December, 1999
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Clash over biotech food policies

Memoranda showing internal FDA dissent over regulating genetically engineered foods aired at hearings

December 13
Chemical & Engineering News

In response to rising concerns over the safety of genetically engineered food, the Food & Drug Administration is holding a series of three public hearings designed to ask the public whether FDA's policies for ensuring the safety of such foods should be modified and to solicit comments on whether genetically modified foods should be labeled.

The first hearing was held in Chicago on Nov. 18 and the second in Washington, D.C., on Nov. 30. The most striking revelations to come out of the Washington meeting were numerous memoranda showing that a number of FDA officials and scientists strongly disagreed with the agency's policy of regulating genetically modified food in the same way as conventional varieties. For example, in 1992, the FDA official in charge of the Center for Veterinary Medicine, Gerald B. Guest, expressed grave doubts about this policy, especially when applied to feed intended for livestock.

"Animal feed derived from genetically modified plants presents unique animal and food safety concerns," Guest wrote. These concerns arise partly because one crop—field corn—supplies 50 to 75% of the diet of most domestic animals, so small changes in nutrient levels from genetic engineering can have large effects on animal health. The antibiotic resistance marker genes contained in most crops would likely make animals resistant to some antibiotics, especially neomycin, which is used in animal feed, he added.

Furthermore, he wrote, toxicant residues from transgenic crops could end up in meat and milk products and may pose human food safety problems. 

At the opening of the Washington meeting, Joseph A. Levitt, director of FDA's Center for Food Safety & Applied Nutrition, described the agency's current policies for regulating genetically engineered food. The policies were finalized in 1992 as FDA's interpretation of the Food, Drug & Cosmetic Act [Fed. Regist.,57 , 22984 (1992)]. At that time, FDA decided to regulate genetically engineered food in the same way as any other food and to require no label unless the food was substantially different in terms of its nutrient or allergen content.

FDA decided not to regulate the new proteins introduced to food through genetic engineering as food additives— which are tested extensively—but as materials generally recognized as safe, Levitt said. FDA chose to utilize an approach that is "identical in principle to that applied to foods developed by traditional plant breeding," he said. 

Under this policy, companies that develop a new food through recombinant DNA techniques are encouraged—but not required—to consult with FDA before marketing the food. Only if a substance added to a food as a result of gene splicing raises "questions of safety" would FDA require formal premarket review and approval, which might include toxicological tests. 

"We believe our oversight has been substantive and credible," Levitt said. Even though the developers of genetically engineered foods are not required to consult with FDA before marketing a new food, they have done so in every case, he noted.

James H. Maryanski, biotechnology coordinator at FDA's Center for Food Safety & Applied Nutrition, explained that there could be circumstances in which a new genetically modified food should be tested in animals. For example, a potato developed in Europe, which contains toxic proteins called lectins, would be tested, he said. But testing in animals is not generally recommended because "feeding whole foods to animals is complicated." At the meeting, two six-member panels critiqued FDA's policies. On each panel, some members said FDA's current regulatory regime is satisfactory, while others were highly critical.

The process FDA has established for regulating genetically engineered crops "is working very well," but it needs to be flexible to take account of new situations as they arise, said Peter R. Day, director of the Center for Agricultural Molecular Biology at Rutgers University, New Brunswick, N.J. The greatest benefit of biotech crops is their potential for helping the developing world, he said. Rice engineered with higher than normal levels of vitamin A and iron could do much to relieve malnutrition in poor countries, he explained.

Samuel B. Lehrer, research professor of medicine at Tulane University Medical Center, New Orleans, said the fear that genetically modified foods will give rise to new allergies is largely unfounded. Most allergens are proteins, and genetic engineering precisely determines which proteins are introduced, he explained. Consequently, the new proteins can be tested, and "the likelihood these proteins will be allergenic is minimal," he said. 

Rebecca J. Goldburg, senior scientist at the Environmental Defense Fund, strongly disagreed with Lehrer. The biochemical characteristics of the new proteins can be screened to see if they are similar to those of known allergens, Goldburg said, but there is no predictive methodology for testing for the allergenicity of most proteins introduced to food via genetic engineering. "Our concern is that, by adding proteins to food through biotechnology, some people may become allergic to foods they previously could safely consume," she said.

