WASHINGTON DC – Agencies within the Bush administration are wrestling internally on how to handle the Food and Drug Administration’s approval for market release of cloned animals to produce meat and milk, according to sources familiar with a White House meeting conducted this week.
The FDA is poised to release its risk assessment of the safety of meat and milk from cloned animals and their offspring, which is expected to clear these products as safe, as a draft assessment released on Jan. 2, 2007 did.
But the U.S. Department of Agriculture (USDA) and the Office of the U.S. Trade Representative (USTR) are alarmed that a premature release of cloned animals into the market could lead to trade frictions if the U.S. moves too far ahead with the technology compared to other countries.
But proponents of quick action claim such problems are unlikely because food produced from cloned animals are not likely to hit the market for another three to five years, and that this would give time for trading partners to consider the issue.
Among agriculture groups, the U.S. dairy industry does not see any benefit for producers or consumers in releasing cloned animals and their products into the market. In contrast, U.S. beef producers represented by the National Cattlemen’s Beef Association back it along with the American Meat Institute, which represents meat processors. The American Farm Bureau Federation is also in favor of the technology while the the Food Marketing Institute supports the continuation of a voluntary ban on the sale of food from cloned animals.
In the internal debates, USDA and USTR are not questioning the FDA finding that cloned animals do not pose a risk but fear that trading partners may reject products from these animals or the offspring of these animals if they have no familiarity with cloning technology.
For example, trade frictions may arise with Japan or Canada, which does not have regulations to deal with food products from clones, according to one informed source. Canada may question whether such U.S. meat and dairy products from clones or their offspring should enter its market, he said.
By giving these countries time to familiarize themselves with the impact of the new technology, the U.S. can avoid trade frictions, some sources said. This does not necessarily mean these countries would approve the sale of cloned animals and their products domestically, one source said.
He cited as an example the Canadian handling of the use of a milk production-boosting hormone commonly used in the U.S.
Canada did not approve the use of this hormone in its territory, but did not block products made from milk from cows to which the hormone had been administered.
One way to avoid these trade frictions is to ensure that FDA will maintain a voluntary moratorium on the release of products from cloned animals into the market, which the clone industry has upheld up to now. Many clone skeptics believe the voluntary moratorium should continue, a view also shared by Sen. Barbara Mikulski (D-MD). She successfully offered an amendment to the Senate version of the 2007 farm bill that would require two studies before the FDA can lift the voluntary moratorium.
These would include a National Academy of Sciences review of the FDA risk assessment to see whether cloned animals would hurt public health, and a USDA study on the economic and trade implications of the move. The House farm bill does not contain such a cloning provision and the two versions still have to be reconciled in conference.
However, the omnibus appropriations bill Congress passed last year was accompanied by report language that presses the FDA to delay releasing its risk assessment and to do further studies on the issue.
The European Food Safety Authority (EFSA) is also poised to release its own draft risk assessment of the safety of food products from clones and their offspring. Sources agreed the two agencies reviewed much of the same data, so they may reach similar conclusions.
The draft opinion that EFSA issues will be released for public consultation, and an EFSA spokesperson said a final opinion may be adopted in April 2008. A report on cloning from the European Group on Ethics in Science and New Technologies is also pending. The group issues opinions to the European Commission which advise on legislation or policies. EU sources expect this opinion to come out as early as this month.
Cloning is bound to be controversial in the EU where at least one member state, Denmark, has already banned cloning.
FDA found in its draft assessment issued last year that the health of clones is not “qualitatively different” from conventionally bred commercial animals. More clones died during gestation than with traditional breeding practices, but calves that survived past 150 days were normal, FDA found. Consumer groups have charged that the FDA did not consider a large enough sample of animals in its research, Michael Hansen of the Consumers Union said that the FDA has failed to consider whether clones require more drug treatments.
By Erica Lee Nelson
Published in Inside US Trade, January 11, 2008. This article, on the internal controversy over cloning in the Bush administration, beat a Washington Post article on the same issue on Jan. 15