The New York Times
Wednesday 16 January 2008
After years of debate, the Food and Drug Administration on Tuesday declared that food from cloned animals and their progeny is safe to eat, clearing the way for milk and meat derived from genetic copies of prized dairy cows, steers and hogs to be sold at the grocery store.
The decision was hailed by cloning companies and some farmers, who have been pushing for government approval in hopes of turning cloning into a routine agricultural tool. Because clones are costly, it is their offspring that are most likely to be used for producing milk, hamburgers or pork chops, while the clones themselves are reserved for breeding.
"This is a huge milestone," said Mark Walton, president of ViaGen, a leading livestock cloning company in Austin, Tex.
Farmers had long observed a voluntary moratorium on the sale of clones and their offspring into the food supply. The F.D.A. on Tuesday effectively lifted that for clone offspring. But another government agency, the Agriculture Department, asked farmers to continue withholding clones themselves from the food supply, saying the department wanted time to allay concerns among retailers and overseas trading partners.
"We are very cognizant we have a global environment as it pertains to movement of agricultural products," said Bruce I. Knight, under secretary of agriculture for marketing and regulatory programs. He said it was his goal to have the transition last months, not years.
Animal breeding takes time, so even with Tuesday's actions, it is likely to be several years before products from the offspring of clones are at the grocery store in appreciable quantity.
While acknowledging that consumer acceptance remains a hurdle, proponents of cloning technology say it could have a major impact on the livestock industry by providing meat and milk that is better and more consistent.
"When you buy a box of Cheerios in New York and one in Champaign, Illinois, you know they are going to be the same," said Jon Fisher, president and owner of Prairie State Semen in Illinois. "By shortening the genetic pool using clones, you can do a similar thing."
"It could improve the quality of meat in the supermarket," Mr. Fisher added. "It depends if customers allow it."
Consumer groups immediately lambasted the F.D.A.'s report, saying that the science remains inadequate and that many consumers oppose cloning for religious or ethical reasons. Some members of Congress had sought to delay a decision until further studies were completed.
"It flies in the face of Congress's wishes. It flies in the face of consumer wishes," said Michael Hansen, a senior scientist at Consumers Union, the advocacy group that publishes Consumer Reports.
But Stephen Sundlof, director of the F.D.A. Center for Food Safety and Applied Nutrition, said food from cloned animals was "indistinguishable" from that of conventionally bred animals.
"It is beyond our imagination to even have a theory for why the food is unsafe," he said.
The F.D.A.'s approval extends to cloned cows, pigs and goats but not other farm animals like sheep; the agency cited insufficient data on cloned sheep. The F.D.A. said meat and milk from cloned animals and their offspring would not be labeled because it was the same as conventional food and did not pose a safety risk.
However, Representative Rosa DeLauro, Democrat of Connecticut, has introduced legislation to require labels on cloned products, and consumer groups suggested that labeling would be a battleground in the near future.
The F.D.A.'s announcement came with an asterisk, given the Agriculture Department's request for a continued moratorium on the sale of clones into the food supply. That request is likely to have little effect, since producers are not looking to sell clones; each still costs thousands of dollars. But it could force a few owners of dairy clones to dispose of milk from the animals rather than sell it.
"That doesn't cause me any particular heartburn," Mr. Walton said of the extended moratorium.
It remains to be seen how widely the technology will be adopted. Interest from the food industry has been tepid, with some companies declaring that they will not sell milk or meat from cloned animals or their offspring. Other types of reproductive technology, such as artificial insemination, faced resistance on farms when they were first developed but eventually became widespread.
Tuesday's decision means cloning technology could move into commercial use little more than a decade after the world learned of Dolly the sheep, the first mammal cloned from an adult cell, in Scotland.
To create Dolly, scientists took an unfertilized sheep egg and removed the genetic material. They then inserted the genetic material from an adult cell. Machinery within the egg somehow reset the clock on the adult genes, and the new cell, after implantation into a surrogate mother sheep, developed into Dolly.
This technique has since become routine in laboratories, with clones produced in numerous species - not including humans, so far as is known. In public discussion, the technology is sometimes confused with other techniques that involve genetic manipulation, such as the transfer of genes into animals from unrelated species. But cloning is simply the creation of an identical genetic copy.
The F.D.A. tentatively declared food from cloned animals safe in 2003 and then came to the same conclusion after a draft risk assessment at the end of 2006.
The agency said it received more than 30,500 comments on that risk assessment, many of them form letters. It took some of those comments into account and added data from new studies to come out with the final risk assessment issued Tuesday.
The agency said that while some cloned animals have birth defects, presumably because genes are turned on or off at the wrong times, the ones that survive past a few weeks appear to be as healthy as conventional animals. And whatever those genetic abnormalities are, it said, they are not passed on to the conventionally bred offspring of clones.
