FDA staff release draft guidelines for genetically engineered
animals
How about a little mouse DNA with that side of bacon? Pigs
spliced with mouse genes are no longer the stuff of science
fiction. If approved by Food and Drug Administration (FDA) staff,
food from genetically-engineered animals could end up in grocery
stores and on the dinner plate without any labeling
requirements.
FDA staff release draft guidelines for genetically engineered animals
How about a little mouse DNA with that side of bacon? Pigs spliced with mouse genes are no longer the stuff of science fiction. If approved by Food and Drug Administration (FDA) staff, food from genetically-engineered animals could end up in grocery stores and on the dinner plate without any labeling requirements.
Pigs with mouse genes could be used in factory farms, said Michael Hansen, a senior scientist for Consumers Union, the nonprofit that publishes Consumer Reports. They were spliced with mouse genes to create pigs that produce less polluting excrement.
On September 19, FDA staff released draft guidance on the regulation of genetically engineered animals – animals whose DNA was spliced with DNA from a different organism, according to a Web site from the FDA. The document is open for public comment until November 18.
“We’re subject to the Federal Food Drug and Cosmetic Act that says that we cannot require labeling unless that produce is materially different than conventional products,” said Siobhan DeLancey, a spokesperson for the FDA.
Some people think labels should be required. That a product comes from a genetically-engineered animal is a material fact that consumers want to know, Hansen said.
“We require labeling of all sorts of things,” Hansen said. “We have to label whether juice comes from concentrate or is fresh squeezed.”
Milk must be labeled as homogenized or non-homogenized, Hansen said.
“Those are all really minor bits of information, but yet if that is not on the label, it is illegal,” Hansen said. “You can also argue that the genetic material has never been in there before so it is an ingredient.”
If pork from a genetically-engineered pig is higher in omega-3 fatty acid than conventional pork, the label would indicate that fact, DeLancey said.
The key phrase in the federal legislation is material difference, DeLancey said.
“Unless we can prove that that animal is in fact from a GE animal, then we can’t require labeling,” DeLancey said. “It has to be something that we could actually see proof of.”
Although the difference may not be visual, a scientist could prove that a product was genetically engineered, Hansen said.
“If you truly wanted to be sure that you were avoiding it, you could always purchase organics,” Hansen said.
Genetically-engineered products cannot be labeled organic, DeLancey said.
“That doesn’t prohibit anybody from voluntarily labeling a product, as long as that label is truthful and not misleading,” DeLancey said
Outside a local grocery store, Adam Sanders, a San Benito resident, said he would not eat genetically-engineered meat if given a choice.
“If it is given to the consumer, then it should be clearly labeled and with a warning from the surgeon general that this product has not been thoroughly studied,” Sanders said. “We know how likely that is.”
Sanders buys organic as much as possible.
“If you’re in a restaurant buying the pork Manchu, I wouldn’t be so cognizant of it that I would ask the restaurant if it was [genetically engineered],” Sanders said.
Joe Morris, owner of the San Benito County based company Morris Grass Fed Beef, agrees that genetically-engineered products have not been studied enough.
“I don’t want to be a guinea pig,” Morris said. “I wouldn’t really want my kids to be a guinea pig.”
FDA staff have between 20 and 50 applications for genetically engineered animals, DeLancey said.
FDA staff do not know how far in the future approval might be, DeLancey said.
“I can’t give you a timeline. All I can tell you is that we won’t approve anything until it has been proven safe and effective,” DeLancey said.
Morris is leery about genetically engineered food.
“I think the assumption behind genetically engineered food is that we can improve upon nature and it has to be done in a laboratory,” Morris said. “I think that’s a false assumption.”
Hansen pointed out that government agencies have been proven wrong in the past when they approved products.
“Thirty and 40 years ago, what did they say about pesticides?” Hansen asked. “They are totally safe and you people who are worried about them are environmental whackos.”
Some pesticides posed problems to human health and the environmental, Hansen said.
“You’d think with any radically new technology they’d be a little bit cautious about introducing them,” Hansen said.
The lack of transparency in the FDA approval process is a problem, Hansen said.
“Because these things are being treated like new animal drugs, the downside to that is that new drugs are confidential until they make a decision,” Hansen said. “That’s what the rub always has been, because there is not other regulation that would allow any pre-market oversight.”
Genetic engineering mostly used for medicine
Genetic engineering is the wild west of science, said Michael Hansen, senior scientist for Consumers Union, the nonprofit publisher of Consumer Reports.
“Some of these things are just weird,” Hansen said. “There is a goat that produces spider silk in its milk.”
Spider silk is incredibly strong, Hansen said.
“For its size and weight, it is stronger than steel,” Hansen said. “They originally talked about bulletproof vests for police.”
While everybody has been concentrating on food, animals are also being genetically engineered to improve human health, said Sibohan DeLancy, a spokesperson for the Food and Drug Administration.
“We expect that the number of applications for food will be very small in comparison to biopharm,” DeLancey said.
Some biopharm animals were genetically engineered to produce a therapeutic protein in their blood or milk that can be further processed as medicine, DeLancey said.
Other animals were genetically engineered for human organ transplants, such as pigs, Hansen said.
To avoid the human body rejecting a pig organ, some pigs were modified so that their bodies mimic human receptor proteins, Hansen said.
One concern is the potential for the introduction of new diseases into human populations, Hansen said. The process could cause the spread of diseases that were specific to pigs into humans.
“When a disease first appears in a human, there is usually a fairly high mortality rate,” Hansen said.
FDA staff are putting products from genetically engineered animals through the most rigorous evaluation process possible, DeLancey said.
“This is a very rigorous approval process, much more rigorous than the food additive approach,” DeLancey said.
To comment, go to www.regulations.gov and enter Docket No. FDA-2008-D-0394. The comment period closes Nov. 18,2008.
