FDA Says Clones Are Safe For Food

Release of the analysis was slowed for years by several forces, including the dairy industry, concerned about the potential impact on exports of U.S. whey solids, foreign sales of which are growing for use as a protein supplement.

In the past month, as an announcement neared, members of Congress, led by Sen. Barbara A. Mikulski (D-Md.), sought to delay approval through legislation.

Trade-related agencies including the Foreign Agricultural Service and the Office of the U.S. Trade Representative, which for years have struggled to get countries to accept U.S. gene-altered crops, also raised red flags.

A final blitz of meetings with FDA officials last week brought grudging acquiescence, insiders said. And it is possible, sources said, that even after the risk analysis is released, there will be calls for farmers to voluntarily refrain from selling products from clones until the trade issues can be resolved.

To create its final risk assessment, the FDA gathered data on nearly all of the more than 600 U.S. farm-animal clones produced and hundreds of their offspring, as well as many from overseas. But it faced challenges in the process.

Those animals were made by scientists scattered among various universities and companies using different methods that in many cases were difficult to compare.

Moreover, many of those animals were not just clones but also had genes added to them for projects unrelated to food production.

In those cases, it was difficult for FDA reviewers to decide whether any problems were caused by those animals being clones or by their particular genetic alterations. (The FDA has said it will not approve gene-altered animals as food without additional tests for safety.)

Finally, there was the overarching problem of deciding which measures would best predict whether the food was safe. Most puzzling was whether to take into account the subtle alterations in gene activity, called epigenetic changes, that are common in clones as a result of having just one parent.

In the end, facing the reality that epigenetics have never been a factor in assessing the wholesomeness of food, agency scientists decided to use the same simple but effective standard used by farmers since the dawn of agriculture: If a farm animal appears in all respects to be healthy, then presume that food from that animal is safe to eat.

Scientists inside and outside the agency studied thousands of pages of veterinary reports describing weight, size, organ function, blood characteristics and other measures of clones and offspring. For cattle -- the animals for which the most data exist -- full health assessments were conducted for each of five different stages of the animals' life: fetal, newborn, juvenile, sexually mature, and old.

They concluded that newborn cattle are often unhealthy, probably because of epigenetic changes. They are usually extremely overweight and have respiratory, gastrointestinal and immune system problems. (Cloned pigs and goats are mostly healthy from the start.)