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NEW: Friends of Animals Comments to the FDA on Cloned Animal Grocery Products (March-06-2007)

Comments on the Food and Drug Administration’s

2007 Draft Documents on the Safety of Animal Clones

Submission from: Friends of Animals, Inc., 777 Post Road, Darien, Conn. 06820

To: U.S. Food and Drug Administration (FDA)
Date: 6 March 2007

Docket number: 2003N-0573

I. INTRODUCTION

This comment represents the views and concerns of Friends of Animals (“FoA”). Established in 1957 as a non-profit corporation in the state of New York, FoA addresses several areas of research, advocacy, and ethical education, including global climate and food supply issues, genetic engineering, and the moral and legal status of nonhuman animals.

The U.S. Food and Drug Administration (“FDA”) has issued three documents on the safety of animal cloning -- a draft risk assessment; a proposed risk management plan; and a draft guidance for industry.

Examining breeding techniques, animal health, and food consumption risks, the FDA draws conclusions aligned with those of the 2002 National Academy of Science report, which concluded that products derived from cloned animals do not “present a food safety concern,” a conclusion which the FDA tentatively approved in 2003, but from which it notably retreated after its own advisory panel found insufficient scientific agreement.

In this submission we formally respond to the documents, collectively known as the Draft Documents on the Safety of Animal Clones (“FDA Draft Documents”). We oppose FDA approval of products from any cloned animals and their offspring, for the reasons stated herein.

II. IMPACT ON THE NONHUMAN SUBJECTS: CLAIMS AND REALITIES

The proposed risk management plan addresses the risks that cloning poses to the animals involved. It finds that these risks all have been observed in other breeding technologies already in use in animal agribusiness. The FDA’s draft risk assessment downplays both the novelty and the manipulative character of cloning by referring to an animal clone as “a genetic copy of a donor animal, similar to identical twins but born at different times.”1

In reality, the production of clones is radically different from the natural occurrence of twins. Cloning represents a new level of control over living beings, by an insular group of allies from laboratories and corporate settings. Moreover, to call the risks of cloning similar to those common in current agribusiness is, in our view, disingenuous. Cloning undeniably causes additional and severe suffering in many of the surrogate mothers and in the clones, who face disproportionate and dramatic risks of deformities, organ failure and stillbirth.2

As recently as July 2005, scientists at Texas A&M University, deemed the world’s leading cloning team, acknowledged that 95 to 99 percent of cloning procedures resulted in failures. 3Of A&M's surviving cloned animals deemed healthy, researchers themselves have acknowledged uncertainty about whether they'll have problems later. Mark Westhusin, A&M’s lead cloning researcher, has stated: “It's slow, painstaking work to get little bitty pieces of information that you hope will one day help and improve the technology.” 4Yet the FDA suggests to the public -- based on reports that integrate large amounts of information presented from two interested companies -- that these uncertainties have been tidily resolved.

The hype on the cloning companies’ websites is telling. “Cloning enhances animal wellbeing,” declares the Biotechnology Industry Organization; and Clonesafety.org, sponsored by cloning firms Cyagra, stART Licensing, and ViaGen, Inc., assures us: “In fact, clones are the ‘rock stars’ of the barnyard, and therefore are treated like royalty.” Notwithstanding such absurdities, the FDA’s draft risk assessment relies substantially on the work of these same cloning corporations.5

The proposed risk management plan further suggests that the FDA would work with scientific and professional societies with expertise in animal health and reproduction to develop care standards for animals involved in cloning. Applied to the cloned animals themselves, however, the term “care” is oxymoronic. The FDA itself acknowledges that this approval would involve “technology early in its development”; 6that “cloning has been accomplished in relatively few species”;7 and that cloned animals are susceptible to birth defects and life-threatening problems, 8but dismisses the issue, insisting that clones surviving to reproductive age “appear to be normal in all of the measures that have thus far been investigated, and appear to give rise to healthy, apparently normal progeny”9 and that normal federal inspections will keep problems out of the food supply.10

There is no serious framework to deal with harm caused to the cows, calves, pigs, and piglets, and goats treated as experimental subjects in this process, or the harm that is and will continue to be visited on other animals such as the sheep and chickens presumably next to be considered for such approvals, to mice, also used in related experiments,11 or to animals in future generations, once out of the labs. Nor could there be. In reality, applying federal regulations to cloning would settle the matter to the animals’ detriment, because the law takes for granted that any use it codifies is acceptable. Regulating the relevant procedures does not mitigate the harm that cloning imposes.12

III. PRIMARY DRIVE BEHIND LIFTING MORATORIUM INVOLVES ADVANCING A FEW INVESTORS’ INTERESTS AT THE EXPENSE OF THE PUBLIC INTEREST

The mission of the FDA is to “promote the public health by promptly and efficiently reviewing clinical research and taking appropriate action on the marketing of regulated products in a timely manner.” 13 Thus, the core of the FDA’s duty is to promote the public health.

