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Statements and Comments
Biotechnology
February 26, 2001
Ms. Janet L. Anderson
Office of Biopesticides and Pollution Prevention
U.S. Environmental Protection Agency
Ariel Rios Building
1200 Pennsylvania Avenue, NW
Washington, DC 20460
Mr. L. Robert Lake
Office of Regulation and Policy
U.S. Food and Drug Administration
200 C Street, SW, Room 5807
Washington, DC 20204
Dr. David R. Shipman
Office of the Administrator
U.S. Department of Agriculture
Grain Inspection, Packers and Stockyards Administration
1400 Independence Avenue, SW
Washington, DC 20250
Re: Adventitious Presence; StarLink(tm) Corn
Dear Ms. Anderson, Mr. Lake, and Dr. Shipman:
The American Seed Trade Association (ASTA) would like to thank all of you for meeting with us and seed company representatives on Feb. 9 to discuss the regulatory and other aspects of testing and addressing adventitious Cry9C protein or nucleic acid in corn seed (hereinafter, Cry9C is referred to as "StarLink(tm)"). As we explained, there are several agronomic and other considerations that pertain to StarLink(tm) testing in seed. These factors are summarized in this letter in hopes that we can follow up on them with you in meetings over the next several months. These meetings would be for the purpose of discussing the adventitious presence of StarLink(tm) in corn seed and the broader topic of adventitious transgenic events in conventional seed. Our objectives would be the same as those outlined in the Feb. 9 meeting, namely to:
- help our members accurately identify seed lots with StarLink(tm) and take all necessary steps to ensure that this seed is properly disposed;
- help minimize StarLink(tm) content in next year's commercial corn crop, yet ensure that the regulatory agencies understand that StarLink(tm) is not primarily a seed industry issue;
- minimize the financial impact to the hybrid corn seed industry caused by the disposal of seed inventory containing StarLink(tm); and
- gain support for realistic levels of adventitious transgenic content in conventional seed and for process-based procedures to ensure such levels are met.
We also wish to put into perspective preliminary data that an ASTA member shared with you during our Feb. 9 meeting, which are apparently being widely disseminated and misunderstood. The data suggested that adventitious StarLink(tm) was being found in one to five percent of all corn seed lots tested in accordance with the USDA's recommended protocol or more stringent criteria. The percentages represent a broad range of possibilities pertaining to certain seed lots that were tested for StarLink(tm). Such lots are not representative of all corn seed lots, nor of those distributed by the major members of ASTA. These percentages were presented only for the purpose of demonstrating the extent of possible economic consequences that members may face in light of the StarLink(tm) problem. Therefore, they should not be represented as seed industry statistics on current levels of StarLink(tm) in conventional seed.
More importantly, we wish to re-emphasize that ASTA members and the seed industry at large are very aware of the efforts of the federal agencies, including the EPA, FDA, and USDA, to remove StarLink(tm) from the food chain. Seed companies also are well aware of FDA's and USDA's StarLink(tm) testing recommendations and guidelines. Considerable effort has been and is being expended by the seed industry to test for StarLink(tm) and remove seed containing StarLink(tm) from distribution channels, consistent with USDA's and FDA's recommendations. Moreover, the seed industry is acutely aware of the potential legal ramifications of planting StarLink(tm) corn.
We also wish to reiterate that ASTA came into the Feb. 9 meeting to discuss testing for StarLink(tm) and the disposition of StarLink(tm)-positive seed in the context of the difficult issues that such testing and disposition requirements present, both domestically and internationally. In light of these issues, we wish to re-emphasize the following points:
- the majority of the seed industry, like others in the food chain, is a victim of the present set of unfortunate and unique circumstances;
- agency testing, sampling, and disposal recommendations, based on a variety of considerations apparently unrelated to food safety, can involve more regulatory flexibility than is currently evident, particularly since a zero level of adventitious StarLink(tm) or other transgenic event cannot be easily achieved;
- the agency recommendations, promulgated as guidelines, were developed without seed company involvement, but now the seed industry seems to have the primary burden for complying with them ; and
- seed company margins are generally very low, hence, the StarLink(tm) situation may create particularly dire economic and other hardships for many seed companies.
