News; FDA Is Set To Approve Milk, Meat From Clones

October 18, 2006

FDA prepared to OK milk, meat from cloned animals The FDA by the end of the year is expected to back marketing of clonedanimals for public consumption. The agency's chief of veterinary medicinesays an evaluation indicates that "food from cloned animals is as safe asthe food we eat every day." The Washington<http://r.smartbrief.com/resp/eGiAeldTffefoXCiaWolLhOM> Post FDA Is Set To Approve Milk, Meat From ClonesBy Rick WeissWashington Post Staff WriterTuesday, October 17, 2006; A01Three years after the Food and Drug Administration first hinted that itmight permit the sale of milk and meat from cloned animals, prompting publicreactions that ranged from curiosity to disgust, the agency is poised toendorse marketing of the mass-produced animals for public consumption.The decision, expected by the end of this year, is based largely on new dataindicating that milk and meat from cloned livestock and their offspring poseno unique risks to consumers."Our evaluation is that the food from cloned animals is as safe as the foodwe eat every day," said Stephen F. Sundlof, the FDA's chief of veterinarymedicine, who has overseen the long-stalled risk assessment.Farmers and companies that have been growing cloned barnyard animals fromsingle cells in anticipation of a lucrative market say cloning will bringconsumers a level of consistency and quality impossible to attain withconventional breeding, making perfectly marbled beef and reliably lean andtasty pork the norm on grocery shelves.But groups opposed to the new technology, including a coalition of powerfulfood companies concerned that the public will reject Dolly-the-Lamb chopsand clonal cream in their coffee, have not given up.On Thursday, advocacy groups filed a petition asking the FDA to regulatecloned farm animals one type at a time, much as it regulates new drugs, achange that would drastically slow marketing approval. Some are alsoquestioning the ethics of a technology that, while more efficient than itused to be, still poses risks for pregnant animals and their newborns."The government talks about being science-based, and that's great, but Ithink there is another pillar here: the question of whether we really wantto do this," said Carol Tucker Foreman, director of food policy at theConsumer Federation of America.That there is a debate at all about integrating clones into the food supplyis evidence of the remarkable progress made since the 1996 birth of Dolly,the world's first mammalian clone, created from an udder cell of ananonymous ewe.Scientists have now applied the technique successfully to cattle, horses,pigs, goats and other mammals. Each clone is a genetic replica of the animalthat donated the cell from which it was grown.Cloning could solve a number of long-standing farm problems. Many prizemales are not recognized as such until long after they have been tamed bycastration. With cloning, that lack of semen would not matter. Cloning alsoallows farmers to make many copies of exceptional milk producers; withnatural 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 stringof advances such as artificial insemination and in vitro fertilization thathave given farmers better control over animal reproduction."Clones are just clones. They are not genetically engineered animals," saidBarbara Glenn, chief of animal biotechnology at the Biotechnology IndustryOrganization.The FDA agrees with that distinction, Sundlof said. The agency has alreadysaid it will regulate transgenic animals -- those that have been engineeredby adding specific, valuable genes -- in much the way it regulatespharmaceuticals, under a new category called "New Animal Drugs." No suchanimals are currently on the market.By contrast, proponents say, clones are simply twins, albeit born ageneration apart.It was October 2003 when the FDA released its first draft documentconcluding that clones and their offspring are safe to eat, promptingseveral cloning companies to scale up their operations.But an agency advisory panel and the National Academies, while generallysupportive, raised flags, citing a paucity of safety data.That, and opposition led largely by the International Dairy FoodsAssociation, which represents such large, brand-sensitive companies as Kraft<http://financial.washingtonpost.com/custom/wpost/html-qcn.asp?dispnav=business & mwpage=qcn & symb=KFT & nav=el> Foods, Dannon, General<http://financial.washingtonpost.com/custom/wpost/html-qcn.asp?dispnav=business & mwpage=qcn & symb=GIS & nav=el> Mills and Nestlé USA, put FDA approval onhold. For years the agency has asked producers to keep clones off the marketvoluntarily while the issues got sorted out, a delay that bankrupted onemajor company and has left others increasingly frustrated.But now a large collection of new data submitted to the FDA has revitalizedthe effort, according to government officials and others.The biggest new study is