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News Releases
| DATE: | July 8, 2004 | | CONTACT: | Dick Crowder | | | (703) 837-8140 |
A SEED INDUSTRY RESPONSE TO ISSUES RAISED BY THE PRESENCE OF BIOTECH SEED IN CONVENTIONAL SEED LOTS EXECUTIVE SUMMARY
Commentaries on the presence of biotech seed in conventional seed lots have often mischaracterized modern seed production practices and offered recommendations unsupported by science, regulation, and modern farm practices.
The American Seed Trade Association (ASTA) believes the following with respect to the presence of biotech seed in conventional seed lots:
1. The presence of trace amounts of commercially-approved, biotechnology-enhanced seed in conventional seed lots is accepted in crop production and presents no risk to humans or the environment.
2. Fully tested, deregulated biotech seeds are not “contaminants.” They are free to move through U.S. commerce, the same as any other seed.
3. Fully tested, deregulated biotech seeds have neither special rules regarding handling nor threshold levels to be maintained in food or feed in the U.S.
4. Because fully tested, deregulated biotech seeds move through the same channels as conventionally bred seeds: some low level of commingling is fully understood and expected.
Some reports have made two primary assertions--both unfounded; namely:
1. That if deregulated traits can be found in food or feed, it would be “minimally prudent” to assume that experimental, regulated traits also are present in the food and feed supply.
In response, the seed industry asserts that these experimental traits are stringently regulated precisely to prevent this sort of commingling.
2. That biotechnology is a threat to the organic industry.
On the contrary, biotech crops pose essentially no threat to organic certification. According to existing regulations, farmers growing for organic certification can’t plant biotech crops. But there are no restrictions on what is allowable in terms of unintended biotech presence. This issue is one that seed companies and farmers will continue to address using appropriate economical solutions and market approaches.
The American seed industry has had a long and rich history of producing quality products that meet rigorous seed purity standards. Federal and international seed purity standards set stringent guidelines that allow the commingling of commercially-approved seeds. Working within these standards, our industry will continue to fulfill its responsibility for producing high quality, economically viable seeds that benefit farmers, consumers, and our global food production system.
Introduction – Regulated vs. Deregulated Traits
The development of seeds that contain biotechnology traits is regulated by three agencies of the federal government. Developers of such seeds must conduct an extensive array of studies to demonstrate the health and environmental safety of their products prior to commercialization. These studies are reviewed by the U.S. Food and Drug Administration (FDA), the U.S. Department of Agriculture (USDA) and in some cases the U.S. Environmental Protection Agency (EPA). During this developmental and testing phase, seeds containing the biotech trait are not to be commingled with conventional seeds, and extensive protocols are in place to prevent commingling.
When regulators receive enough scientific data to conclude that biotech seeds are substantially equivalent to and therefore as safe as their conventional counterpart, the seeds are de-regulated. De-regulation means just what it implies. There are no special rules concerning the planting of de-regulated seeds. Likewise, food safety regulations treat the presence of de-regulated transgenic material in food or feed no differently than any other agricultural commodity because they are considered as safe as their conventionally bred counterparts. Once a biotech trait has been de-regulated, the seeds and grain may enter the commodity system in countries where the trait is approved and typically are handled the same as conventionally-bred seeds and non-GM grain.
The Presence of De-regulated Biotech Seed in Conventional Seed Lots Are Not “Contaminants”
The presence of biotech seed in conventional seed lots has been characterized by some as “contaminants.” Using the word “contaminant” to depict the presence of biotech seed in conventional seed lots unnecessarily confuses the public by implying that the U.S. seed industry must segregate de-regulated biotech seeds from conventionally bred seeds when, in fact, there is no regulation that requires segregation and no science that would justify it. Such claims disregard the seed industry’s use of stringent purity standards in its production systems for many years and the vast differences between handling procedures for regulated and de-regulated biotech traits. It is erroneous to assume that if de-regulated biotech seeds can be found in non-biotech seed bags, then regulated, experimental seeds are present as well.
Industry Purity Procedures Pre-date Biotechnology
While there are no requirements to segregate deregulated seeds, the U.S. seed industry does strive to serve all segments of its customer base, and some customers choose to plant non-transgenic seeds. Seed companies are providing such seeds in adherence with industry-wide purity standards that were in place long before biotech seeds were developed.