Sidebar: Hearing addresses four questions

Steven M. Druker, executive director of the Alliance for Bio-Integrity, an advocacy group based in Iowa City, Iowa, presented the most striking testimony. His organization, along with the Washington, D.C.-based International Center for Technology Assessment, has sued FDA, claiming that its current regulatory policies violate provisions of the Food, Drug & Cosmetic Act. The suit demands rigorous testing and labeling of genetically modified foods. During the discovery procedure for this lawsuit, FDA memoranda came to light that revealed internal dissent within the agency when the policies were under development in 1991 and 1992.

In his testimony, Druker read from several of these memos. They show that a number of FDA scientists repeatedly cautioned that foods produced through DNA technology present different risks than do their conventional counterparts. Memorandum after memorandum warns about the unique hazards of genetically engineered food.

In one 1992 memo that comments on the agency's proposed Federal Registernotice, FDA microbiologist Louis J. Pribyl wrote: "There is a profound difference between the types of unexpected effects from traditional breeding and genetic engineering, which is just glanced over in [FDA's policy] document." Several aspects of gene splicing may in some cases be more hazardous than traditional breeding, he continued. The document "reads very pro-industry, especially in the area of unintended effects," he wrote. "What has happened to the scientific elements of the document?" he asked.

In another memo, Edwin J. Matthews, an FDA pharmacologist, warned that genetically modified plants could contain unexpectedly high concentrations of plant toxicants, which could be "uniquely different" from the chemicals that are "usually expressed in unrelated plants."

A 1992 memo from FDA compliance officer Linda Kahl states: "The processes of genetic engineering and traditional breeding are different and, according to the technical experts in the agency, they lead to different risks."

In light of these risks, a number of FDA divisions and individual scientists advised in late 1991 and early 1992 that genetically engineered foods should undergo special testing. FDA's Division of Food Chemistry & Technology warned: "Every transformant [transgenic food] should be evaluated," with toxicological tests before it enters the marketplace.

The memos reveal that, at that time, FDA officials were well aware of uncertainties and warnings emanating from agency scientists and from the broader scientific community. Maryanski, who was coordinating biotechnology policy, wrote in a letter to a Canadian official in late 1991 that there was no scientific consensus concerning the need for toxicology tests on genetically engineered food and that it was "particularly difficult to predict" whether some substances in these foods would cause allergic reactions.

Prior to the FDA hearing in Washington, these memos were not available to the general public, even though several environmental activists had obtained some—but not all—of them. FDA refuses to comment on the memos because they are the subject of litigation in the D.C. district court. The panelists at the Washington, D.C., meeting were also sharply divided over whether genetically engineered food should be labeled, and whether the labeling should be mandatory or voluntary.

Carol Tucker Foreman, director of the Food Policy Institute of the Consumer Federation of America, said mandatory labeling of transgenic food would increase public confidence in these foods. Goldburg said that FDA's current policy concerning labeling "may not adequately protect public health." If some genetically engineered foods do indeed cause allergies, and they are not labeled, consumers will not be able to distinguish between the foods that cause allergic reactions and other nonallergenic foods, Goldburg maintained.

The industry representatives on the panel favored voluntary labeling. Richard Frank, vice president of Food Distributors International (FDI), said he opposed mandatory labeling requirements. "But FDI does support voluntary labeling provided the statement is truthful and the label does not imply that nonbiotech foods are superior," he said. "Consumer education along with a voluntary label will help people better understand what genetically modified organisms are," he said.

Kendal Keith, president of the National Grain & Feed Association, also warned against a mandatory labeling regime, but said he "does not oppose voluntary labeling." However, Mario Teisl, assistant professor of economics at the University of Maine, Orono, said that labeling may not be the best way to convey information about transgenic food. It may only increase uncertainty, he said.

Observers expect that FDA will wait until next year to decide on policy changes for genetically engineered foods. Michael Hansen, a research associate at the Consumer Policy Institute, the research arm of Consumers Union, predicts that FDA will decide to make industry consultations mandatory, rather than voluntary. In other words, industry will be required to consult with FDA before marketing a new transgenic food. He also predicts that FDA will decide to encourage the voluntary labeling of foods that contain genetically modified ingredients. Many industry groups now favor voluntary labeling because they fear they will not be able to sell transgenic foods or their traditional counterparts to Europe unless the transgenic foods are labeled.

