The Food and Drug Administration is investigating whether pigs produced as part of a bioengineering study at the University of Illinois in Urbana-Champaign were sold for food, in violation of FDA requirements for the study.
The FDA has forbidden the sale of genetically modified animals and their offspring for food without the express permission of the agency's Center for Veterinary Medicine.
Officials with the FDA said this is a precaution being taken while the agency studies the safety of consuming the meat and other products of genetically modified animals, which are classified as investigational new animal drugs.
FDA officials said researchers at the University of Illinois may have failed to comply with this requirement by selling 386 pigs that were the offspring of genetically modified animals to a livestock dealer for food without FDA permission. The FDA said the sales took place between April 2001 and January 2003.
University officials contend that the researchers made FDA officials aware of the sale of the animals early in the study and believed they were in compliance with FDA requirements.
"There seems to be a basic case of misinformation," said Bill Murphy, associate chancellor for public affairs at the university.
Both sides said they believe the animals do not pose a public health risk.
In an effort to produce pigs that grow rapidly, researchers from the university's department of animal sciences in the College of Agricultural, Consumer, and Environmental Sciences have been bioengineering pigs since 1999. The study involved inserting various combinations of two bovine genes into pigs. One is a gene that codes for increased milk production. The other is an artificially altered bovine gene designed to aid young pigs in the digestion of milk.
According to university officials, not all the offspring of the altered animals inherited the bovine genes. They said offspring that did not inherit either gene were sold to a livestock dealer. A total of 490 animals were sold during the course of the study, Murphy said. FDA officials said in a statement that they could not confirm that the animals did not possess the altered genes, because of poor record keeping by the researchers.
University researchers informed the FDA about the sale of these animals during an inspection in April 2001, Murphy said. The FDA contends that, under the terms of the study protocols, the animals involved in the study were to have been destroyed by incineration or rendering to prevent their introduction into the human food supply.
According to a spokesman for the Center for Veterinary Medicine, the FDA became aware of a potential problem in November 2002 when a university researcher notified the agency that a pig possessing both the bovine genes had mistakenly been sold. Murphy confirmed that a researcher reported to the FDA that a pig with altered genes had mistakenly been sold to an animal dealer.
This report led to an FDA inspection at the university between Jan. 29 and 31. Sale of research animals for food was temporarily halted by university officials during the inspection and for several days after to allow the university to review its disposal procedures. Murphy said the university is cooperating with the FDA.
"We have been in touch with the FDA," Murphy said. "Relations are cordial and we're working this out."
At press time, the Center for Veterinary Medicine had received a preliminary report on the inspection and was anticipating a final report within a few weeks. The Department of Agriculture is collaborating with the FDA on this investigation.
New field, new challenges
The investigation highlights some of the challenges the FDA and other government agencies face in trying to regulate new animal biotechnologies. It also highlights the challenges facing researchers working in the emerging field of biotechnology.
"There's a learning curve for the (university) and the FDA," Murphy said.
The FDA recently received a National Academy of Sciences report on the potential risks posed by genetically modified animals.
A Center for Veterinary Medicine spokesman said the agency is studying the report and considering what regulatory measures to take in response to the hazards identified in the report.