The FDA's scientific conclusion that meat and milk from cloned cows, pigs and goats and their offspring is safe has elicited a flurry of responses from both sides of the fence, raising issues such as financial gain, trade opportunities, and organic standards.
The government agency published its long awaited risk assessment on the controversial technology yesterday.
Despite saying that there is no scientific evidence that consuming products from cloned animals and their offspring could have a detrimental effect on human health, it requested that the voluntary moratorium on meat and milk from cloned animals entering the food supply remain in place, pending further inquiries requested by some senators.
However the voluntary moratorium on products from the offspring of cloned animals is lifted.
Big biotech welcome
Mark Walton, president of ViaGen, a gene banking and cloning service supplier, applauded the level of science that went into the FDA's report and said the safety review was the most extensive in FDA's history.
"Cloning companies will continue to work out an orderly marketing transition with the food industry and relevant government agencies - including FDA and USDA - as we move toward commercialization."
Consumers are unlikely to ever actually eat a cloned animal itself thanks to tracking systems. Clones of high quality animals are to be used as breeding animals, with their offspring and product from their offspring being sold to food.
The National Milk Producers' Federation said it supports the FDA's request to maintain the voluntary moratorium on marketing of cloned animals and their products pending additional reviews, particularly insofar as their entry could have economic implications in the marketing environment.
While Jerry Kozak, president and CEO of the NMPF, said the federation is "reassured" by FDA's risk assessment, he said it also needs to make sure that the regulatory status of cloned animals and animal products in the US parallels that of major export markets.
"We are ready to work with USDA and other government agencies to facilitate the regulatory review of animal cloning in other countries."
This sentiment was echoed by the International Dairy Foods Association (IDFA).
"US dairy exports have grown significantly during the past few years, reducing the cost of government support programs," said IDFA president and CEO Clio Tipton.
"However, milk and food from cloned animals have not been approved for consumption in most countries that are importing our products. Therefore, it would be prudent to wait until all major foreign trading partners have reviewed and approved the same cloning technology in their respective countries."
Consumer health and education
Tipton added that surveys show consumers are not yet comfortable with the idea of buying milk from cloned cows, and they need more time to gain more understanding of the new technology.
If milk from clones is introduced before consumers have a chance to get to grips with it, the result could be reduced consumption - with drastic public health consequences.
While the moratorium holds, she believes it is down to the biotech industry to help educate consumers.
No such thing as organic clones
The organic sector of the food industry has reiterated that meat, milk and other products from cloned animals will not be able to be sold as organic in the United States.
The Organic Trade Association (OTA) said that the national organic standards enforced by the require that organisms be developed and grown by systems compatible with natural conditions and processes, and this includes the breeding and raising of animals for meat and dairy.
Thus cloning as a production method is incompatible with the Organic Foods Production Act and is prohibited under the National Organic Program regulations.
Avoiding the clones… organically
Caren Wilcox, executive director of OTA, indicated that the issue gives organics another level of differentiation in the marketplace.
"In the future, consumers who seek to avoid cloned meat, dairy or other animal products should look for the organic label on products."
This is particularly important since the FDA is not currently planning to make it necessary to label foods from cloned animals or their offspring - although there has been some talk of a 'non-cloned' label being available.
"The arrogance of some in corporate agribusiness will likely, once again, drive consumers to purchase organic food, the last bastion of authenticity in the human food chain," said Mark Kastel, senior farm policy analyst at the Cornucopia Institute.
He believes that, if meat companies go down the clone route, they will drive consumers to the natural food cooperatives and grocers stocking organic meat.
All about the money
Organic family farmer cooperative Organic Valley went further, opposing the FDA's opinion that food from cloned animals is safe.
"As concerned citizens, parents and food eaters, we're alarmed at the FDA's assessment," said George Siemon, chief executive officer for Organic Valley. "It places the nation's food supply at risk, and threatens the existence of the family farmer."
He believes the FDA has rushed to judgment with a decision aimed at supporting large corporations seeking to increase profits and raise the value of their stock - without the consideration of ordinary people.
Kastel agreed: "Regardless of what the proponents claim this is all about bottom-line profit and producing more and more of our food from giant industrial-scale farming operations "
The next Irish potato famine?
Kastel also expressed fears that widespread adoption of cloning could lead to a dramatic loss of genetic diversity in livestock.
"This may leave farmers and our nation's food supply susceptible to devastating epidemics due to a monoculture gene pool-think the Irish potato famine."
Siemon said that the long term effects of cloned animals on public health and our planet are simply not known.
"Over a generation, how will this impact our ecological system? Allergies? Nutritional balance? Antibiotic resistance?" he asked.
Animal health and the long-term view
Because cloning has already been seen to have an adverse effect on animal health, with recorded incidences of birth defects, abnormal growth and lack of genetic diversity, Seimon thinks the FDA should be applying the precautionary principal.
Animal protection groups Farm Sanctuary and the American Anti-Vivisection Society (AAVS) jointly denounced the FDA's "endorsement of animal cloning".
They say there was "massive opposition from many corners, including Congress, the dairy industry, and animal protection and consumer advocacy groups", and are calling for mandatory moratorium on cloned animals and their offspring to be established immediately.
This should remain in place until an advisory committee is set up to deliberate issues beyond food safety, and beyond the FDA's analysis. Such issued include concerns about animal welfare and ethical implications.
Moreover, the organizations claim the final risk analysis is riddled with twists of logic, assumptions and misrepresentations.
For instance, they say the agency did not assessing the frequency or severity of health problems experienced by cloned animals - merely the tally.
"By the FDA's logic, something that causes severe side effects in 30 per cent, 50 per cent, even 70 percent of cases should be treated no differently than something that causes minor effects in less than five percent of cases."
Julie Janovsky, Farm Sanctuary's director of campaigns, said: "It is an outrage that the FDA has misrepresented animal health and welfare implications. Cloning is a scientifically unsound and ethically challenged technology that has extremely disturbing welfare implications for animals."
Tracie Letterman, executive director of AAVS, said:
"The FDA has admitted that it does not evaluate the moral, ethical, or religious concerns with animal cloning. To protect the interests of consumers and animals alike, these issues need to be factored into any decision, as they are in Europe, Canada, and elsewhere around the world."