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Comments to APHIS regarding impact on functionality of products

Industry Comments to APHIS
Regarding the Deregulation of 3272 Amylase Corn Trait

January 20, 2009

Docket No. APHIS-2007-0016
Regulatory Analysis and Development, PPD
APHIS, Station 3A-03.8
4700 River Road, Unit 118
Riverdale, MD  20737-1238

Comment on Docket No: APHIS-2007-0016 Re: Syngenta Seeds, Inc.; Availability of Petition and Environmental Assessment for Determination of Nonregulated Status for Corn Genetically Engineered To Produce an Enzyme That Facilitates Ethanol Production

The undersigned trade associations representing the grain handling, grain export, food and feed industries in the United States and North America appreciate this opportunity to comment on the petition to deregulate Syngenta’s Alpha-Amylase Maize Event 3272.  We write to urge the Department to suspend its consideration of Event 3272 until such time as the effects the event might have on food and feed can be adequately assessed and understood.

Syngenta’s Alpha-Amylase Maize Event 3272 was specifically developed for use in the manufacture of ethanol.  Although the corn variety promises to be a useful technology for ethanol production, there are several outstanding questions concerning the effects on corn milling, feed quality attributes, and food processing.  Consequently, Syngenta’s plans for handling the genetically altered corn in a closed-loop system have not been adequately characterized or developed to ensure that there is no impact on downstream stakeholders or related industries and therefore these systems are also of utmost interest.

Regrettably, the docket and petition for deregulation lacks adequate scientific data or documentation necessary to evaluate the possible impacts on food and feed functionality should this maize event be comingled with commodity supplies of corn.  Syngenta has publicly acknowledged that there are negative effects on certain food processes if this Maize Event 3272 is not managed appropriately and in response has developed a closed-loop channeling program to attempt to keep it separate from the food and feed supply chain.

We believe that as part of any deregulation of any GM crop with unique functional characteristics, the public record should include an appropriately comprehensive analysis of the impacts of the product on existing food and feed processes and products to determine the level of inclusion that such a product can be present without significantly impacting product functionality and thus rendering it a plant pest. Such studies and the results of any initial tests are critical to inform Syngenta and all industry sectors potentially affected, and more importantly to provide information regarding risk and risk abatement mechanisms that will be required to ensure the food and feed sectors are not harmed by this deregulation.

In the absence of this data, it is impossible to determine whether the proposed closed loop channeling program is sufficient. To date, Syngenta has only agreed to provide what data it has generated to those companies and organizations that agree to be bound by the restrictions of confidential disclosure agreements and as such there is no basic stakeholder understanding if the existing data is sufficient or if the proposed management programs for the event are appropriate for this event deregulation.

As is the case with the deregulation and commercialization of all GM events that contain unique functional characteristics, in the absence of an adequate risk assessment, risk management, and risk responsibility plan, the deregulation of Event 3272 has the potential to become a plant pest and these damages may extend to all users of corn for food, feed and processing. In light of the U.S. District Court ruling in Geertson Farms, Inc. v. Johanns, we believe that the deregulation of products with unique functional characteristics requires a more comprehensive, transparent approach and the existing data in this submission is insufficient.  In short, the limited information available on this subject causes us to question whether Alpha-Amylase Maize Event 3272 is “functionally equivalent” to corn and has the potential to become a plant pest.

Approximately 70 percent of the corn produced in the U.S. is used in processed food, feed and industrial products.  It is important that information regarding “functionality” effects be understood by the applicant requesting deregulation and that appropriate risk assessment, risk management, and risk responsibility has been established and made available to the public prior to a deregulation of this class of products.  Differences in functionality could have negative, costly impacts on ready-to-eat cereals, snack foods,  blended corn products used for food aid, as well as livestock feed if such products are not adequately characterized and managed.  These unknown effects could also negatively affect the exports of U.S. products, result in increased capital costs to processing facilities, and require expensive testing through the grain handling and processing system. In addition, without adequate assessment and risk mitigation in place, we fear the establishment of regulatory and commercial restrictions on U.S. corn in international markets.

Given the uncertainty and lack of publicly-available information regarding the risk assessment and risk management associated with Syngenta’s Alpha-Amylase Maize Event 3272 application, deregulation of this product should occur only after the potential for this corn event to be a plant pest can be accurately assessed by the U.S. government in consultations with relevant industry stakeholders.  In addition, agencies of the U.S. government charged with assessing the legal standards should be consulted and rule prior to the deregulation of this product.  We therefore request a suspension of the deregulatory process until the U.S. government agencies responsible for the oversight of agricultural biotechnology can reconsider the docket and the applicant requesting deregulation can present appropriate and necessary information to assess the impact of corn amylase on food, feed and processing and, subsequently, its potential to become a plant pest.

The National Grain and Feed Association (NGFA), a not-for-profit trade association established in 1896, consists of 900 member companies from all sectors of the grain, feed, processing and exporting business that operate about 6,000 facilities nationwide and handle more than 70 percent of all U.S. grains and oilseeds. The NGFA’s membership encompasses all sectors of the industry, including country, terminal and export elevators; feed and feed ingredient manufacturers; cash grain and feed merchants; end users of grain and grain products, including processors, flour millers, and livestock and poultry integrators; commodity futures brokers and commission merchants; and allied industries. The NGFA also consists of 35 affiliated state and regional grain and feed associations, as well as two international affiliated associations.

The North American Export Grain Association (NAEGA), a not for profit trade association, established in 1912, consists of private and publicly owned companies and farmer-owned cooperatives that are involved in and provide services to the bulk grain and oilseed exporting industry.  NAEGA’s mission is to promote and sustain the development of commercial export of grain and oilseed and their primary products. Through a reliance on member action and support, NAEGA acts to accomplish this mission from its office in Washington D.C., and in markets throughout the world.

The North American Millers’ Association (NAMA), is the trade association of the wheat, corn, oat and rye milling industry. It is comprised of milling member companies operating mills in the United States and Canada and associate member companies representing the industries providing products and services to the mills. The aggregate production capacity of NAMA milling members is more than 160 million pounds of product daily, which is about 95% of the total U.S. capacity.

Sincerely,

Kendell Keith, President
National Grain and Feed Association

Gary C. Martin, President and CEO
North American Export Grain Association

Betsy Faga, President
North American Miller’s Association

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