Not Ready for Prime Time: FDA’s Flawed Assessment

Not Ready for Prime Time
FDA’s Flawed Approach to Assessing the Safety of Food from Animal Clones


Last December, the Food and Drug Administration (FDA) announced it had completed its “risk assessment” (i) on food from animal clones, and stated that it would soon approve the use of clones for food. But a close reading finds that the Agency’s assessment lacks a rigorous food safety analysis. The Center for Food Safety’s report, “Not Ready for Prime Time: FDA’s Flawed Approach to Assessing the Safety of Food from Animal Clones” critically analyzes FDA’s risk assessment and finds that it is based on unsubstantiated assumptions, misreported findings, and flawed analyses of scientific research.

In light of the findings in its report, summarized below, The Center is calling on FDA to enact a mandatory ban on the use of clones in food production until long-term studies have demonstrated that the food safety problems and animal welfare issues in cloning have been resolved, and until the troubling ethical questions about the technology have been adequately addressed through broad public discussions and debate.

Summary of Findings
1. FDA concludes that there is “no difference” between food from clones and their progeny and food from naturally-bred animals.

But FDA’s risk assessment found virtually no direct food safety studies to support this conclusion. For example:
• FDA found no peer-reviewed studies on meat from cloned cattle or on milk or meat from the offspring of cow clones.
• FDA found no peer-reviewed studies on meat from cloned pigs or their offspring.
• FDA found no peer-reviewed studies on meat or milk from cloned goats or their offspring.
• FDA found just three peer-reviewed studies on milk from cloned cows; all three studies showed differences in milk from clones that should have prompted further research.

2. FDA argues that cloning produces identical “twins” and that cloning is needed to reproduce the best animals for milk and meat quality. But studies show that clones from the same line often display traits different than their donor and/or each other. Cloning is promoted as a way to reproduce the fittest livestock, but FDA’s review shows that even
“healthy” clones are often underweight or grossly overweight, have more health problems, and produce fewer and less fit offspring than natural animals. A recent scientific review stated “clones are not exact copies of an already existing animal…doubts were therefore raised both from a scientific and breeder perspective as to whether the technology could
produce copies of animals with desired traits for the breeding industry.”(ii)

3. FDA argues that defects in clones will not pose food safety hazards since defective animals will be removed from the food supply.

But scientists have found that defects in clones can be hidden and undetectable, and could pose food safety risks.iii FDA also admits that even young clones that fall sick or die early could in some circumstances “be sent into the food supply,”iv and that some health problems found in clones “are not conditions that typically exclude animals from food

4. FDA argues that health defects do not pose problems in older clones, but only in younger cloned animals that would not be used for food.

But FDA’s risk assessment clearly demonstrates that most studies have looked only at younger clones. For mature animals- the period of the highest food risk- the Agency found “little information” on cow clones,(vi) and “no reports” at all on pig clones.vii FDA ignored vast evidence showing problems in clones at all ages. In fact, cloning scientists have seen sudden illnesses and/or deaths in adult clones so often that one
has termed it “adult clone sudden death syndrome.”(viii)

5. FDA argues that defects in cloned animals are seen in all other reproductive techniques, and differ in clones only by degree.

But FDA regulators admitted that the Agency had little evidence to support this conclusion.ix Furthermore, the massive difference in degree between the incidences of defects in clones versus natural animals is cause for serious concern. For example, the rate of hydrops, an abnormality that can lead to stillborn animals, early death, and/or death of the surrogate cow, is as high as 42% in cloning, but occurs only 1 in 7500 cases in other methods.x Following the Agency’s logic, a disease that causes cancer in 1 out of 2.5 patients is no different than one with a cancer rate of 1 out of 7500.

6. FDA argues that the cloning technology is improving, as the methods and science advances, and thus harmful outcomes for cloned animals are decreasing.

But a 2005 scientific review found that “The success rates [in cloning] remain low (less than 5%) no matter what [the] methodology.”(xi) Data reported by FDA shows that survival rates for clones in the most recent studies are actually lower than the rate in earlier studies.

7. FDA argues that progeny, not clones, will be used for food and that that the reproduction of progeny “corrects” the common defects found in clones.

But a 2004 paper by the National Academy of Sciences questions the certainty of FDA’s assumption, stating “Little evidence is available in the scientific literature to assess whether the progeny of cloned animals are at increased risk for inherited or developmental defects.”(xii) In its assessment, FDA misleadingly downplays or omits evidence that some abnormalities in clones have been reproduced in clones’ progeny.(xiii)

8. FDA has stated that it will not require labels on food from animal clones.

But a 2004 National Academy of Sciences study noted that a national system to identify and track food from animal clones “must be implemented” before cloned foods are marketed.

In conclusion, FDA’s risk assessment falls far short of providing the type of rigorous scientific assessment needed to confidently make this important decision about whether to allow cloned animals and their progeny in food.

Given the substantial unresolved food safety risks and the disturbing animal cruelty and ethical concerns that remain outstanding, the Center for Food Safety calls on FDA to institute a mandatory ban on the use of clones in food production until the aforementioned issues can be resolved.

(i_ Food and Drug Administration (2006). “Animal Cloning: A Draft Risk Assessment.” December 28, 2006. (hereafter referred to as
(ii) Geir Tveit & Peter Sandøe (eds) (2005), “The Science and Technology of Farm Animal Cloning: A review of the state of the art of the science, the technology, the problems and the possibilities.” Danish Centre for Bioethics and Risk Assessment, project report 6, online at, p. 24
(iii) NAS (2004), p. 222-228
(iv) FDA RA, Appendix E, p. E-29
(v) FDA RA, Appendix E, p. E-13
(vi) FDA RA, p. 225-6
(vii) FDA RA, p.163
(viii) Jerry Yang, University of Connecticut, quoted in Sherry Morse, “Pig Heart Attacks Raise New Fears About Cloning,” 2003 Animal
News Center, Inc., online at
(ix) Larisa Rudenko and John C. Matheson (2007). “The US FDA and animal cloning: Risk and regulatory approach.” Theriogenology 67, 198–206
(x) FDA RA, p. 111
(xi) Geir Tveit & Peter Sandøe (eds) (2005). Note 7, p. 11
(xii) National Academy of Sciences (2004). afety of Genetically Engineered Foods: Approaches to Assessing Unintended Health Effects.
Subreport: Methods and Mechanisms of Genetic Manipulation and Cloning of Animals, p. 222.
(xiii) Betts, (2005). “Telomere Length Analysis in Goat Clones and Their Offspring.” Molecular Reproduction and Development, 72: 461-470; Rakyan, et. al. (2003) “Transgenerational inheritance of epigenetic states at the murine AxinFu allele
occurs after maternal and paternal transmission.” PNAS, vol. 100, no. 5, 2538-2543



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