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FDA: Cloned animals' meat is safe
By Elizabeth Weise, USA TODAY
The government declared Thursday that food from cloned animals is safe to eat. After more than five years of study, the Food and Drug Administration concluded that cloned livestock is "virtually indistinguishable" from conventional livestock.
FDA believes "that meat and milk from cattle, swine and goat clones is as safe to eat as the food we eat every day," said Stephen F. Sundlof, director of the FDA Center for Veterinary Medicine.
Officials said they don't think special labels are needed, although a decision on labeling is pending.
The question of whether the public would buy it is less clear.
Because of unknown health risks associated with cloning, the FDA put a voluntary moratorium on the sale of meat and milk from cloned animals in 2001. The agency's "risk assessment" to be released today includes more than 300 pages on the potential effects of allowing clones into the food supply, said the source, who is not authorized to speak publicly about the announcement.
"None of the studies … identify any remarkable nutritionally or toxicologically important differences in the composition of the meat or milk," according to a draft of a paper to be published Jan. 1 in Theriogenology, a scientific journal on animal reproduction. The paper was written by scientists at the FDA's Center for Veterinary Medicine.
Though the safety of cloned animals may not be in question, public opinion is another matter, said Michael Fernandez of the Pew Initiative on Food and Biotechnology. A poll in September by the non-profit group found that 64% of people were uncomfortable with animal cloning. "It's clear that people have a set of concerns that are independent of safety," he said.
Animal cloning arrived in 1996 with the birth of Dolly the sheep. Cloning is the process of taking a single cell from an adult animal, inserting it into a hollowed-out egg from that species and using an electric shock to "trick" the egg into thinking it has been fertilized. If all goes well, the host mother gives birth to an exact copy — a genetic twin — of the adult animal.
The process is not very efficient; it requires up to 100 tries to go from egg to live birth. And clones have an increased risk of premature death and birth defects, according to the Theriogenology paper.
Cloning also is too expensive to be used to produce individual animals for slaughter, the journal article said. Instead, it's expected that cloning will be used mostly to make copies of animals with outstanding characteristics such as high milk production, excellent meat marbling or quick growth. Those clones would then be used to breed animals for market.
If the FDA does approve such sales, they will not have to be labeled as coming from cloned animals or their offspring.
MORE INFO
FDA backs safety of meat, milk from cloned animals
As expected, the Food and Drug Administration announced Thursday that its scientific assessment of meat and milk from cloned animals determined they were safe for human consumption. The announcement, coming after four years of review and research, is just the beginning of what will be a year or more process of public input and discussion before these products can be sold. USA TODAY's Elizabeth Weise explains the issues involved.
Q: How are clones made?
A: Let's use a cow as an example, as cattle are the most commonly cloned farm animals right now. A single cell is taken from an adult cow. Its genetic material is inserted into another cow's egg that has had its genetic material removed. A jolt of electricity tricks the egg into thinking it has been fertilized and it begins to grow. The resulting embryo is implanted into the uterus of a surrogate cow, which gives birth to the cloned calf.
STORY: FDA says cloned animals' meat is safe
Q: Will cloned meat and milk be on supermarket shelves soon?
A: No. After public comment is collected during a 90-day period, the agency has to go through it all and incorporate it into its guidelines for the industry. FDA doesn't expect to finish that process until the end of 2007 at the earliest. The voluntary moratorium on the sale of meat and milk from cloned animals will remain in effect until that happens, so nothing should arrive in stores until at least 2008.
Q: So in 2008 all our meat and milk will be from clones?
A: No. Clones are expensive to produce, about $20,000 per animal. For example, there are only about 150 cloned cows in the USA today. They're too pricey and too rare to use as meat or really even as milking cows. Instead, they'll be used like elite breeding stock, "to pass on naturally occurring, desirable traits such as disease resistance and higher-quality meat to production herds," in the FDA's words.
Q: We won't be eating clones?
A: Very few. What we'll likely get is some meat and milk from the offspring of clones. If a cloned cow or bull is at the end of its life span, it might end up as hamburger, but it will be a microscopic amount of the nation's meat supply.
Q: Are clones dangerous to eat?
A: The FDA says all its research shows that you can't tell a cloned animal from a conventionally bred one even down to the chemical level, so they're not more dangerous than a normal cow, pig or goat. One French study found that some cloned cows reached puberty later and had slightly different fat metabolism than normal cattle and suggested a need for further research.
