Allergenic GM Papaya Scandal

[Guest guest]

The Institute of Science in SocietyScience Society Sustainability

http://www.i-sis.org.uk

Allergenic GM Papaya Scandal

 

How Prof. Joe Cummins 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 ‘Sunset’ 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.

 

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.

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.

United States General Accounting Office Report to Congressional Requesters

" Genetically Modified Foods " GAO-02-566 May 2002.

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.

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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