Washington Editor

A report released last week by the National Academy of Sciences on the safety of genetically engineered foods is receiving a warm reception by industry representatives, including one company president who referred to it as a "very sound" study.

Indeed, Sara Davis, president of ViaGen Inc., is among industry experts publicly supporting the academy's work. ViaGen, of Austin, Texas, is a genetic improvement company that primarily works in food animals such as beef cattle, pigs and shrimp. Meanwhile, others offering nods of approval include the Biotechnology Industry Organization and the Competitive Enterprise Institute, both of Washington.

The report said federal agencies should assess the safety of genetically altered foods - whether produced by genetic engineering or by other techniques, such as conventional breeding for desirable traits - on a case-by-case basis to determine whether unintended changes in their composition could adversely affect human health.

Furthermore, the National Academy of Sciences (NAS - it is not a government agency) report says the scope of each safety evaluation should not be based solely on the technique used to alter the food, because even traditional methods, such as crossbreeding, can cause unexpected changes. Instead, greater scrutiny should be placed on foods containing new compounds or unusual amounts of naturally occurring substances, regardless of the method used to create them.

Bettie Sue Masters, who chaired the 14-member committee that wrote the report, released a statement saying genetic engineering is more likely to cause unintended changes than some techniques, such as simple selection, but less likely to do so than other currently used methods, such as those that use radiation or chemicals. Because all methods can cause those changes, the committee concluded that attempts to assess food safety based solely on the method of breeding are "scientifically unjustified." Masters is a distinguished professor of chemistry at the Robert A. Welch Foundation, University of Texas Health Science Center in San Antonio.

"One thing that is very clear here is that we should not be regulating the process, but we should be regulating the product," Scott Davis, president of the intellectual property, licensing and investments division of Phoenix-based Exeter Life Sciences, the parent company of ViaGen, told BioWorld Today. "I think that was an affirmation by the NAS that there is nothing inherently [hazardous], for example, in transgenic technology that is a cause for concern."

As for the look at traditional breeding methods (to include genetic engineering, crossbreeding and mutation breeding), Scott Davis said, "We have been using these technologies for a hundred years without regulation, and I think it was actually quite a paradigm shift for the NAS to say that anytime you are messing with the genetics of an organism, even if it is with one of these technologies, we need to look at the products that result from the manipulation and make an intelligent assessment of what we need to do to make sure it is safe."

According to the report, which makes a number of recommendations for assessing safety going forward, "no adverse health effects attributed to genetic engineering have been documented in the human population" to date.

The FDA, U.S. Department of Agriculture and the Environmental Protection Agency commissioned the study, conducted by the NAS's National Research Council and the Institute of Medicine.

In the report, "genetic modification" refers to breeding techniques ranging from traditional crossbreeding to genetic engineering to the use of chemicals or radiation to alter plant and animal traits that can be inherited from one generation to the next. "Genetic engineering" refers to a specific type of alteration that uses molecular biology techniques to delete genes or to transfer genes for particular qualities from one species to another. For example, plant breeders have engineered crops to resist pests by inserting a protein from a soil bacterium, and efforts are under way to develop foods with enhanced nutritional content.

The committee also looked at safety issues related to foods that come from cloned animals, and concluded that "there is no evidence that foods from cloned animals pose an increased risk to consumers."

That finding, Sara Davis said, is important to ViaGen. "Clones and their offspring are perfectly safe in the food supply," she said. "As a scientist, we know that clones are basically identical twins displaced in time, so we wouldn't expect any genetic difference or product differences or any differences."

But as with crops and foods, committee members said safety evaluations of such products should focus on the product itself, rather than the process used to create it. Also, the committee recommended that evaluations compare foods from cloned animals with those from noncloned animals.

Among other recommendations, the committee said there should be standardized sampling methodologies, validation procedures and performance-based techniques for targeted analysis and profiling of GM foods.

Sara Davis said a standardized set of comparisons is a reasonable request. "In our case, we have done every sort of biochemical tests that we can think of to provide data to the FDA on meats and clones and meats for the offspring of clones because there is no set standard that says if you look at all of these things and don't find any differences, then it is safe," she said.

The entire report can be viewed at www.nap.edu.

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