Eat, Drink, And Be Wary- More on GE Foods

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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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