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| Commercialization |
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Seed commercialization is the process of delivering top quality seed to the marketplace so farmers will have the best possible chance of economically producing high yielding, high-quality crops.
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| Introduction |
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 Seed commercialization is the process of delivering high quality seed to the marketplace so farmers will have the best possible chance of consistently producing high yielding, valuable crops. One important component of commercialization is identity preservation, a system that segregates and maintains the integrity and varietal purity of agricultural commodities to enhance the value of the final product. In its simplest form, identity preservation has been used since the beginning of agriculture when seeds and grain of different crops were first traded separately. As crops and production have diversified to meet market demands, the need for segregation through stewardship programs* and identity preservation has become more important. Crop varieties with unique traits – such as high oleic sunflowers – require programs to channel these commodities to specific markets to capture the added value. Similarly, organic commodities must be produced according to specific criteria and segregated in the marketplace in order to receive premium prices.
Seed genetic purity standards have been established to assure that when growers buy seed, what’s listed on the label is what’s in the bag. While in production agriculture, it is virtually impossible to assure that no unwanted or off-type plants or pollen are present in a seed production field and that all handling and conveyance equipment and storage facilities are 100 percent free of contamination, seed certification ensures buyers that their seed is within purity tolerances. The introduction of genetically engineered (GE) varieties has created additional issues for seed genetic purity, particularly for producers seeking to meet organic marketing standards or who are engaged in international trade. GE varieties are individually regulated by national agencies, so approval generally is required from the importing country before those varieties can be legally traded.
Intellectual property protection (IPP) allows plant breeders to control commercialization of their plant varieties and plant products (such as seeds), but agricultural patents can also make it difficult for researchers to access patented technologies when developing specialty crops or crops for humanitarian purposes. Groups such as the Public Intellectual Property Resource for Agriculture (PIPRA) promote licensing practices that provide sufficient motivation for developing new crops and technologies while allowing researchers access to the intellectual property information they need to utilize scientific innovations for the greater good.
| Stewardship programs |
Crops that are produced with a set of defined practices or are excluded from the majority of a commodity require programs to channel them to specific markets. Crops developed using biotechnologies also require channeling programs, as markets differ in their acceptance of these commodities. |
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| Identity preservation |
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Identity preservation refers to a system of production, handling and marketing practices that maintains the integrity and purity of agricultural commodities. In its simplest form, identity preservation has been employed since the beginning of agriculture when the seeds and grain of different crops were first traded separately. As seed and food industries developed, the purity and quality expectations of buyers and processors increased and standards were established. Seed certification programs such as that represented by the Association of Official Seed Certifying Agencies (AOSCA) play a major role in maintaining seed purity standards and levels established by the industry for national and international trade. Similarly, commodity traders, marketing organizations and food processors have established purity and quality tolerances for specific end-product uses. As crops and production systems diversify to meet market demands, the need for segregation and identify preservation of agricultural commodities has increased.
Crop varieties with unique traits require identity preservation programs to channel these commodities to specific markets to capture the added value. Similarly, organic commodities must be produced according to specific criteria and segregated in the marketplace in order to receive premium prices. Crops developed using biotechnologies also require market segregation, as markets differ in their acceptance of these commodities.
While an increasing number of countries - including the United States, Canada, Argentina, Brazil, Australia, China, and India – have allowed the production of crops enhanced through biotechnology and additional countries such as Japan have authorized imports of GE foods, this has not been the case everywhere, particularly in the European Union. Also, some countries are instituting labeling laws that require segregation and identification of seed and food products developed using biotechnology.
Thus, additional criteria for identity preservation are based upon the method by which a variety was developed and whether it contains traits introduced via biotechnology. Together, these factors are increasing the demand for programs that can certify the identity and composition of agricultural commodities. In many cases, changes in production and marketing procedures are required to meet the more stringent standards, which increase the cost of delivering a product to market.
Asynchronous approvals of specific biotech crops in different countries can also create problems as products approved in some countries begin to be traded and can arrive in countries where such approvals have not yet been granted*.
* See: Growing number of genetically modified crops worldwide could disrupt international trade
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| Genetic purity |
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Genetic purity refers to the percentage of contamination by seeds or genetic material of other varieties or species. The genetic purity of any commercial agricultural product propagated by seed begins with the purity of the seed planted. In general, the genetic purity of the seed planted must equal or exceed the final product purity standard required, as purity generally decreases with each subsequent generation of propagation.
It is virtually impossible to assure that no off-type plants or pollen is present in the seed production field and that all handling and conveyance equipment and storage facilities are completely free of contamination. As a result, commercial planting seed is seldom 100% pure. In practice, practical seed genetic purity standards have been established by state seed laws and by seed certification agencies to ensure that the purchaser receives seed that is within certain purity tolerances.
