Eat, Drink, And Be Wary

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http://www.alternet.org/story.html?StoryID=16577

 

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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