FDA Set to OK Food From Cloned Animals
The government has decided that food from cloned animals is safe to eat and does not require special labeling.
http://www.truthout.org/issues_06/122806HA.shtml
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Cloned milk and meat expected to go on sale in months after winning US approval
Food won't be labelled as cloned
UK must decide if it will follow suit
Tim Reid in Washington and Nigel Hawkes
http://www.timesonline.co.uk/article/0,,3-2522437,00.html
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The sale of milk and meat from cloned animals moved a step closer yesterday after the US Government ruled that the products were safe to eat and could be sold in supermarkets without labelling.
The landmark draft decision, taken by the US Food and Drugs Administration, was condemned by consumer groups and food safety experts, who gave warning of the implications for food consumption throughout the world.
FDA officials said that they saw little problem with the controversial technology, which could result in cloned food being sold in the US within months without any labels identifying its origins. They added that cloned food products, if approved, could also be exported.
Authorities in Britain have yet to address the issue of the sale of food from cloned animals, including those approved by the US — cattle, pigs and goats. However, precedents set by the FDA are often followed by UK and European authorities. The Food Standards Agency said last night that it had not received an applications for the marketing of food products from cloned animals in the United Kingdom.
The move would have to be approved by the European Union before such products could be introduced, even if they were only being imported from the US. The UK’s Advisory Committee for Novel Foods would also be consulted.
The FDA, which overseas food safety for the US Government, determined after a five-year review that food from cloned livestock was as safe to eat as food from conventionally bred animals. The decision was all the more controversial because the agency declared that special labels were not needed to alert shoppers to its origin.
Decrying the ruling, consumer groups gave warning that cloned food would enter the food chain untested on humans, and from a field of science in which cloned animals are often born sick or with severe abnormalities. “Consumers are going to be having a product that has potential safety issues and a whole load of ethical issues tied to it, without any labelling,” said Joseph Mendelson, legal director of the Washington-based Centre for Food Safety.
Some US consumer groups maintain that surrogate mothers, in which the cloned animals are grown, are treated with high levels of hormones. They claim that clones are often born with severely compromised immune systems and receive massive doses of antibiotics, opening the way for large quantities of pharmaceuticals to enter the food supply.
The US National Academy of Sciences also warned recently that the commercialisation of cloned livestock for food production could increase the incidence of food-borne illness, such as E-coli infections.
Barbara Mikulski, a Democrat senator from Maryland, wrote in an open letter to the FDA: “Just because a scientist can manufacture food in the laboratory, should Americans be required to eat it?” Experts say it would probably take years for sales of cloned food to begin in earnest, because the technology’s high cost makes it prohibitive for most farmers. It costs about $15,000 (£7,500) to clone one dairy cow. But already several hundred cattle among America’s nine million have been cloned.
The FDA pointed out that many consumers confuse cloning with genetic modification. To produce a clone, the nucleus of a donor egg is removed and replaced with the DNA of a cow or other animal. A tiny electric shock coaxes the egg to grow into a copy of the original animal. Supporters of the technology say that it will be used primarily for breeding good milk and meat producers, and that produce will most likely be drawn from offspring, rather than the cloned animal.
The FDA said yesterday that meat and milk from clones was as safe to consume as products derived from naturally raised animals. Within six to eighteen months, cloned animals were “virtually indistinguishable” from conventionally-bred livestock, it said. “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, the director of the FDA Centre for Veterinary Medicine.
Final approval for lifting the current ban on cloned food could come early next year. The agency will accept comments from the public for the next three months before announcing a final decision.
The Consumer Federation of America said that it would run a publicity campaign to ask food companies and supermarkets to refuse to sell cloned food. Polls show already that most Americans do not favour eating such a product, and many food companies are skittish about selling cloned food.
Opponents also maintain that cloning results in high failure rates and distress for the cloned animals. The Centre for Food Safety points to the example of Greg Wiles, whose Maryland farm was the first to have cloned cows. He says he told the FDA that one of his cloned cows was having terrible health problems, but was ignored.
Making Your Voice Heard at FDA: How to Comment on Proposed Regulations and Submit Petitions
http://www.fda.gov/opacom/backgrounders/voice.html
However, I couldn't find a comment link regarding milk and beef from cloned animals.