a detailed comparison of meat from the offspring ofcloned and conventional boars created by Austin-based ViaGen Inc., a majorproducer of cloned farm animals. Company scientists agreed to share keyresults with a reporter but withheld details as required by the journalTheriogenology, which will publish the full report in its January issue.Semen from four clones and three conventional boars was used to inseminate89 females. A total of 404 progeny (242 from clones) were raised identicallyby government scientists at the U.S. Department of Agriculture's Meat AnimalResearch Center in Clay, Neb., and slaughtered when they reached marketsize. (Because clones are so valuable, companies for now anticipate sendingonly their offspring to market.) Of the 14,036 measures of proteincomposition, fatty acid profiles and other meat components done on theoffspring of clones by an independent lab, all but three were within thesame range as those of the conventional animals, and only one was outsidewhat the Agriculture Department considers normal.The other large research report came from Cyagra, a cloning company inElizabethtown, Pa.In that study, 80 blood and urine measures, including various hormonelevels, were taken in 10 newborn, 46 weanling and 18 adult clones. Resultswere indistinguishable from those obtained from conventional animals. Then79 biochemical measurements from three cuts of meat taken from five male andsix female adult clones were compared with those from matched cuts fromconventional animals. Again, no differences were found, said Cyagra'sdirector of marketing, Steve A. Mower. The results have been submitted tothe FDA and are being reviewed by a scientific journal."The data are very clear," said ViaGen President Mark Walton. "You reallycan't tell them apart."In light of the new findings, and the FDA's near completion of acomplicated, interagency review demanded by the White House Office ofManagement and Budget, Sundlof anticipates releasing a formal draft riskassessment by the end of the year, along with a proposed "risk management"plan. Those documents would allow the marketing of clones and theiroffspring for food and milk after a final period of public comment.Unless, that is, the opponents manage to stop the process, which they aretrying to do on two fronts.One is the petition filed Thursday by the Washington-based Center for FoodSafety. It asks the FDA to regulate clones, not just transgenics, as NewAnimal Drugs. It also calls for environmental impact statements to evaluatethe environmental and health effects of each new proposed line of clones."The available science shows that cloning presents serious food safetyrisks, animal welfare concerns and unresolved ethical issues that requirestrict oversight," the petition states.Industry scientists derided the petition's safety concerns, built largely ona theoretical possibility that subtle genetic changes seen in some clonesmay alter the nutritional nature of meat. If those genetic changes weresignificant, Mower said, they would cause biochemical changes in milk ormeat, none of which have been found.But issues of ethics and public acceptance are not easily dismissed, severalexperts said.Surveys show that more than 60 percent of the U.S. population isuncomfortable with the idea of animal cloning for food and milk. The singlebiggest reason people give is "religious and ethical," with concerns aboutfood safety coming in second, said Michael Fernandez, executive director ofthe Pew Initiative on Food and Biotechnology, a nonpartisan research andeducation project.Those sentiments are a big concern to dairy companies, which fear that anyassociation with cloning could harm milk's carefully honed image ofwholesomeness.Confidential documents from the International Dairy Foods Association,obtained by The Washington Post, indicate the group has played a key role inslowing FDA action and propose a strategy for blocking any future FDAapproval.Association spokeswoman Susan Ruland said the group opted not to adopt thelobbying strategy described in those documents, which included using friendsin Congress and "continued outreach to the White House."In any case, Sundlof said, the FDA has no authority to make decisions basedon ethics concerns. Nor is it inclined to call for labeling of products fromclones, as some have demanded. For one thing, clonal meat or milk would beimpossible to authenticate, since there is no way to distinguish them fromconventional products.The FDA may already be too late. Several owners of clones have been sellingsemen to farm clubs and others vying to grow prize-winning cattle. Most ofthose animals end up being slaughtered, sold and eaten, experts said."That you can go online today to any number of different Web sites andpurchase semen from cloned bulls tells you there are cloned sires out therefathering calves in the food supply," Walton said.Like it or not, Walton and others said, the clones are out of the barn.

