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More on frankenfood and our dear FDA. (Archive.)

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Eat, Drink, And Be Wary

By Shelley Smithson, Grist Magazine
August 11, 2003

Last January, inspectors with the U.S. Food and Drug Administration
paid a visit to the University of Illinois, where researchers have
been studying the DNA of pigs. The pig project, based in Champaign-
Urbana, is one of dozens of experiments being conducted across the
country in which scientists are altering the genetic structure of
animals in hopes of making them fatter, healthier, and more
profitable.

In the University of Illinois project, cow genes were inserted into
sows to increase their milk production, and a synthetic gene was
added to make milk digestion easier for the piglets, thereby causing
them to grow faster. But instead of the experimental swine being
destroyed, as required by the FDA, 386 piglets were sold to
livestock brokers, who then sold them to slaughterhouses, who sold
them to grocery stores, who sold them to consumers as pork chops,
sausage, and bacon.

University officials claim the piglets did not inherit the genetic
baggage of their moms, and the government does not believe the
incident presented a public-health risk. But the slipup is
emblematic of a federal regulatory system that is behind the times
when it comes to the next phase of bioengineered food: genetically
modified animals.

Over the past five years, GM soybeans and corn have become mainstays
in processed food sold in the United States, despite nagging
questions about the safety of the products and their potential
capacity to cause ecological harm. Now, scientists,
environmentalists, and food-safety advocates are concerned that GM
meat, eggs, and milk could follow in the footsteps of transgenic
crops, becoming a part of the U.S. diet before they have been shown
to be safe for humans, animals, and the environment.

Universities and biotechnology companies are conducting experiments
that mix and match genes from different organisms to produce animals
that could not occur in nature: bioengineered salmon that grow five
times as fast as their wild cousins, hens genetically manipulated to
lay low-cholesterol eggs, cows with disease-resistant genes,
chickens that produce anti-cancer drugs. Some say this work holds
great promise for preventing disease, boosting agricultural
productivity, and eradicating world hunger. But public-interest
groups worry that in the absence of a unified regulatory system, the
patchwork of outdated rules applied by different federal agencies
could jeopardize food safety and the environment.

Just Say No to Drug-Style Reviews

To date, no GM animals have been approved for sale within the U.S.
food industry, and it will probably be several years before
genetically modified eggs, milk, and meat make their way into U.S.
grocery stores and restaurants. The FDA is currently reviewing 10
applications from companies seeking to sell GM animal products to
consumers - but rather than evaluating these products as food, the
FDA is reviewing them under the rules that govern new drugs for
animals. The agency reasons that adding a foreign substance - genes
from another organism or synthetic genes - to an animal's DNA is
similar to feeding the animal a drug because it creates a physical
change in the animal, such as faster growth or disease resistance.

Jane Rissler, a senior staff scientist for the Union of Concerned
Scientists, calls the use of the drug rule to regulate GM animals a
"contortion." Rissler spent four years at the U.S. EPA helping to
formulate biotechnology regulations before joining UCS, a Cambridge,
Mass.-based nonprofit, in 1993. She is concerned about the use of
the drug law to regulate GM animals because it "is weak on the
environment and it allows zero public participation."

Under the animal drug law, the FDA cannot discuss anything about the
GM animal products currently being reviewed - not the names of the
companies involved, the types of animals being modified, the ways
their genetic structures have been altered, or the potential effects
on food safety, animal health, or the environment. "We cannot reveal
that type of information. It's considered a violation of our rules,"
says Linda Grassie, an FDA spokesperson. The agency will issue a
report on its findings only after a product has been approved and
gone on the market.

By contrast, when Procter & Gamble, the makers of Olestra, asked the
FDA for permission to add its artificial fat substitute to potato
chips, the controversial product was evaluated under food-additive
laws. In that process, the FDA files a notice in the Federal
Register and public-interest groups collect and present scientific
data to the FDA in writing and at open hearings.

The secretive process now being used to review GM animals is at odds
with what the American people seem to want. A 2001 survey conducted
by the Pew Initiative on Food and Biotechnology indicated that
people desire more information about GM food. Sixty-five percent of
respondents were concerned about eating bioengineered food and 45
percent lacked confidence in the government's ability to ensure the
safety of such food.

"A large element of what people are looking for with this technology
is having a process that is not only scientifically sound, but
having a process that the public can trust," says Michael Taylor,
former deputy commissioner for policy at the FDA. "That transparency
is an important part of public confidence in the outcome."

