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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
.