Scientists in Italy study GM rice

December 13
Reuters

An international team of scientists at the Catholic University of Piacenza in northern Italy is studying genetically altered rice, spliced with a gene from soya, that resists parasites, a spokesman said Monday.

Corrado Fogher, a plant geneticist and lecturer at the university, said the rice resisted an insect called "chilo supresalis" which was common in paddyfields in the south of France and in China. He said genetic alteration of rice would remove the need for pesticides.

"I hope that it may be possible to grow the rice commercially in four to five years, depending on EU authorizations," Fogher told Reuters in a telephone interview.

EU governments said Monday they had approved a deal reached by environment ministers in June to tighten the bloc's system for approving new genetically modified organisms (GMOs). The 15-member EU has been trying to agree new rules on approving GMOs to counter growing public fears about the safety of food manufactured from GM crops.

The EU is also under pressure from biotech companies and the United States, which says it is losing hundreds of millions of dollars in commodity exports to Europe, because GM crops widely grown in the U.S. have not been approved for use in the EU.

No new GM crops have been authorized in the EU since April 1998. Italy was chosen as the venue for the EU-sponsored GM rice experiment, which began last year and will finish in 2002, because the  country is the EU's main rice producer and grows several varieties of the crop, Fogher said.

Risks played down

He played down any health risks from the GM rice, and said the experiments would introduce no toxins into the environment. Fogher said Piacenza scientists were cultivating experimental paddyfields to determine the frequency with which the genes were transmitted to other varieties of rice plants. 

Pollen can travel hundreds of meters, potentially transferring the characteristics of genetic modification to other plants.

Environmental activists in Europe, particularly Britain, have expressed serious concerns over possible health and environmental risks from genetically altered plants. In Britain, they have torn up GM crops. Environmental group Greenpeace put up a giant condom-covered corn cob in front of the Rome Health Ministry in August to protest against GM foods it said were unwanted and risky.

The consciousness of Italians to possible risks from GM food was low, Fogher said.

"Scientists have a responsibility to explain why we are carrying out these experiments, and the benefits they could bring," he said. 

He said research was also under way at the Catholic University of Piacenza to produce a sweet, low-calorie GM grape. 

Italian science magazine Newton said in its December edition that scientists at life sciences company Metapontum Agrobios (Matera) were experimenting with potatoes and aubergines resistant to Colorado beetle and tuber moths respectively.

Gene therapy firms resist publicity

December 11
Washington Post

Federal officials overseeing the field of gene therapy searched in vain yesterday for common ground between drug companies that want to keep details of their experiments secret and advocates who favor a more open airing of the field's recently revealed problems.

On the final day of an emotionally exhausting gene therapy conference at the National Institutes of Health in Bethesda, federal officials wrangled over the difference between "serious" and "severe" side effects, biotechnology company officials pushed for less burdensome regulations, and parents of sick children pleaded for more help from both the regulators and those who hope to profit from gene therapy.

The three-day meeting was prompted by the awkward confluence of two events: the September death of a teenager in a University of Pennsylvania gene therapy experiment, and recent efforts by some gene therapy companies to scale back the amount of information about side-effects they must submit to the NIH.

Researchers and companies testing genetic therapies on people are required by the NIH to release to the public more details of their work than are researchers who test conventional drugs. Those rules were devised to ensure that subtle side-effect trends are noticed more quickly, and to foster public confidence in the novel field that seeks to cure diseases by giving people new genes.

Gene therapy has yet to cure anyone. But as the field has grown from one dominated by academic researchers to one driven by companies with millions of dollars at stake, pressure has built to trim the NIH public disclosure rules and have research results reviewed mostly by the Food and Drug Administration, which keeps such information confidential.

"Virtually every detail about the design, size or status of a clinical trial is of potential competitive value," according to a statement by the Biotechnology Industry Organization (BIO) for the NIH Recombinant DNA Advisory Committee (RAC) yesterday. That includes details of "adverse events," the industry group said, which "are, by definition, trade secrets and confidential commercial information."

BIO board member H. Stewart Parker told officials that biotechnology companies were willing to submit to the NIH some details of the most serious and unexpected adverse events as they occurred but only if the companies and the agency could first agree on how much of that information would be made public. NIH now makes all such information available to the public.

