From the archive, originally posted by: [ spectre ]

Meat, milk from cloned animals OK’d
FDA study says it needs no labels
by Karen Kaplan /  December 24, 2006

“A long-awaited study by US scientists has concluded that meat and milk from cloned animals and their offspring are safe to eat and drink and should be allowed to enter the food supply without any special labeling. The finding is a strong signal that the Food and Drug Administration will endorse the use of cloning technology for cattle, goats, and pigs when it publishes a key safety assessment intended to clear the way for formal approval of the products. That assessment is expected this week. “All of the studies indicate that the composition of meat and milk from clones is within the compositional ranges of meat and milk consumed in the US,” the FDA scientists concluded in a report published in the Jan. 1 issue of the journal Theriogenology, which focuses on animal reproduction. The study, however, prompted a sharp reaction from food safety advocates. The FDA “has been trying to foist this bad science on us for several years,” said Andrew Kimbrell, executive director of the nonprofit Center for Food Safety in Washington. “When there is so much concern among so many Americans, this is really a rush to judgment.”

Many ranchers and dairy producers have already cloned animals for meat and milk production, but a voluntary moratorium initiated about five years ago by the FDA has largely kept them and their offspring out of grocery stores and restaurants. However, ranchers say there is no doubt that some of the animals taken to slaughterhouses in the past couple of years have been fathered by clones. “There’s been lots and lots of them that went into the food chain,” said Larry Coleman, who raises limousin cattle in Charlo, Mont., and has made five clones of his prize bull, named First Down. He estimated that at least 10 of their offspring have wound up on dinner tables. Since Dolly the sheep was cloned in 1996, agricultural scientists have imagined a time when they could dispense with the uncertainties of conventional breeding and make exact copies of their best animals. Cows were cloned in 1998 and pigs followed in 2000. Consumers greeted the news with a combination of amazement and revulsion.

Cloning involves removing the nucleus from a donor egg and replacing it with DNA from a prized animal. If all goes well, a tiny electric shock induces the egg to grow into a genetic copy of the original animal. Scientists often refer to clones as identical twins born at a different time. The FDA sees cloning as a natural extension of the livestock reproductive technologies — such as artificial insemination and in vitro fertilization — that have become routine, said spokesman Doug Arbesfeld. Though cloning is expensive — Coleman paid $60,000 to clone First Down — producers have embraced it for the efficiencies it can bring to a farm or ranch. If a particular bull consistently produces strong offspring or a dairy cow is an unusually prolific milk producer, those advantages can be multiplied with clones.

But a study released this month by the Pew Initiative on Food and Biotechnology found that 64 percent of Americans are uncomfortable with animal cloning and that 43 percent believe food from clones is unsafe. Safety isn’t the only concern among consumers. Carol Tucker Foreman, director of the Food Policy Institute at the Consumer Federation of America, based in Washington, said the primary issue is that the food should be labeled so consumers can avoid products derived from clones if they wish. “I should have freedom not to spend my money and not to eat products that offend me,” she said. “Some people only drink free trade coffee. Others only choose organic food. Others choose halal or kosher food. This product, which causes great discomfort to a great number of people, goes on the market with no labeling that enables me to make a choice.” The FDA scientists who wrote the paper, Larisa Rudenko and John C. Matheson, concluded there was no basis for flagging the meat and milk products or for treating them differently than other food products. “The US food safety system is designed to screen meat and milk for hazards, regardless of the means by which the animals were derived,” they wrote. “There is no science-based reason to apply additional safeguards.”

The paper relies on dozens of studies from around the world, many of which examined genetic and health problems in cloned animals and the risks to surrogate mothers that carry cloned embryos to term. The scientists also analyzed 13 studies on the composition of meat and milk from clones and their offspring. Vitamins, minerals, proteins, fat, and other content showed no “nutritionally or toxicologically important differences,” they concluded. Skeptics remain unconvinced. Kimbrell, of the Center for Food Safety, said too few animals have been cloned to conclude that they are safe to eat. He also said more independent research is needed. Senator Dianne Feinstein, Democrat of California, and six other senators sent a letter recently to Health and Human Services Secretary Mike Leavitt, whose department includes the FDA, asking that he require a more thorough review of the available scientific data.”

Larisa Rudenko
larisa [dot] rudenko [at] fda [dot] hhs [dot] gov

published online 23 October 2006.

