United Poultry Concerns  

Animal Cloning and the FDA, November 2003


November 20, 2003
Number 35, Volume 2

1. The FDA'S Risk Assessment of Animal Cloning
2. Risks to Animals
3. Health Issues of Older Cloned Animals
4. Additional Animal Risk Concerns
5. Benefits to Animals
6. Food Safety
7 . The Offspring of Clones
8. Limited Information; Advisory Panel Response
9. FDA Reaction
10 Industry/Political Pressure
11 Ethical Issues
12 Genetic Engineering

Following the Halloween release of its preliminary risk assessment on animal cloning {1} , the Food and Drug Administration (FDA) conferred with its Veterinary Medicine Advisory Committee (VMAC) at a public meeting on Nov. 4th {2 (see also #4: http://tinyurl.com/v97e )}. The document, an 11-page draft executive summary of an estimated 300-page report on published studies and data submitted by cloning companies, assessed health risks to animals and potential food safety risks to humans {3}. It compared the risks of cloning to those of other "assisted reproduction technologies" (ARTs, e.g., artificial insemination), concluding that although risks to animals occur more frequently with cloning they are not different in type ("quality"). It also concluded, with relatively high confidence, that "Edible products from normal, healthy clones or their progeny do not appear to pose increased food consumption risks relative to comparable products from conventional animals"{1}. Last year, the National Academy of Sciences (NAS) Committee on Animal Biotechnology said that, although food from cloned animals posed a low level of food safety concern, it would be prudent to have more data. The committee deemed animal welfare to be a serious concern {4, 5 (see also #1 of: http://tinyurl.com/vbxx )}.

Among the risks to animals the FDA identified were: a high failure rate with clone embryos, oversized fetuses, a low frequency of live normal births, neonatal respiratory failure and heart disease {1, and see 7}. Most clones do not survive to birth, and of those who do many die within a few days. A Washington Post science reporter elaborated: "Many are monstrously overweight -- several times their normal size -- and filled with fluids to the point of looking like they're about to burst. Others are born with normal bodies but big, hideous, so-called ‘bull heads.' Others look okay on the outside but have peculiar abnormalities of the heart, lungs or other organs -- including livers that are mysteriously filled with fat -- or defective thymus glands that blunt normal development of the animals' immune systems"{6}. Earlier, the FDA had noted that repeatedly subjecting individual animals to invasive procedures in order to obtain eggs for cloning is likely to cause them pain and distress {7}. Large Offspring Syndrome also puts the females used to gestate cattle and sheep clones at increased risk for difficult pregnancies and caesarean sections {1}. Other health problems in cloned animals include pneumonia, brain lesions, skeletal malformations, and underdeveloped blood systems {8 (and see #4: http://tinyurl.com/v97e )}. At the meeting, in response to the FDA's claim that the frequency of live normal births appears to be increasing as cloning technology advances, Dr. Michael Appleby of The Humane Society of the U.S. stated: "Yes, it is increasing from very, very bad to very bad" {8}.

While the report noted that some cloned animals have also died during the juvenile period from congenital abnormalities or failure to thrive, the FDA stated: "By the time clones reach adolescence, however, anomalies that may have been noted at birth are generally resolved and the clones are as normal and healthy as their conventional counterparts"{4}. Others, however, including New Scientist magazine, report that many cloned animals have abnormalities that are not initially apparent. Evidence shows that cloned animals -including Dolly, the famous cloned sheep- have shorter lifespans and are more susceptible to disease {9}. For example, even among bovine clones who survived the neonatal period, one-third of them died by the age of one year {8}. Michael Hansen, with the Consumer Policy Institute, cited a study that found cloned mice appeared to have an immune system defect. The study suggested that some effects of cloning are not apparent in the days, weeks or even years after birth. Hansen said that conclusions about the normalcy of surviving cloned animals need to be based on detailed molecular analyses of tissue from adult cloned animals rather than superficial clinical examinations {10, and see 23}. Both Appleby and Hansen called attention to a relatively recent case not mentioned by the FDA in which 3 cloned pigs died of heart failure just prior to reaching 6 months of age. The lead scientist in the study said "It was totally shocking," and dubbed the fatalities "Adult Clone Sudden Death Syndrome." The novel cloning method that had been used resulted in 2-3 times more animals surviving the initial few days of growth than had been achieved with other methods {11}.