Yet t he key interest promoted by the Draft Documents is that of a handful of companies. Prairie State Semen Inc. of Illinois wants a green light to ship out the semen of cloned show pigs 14 Backed by a billionaire investor, the cloning company ViaGen of Austin, Texas is expected to benefit most from a positive FDA ruling.15The company website showcases clones of animals such as the “legendary barrel racing champion Scamper,” and “Kung Fu, the mother of many famous rodeo bulls.”16 About the FDA Draft Documents on cloned animal products for the retail market, the president of ViaGen has been publicly quoted saying "I think that this draft is going to provide the industry the comfort it needs."17

In its draft guidance for industry, which addresses the use of food and feed products derived from cloning procedures, the FDA recommends no special measures. CVM director Stephen F. Sundlof states that “the draft risk assessment has determined that meat and milk from clones and their offspring are as safe as food we eat every day.”18

Even if we were to accept that determination for the sake of argument, it’s not the real question at issue; nor would regulations or a ruling on labels offer a real solution. The issue isn’t whether people have an option to reject cloned products; people never asked for them. This process is result-oriented, not oriented to consumer well-being, and, under the guise of the promotion of health, it is being foisted on the U.S. public.19According to a widely cited series of polls (up to date as of December 2006) carried by the Pew Initiative on Food and Biotechnology, at least 60% of that public are uncomfortable with animal cloning.20

Dr. Larisa Rudenko, a molecular biologist and risk assessor in the FDA’s Center for Veterinary Medicine (“CVM”), has said, regarding particularly disease-resistant animals, “You can expand that genome through cloning, and then breed that resistance into the overall population and help eliminate major diseases in livestock.”21 Citing that statement, an article in the FDA Consumer states, “Cloning has the potential to improve the welfare of farm animals by eliminating pain and suffering from disease.”22

The claim that more manipulation is best for animal welfare replicates claims of the biotechnology industry itself, which, for example, has declared, “Because breeding the best possible stock improves the over-all health and disease resistance of animal populations, cloning should reduce animal suffering over time.”23

The key interest here is not animal welfare, but the welfare of corporate interests. And the health such work promotes is the health of industry; it does not advance the most healthful human diet or the health of the North American ecology.24

IV. CONCLUSION

As noted above, the interests represented by the research assessed in the Draft Documents are poised in conflict with important public interests. The FDA lacks authority to address the ethics of animal cloning; yet the issue of cloned animals has enormous ethical ramifications—with regard to human health, the state of the world’s ecology, and the interests of nonhuman animals.

Dr. Sundlof has acknowledged that "the release of the draft risk assessment and proposed risk management plan marks the beginning of our interaction with the public on these issues,” and thus the FDA is “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."25 The FDA has invested some eight years of cumulative time into producing the documents on which the public has only 90 days to comment. The FDA has a widely reported interest in lifting the moratorium at the end of this period. But c onsideration of the public’s comments should not be folded into a rubber-stamping exercise.

Moreover, were the FDA’s report adopted, the United States will be the first country to approve animal cloning in food production, putting pressure on the international community to adjust to new commercial realities and ethical questions, yet in which they lacked a meaningful opportunity to participate.

Global society has not provided a consensus that conscious beings should be the objects of such applications.26We strongly urge that that they should not be. Gaining strength in the national and global view are moral concerns about the value of nonhuman individuals, not as resources, but on their own terms. This concern is not antithetical to science. Scientists are well aware that humans are part of a biocommunity, not set apart from it.27

In summary, implicated here are multiple questions whose answers can only be found at a deeper level than a regulatory body can reach, the most fundamental being: Why clone at all? It’s precisely because the FDA cannot answer this question (and many others) that any approval by the FDA of cloning for the retail market will indeed, to some degree, be a result-oriented exercise. Such an acceptance would permit this decision to evade review at the most important level of the question.

