WebMD Medical News
Louise Chang, MD
Sept. 18, 2008 -- New rules proposed by federal regulators don't require consumer labeling of many genetically altered animals that are expected to soon reach grocery story shelves as meat, poultry, or seafood.
The proposed regulations govern a wide range of genetically altered animals, including some already under development and some that are expected to come to market in the next few years.
Biotech companies and livestock producers are keenly interested in DNA engineering as a way to breed larger or healthier animals for food, and also as a potential source of pharmaceuticals produced in milk or animal's blood.
FDA officials say they will require public hearings before companies can sell genetically modified animals as food to the public. They say the process would bring transparency to a form of food production that could make some consumers uneasy.
"We'll need to do a full evaluation of food and feed safety," says Randall Lutter, PhD, FDA's deputy commissioner for policy.
But the agency also says producers would not be required to label most genetically engineered meat, poultry, or seafood. The rules treat altered DNA inserted into livestock as drugs. Companies are not required to alert consumers when antibiotics, hormones, or other drugs are used in raising the animals.
"There is no special labeling requirement simply because the animal itself was engineered," Lutter says.
One exception is if genetic engineering alters the makeup of food. For example, companies are developing DNA that causes pigs to produce more omega-3 fatty acids in their muscles. Officials say the proposed rules would require a label indicating the product as high in the fatty acids, but not that it is genetically modified.
"The labeling will be based on the changes in the composition of the product," Lutter told reporters during a conference call.
The decision does not affect cloned animals or their offspring, which earlier this year were declared safe as a food source by the FDA.
Michael Hansen, PhD, senior scientist at Consumers Union, praised the requirement of public hearings before genetically altered animals are sold as food.
"It is positive that unlike with [genetically engineered] plants, they are going to require a safety assessment," he tells WebMD.
But Hansen criticizes the agency for taking what he says was a lax approach toward consumer labeling of such products.
"It's outrageous that they would not require these things to be labeled. Come on, they require orange juice to be labeled if it's from a concentrate vs. fresh-squeezed. Milk is labeled homogenized vs. not. That's enough to label, but an engineered animal isn't?" he says.
The Biotechnology Industry Organization, an industry group, says it supports the proposed rule.
"Animals that are genetically engineered can have improved food production capabilities, enabling them to help meet the global demand for more efficient, more nutritious, higher quality and lower-cost sources of food," says Barbara Glenn, PhD, the group's managing director for animal biotechnology.
Dozens of genetically altered animals are under development. For example, researchers at the University of Illinois are experimenting with cow DNA that increases hormone production in the milk of pig sows. The hormone can cause piglets to grow faster and reach a higher body weight.
Researchers are also developing genes for pigs so their waste contains less phosphorus, an environmental pollutant. Genes from spiders can even get goats to produce spider silk in their milk for use in bullet-proof vests.
SOURCES:FDA: "The Regulation of Genetically Engineered Animals Containing
Heritable rDNA Constructs."Randall Lutter, PhD, deputy commissioner, FDA.Michael Hansen, PhD, senior scientist, Consumers Union.Barbara Glenn, PhD, managing director for animal biotechnology,
Biotechnology Industry Organization.
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