The seed industry assures seed varietal purity by production processes based on best management practices, quality assurance processes, and quality control checks. These standards ensure a very high level of purity, but the industry and its customers know that it is impossible to ensure that a shipment of conventional seed is 100 percent free of off-types, including biotech traits. Just as a low level of off-types is expected in a bag of a specific hybrid or variety, it is possible that conventionally-bred seed will have a low level biotech presence.
If a higher degree of seed purity is requested and the customer is willing to pay for such an extra measure of purity, the seed industry can take steps to further reduce commingling. Even then, however, when millions of tons of conventional and de-regulated biotech seeds are produced, shipped and stored each year, it is inevitable that some genetic and physical commingling will still occur at low levels.
Requirements for Regulated Seeds
Unlike de-regulated commodities, which are grown on millions of acres, regulated traits in development are grown on small test plots. Consistent with current rigorous regulatory requirements, these plots are isolated from de-regulated material and measures such as shoot and tassel bagging may be in place to control pollen flow. The American Seed Trade Association supports these rigorous and mandatory precautions for regulated material and agrees that biotech traits that have not met the safety criteria for food and feed use should not be tolerated in commodities.
Crops Grown for Specialty Uses
A number of pharmaceutical and industrial traits are now being tested, with the intention to extract specialty proteins from plants and use them to make high-value end products. Even when these high-value crops receive regulatory approvals, they are grown in very limited quantities, on small plots, by only a few experienced growers specifically selected by the manufacturers for their ability to adhere to rigorous containment procedures. These growers readily agree to maintain proper procedures because they know they derive significant financial benefit from producing a high-value, premium crop, which may be rendered valueless if it exceeds specifications for material from conventional or other biotech crops.
None of these rigorous requirements apply to de-regulated crops. When growers farm conventional crops or crops with deregulated traits, they can use the same planting and harvesting equipment, storage facilities and shipping procedures. Consequently, some level of commingling is inevitable. Since de-regulated biotech seeds have regulatory clearance in the U.S. and are considered to be as safe as conventionally-bred seeds, there is no safety concern that pollen may be transferred from one crop to another; and no need to ensure that volunteer crops are destroyed for safety purposes in following years.
But with regulated crops, the situation is almost the direct opposite. There must be segregation or extensive cleaning of equipment, storage facilities and shipping vessels; every practical measure must be taken to avoid pollen transfer either from or to the site; and volunteer crops must not be allowed to grow.
Government Oversight of Field Trials
Field trials for experimental traits are regulated by the USDA’s Animal and Plant Health Inspection Service (APHIS). Field testing of regulated crops is conducted in phases. Field testing typically begins with a small number of plants contained in greenhouses and expands to small field plots as more data are generated. Developers conduct initial testing in USDA-approved laboratories and greenhouses that meet or exceed USDA standards. After those evaluations, trait developers seek APHIS approval to conduct confined, isolated, small-scale field trials typically consisting of only a few dozen plants. Only when the required information has been gathered can developers receive permission to move to larger scale field trials, but the material is still regulated. APHIS evaluates each request for a regulated field trial on a case-by-case basis and develops appropriate procedures for each trial.
APHIS typically requires a combination of procedures to ensure that regulated biotech traits are not commingled with conventional seed. These procedures include:
• Proper isolation - The regulated crop must be planted in a defined area with a buffer between it and its conventional commercial counterpart. The distance of the buffer strip varies depending on the trait being tested and the type of crop. For pharmaceutical and industrial traits, APHIS requires a one-mile buffer.
• Crop destruction - All seeds and plant material from the field trial must be destroyed, with the exception that developers may collect and safely store enough plant material and seeds to continue testing.
• Equipment hygiene - Any equipment used in planting or harvesting the field trial must be thoroughly cleaned before it can be used for other trials. In some cases, equipment may be dedicated solely for the trait being tested.
• Pollen Containment - In addition to buffer strips, other procedures may be required to minimize out crossing. For example, corn tassels may be removed or covered with bags to control pollen from moving off site.
