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July 2001, Week 1

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Subject:
REUTERS: StarLink bio-corn found in white corn products (News/US) (FW)
From:
Ericka <[log in to unmask]>
Reply To:
Iowa Discussion, Alerts and Announcements
Date:
Wed, 4 Jul 2001 14:40:23 -0500
Content-Type:
text/plain
Parts/Attachments:
text/plain (259 lines)
Happy Fourth of July!!! Wonder if it'll show up in red and blue as well as
white corn?

I'm so glad corn seed has a decent shelf life... we're definitely hanging on
to some seed from all of our corn varieties (many types and colors) that
were harvested 3 or more years ago while we wait for this Starlink and
(other GE) corn situation to pan out. Anyway, read on - good article.

Whether or not the EPA caves in to market & corporate pressure and approves
Starlink for human consumption, if folks ARE in fact allergic to the Cry9C
protein (or part of ANY Genetically Engineered corn or other GE food product
that we're all eating now) people will still get sick. No long term testing
or consumption = no long term knowledge... you might want to see Aventis'
EPA "Starlink approval for human consumption appeal" letter - pasted below
this article (Nov. 28, 2000).

Keep in mind that every cell of a Bt GE'd corn plant (Starlink is only one
of many examples) IS itself an insecticide (EPA registered), and that
Starlink is not only engineered with Bt, but also GE'd to be herbicide
tolerent. So Starlink corn is essentially an insecticide that can be doused
with herbicides and fed to animals as feed corn, and to us as "safe food" if
the EPA makes that decision later this month (July 17th).
Ericka Dana
----------
Date: Wed, 4 Jul 2001
To: [log in to unmask]
Subject: B-GE:Reuters: StarLink bio-corn found in white corn products
(News/US)

http://biz.yahoo.com/rf/010704/n04242731.html

StarLink bio-corn found in white corn products

By Andrea Shalal-Esa

WASHINGTON, July 4 (Reuters) - StarLink corn, the genetically modified
yellow variety whose presence in food products last fall resulted in
widespread recalls, has been found for the first time in a white corn
product.

The U.S. Food and Drug Administration (FDA) said it found genetic material
from StarLink corn, which has not been approved for human consumption, in
Kash n' Karry White Corn Tortilla Chips last month while investigating a
complaint from a Florida optometrist, Dr. Keith Finger.

Finger, who had suffered an allergic reaction to yellow corn products
tainted with StarLink, alerted the FDA because he had a milder reaction
after eating the white corn chips.

FDA's discovery of StarLink in a white corn product is significant because
many food manufacturers last year switched to white corn, which makes up
less than 3 percent of the U.S. corn market, to reassure consumers concerned
about the possible presence of StarLink in their taco shells and corn chips.

At the time, producers said using white corn eliminated the risk of
inadvertently introducing StarLink, which was modified to protect young
plants from destructive plants, into their products.

``We tested your sample for the presence of DNA of the gene coding for the
pesticidal protein of StarLink corn. The gene was found,'' Frederick Deddy,
acting branch chief of the FDA's Import Programs Branch, wrote in a letter
to Finger, which was obtained by Reuters.

An FDA official said the agency did not request a recall, but both the Kash
n' Karry and Food Lion grocery chains pulled the house brand product from
their shelves on Tuesday, The Washington Post reported on Wednesday.

No immediate comment was available from FDA officials or Aventis SA , the
Franco-German pharmaceutical group that makes the biotech corn.

ENVIRONMENTAL GROUPS TROUBLED BY NEWS

Environmental Protection Agency spokesman Dave Deegan also had no immediate
comment on the report, or its implications for EPA's assessment of possible
human exposure to StarLink.

Larry Bohlen of Friends of the Earth, whose research first alerted FDA to
the spread of StarLink into human food products, said the news was
troubling.

``Millions of people may have thought they were avoiding eating StarLink
corn by eating white corn. So now we see it's contaminated too,'' he said.

He noted the continuing spread of StarLink into human food products had
already prompted some countries like Sri Lanka to ban any use of the biotech
corn.

``The U.S. government's inability to contain StarLink shows how other
undesirable biotech crops could get loose in the world food supply,'' Bohlen
said.

StarLink, was barred by U.S. regulators for human use because of concerns it
might trigger allergic reactions such as rashes, diarrhea or breathing
problems.

EPA in 1998 approved the biotech corn variety only for feed use, and
required Aventis to keep it away from human products.

But traces of StarLink corn found their way into taco shells, chips and
other food products, triggering the eventual recall of more than 300 U.S.
foods.

The detection of StarLink in white corn raises serious new questions about
the spread of the genetically engineered crop, Bohlen said, suggesting the
gene could have found its way into white corn through cross-pollination.

White corn is grown and distributed separately from yellow corn, and
industry observers said there are no genetically modified varieties.

But they said there could be co-mingling of conventional and modified corn,
as well as white and yellow corn, during processing, transportation and
through cross-pollination.

QUESTIONS ABOUT ALLERGY TESTS

Dozens of people initially reported experiencing allergic reactions linked
to StarLink-tainted food products last year.

The U.S. government last month released a report showing 17 people who
complained of possible allergy attacks after eating corn products --
including the Florida case -- had failed to show any signs of antibodies to
StarLink's key component.

But environmentalists said the report was flawed and inconclusive. They said
the latest news underscored the need for more comprehensive tests.

An EPA advisory panel of experts will meet in Washington on July 17 to
review new StarLink information and recommend whether or not to grant a
request by Aventis to retroactively approve StarLink for human consumption.

