the market.

According to the lawsuit, the EPA has allowed genetically engineered Bt plants to enter the market despite recent research indicating that they will speed up the development of pest resistance to natural Bt sprays (an important tool for organic farmers); transfer engineered Bt traits to weedy relatives, creating so-called "Superweeds;" and have adverse impacts on beneficial insects and other non-target organisms. In addition, the EPA has ignored a requirement under NEPA to prepare an environmental impact statement that analyzes the environmental, socio-economic and cumulative impacts of its program approving genetically engineered Bt plants.

"EPA has shown a blatant disregard for federal law and their own regulations by approving Bt crops without fully assessing their environmental safety," says Joseph Mendelson, legal director of the Center for Food Safety.

Mendelson points out that both the Cornell University study on Monarch butterflies and the New York University study describing how engineered Bt remains toxic in the soil were not required to be done at all, let alone before the crops entered the marketplace.

Dr. Charles Benbrook, a former member of the National Academy of Sciences, believes that the NYU study is as important as the Monarch butterfly study, which has received a great deal of media attention. "What goes on underground in a field planted with today's Bt-corn varieties is largely a mystery. Enhance the toxin levels 100- to 1,000-fold and it becomes a mystery of some consequence and immediacy," Benbrook says.

The registrations for the current wave of engineered Bt crops expire in 2001. The real challenge for the EPA will be the next round of genetically engineered Bt corn -- which is expected to be one, two or three orders of magnitude more powerful than existing varieties. The new varieties will be designed to address the corn rootworm complex, a particularly stubborn pest which has developed a resistance to every single pest tool including crop rotation, according to Benbrook. "It's going to take a pretty high level of Bt to control them."

While the environmental risks of genetically engineered Bt crops are slowly emerging, even less is know about the human health risks of eating Bt foods. The EPA has determined that the Bt pesticide in spray form is safe for consumers to eat. But EPA has not required studies on the long-term and short-term effects of eating foods with the Bt pesticide spliced into every cell.

EPA's Pest Resistance Resistance

Although genetically engineered Bt crops have been planted in U.S. fields since 1995, the EPA has yet to put together a plan to address the potential effects of pest resistance.

Both the biotech industry and the EPA recognize that genetically engineered Bt crops will speed up the development of resistance to Bt by the major target pests -- the pink bollworm (cotton) and the corn borer (corn). Margaret Mellon, of the Union of Concerned Scientists, estimates that Bt crops could lead to pest resistance in as little as two to four years. In fact, AgrEvo's Bt corn, Starlink, is a second generation Bt crop designed to be effective if resistance develops.

To slow the development of resistance, the biotech industry and some farmers associations are pushing a solution built around refuges -- designating an area where conventional crops would be grown next to engineered crops. The conventional crops would allow for the continued survival of insects that are not resistant to Bt. These insects breed with Bt-resistant insects and thereby keep the Bt-resistant genes from being passed along to the next generation.

But the buffer zone resistance plans are "based in large part on computer models and not on large-scale field experiments," says EDF's Goldburg. "Elements of the plans are highly controversial among entomologists and others who believe they are inadequate to forestall the evolution of resistant pests."

According to Benbrook, if pests develop a resistance to the Bt pesticide, it could be disastrous -- particularly for organic farmers who rely on Bt sprays as last resort. "That is a loss that could plague farmers for decades if not centuries," he says.

Drifting Liability

Earlier this year, British researchers at the John Innes Center in Norwich found that genetically engineered pollen can travel up to three miles carried by wind, bees and other insects. Genetic contamination of conventionally grown crops usually occurs when wind-blown pollen from engineered corn and canola crops cross-pollinates with conventional crops in nearby fields. There is not as much of a threat of contamination for plants like soybeans that self-pollinate.

The threat of unknown genetically engineered material flying through the air to another farmer's land is very real. Organic farmers are especially vulnerable. An organic farmer in Texas supplied organic corn to the Wisconsin chip maker Terra Prima. But upon arrival in Europe last March, the corn was returned after testing positive for genetically engineered material. The genetically engineered material drifted from a neighboring farm and cost the company nearly $300,000. Cissy Bowman, another organic farmer, told the FDA that "I literally can be put out of business in one breeze."

So far, neither the EPA nor USDA are regulating problems associated with genetic drift, and there are no existing regulations to deal with it. "It's one of the GM [genetically modified] hot potatoes that nobody wants," says Benbrook.

Legislation is expected to be introduced in Congress next year that will assign liability to the biotech companies in cases where genetic drift has caused damage.

USDA's Blind Field Tests

The USDA has played the role of cheerleader for the biotech industry, trying to push open markets in other countries like the European Union, and actually helping to develop new genetically engineered crops like the "Terminator" technology -- in which seeds develop into plants which themselves do not germinate, preventing farmers from saving the seed for planting or trade.

In 1998, USDA proposed standards to define what is "organically grown." USDA received over 300,000 letters of opposition to a proposal that would have allowed genetically modified crops to be labeled "organic," more comments than any other proposed rule in U.S. history. But this consumer outcry has apparently done nothing to dampen USDA's enthusiasm for GE crops.

The USDA's most important regulatory role comes through its Animal and Plant Health Inspection Service, which is responsible for evaluating the potential environmental impacts of field tests of genetically engineered crops. The USDA has received notices of 22,400 outdoor tests of new genetically engineered crops, according to government estimates. The tests are authorized under 5,100 permits and streamlined arrangements called notifications, in which companies essentially tell the government what they are planting -- but are not required to report the results. USDA has never denied a notification for a biotech company.

Pressure from other countries and U.S. environmental and consumer organizations, as well as emerging science, may force the U.S. regulatory agencies to make major changes in the coming year. The FDA is accepting public comments through January to decide whether it needs to reconsider its current policies. The agency is also the subject of a lawsuit challenging its interpretation of the Food Drug and Cosmetic Act.

Additionally, the EPA, also the subject of a lawsuit, may finally have to face the emerging scientific consensus that genetically engineered crops pose unique threats in the field. An EPA Advisory Panel recently recommended that the agency require testing that looks at any harmful effects from genetically engineered crops on mallard ducks, rainbow trout, honeybees and other wildlife. The advisory panel's recommendations, expected in February, could spur a change in EPA's current approach.

Where the agencies are incapable of reorienting their own policies, Congress may step in. Legislation is expected to be introduced this year that would reconstitute the current regulatory structure.

The U.S. regulatory system is balkanized and its approval of genetically engineered crops seems premature to a growing proportion of consumers and the citizenry. As scientific evidence concerning the crops' potential threat to the environment and consumers continues to be discovered, biotech's biggest boosters, including Senator Bond, will likely find it increasingly difficult to convince the public to accept GE foods on the grounds that the U.S. regulatory system has done its job.