Due to the above factors, we again ask the government agencies to work with us in addressing the presence of StarLink(tm) in seed and the problems that such presence imposes on the seed industry. We specifically ask the government agencies to:
- reconsider the levels of StarLink(tm) that are deemed acceptable in seed;
- find other solutions to the StarLink(tm) seed problem that are based less on regulatory compliance considerations; and
- support economic and other types of relief that will help the seed industry bear the disproportionate effects of FDA's and USDA's StarLink(tm) grain and food recommendations.
Conventional Seed Purity
While our meeting focused on StarLink(tm), the broader discussion was about the adventitious presence of proteins, nucleic acids, or both in approved and unapproved* transgenic events in all seed and grains. As you may know, seed is produced in and subject to open environments and therefore, is open-pollinated. As the physiology of all agronomic and horticulture plants varies, the same practices, or assumptions with regard to seed purity cannot be applied across the board to all seed. Each seed crop or crop category often has specific national, international, as well as company purity standards that are based on production realities, research and development, available technology, and consumer demand. There are a variety of regulations already applicable to seed, one of the most regulated agricultural products in the world. Phytosanitary, noxious weed, and seed labeling regulations exist, as well as certification and physical and genetic purity standards among others.
The existing seed standards involve physical (mechanical or phenotypic) and genetic (varietal) purity. Physical purity refers to the percentage of pure seed, excluding soil particles, weed seed, and seed parts, among other materials. Genetic purity refers to the homogeneity of a seed lot with respect to a specific variety that has been determined to be distinct, uniform, and stable. Genetic purity standards, field inspection techniques, and production isolation distances between fields are utilized to maintain the genetic purity of parent, foundation, and certified seed. Each seed crop often has different isolation distances and purity standards.
Loss of genetic purity or varietal changes can occur due to a variety of reasons. Handling methods, storage facilities, natural crosses, genetic mutations, random genetic drift, and other selection factors can affect genetic purity. Therefore, no commercial seed is one hundred percent genetically or mechanically pure. In other words, for the same reasons that make it almost impossible to sell traditional seed that is one hundred percent "genetically pure," it is currently impossible to guarantee that traditional seed will not have any adventitious transgenic presence.
Zero Adventitious Presence
In light of the foregoing considerations, we hope that the EPA, FDA, and USDA all understand that the goal of achieving zero adventitious presence of StarLink(tm) or any other transgenic event is very difficult to attain. Indeed, since analytical detection methods and seed sampling and handling procedures all have their own limitations, too, a certain tolerance or other level of adventitious presence must be allowable; otherwise, no seed, grain, or food/feed product can be effectively marketed. In terms of sampling methods, a zero level of adventitious presence in seed cannot be assured unless all the seed kernels are tested for adventitious presence, in which case, no seed would be left to sell because seed is destroyed in the testing process.
Current regulatory examples of other forms of adventitious allowances are defect action levels and action levels, which are set by FDA. These levels pertain to the presence in foods of insect filth and larvae, mold, and rodent filth, among other substances, and for contaminants, including various pesticides and other chemicals, such as lead and mercury. These types of limits may be based on safety considerations and/or detection and sampling limitations. Such levels may also be based upon marketing considerations in accordance with current market demands, such as in the case of organic foods. These types of limits, whether they are called tolerances or action levels, can be described from a regulatory standpoint as minimal acceptance levels, regardless of whether such levels involve substances that are approved or unapproved.