Less serious adverse events should not have to be reported to the NIH at all except in annual summary reports, Parker and other industry representatives said, because those details are too easily misconstrued negatively by the public.

"Immediate disclosure of adverse events is bad science," said an official from Schering-Plough Corp. of Kenilworth, N.J., a company whose recent effort to declare its NIH adverse-events reports "confidential" helped prompt yesterday's reassessment of reporting rules.

Others at the meeting objected to that view, saying so much is still unknown about gene therapy that open sharing of results may help prevent tragedies like the one that befell Jesse Gelsinger, the Arizona teenager who died in September. Even if gene therapy is not more dangerous than other experimental approaches, some said, it is scary enough to the public to warrant extra openness.

"My feeling is it's still a unique field," said W. French Anderson, the University of Southern California researcher who conducted the nation's first gene therapy test in 1990. "Standard medical research doesn't strike the same nerve as changing genes and changing the core of what we are as human beings. It's not a safety issue. It's a public confidence issue. And that will remain until people are really starting to see some cures," perhaps in three to five years, Anderson predicted.

Some RAC members questioned whether the NIH had the right to demand so much data if it didn't have the resources to make sense of it. The agency is years behind in its effort to create an online database of gene therapy trials and adverse events.

Others expressed concern that public reporting could run afoul of new patient privacy regulations under construction. Even a few details in an adverse-event report could inadvertently and illegally give away the identity of a clinical test volunteer with a rare disease. If that's the case, some said, it may be that gene therapy volunteers should be asked to sign a special consent form, which states that they accept the possibility that their identities may become public.

Asked if that extra level of public exposure was appropriate to ask of volunteers, Paul Gelsinger, Jesse's father, acknowledged that some might not be as willing as he and his son were to step into the limelight. "That's a tough one. It's a personal choice," he said. "But I'd advise people to be willing to be public, because it's so important that all the information get out."

RAC officials said they would continue the discussion at future meetings, and would welcome public comments on the issue.

Growing evidence of widespread GMO contamination

December 1
Environmental Science and Technology

Now that millions of tests have been conducted in response to escalating worldwide concern over genetically modified organisms (GMOs) in food, it is increasingly clear that GMO contamination of conventionally grown food is a serious issue. Ultimately, it may trigger legal action.

GMO testing has increased astronomically in recent months, and it now happens "quite often" that farmers are surprised to learn that crops they grew in the United States from non-GMO seeds test positive for GMOs when they reach Europe, said John Fagan, founder of Genetic ID of Fairfield, Iowa. Genetic ID became the world's first laboratory to offer GMO testing in 1996 and now licenses its nearly foolproof method for detecting GMOs, which is based on the "TaqMan" DNA testing technique, to laboratories around the world.

Nine GMO food crops are currently grown in the United States, including soybeans, corn, canola, tomatoes, and potatoes. GMO versions of quite a few other crops, most notably wheat, are in the works. The GMOs in most of these crops can only be detected by DNA testing, which must be conducted in a laboratory and costs $200-$400. But Monsanto's Roundup Ready soybeans can also be identified by a $5.75 protein-based test being sold by Strategic Diagnostics Inc. (SDI), of Newark, Del., which produces results in 3-5 minutes.

SDI began offering its tests this spring and has already sold millions of them, said Joe Dautlick, the company's marketing manager. By this month, SDI also expects to be offering tests capable of identifying GMO corn. Although there are 13 varieties of GMO corn and SDI is only planning to offer tests that will be able to detect four of the most popular Bt and Liberty Link varieties, Dautlick expects them to be very popular.

The European Union, Japan, South Korea, Australia, and New Zealand have all passed or are considering laws requiring that food containing GMOs be labeled. But almost all GMO testing is conducted by and for businesses that demand proof the commodities they are buying contain no detectable GMOs. Even in the United States, where the official policy holds that GMO food is nutritionally identical to conventional food and therefore requires no label, some prominent U.S. food manufacturers have pledged not to include GMO ingredients in their lines. These include the leading manufacturers of baby food, Gerber and Heinz, as well as pet food maker Iams and a wide variety of health food companies. U.S. Agricultural Secretary Dan Glickman has also encouraged the food industry to voluntarily label GMO food.

