November 27, 2000

Re: Docket Control Number - OPP-00688

Members of the FIFRA SAP, I appreciate this opportunity to submit these comments on behalf of Beyond Pesticides/National Coalition Against the Misuse of Pesticides (Beyond Pesticides/NCAMP). Beyond Pesticides/NCAMP is a national, membership organization that represents a range of people seeking to protect human and environmental health from the misuse of pest control technologies. We are working to improve protections from pesticides and promote sound, ecologically based pest management and agricultural strategies. To that end, I submit these comments in opposition to the petition by Aventis CropScience USA for an exemption from the requirement of a tolerance for the genetically engineered (GE) plant-pesticide in StarLink corn.

This petition, seeking an exemption for a tolerance for the pesticide in StarLink, highlights two issues. The first, and most important for the FIFRA SAP, is whether Aventis fails to satisfy the requirements for an exemption under the Federal Food, Drug and Cosmetic Act (FFDCA) (21 USC 9) § 346a. The revised updated safety assessment supplied by Aventis does fail to satisfy FFDCA § 346a in the opinion of Beyond Pesticides/NCAMP. Therefore, the FIFRA SAP should advise EPA that it cannot grant the exemption of a tolerance for Cry9C found in StarLink.

The second issue is important while considering the efficacy of the current regulatory system that exists for GE crops. The fact that Cry9C was discovered in food destined for human consumption raises the question of whether the Food and Drug Administration (FDA) can enforce EPA's registrations of GE foods. The obvious answer drawn from this crisis is that FDA cannot adequately police the contamination of the food supply with unregistered GE pesticidal crops. This, in turn, calls into question whether EPA can continue to register GE pesticidal crops while protecting human and environmental health.


StarLink corn has been genetically engineered to produce the pesticidal protein Cry9C. According to documents submitted by Aventis, EPA registered StarLink corn in 1998 for use as an animal feed and for certain industrial uses. EPA did not grant a tolerance for Cry9C for use in human food because EPA was not able to determine whether Cry9C was an allergen. Pursuant to the registration, StarLink corn was planted in 1998, 1999, and 2000. Under the law, FFDCA § 331, this corn cannot be used in the production of food destined for human consumption.

In September of 2000, the advocacy group Genetically Engineered Food Alert published the results of test that showed that the Cry9C protein from StarLink corn was in taco shells. This was a clear violation of EPA's registration of Cry9C. Subsequent testing found Cry9C in a number of food products on the shelves in supermarkets. Dozens of products containing the corn have been recalled as a precaution, costing millions of dollars. Aventis filed a petition with EPA requesting that the agency grant an exemption to the tolerance requirement for Cry9C.

Aventis does not Satisfy the Requirements for an Exemption

Aventis has supplied EPA with a revised updated safety assessment of the pesticide Cry9C as part of its petition for an exemption from the requirement of a tolerance. This safety assessment does not meet the standard for such an exemption under FFDCA. Under FFDCA § 346a(c), EPA cannot establish an exemption from the requirement for a tolerance for a pesticide until the agency can conclude that there is a reasonable certainty that no harm will result from exposure to the pesticide. The revised safety assessment fails to provide EPA with adequate information to reach that conclusion.

Assumption of Limited Exposure is Invalid

The revised assessment states at page 10 that the analysis takes into account available information about the amount of StarLink corn planted in 1999 and 2000 and the known or probable disposition of that corn. This statement suggests that if Cry9C were granted the exemption sought by Aventis, that the amount of StarLink corn would not increase in the human food supply. In fact, the conclusion of the assessment is based on this assumption (see page 10 of assessment).

This assumption, of very limited exposure to Cry9C due to the relative quantity of StarLink corn in the human food stream, would change if the exemption were granted. Therefore, the entire analysis is flawed. In order to conclude that Cry9C does not pose an unreasonable risk to human and environmental health, EPA must consider data that reflects the amount of Cry9C that could enter the human food stream as a result of the exemption. The agency cannot reach that conclusion based on the revised assessment.

Exposure to Infants and Children

Aventis fails to provide EPA with information necessary to assess the risk of the pesticide to infants and children under FFDCA § 346a(b)(2)(C). Aventis stresses in its revised assessment that throughout the grain handling process there is a continuous blending and commingling of corn from any one farm (see page 11 of revised assessment). Therefore, it is impossible to ascertain how much StarLink corn could find itself in any given food product. This problem is compounded by the potential increase in the amount of StarLink corn introduced into the human food stream if an exemption were granted.

There is currently inadequate information about the allergenicity of Cry9C to make a determination about the special susceptibility of infants and children to this pesticide as required under FFDCA. Until Aventis can provide EPA with this information the agency should be precluded from granting an exemption.

FFDCA requires EPA to assess the risk of Cry9C based on available information concerning the cumulative effects and aggregate exposure on infants and children. The revised assessment states at page 16 that for StarLink corn, there is no history of significant consumption and the conclusions reached by the revised assessment are based on this fact. EPA cannot conclude that the cumulative or aggregate effects of Cry9C would not pose an unreasonable risk to children based on the limited amount of information currently available.

FDA's Inability to Enforce Tolerance Registrations

EPA has established a process to register the pesticides found in GE crops. StarLink was registered only for animal feed and some industrial uses as a result of that process. Tests conducted by non-governmental organizations found Cry9C in a number of food products destined for human consumption. More recently, a Washington Post article (11/22/2000) reports that Cry9C has been found in a corn hybrid other than StarLink. Aventis has admitted it has no idea how the Cry9C protein got into the other hybrid. Has FDA begun a process of looking into what other types of GE products have found their way into the human food stream in violation of their current tolerance registrations?

Has EPA brought an action against Aventis, or any other company, for violation of FFDCA § 331? The law prohibits the introduction of adulterated food into commerce. FFDCA § 342 deems food to be adulterated if it contains a pesticide chemical that is unsafe. A pesticide is defined as unsafe if it does not have a tolerance in effect. Cry9C does not currently have a tolerance in effect for human food and yet it has been found in a variety of food products.


The FIFRA SAP should consider both the inadequacy of the data provided by Aventis in its revised safety assessment as well the federal governments inability to enforce its tolerance registrations while developing its recommendations to EPA. The information provided in the revised assessment cannot allow EPA to conclude that Cry9C does not pose an unreasonable risk to human health. This is particularly true when considering the effects of exposure of Cry9C to infants and children.

Current events demonstrate that the federal government is incapable of enforcing its pesticide tolerance registrations. In addition, GE pesticides are drifting into other hybrid varieties, and the biotechnology companies like Aventis cannot explain how that is happening.

For these reasons, FIFRA SAP should not recommend that EPA grant the tolerance exemption sought by Aventis for Cry9C.