USDA Recommends That Food From Clones Stay Off the Market
By Rick Weiss
The Washington Post
Wednesday 16 January 2008
The U.S. Department of Agriculture yesterday asked U.S. farmers to keep their cloned animals off the market indefinitely even as Food and Drug Administration officials announced that food from cloned livestock is safe to eat.
Bruce I. Knight, the USDA's undersecretary for marketing and regulatory programs, requested an ongoing "voluntary moratorium" to buy time for "an acceptance process" that Knight said consumers in the United States and abroad will need, "given the emotional nature of this issue."
Yet even as the two agencies sought a unified message - that food from clones is safe for people but perhaps dangerous to U.S. markets and trade relations - evidence surfaced suggesting that Americans and others are probably already eating meat from the offspring of clones.
Executives from the nation's major cattle cloning companies conceded yesterday that they have not been able to keep track of how many offspring of clones have entered the food supply, despite a years-old request by the FDA to keep them off the market pending completion of the agency's safety report.
At least one Kansas cattle producer also disclosed yesterday that he has openly sold semen from prize-winning clones to many U.S. meat producers in the past few years, and that he is certain he is not alone.
"This is a fairy tale that this technology is not being used and is not already in the food chain," said Donald Coover, a Galesburg cattleman and veterinarian who has a specialty cattle semen business. "Anyone who tells you otherwise either doesn't know what they're talking about, or they're not being honest."
Yesterday's awkwardly meshed announcements by FDA and USDA officials, made at a joint news conference in Washington, reflected continuing divisions among U.S. regulatory agencies on how to deal with the issue of food from clones.
Stephen F. Sundlof, director of FDA's Center for Food Safety and Applied Nutrition, spoke from his perspective as the person who oversaw that agency's six-year review of the safety of milk and meat from clones and their offspring. He released the results of that 968-page "final risk analysis," saying "meat and milk from cattle, swine and goat clones are as safe as food we eat every day."
That conclusion amounted to handing the cloned-food hot potato to the USDA's Knight, whose agency has the responsibility of getting those products accepted on the market.
Recent surveys indicate that the agency has a challenge. Last year, 22 percent of Americans who responded to a major survey said they had a favorable impression of food from clones.
That was up from 16 percent a year earlier. Nonetheless, about 50 percent have an unfavorable impression, said Danielle "Dani" Schor of the International Food Information Council Foundation, an industry-funded interest group that has conducted the survey of 1,000 Americans annually since 2004.
At issue are clones of beef cattle, dairy cows, pigs and goats, as well as their offspring, which farmers in the United States and a few other countries are starting to raise in an effort to produce more consistently high-quality milk and meat.
In recent weeks, as it became clear that the FDA was ready to release its positive safety report, officials there began encountering resistance from other agencies that would have to deal with the consequences of food from clones entering the U.S. food supply.
Some of them, including the USDA's Foreign Agricultural Service and the Office of the U.S. Trade Representative, have been struggling for years to persuade countries in Europe and other parts of the world to accept gene-altered crops from the United States. The last thing those agencies needed, insiders said, was a new U.S. product that nobody wants.
The USDA's request that farmers keep their clones out of the food chain, probably for a few more years, "is simply allowing the time for an orderly transition to occur," Knight said, adding that the department is already having conversations with U.S. trading partners and trying to smooth the way to acceptance.
Some U.S. consumer groups have expressed concern for the cloned animals, which often have health problems, and have suggested that the American public may be as tough a sell as the wary consumers in the European Union and Japan.
"Despite the fact that cloned animals suffer high mortality rates and those who survive are often plagued with birth defects and diseases, the FDA did not give adequate consideration to the welfare of these animals or their surrogate mothers in its deliberations," said Wayne Pacelle, chief executive of the Humane Society of the United States.
Some U.S. groups have demanded that food from clones be labeled to give consumers the "right to choose."
But James Greenwood, president of the Biotechnology Industry Organization, whose members include the nation's biggest farm-animal cloning companies, rejected that idea, as has the FDA. He said cloning is simply a way to make offspring. Other methods of farm animal procreation, such as in vitro fertilization and artificial insemination, are not listed on food labels.
He and other industry representatives specifically rejected proposals to label food from conventionally conceived offspring of clones.
While the now-expired FDA moratorium sought to keep both clones and their offspring off the market, the new USDA moratorium requests only that clones themselves be withheld, so the offspring might make it to store shelves within a few years.
But imagine the labels that would appear if certain rules were in place, Greenwood said:
" 'This steak's father was a clone.' 'This steak's grandfather was a clone.' 'This steak's great-grandmother was a clone.'
"At what point does it become absurd?"
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Staff researcher Madonna Lebling contributed to this report.
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