Q: What about the ethical and moral issues?
A: FDA's mandate is to ensure that the U.S. food supply is safe and wholesome. Its research looks only at safety. But numerous animal welfare groups believe that cloning is unethical because it harms animals. Cloned animals have a higher rate of birth defects and abnormalities than conventionally bred animals.
Q: What does FDA say?
A: FDA's position is that none of the problems seen with clones are different from problems that occur in many of the assisted reproductive technologies commonly used today on farms.
Q: What countries allow the sale of meat and milk from cloned animals?
A: None. The USA will be the first, though numerous other countries are watching FDA's process closely.
Q: Will cloned meat and milk be labeled at the store?
A: Probably not. FDA says that it hasn't yet decided whether it will require labeling. In general, the agency requires products to be labeled only if they might be misleading (butter vs. margarine) or for nutritional labeling (canola oil that is genetically engineered to have high oleic acid). Because FDA has said that meat and milk from cloned animals is indistinguishable from conventionally bred animals, there appears to be no basis for the agency to require labeling.
Q: Are there exceptions?
A: A very few. The agency requires labeling if there are material facts of importance to consumers. Examples include the labeling of foods as irradiated or wines that contain sulfites because some people are allergic to them. Another example is protein-based chemicals like MSG. Because these can come from plant or animal, labeling allows vegetarians or observant Jews and Muslims to avoid either meat or pork-based additives.
Q: What did FDA do?
A: FDA released three draft documents about animal cloning. They found that meat and milk from cloned animals are as safe to eat as those from conventionally bred animals and discussed ways FDA might work with scientific and professional societies to develop care standards for animals involved in the cloning process.
Q: Why was the FDA assessment a draft?
A: FDA first releases draft information, then begins a 90-day period of public comment. Then it takes the public and industry comment and incorporates it into the agency's risk assessment.
Q: How can I throw in my opinion during the 90-day period of public comment?
A: To submit electronic comments, visit www.accessdata.fda.gov/scripts/oc/dockets/comments/commentdocket.cfm?AGENCY=FDA and search for docket 2006P-0415. Written comments: Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. Comments must be received by April 2 and should include the docket number 2006P-0415.
By Elizabeth Weise, USA TODAY
The government declared Thursday that food from cloned animals is safe to eat. After more than five years of study, the Food and Drug Administration concluded that cloned livestock is "virtually indistinguishable" from conventional livestock.
FDA believes "that meat and milk from cattle, swine and goat clones is as safe to eat as the food we eat every day," said Stephen F. Sundlof, director of the FDA Center for Veterinary Medicine.
Officials said they don't think special labels are needed, although a decision on labeling is pending.
The question of whether the public would buy it is less clear.
Because of unknown health risks associated with cloning, the FDA put a voluntary moratorium on the sale of meat and milk from cloned animals in 2001. The agency's "risk assessment" to be released today includes more than 300 pages on the potential effects of allowing clones into the food supply, said the source, who is not authorized to speak publicly about the announcement.
"None of the studies … identify any remarkable nutritionally or toxicologically important differences in the composition of the meat or milk," according to a draft of a paper to be published Jan. 1 in Theriogenology, a scientific journal on animal reproduction. The paper was written by scientists at the FDA's Center for Veterinary Medicine.
Though the safety of cloned animals may not be in question, public opinion is another matter, said Michael Fernandez of the Pew Initiative on Food and Biotechnology. A poll in September by the non-profit group found that 64% of people were uncomfortable with animal cloning. "It's clear that people have a set of concerns that are independent of safety," he said.
Animal cloning arrived in 1996 with the birth of Dolly the sheep. Cloning is the process of taking a single cell from an adult animal, inserting it into a hollowed-out egg from that species and using an electric shock to "trick" the egg into thinking it has been fertilized. If all goes well, the host mother gives birth to an exact copy — a genetic twin — of the adult animal.
The process is not very efficient; it requires up to 100 tries to go from egg to live birth. And clones have an increased risk of premature death and birth defects, according to the Theriogenology paper.
Cloning also is too expensive to be used to produce individual animals for slaughter, the journal article said. Instead, it's expected that cloning will be used mostly to make copies of animals with outstanding characteristics such as high milk production, excellent meat marbling or quick growth. Those clones would then be used to breed animals for market.