One of the reasons that the pace of testing has skyrocketed in recent months is because businesses want to avoid embarrassment. Gerber made its no-GMO vow after Greenpeace used DNA testing to show that the company's dry cereal baby food contained GMOs, for example. Other companies who have promised GMO-free food have had their claims refuted by testing.

Much of the GMO contamination that such tests reveal can be traced to practices that fail to preserve the identity of non-GMO crops, Dautlick said. Commodities like soybeans, corn, and canola travel along a complex and convoluted path from the farm field to their ultimate destination on a consumer's table, passing through a series of grain elevators, transport trucks, ocean barges, ports, and food companies. Because many businesses in Germany and Japan require that products be certified to contain less than 0.1% or even 0.01% of GMOs, careless practices like not properly cleaning out a weighing bin can lead to contamination. People involved in moving these products "don't want to get stung," so they have begun testing at many points along the way, Dautlick said.

But even if standardized practices for handling non-GMO crops were instituted worldwide tomorrow, they would not solve all of the GMO food contamination problems, according to Fagan. Genetic ID's testing has documented that GMO contamination of conventionally grown crops occurs when wind-blown pollen from GMO corn and canola crops in nearby fields cross-pollinates with non-GMO corn or canola, he said. (This is not much of a threat for plants like soybeans that self-pollinate.) Genetic ID has also amassed proof that seeds sold as non-GMO by seed companies are in fact contaminated with GMOs.

Terra Prima, a company that sells organic corn chips, used DNA testing to prove that corn grown by a certified organic farmer in Texas was contaminated by cross-pollination from a nearby field where Bt corn was grown. The company was forced to destroy $87,000 worth of its chips because the contamination did not come to light until after the corn was made into chips; it is a plaintiff in a lawsuit filed against EPA this February alleging that the agency registered genetically engineered crops without adequately considering their health and environmental impacts. In addition to the cases he has documented, Fagan believes there are many other cases where non-GMO corn and canola crops became contaminated by cross-pollination from GMO crops.

Pollen can easily travel beyond the "refuges" of non-GMO crops that EPA suggests farmers plant to inhibit the development of insect resistance to the Bt toxin, according to research conducted by the British Broadcasting Company in conjunction with Friends of the Earth. They employed a German laboratory to conduct DNA testing that showed pollen from a GMO canola field ended up 2.8 miles away in a bee hive. Greenpeace also conducted a test in Germany last October that documented corn pollen's drift into a neighboring field, said Charles Margulis, a campaigner with Greenpeace.

Genetic drift in which pollen from one kind of plant is taken up by another plant, creating a new kind of hybrid, is also a concern, Margulis said. The United Kingdom's National Institute of Agricultural Botany reported in April that a hybrid "super weed" my have been created after canola pollen was taken up by wild turnips growing nearby. Some of these hybrid plants have proven to be resistant to the herbicide for which the canola was engineered to be resistant.

Genetic ID's scientists became convinced that GMO corn seeds were mixed in with conventional seeds after they tested products from four major seed companies. They obtained five large samples of each of five different conventional seed varieties from each company, Fagan said. What Genetic ID found after conducting its tests—which are considered the most accurate method for detecting GMOs because they involve triple-checking for the presence of GMO DNA—was that all of the varieties of allegedly non-GMO seeds from each company contained between 0.01% and 1% GMOs, Fagan said.

Though Genetic ID refuses to divulge the identity of the companies whose seeds were tested, farmers are already concerned about the purity of the seed stock and many are sending their seeds to be tested before they plant, Fagan said. Genetic ID has contacted the offending seed manufacturers and is offering to conduct the testing necessary to certify that their seed lots are GMO-free, according to a company spokesperson. Last summer, a European affiliate of Pioneer Hi-Bred International acknowledged that it sold conventional corn seed that was contaminated with GMOs.

Ultimately, this evidence of how conventionally grown crops are being contaminated by windborne pollen and how seeds are falsely labeled as being non-GMO could give organic farmers grounds for a class-action lawsuit, said Michael Hansen, a research associate with the Consumer Policy Institute. The basis of such a suit could be the toxic trespass laws passed by many states to provide citizens with legal recourse against anyone who introduces toxins into the environment, Hansen said.