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[Gene GeRue <genegerue AT ruralize.com>]

Without U.S. Rules, Biotech Food Lacks Investors
Paul Darrow for The New York Times

Even though these Atlantic salmon are roughly the same age, the big  
one was genetically engineered to grow at twice the rate of normal  
salmon.

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By ANDREW POLLACK
Published: July 30, 2007

This little piggy’s manure causes less pollution. This little piggy  
produces extra milk for her babies. And this little piggy makes fatty  
acids normally found in fish, so that eating its bacon might actually  
be good for you.
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Farming With Borrowed GenesGraphic
Farming With Borrowed Genes
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Jim Ross for The New York Times

Meet the Enviropigs. They have cleaner manure and healthier meat, say  
their developers, at left, Dr. John Kelly of MaRS Landing of Ontario  
and Dr. Cecil Forsberg of the University of Guelph near Toronto.

The three pigs, all now living in experimental farmyards, are among  
the genetically engineered animals whose meat might one day turn up  
on American dinner plates. Bioengineers have also developed salmon  
that grow to market weight in about half the typical time, disease- 
resistant cows and catfish needing fewer antibiotics, and goats whose  
milk might help ward off infections in children who drink it.

Only now, though, do federal officials seem to be getting serious  
about drafting rules that would determine whether and how such meat,  
milk and filets can safely enter the nation’s food supply.

Some scientists and biotechnology executives say that by having the  
Food and Drug Administration spell out the rules of the game, big  
investors would finally be willing to put up money to create a market  
in so-called transgenic livestock.

“Right now, it’s very hard to get any corporate investment,” said  
James D. Murray, a professor at the University of California, Davis,  
who developed the goats with the infection-fighting milk. “What  
studies do you need to do? What are they looking for?” he said,  
referring to government regulators. “That stuff’s not there.”

But some experts caution that even if the F.D.A. clears the  
regulatory path in coming months, investors and agribusiness  
companies might still shy away. Many fear that consumers would shun  
foods from transgenic animals, sometimes referred to as genetically  
modified organisms, or G.M.O.’s.

“The companies we have spoken to have gone organic, and they are very  
concerned, at least up to the present time, of having G.M.O.  
associated with their name,” said Cecil W. Forsberg, a professor at  
the University of Guelph in Ontario, Canada, who helped developed the  
“Enviropig” with the cleaner manure. Smithfield Foods, for one, the  
world’s largest hog producer and pork processor, says it is doing no  
research on genetically engineered animals.

Critics say changing the genes of animals could lead to potentially  
harmful changes in the composition of milk or meat, like the  
introduction of a protein that could cause allergic reactions. They  
say there could also be risks to the environment if, for example,  
extra-large salmon were to escape into oceans and out-compete wild  
salmon for food or mates. Some also say that some of the processes  
used to create transgenic livestock can harm the animals themselves.

The federal guidelines would come after more than 15 years of talks  
and false starts at the F.D.A., a delay irking not only developers of  
the transgenic animals but also critics of biotechnology.

“The fact that the agency has sat there for years staring this  
problem in the face and really hasn’t come up with a clear way to  
regulate this is abdicating its responsibilities,” said Joseph  
Mendelson, the legal director of the Center for Food Safety, a  
Washington advocacy group.

Even now, the F.D.A. will not say when the rules will be ready.

“We want to get it out, but we also want to get it right,” said Julie  
Zawisza, a spokeswoman for the agency, which declined to make any  
other officials available for comment.

Some industry executives and former and current government officials  
say one reason for the delay was that some government officials, in  
part because of a preference for fewer regulations, wanted less  
stringent rules than the F.D.A. is considering.

Meanwhile, the biotechnology industry is actually pushing for the  
tougher standards.

“Our overarching goal is to have public confidence in our products,”  
said Barbara Glenn, the managing director for animal issues at the  
Biotechnology Industry Organization, a trade group. “We won’t have  
that unless we have a very strong review process.”

The F.D.A. is turning to transgenic animals after having tentatively  
declared in December that milk and meat from livestock that is cloned  
— but not otherwise genetically manipulated — was safe for people to  
eat.

The F.D.A. considers clones to be less biologically radical than  
genetically engineered animals — which instead of being mere replicas  
of naturally occurring animals are given foreign DNA, usually from  
another species.