On January 15th, FDA issued its final risk assessment on the safety of meat and milk from healthy cloned animals and their offspring. Consistent with FDA’s 12/06 draft guidance, it concluded that there is no incremental risk to humans from consumption of these foods. See, “Cloned Foods.” FDA does not currently plan to impose a requirement that foods from cloned animals be labeled as such. A voluntary moratorium on products from the offspring of cloned animals is lifted. FDA nevertheless asked that the voluntary moratorium on using milk from cloned animals remain in place, pending further inquiries as requested by certain Senators. Some food companies have promised that they will not use cloned milk or meat in their products. Organic producers say that meat, milk and other products from cloned animals will not be sold as “organic” in the United States. Some critics have suggested that FDA’s analysis is faulty because it focused on the total number of animals that appear to be adversely affected, not the frequency or severity of the health problems.
In most other countries, milk and food from cloned animals have not been approved for consumption. The EU has no laws regulating animal cloning and food derived from cloned animals. The European Food Safety Authority (“EFSA”), commissioned last February by the European Commission, issued a draft opinion on January 11th that meat and dairy products from cloned animals are probably safe for human consumption. The EFSA report says that milk and meat from healthy cattle and pig clones and their offspring are “within the normal range with respect to the composition and nutritional value of similar products obtained from conventionally bred animals.” The report acknowledged that the data available on safety are “limited.” Study size has so far been small; few animals have been followed for extended periods of time. EFSA is soliciting opinions from experts and the general public.
The European Group on Ethics, 15 experts appointed by the European Commission, issued a statement claiming that using cloned animals for production of food such as meat or milk is not justified. The group asserted that cloned animals experience a higher rate of disease than animals produced conventionally, including malformations, respiratory problems, enlarged livers, hemorrhage, and kidney abnormalities. The Center for Food Safety praised the Group’s statement. Others have suggested that cloning will diminish genetic diversity.
California is now considering a bill introduced in that state’s Senate calling for labeling of bills from cloned animals. Consumers Union and the Center for Food Safety have issued statements of support. Legislation such as this, of course, creates the risk that producers could be faced with differing requirements in different states. Last year, Governor Schwarzenegger vetoed a similar bill that was passed by the legislature because he concluded that the bill was preempted by federal law.
Thus, the controversy over food from cloned animals continues. At present, the cost of raising a cloned animal is considered too high to be cost-effective. Clones of high-quality animals will likely be used for breeding, and their offspring and products from their offspring will be sold as food. The economic model is that clones of the best breeding stock will produce high-quality offspring for human consumption or for production of milk. Proponents argue that cloning may permit better quality meat to be marketed, from animals with increased disease resistance.
Interestingly, CSPI seems to be maintaining a relatively low profile. Although it points to unanswered questions on animal welfare, ethical and environmental implications of cloning and so forth, its biotechnology director has been quoted as saying that “while the safety of any food cannot be proven with absolute certainty, consumers should have confidence that meat and milk from cloned animals and their offspring will be safe.”
It is too early to predict the outcome of this debate. The odds are good that if cloned animals do become regular sources of food, many will continue to raise safety questions, and studies will probably be needed to determine the long-term health effects of widespread consumption.