Official Newsletter of the WANA Seed Network
No. 29,
July 2005
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News, views, comments and suggestions on varieties and seeds are included in this section. It is also a forum for discussion among professionals in the seed sector.
Genetically Modified Organisms (GMOs)-Patents, Licenses and Liability
The application of biotechnology is growing rapidly in plant breeding and the seed industry. At present, there is significant commercial production of transgenic crop varieties with herbicide tolerance (e.g. maize, soybean, canola in the Americas) and insect resistance (e.g. cotton in China, India, USA). In some countries of Central West Asia and North Africa (CWANA), a number of agricultural research institutions have developed the technical and human resource capacity to experiment different biotechnological tools and have started using them in plant breeding.
It is important to note that, however, many aspects of biotechnology are protected by patents including genes, gene manipulation technologies, laboratory tools and in some countries even the whole varieties or groups of varieties. In patent protection the originator of the invention has the right to decide who is allowed to use the technology. Therefore, agricultural researchers, plant breeders and seed producers need to have a license to use the innovation. This new development will change the present situation in most CWANA countries where government agricultural research institutions produce varieties which are of 'public good' i.e. freely available for whoever wants to use them. It is even different from situations where Plant Breeder's Rights (PBR) are operational, since patents have a much greater 'reach' and provide stronger rights than PBR where breeders are exempted for using the new variety for breeding purposes. Whether patents are actually very restrictive depend on a number of issues.
First, currently most public research institutes in developing countries potentially have a relatively easy access to patent-protected inventions. In patents, the protection is territorial, which means that a patent holder must specifically apply in each country where he wants to protect his right. Most biotechnology companies focus on big markets in North America, Europe and possibly developing countries like Argentina, Brazil, China, India, and South Africa. Therefore, most relevant patents on biotechnology are not yet operational in CWANA countries and researchers may use them freely within the borders of their country where protection is not yet available.
Second, research institutions can easily get a so-called research license, which specifies a freedom to use for such purposes, but also the rules that may apply when a commercial product is developed using the invention. Thus, the license issue becomes important in the final stages of plant breeding and in commercial seed production. Plant breeders and seed producers have to have a valid license from the holder of the patent right (often a company or institution in America or Europe) in order to develop and use the variety. The license agreement is likely to stipulate the markets in which the seed may be sold, the quantities to be sold, and determines a royalty payment to the inventor.
Third, there is the possibility to negotiate what are called 'humanitarian licenses'. These are license agreements that stipulate the boundaries of free use of the invention for a 'humanitarian cause'. This is commonly the case where protected technologies or information can be used for poverty alleviation or nutritional security. This option is not likely to extend to large-scale commercial seed production, but more specifically to public or participatory seed programs directed to improve livelihoods of resource-poor farmers. When researchers have negotiated such an agreement, seed producers have to carefully study the agreement in order to establish their 'freedom-to-operate'.
The examples of such licenses relevant to seeds is the one offered by Monsanto about 10 years ago for the use of virus resistance genes in potato varieties for smallholder farmers in Mexico (while the patent remained valid for big commercial variety in the same country), and a license by Syngenta on the Golden Rice technologies, that allow rice breeders to introduce high levels of pro-vitamin A in the grain. One could consider the agreement between the Agricultural Genetic Engineering Research Institute in Egypt and Pioneer for the introduction of Bt insect resistance to local maize varieties as humanitarian license, but the fact that Pioneer gains access to Egyptian Bt strains and information makes it more like a business deal.
There are several examples of large multinational companies providing access to protected technologies to developing countries on a preferential basis, but recent developments may change their willingness to enter such agreements. Seed producers are used to different levels of liability in different countries. In some cases the seed producers or seed dealers have to replace the seed free if the commercial seed that was sold proved to be of poor quality, but in some countries (e.g. India) seed suppliers run the risk of much higher penalties, because they have to pay the total value of the crop that a farmer lost by planting poor quality seed.
With genetically modified crops, the liabilities are getting even tougher. Whether or not GM crops can cause physical harm, there is a perception that GM products may be unsafe for consumption, ecologically undesirable, or creating certain economic risks. An example is the recent US litigation over Starlink maize, in which the unintentional commingling of GM maize, which was unapproved for human consumption, with conventional maize, exposed Aventis CropScience to millions of dollars in liabilities.
Article 27 of the Cartagena Protocol calls upon the parties to that agreement to investigate the 'elaboration of international rules and procedures in the field of liability and redress for damage resulting from transboundary movements' of GMOs. There is a fear that liability issues become overriding arguments for the limitation of humanitarian licenses, i.e. when the originator of a technology may be held responsible for damages caused by the products irrespective of how these products were handled.
It is important for Seedsmen, both in the public and the private sector to acquaint themselves with liability matters, when they start dealing with transgenic varieties and seeds. N.P. Louwaars, Center for Genetic Resources, Wageningen University and Research Center, P.O. Box 16, 6700 AA Wageningen, The Netherlands; E-mail: niels.louwaars@wur.nl
Global Status of Commercial Biotech Crops
In ISAAA Brief 32 released in January 2005 the global status of commercialized transgenic or genetically modified (GM) crops, now collectively called 'biotech crops', confirms that the global area continued to grow for the ninth consecutive year at a sustained double-digit rate.