Richard Wood of Food Animal Concerns Trust (FACT), a consumer advocate on the panel, questioned the appropriateness of using ARTs as a benchmark instead of comparing conventional breeding {12}. According to a review article on cloning, the proportion of embryos which developed to become live young was between 0 & 4%, a figure far lower than that for other ARTs {10}. Appleby pointed out that currently employed artificial selection methods have contributed to numerous production-related diseases, such as mastitis in cows, skeletal problems in chickens and turkeys, osteoporosis in hens, and stress susceptibility in pigs. Cloning would exacerbate this by copying the animals in which these problems are the worst, those with maximum production. (According to a professor at Texas A&M , many cloned animals have not been as "high performance" as those whom they have been cloned from {13}.) He also cautioned against equating increased production with improved production {8}.

The FDA found no differences in overall behavior of juvenile and adult animal clones compared to non-cloned animals {4}. However, researchers at North Carolina State University have reported that cloned animals can have the same degree of variability in both physical appearance and behavior as do normally bred animals {14}.

The FDA said cloning has the potential to improve the welfare of farmed animals by eliminating pain and suffering from disease by selecting for disease-resistance {7}. However, some scientists warn that large populations of cloned animals could hinder disease control. Dr. Peter Rosset of the Institute for Food and Development Policy explains "Putting cloned animals in cramped quarters in a factory farm runs counter to the basic epidemiology of disease control" {9}. When asked to comment on this, a spokesperson for the Biotechnology Industry Organization responded "We don't have a whole lot of information on that yet. We usually look to the FDA"{9}. Reducing the number of unwanted animals was presented as another benefit of cloning by, for example, ensuring the creation of animals of a specific gender {7}.

Due to the limited availability of data, the FDA based its decisions about the safety of cloned animals in the food supply on certain assumptions. It assumed that all clones and their products would be subjected to the same regulations as non-cloned animals. Therefore it only considered cloned animals who appeared healthy on the basis that local, state, and federal "rules exclude frankly malformed, diseased, and otherwise unhealthy animals from the human food supply." The agency based its determination that food from cloned animals is probably safe on the hypothesis that a healthy animal is likely to produce safe food products {1}. "[I]t's hard to imagine that healthy animals would somehow be capable of producing unsafe food," contended Stephen F. Sundlof, the director of the FDA's Center for Veterinary Medicine. "No scientist I've talked to can come up with any rational theory of how that could possibly occur," he said {5}. The FDA report also noted that dying or euthanized clones who enter the food supply via rendering would not likely pose risks greater than those from non-cloned animals if they met all of the conditions imposed for them {1}.

Appleby corrected the FDA on its faulty assumption that sick animals do not get into the food supply (8, and see #4: http://tinyurl.com/vd7e ). Hansen called the FDA's assumptions "amazing leaps of logic," noting "If one agrees that an animal that looks healthy must be safe to eat, then we have no need of an entire HACCP [meat inspection] system, because all health hazards would be visible and obvious" {10}. Hansen also questioned the FDA's attention only to qualitative and not quantitative differences, noting that the assessment had not taken into account frequency and incidence of disease, bacterial infection, allergens, etc {3}. He reiterated the NAS assertion that stress from developmental problems associated with cloning could cause the shedding of pathogens in feces, resulting in higher contamination levels of meat from clones {12}.

While some farmed animal clones have produced offspring, very few have lived to reproductive age. The FDA assumes that any genetic abnormalities caused by cloning would not be passed on to clone offspring. Relying on biological assumptions, "limited but consistent" empirical observations of the species evaluated, and evidence from cloned mice, the agency further reasoned that edible products from the offspring of clones are likely to be as safe to eat as corresponding products from non-cloned animals {1}. Hansen disputed the normality of cloned animals' offspring by citing contrary published research {10}.

