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STATEMENT OF MICHAEL J. PHILLIPS, PH.D.
EXECUTIVE DIRECTOR FOR FOOD AND AGRICULTURE
BIOTECHNOLOGY INDUSTRY ORGANIZATION
1625 K STREET NW SUITE 1100
WASHINGTON DC 20006
FIFRA Scientific Advisory Panel Open Meeting
November 28, 2000
Good morning. I am Dr. Michael J. Phillips, Executive Director for Food and Agriculture at the Biotechnology Industry Organization (BIO). I am privileged to be here today on behalf of the Biotechnology Industry Organization. Our membership includes over 900 member companies and research institutions in North America and around the world. These members are actively involved in research and development of new medicines, foods, and industrial products to benefit the lives of people and the environment.
I am here in support of the Supplemental Safety Assessment submitted by Aventis. The data in the Supplemental Safety Assessment reinforces the conclusion that the Cry9C protein in StarLink corn is not an allergen and is not likely to lead to an allergic reaction. The proteins that cause an allergic reaction have certain physicochemical characteristics in common. The Cry9C protein does not have these characteristics.
The most important
characteristics are those which effect the quantity of protein
likely to be present in the gastro-intestinal tract. Both stability
to digestion and level of protein together affect this quantity.
Significantly, the Cry9C protein represents an extremely small amount, only 0.0129 percent of the total protein in grain from StarLink corn. In contrast, typical food allergens on average represent between 1 percent and 40 percent of the total protein in the raw food or grain.
It is also worth noting that in
a rodent toxicology study, no adverse immunological effects were
observed at the very highest dose tested, which implies that Cry9C
is not easily or adversely perceived by the immune system.
Furthermore, presently corn-allergic individuals were shown by
Aventis to be no more sensitive to StarLink corn than to traditional
corn, which leads to the conclusion that StarLink corn is not a threat to these "at risk individuals." Protecting food allergy patients from unwanted and unexpected sources of allergens which cause their illness represents an important public health dimension to any allergy assessment of foods, whether traditional or derived through biotechnology.
Aventis has requested a time limited exemption from the requirement of a tolerance for the Cry9C protein expressed in StarLink Corn in food. This clearance would cover any StarLink corn grown in 1999 and 2000. Also, since Aventis has withdrawn its EPA license for StarLink, there will be no further production of this corn in 2001. Therefore, there is a completely new context for granting a temporary exemption from the requirement of a tolerance for Cry9C protein in StarLink corn, which is that the total amount of StarLink corn in the food supply, while extremely low today, will rapidly decline.
It is important to highlight the new information that has been provided in the Supplemental Safety Assessment. In addition to new digestibility results demonstrating that Cry9C is in fact digestible, the new submission by Aventis contains two important new scientific studies.
The first is that Cry9C protein
did not cause allergic reactions in individuals who are allergic to other foods, such as soybeans, peanuts, wheat, rice, milk, eggs and shrimp (which are clinically among the most important food allergens present in the food supply). This study means that Cry9C is not a cross-reactive allergen which could cause symptoms in food allergy sufferers generally.
The second is a comprehensive new risk assessment that makes the hypothetical assumption that Cry9C protein is, in fact, a potential allergen. In this analysis, Aventis and Novigen Sciences show that even if Cry9C is an allergen which is as potent as the most notorious food allergen known, in peanuts, that insufficient Cry9C protein would be
present in foods to possibly
elicit an allergic reaction. In other words, if Cry9C is as potent
as peanut allergens, there would still be a significant safety
factor due to the extremely low quantity of Cry9C protein and the
extremely low percentage of StarLink corn in the total corn food supply. Peanut is used in the Aventis risk assessment as a hypothetical and conservative basis for comparison. Remember, however, that Cry9C is unlikely to be an allergen as potent as peanuts. Thus, this worst-case scenario should be viewed as illustrative of the reasonable certainty that StarLink corn presents no harm in the food supply.
In addition, BIO contracted with Medallion Laboratories to quantify the amount of Cry9C protein in finished products. The results of this study show that while the Starlink protein is detectable at the expected level in the grain, it is not detected easily in any of the other samples. During the masa process, discarded steep and wash water fractions were analyzed and none of the target protein was detected. In the masa dough, a very (very) low level of the target protein was detected. This is at the limit of detection of the method, below the level that can be quantified reliably. At or below this extremely low level, accurate or reliable interpretation of the results is not possible. The limit of detection of the protein for the two Western Blot assays used is 50 picograms of protein in a single band. In the samples representing a dough process and a cereal process the level of the target protein was slightly higher, although still barely above the level of detection. Again this was not at a level that can be quantified without further extensive experimentation.
This study confirms the premise that the processing of corn containing the Starlink protein Cry9C, significantly reduces the level of detectable protein. To put this in perspective StarLink has only 0.0129 percent of the total protein in grain in the raw product. By the time the corn is processed into a finished product, protein is barely detected at 50 picograms which is several orders of magnitude below the level of detection in the raw product. The report from Medallion Laboratories is attached.
Given all this information, StarLink corn cannot be considered a potential allergen, especially under the circumstances of limited exposure. I urge you to provide the EPA with a report that clearly states the science in this matter and the limited exposure of the public to StarLink. And finally, I encourage you to urge the EPA to grant a time limited exemption from the requirement of a tolerance for StarLink corn.
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