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aint nobody here but us chickens



January 28, 2003
Prof. Joe Cummins
e-mail: jcummins@uwo.ca
“Aint nobody here but us chickens”
An old jive doggerel by J. Cramer and J. Whitney goes “ Ain't Nobody Here But Us Chickens”
“One night Farmer Brown was taken 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”
One cannot help but think of that fine old tune in dealing with bureaucrats who are responsible for administrating the safety evaluation of genetically modified (GM) crops. The bureaucrats seem to be active , as the song goes “Tomorrow is a busy day, we've got things to do, we've got eggs to lay We got ground to dig and worms to scratch” however, a question remains , are the bureaucrats up to scratch? Are the bureaucrats looking out for the safety of the public, or are they just clucking? Recently the bureaucrats in the United States Department of Agriculture, Animal and Plant Health Inspection Service, US EPA and US FDA approved the commercial production of “Sunset” transgenic papaya which is resistant to papaya ring spot virus. The transgenic crop is modified with a gene for papaya ringspot virus coat protein which produces messenger RNA and coat protein, following virus infection, virus replication is prevented via post transcriptional gene silencing (1). The possibility that genetically modified (GM) crops may introduce novel allergens (compounds that cause allergy) has been discussed a great deal because the GM crops are deemed substantially equivalent to unmodified crops and the approval processes has promised to try to identify potential allergens before the crops are released for commercial production . In spite of the promise a recent publication (2) identified the protein product of the papaya ringspot virus coat protein as a likely allergen because it contained a string of amino acids identical to a known epitope (string of amino acids in a protein that provokes an allergic response). GM papaya appears to have been approved for commercial production even though the virus coat protein transgene it contained had protein sequence identical to a known epitope for an allergen. The United States General Accounting Office (GAO) report to congress on Genetically Modified Foods (3) assured the congress and public that FDA’s regimen of safety test as 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 antinutrients.” GAO believed that the sequences of transgenic proteins would be studied and identification of allergy epitope sequences should trigger fuller study to establish the potency of the identified epitope. I contacted an official from FDA about the apparent allergenicity of the virus coat protein.’ Original Message----- From: jcummins [mailto:jcummins@uwo.ca] Sent: Wednesday, January 22, 2003 2:23 PM
To: Maryanski, James H
Subject: GM papaya with a coat protein gene from ring spot mosaic virus

       Recently the United States released GM papaya with a coat protein gene
from ring spot mosaic virus for commercial production. The papaya ring spot virus coat protein has been found to have an epitope characteristic of an allergen as is shown in the accompanying publication. I understand that your agency uses the amino acid sequence of potential epitopes to screen allergens. Is your agency re-evaluating the commercial release of transgenic papaya bearing the virus coat protein? Is your agency taking steps to insure that the transgenic papaya is being labeled as a potential allergen in the market?
Sincerely, Prof. Joe Cummins
The reply:
               Date: Mon, 27 Jan 2003 09:24:46 -05

Dear Mr. Cummings,
Thank you for sending the paper by Kletter and Peijnenburg on screening transgenic proteins for IgE binding epitopes using sequence information. 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.
Sincerely,
James H. Maryanski, Ph.D.
Biotechnology Coordinator
Center for Food Safety and Applied Nutrition”
Essentially then I was sent off to EPA but my search of the EPA public information the information that coat protein of papaya ringspot virus and the genetic material necessary for its production had been granted an exemption from the requirement of a tolerance (4). That exemption was based on the belief that the material was safe for consumption by humans and animals even though no mention was made of study of the amino acid sequence of the virus protein. Finally, the USDA Animal and Plant Health Inspection Service made a determination of non-regulated status for Sunset Papaya lines (5) because the reviewers believed that the GM crop was not harmful. GAO seems to be woefully misinformed about the actual evaluation of GM crops in the “real world”. Of course, GAO may have modeled their approach to that of the giant accounting corporations such as RD Anderson, but I hope that is not the case. However, it is very clear that what the congress and public have been made to believe things about the safety regulation of GM crops that are unrealistic and potentially injurious to the public. A realistic review of the safety evaluation of GM crops by a truly independent agency seems essential at this time.
References
1.Tennant,P,Fermin,G,Fitch,M,Manshardt,R, Slighton,J and Gonsalves,D. “Papaya ingspot 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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