The VMAC panel was expected to rubber-stamp the agency's opinion on the safety of food from animal clones {15}. Instead, several were deeply troubled by the lack of scientific evidence supporting the report. "The assumption made was that there would be no problem, but they didn't present any real evidence one way or the other," one scientist on the panel said afterward. "Most of the data presented this week was based on the result of one company's work," he added {2}. Despite the high degree of confidence the FDA stated it had in its conclusions, the report acknowledged that much of its opinion was based on single, small studies with confounding factors, "compelling evidence" from experiments on mice, and biological assumptions. The agency had only one study on the composition of milk from cloned animals and none on meat {1, and see #2 of: http://tinyurl.com/o8k6 }. Industry groups also expressed concern, including the International Dairy Foods Association {16}, and a spokesperson for the National Food Processors Association who also pointed out that the FDA is relying on industry data generated by cloning companies {17}. Carol Tucker Foreman, with Consumer Federation of America, noted that no feeding studies have been done to realize the consequences of long-term consumption. Hansen admonished the FDA for "a risk assessment that appears to be based largely on speculation and scientific theory, not on data." He called the framework used for the assessment "highly questionable and unscientific"{15}.

According to The Washington Post, 8 of the 10 panel members concurred with the FDA opinion on the safety of animal products from animal clones, but the panel deadlocked 5:5 on whether the FDA had properly characterized the risks to animals {11}. According to The New York Times, the panel said there wasn't enough data to support the FDA's conclusion on either food safety or animal risk {3}. The Post reported: "Committee members called for a far more rigorous assessment of the risks and the potential level of suffering for cloned animals"{18}.

The FDA usually follows the guidance of its advisory panels but is not required to do so {18}. It still plans to make the complete risk assessment available for public comment before the end of the year. The agency is under pressure from the industry to treat meat and dairy products from animal clones and their offspring like conventional products rather than regulate them as it does drugs{2}. The budding cloning industry is not well financed, and several companies have already sold out or folded {18}. [One meeting attendee speculated aloud that the FDA announcement was intended to elicit a financial infusion for the industry.] It has vigorously fought expanded oversight by any agency {5}. If the FDA determines that cloning does not pose a hazard, food from cloned animals may not be subjected to special regulations {19}. (A staff report released in late October said the FDA's review had turned up no evidence that food derived from cloned animals should be regulated or even labeled {2, 20}.) The agency intends to also release a document by next spring on the potential marketing [e.g., labeling] options of food from animal clones or their offspring {12}.

The agency has been criticized by scientists and others for making premature statements that have resulted in headlines proclaiming food from cloned animals to be safe {9, 8}. Foreman charged the FDA with putting cloning on the fast-track for approval despite widespread anti-cloning sentiment among the U.S. public {9}. "FDA prides itself on being a science driven agency but in this case it seems to have been driven by political pressure to promote animal cloning than to promote public health," she said {21}. (The biotechnology industry is closely aligned with the Bush administration {5}.) VMAC panel member Wood (see section 4) questioned whether the FDA is the only agency with the authority to regulate food derived from cloned animals {2}. There appears to be no federal law or policy empowering the government to prevent cloning on the basis of animal welfare concerns {18, 5}. Accommodating these concerns could require new legislation {5}. Appleby urged the FDA to investigate more effective mechanisms than the voluntary moratorium presently in place to prevent products from cloned animals being marketed {8}. Foreman and Hansen joined him is urging a brake on the technology.

In announcing the risk assessment, the FDA said that although the document did not specifically address ethical issues the agency was not overlooking them {4, 20}. Both Appleby and Foreman criticized the FDA for addressing food safety concerns without first having considered the ethical implications of cloning. The NAS report deemed it important for the government to recognize and address moral and social concerns raised by animal cloning {19, 21}. Most scientists, including some conducting animal cloning research, have ruled out reproductive cloning of humans as inherently dangerous given the poor health of other cloned animals {22, 11}. Appleby noted that the FDA has stated that if it found "human subjects are or would be exposed to an unreasonable and significant risk of illness or injury" it would be sufficient reason to put a study on clinical hold. He urged the agency to exert its authority to prevent unnecessary suffering by extending the same protection to animals {8}. In addition to the risks to animals, Appleby and Foreman pointed out that the U.S. is already glutted with meat and milk and is subsidizing production. They argue that the technology will only benefit large corporations while further exacerbating the loss of small farms, and that poor countries won't be able to afford it either {7, 9, 23}. Foreman called on the Bush administration to submit for broad public discussion questions addressing "the moral and ethical issues inherent in making basic changes in sentient beings" {5, 21}. Opinion polls have consistently shown that most Americans oppose animal cloning {21, see also #2: http://tinyurl.com/o8k6 }.