October 18, 2006

i liked the statements

The decision, expected by the end of this year, is based largely on new dataindicating that milk and meat from cloned livestock and their offspring poseno unique risks to consumers."Our evaluation is that the food from cloned animals is as safe as the foodwe eat every day," said Stephen F. Sundlof, the FDA's chief of veterinarymedicine, who has overseen the long-stalled risk assessment.

yes, we believe eating dead flesh from clones is no different then eating dead flesh from any other factory farmed animal that is tortured and killed...you have the same risks of e coli and heart disease, no more, no less

zurumato Oct 18, 2006 10:23 AM Vegan_Animal_Rights , veganchat , vegaNZchat News; FDA Is Set To Approve Milk, Meat From Clones

FDA prepared to OK milk, meat from cloned animals The FDA by the end of the year is expected to back marketing of clonedanimals for public consumption. The agency's chief of veterinary medicinesays an evaluation indicates that "food from cloned animals is as safe asthe food we eat every day." The Washington<http://r.smartbrief.com/resp/eGiAeldTffefoXCiaWolLhOM> Post FDA Is Set To Approve Milk, Meat From ClonesBy Rick WeissWashington Post Staff WriterTuesday, October 17, 2006; A01Three years after the Food and Drug Administration first hinted that itmight permit the sale of milk and meat from cloned animals, prompting publicreactions that ranged from curiosity to disgust, the agency is poised toendorse marketing of the mass-produced animals for public consumption.The decision, expected by the end of this year, is based largely on new dataindicating that milk and meat from cloned livestock and their offspring poseno unique risks to consumers."Our evaluation is that the food from cloned animals is as safe as the foodwe eat every day," said Stephen F. Sundlof, the FDA's chief of veterinarymedicine, who has overseen the long-stalled risk assessment.Farmers and companies that have been growing cloned barnyard animals fromsingle cells in anticipation of a lucrative market say cloning will bringconsumers a level of consistency and quality impossible to attain withconventional breeding, making perfectly marbled beef and reliably lean andtasty pork the norm on grocery shelves.But groups opposed to the new technology, including a coalition of powerfulfood companies concerned that the public will reject Dolly-the-Lamb chopsand clonal cream in their coffee, have not given up.On Thursday, advocacy groups filed a petition asking the FDA to regulatecloned farm animals one type at a time, much as it regulates new drugs, achange that would drastically slow marketing approval. Some are alsoquestioning the ethics of a technology that, while more efficient than itused to be, still poses risks for pregnant animals and their newborns."The government talks about being science-based, and that's great, but Ithink there is another pillar here: the question of whether we really wantto do this," said Carol Tucker Foreman, director of food policy at theConsumer Federation of America.That there is a debate at all about integrating clones into the food supplyis evidence of the remarkable progress made since the 1996 birth of Dolly,the world's first mammalian clone, created from an udder cell of ananonymous ewe.Scientists have now applied the technique successfully to cattle, horses,pigs, goats and other mammals. Each clone is a genetic replica of the animalthat donated the cell from which it was grown.Cloning could solve a number of long-standing farm problems. Many prizemales are not recognized as such until long after they have been tamed bycastration. With cloning, that lack of semen would not matter. Cloning alsoallows farmers to make many copies of exceptional milk producers; withnatural 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 stringof advances such as artificial insemination and in vitro fertilization thathave given farmers better control over animal reproduction."Clones are just clones. They are not genetically engineered animals," saidBarbara Glenn, chief of animal biotechnology at the Biotechnology IndustryOrganization.The FDA agrees with that distinction, Sundlof said. The agency has alreadysaid it will regulate transgenic animals -- those that have been engineeredby adding specific, valuable genes -- in much the way it regulatespharmaceuticals, under a new category called "New Animal Drugs." No suchanimals are currently on the market.By contrast, proponents say, clones are simply twins, albeit born ageneration apart.It was October 2003 when the FDA released its first draft documentconcluding that clones and their offspring are safe to eat, promptingseveral cloning companies to scale up their operations.But an agency advisory panel and the National Academies, while generallysupportive, raised flags, citing a paucity of safety data.That, and opposition led largely by the International Dairy FoodsAssociation, which represents such large, brand-sensitive companies as Kraft<http://financial.washingtonpost.com/custom/wpost/html-qcn.asp?dispnav=business & mwpage=qcn & symb=KFT & nav=el> Foods, Dannon, General<http://financial.washingtonpost.com/custom/wpost/html-qcn.asp?dispnav=business & mwpage=qcn & symb=GIS & nav=el> Mills and Nestlé USA, put FDA approval onhold. For