• Control of Volunteer Plants - After a trial has been completed, the site must be monitored for volunteer plants the following season and procedures implemented to destroy them. Also, no crop of the same species can be planted on that site the following season. This prevents any volunteers from the field trial from being harvested accidentally.
In addition to these in-field procedures, APHIS requires a number of restrictions on the shipping and handling of seed and plant material to ensure against release into the environment.
Since 1986, when the first biotech field trials were begun, there have been tens of thousands of regulated field tests for various traits, primarily agronomic. Because seed developers have adhered rigorously to prescribed testing measures for regulated trials, these field trials have not resulted in any known commingling with conventional seeds.
Now, in an effort to achieve more flexibility to anticipate and keep pace with new types of biotech seeds, such as pharmaceutical and industrial traits, APHIS is proposing to enhance its regulations. By formalizing its authority under the Plant Protection Act, APHIS will in all likelihood add new restrictions for field testing and strengthen the regulation of certain traits that may be perceived to have higher risk. Some traits may never reach the de-regulated status and always be managed as a regulated event.
ASTA supports APHIS' intent to review and strengthen its regulations. The current system has been effective and protective, but the proposed changes will give APHIS a stronger statutory footing for its science-based oversight and will provide increased assurance that unfamiliar regulated biotech traits will not commingle with the commercial seed supply.
Presence of De-regulated Material Does Not Mean Presence of Regulated Material
Given the preceding, it is clearly incorrect to conclude that because de-regulated material has been commingled, this must also be the case for regulated material. The procedures followed and the precautions taken in each case are entirely different and there is no evidence that the commingling of regulated traits with other crops has occurred. Moreover, the proposed changes in regulation will provide further assurances that commingling of regulated traits will remain highly unlikely.
Biotech Seeds Do Not Threaten Organic Markets
Biotechnology poses essentially no threat to organic certification. When the United States was in the process of adopting standards for organic certification, organic producers requested that the planting of biotech seeds not be allowed. Thus, even though some biotech crops control important insect pests without the use of chemical insecticides, they were not approved for use in organic operations. However, contrary to what some may believe, U.S. organic standards do not prohibit the adventitious or unintended presence of biotech-derived material in organic produce.
USDA’s National Organic Program website http://www.ams.usda.gov/nop/Q&A.html#Production/Handling explains the regulatory policy:
“This regulation prohibits the use of excluded methods [which include biotech varieties] in organic operations. The presence of a detectable residue of a product of excluded methods alone does not necessarily constitute a violation of this regulation. As long as an organic operation has not used excluded methods and takes reasonable steps to avoid contact with the products of excluded methods as detailed in their approved organic system plan, the unintentional presence of the products of excluded methods should not affect the status of an organic product or operation."
In other words, an organic producer is not prohibited from selling his or her produce as certified organic if it contains unintentional or adventitious levels of biotech material as long as the producer has followed the certification process. The product could still be certified organic and the producer could realize any premiums that such a certification would afford in the marketplace. In order to sell their crops as organic under U.S. regulations, growers must be able to demonstrate that they did not intentionally plant a biotech variety.
The National Organic Program has not established any threshold for the presence of biotech material in organic food as it does for residues of other prohibited substances, such as pesticides. If an organic crop is unintentionally contaminated by a pesticide, the crop cannot be sold as organic if the pesticide residues exceed five percent of the amount allowed on non-organic foods. USDA established no such yardstick for the presence of de-regulated biotechnology traits in organic material. It is incongruous that some call for a zero tolerance for biotech materials, which are de-regulated and have been found to be as safe as conventionally derived material, when allowances are made for residues of other non-organic materials.
Biotechnology has had no effect on the vast majority of organic growers, who tend to specialize in higher value fruit and vegetable crops. In North America, the primary biotech food crops to be commercially planted are canola, field corn and soybean. In 2003, organic production accounted for only 0.22 percent of the acres devoted to those three crops. In contrast 60 percent of the acres of those crops were planted with biotech seeds – 80 percent of soybeans, 70 percent of canola and 41 percent of corn planted in the U.S. and Canada in 2003 were biotech. Farmers choose biotech seeds because they help them cut back on pesticide usage, reduce tillage trips and fuel consumption, produce higher yields and reduce costs.