There is no clear reason, apart from the advancement of profit, for the moratorium on the sales of clones’ milk and flesh which has applied since 2001 to be lifted today. It is the position of Friends of Animals, therefore, that the FDA should not lift the moratorium on the cloning of animals for the retail market.

 

Submitted by Lee Hall,
Legal Director,
Friends of Animals;
6 March 2007.

  • 1. See “ FDA Issues Draft Documents on the Safety of Animal Clones,” FDA News (28 Dec. 2006), (last visited 2 Mar. 2007).
  • 2. See P. Loi et al., “ Placental Abnormalities Associated With Post-Natal Mortality in Sheep Somatic Cell Clones, ” Theriogenology (Apr. 2006); Juan A. Lozano, “Texas A&M Leads World in Cloning Animals” (Associated Press, 17 Jul. 2005) (observing that a Texas A&M study released in 2002 documented a 94 percent failure rate in efforts to clone pigs, and describing fatally deformed piglets).
  • 3. Similar news has emerged from recent reports in Japan, where somatic cell cloned cattle continue to show many abnormalities. See Citizens' Biotechnology Information Center, Bio Journal ( Japan, Jan 2006); (last visited 2 Mar. 2007). The summary states that the data on cloned animals up to late 2005 shows 474 somatic cell cloned cattle born -- 72 stillbirths, 80 dying immediately following birth, 102 with fatal illnesses, and only 104 survivors, showing that “abnormality has now become the norm.”
  • 4. Scientists at Texas A&M University indicate that failures in cloning procedures are the norm. Lozano, “Texas A&M Leads World in Cloning Animals” (note 2 above) (citing Mark Westhusin, lead researcher of the A&M cloning team, specializing in embryonic transfer).
  • 5. See, e.g., Appendix E: The Cyagra Dataset ; Appendix E(b): Addendum to the Cyagra Dataset; Appendix F: The Viagen Dataset; Appendix F(b): Raw Data from the Viagen Dataset.
  • 6. U.S. FDA’s “Animal Cloning: A Draft Risk Assessment, Chapter VII, Summary and Conclusions.
  • 7. Ibid.
  • 8. U.S. FDA’s “Animal Cloning: A Draft Risk Assessment, Chapter VII, Summary and Conclusions (discussing Large Offspring Syndrome, edema, abnormalities of the lungs and other parts of the body, and cardiovascular and respiratory problems, and stating that in cattle and sheep the “incidence of these adverse outcomes appears to be higher in clones than in other forms” of breeding technologies).
  • 9. See U.S. FDA’s “Animal Cloning: A Draft Risk Assessment, Chapter VII, Summary and Conclusions.
  • 10. See Guideline No. 179, Guidance for Industry Use of Edible Products From Animal Clones or Their Progeny for Human Food or Animal Feed (28 Dec. 2006).
  • 11. See U.S. FDA’s “Animal Cloning: A Draft Risk Assessment” at Chapter V, Animal Health Risks.
  • 12. Nor will there be recourse to animal cruelty statues, for such laws have traditionally had no bearing on industrially useful practices, no matter how painful. Cruelty prosecutions are reserved for unusual cases of gratuitous harm. Animal cruelty laws come down to offending the norm, and a high failure rate in cloning is the norm
  • 13. Federal Food, Drug and Cosmetic Act: FDA Mission. Section 903 (21 U.S.C. 393).
  • 14. “ Clone-Generated Milk, Meat May Be Approved; Favorable FDA Ruling Seen as Imminent” The Washington Post (6 Oct. 2005).
  • 15. Paul Elias, “Cloned Food Years From Shelves: FDA Approval Spurs Companies' Hopes” (Associated Press, 2 Jan. 2007); (last visited 2 Mar. 2007).
  • 16. “ViaGen: About Us,” available: (last visited 2 Mar. 2007).
  • 17. A. Pollack and A. Martin, “F.D.A. Says Food From Cloned Animals Is Safe,” New York Times (29 Dec. 2006) (quoting Mark Walton, president of ViaGen).
  • 18. According to the U.S. FDA’s Center for Veterinary Medicine: “The agency believes that food products from clone progeny are suitable to enter the food and feed supply under the same controls as applied to any animal that is the product of sexual reproduction. Therefore, FDA does not have recommendations for any additional measures related to the use of the progeny of clones for the production of food for humans or feed for animals that are based on the fact that these are progeny of clones.” Guideline No. 179, Guidance for Industry Use of Edible Products From Animal Clones or Their Progeny for Human Food or Animal Feed (28 Dec. 2006).
