PCC Sound Consumer

Pharmaceutical food crops
(In a field near you?)

by Karen Perry Stillerman

• What you can do

(March 2007) — Ask the people around you if they think genetically engineered (GE) food crops that produce experimental drugs should be grown in Washington and chances are they’ll say no. Then tell them a Canadian biotech company has applied for a permit to grow more than 1,000 acres of drug-producing safflower in eastern Washington this spring.

Production on this scale wouldn’t be allowed in the company’s home country, but it is here in the United States. In fact, the U.S. Department of Agriculture (USDA) is seeking public comments on its assessment of the pending permit. Your input is important.

Most of the safflower would be engineered with a gene for carp growth hormone to produce a drug for farmed shrimp. The company also has applied to plant an acre of safflower engineered with a human gene to produce experimental insulin for treating diabetes.

If the USDA approves the 1,000-acre request, it would make Washington home to the biggest planting of pharmaceutical food crops ever allowed in the United States.*

The company, SemBioSys Genetics, Inc., claims its products will enhance shrimp farming worldwide and lower the cost of insulin. The jury is still out on whether these benefits actually will materialize.

In any case, producing drugs such as insulin and other hormones in food crops — especially in crops grown outdoors — poses a serious threat to consumers, farmers, food producers and exporters in Washington and elsewhere.

Biopharming with food crops is risky
For more than a decade, the USDA has allowed pharmaceutical (or “pharma”) and industrial crops to be grown outdoors in 35 states. Food crops such as corn, soybeans, rice, peas, barley and safflower have been engineered to produce human and veterinary drugs, hormones, plastics, detergents and other pharmaceutical and industrial substances. Never intended for general public consumption, these chemicals may be harmful if accidentally ingested in food.

“The drugs, hormones and other chemicals in these crops are not intended for consumption by the general public, and their effects on human health are unknown,” said J. David Heywood, M.D., of Washington Physicians for Social Responsibility. “Insulin, blood thinners and other pharma crop compounds have the potential to provoke allergic reactions or other adverse health effects, and we lack scientific evidence documenting their safety.”

Yet pharma and industrial crops easily can infiltrate our food supply when seeds are mixed accidentally or when crops cross-pollinate. In 2002, a company called ProdiGene experimented with small plots of pharma corn (containing a vaccine for pig diarrhea), and allowed the corn to mix with half-a-million bushels of soybeans headed for the food supply.

ProdiGene’s pharma corn also may have cross-pollinated with feed corn in Iowa that year. In both cases, contamination of the food supply was narrowly averted, at a cost of nearly $3 million to purchase and destroy the tainted crops.

Similarly, last fall an unapproved strain of GE rice was found to have widely contaminated the nation’s rice crop. Although the rice was not a pharma crop, the incident revealed continuing gaps in the regulatory system governing GE crops.

Mirroring previous food contamination accidents, the contamination of rice with an unapproved GE variety has seriously impacted the commercial rice industry. Import markets in Japan and Europe are deeply suspicious of U.S. long grain rice, and analysts predict market losses may reach $150 million.

Producing drugs and chemicals in food crops is a bad idea from a food safety perspective. The National Academy of Sciences, a nongovernmental body of scientists and professionals, has warned in two reports that it’s virtually impossible to keep pharma compounds out of the food supply if food crops are used. It’s likely that contamination of the food system already has occurred, and there’s no reason to believe it won’t continue, especially as the acreage planted with pharma crops increases.

A 2005 report from the USDA’s own auditor sharply criticized the department’s oversight of pharma and other GE crops. The Office of the Inspector General (OIG) found the USDA has failed to inspect pharma crop fields as promised and to document inspections properly. The OIG also found the USDA didn’t even know where some pharma crops were planted or where the harvests were stored.

The report concluded: “... current regulations, policies and procedures do not go far enough to ensure the safe introduction of agricultural biotechnology.” If companies and the USDA are so lax with small plots of pharma crops, how will they manage the large-scale production proposed for Washington?

Economic boon or liability?
The SemBioSys safflower is not the first pharma crop to be planted in Washington. Since 2001, the state’s land-grant university, Washington State University (WSU), has been experimenting with barley, injecting human genes to produce a variety of substances. (See the September 2004 issue of Sound Consumer.) WSU’s ongoing experiments have been much smaller than the proposed safflower production by SemBioSys; this year, WSU has applied to plant 0.2 acres of its drug-producing barley.