Taylor was a contributing author to a 2002 National Academy of
Sciences report on GM animals that noted several food-safety
concerns, including allergies, digestive disorders, and antibiotic
resistance. According to the report, people with weak digestive
systems - such as those with gastroenteritis - could absorb whole
proteins into their blood streams, potentially causing allergic
reactions. Infants in particular could be threatened, because their
digestive systems are not fully developed. But people with healthy
digestive tracts also could be at risk: "Food products containing
antimicrobial proteins might present a food safety concern in view
of their potential to alter the balance of consumers' intestinal
flora, and might foster the evolution of microbial strains
resistant to specific agents," the report says.

What Price Cheap Salmon?

Many scientists also worry about the ecological effects of tinkering
with the genetic structure of animals. On the bright side, some
environmental problems could be mitigated by bioengineered animals,
such as pigs that produce low-phosphorus poop (which would cut down
on emissions of methane, a greenhouse gas) and fluorescent, color-
coded fish that would indicate the presence of different water
pollutants.

But there is concern that GM animals, especially fish, could escape
from holding pens and breed with wild populations, causing dramatic
shifts in ecosystems. Scientists at Purdue University in West
Lafayette, Ind., described a scenario in which fish engineered to
grow faster would compete with wild fish for food and mating
partners, potentially driving them to extinction. Opponents of
genetic modification worry that a bioengineered salmon currently
being reviewed by the FDA could cause Atlantic salmon, already
listed as an endangered species, to become extinct.

"In return for possibly slightly cheaper salmon, you run the risk of
wiping out wild salmon populations," says Jean Halloran, director of
the Consumer Policy Institute at Consumers Union, the New York
research institute that publishes Consumer Reports. "Yeah, I guess
it would be an advantage if [salmon] were cheaper, but at what
price?"

Under the current rules, the FDA - not the EPA - is responsible for
environmental assessments of GM animal projects; these assessments
are also conducted without public input. "The FDA is absolutely not
qualified to regulate the environmental risks of any animals,"
Rissler says. "They are not environmental specialists." The EPA
studies the environmental risks posed by GM crops, and Rissler says
the agency should also assess the potential ecological impacts of
bioengineered animals, because its scientists have the expertise to
ask the right questions.

The FDA insists it is qualified, even though its primary mission is
not environmental regulation. "When we have expertise deficiencies
in a particular area, we go out and get experts," says John
Matheson, a senior regulatory review scientist for the FDA's Center
for Veterinary Medicine. Matheson, who is an aquatic ecologist, says
that in the case of the GM salmon, the FDA is working with the EPA
and the U.S. Fish and Wildlife Service to conduct a thorough review.
However, according to the National Academy of Sciences report, the
FDA does not have the legal authority to deny a GM animal
application based on an environmental assessment.

Just Eat It?

Until the glitch at the University of Illinois was discovered a few
months ago, the FDA did not require researchers to inform them that
they were conducting GM animal experiments. Nor did they make it
clear to research organizations that GM animals could not be sold
into the commercial food supply. In fact, the Illinois researchers
were working closely with the FDA, and still did not understand the
rules governing their experimental animals.

In May, the FDA sent a letter to all land-grant universities
reminding researchers that their work "may require" licensing under
the animal drug law. "Because much is yet to be learned about the
positive and negative facets of this type of research, it is
imperative that all safety regulations be followed scrupulously,"
the FDA letter admonished. That seems like a reasonable request -
but, as Halloran of Consumers Union puts it, "I can't imagine how a
researcher would know what the rules are, because they don't exist
in writing."

The agency is hoping to have voluntary guidelines for applicants
completed within a year, the FDA's Matheson says. "With animal
biotech, there's such a diversity; it's hard to anticipate the next
one to come in the door," he says. Because the technology is
new, "we're not yet in a place to decide in stone what kind of
requirements might be applied."

Public-interest groups say it's time for the FDA to start deciding.
They're calling on the agency to develop regulations specifically
for bioengineered food products rather than trying to adapt old
rules, intended for conventional food and drugs, to a radically new
technology. These new regulations, they say, could spell out the
roles of different federal agencies and could require applicants to
follow specific testing criteria on matters such as sample sizes and
duration of experiments. They also could outline a public
participation process and require the labeling of products
containing genetically engineered organisms - something
that is not now done.

"The public is currently in the situation of not even having
awareness that anyone is thinking about genetically engineering
animals for human consumption," Halloran says. "And the way the
structure is currently set up, that's going to go on until one day
the FDA says, 'We've just approved a genetically engineered animal
and we're not going to label it. So, here it is; eat it.'"

Shelley Smithson is a freelance writer in Farmington, N.M.

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Re: More on frankenfood and our dear FDA. (Archive.)

Re: More on frankenfood and our dear FDA. (Archive.)

Re: More on frankenfood and our dear FDA. (Archive.)

Re: More on frankenfood and our dear FDA. (Archive.)

Re: More on frankenfood and our dear FDA. (Archive.)