Without U.S. Rules, Biotech Food Lacks Investors

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.

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.

Larisa Rudenko, a senior biotechnology adviser in the
F.D.A.’s veterinary drug division, said in a May
presentation at the biotechnology industry’s annual
convention that each new type of genetically
engineered animal would require approval for use in
the food supply. That will be done, she said, under
the umbrella of existing rules for drugs used in
treating animal diseases.

While the implanted gene is somewhat like a drug, the
existing rules would have to be stretched to fit.

But industry executives and some former agency
officials said it was unlikely that Congress would
enact totally new laws for transgenic animals. And
using the drug laws, they say, would provide tighter
control than an alternative approach of using the
rules governing food additives. Agency officials have
said that the veterinary drug rules would be used, and
they have already been overseeing some experimental
work on that basis. But they continued to debate the
issue, and the policy has never been made official.

The regulatory guidelines would indicate how the drug
rules would be interpreted for transgenic animals, and
what types of data would be needed to prove safety and
efficacy. But there are open questions about how the
drug rules would actually translate. While a chemical
drug must be shown to be consistent and stable, for
instance, it is unclear how that standard would apply
to a gene passed from generation to generation. Some
critics say that while the drug rules do provide
fairly strict regulation of food safety, there are
drawbacks to adapting that approach. Because
applications for approval of drugs are confidential,
for instance, there would be no opportunity for public
comment before the agency acted.

“In order to create confidence in a new technology,
you really don’t want behind-closed-door proceedings,”
said Margaret Mellon, director of the food and
environment program at the Union of Concerned
Scientists.

Another worry is that the F.D.A. might not have enough
expertise or authority to conduct a vigorous review of
the environmental impact of transgenic animals. The
F.D.A. has dismissed this concern, however, saying it
has sufficient expertise and can consult with other
agencies.

The biotechnology regulatory branch of the Department
of Agriculture created an animal division last
December to figure out what its role should be.

Genetically engineered animals are often created by
injecting the gene of interest into a single-cell
embryo. A more recent technique that is more efficient
is to put the gene into a skin cell and create an
embryo from that cell by cloning.

In both cases, the embryo with the foreign gene is
then implanted into the womb of a surrogate mother.
After some transgenic animals are born, additional
ones can be made by conventional breeding, because the
foreign gene generally will be passed on to some of
the offspring, as would any other gene.

The fast-growing salmon is the transgenic animal that
has been swimming upstream the longest at the F.D.A.
Its developer, Aqua Bounty Technologies of Waltham,
Mass., has been working to win agency approval for
about 10 years. Aqua Bounty’s fish are Atlantic salmon
that have been given a growth-hormone gene from the
Chinook salmon. They have also been equipped with a
genetic on-switch from a fish called the ocean pout, a
distant cousin of the salmon.

Normally, salmon produce growth hormone only in warmer
months, but the pout gene’s on-switch keeps the
hormone flowing year round. That enables the Aqua
Bounty fish to grow faster, reaching their market
weight in about 18 months instead of 30.

Elliot Entis, Aqua Bounty’s chief executive, said the
company had already given the F.D.A. studies showing
that the fish were healthy and that the implanted gene
remained stable over generations.

He said the company also had tests done to show that
its fish contained the same level of fats, proteins
and other nutrients as other farmed salmon and would
not set off unexpected allergic reactions in people
who eat them. The fish also taste the same as other
farmed Atlantic salmon, Mr. Entis said.

“Nobody has ever analyzed salmon as closely as we have
had done,” he said. But the F.D.A. is asking for more
data on safety and potential environmental effects on
wild salmon.

Industry executives say the Enviropigs would be the
next candidate for F.D.A. approval. The pigs contain a
bacterial gene that allows them to produce an enzyme
that helps them more fully digest a vital nutrient,
phosphorus, in their feed. That means less phosphorus
in the manure, which in turn could mean less
phosphorus running off into lakes and oceans, where it
can cause algal blooms and fish kills.

MaRS Landing, a technology promoting organization in
Ontario, is trying to find a corporate partner for the
pig, said John Kelly, the agency’s executive director.

Less far along in the approval pipeline are pigs that
contain a gene from the roundworm allowing them to
produce omega-3 fatty acids, a nutrient normally found
in fish that is good for the heart. That, in theory,
could make eating pork or bacon healthier, although
that has yet to be tested.

Jing X. Kang, an associate professor at Harvard
Medical School who helped direct the project, said the
researchers were looking for corporate backers while
also trying to raise the level of omega-3 in the meat.

Carol Tucker Foreman, director of the Food Policy
Institute at the Consumer Federation of America, a
consumer advocacy group in Washington, said
regulations might not assuage consumers, many of whom
object to the genetic engineering of animals on humane
or ethical grounds, more than on safety concerns.

“The fact that the F.D.A. has a powerful regulatory
process for reviewing genetically engineered animals,
far greater than they apply to genetically engineered
crops, may not make any difference at all,” Ms.
Foreman said. “Because that’s not what it’s all
about.”

Found at: http://www.nytimes.com/2007/07/30/washington/30animal.html?_r=1&hp&oref=slogin