GENET archive


2-Plants: Environmental Defense, USA, warns about allergenicity of AgrEvo's Cry9C-Bt-corn

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TITLE:  Comments from Environmental Defense on EPA's
        "Cry9C Food Allergenicity Background Document"
SOURCE: Environmental Defense Fund, USA
DATE:   March 2000

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Comments from Environmental Defense on EPA's "Cry9C Food 
Allergenicity Background Document"

Presented to the EPA Science Advisory Panel
Arlington, VA February 29, 2000

Luca Bucchini, Ph.D.
School of Public Health
Johns Hopkins University
Baltimore, MD

Rebecca Goldburg, Ph.D.
Senior Scientist
Environmental Defense
New York, NY


Thank you for the opportunity to present the comments of 
Environmental Defense on a pesticide petition (9F5050) submitted by 
AgrEvo USA Company to the U.S. Environmental Protection Agency (EPA). 
AgrEvo has petitioned EPA to expand the current exemption from the 
requirement of a tolerance for Cry9C Bt toxin produced in genetically 
engineered corn. To date, EPA has limited use of the Cry9C toxin to 
corn used for animal feed, because the biochemical properties of 
Cry9C toxin indicate that this protein has the potential to cause 
allergic reactions in humans. AgrEvo would now like to expand use of 
Cry9C corn to human foods. As explained below, Environmental Defense 
urges EPA to not approve at this time AgrEvo's petition to expand the 
use of Cry9C toxin to corn used in human food. AgrEvo has not 
provided adequate evidence to assure a reasonable certainty of no 
harm from the use of Cry9C toxin for use in human food. Nevertheless, 
Environmental Defense does hold open the possibility that the Cry9C 
could be approved for use in human food if foods containing the toxin 
were labeled as potentially allergenic and a system of post-market 
surveillance was implemented.

[the entire document is available at


Environmental Defense urges EPA to reject AgrEvo's petition and to 
not approve at this time the use of Cry9C toxin in human food. The 
scientific information provided to EPA by AgrEvo is at best 
insufficient to assure that exposed populations would have a 
reasonable uncertainty of no harm from allergic reactions to Cry9C 
toxin in corn. Two of the four criteria that EPA is using to assess 
the allergenicity of Bt toxins indicate that the Cry9C toxin has the 
potential to be an allergen. EPA and AgrEvo have developed additional 
information concerning the Cry9C toxin beyond the four criteria; 
however, this supplementary evidence is far from adequate as a basis 
for a determination that the Cry9c is not, or at least highly 
unlikely to be, an allergen.

Approval of AgrEvo's petition by EPA would be extremely troubling. 
Given the paucity of evidence to support a determination that the 
Cry9C toxin is unlikely to be an allergen, such an approval would 
suggest that EPA is unlikely to ever make a decision to protect US 
consumers from potential allergens introduced to the food supply via 
genetic engineering (unless perhaps an introduced protein was 
homologous to a known allergen). For EPA to go forward with an 
approval would be to greatly favor industry profits at the expense of 
consumer protection. Such an action by EPA would greatly undermine 
consumer confidence that EPA is capable of meaningful review of 
genetically engineered plant-pesticides.

At the same time, we recognize that AgrEvo may feel caught in a 
difficult situation. The company's Cry9C toxin has biochemical 
properties associated with food allergens, yet there is no clear 
scientific path to prove or disprove that the toxin is likely to be 
an allergen. AgrEvo's situation is in large part a result of inaction 
by federal agencies. In the six years since the 1994 interagency 
meeting on food allergy, federal agencies have done disappointingly 
little to resolve scientific issues concerning the assessment of 

There are at least two constructive approaches - not mutually 
exclusive -- to the current situation. The first would be to allow 
AgrEvo to market Cry9C corn for use in human food, with an agreement 
that the Food and Drug Administration (FDA) would require labeling of 
food products made from the corn as potentially allergenic. In 
addition, a rigorous postmarket surveillance system would be 
established to assess whether the Cry9C toxin causes allergic 
responses in consumers and in occupational settings. Clinicians who 
treat allergies and asthma would be alerted to be vigilant for 
development of new allergies to this novel protein.

A second approach would be for EPA and FDA to use their scientific 
resources to develop and publish guidance to industry on how to 
assess the allergenic potential of proteins. Environmental Defense 
has already urged FDA to develop such guidance. Given the existing 
uncertainties about assessment of potential allergens, such guidance 
would be both helpful to AgrEvo and other companies and reassuring to 
consumers. Without such guidance, there will continue to be no 
accepted methodology with which to assess the allergenicity of most 
proteins added to foods via genetic engineering.


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