StarLink Scandal Reveals EPA's Dangerous Deregulation of GE Crops

StarLink Bt Corn Scandal--Just the Tip of the Iceberg

In this excellent overview article on the failures of US regulators, the
EPA admits that it knew Aventis was having trouble tracking the Starlink
corn in 99, but did nothing about it.

The Houston Chronicle
October 22, 2000, Sunday 2 STAR EDITION

Biotech food on our tables;
Reaping what science sows;
Recent problems have raised questions about biotechnology

BY DAVID IVANOVICH, Houston Chronicle Washington Bureau

WASHINGTON - The worldwide debate over genetically modified food is now
confronting Americans in their neighborhood grocery stores. Kraft Foods
recalled more than 2 million boxes of Taco Bell-brand taco shells last
month after learning the shells had been made with a kind of genetically
altered corn not approved for human consumption. The recall has since
snowballed, with red-faced regulators continuing to investigate the
contamination. Industry officials now concede the unapproved corn may have
spread widely through the nation's food supply. Indeed, an estimated 9
million bushels from this fall's harvest alone are unaccounted for. The
contamination raises disturbing questions about the ability - and
determination - of the biotech industry and the federal government to
protect the public against the potential dangers of genetic engineering. As
the investigation unfolds, this black eye for the U.S. biotech industry may
well prompt Americans to focus on a debate that has raged overseas but been
largely ignored here at home.

"What it really indicates is that the entire food production system is
ill-equipped to deal with these genetically engineered products," insists
Rep. Dennis Kucinich, D-Ohio, a long-time critic of the industry.
Regulators have characterized the health risks from the unapproved corn as
"remote," although no one truly knows for sure. But this incident could
create a massive public relations problem for the biotech business, whose
future depends on the trust of consumers. Consumers are being given little
information with which to determine which products already on their dinner
tables may contain the adulterated corn. The Food and Drug Administration,
by its own regulations, must remain tight-lipped. While many questions
remain unanswered, this much is clear: For three years, U.S. farmers have
been growing a variety of genetically engineered corn that medical experts
fear could cause allergic reactions in humans, ranging from nausea to
shock. The corn, created by North Carolina-based Aventis CropScience and
sold under the brand name StarLink, was supposed to be restricted for use
as an animal feed or production of products such as ethanol. Aventis tried
to control distribution of the corn by relying on an honor code, of sorts,
among farmers. But that system failed.

"We are taking every reasonable, responsible step to locate all StarLink
corn and ensure that it is directed . . . to approved uses," Aventis
officials said in a prepared statement. Regulators aren't hesitating to
point fingers Aventis "blew it," said one senior official at the U.S.
Environmental Protection Agency. In fact, there's plenty of blame to go
around. The federal government oversaw Aventis' method for shielding the
food supply from its product, but regulators lacked the scientific
procedures to know if StarLink had found its way into the human food chain.
Instead, it fell to a loose coalition of environmental and consumer groups
known as the Genetically Engineered Food Alert to sound the alarm.

"What in heaven's name is the Food and Drug Administration doing?" asks
Phil Clapp, president of the National Environmental Trust and a member of
the coalition. "Why is a watchdog group doing testing that the Food and
Drug Administration should be doing?" This controversy comes at a pivotal
moment for the biotech industry. The use of this revolutionary technique of
inserting foreign plant, animal and even human genetic material into
domesticated crops to achieve desirable traits may be about to explode.
Scientists first began inserting foreign DNA material into crops back in
1985. Field tests were conducted three years later, and the first
commercial crops were planted five years ago. Regulators have approved 45
genetically modified plant for commercial production in the United States.
Another 6,700 others have been authorized for field testing. This year, 70
million acres of genetically modified crops were planted in the United
States. That included 61 percent of the nation's cotton crop, 54 percent of
the soybeans and 25 percent of the U.S. corn crop. The StarLink corn at the
center of the controversy represents less than .01 percent of the total
corn acreage planted this year. The expansion of this new technology has
caused uproars in both Western Europe and Japan, where cultural
associations with food are strong and protectionists' sentiments run high.
Critics in Europe and elsewhere have dubbed genetically engineered crops
"Frankenfood" and severely restricted their import.

But in the United States, consumers have been largely tolerant of
genetically modified foods, confident the federal government would
safeguard the food supply. American farmers, meanwhile, have been quick to
adopt a technology that can improve efficiency, reducing, for instance, the
need for chemical pesticides. Only a handful of food companies, including
Frito-Lay, the United States' largest salted snack food maker, and Gerber,
the baby food giant, have refused to accept genetically modified varieties.
Instead, most of the concern in the United States has centered around
potential damage to the environment as researchers struggled to understand
if these plants were harming creatures like the monarch butterfly.
Oversight of this brave new world is fractured. The FDA, as the arm of the
federal government charged with ensuring food safety, is the lead agency
charged with regulating this industry. It shares responsibility with the
EPA, which regulates pesticides, and the U.S. Department of Agriculture,
which has jurisdiction over meat and poultry. Federal regulators have
resisted calls for labeling of genetically modified crops, contending these
varieties are not substantially different from conventional foods. This
fall, the FDA is expected to propose new rules, which would require
companies to consult with the agency before trying to commercialize new
genetically modified products.

