[Homestead] Biotech food, Page Two of TNYT article
genegerue at ruralize.com
Mon Jul 30 08:25:47 EDT 2007
(Page 2 of 2)
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.
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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
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
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
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.”
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