Post by Kelsey on Oct 17, 2006 17:38:39 GMT -5
FDA set to allow cloned meat and milk
By Rick Weiss
The Washington Post
WASHINGTON — Three years after the Food and Drug Administration (FDA) first hinted that it might permit the sale of milk and meat from cloned animals and their offspring, prompting public reactions that ranged from curiosity to disgust, the agency is poised to endorse marketing of the mass-produced animals for public consumption.
The decision, expected by the end of this year, is based largely on new data indicating that milk and meat from cloned livestock and their offspring pose no unique risks to consumers.
"Our evaluation is that the food from cloned animals is as safe as the food we eat every day," said Stephen Sundlof, the FDA's chief of veterinary medicine, who has overseen the risk assessment.
Sundlof said the agency is not inclined to call for labeling of products from clones, as some have demanded. For one thing, clonal meat or milk would be impossible to authenticate because there is no way to distinguish them from conventional products.
Farmers and companies that have been growing cloned barnyard animals from single cells in anticipation of a lucrative market say cloning will provide a level of consistency and quality impossible to attain with conventional breeding, making perfectly marbled beef and reliably lean and tasty pork the norm on grocery shelves.
But groups opposed to the new technology, including a coalition of powerful food companies, have not given up. On Thursday, advocacy groups filed a petition asking the FDA to regulate cloned farm animals one type at a time, much as it regulates new drugs, a change that would drastically slow marketing approval. Some are also questioning the ethics of a technology that, while more efficient than it used to be, still poses risks for pregnant animals and their newborns.
"The government talks about being science-based, and that's great, but I think there is another pillar here: the question of whether we really want to do this," said Carol Tucker Foreman, director of food policy at the Consumer Federation of America.
Surveys show that about half the U.S. population is uncomfortable with the idea of animal cloning for food and milk. The single biggest reason people give is "religious and ethical," with concerns about food safety coming in second, said Michael Fernandez, executive director of the Pew Initiative on Food and Biotechnology, a nonpartisan research and education project.
That there is a debate at all about integrating clones into the food supply is evidence of the remarkable progress made since the 1996 birth of Dolly, the world's first mammalian clone, created from an udder cell of an anonymous ewe.
Scientists now have applied the technique successfully to cattle, horses, pigs, goats and other mammals. Each clone is a genetic replica of the animal that donated the cell from which it was grown.
Cloning could solve a number of long-standing farm problems. Many prize males are not recognized as such until long after they have been castrated. With cloning, that lack of semen would not matter. Cloning also allows farmers to make many copies of exceptional milk producers; with natural breeding, cows have only one offspring per year, and half are males.
In the eyes of many in agriculture, cloning is simply the latest in a string of advances that have given farmers better control over animal reproduction.
"Clones are just clones. They are not genetically engineered animals," said Barbara Glenn, chief of animal biotechnology at the Biotechnology Industry Organization.
The FDA agrees with that distinction, Sundlof said. The agency already has said it will regulate transgenic animals — those that have been engineered by adding specific, valuable genes — in much the way it regulates pharmaceuticals, under a new category called "New Animal Drugs." No such animals are now on the market.
By contrast, proponents say, clones are simply twins, albeit born a generation apart.
It was October 2003 when the FDA released its first draft document concluding that clones and their offspring were safe to eat, prompting several cloning companies to scale up their operations.
But an agency advisory panel and the National Academies, while supportive, raised caution flags, citing insufficient safety data.
That — along with opposition led largely by the International Dairy Foods Association, which represents such large, brand-sensitive companies as Kraft Foods, Dannon, General Mills and Nestlé USA — put FDA approval on hold. For years the agency has asked producers to keep clones off the market voluntarily while the issues got sorted out, a delay that bankrupted one major company and has left others increasingly frustrated.
But now a large collection of new data submitted to the FDA has revitalized the effort, according to government officials and others.