These tolerances are established based on the biology of the species (i.e., self- or cross-pollinated), the type of variety (i.e., open-pollinated, hybrid, synthetic), and market-driven standards for final product quality. Earlier generations of seed (e.g., foundation or registered seed) have stricter standards in order to be able to meet the certified seed purity criteria. The main sources of contamination of a seed crop are the prior crop grown in a field, transfer of pollen from a nearby field, and mixtures during harvesting and handling.
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| Coexistence |
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Co-existence for crop agriculture can be defined as the sustainable production of seed, food and fiber from diverse plant varieties, crop types and production practices.
Co-existence principles have been the key to successful diversification of plant varieties and production systems for food and seed as practiced by growers and shepherded by national and international seed associations from 70 countries over the last 100 years (AOSCA, 2008; ISF, 2008).
The foundation of co-existence is good communication among growers, handlers, shippers and marketers and respect for each others’ practices and requirements.
There is general agreement in agriculture that a zero tolerance or 100% purity standard is not practical in field production systems, but tolerances and thresholds for the presence of low levels of undesired materials allow efficient marketing while meeting end use quality and safety criteria (FDA, 1998).
It is customary that the primary responsibility for meeting specific market standards is on the entity economically benefiting from it, usually the producer who is compensated for higher quality products (CropLife, 2006; Fernandez and Polansky, 2006; SCIMAC, 2006).
SOURCES
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| Certification programs |
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Seed certification programs have been in existence for over 100 years. They have effectively defined and monitored standards to guarantee specific purity standards of the final product or seed. The standards developed reflect the genetic purity and quality of the final product (including seed) based on the final market requirements.
Seed classes: breeder, foundation, registered, certified, commercial, variety undeclared
U.S. National Organic Program (NOP)
The National Organic Program (NOP) in the United States (USDA, 2005) and several other countries define production practices that must be adhered to in order to market products and seeds bearing an “Organic” label. These programs are processed-based rather than being based on the final quality of the product. For example, although only certain approved compounds with pesticidal or fertilizer properties may used in producing organic seed or products, minimum thresholds are established for the inadvertent presence of non-approved compounds. To produce organic products in the US, growers must first begin with organically produced seed. If it is not available, they can use seed that has not been treated with unapproved (usually synthetic) compounds. Although organic programs have chosen to exclude genetically engineered (GE) varieties from the program, there are no established thresholds for the presence of GE materials in organic products. In fact, as long as growers follow an NOP-approved production plan, the USDA has assured that they will not lose organic certification if GE materials are inadvertently found in their seed or products.
SOURCES
ARTICLES
The California Crop Improvement Association (CCIA)
By Diane Nelson, Writer, University of California, Davis, Department of Plant Sciences
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| Intellectual property protection |
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Intellectual property (IP) refers to various legal rights attached to names, words, symbols (trademarks), recorded media (copyrights), inventions (patents) or valuable information or material that has not been patented (trade secrets). Owners of these entitlements may exercise exclusive rights known as Intellectual Property Rights or IPR. The seed industry has undergone substantial change in recent years in regard to IPR. Prior to 1975, all of a species’ heritable traits were available to a plant breeder. Even if these traits existed only in proprietary varieties that were protected under a Plant Patent (1930) or under the Plant Variety Protection Act (PVPA, 1970 and 1994), cross-pollination of the protected variety and reselection were and still are allowed under a breeder’s exemption. Farmers are also allowed to save seed of varieties protected under the PVPA for their use. The PVPA protects varieties that are seed propagated and plant patents confer similar rights to plants that are clonally propagated such as strawberries.
Now that plant varieties and unique genetic traits also are being granted utility patents, the rights to these traits or crossing to such varieties in a breeding program is restricted without having a license. Although utility patents may allow the developer to gain maximum value from their investment in research, it limits the further improvement of that germplasm by other breeders. This creates the opportunity for seed organizations to maintain market dominance in areas where they possess elite germplasm or collect revenue through licensing agreements on germplasm or technology. In practice, companies routinely cross-license their germplasm or traits.
Intellectual property protection allows plant breeders to control commercialization of their plant varieties and plant products (such as seeds) to ensure return on their investment, but agricultural patents also make it difficult for researchers to access patented technologies when developing specialty crops or crops for humanitarian purposes. Groups such as the Public Intellectual Property Resource for Agriculture (PIPRA) promote licensing practices that provide sufficient motivation for developing new crops and technologies while allowing researchers access to the intellectual property information they need to utilize scientific innovations for the greater good. PIPRA helps improve agriculture in emerging economies by decreasing intellectual property barriers and increasing technology transfer. They also work with farmers and scientists in mature economies who are growing specialty crops and help member institutions achieve their humanitarian mandates by making sure their technological innovations get to those who need it most.
Additional resources:
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| Fingerprinting & barcoding |
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Additional resouces:
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| Genotyping |
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An organism’s specific genomic complement, or the DNA sequences of all of its genes and intervening DNA regions, constitutes its genotype.