years the agency has asked producers to keep clones off the marketvoluntarily while the issues got sorted out, a delay that bankrupted onemajor company and has left others increasingly frustrated.But now a large collection of new data submitted to the FDA has revitalizedthe effort, according to government officials and others.The biggest new study is a detailed comparison of meat from the offspring ofcloned and conventional boars created by Austin-based ViaGen Inc., a majorproducer of cloned farm animals. Company scientists agreed to share keyresults with a reporter but withheld details as required by the journalTheriogenology, which will publish the full report in its January issue.Semen from four clones and three conventional boars was used to inseminate89 females. A total of 404 progeny (242 from clones) were raised identicallyby government scientists at the U.S. Department of Agriculture's Meat AnimalResearch Center in Clay, Neb., and slaughtered when they reached marketsize. (Because clones are so valuable, companies for now anticipate sendingonly their offspring to market.) Of the 14,036 measures of proteincomposition, fatty acid profiles and other meat components done on theoffspring of clones by an independent lab, all but three were within thesame range as those of the conventional animals, and only one was outsidewhat the Agriculture Department considers normal.The other large research report came from Cyagra, a cloning company inElizabethtown, Pa.In that study, 80 blood and urine measures, including various hormonelevels, were taken in 10 newborn, 46 weanling and 18 adult clones. Resultswere indistinguishable from those obtained from conventional animals. Then79 biochemical measurements from three cuts of meat taken from five male andsix female adult clones were compared with those from matched cuts fromconventional animals. Again, no differences were found, said Cyagra'sdirector of marketing, Steve A. Mower. The results have been submitted tothe FDA and are being reviewed by a scientific journal."The data are very clear," said ViaGen President Mark Walton. "You reallycan't tell them apart."In light of the new findings, and the FDA's near completion of acomplicated, interagency review demanded by the White House Office ofManagement and Budget, Sundlof anticipates releasing a formal draft riskassessment by the end of the year, along with a proposed "risk management"plan. Those documents would allow the marketing of clones and theiroffspring for food and milk after a final period of public comment.Unless, that is, the opponents manage to stop the process, which they aretrying to do on two fronts.One is the petition filed Thursday by the Washington-based Center for FoodSafety. It asks the FDA to regulate clones, not just transgenics, as NewAnimal Drugs. It also calls for environmental impact statements to evaluatethe environmental and health effects of each new proposed line of clones."The available science shows that cloning presents serious food safetyrisks, animal welfare concerns and unresolved ethical issues that requirestrict oversight," the petition states.Industry scientists derided the petition's safety concerns, built largely ona theoretical possibility that subtle genetic changes seen in some clonesmay alter the nutritional nature of meat. If those genetic changes weresignificant, Mower said, they would cause biochemical changes in milk ormeat, none of which have been found.But issues of ethics and public acceptance are not easily dismissed, severalexperts said.Surveys show that more than 60 percent of the U.S. population isuncomfortable with the idea of animal cloning for food and milk. The singlebiggest reason people give is "religious and ethical," with concerns aboutfood safety coming in second, said Michael Fernandez, executive director ofthe Pew Initiative on Food and Biotechnology, a nonpartisan research andeducation project.Those sentiments are a big concern to dairy companies, which fear that anyassociation with cloning could harm milk's carefully honed image ofwholesomeness.Confidential documents from the International Dairy Foods Association,obtained by The Washington Post, indicate the group has played a key role inslowing FDA action and propose a strategy for blocking any future FDAapproval.Association spokeswoman Susan Ruland said the group opted not to adopt thelobbying strategy described in those documents, which included using friendsin Congress and "continued outreach to the White House."In any case, Sundlof said, the FDA has no authority to make decisions basedon ethics concerns. Nor is it inclined to call for labeling of products fromclones, as some have demanded. For one thing, clonal meat or milk would beimpossible to authenticate, since there is no way to distinguish them fromconventional products.The FDA may already be too late. Several owners of clones have been sellingsemen to farm clubs and others vying to grow prize-winning cattle. Most ofthose animals end up being slaughtered, sold and eaten, experts said."That you can go online today to any number of different Web sites andpurchase semen from cloned bulls tells you there are cloned sires out therefathering calves in the food supply," Walton said.Like it or not, Walton and others said, the clones are out of the barn.