The biggest study compares meat from the offspring of cloned and conventional boars created by Austin, Texas-based ViaGen, a major producer of cloned farm animals. Company scientists agreed to share key results with a reporter but withheld details as required by the journal Theriogenology, which will publish the report in its January issue.
Semen from four clones and three conventional boars was used to inseminate 89 females. A total of 404 progeny (242 from clones) were raised identically by government scientists at the U.S. Department of Agriculture's Meat Animal Research Center in Clay, Neb., and slaughtered when they reached market size. (Because clones are so valuable, companies for now anticipate sending only their offspring to market.) Of the 14,036 measures of protein composition, fatty acid profiles and other meat components done on the offspring of clones by an independent lab, all but three were within the same range as those of the conventional animals, and only one was outside what the Agriculture Department considers normal.
The other large research report came from Cyagra, a cloning company in Elizabethtown, Pa.
In that study, 80 blood and urine measures, including various hormone levels, were taken in 10 newborn, 46 weanling and 18 adult clones. Results were indistinguishable from those obtained from conventional animals.
Then 79 biochemical measurements from three cuts of meat taken from five male and six female adult clones were compared with those from matched cuts from conventional animals. Again, no differences were found, said Cyagra's director of marketing, Steve Mower. The results have been submitted to the FDA and are being reviewed by a scientific journal.
"The data are very clear," ViaGen President Mark Walton said. "You really can't tell them apart."
In light of the new findings, and the FDA's near completion of a review demanded by the White House Office of Management and Budget, Sundlof expects to release a formal draft risk assessment by the end of the year, along with a proposed "risk management" plan. Those documents would allow the marketing of clones and their offspring for food and milk after a final period of public comment.
Unless, that is, the opponents manage to stop the process.
In its petition filed Thursday, the Washington-based Center for Food Safety asked the FDA to regulate clones, not just transgenics, as New Animal Drugs. It also called for environmental-impact statements to evaluate the environmental and health effects of each new proposed line of clones.
"The available science shows that cloning presents serious food safety risks, animal welfare concerns and unresolved ethical issues that require strict oversight," the petition states.
Industry scientists derided the petition's safety concerns, built largely on a theoretical possibility that subtle genetic changes seen in some clones may alter the nutritional nature of meat. If those genetic changes were significant, Mower said, they would cause biochemical changes in milk or meat, none of which have been found.
But issues of ethics and public acceptance are not easily dismissed, several experts said.
Public sentiment is a big concern to dairy companies, which fear that any association with cloning could harm milk's carefully honed image of wholesomeness.
Sundlof noted that the FDA has no authority to make decisions based on ethics concerns.
In any case, the FDA already may be too late. Several owners of clones have been selling semen to farm clubs and others vying to grow prize-winning cattle. Most of those animals end up being slaughtered, sold and eaten, experts said.
"That you can go online today to any number of different Web sites and purchase semen from cloned bulls tells you there are cloned sires out there fathering calves in the food supply," ViaGen's Walton said.
---------------------
Clone-study results:
Two new studies and a number of earlier ones have compared the meat and milk from clones and conventional livestock. A summary of the earlier findings:
• A 2002 Japanese study found "no biologically significant differences" in blood counts and blood chemistry, chemical composition of milk or meat, digestibility of meat fed to rats, allergenicity, or health or behavior of rats raised on clonal food.
• A 2004 study of rats raised on milk and meat from cloned animals showed no differences in growth rates, food consumption, behavior and reflexes, or breeding. Measures of their blood and urine were the same as for rats fed conventional chow, and their tissues were normal at autopsy.
• Another 2004 study found milk from cloned and conventional cows to be biochemically identical.
• A 2005 study also found the two types of milk to be virtually identical; all but 12 of more than 100 meat measures were also the same. Eight of the measures that were higher in the clones were for desirable fats and fatty acids that had been selected for those clones. The other four were all within normal range.