Most genes are present in a species in a number of different variants, or alleles, which may or may not affect the function of the gene. By scoring genetic locations within an individual’s genome to know which alleles it has inherited from its parents, the specific genotype can be identified.
For example, if a particular gene confers resistance to a disease, seedling plants can be screened for the presence of this gene and only those with the resistant allele of the gene can be grown for further testing and propagation.
Such early genotyping and selection can result in large savings in labor, land and materials when screening large populations, particularly when alternative phenotypic screens, such as infecting all of the plants with the disease organism, are labor-intensive and expensive.
High-throughput methods enable the simultaneous testing of thousands of genes in hundreds of individuals, making it feasible to select for multiple traits in large plant populations.
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| Regulation of genetically engineered varieties |
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The introduction of genetically engineered (GE) varieties (those developed using recombinant DNA techniques in addition to sexual crossing and selection) has created additional issues for seed genetic purity, particularly for producers seeking to meet organic marketing standards or who are engaged in international trade. The U.S. National Organic Program (NOP) does not allow the use of seed developed using recombinant DNA techniques to produce crops that will be certified as organic. It also requires the use of seeds that have been produced using organic methods when such seeds are commercially available. Current regulations do not specify an acceptable threshold level for the unintended presence of GE materials in an organic product (there is an implied zero tolerance), and there is also no requirement to test for such inadvertent presence. Neither an organic grower nor the organic product would automatically lose organic certification if such unintended contamination occurred.
Nonetheless, it is clearly the expectation of consumers purchasing organic foods that those foods do not contain materials developed using genetic engineering. In addition, GE varieties are individually regulated by national agencies, so approval generally is required from the importing country before those varieties can be legally traded. The presence of even a small amount of an unapproved GE variety, if detected, can block an entire shipment. Thus, achieving and maintaining high seed genetic purity has become even more important following the introduction of GE varieties. The principles for producing seed crops that are free of GE materials are the same as those for seed certification. The main sources of contamination of a seed crop are the prior crop grown in a field, transfer of pollen from a nearby field, and mixtures during harvesting and handling.
Bradford, K. J. 2006. Methods to Maintain Genetic Purity of Seed Stock. Agricultural Biotechnology in California Series. Publication 8189.
http://anrcatalog.ucdavis.edu/pdf/8189.pdf
In the United States, three agencies have regulatory jurisdiction over genetically engineered organisms: the U.S. Department of Agriculture (USDA), the Food and Drug Administration (FDA) and the Environmental Protection Agency (EPA). Equivalent agencies regulate transgenic crops in other countries in the context of agriculture, the environment and food safety and labeling. In the US, once a transgenic variety has been evaluated by the USDA, the FDA and/or the EPA and approved for production and sale (i.e., is de-regulated), there are no additional identity preservation requirements beyond those normally in place for that commodity. So a soybean, cotton or corn variety may contain herbicide or insect resistance, but regulatory agencies have determined that those varieties are substantially equivalent with respect to their food or fiber value to similar varieties without the transgenic traits. This lack of distinction is not the case in many other countries to which U.S. agricultural products are exported. Even in the United States, some processors and retailers are reluctant to include biotech crops in their products due to the possibility of consumer rejection.
On an international scale, the Cartagena Protocol for Biodiversity (CPB) aims to regulate the movement of genetically modified organisms across international borders. The CPB has been signed and ratified by at least 140 countries. It aims to set minimum standards to regulate genetically modified organisms for countries that have signed and ratified it. The importation of biotech seeds or products into countries that have not signed and ratified the CPB, such as the U.S., is not bound by the CPB rules. The implementation of the CPB is still being discussed in international meetings.
There are several methods used to test for the absence or presence of transgenes in seed and grain products, each with its specific advantages and disadvantages. Seed bioassays* for herbicide tolerance are easy to use and relatively inexpensive but require significant time and resources. Lateral flow strips and enzyme-linked immunosorbent assays (ELISAs) use immunological techniques based on antibodies to detect specific proteins associated with the trait of interest. Flow strips are simple and rapid, but can have a relatively short shelf life and their reliability can be significantly influenced by the level of protein in the sample. Various techniques can be used to detect specific DNA sequences, but most commonly the DNA of interest is amplified using polymerase chain reaction (PCR), a procedure that uses enzymes to synthesize specific DNA sequences in the test tube. PCR assays are extremely sensitive, capable of detecting just a few molecules of the target DNA. However, this sensitivity also makes PCR assays subject to false positive results if stringent sample preparation and cleanliness procedures are not followed.
Currently, even though some countries require testing and labeling of transgenic commodities, there are no accepted national or international test standards for detection of specific crop genetic traits. The USDA’s Grain Inspection, Packers and Stockyard Administration is in the process of establishing a U.S. laboratory accreditation system for this purpose, but trait reporting methods can vary among laboratories.
| Bioassay |
Bioassay is a procedure for testing and/or measuring the activity of a chemical based on the response of an organism to the chemical sample.
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