- 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unified regulatory system, the patchwork of outdated rules applied by different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 Ð 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 Ð genes from another organism or synthetic genes Ð 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 Ð 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 Ð such as those with
gastroenteritis Ð 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 Ð not the EPA Ð
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 Ð 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 Ð 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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Magazine's <http://www.gristmagazine.com/signup/>free email service.
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- <http://www.alternet.org/>© 2003 Independent
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- http://www.alternet.org/story.html?StoryID=16577
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