October 20, 2006

i have a few of my thoughts about it.

1. why is the fda using it's own inside scientist to asure people

that its ok to eat the meat of cloned animals. why not have

outside/neutral scientist decide that? In that article there is

another opinion saying cloned meat is ok to eat, given by a cloning

company. gee...!?

2. what long term studies have been done on this? The article

indicates that they will not label, but shouldn't the public have the

right to decide if they want to purchase this meat?

(of course I will never have to worry about any of this. I'm vegan

3. your right fraggle, this article says that the meat of cloned

animals is the same as regular animals. The same???

so they mean that is contains that same saturated fats that

contribute to heart disease which acording another governement agency

the CDC

is the number one premature killer in the us?

4. how come there is such controversy at the " ethics " of cloning

people. but there no moral problem cloning other animals for

consumption.

5. why should the public trust the FDA, known for its slackness in

regulations, allowing ingredients such as antifreeze in

children's tylenol. (also known as propelyne glycol) and other

cancerous/toxic ones, too many to mention?

-anouk

October 20, 2006

Hi Anouk

All very good points. What really frustrates me is... they have all this technology - so why don't they pump the resources into " growing " meat - so that people who like the taste of meat can eat it without having to have something suffer and die in the process???

(BTW - that's a rhetorical question - I don't really expect anyone to have an answer!)

BB

Peter

On 20/10/06, flower child <zurumato wrote:

i have a few of my thoughts about it.1. why is the fda using it's own inside scientist to asure people

that its ok to eat the meat of cloned animals. why not haveoutside/neutral scientist decide that? In that article there isanother opinion saying cloned meat is ok to eat, given by a cloningcompany. gee...!?

2. what long term studies have been done on this? The articleindicates that they will not label, but shouldn't the public have theright to decide if they want to purchase this meat?(of course I will never have to worry about any of this. I'm vegan

3. your right fraggle, this article says that the meat of clonedanimals is the same as regular animals. The same???so they mean that is contains that same saturated fats thatcontribute to heart disease which acording another governement agency

the CDC is the number one premature killer in the us?4. how come there is such controversy at the " ethics " of cloningpeople. but there no moral problem cloning other animals forconsumption.

5. why should the public trust the FDA, known for its slackness inregulations, allowing ingredients such as antifreeze inchildren's tylenol. (also known as propelyne glycol) and othercancerous/toxic ones, too many to mention?

-anoukTo send an email to -