Teresa
FOR IMMEDIATE RELEASE
P06-215 December 28, 2006
http://www.fda.gov/bbs/topics/NEWS/2006/NEW01541.html
Media Inquiries: Michael Herndon, 301-827-6242
Consumer Inquiries: 888-INFO-FDA
FDA Issues Draft Documents on the Safety of Animal Clones Agency Continues to Ask Producers and Breeders Not to Introduce Food from Clones into Food Supply
The U.S. Food and Drug Administration (FDA) today issued three documents on the safety of animal cloning -- a draft risk assessment; a proposed risk management plan; and a draft guidance for industry. Draft risk assessment
The draft risk assessment finds that meat and milk from clones of adult cattle, pigs and goats, and their offspring, are as safe to eat as food from conventionally bred animals. The assessment was peer-reviewed by a group of independent scientific experts in cloning and animal health. They agreed with the methods FDA used to evaluate the data and the conclusions set out in the document.
The draft risk assessment presents an overview of assisted reproductive methods widely used in animal agriculture, the extensive scientific information available on animal health and food consumption risks, and draws science-based conclusions. These conclusions agree with those of the National Academies of Sciences, released in a 2002 report. Due to limited data on sheep clones, in the draft guidance FDA recommends that sheep clones not be used for human food.
"Based on FDA's analysis of hundreds of peer-reviewed publications and other studies on the health and food composition of clones and their offspring, the draft risk assessment has determined that meat and milk from clones and their offspring are as safe as food we eat every day," said Stephen F. Sundlof, D.V.M., Ph.D., director of FDA's Center for Veterinary Medicine. "Cloning poses no unique risks to animal health when compared to other assisted reproductive technologies currently in use in U.S. agriculture."
An animal clone is a genetic copy of a donor animal, similar to identical twins but born at different times. Cloning is not the same as genetic engineering, which involves altering, adding or deleting DNA; cloning does not change the gene sequence. Proposed risk management plan
The proposed risk management plan addresses risks to animal health and potential remaining uncertainties associated with feed and food from animal clones and their offspring.
The proposed plan outlines measures that FDA might take to address the risks that cloning poses to animals involved in the cloning process. These risks all have been observed in other assisted reproductive technologies currently in use in common agricultural practices.
One such measure could be that the agency would work with scientific and professional societies with expertise in animal health and reproduction to develop a set of care standards for animals involved in the cloning process. Although the agency does not have authority to address the ethics of animal cloning, the proposed risk management plan does state that FDA plans to continue to provide scientific expertise to interested parties working on these issues.
"Because the release of the draft risk assessment and proposed risk management plan marks the beginning of our interaction with the public on these issues, we are continuing to ask producers of clones and livestock breeders to voluntarily refrain from introducing food products from these animals into commerce so that we will have the opportunity to consider the public's comments and to issue any final documents as warranted," said Sundlof.
Draft guidance for industry
The draft guidance for industry addresses the use of food and feed products derived from clones and their offspring. The guidance is directed at clone producers, livestock breeders, and farmers and ranchers purchasing clones. It provides the agency's current thinking on use of clones and their offspring in human food or animal feed.
In the draft guidance, FDA does not recommend any special measures relating to human food use of offspring of clones of any species. Because of their cost and rarity, clones will be used as are any other elite breeding stock -- to pass on naturally-occurring, desirable traits such as disease resistance and higher quality meat to production herds. Because clones will be used primarily for breeding, almost all of the food that comes from the cloning process is expected to be from sexually-reproduced offspring and descendents of clones, and not the clones themselves.
FDA is seeking comments from the public on the three documents for the next 90 days.
To submit electronic comments on the three documents, visit
http://www.accessdata.fda.gov/scripts/oc/dockets/comments/commentdocket.cfm?AGENCY=FDA.
Written comments may be sent to: Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD, 20852.
Comments must be received by Apr. 2, 2007 and should include the docket number 2003N-0573.
For more information, visit
http://www.fda.gov/cvm/CloneRiskAssessment.htm.
Submit Comments
http://tinyurl.com/y8o9ag
Squeamish consumers may balk as FDA backs cloned meat, milk.
http://online.wsj.com/article/SB116731300210161476.html
The FDA declared meat and milk from cloned animals safe to eat, though industry concerns about consumer reactions make their sale unlikely anytime soon.
Wall Street Journal. 29 December 2006.
Consistent with its stance as representative of patent-investors, the FDA's preliminary decree is reported to state that milk and beef from cloned animals will not have to be labeled as such!
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Feasting on clone lies far in future
Experts say it's too expensive, customers not ready for change
By BEN van der MEER
BEE STAFF WRITER
December 29, 2006
http://www.modbee.com/local/v-dp_morning/story/13151171p-13796729c.html
Informant: binstock
http://freepage.twoday.net/search?q=cloned+animals
http://tinyurl.com/yy4hzr
http://tinyurl.com/y4thqn