It is also important to note that there are a growing number of companies in the American Seed Trade Association that are focused on providing the organic producer with high quality organic seed varieties produced using organic standards. These companies are certified under current National Organic Program requirements to produce certified organic seed and continually endeavor to meet the market needs and desires of organic producers.
Given that the majority of farm producers are choosing to plant biotech seeds, it seems inappropriate to impose the large costs of a zero tolerance policy on the entire seed industry, and ultimately the consuming public. This is especially true when the presence of biotech traits poses no certification restrictions or safety issues and there are a number of seed companies that are successfully meeting the requirements of the organic niche market and its customers.
A survey conducted by the Organic Farming Research Foundation in 2003, indicates that organic growers with the potential to be affected by neighboring GM crops have felt very little adverse impact. The survey shows that the vast majority (92 percent) have not incurred any costs or losses due to GM crops having been grown near their crops. Only 4 percent reported any lost organic sales or downgrading of produce as a result of GM adventitious presence. The other 4 percent incurred small additional costs for testing only.
Lowering Adventitious Presence Increases Seed Costs
The seed industry understands that there is a market for conventional seed. Indeed, a significant minority (about 40 percent) of non-organic crop acres are planted with conventionally bred seeds. For that market, the seed industry strives to deliver products that are of high varietal purity and, as a result have low presence of biotech traits. The quality control practices that seed companies have used for many years minimize the amount of off-types.
As discussed previously, in seed production it is impossible to ensure 100 percent purity. It is possible to achieve lower levels of off-types, including biotech off-types, by employing a number of strategies such as:
increasing field isolation distance
increasing the isolation time
increasing male field border rows
harvesting fields separately
cleaning equipment more thoroughly
moving the seed production to areas where the commodity crop is not grown
However, these measures increase the cost of producing seed while still not ensuring zero tolerance. A recent study by Dr. Nick Kalaitzandonakes of the University of Missouri-Columbia explores the economic impacts of variable thresholds on the global corn seed industry and its customer base. Assuming co-existence of GM and non-GM crops, researchers used industrial and economic simulation models that were calibrated with data from company records and practices of seed production facilities in the Midwest in order to quantify the potential economic impact of complying with various adventitious presence threshold levels. The research found, through a survey of seed companies worldwide, that a company’s average per unit costs would increase by 5-15 percent by going from a 2 percent to a 1 percent threshold. At a stricter 0.3 percent threshold, a company’s average per unit cost would go up by 27-42 percent.
Some growers may be interested in obtaining seed with extremely high levels of purity and may be willing to pay the cost for such seed. Since the needs of growers vary widely, demands regarding seed purity are more appropriately managed at the individual customer level, not as an overall national standard.
Having a low level of off-type material in seed won't be of consequence to a grower who is not planning to meet a specific contract or marketing standard, yet that grower would pay a higher cost for ‘traditional’ seed if a more stringent standard were broadly applied. Additionally, a grower who isn’t taking appropriate measures to meet a contract or market quality standard would not benefit from a specific varietal standard.
Rather than strive for unobtainable levels of seed purity that would increase costs to everyone, the seed industry believes the best course is to serve the vast majority of customers, who simply want high quality seed at an economical price.
Biotechnology’s Effect on Foreign Markets
According to the report, “Global Status of Commercialized Transgenic Crops: 2003,” by the International Service for the Acquisition of Agri-Biotech Applications (ISAAA), farmers planted 67.7 million hectares of biotech crops in 2003, an increase of 15% from 2002. For the seventh consecutive year, farmers around the world continued to increase the amount of biotech crops they planted in 2003. In addition, 7 million growers planted biotech crops in 17 countries in 2003, up from 6 million growers in 16 countries in 2002.
With increased acceptance of biotech crops worldwide, the global market for GM crops such as corn, soybean, and canola continues to grow. The global market potential for biotech crops and products remains strong despite existing barriers to the export of these crops to some parts of the world. ASTA supports the establishment of a science-based process for acceptance of adventitious presence of traits that have an approval by a member country of the Organization of Economic Cooperation and Development (OECD). This process would allow a realistic level of biotech seeds to be present in shipments of conventional seeds and would largely remove any barriers to the transport of U.S. seed and crops.
