Kathleen Killoy

March 2, 2007

The Food and Drug Administration (FDA) recently issued draft documents that approve the marketing of milk, eggs, and meat from cloned animals. The FDA's approval comes despite wide-scale public opposition to cloned animal products, as evidenced by a survey conducted by the Pew Initiative for Food and Biotechnology in September 2006, which demonstrated that 64% of Americans do not want to eat cloned animals. Opposition comes from consumers, the scientific community, and politicians alike. For example, in December 2006, a bipartisan group of seven senators led by Vermont Senator Patrick Leahy wrote a letter to the FDA calling for a more rigorous and public approval process before cloned animals are allowed into the food supply.

The FDA has little understanding of the consequences cloned animal products may impose on the American population and the United States would be the first to approve such products. This follows the similar path taken by the FDA regarding genetically-modified organisms. In both of these biotechnological advances, as there has been limited testing regarding the environmental and human health affects of bioengineered foods, the American consumer will be the first guinea pigs.

Many other ethical concerns also exist. For example, many cloned animals are born with painful deformities. The FDA has chosen to ignore the genetic abnormalities common in clones despite reports from scientists and farmers who have seen the abnormalities first hand. Also, a low number of clones actually survive due to intestinal blockages; diabetes; shortened tendons; deformed feet; weakened immune systems; dysfunctional hearts, livers, brains, and kidneys; and respiratory and circulatory ailments.

Another concern is that large quantities of veterinary pharmaceuticals may enter the human food supply. During the cloning process, both surrogate mothers and cloned offspring are often treated with massive doses of hormones and antibiotics. Additionally, hormonal and other imbalances in clones could compromise the quality and safety of cloned products.

Besides the ethical and human health considerations, other there is other economic concerns for farmers and consumers. Many nations have refused to import U.S. foods that are not certified non-GMO. These same countries are likely to refuse importation of products that are not certified as non-cloned.

The FDA's draft documents also announced that there will likely be no labeling requirements for the cloned animal products. The FDA's perception is that U.S. consumers would treat cloned-labeled food as a black-mark and avoid any purchase the cloned foods. If this is true, the bioengineering companies would be at a substantial economic loss.

Hopefully, despite the lack of a federal requirement for clone-labeling, the free market will develop labeling anyways. For example, many companies choose to label their foods as non-GMO despite the lack of any labeling requirements. Unfortunately, while the

As much of the public currently lacks information about cloned animal products, as does the scientific and regulatory communities, clone-labeling would be a beneficial precautionary measure in a future food market filled with uncertainty regarding environmental and public health risks. Clone-labels would enable consumers to make a personal decision in light of the great scientific uncertainty.

Currently the FDA's draft documents are open for public comment until April 2007, after which the FDA will promulgate a final rule. To file a comment regarding the FDA proposal, visit the Organic Consumers Association website, http://www.organicconsumers.org.

For more information:

Take Action: FDA approves Food from Clones, Democracy in Action, http://www.democracyinaction.org/dia/organizationsORG/oca/campaign.jsp?campaign_KEY=6433.

Joseph Mendelson, Despite Lack of Science and Strong Public Concern, FDA Okays Food from Cloned Animals, Dec. 28, 2006, http://www.centerforfoodsafety.org/Cloning_PR12_26_06.cfm.

Andrew Pollack, F.D.A. Says Food from Cloned Animals Is Safe, N.Y. Times, Dec. 29, 2006, http://www.nytimes.com/2006/12/29/business/29fda.html.

News Release, FDA Issues Draft Documents on the Safety of Animal Clones, U.S. Food & Drug Adm. (Dec. 28, 2006), available at http://www.fda.gov/bbs/topics/NEWS/2006/NEW01541.html.

A Risk-Based Approach to Evaluate Animal Clones and Their Progeny – DRAFT, U.S. Food & Drug Adm., http://www.fda.gov/cvm/CloneRiskAssessment.htm.