-------------------------
The Seattle Times, Oct. 17, 2006
By Rick Weiss
The Washington Post
WASHINGTON — Three years after the Food and Drug Administration (FDA) first hinted that it might permit the sale of milk and meat from cloned animals and their offspring, prompting public reactions that ranged from curiosity to disgust, the agency is poised to endorse marketing of the mass-produced animals for public consumption.
The decision, expected by the end of this year, is based largely on new data indicating that milk and meat from cloned livestock and their offspring pose no unique risks to consumers.
"Our evaluation is that the food from cloned animals is as safe as the food we eat every day," said Stephen Sundlof, the FDA's chief of veterinary medicine, who has overseen the risk assessment.
Sundlof said the agency is not inclined to call for labeling of products from clones, as some have demanded. For one thing, clonal meat or milk would be impossible to authenticate because there is no way to distinguish them from conventional products.
Farmers and companies that have been growing cloned barnyard animals from single cells in anticipation of a lucrative market say cloning will provide a level of consistency and quality impossible to attain with conventional breeding, making perfectly marbled beef and reliably lean and tasty pork the norm on grocery shelves.
But groups opposed to the new technology, including a coalition of powerful food companies, have not given up. On Thursday, advocacy groups filed a petition asking the FDA to regulate cloned farm animals one type at a time, much as it regulates new drugs, a change that would drastically slow marketing approval. Some are also questioning the ethics of a technology that, while more efficient than it used to be, still poses risks for pregnant animals and their newborns.
"The government talks about being science-based, and that's great, but I think there is another pillar here: the question of whether we really want to do this," said Carol Tucker Foreman, director of food policy at the Consumer Federation of America.
Surveys show that about half the U.S. population is uncomfortable with the idea of animal cloning for food and milk. The single biggest reason people give is "religious and ethical," with concerns about food safety coming in second, said Michael Fernandez, executive director of the Pew Initiative on Food and Biotechnology, a nonpartisan research and education project.
That there is a debate at all about integrating clones into the food supply is evidence of the remarkable progress made since the 1996 birth of Dolly, the world's first mammalian clone, created from an udder cell of an anonymous ewe.
Scientists now have applied the technique successfully to cattle, horses, pigs, goats and other mammals. Each clone is a genetic replica of the animal that donated the cell from which it was grown.
Cloning could solve a number of long-standing farm problems. Many prize males are not recognized as such until long after they have been castrated. With cloning, that lack of semen would not matter. Cloning also allows farmers to make many copies of exceptional milk producers; with natural breeding, cows have only one offspring per year, and half are males.
In the eyes of many in agriculture, cloning is simply the latest in a string of advances that have given farmers better control over animal reproduction.
"Clones are just clones. They are not genetically engineered animals," said Barbara Glenn, chief of animal biotechnology at the Biotechnology Industry Organization.
The FDA agrees with that distinction, Sundlof said. The agency already has said it will regulate transgenic animals — those that have been engineered by adding specific, valuable genes — in much the way it regulates pharmaceuticals, under a new category called "New Animal Drugs." No such animals are now on the market.
By contrast, proponents say, clones are simply twins, albeit born a generation apart.
It was October 2003 when the FDA released its first draft document concluding that clones and their offspring were safe to eat, prompting several cloning companies to scale up their operations.
But an agency advisory panel and the National Academies, while supportive, raised caution flags, citing insufficient safety data.
That — along with opposition led largely by the International Dairy Foods Association, which represents such large, brand-sensitive companies as Kraft Foods, Dannon, General Mills and Nestlé USA — put FDA approval on hold. For years the agency has asked producers to keep clones off the market voluntarily while the issues got sorted out, a delay that bankrupted one major company and has left others increasingly frustrated.
But now a large collection of new data submitted to the FDA has revitalized the effort, according to government officials and others.
