- The Washington Times - Monday, January 6, 2003

WASHINGTON, Jan. 6 (UPI) — Genetically engineered animals — which could be in food markets by next year — could pose hazards to human health and the environment, experts told United Press International Monday.

The comments came as a panel of scientists convened by the government kicked off a three-day meeting to discuss the health risks of genetically modified plants and animals.

"We don't know as much as we'd like to about potential unexpected changes that can occur in animals with genetic engineering," said Douglas Gurian-Sherman, science director for the biotechnology project at the Center for Science in the Public Interest in Washington.

A panel convened by the National Academy of Sciences began their second meeting Monday to discuss methods for identifying unintended health effects of genetically engineered foods.

The panel will address issues related to both genetically modified plants and animals. The first meeting was held in September and panelists expect to issue a report on their conclusions in 2004 to help the Food and Drug Administration and other agencies determine how to regulate these products.

FDA representatives will make a presentation at the NAS meeting, in which they will report the agency has decided to classify genetically engineered or transgenic animals as drugs for regulatory purposes. This has the benefit of requiring a mandatory safety review for these animals — for genetically modified plants, the safety review is voluntary.

"But the problem is the process is completely secret," Gurian-Sherman said. "It doesn't allow public input or comment" and the public will not be told which transgenic animals the agency is reviewing.

A report issued by a different NAS panel in August concluded transgenic animals probably were safe to eat but recommended further research before finally declaring them totally safe for humans.

Although no genetically engineered animals have been approved by the FDA for human consumption in the United States, several are being developed. In addition, Cuba has approved a strain of tilapia fish genetically engineered to grow rapidly and a genetically engineered carp might be approved in China.

The species closest to market in America is a salmon that has been genetically modified to produce more growth hormone, which causes it to grow more rapidly than non-modified fish. The salmon producer, Aqua Bounty Farms of Waltham, Mass., said it currently is completing safety studies and the fish appears to be no different than normal salmon.

"We have no reason to believe there is anything unusual occurring in these fish," Aqua Bounty spokesman Joe McGonigle told UPI. He noted all the safety studies "will eventually … go up on our Web site, among other places" to make them available to the public. The company plans to file for FDA approval in the latter half of this year, which could make the transgenic salmon available to consumers in 2004.

Robert Schwartz, a cell biologist at the Baylor College of Medicine and co-founder of Advisys, a company in The Woodlands, Texas, that is involved in improving the growth of livestock, agreed transgenic animals are safe for consumption.

"There's no evidence of toxicity" of genetically engineered animals, said Schwartz, who will also make a presentation at the NAS meeting.

However, he noted there are no standards for testing the safety of these animals. The FDA should establish criteria for how these tests should be conducted, which would help assure the public these animals are safe, he said.

Schwartz's company is working on a pig with a gene for a protein called insulin-like growth factor that increases the animal's weight. Other transgenic animals being developed include cattle with antibacterial genes to make their milk safer.

"It is highly doubtful" that any of these animals are toxic to humans "but there would have to be testing, some sort of standards … to prove it," Schwartz said, adding better education of what these products can do and informing consumers on packaging the product comes from a genetically modified animal also would be helpful.

The Center for Food Safety in Washington, which filed a legal petition with the FDA and other governmental agencies to keep the transgenic fish from coming to market, also has concerns about the health risks posed to humans consuming the fish. The FDA needs to establish "a real process of looking at the human health impacts of the fish," said Joseph Mendelson, the center's legal director.

Elevated levels of growth hormones could create risks or unintended effects, such as allergies in some people, Mendelson said. There are also humane issues to consider because the fish are being created merely to improve industry efficiency, he said.

So far the FDA has not responded to the legal petition, which the Center filed along with 75 other environmental and consumer groups, Mendelson said, but they have received 50,000 public comments in support of the petition.

Another problem is the environmental impact of transgenic animals, Gurian-Sherman said. Indeed, the NAS report in August concluded the impact of these animals escaping into the environment was the most worrisome because there was no way to predict what might happen or to reverse such a situation if it turns out to have disastrous consequences.

"Studies show that potentially a genetically engineered salmon, if it escapes, could cause extinction of endangered salmon species," Gurian-Sherman said.

The FDA review process requires companies to assess the environmental impact these animals could have, but there are some barriers to putting that into practice, Gurian-Sherman said. "It is not clear how much authority the FDA has to do a thorough environmental analysis and there is also a lot of concern that they don't have the expertise because they don't usually do that kind of analysis," he said.

Aqua Bounty's McGonigle said his company still is working with the FDA to determine how to do an environmental impact assessment of the salmon. That study has not yet begun, he said.

The FDA did not return repeated phone calls from UPI seeking comment by presstime.

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