The FDA's determination on cloning will also guide future decisions on genetic engineering. (Cloning involves using cells of one animal to make a duplicate, whereas genetic engineering entails combining the genes of different animals/species) {7}.

1. "Animal Cloning: A Risk Assessment" (draft executive summary), The Food and Drug Administration, Oct. 31, 2003.
2. "More Clone Data Needed," The Scientist, Merrill Goozner, November 10, 2003.
3. "Panel Doubts Finding On Cloned-Food Safety," The New York Times, Elizabeth Olson, November 5, 2003.
4. "FDA Issues Draft Executive Summary of its Assessment of Safety of Animal Cloning," Food And Drug Administration, October 31, 2003.
5. "FDA Says Cloned Animals Are Safe as Food," Washington Post, Justin Gillis, October 31, 2003
http://tinyurl.com/vqxy or http://www.washingtonpost.com/ac2/wp-dyn?pagename=article&node=&contentId=A44602-2003Oct30&notFound=true
6. "At Stake on Your Table," The Washington Post, Rick Weiss, November 9, 2003.
7. "Cloning: Revolution or Evolution in Animal Production?" FDA Consumer Magazine, Linda Bren, May-June 2003.
8. Verbal and written comments to the FDA's Veterinary Medicine Advisory Committee consultation on cloning, The Humane Society of the United States, Dr. Michael Appleby (verbal comments co-written by Tamiko Thomas), November 9, 2003.
See also "HSUS Asks The FDA to Ban Sales of Products From Cloned Farm Animals," The Humane Society of the United States, October 9, 2002.
9. "Questions of Food Safety Dog Cloned Beef," Inter Press News Service, Nov. 11, 2003.
10. "Testimony Before the Veterinary Medicine Advisory Committee," Consumer Policy Institute, Michael K. Hansen, November 4, 2003.
11. "Adult Clones in Sudden Death Shock," Nature, Helen Pearson, 27 August 2003.
12. "Panel: Cloning Conclusion Premature," Newsday, Earl Lane, November 11, 2003.
13. "Sales of Cloned Cattle Multiply in Texas," Associated Press (USA Today), 11/3/2003.
14. "Cloned Pigs Differ from Originals in Looks and Behavior," North Carolina State University, April 14, 2003.
15. "Cloned Food: More Study Needed,"WebMD Medical News, Daniel J. DeNoon & Jeanie Lerche Davis (reviewed By Brunilda Nazario, MD), November 05, 2003.
16." IDFA Concern about Milk from Cloned Cows," US Ag Net, 11/06/2003. http://www.wisconsinagconnection.com/story-national.cfm?Id=1200&yr=2003
17. "FDA Panel: Data Not in on Safety of Clones' Meat," USA Today, Elizabeth Weise, November 5, 2003.
18. "FDA Panel Backs Cloning In Agriculture," Washington Post, Michael Barbaro and Justin Gillis, November 5, 2003.
19. "FDA: Food from Animal Clones Safe to Eat," Associated Press (CNN), October 31, 2003.
20. "Cloned Products Could Blend into Food Supply," The Los Angeles Times, James Gerstenzang, November 1, 2003.
http://tinyurl.com/tje5 or http://www.latimes.com/news/nationworld/nation/la-na-clone1nov01235430,1,585341.story?coll=la-headlines-nation-manual
21. "Statement of Carol Tucker Foreman Before the FDA VMAC Committee," Consumer Federation of America, November 4, 2003.
"CFA's Carol Tucker Foreman on FDA's Risk Assessment on Animal Cloning," Consumer Federation of America, October 31, 2003.
22. "Clone Products Okay to Eat," The Scientist, Jack Lucentini, Oct. 31, 2003. http://www.biomedcentral.com/news/20031031/04/
23. "Lots of Animals Cloned, but Nature Doesn't Make it Easy; Monkeys? Forget it," Associated Press (The News & Observer), Malcolm Ritter, Nov. 9, 2003.

Mary Finelli, Editor
Farmed Animal Watch is a free electronic news digest of information concerning farmed animal issues gleaned from an array of academic, industry, advocacy and mainstream media sources. Previous issues are archived at: http://www.FarmedAnimal.net

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