Moreover, we believe that any statements to the effect that testing or other practices will ensure that no StarLink(tm) or other transgenic event is present in the food supply are inherently misleading. The use of different testing methods and practices to try to achieve the complete absence of adventitious presence of StarLink(tm) or other transgenic events in conventional seed may create the false expectation that a zero tolerance level can be easily achieved. This false expectation leads consumers and others to believe wrongly that anything more than zero presence is unacceptable. As a result, market acceptability here and abroad is threatened. Recent events involving StarLink(tm) painfully demonstrate how different market sectors can be drastically affected by such a false expectation.
For all of the above reasons, when levels of adventitious presence that apply to the seed industry are set or recommended by government agencies, ASTA requests that it be notified in advance. This will help ensure that criteria are developed that can be achieved by the seed industry, the first link in the food chain. Seed industry input on the development of such criteria is particularly important because such levels in processed foods do not necessarily correlate with levels in seed.
International Seed Network Initiative
Consistent with its current efforts with respect to StarLink(tm), the seed industry passed in May 1999 a resolution within the International Seed Trade Federation recognizing adventitious transgenic presence in traditional seed. In June 1999, the seed industry designed an initiative named the International Seed Network Initiative (ISNI) to scientifically address the problem. Subsequently, in August 1999, ASTA, under the umbrella of the International Seed Trade Federation (FIS), officially launched the initiative and sought the participation of interested governmental, national seed associations, and international seed-regulatory organizations.
The objectives of the ISNI are to establish realistic tolerances or thresholds for adventitious transgenic presence in conventional seed; provide science-based information that will assist in the establishment of a globally accepted tolerance level for adventitious transgenic presence, resulting in minimal disruption to international seed trade; develop confidentiality and licensing agreements between technology providers and public and private laboratories for the global dissemination of primers and test protocols that can be used to verify adventitious transgenic presence pertaining to specific events; design and implement enhanced quality assurance systems for seed production to minimize adventitious transgenic presence in conventional seed, including a focus on minimum distances and pollen flow; and gain global consensus that the minimization of adventitious presence can be achieved through a process-based approach in addition to testing.
With respect to the current status of the ISNI, despite three separate attempts by ASTA, FIS, and Organization for Economic Cooperation and Development (OECD) to obtain international support, the initiative was not formally adopted under the OECD Seed Schemes. The European Union was the primary obstacle. Moreover, the U.S. government refused to grant legal status to the initiative and agree to a one percent tolerance for all known events, only for events approved in the United States. The FIS as well as other international organizations, including the OECD Secretariat, have agreed to proceed with the ISNI on an experimental basis since Europe has refused to participate. A number of other countries have been identified as potential participants in the experiment, while the seed industry continues to test its seeds, press for an internationally-supported level of adventitious presence of one percent for all known transgenic events, and legal status for the ISNI.
We hope that this letter adequately details our StarLink(tm) discussion as well as summarizes key points outlined at our Feb. 9 meeting. We believe that the seed industry has an important role in addressing the StarLink(tm) situation and ASTA takes this responsibility seriously.
We look forward to working with you on a continuing basis to establish criteria that ensure the acceptability of seeds derived through the use of modern biotechnology. By the same token, we hope the federal agencies will recognize the unique problems that StarLink(tm) has created for all members of the food chain and the seed industry in particular. There is a need for immediate governmental solutions to our seed problems, beyond testing, in order to reach the mutual goal of eliminating StarLink(tm) from the food supply as quickly as possible.
If we can be of more immediate assistance, please let us know.
Cordially yours,
Dean Urmston
Executive Vice President
cc: American Crop Protection Association
American Farm Bureau
Biotechnology Industry Organization
Corn Refiners Association
Food Marketing Institute
Grocery Manufacturers of America
National Corn Growers Association
National Feed and Grain Association
National Food Processors Association
* We use herein the terms "approved" and "unapproved" to refer generally to premarket and other reviews conducted by the EPA, USDA, and FDA, including research permits or authorizations and the registration of pesticides by EPA and deregulation of plants by USDA that pose plant pest risks. "Unapproved" in the context of StarLink(tm) refers to the lack of EPA registration and tolerances or exemptions from tolerances with respect to human food use.
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