An FDA risk assessment that is expected to declare meat and milk derived from cloned animals safe for the food supply is currently being reviewed by the government, and is due to be released by the end of the year.
If these documents are finalized, cloned animal products will become part of the food supply, without the requirement for such foods to carry special labeling. And this could result in a backlash of absence claims, with 'clone-free' products starting to appear on supermarket shelves.
However, the move has inspired fierce criticism from consumer advocacy groups, which claim that there is insufficient science to guarantee the safety of products from cloned animals.
There is currently no regulation preventing cloned food from entering the nation's food supply. But the Food and Drug Administration (FDA) has asked clone producers and livestock breeders to voluntarily refrain from introducing food products from clones or their offspring into the food supply until the agency endorses the findings of a National Academy of Science (NAS) report it commissioned in 2002 that declared cloned products safe for human consumption.
The FDA said its draft risk assessment is currently "in the clearance process" and is being reviewed within the department and by other governmental agencies, particularly the US Department of Agriculture (USDA).
The documents are expected to be released by December, said the FDA in a statement last week.
But while the government continues to examine the issue, a number of consumer and industry groups have raised their voices against the approval of such products.
According to public interest group Center for Food Safety (CFS), there is "serious scientific concern about the food safety of products from clones." The group points in particular to a 2004 New England Journal of Medicine report, which stated that "given the available evidence, it may be exceedingly difficult, if not impossible, to generate healthy cloned animals."
However, the FDA said its draft risk assessment drew on over 100 scientific studies. Published in 2003, it concluded that "the current weight of evidence suggests that there are no biological reasons to indicate that consumption of edible products from the clones of cattle, pigs, sheep or goats poses a greater risk than consumption of those products from their non-clone counterparts."
At this stage, one of the main concerns for the industry is a lack of definitive and forceful guidance from the FDA.
"We'd like to avoid going down the same path as twelve years ago after FDA approved rBST (a genetically engineered bovine growth hormone that increases milk production in cows). To this day there are still a lot of different disclaimers being used, which must be accompanied by an asterisk and explanatory text," said Chris Galen of the National Milk Producers Federation (NMPF).
Galen told FoodNavigator-USA.com that the NMPF does not at this time support milk from cloned cows entering the marketplace until FDA determines that this is the same as milk from conventionally bred animals. And when this happens, the agency needs to be proactive and clearly and forcefully specify what claims are allowed, he said.
But other groups are taking a harder stand. Last week, the CFS, along with reproductive rights, animal welfare, and consumer protection organizations, filed a legal petition with the FDA calling for a moratorium on the introduction of food products from cloned animals.
The petition calls for the establishment of mandatory rules for pre-market food safety and environmental review of cloned foods. The petition also calls for the Department of Health and Human Services to establish a federal review committee to advise FDA on the troubling ethical issues raised by animal cloning.
According to CFS, recent polls have shown that Americans would refuse to buy food from cloned animals, and that they have serious concerns about the ethics of animal cloning, with a majority of consumers saying they would not buy cloned food, even if FDA deemed the products safe.
However, according to Dr Mark Richards of KRC Research, "it is hard to predict consumer behavior from polls, especially when they know little about the issue."
"Before the introduction of rBST, experts predicted up to a 20 percent drop in milk consumption. But milk consumption levels were not affected at all," he told FoodNavigator-USA.com.
For the time being, the FDA said that "in the spirit of transparency" it is requesting producers of cloned animal products to continue to refrain from introducing their products into the food supply until there has been an opportunity for public comment and the risk assessment is finalized.