Pigs in Genetic Study May Have Ended Up as Food

Federal drug and agriculture officials are investigating whether genetically modified pigs, created by scientists at the University of Illinois, were not destroyed as they should have been, and instead have been making their way onto dinner plates for more than a year.

In addition, a university spokesman said Wednesday that scientists on two occasions had sent gene-altered pigs to a rendering plant in violation of an agreement with the Food and Drug Administration. Those pigs would have been processed into materials for animal feed and other products not destined for human consumption.

Some people worry that genes inserted into plants and animals will produce proteins that prompt allergic reactions if consumed. In addition, some worry that the process of inserting the genes will disrupt other genes and biological mechanisms in the plants or animals, creating toxins or allergens.

But the FDA said that based on what it knows so far, the incidents do not appear to pose a health risk.

Still, the events in Illinois are the latest of several incidents in which genetically altered organisms have been inadequately segregated from traditional food crops or animals.

In December, federal officials fined a Texas company $3 million for failing to protect traditional crops from its gene-altered corn, which had been engineered to grow a vaccine for pigs. In 2000, a modified corn known as StarLink, which was not approved for human consumption, turned up in 430 million bushels of corn and triggered the recall of more than 300 brands of processed foods.

At the University of Illinois, scientists at the Urbana-Champaign campus have been inserting cow genes and synthetic genes into sows in an attempt to make faster-growing animals, said Bill Murphy, a university spokesman. They also bred those animals to produce piglets, only some of which inherited the inserted genes, also known as transgenes.

Piglets were tested so that researchers could segregate animals that inherited the cow and synthetic genes for further research. If the test determined that a piglet had neither transgene, it was often sold to a broker, who may in turn have sold it to a meat packer for use as food, Murphy said.

Murphy said the university believed that it had obtained FDA permission in 1999 to sell these animals for food. He said that 386 animals had gone to market since April 2001 and that others had been sold for at least two years before then.

But the FDA on Wednesday said that all animals from the program were to have been incinerated or rendered to prevent their introduction into the human food supply. The agency said that it had not yet determined the safety of the genetic material that was being inserted into the sows, and that researchers “did not conduct sufficient evaluation” to show that its genetic test was effective in ensuring that only piglets without the transgenes would be sold into the food supply.

At the same time, the agency said it believed that the incident posed “no public health risk.” The genes involved were engineered so that they would produce proteins primarily in the mammary glands of lactating sows, and none of the pigs sent to slaughter are believed to have been old enough to lactate, the agency said.

The Illinois scientists were using the cow gene to make proteins that boost milk production in sows, Murphy said. A second gene, created by scientists and modeled on a human “insulin-like” gene, produces proteins in the sow’s milk that improves the ability of piglets to digest milk.

“The purpose of the whole thing ... is to get piglets that will grow faster and healthier and without the use of drugs,” he said.

Lester Crawford, deputy commissioner of the FDA, said he could not rule out that some of the piglets sold to market had nursed from sows that carried transgenes. But any proteins the piglets consumed “would have been digested, and there is no reason to believe that there would be a residue from them in the meat,” he said.

Crawford said the incident shows that federal regulators are doing a good job of watching for violations of its policies on transgenic animals.

“The fact that it was detected makes us think the system was working,” he said. He said the agency had been keeping an eye on the university because it was producing a large number of pigs that were not intended for human consumption.

Murphy, the university spokesman, said it was the university itself that called in FDA inspectors. In December, he said, researchers told the FDA that they had improperly sold a transgenic pig to a rendering plant. FDA inspectors arrived Jan. 29, he said, and “voiced some objection” to how the university was disposing of animals.

He said researchers and administrators were puzzled by the FDA action, because they had informed the agency several times since 1999 of how it was disposing of the piglets.

“There was clearly a misunderstanding,” he said.

Murphy also said that under its agreement with the FDA, piglets that were found to have one of the inserted genes, but not both, were to be disposed of through rendering. In 2001 and again last December, he said, the university reported to the FDA that it had improperly sent pigs with both transgenes to rendering plants.

Crawford said the university, if confirmed to have sold animals in violation of its FDA-approved study protocol, could be fined or penalized in other ways, including the suspension of research programs. The U.S. Department of Agriculture is also investigating.

Some scientists and biotechnology executives have worried that previous incidents of poor controls on genetically modified organisms have undermined confidence in altered plants and animals.

Environmental groups have long argued that such crops are inadequately tested for their effect on health and the environment, and their case could be strengthened by such incidents.