  • 19. Even the FDA’s moratorium on cloned products in the food supply has been voluntary, and it has it has recently become clear that a few offspring of cloned pigs and cows are already trickling into the food supply. See “ Clone-Generated Milk, Meat May Be Approved; Favorable FDA Ruling Seen as Imminent,” Washington Post (6 Oct. 2005) . The FDA's Sundlof has written that FDA had heard of clone progeny moving into the food supply, but was "not aware of any proof." Ibid. Yet Wisconsin dairy farmer Bob Schauf feeds the milk of cloned Holstein cattle to family members and employees. Frederic J. Frommer, “Would You Drink Milk from a Cloned Cow?” (Associated Press, 11 Jul. 2005).
  • 20. Not mentioned by the FDA is the reality that consuming any animal products, let alone cloned ones, is wholly unnecessary and probably problematic to human health. See, e.g., “Vegetarian Diets: Position Statement of The American Dietetic Association.” According to the Association, “[s]cientific data suggest positive relationships between a vegetarian diet and reduced risk for several chronic degenerative diseases and conditions, including obesity, coronary artery disease, hypertension, diabetes mellitus, and some types of cancer.” Underscoring the imprudence of the FDA’s drive to approve cloning, thereby to advance and promote animal agribusiness, is the United Nations’ recent report with its conclusion that this sector is responsible for more greenhouse emissions than the transport sector. See H. Steinfeld et al., “Livestock’s Long Shadow: Environmental Issues and Options” (United Nations Food and Agriculture Organization, 2006), (last visited 2 Mar. 2007).
  • 21. Linda Bren, “ Cloning: Revolution or Evolution in Animal Production?” FDA Consumer (1 May 2003), available on ViaGen’s website at: (last visited 21 Jan 2007); also available on the U.S. FDA website, at (last visited 1 Mar. 2007).Texas A&M researchers are trying to create animals resistant to disease, particularly foot-and-mouth and mad cow disease. See Lozano, “Texas A&M Leads World in Cloning Animals” (note 2 above). If such resistance is obtained, it may be a double-edged sword. If the cloning decreases genetic diversity, it may make animals less susceptible to current diseases, but then make the animals vulnerable to new diseases, potentially affecting the surrounding natural biocommunity as well. See Susanne Quick, “Cloning's Promise Unfulfilled in Farming,” Milwaukee Journal-Sentinel Online, Health and Science section, (last visited 2 Mar. 2007) (noting that cloning could make whole herds susceptible to new diseases).
  • 22. See Linda Bren,, “ Cloning: Revolution or Evolution in Animal Production?” (note 20 above).
  • 23. See CloneSafety.org, “FAQs” [Frequently Asked Questions]; (last visited 21 Jan 2007). The website CloneSafety.org is sponsored, according to the “About Us” section of the site, “by Cyagra, stART Licensing, and ViaGen, Inc., the world's premier animal cloning and livestock genetics companies, in cooperation with the Biotechnology Industry Organization and leading scientists.”
  • 24. See note 20 above.
  • 25. See “ FDA Issues Draft Documents on the Safety of Animal Clones” (note 1 above).
  • 26. A 2002 Gallup poll found that 66 percent of U.S. consumers said that cloning animals was “morally wrong.'' See Frederic J. Frommer, “Would You Drink Milk from a Cloned Cow?” (Associated Press, 11 Jul. 2005).
  • 27. Underscoring the point that no firm ethical line between humans and all other conscious life has been drawn, when a panel of 22 scientists, lawyers, and philosophers recently debated, for more than a year, the wisdom of inserting human stem cells into monkey brains, the team's scientists weren't sure how to ethically separate humans from other primates. The report's lead author is Mark Greene, formerly of Johns Hopkins University and since then a professor at the University of Delaware. A brief summary in lay terms is supplied in Robert Roy Britt, “Stem Cell Research With Monkeys Sparks Debate: Grafting Human Cells Into Animals’ Brains Seen Having Ethical Ramifications,” LiveScience(14 Jul. 2005), (Last visited 1 Mar. 2007). At least in reference to primates, the panel’s conclusions, reported in the July 15 issue of the journal Science, cast significant uncertainty on any suggestion that the mainstream research position on the intrinsic value of nonhumans means no ethical consideration applies to decisions about whether to clone nonhuman animals for the advancement of human profit.