“The Food and Drug Administration’s (FDA’s) Center for Veterinary Medicine issued a voluntary request to producers of livestock clones not to introduce food from clones or their progeny into commerce until the agency had assessed whether production of cattle, swine, sheep, or goats by somatic cell nuclear transfer (SCNT) posed any unique risks to the animal(s) involved in the process, humans, or other animals by consuming food from those animals, compared with any other assisted reproductive technology (ART) currently in use. Following a comprehensive review, no anomalies were observed in animals produced by cloning that have not also been observed in animals produced by other ARTs and natural mating. Further systematic review on the health of, and composition of meat and milk from, cattle, swine, and goat clones and the progeny of cattle and sheep did not result in the identification of any food-consumption hazards. The agency therefore concluded that food from cattle, swine, and goat clones was as safe to eat as food from animals of those species derived by conventional means. The agency also concluded that food from the progeny of the clone of any species normally consumed for food is as safe to eat as those animals. The article also describes the methodology used by the agency to analyze data and draw these conclusions, the plans the agency has proposed to manage any identified risks, and the risk communication approaches the agency has used.”

Despite Lack of Science and Strong Public Concern, FDA Expected to OK
Food From Cloned Animals / December 26, 2006

“The U.S. Food and Drug Administration (FDA) is expected later this week to release a preliminary safety assessment that clears the way for marketing of meat and dairy products from cloned animals for human consumption. The assessment and the agency’s expected endorsement of cloned food comes despite widespread concern among scientists and food safety advocates over the safety of such products. The move to market cloned milk and meat also flies in the face of dairy and food industry concern and recent consumer opinion polls showing that most Americans do not want these experimental foods. “Instead of doing its job, the Bush FDA has ignored the science and fast-tracked this decision for the benefit of a few cloning companies,”said Joseph Mendelson, Legal Director for the Center for Food Safety (CFS). “This is a lose-lose situation for consumers and the dairy industry.”

The FDA action follows the recent news that the agency has refused to investigate health problems in animal clones on a U.S. dairy farm. Greg Wiles, whose Williamsport Maryland “Futuraland 2020″dairy was the first farm in the nation to have cloned cows, told FDA that one of his two cow clones was suffering from unexplained health problems. Wiles told Food Chemical News that the clone “just stopped growing…she just looks terrible,” but says that when he reported the problems to FDA and other federal officials, he was “paddled around like a tennis ball from agency to agency.”CFS has asked the Agriculture Department to intervene in the case to stop any sale and prohibit the slaughter of clones and their progeny for food.

In October, CFS, joined by a coalition of consumer, environmental and animal welfare organizations, filed a legal petition with the FDA seeking a moratorium on foods produced from cloned animals and establishment of mandatory rules for pre-market food safety and environmental review of cloned foods (see the petition HERE). The petition also requested that the Department of Health and Human Services establish a federal review committee to advise FDA on the ethical issues raised by animal cloning.

Recent opinion polls also show that Americans are overwhelmingly concerned about animal cloning for food production. A November 2006 food industry poll conducted by the International Food Information Council showed that 58% of Americans surveyed would be unlikely to buy meat or milk from animal clones even if FDA found such products to be safe. In the same poll, only 16% of Americans had a favorable opinion of animal cloning. A December 2006 poll by the Pew Initiative found that 64% of those polled were uncomfortable with animal cloning, with 43% saying that cloned food is unsafe, while another 36% felt unsure about cloned food safety.

The FDA’s action also follows growing opposition to the use of clones and their progeny for food products on Capitol Hill. In November, Senator Barbara Mikulski sent a letter to the FDA requesting a complete overview of how the agency came to its decision of using clones in food.  In early December, a bi-partisan group of seven senators led by Senator Patrick Leahy asked FDA to reconsider its assessment of cloned animals.   The International Dairy Foods Association, representing major dairies and food makers including Kraft, Nestle and others, also has opposed allowing products from cloned animals into the food supply at this time.

Cloning scientists have acknowledged that genetic abnormalities are common in clones, yet FDA failed to address how food safety and animal welfare concerns could be managed if cloning is widely adopted by the livestock industry. Some of the health and safety problems in animal cloning include:

* Surrogate mothers are treated with high doses of hormones; clones are often born with severely compromised immune systems and frequently receive massive doses of antibiotics. This opens an avenue for large amounts of veterinary pharmaceuticals to enter the human food supply;
* Imbalances in clones’ hormone, protein, and/or fat levels could compromise the quality and safety of meat and milk;
* The National Academy of Sciences warned that commercialization of cloned livestock for food production could increase the incidence of food-borne illnesses, such as E. coli infections;
* Cloning commonly results in high failure rates and defects such as intestinal blockages; diabetes; shortened tendons; deformed feet; weakened immune systems; dysfunctional hearts, brains, livers, and kidneys; respiratory distress; and circulatory problems.

“There is widespread concern among Americans, and scientific concern that cloned food may not be safe and that cloning will increase animal cruelty,”said Mendelson. “We intend to pursue our legal action to compel FDA to address the many unanswered questions around cloned food.”

Center for Food Safety’s Legal Petition and background documents are available HERE

Letter from Senator Patrick Leahy, et al  to Dept of Health and Human Services at

The International Food Information Council poll report and results are at

The Pew Initiative on Food and Biotechnology poll and results are at http://pewagbiotech.org/research/2006update/

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