The public comment period on the proposal closed last week, a month later than the original date set.
The FDA's announcement of its cloned food plan at the start of the year sparked a fierce debate on the safety and ethics of the proposal, and the agency has since received a flood of responses to its invitation for public comments.
Consumer advocacy and public interest groups have been particularly vocal about their opposition to the new technology, and consumer polls have reveled that the majority (two-thirds) of the American public remains skeptical of the food production process. In turn, increasing numbers of food producers have responded to these consumer concerns, announcing that their products will remain 'clone-free' if the technology is eventually approved.
Consumer and industry concerns were also significantly increased by an independent review of the FDA's risk assessment for cloning, published in March, which claimed that FDA found virtually no scientific evidence to support the commercial release of these experimental foods.
Conducted by the Center for Food Safety (CFS), a non-profit science-based public interest group, the report claimed that FDA's assessment that cloned food was safe for human consumption was based on "flawed assumptions and misrepresented findings".
Reiterating its position on the closing of the comment period last week, CFS stated: "in its risk assessment of cloned food, the FDA claims to have evaluated extensive peer reviewed studies on the safety of food from clones to support its conclusion, yet a recent report issued by the Center for Food Safety, 'Not Ready for Prime Time', shows the assessment only references three peer-reviewed food safety studies, all of which focus on the narrow issue of milk from cloned cows."
"What is even more disturbing is that these studies were partially funded by the same biotech firms that produce clones for profit. None of the studies focus on the safety of meat from cloned cows or pigs, or milk or meat from the offspring of cloned animals, and there was absolutely no data on milk or meat from cloned goats, - all major issues critical to determining the safety of the proposal."
CFS joined forces with a coalition of consumer, environmental and animal welfare organizations to oppose the FDA's proposal, announcing the submission of over 130,000 comments to the federal agency.
Other groups opposing the plan include Consumers Union, Food and Water Watch, The Humane Society of the United States, the American Anti-Vivisection Society, the Consumer Federation of America and the Organic Consumers Association.
Another aspect of FDA's plan that has invited significant opposition is that the labeling of meat and milk products from cloned animals would not be required.
"This flood of public comments should send a strong signal to FDA that the public is not ready for food from animal clones, and if such food is put on the market they want it labeled" said Michael Hanson of Consumers Union, the nonprofit publisher of Consumer Reports, and author of a CU scientific critique of FDA's risk assessment.
"We hope the agency will listen and rethink their proposal in light of public sentiment and the many unanswered questions about the science of animal cloning."
However, over 200 scientists have signed a public statement in support of FDA's draft risk assessment. The sign-on letter was distributed by the Federation of Animal Science Societies (FASS).
"This is one of the most rigorous food safety reviews ever conducted. The American people should be absolutely confident in the FDA's good work," said Jerome Baker, chief executive officer of FASS.
The statement has been signed by some of the leading global scientists in the field, including Dr Terry Etherton, who was on the National Academy of Sciences panel that evaluated the safety of food from cloned animals and their offspring, and Dr Ian Wilmut, one of the 'fathers' of Dolly the Sheep.
FASS also targeted skeptic consumers through an advertisement in the Wednesday, May 2 Washington Post, which claimed that "the scientific evidence is absolutely, robustly clear. There is no food safety risk from the meat or milk from clones, or from their conventionally bred offspring."
The FDA has said it will now review all public comments received during the 120-day comment period, and will likely make a decision on food from cloned animals by the end of the year.