Critics complain these changes will do little to beef up regulations of
this industry. While the debate over genetic engineering has been fairly
tame in the United States, regulators recognized enough concern to convene
a special panel of the National Academy of Sciences to examine these
issues. Earlier this year, that body declared it was "not aware of any
evidence that foods on the market are unsafe to eat as a result of genetic
modification." Now there are empty spaces in the international foods aisle,
where the taco shells used to be sold. Three years ago, the EPA approved a
request from Aventis to license the StarLink technology. StarLink enjoyed
some distinct advantages over other genetically engineered corns. Like
other varieties, it could resist attacks by pests such as the European corn
borer by releasing a protein, borrowed from a bacterium, which would act
like a pesticide. StarLink also allowed farmers to spray a popular
herbicide on their fields without harming their corn plants. But unlike all
other genetically engineered varieties on the market, the EPA insisted
StarLink be used only for animal feed and industrial purposes, such as the
production of the gasoline component ethanol. Regulators have approved 45
genetically modified plants for commercial production in the United States.
Another 6,700 varieties have been authorized for field testing.

"That sent a red flag up for us," the senior EPA official said. Earlier
this year, the EPA asked a special scientific advisory board to evaluate
the StarLink technology. The panel said it could find no evidence the corn
would cause allergic reactions in humans, although the experts also said
they could not rule out that possibility. Steve Taylor, a professor at the
University of Nebraska at Lincoln, sent a letter to Kraft - which the
company promptly posted on his web site - arguing that StarLink is not
allergenic. A reaction to a novel protein would require multiple exposures
over an extended period of time, Taylor noted. For the EPA, the panel's
inability to dispel all concerns ended the debate. Agency experts had no
plans to authorize StarLink for human use, the senior EPA official said.

Up until the last few weeks Aventis officials thought the issue remained on
the table. In order to get approval to license StarLink, Aventis assumed
responsibility for ensuring the product did not get into corn-derived foods
for humans. Aventis licensed the StarLink technology to 11 different seed
companies to produce and sell the seed, according to the National Corn
Growers Association. (Aventis officials would not confirm the Corn Growers'
figures, but they did not dispute them.) Garst Seed Co. of Slater, Iowa,
emerged as the nation's primary distributor, typically shipping its
StarLink hybrids to dealers, who in turn delivered them to farmers. This
year, somewhere between 2,500 and 3,000 farmers - Aventis officials concede
they don't know exactly how many - planted the corn on as much as 352,000
acres from Texas to Minnesota.

To ensure this seed didn't end up on grocery shelves, farmers planting
StarLink corn were supposed to receive a "stewardship" agreement, laying
out the restrictions for StarLink. Aventis, Garst and others in the
industry also tried to get the word out to farmers. "Aventis would do
mailings to farmers," Garst President David Witherspoon said. "We did
mailings. . . . We would talk about the restrictions at various type
meetings. Letters would be sent to customers and letters sent to dealers."

The farmers were responsible for filling out the stewardship agreements and
sending them back to Aventis, Witherspoon said. Garst did not assume
responsibility for ensuring the growers complied with the restrictions,
Witherspoon said. That was Aventis' problem. Some farmers say they never
received stewardship agreements, never knew about the guidelines. Fred
Rosenberger of Rineyville, Ky., for instance, grew 8,000 bushels of
StarLink corn and then mixed that corn with 52,000 bushels of other
varieties. "We didn't know any different," Rosenberger said.

Now, Rosenberger can't sell any of his corn to some of his major customers,
the distilleries in his region. The number of farmers who failed to sign
stewardship agreements is not clear. EPA regulations also require that
StarLink corn not be grown within 660 feet of other crops, in an effort to
keep pollen from the restricted crop from drifting to other foods. At the
same time, farmers may well have believed that some small amount of
StarLink corn would be acceptable in loads of other corn. The European
Union, for instance, permits shipments of conventional corn to contain up
to 1 percent of genetically modified varieties and still be classified as
conventional corn.

The EPA, however, set no acceptable level of StarLink in corn for human
use. Federal regulators, when conducting an audit of Aventis' 1999
operations, learned the biotech firm could not account for all of the
StarLink seed sold that year. Company officials "assured us it was really
an accounting problem," the senior EPA official said. "We had no reason or
evidence to believe that was not the case." EPA officials refused to say
exactly when they learned about the problem, insisting they had to protect
Aventis' proprietary information.

