V. Recent FDA Proposal

Since the late 1990s, the FDA and the Center for Veterinary Medicine (“CVM”)138 have been examining the potential for using somatic cell nuclear transfer (“SCNT”) to produce animal clones.139 In particular, the FDA and CVM have sought to understand and discuss the safety and regulatory implications of cloned animals. To this end, CVM delegated to the National Academy of Sciences (“NAS”) the task of “performing an independent, scientific review of the available data on the safety of cloning, including holding a public meeting to identify science-based concerns and elicit data and information on clones and their food products from the scientific community.”140

As a precautionary measure, in July 2001, the CVM asked producers of milk and meat products derived from cloned animals to delay introducing their products into the market until all safety issues had been examined.141 In October 2002, the NAS published a report entitled Animal Biotechnology: Science-Based Concerns, which found “no evidence that food products derived from adult somatic cell clones or their progeny pose a hazard (i.e., there is no evidence that they present a food safety concern).”142 In late 2006, the FDA released its findings regarding the safety and regulatory concerns for cloned beef.

On December 28, 2006, the FDA released three documents discussing the safety of animal cloning: Animal Cloning: A Draft Risk Assessment (“DRA”);143 Animal Cloning: Proposed Risk Management Plan for Clones and Their Progeny (“PRMP”);144 and Draft Guidance for Industry: Use of Edible Products from Animal Clones or Their Progeny for Human Food or Animal Feed (“DGI”).145 The DRA, peer-reviewed by independent scientific experts, provides “extensive scientific information . . . on animal health and food consumption risks,”146 and ultimately concludes that food products from cloned animals are as safe to eat as those from non-cloned sources. The PRMP outlines steps the FDA might pursue in order to address and manage the risks to animal health resulting from the cloning process.147 Finally, the DGI offers guidance to ranchers and breeders of cloned animals regarding human consumption, and ultimately concludes that no special measures are needed at this time.148

A. DRA-“Cloned beef: Not materially different”

The DRA focuses exclusively on the safety of cloned food products and the risks to the clones themselves. The two objectives of the DRA are to determine “whether cloning poses any health risks to the animals involved in the cloning process”149 and “whether any hazards arise during the development of clones or their progeny that may pose food consumption risks.”150 The report makes no recommendations for managing the risk and provides no insight into ethical issues.151 Further, it does not discuss any potential circumstances in which the FDA might recommend the release of cloned animal food products for commercial use.152

Before analyzing a vast amount of scientific data, the DRA provides background information on cloning technology and general risk-assessment methodology. To assess the health of animal clones, the life cycle of the clones was broken into five distinct “developmental nodes”:153 pregnancy and parturition;154 perinatal period;155 juvenile development;156 reproductive development and function;157 and post-pubertal maturation and aging.158 Each node represents a different functional phase of the cloned animal's life cycle.159

Most of the complications that occurred in the study arose during the first two developmental nodes.160 During the pregnancy and parturition node, the most common complications were dystocia,161 hydrops,162 and high gestational mortality.163 During the perinatal node, the most common complications included Large Offspring Syndrome164 and post-natal mortality.165 Based on the data, post-natal mortality was concentrated in the perinatal period, usually within one month of birth, and post-natal mortality was higher in cloned animals than in animals produced using other assisted reproductive technologies.166 Outside the critical perinatal period, animal clones appear to develop normally.167 Data indicate that animals allowed to reach reproductive age are able to produce healthy offspring.168

Although the cloning process does increase the frequency of some animal health risks, most clones survive the perinatal period and develop into healthy animals, capable of producing healthy offspring.169 Currently, scientific data examining the health of clones in the third, fourth, and fifth development nodes are limited.170 Nonetheless, initial data suggest that clones “surviving the first 30 to 60 days postpartum are 'healthy and normal.'”171 The fertility and semen quality of clones appears to be comparable to the overall reproductiveness of conventional, non-cloned animals.172 Along similar lines, the progeny from clones “appear to grow and develop normally” as compared to the progeny of non-clones.173

To evaluate consumption risks to humans, the FDA established a two-prong analysis. The first prong, the Critical Biological Systems Approach, assumes as a hypothesis that a “healthy animal is likely to produce safe food products.”174 The second prong, Compositional Analysis Method, “assumes that food products from healthy animal clones and their progeny that are not materially different from corresponding products from conventional animals pose no additional risks.”175 Using the two-prong approach, the FDA considered whether eating meat or drinking milk from clones poses any additional risks compared with animals bred using other assisted reproduction technologies. The FDA concluded: “[A]nalysis of the composition of meat . . . and milk from bovine clones consistently indicates that there is no biologically relevant differences between the composition of food from clones . . . [and] food commonly consumed from these species on a daily basis.”176 This conclusion is supported by the fact that the progeny of clones, rather than the actual clones, comprises the overwhelming majority of clone-derived food products in the United States.177 Offspring of clones appear by every indication to be as healthy as cattle from conventional reproduction, meaning that the chance of any adverse human health effects is minimal.178

B. Proposed Risk Management Plan and Draft Guidance for Industry-“Cloned beef: No labels required”

Based on the findings in the DRA, the FDA issued the PRMP to discuss measures that might be undertaken to address current risks of cloned animals as well as future, potential risks. Like the DRA, the PRMP does not address ethical or non-science animal cloning issues.179 The PRMP recommends that no special regulatory action be taken with regard to: feed for animal consumption produced from cloned animals; food for human consumption from cloned animals; or food for human consumption from clone progeny.180 However, the FDA is required to conduct “continuing surveillance of the state of the science” including: monitoring additional health and food consumption data; reviewing new animal cloning technologies; consulting with clone producers; and maintaining awareness of the biology of animal clones and epigenetics.181

The DGI “describes FDA's recommendations regarding the introduction of edible products from animal clones and their progeny into the food and feed supply.”182 Consequently, the FDA concluded that there was “no science-based reason to recommend any additional safeguards”183 for human food derived from animal clones, and thus, the 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 . . . .”184 In other words, no labeling requirement is necessary.