If the FDA does approve such sales, they will not have to be labeled as coming from cloned animals or their offspring.
MORE INFO
FDA backs safety of meat, milk from cloned animals
As expected, the Food and Drug Administration announced Thursday that its scientific assessment of meat and milk from cloned animals determined they were safe for human consumption. The announcement, coming after four years of review and research, is just the beginning of what will be a year or more process of public input and discussion before these products can be sold. USA TODAY's Elizabeth Weise explains the issues involved.
Q: How are clones made?
A: Let's use a cow as an example, as cattle are the most commonly cloned farm animals right now. A single cell is taken from an adult cow. Its genetic material is inserted into another cow's egg that has had its genetic material removed. A jolt of electricity tricks the egg into thinking it has been fertilized and it begins to grow. The resulting embryo is implanted into the uterus of a surrogate cow, which gives birth to the cloned calf.
STORY: FDA says cloned animals' meat is safe
Q: Will cloned meat and milk be on supermarket shelves soon?
A: No. After public comment is collected during a 90-day period, the agency has to go through it all and incorporate it into its guidelines for the industry. FDA doesn't expect to finish that process until the end of 2007 at the earliest. The voluntary moratorium on the sale of meat and milk from cloned animals will remain in effect until that happens, so nothing should arrive in stores until at least 2008.
Q: So in 2008 all our meat and milk will be from clones?
A: No. Clones are expensive to produce, about $20,000 per animal. For example, there are only about 150 cloned cows in the USA today. They're too pricey and too rare to use as meat or really even as milking cows. Instead, they'll be used like elite breeding stock, "to pass on naturally occurring, desirable traits such as disease resistance and higher-quality meat to production herds," in the FDA's words.
Q: We won't be eating clones?
A: Very few. What we'll likely get is some meat and milk from the offspring of clones. If a cloned cow or bull is at the end of its life span, it might end up as hamburger, but it will be a microscopic amount of the nation's meat supply.
Q: Are clones dangerous to eat?
A: The FDA says all its research shows that you can't tell a cloned animal from a conventionally bred one even down to the chemical level, so they're not more dangerous than a normal cow, pig or goat. One French study found that some cloned cows reached puberty later and had slightly different fat metabolism than normal cattle and suggested a need for further research.
Q: What about the ethical and moral issues?
A: FDA's mandate is to ensure that the U.S. food supply is safe and wholesome. Its research looks only at safety. But numerous animal welfare groups believe that cloning is unethical because it harms animals. Cloned animals have a higher rate of birth defects and abnormalities than conventionally bred animals.
Q: What does FDA say?
A: FDA's position is that none of the problems seen with clones are different from problems that occur in many of the assisted reproductive technologies commonly used today on farms.
Q: What countries allow the sale of meat and milk from cloned animals?
A: None. The USA will be the first, though numerous other countries are watching FDA's process closely.
Q: Will cloned meat and milk be labeled at the store?
A: Probably not. FDA says that it hasn't yet decided whether it will require labeling. In general, the agency requires products to be labeled only if they might be misleading (butter vs. margarine) or for nutritional labeling (canola oil that is genetically engineered to have high oleic acid). Because FDA has said that meat and milk from cloned animals is indistinguishable from conventionally bred animals, there appears to be no basis for the agency to require labeling.
Q: Are there exceptions?
A: A very few. The agency requires labeling if there are material facts of importance to consumers. Examples include the labeling of foods as irradiated or wines that contain sulfites because some people are allergic to them. Another example is protein-based chemicals like MSG. Because these can come from plant or animal, labeling allows vegetarians or observant Jews and Muslims to avoid either meat or pork-based additives.
Q: What did FDA do?
A: FDA released three draft documents about animal cloning. They found that meat and milk from cloned animals are as safe to eat as those from conventionally bred animals and discussed ways FDA might work with scientific and professional societies to develop care standards for animals involved in the cloning process.
Q: Why was the FDA assessment a draft?
A: FDA first releases draft information, then begins a 90-day period of public comment. Then it takes the public and industry comment and incorporates it into the agency's risk assessment.
Q: How can I throw in my opinion during the 90-day period of public comment?
A: To submit electronic comments, visit www.accessdata.fda.gov/scripts/oc/dockets/comments/commentdocket.cfm?AGENCY=FDA and search for docket 2006P-0415. Written comments: Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. Comments must be received by April 2 and should include the docket number 2006P-0415.