###

> Aventis pushes for food okay on Cry9 protein
>
> Selected by Pro Farmer Editors
> Business Wire November 28, 2000
>
> RALEIGH, N.C. -- Aventis CropScience presented today to the Scientific
> Advisory Panel of the Environmental Protection Agency regarding the
> "Assessment of Scientific Information Concerning StarLink Corn." Attached is
> a copy of a letter dated November 22, 2000 to the Environmental Protection
> Agency concerning updated information regarding the potential risk of
> allergenicity of Cry9C protein, the genetically modified material associated
> with StarLink corn. StarLink corn was originally developed to be resistant
> to an insect pest, the European corn borer. The Environmental Protection
> Agency has confirmed that the risk of an allergic reaction in people, to
> food containing StarLink corn, if any, is extremely low.
>
> Aventis CropScience submitted this letter, along with an executive summary,
> in an effort to demonstrate that StarLink corn should be granted a
> time-limited food tolerance exemption by the Environmental Protection
> Agency, which would limit the potential disruption to the food chain from
> any StarLink corn prior to the voluntary withdrawal of the StarLink
> registration.
> ----------
> November 22, 2000
>
> Aventis
> Public Information and Records Integrity Branch
> Information Resources and Services Division (7502C)
> Office of Pesticide Programs (OPP)
> Environmental Protection Agency
> Rm. 119, CM #2, 1921
> Jefferson Davis Highway Arlington, VA 22202
>
> Attn.: Mr. Paul Lewis, Designated Federal Official,
> Office of Science Coordination and Policy
>
> RE: Docket Control Number OPP-00688
> Comments from Aventis CropScience USA LP regarding the FIFRA SAP
> Meeting on November 28, 2000 titled "Assessment of
> Scientific Information Concerning StarLink Corn".
>
> Dear Mr. Lewis:
>
> On behalf of Aventis CropScience USA LP (Aventis), thank you for the
> opportunity to submit written comments for the November 28, 2000, Scientific
> Advisory Panel (SAP) meeting titled "Assessment of Scientific Information
> Concerning StarLink Corn", docket control number OPP-00688. Following an
> overview of the background leading up to the upcoming SAP is an executive
> summary of Aventis' recently submitted addenda to the food tolerance
> exemption petition, and specific comments for most of the questions that the
> EPA has asked the SAP to address.
>
> Cry9C is an insecticidal protein that has been added to certain corn hybrids
> with the product name of StarLink(TM). Since the Cry9C protein represents a
> new class of Bt proteins for the market place, Aventis developed extensive
> data on the mammalian toxicity and potential for Cry9C to act as a food
> allergen. In November 1998 Aventis (formerly AgrEvo USA Company) submitted a
> petition of data to establish exemptions from the requirement of a tolerance
> for both food and feed uses for the plant-pesticide described above. These
> data have been submitted to and reviewed by the EPA. Most of these data are
> summarized in documents written by both Aventis (formally AgrEvo) (response
> letter to EPA background document dated December 14, 1999) and the EPA
> ("Cry9C Food Allergenicity Assessment Background Document"). The Cry9C
> protein was the subject of a SAP in February 2000, because the protein
> digests more slowly than other proteins currently on the market. The June
> 2000 SAP report from that meeting on the allergenic potential of the Cry9C
> protein was not conclusive.
>
> In May 1998 the EPA granted an exemption from the requirement of a tolerance
> for animal feed uses of StarLink corn. Aventis, working with the EPA and the
> seed companies to which it licenses its technology, established a
> stewardship program to ensure compliance with the EPA's limited approval.
> However, beginning in September 2000, StarLink corn DNA was found in taco
> shells. Promptly after verification of the first StarLink corn DNA finding
> in the US, Aventis took unprecedented, voluntary action and halted all
> future sales of StarLink corn and launched, a program to successfully
> contain StarLink corn grain on the farm and channel it, under USDA
> supervision, to approved feed and non-food industrial uses. StarLink corn is
> not a health issue. The EPA, in September, said the "health risk, if any, is
> extremely low."
>
> On October 25, 2000, Aventis CropScience submitted an addendum to its
> original food tolerance exemption petition for StarLink corn. The addendum
> supports the establishment of a time-limited tolerance exemption for the
> Cry9C protein in food. The submission includes a new safety assessment
> prepared by Novigen Sciences, Inc. on behalf of Aventis. This focuses on the
> Cry9C protein since, according to previous findings of the EPA, cry9c DNA
> does not require a risk assessment or pose a health risk to humans as it has
> been determined to be "Generally Recognized As Safe". While the presence of
> Cry9C protein has not been documented in foods to date, the Novigen work
> presents a worst case risk assessment based upon very conservative estimates
> of potential exposure to StarLink corn in food products. A revised safety
> assessment was submitted November 3, 2000 after discussions with the EPA.
> The revised approach parallels the way the EPA estimates dietary exposure to
> pesticide residues.
>
> Aventis maintains that all the data it has developed, including the
> supportive exposure information, taken together provide a weight of evidence
> supporting a lack of food allergenic potential for the Cry9C protein. In
> particular, the low abundance of the Cry9C protein in grain and processed
> grain fractions is to be considered in light of the fact that known food
> allergens are present in high levels in foods. Taken together, this
> information collectively provides overwhelming support for the establishment
> of a time-limited exemption from the requirement of a tolerance for Cry9C
> protein and the DNA required for its expression in StarLink corn. This
> request is based on a "reasonable certainty of no harm" safety standard as
> defined by the Food Quality Protection Act.
>
> Our comments to specific questions are provided beneath each question posed
> by the EPA to the members of the SAP. The above overview, and the attached
> executive summary and answers to questions summarize Aventis written
> comments for this important SAP meeting. Thank you for the opportunity to
> comment.
>
>
> Sincerely,
>
> Sally Van Wert, Ph.D.
> Director, Regulatory Affairs-Biotechnology
> Aventis CropScience USA LP

###

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