The biggest study compares meat from the offspring of cloned and conventional boars created by Austin, Texas-based ViaGen, a major producer of cloned farm animals. Company scientists agreed to share key results with a reporter but withheld details as required by the journal Theriogenology, which will publish the report in its January issue.
Semen from four clones and three conventional boars was used to inseminate 89 females. A total of 404 progeny (242 from clones) were raised identically by government scientists at the U.S. Department of Agriculture's Meat Animal Research Center in Clay, Neb., and slaughtered when they reached market size. (Because clones are so valuable, companies for now anticipate sending only their offspring to market.) Of the 14,036 measures of protein composition, fatty acid profiles and other meat components done on the offspring of clones by an independent lab, all but three were within the same range as those of the conventional animals, and only one was outside what the Agriculture Department considers normal.
The other large research report came from Cyagra, a cloning company in Elizabethtown, Pa.
In that study, 80 blood and urine measures, including various hormone levels, were taken in 10 newborn, 46 weanling and 18 adult clones. Results were indistinguishable from those obtained from conventional animals.
Then 79 biochemical measurements from three cuts of meat taken from five male and six female adult clones were compared with those from matched cuts from conventional animals. Again, no differences were found, said Cyagra's director of marketing, Steve Mower. The results have been submitted to the FDA and are being reviewed by a scientific journal.
"The data are very clear," ViaGen President Mark Walton said. "You really can't tell them apart."
In light of the new findings, and the FDA's near completion of a review demanded by the White House Office of Management and Budget, Sundlof expects to release a formal draft risk assessment by the end of the year, along with a proposed "risk management" plan. Those documents would allow the marketing of clones and their offspring for food and milk after a final period of public comment.
Unless, that is, the opponents manage to stop the process.
In its petition filed Thursday, the Washington-based Center for Food Safety asked the FDA to regulate clones, not just transgenics, as New Animal Drugs. It also called for environmental-impact statements to evaluate the environmental and health effects of each new proposed line of clones.
"The available science shows that cloning presents serious food safety risks, animal welfare concerns and unresolved ethical issues that require strict oversight," the petition states.
Industry scientists derided the petition's safety concerns, built largely on a theoretical possibility that subtle genetic changes seen in some clones may alter the nutritional nature of meat. If those genetic changes were significant, Mower said, they would cause biochemical changes in milk or meat, none of which have been found.
But issues of ethics and public acceptance are not easily dismissed, several experts said.
Public sentiment is a big concern to dairy companies, which fear that any association with cloning could harm milk's carefully honed image of wholesomeness.
Sundlof noted that the FDA has no authority to make decisions based on ethics concerns.
In any case, the FDA already may be too late. Several owners of clones have been selling semen to farm clubs and others vying to grow prize-winning cattle. Most of those animals end up being slaughtered, sold and eaten, experts said.
"That you can go online today to any number of different Web sites and purchase semen from cloned bulls tells you there are cloned sires out there fathering calves in the food supply," ViaGen's Walton said.
---------------------
Clone-study results:
Two new studies and a number of earlier ones have compared the meat and milk from clones and conventional livestock. A summary of the earlier findings:
• A 2002 Japanese study found "no biologically significant differences" in blood counts and blood chemistry, chemical composition of milk or meat, digestibility of meat fed to rats, allergenicity, or health or behavior of rats raised on clonal food.
• A 2004 study of rats raised on milk and meat from cloned animals showed no differences in growth rates, food consumption, behavior and reflexes, or breeding. Measures of their blood and urine were the same as for rats fed conventional chow, and their tissues were normal at autopsy.
• Another 2004 study found milk from cloned and conventional cows to be biochemically identical.
• A 2005 study also found the two types of milk to be virtually identical; all but 12 of more than 100 meat measures were also the same. Eight of the measures that were higher in the clones were for desirable fats and fatty acids that had been selected for those clones. The other four were all within normal range.
-------------------------
The Seattle Times, Oct. 17, 2006