Regulators now know at least some StarLink corn found its way to Azteca
Milling, a corn mill in Plainview. Azteca is owned by Gruma S.A., Mexico's
largest tortilla maker, and Archer Daniels Midland, the huge and
politically powerful American food processor. Azteca officials say they buy
corn from about 300 farmers and an unspecific number of elevators in the
region. But Azteca officials say they had a rule barring shipments of any
genetically modified varieties. The mill ground the yellow corn into flour
and shipped it to a number of food processors - how many no one will say.
Both Azteca and FDA officials insist releasing such information would
violate the confidentiality of Azteca's customers. Azteca is known to have
sent some contaminated flour to Mexico, where it was made into taco shells
by Sabritas Mexicali, a division of Pepsico. These shells were then sold to
Kraft Foods for distribution under the Taco Bell label. The mill also sent
yellow corn flour to Mission Foods, an Irving food processor owned by
Gruma. Mission Foods manufactures a variety of Mexican food products - such
as taco shells, tostadas, tortilla chips and corn tortillas - for a variety
of grocery store chains, which often then sell these items under their own
private labels. Mission Foods has repeatedly refused to identify its

Last month, the Genetically Engineered Food Alert, a coalition operating on
an annual budget of about $ 500,000, hired an independent laboratory to
test for the presence of StarLink in foods made from yellow corn. The
activists had 23 different corn products tested. The tests, conducted by
Genetic ID of Fairfield, Iowa, indicated the presence of StarLink in Taco
Bell taco shells, presumably made from corn harvested last year. The
coalition went public with its findings. Kraft then verified the results
and began a recall. The FDA was caught flat-footed. Unlike the private
sector, the agency had not developed any procedures to test for the
presence of StarLink or any other genetically modified food variety. "This
wasn't one of our products," an FDA spokeswoman said. "It was an EPA
issue," since the protein released by the StarLink corn acts as a pesticide.

The FDA tries to allocate its resources to deal with problems known to
sicken or even kill people, such as outbreaks of the Listeria or E. coli
bacteria. After the Food Alert coalition went public with its findings, the
agency adopted testing procedures laid out by another firm, Strategic
Diagnostics of Newark, Del. The tests are not a perfect tool, particularly
when used on processed food. Strategic Diagnostics President Rick Birkmeyer
said the tests can show the presence of the StarLink corn, but they give
experts no clear indication of how much of the StarLink protein is actually
in the product. Birkmeyer says the tests are far more reliable if conducted
on the actual grain, before any processing begins. Azteca has since
purchased kits from Strategic Diagnostics to test shipments coming to the

Dissatisfied with the FDA's response, the Food Alert coalition then tested
more products and again found evidence of StarLink, this time in taco
shells manufactured by Mission Foods and sold at a Safeway store in
suburban Washington. Safeway is the parent company of Houston's Randalls
Food Stores. That revelation eventually forced Mission Foods to pull all of
its corn-based products off store shelves, including products in Kroger,
Albertson's and H.E.B. stores. Since these Mission products are so often
sold under private labels, consumers will have a tough time knowing if
they've already purchased a recalled product. The FDA has ordered no
recalls. The agency is only authorized to do so under extreme
circumstances. In fact, the agency is not permitted to release much
information at all because the voluntary recalls implemented so far have
been classified as "Class 2" actions, in which the health risks are
considered extremely low. FDA investigators have visited the Azteca mill,
trying to trace the extent of the contamination.

The U.S. Department of Agriculture announced plans to buy all StarLink corn
from American farmers, with Aventis picking up the tab. Aventis will then
be permitted to resell the corn into proper channels. Aventis officials,
meanwhile, are busy now trying to track this year's crop. They now believe
about 88 percent of the crop is in storage or has already been sent for use
as animal feed or industrial needs. About 9 million bushels worth of corn,
however, remain unaccounted for. Aventis officials, trying to survey all
270 grain elevators known to have handled StarLink, have discovered at
least 50 facilities that sent the corn on for human use, company officials
said. ConAgra, the large Omaha, Neb.-based food company, halted shipments
from a Kansas mill earlier this month for fear StarLink corn had found its
way into the facility.

In the wake of the debacle, Aventis has withdrawn its application to sell
StarLink. EPA officials say they don't plan to allow any genetically
modified varieties not safe for human use out in the market again anytime
soon. Despite the embarrassment, Aventis officials downplay the whole
affair. "It is important to note," the company said in a prepared statement
released last week, "that the U.S. EPA has said it has no evidence that
food containing StarLink corn will cause any allergic reaction in people,
and that the risks, if any, are extremely low." "At its heart, this is a
technical/regulatory issue, not one of product safety," the company said.
Path to grocery store shelves How genetically modified corn made its way
into taco shells: Aventis CropScience licensed the StarLink technology to
seed companies. Aventis assured the EPA that its genetically modified corn
would not get into the human food supply. Eleven seed companies were
authorized to use the technology. Garst Seed Co. was the nation's largest
distributor. Seed was sold to farmers, who were asked to sign agreements
promising to sell their corn for animal feed or industrial uses. Three
hundred farmers sold corn to grain elevators, coops and mills, including
Azteca Milling L.P. in Plainview, between Amarillo and Lubbock. Sabritas
Mexicali, a division of PepsiCo, used Azteca's ground corn flour in its
taco shells. Kraft Foods marketed the taco shells under the Taco Bell
brand. Modified corn flour from Azteca is used by Mission Foods to make
yellow corn taco shells, tortillas, tostadas and tortilla chips. Mission is
a wholly owned subsidiary of Gruma S.A. Grocery store shelves.

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