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TITLE:  Allergenic GM Papaya Scandal
SOURCE: The Institute of Science in Society, UK
DATE:   Feb 3, 2003

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Allergenic GM Papaya Scandal

How Prof. Joe Cummins (jcummins@uwo.ca) uncovered the great scandal of
how US regulatory agencies approved a GM papaya even though it carries a
viral gene known to be a potential allergen.

Recently the United States regulatory bodies - Department of Agriculture,
Animal and Plant Health Inspection Service (USDA, APHIS), the Environment
Protection Agency (EPA) and Food and Drug Administration (FDA) - united
in approving the commercial production of ŽSunset' transgenic papaya
that's resistant to papaya ringspot virus. It is modified with a gene for
papaya ring spot virus coat protein, the expression of which prevents the
virus from replication by silencing the virus' own gene [1].

The possibility that genetically modified (GM) crops may introduce novel
allergens has been raised by many critics, and as part of the approval
process, potential allergens have to be identified before the crops are
released commercially. But the GM papaya was approved despite a recent
report [2] showing that the papaya ringspot virus coat protein is a
potential allergen because it contained a string of amino acids identical
to a known allergen.

The US General Accounting Office (GAO) Report to Congress on Genetically
Modified Foods [3] assured Congress and the public that the regimen of
safety tests submitted to the FDA are adequate. "Companies that may wish
to submit new GM foods for FDA evaluation perform a regimen of tests to
obtain safety data on these foods, the degree of similarity between the
amino acid sequences in the newly introduced proteins of the GM food and
the amino acid sequences in known allergens, toxins, and anti-nutrients."
GAO believed that when the sequence of a transgenic protein is found to
be similar to that of allergens, further studies would be carried out, at
the very least, before the GM crop or product is commercially released.

I contacted James Maryanski of the FDA by e-mail on 22 January, to alert
him of the allergenic potential of the papaya virus coat protein and the
relevant publication. In his reply (27 January), he wrote,

"FDA and EPA are aware of this recently published paper, though we have
not had an opportunity to fully assess the findings of the paper. FDA is
conducting a review of available scientific literature and intends to use
this information to prepare draft guidelines for industry. Please note
that the traits used to confer resistance to viral disease in papaya are
pesticidal traits (plant incorporated protectants) regulated by EPA, not
by FDA."

So, I was sent off to EPA, and guess what I found. The EPA's public
information stated that coat protein of papaya ringspot virus and the
genetic material necessary for its production had been granted "an
exemption from the requirement of tolerance" [4] in 1997, which
essentially means it is exempt from safety assessment, based on the
belief that the material was safe for consumption by humans and animals.
No mention was made of recent study on the amino acid sequence of the
virus protein. For its part, the USDA APHIS also awarded Sunset Papaya a
non-regulated status [5] in 1996, because the reviewers believed that the
GM crop was not harmful.

These bureaucrats remind me of the old jive doggerel by J. Cramer and J.
Whitney, Ain't Nobody Here But Us Chickens,

"One night Farmer Brown was takin' the air
Locked up the barnyard with the greatest of care
Down in the henhouse somethin' stirred
When he shouted, "Who's There?", this is what he heard
There ain't nobody here but us chickens, there ain't nobody here at all
So calm yourself, stop that fuss, ain't nobody here but us
There ain't nobody here but us chickens, there ain't nobody here at all"

GAO seems to be woefully misinformed about the safety assessment of GM
crops, and may have modeled itself after giant accounting corporations
such as RD Anderson.

This is a wakeup call for Congress and the public everywhere, who may
have been misled into believing that GM food is the most strictly
regulated of all foods, and that the US regulatory system is the best in
the world.

1. Tennant P, Fermin G, Fitch M, Manshardt R, Slighton J and Gonsalves D.
Papaya ringspot resistance of transgenic Rainbow and SunUp is affected by
gene dosage, plant development, and coat protein homology. European
Journal of Plant Pathology 2001, 107, 645-53.

2. Kleter G and Peijnenburg A. Screening of transgenic proteins expressed
in transgenic food crops for the presence of short amino acid sequences
identical to potential, IgE-binding linear epitopes of allergens. BMC
Structural Biology 2002, 2, 8-19.

3. United States General Accounting Office Report to Congressional
Requesters "Genetically Modified Foods" GAO-02-566 May 2002.

4. Rules and Regulations. Coat protein of Papaya Ringspot Virus and the
Genetic Material Necessary for its Production; Exemption From the
Requirement of a Tolerance. Federal Register August 22,1997 62, 44572-75.

5. USDA-APHIS Petition 96-051-01P for the determination of nonregulated
status for transgenic sunset papaya Lines 55-1 and 63-1 Finding of No
Significant Impact September 1996.


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