Animal pharm is coming our way
On Sept. 18, the U.S. Food and Drug Administration released its "guidance" for allowing the sale of genetically modified animals as food. Guidance is agency-speak for "the law will look something like this." With the announcement, a 60-day period for public comment opened.
Right now, the only genetically modified animal licensed for sale is the zebra fish, a pet that glows in the dark. Except for idiots who attempt to swallow it, the fish isn't consumed by humans, and its need for warm water precludes any possibility of it escaping into the wild. But the glowing animal will soon have some odd company in stores near you.
The guidance is primarily directed at animals genetically modified for eating. However, it is based on the approval process used for animals that are genetically altered for drugs, such as pigs designed to grow human livers, or goats that produce insulin in their milk. Under the guidance, all genetically modified animals will be classified as drugs.
Technically, the drug in question is the bit of foreign DNA that's spliced into an animal's cells. The Food and Drug Administration will grant or deny approval to just those bits of DNA, not to the whole organism. This creates a dangerous regulatory gray area, says Jaydee Hanson, a policy analyst at the Center for Food Safety, who calls this arrangement a "fiction."
"The gene is in every cell of the animal, and regulating the animal is the only tool they have to control these genes," he says. "Drugs don't get loose and breed with each other. Animals do."
He recalls the AquAdvantage, a trademarked salmon created by Aqua Bounty Technologies of Waltham, Mass., seven years ago. The regulated drug in this case was a gene that made the salmon secrete extra growth hormone, causing the fish to reach maturity in 18 months instead of 30.
Should any of these fish escape into the wild, they would take their recombinant genes with them, posing unknown -- and therefore, Hanson says, unacceptable -- risks to wild salmon stocks and the ecosystems they inhabit.
It's rumored that AquAdvantage salmon will be the first genetically engineered food animal approved for sale by the federal government. Meanwhile, a growing number of genetically engineered animals are being developed as food, says Hanson, which is why he thinks an approval process is long overdue. But he's troubled by the government's lack of transparency.
"They're not offering good peer review, because the drug-approval process is held in secret," he says.
Many other policy analysts are taking issue with the FDA's stance against labeling foods containing genetically modified animal products. As currently set out in its guidance, only foods that can be shown to have dietary properties different from their non-engineered counterparts require labeling.
"They're talking about pigs that are going to have mouse genes in them, and this is not going to be labeled?" says Jean Halloran, food policy director for Consumers Union, which publishes Consumer Reports magazine. "We are close to speechless on this."
Another concern is how the proprietary rights associated with modified genes will be enforced. Because genetic modifications are easily traceable, small livestock producers who introduce altered animals into their herds, or who unintentionally acquire animals with modified genes, might someday receive an unexpected bill for the use of those genes. In fact, this has already happened: Producers of genetically modified seeds have sued farmers whose crops were accidentally contaminated by genetically modified pollen that escaped from neighboring fields.
On Sept. 19, the day after the drug agency's guidance was released, the Agriculture Department announced a call for public comment on the need to regulate the movement of genetically modified animals to ensure they don't mix with wild animals or other livestock. For producers and consumers alike, the new biotech developments and their potential consequences have created a near-overwhelming amount of information to digest.
But if ever there was an important time to learn about -- and comment on -- food safety, this is it.
To receive a copy of "Guidance for Industry: Regulation of Genetically Engineered Animals Containing Heritable rDNA Constructs," write to the Food and Drug Administration, Communications Staff, Center for Veterinary Medicine, 7519 Standish Place, Rockville, MD 20855. Comments on the guidance must be sent by Nov. 18 to Dockets Management, FDA, 5630 Fishers Lane, Room 1061, Rockville, MD 20852.
Ari Levaux is a contributor to Writers on the Range, a service of High Country News (hcn.org). He writes about food and environmental issues in Missoula, Montana.