Comments of the Competitive Enterprise Institute to the Food and Drug Administration Regarding the Agency’s Animal Cloning Draft

The Competitive Enterprise Institute (CEI) appreciates the opportunity to submit these comments regarding the Food and Drug Administration’s animal cloning Draft Risk Assessment, Proposed Risk Management Plan, and Draft Guidance for Industry.  CEI is a non-profit research and advocacy organization, and it has been extensively involved in issues of food safety, food labeling, novel food production technologies, and other issues of public health and consumer protection.

CEI commends the Food and Drug Administration (FDA) for its careful and thorough investigation into the human and animal health risks that may be associated with somatic cell nuclear transfer (cloning) applied to livestock.  In 2001, FDA requested that producers of animal clones voluntarily refrain from introducing live clones and their progeny, or edible products derived from them, into commerce, until the agency completed its risk assessment of the safety of such products.  In December 2006, FDA made public the draft risk assessment that resulted from this process, and concluded that there are no relevant differences between the safety of food from cloned animals or their progeny and that from other animals.  We now urge FDA to finalize the Risk Assessment, Risk Management Plan, and Guidance for Industry, and to move quickly and decisively to lift the voluntary moratorium on commercial sales of cloned animals and their progeny.  We also urge FDA to resist calls to require special consumer labeling for meat, milk, or other products derived from clones or their progeny.

I. FDA Should Lift the Moratorium on Commercial Sales of Cloned Animals

FDA’s Draft Risk Assessment is one of the most exhaustive food safety studies ever conducted.  The Center for Veterinary Medicine (CVM) analyzed more than 100 scientific studies on cloning from the U.S. and abroad, many of them peer reviewed and published in the scientific literature.  CVM also conducted an independent analysis of all of the available data relevant to assessing the health of clones and their progeny and the potential food consumption risks that may result from consuming meat, milk, and other edible products derived from these animals.  The draft risk assessment was then peer reviewed by an independent panel of scientific experts.

Ultimately, the draft risk assessment shows that there are no relevant differences between the safety of food from cloned animals or their progeny and other animals.  The report concluded that, while cloning poses some modest risks to the health of the animals involved, none of these risks is unique to cloning, and all have been observed previously in animals derived from both natural mating and other assisted reproduction techniques.  Most importantly, the health problems seen in some animal clones do not give rise to legitimate food safety concerns.  After concluding a detailed evaluation of various health measures of individual clone animals, and of the composition of meat and milk derived from clones, no compositional changes that could pose food safety risks were identified.

Because extensive scientific research has provided no meaningful basis for questioning the safety of animal cloning, some critics have tried to exploit religious and ethical concerns about cloning in order to prevent its commercial use.  While FDA can be commended for taking seriously ethical questions related to the humane treatment of animals, the agency’s statutory mission is to focus on consumer and animal safety and leave moral choices to consumers.  Moreover, because each of the health problems seen in certain cloned animals is also present in other assisted reproductive techniques and natural mating, their presence in cloned animals presents no unique ethical or consumer safety issues.

For these reasons, FDA should now move quickly to lift the voluntary moratorium on commercial sales of meat and milk from cloned animals and their progeny.  FDA should also resist calls to require special labeling for edible products derived from cloned animals and their progeny. 

II. FDA Should Not Require Special Labeling For Cloned Animal Products

FDA’s long-standing policy has held that foods developed from new technologies must be labeled if, and only if, the composition of such foods differs “materially” from their conventional counterparts.  Because assisted reproductive technologies such as artificial insemination and in vitro fertilization do not affect the safety of meat or milk, FDA does not require labels to identify them.  Similarly, FDA’s draft risk assessment has concluded that somatic cell nuclear transfer (cloning), does not impart any unique food safety risks.  Nor do meat or milk from cloned animals or their progeny differ materially from their conventional counterparts in micro- or macro-nutrient or lipid composition, or other relevant measures of key nutritional components.  Consequently, FDA should not require special labeling for meat or milk from cloned animals or their progeny.

Advocates of mandatory labeling have criticized FDA’s long-standing food labeling policy, and they have argued that a substantial portion of the American public supports mandatory labeling of edible products from clones.  However, to the extent that some consumers truly wish to purchase meat or milk that is not derived from clones or their progeny, food processors and retailers are already preparing to supply such an option.  Even now, months before food products derived from cloned animals or their progeny are likely to appear in the commercial food stream, some major American dairy producers and food retailers have pledged to use only “non-clone” meat and milk in their products.  In addition, commercial experience with organic, free-range, kosher, halal, and other process-oriented food labeling indicates that consumers are likely to be supplied a broad range of choices, rendering government mandated labels unnecessary. 

Countless such products appear on supermarket shelves across the country, and consumers need only examine their labels to find choices that meet their demands.  Although scientifically irrelevant, there is no satisfactory reason for FDA to forbid food producers from making such truthful and non-misleading label statements regarding the production characteristics of their products.  Thus, we also urge FDA to allow food producers who do not use cloned animals or their progeny, or products derived from them, to label their products as such when it is done in a truthful and non-misleading way.

In addition, proposals for mandatory labeling of food products derived from cloned animals raise important First Amendment freedom of speech issues.  Federal courts have, on several occasions, held that requiring process-oriented food labeling is unconstitutional if it is done for no better reason than to satisfy consumer interest in the information.  The federal Second Circuit Court of Appeals’ decision in International Dairy Foods Association, et al. v. Amestoy, 92 F. 3d 67 (2d Cir. 1996), is typical.  That decision ruled unconstitutional a Vermont statute and companion regulations requiring the labeling of dairy products from cows treated with recombinant bovine somatotropin.  The Court held that “The right not to speak inheres in political and commercial speech alike…and extends to statements of fact as well as statements of opinion.” 

Unless FDA can demonstrate a relevant health risk or other sufficiently substantial governmental concern, mandatory special labeling for meat or milk from animal clones or their progeny may be unconstitutional.  But FDA has already concluded that there are no known consumer health risks arising from the consumption of edible products from clones.  And, because market participants have already indicated a willingness to supply consumer demand for this information, FDA should resist calls for mandatory labeling.

III. Conclusion

In keeping with the FDA’s statutory authority to protect the nation’s food supply and it’s stated emphasis on basing evaluations of food safety on the objective characteristics of the foods themselves, rather than on the processes through which those foods are developed, the Competitive Enterprise Institute strongly urges FDA to finalize the animal cloning Risk Assessment, Risk Management Plan, and Guidance for Industry, and to lift the voluntary moratorium on commercial sales of cloned animals and their progeny.  We also urge FDA to resist calls to require special consumer labeling for meat, milk, or other products derived from clones or their progeny.

Respectfully submitted,

Gregory Conko