Economics are important in debates over pharma crops and, in Washington, biotechnology and agribusiness figure prominently in Governor Gregoire’s 10-year “business plan” for the state. The pharma crop industry touts its technology as a boon to farmers and hard-hit rural communities.

Yet a 2005 report, “The Economics of Pharmaceutical Crops,” authored by an Iowa State University agricultural economist, struck a blow at the notion that farmers will benefit much. The analysis concluded that the claims of pharma crop proponents are inflated and that farmers and rural communities are unlikely to be major beneficiaries.

“Proponents of pharmaceutical crops have inflated the rewards and downplayed the risks,” said Dr. Jane Rissler, senior scientist at the Union of Concerned Scientists, which commissioned the study. “State officials, farmers and rural communities should be wary of rosy, optimistic claims.”

An economic analysis from Virginia Polytechnic Institute and State University similarly found, in the case of pharma tobacco, that the biotech company would be the primary beneficiary. Consumers would benefit comparatively little and tobacco farmers not much at all.

Pharma crops, in fact, could prove to be a liability for Washington’s farm economy. Safflower sometimes is planted in rotation with wheat. If pharma safflower seeds wound up in Washington wheat fields — a result of human error during handling, storms that blow seeds where they don’t belong, transport by birds, or rotation with contaminated safflower — one of the state’s most valuable crops could be compromised.

(Indeed, the latter scenario spawned the 2002 ProdiGene incident in Nebraska: A rotation of soybeans was contaminated by pharma corn “volunteers” seeded from the previous year’s crop.) Detection of a shrimp drug or human insulin in Washington wheat could be a disaster for wheat growers, jeopardizing exports and perhaps leaving them liable for costly cleanups and potential lawsuits.

“I take pride in growing high-quality wheat for customers around the world,” said Eric Zakarison, who raises wheat on 600 acres near Pullman. “The government shouldn’t take chances with the safety of my product and the livelihood of small farmers like me.”

Although safflower is not a major crop in Washington, there are some growers and brokers in the state whose livelihoods also could be threatened if buyers worry that any safflower moved through the state might be contaminated. In Missouri in 2005, rice growers faced the threat of a boycott when a major rice buyer became skittish over proposals to grow pharma rice in that state.

In addition, since most of Washington’s commercial safflower crop (about 1,500 acres annually) is destined for the wild bird seed market, contamination also could pose a hazard to bird populations.

Benefits unsubstantiated
Aside from the risks, there’s little evidence that the pharma crops proposed for Washington will be of great value to anyone but their corporate creators. Like most pharma crop companies, SemBioSys makes expansive claims about the benefits of its new technology, saying in a recent press release that its GE safflower-based insulin could reduce product costs by 40 percent and production costs by 70 percent. The company offers no economic analysis to support its assertions.

Meanwhile, the governors of 11 states with high insulin costs reportedly are urging the U.S. Food and Drug Administration (FDA) to approve generic insulin manufactured the traditional way — in confined tanks. This move alone would likely spur competition and drive down the cost of insulin. It appears that traditional drug companies are ready to meet the growing demand for cheaper generic insulin, given FDA approval.

As for the drug intended for farmed shrimp, this product would serve only to prop up an unsustainable aquaculture industry that crowds too many shrimp too close together, inviting disease and creating other environmental problems.

The risks of contamination from using food crops such as safflower to grow drugs simply outweigh the hypothetical benefits. Approval of large-scale production, such as the 1,000 acres proposed by SemBioSys, would set a precedent, making it easier for companies to plant more and more acres of drug-producing food crops, increasing the chances of a tainted food supply.

The USDA should reject these proposals and implement a nationwide ban on outdoor pharma food crops to ensure that our food supply — in Washington and across the country — remains safe and free of contamination.

If biotech companies want to produce plant-based drugs, they should follow the lead of Dow AgroSciences, which won approval of a chicken vaccine produced by tobacco cells contained in a steel tank. Cell cultures are a proven way to generate pharmaceuticals under controlled conditions — without the risk of introducing drugs into our food.

Karen Perry Stillerman is a senior analyst with the Food & Environment Program at the Union of Concerned Scientists.

* A request from another company to grow 3,000 acres of drug-producing rice in Kansas is pending.