The Banking of non-GM Seeds
Some commentators have specifically advised USDA to establish a reservoir of seeds for non-engineered varieties of major food and feed crops free of transgenically derived sequences.
In response, the American Seed Trade Association points out that the National Plant Germplasm System, (www.ars-grin.gov/npgs), which is part of USDA’s Agricultural Research Service (ARS), maintains a storehouse of seed, ranging from wild relatives of agronomic crops to modern improved varieties. Much of the seed in the facility was collected prior to commercial use of genetically engineered crops. Periodically, the seed samples must be increased to assure viability and provide enough for further research and distribution. These increases are carried out under controlled conditions to maintain the integrity of each germplasm entry in the system. In addition, there are international repositories for nearly every major crop operating under similar procedures to preserve and maintain germplasm resources.
University, Governmental and Private Research
There have been calls on the USDA and land grant (agricultural) universities to reinvigorate the public plant-breeding establishment to help ensure a supply of pure seed of traditional crop varieties.
Many universities are actively engaged in germplasm improvement in both major and minor crops, and routinely collaborate with private breeding programs to ensure that discoveries are incorporated and available in commercially available seeds. These public programs are focused on improving seed varieties, and generally embrace both traditional and advanced technologies, including biotechnology.
The availability of traditional and biotech-improved seeds depends upon market forces that reflect the demand for traditional and biotech varieties. At the present time, demand for traditional and biotech seeds continues and there is choice in the marketplace.
Growers are aware that traditional seed varieties may contain a low level presence of approved biotech traits, and if they need varieties produced to more stringent standards, such as to meet a contractual agreement or marketing quality standard, they can contract with a seed supplier to produce traditional seeds consistent with their needs. In reality, this is rarely done, since the majority of growers planting traditional seeds are currently meeting their contractual commitments.
Summary
In summary, the causes of seed commingling are already well understood, both via hybridization and via mechanical processes. Additionally, transgenic plants currently being commercially grown have been extensively reviewed by the USDA, FDA and in some cases EPA, with regards to food and feed safety and their impacts on the environment. Since these plants have been shown to be substantially equivalent to their conventional counterparts, the commingling of biotech traits in conventional seed is well understood and equivalent to the commingling within conventional seed.
Extensive rules are in place to ensure that crops in development do not commingle with the food and feed supply. Biotech plants not designed for use as food or feed, such as industrial and pharmaceutical crops, are a unique case and specific strategies for appropriate containment are being implemented. Because of distinct differences in the way regulated and de-regulated traits are handled, it is not appropriate to suggest that the presence of de-regulated traits signals that regulated traits are likely to be in the seed supply.
Organic production is a process based system and under the US regulations, organic growers must simply be able to demonstrate that they did not intentionally plant a biotech variety. Therefore, the growing use of biotech-derived crops should not impact the ability of organic producers to market their product as organic.
The demand in some international locales, such as the EU, for GM-free seeds is a frustration in that de-regulated seeds, approved for import, may be rejected. However, the market demand for non-GM is a small fraction of overall commodity sales. The establishment of realistic adventitious thresholds would help to remove existing trade barriers. Setting thresholds at an unrealistically low level would serve only to increase seed costs, and ultimately food costs, for everyone.
Large repositories of non-GM seeds are stored throughout the world, providing assurances that seeds developed before the advent of biotechnology and non-GM seeds developed since that time remain available for future breeding purposes.
The American seed industry has a long and rich history of producing quality products that meet rigorous seed purity standards. Our producers are capable and willing to supply seeds produced to even more rigid standards for customers who need and are willing to pay for such seeds. While we will strive to meet those demands, we stake our reputation on producing high quality, economically viable seeds that make the most sense for the greatest number of customers.
Note: This document was approved by the ASTA Board of Directors during its meeting of July1, 2004 in Philadelphia, Pennsylvania.
### Founded in 1883, the American Seed Trade Association (ASTA), located in Washington, DC, is one of the oldest trade organizations in the United States. Its membership consists of about 900 companies involved in seed production and distribution, plant breeding, and related industries in North America. As an authority on plant germplasm, ASTA advocates science and policy issues of industry importance. Its mission is to enhance the development and free movement of quality seed worldwide.
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