In 2004, the global area of biotech crops continued to grow at a substantial rate of 20%, compared with 15% in 2003. The estimated global area of approved biotech crops for 2004 was 81 million ha up from the 67.7 million ha in 2003. In the same year, from 1.5 billion ha cultivable cropland worldwide, biotech crops occupied 5% of the area. About 8.25 million farmers in 17 countries grew biotech crops up from 7 million farmers in 18 countries in 2003 of which 90% of the farmers were from developing countries.
The increase in biotech crops area between 2003 and 2004, of 13.3 million ha, is the second highest on record. In 2004, there were fourteen (nine developing countries and five industrial countries) biotech mega-countries (>= 50,000 ha), compared with ten in 2003; they were, in order of area USA, Argentina, Canada, Brazil, China, Paraguay, India, South Africa, Uruguay, Australia, Romania, Mexico, Spain and the Philippines.
The continuing rapid adoption of biotech crops reflects the substantial improvements in productivity, the environment, economics, and social benefits realized by both large and small farmers, consumers, and society in both developed and developing countries. During the nine-year period from 1996 to 2004, the global area of biotech crops increased more than 47 fold, from 1.7 million hectares in 1996 to 81 million ha in 2004, with an increasing proportion grown by developing countries. More than one-third of the global biotech crop area of 81 million ha in 2004, equivalent to 27.6 million ha, was grown in developing countries where growth continued to be strong.
The increased area and impact of the five principal developing countries (Argentina, Brazil, China, India and South Africa) growing biotech crops, is an important trend with implications for the future adoption and acceptance of biotech crops worldwide. In 2004, the number of developing countries growing biotech crops (11) was almost double the number of industrial countries (6) adopting biotech crops.
The first decade of the commercialization of biotech crops (1996-2004), during which double-digit growth in global area of biotech crops has been achieved every single year, shows confidence in the technology from the 25 million farmers who have consistently chosen to plant an increasing area of biotech crops year after year.
There is cautious optimism with the global area and the number of farmers planting biotech crops expected to continue growing in 2005 and beyond. In 2004, there were signs of progress in the European Union with the Commission approving, for import, two events in biotech maize (Bt 11 and NK603) for food and feed use, thus signaling the end of the 1998 moratorium. The Commission also approved 17 maize varieties, with insect resistance conferred by MON 810, making it the first biotech crop to be approved for planting in all 25 EU countries. The use of MON 810 maize in conjunction with practical co-existence policies opens up new opportunities for EU member countries to benefit from the commercialization of biotech maize, which Spain has successfully deployed since 1998.
In the near future, the one single event that is likely to have the greatest impact is the approval and adoption of Bt rice in China, probably in 2005. The adoption of biotech rice by China not only involves the most important food crop in the world, but the culture of Asia as well. It will provide the stimulus that will have a major impact on the acceptance of biotech rice in Asia and, more generally, on the acceptance of biotech food, feed and fiber crops worldwide. Taking all factors into account, the outlook for 2010 points to continued growth in the global area of biotech crops, reaching 150 million ha, with nearly 15 million farmers growing biotech crops in about 30 countries. ISAAA predicts that by the end of the decade up to 15 million farmers will grow biotech crops on 150 million ha in almost 30 countries. Source: CropBiotech Update Special Edition 14 January 2005.
European Union Lists Accepted GM Products
The European Commission has recently released a list of 26 genetically modified products that have legally been on the European market, even before the European Union's new legislative framework for authorizing GM food and feed went into effect. The list aims to clarify exactly which GM products are legally permitted to be sold in the EU, and includes products that may continue to be marketed because they fulfilled the notification requirements under Regulation (EC) No 1829/2003. The approved list includes 12 maize varieties (12), oilseed rape (6), cotton (5), soybean (1), one biomass and one yeast cream. Existing products on the EC register are subject to the strict labeling and traceability rules for all GMOs under new EU legislation. Since the implementation of Regulation 1829/2003, all GM food and feed entering the EU market have to undergo thorough safety assessments. Once on the market and in the EC register, existing products can be sold for three to nine years, and may stay for a much longer time if an application for renewal of the authorization is submitted.
AFSTA Congress 2005, Yaoundé, Cameroon
The African Seed Trade Association (AFSTA) Annual Congress 2005 was held from 16-18 March 2005 in Yaoundé, Cameroon. The congress has attracted 97 delegates from 35 countries, among others, the regional and international seed and research organizations. It was an excellent opportunity for the participants to discuss and exchange views on the main issues facing the seed industry at regional and/or global levels. The main topics discussed include: vegetable seed trade in Africa, Intellectual Property Rights, Material Transfer Agreement under the FAO multilateral system, accreditation of seed companies for certification, testing and phytosanitory issues, arbitration in international seed trade, biosafety regulations and stewardship and coexistence of GM and non-GM seeds. All the technical sessions were well attended. The congress was preceded by each half-day workshops on plant variety protection facilitated by UPOV and on cotton seed facilitated by Syngenta Agro.
The AFSTA General Assembly adopted a position paper on Intellectual Property Rights. More position papers will be drafted, among others, on Material Transfer Agreements and on Coexistence of GM and non-GM seeds. A new strategy to address the challenges of the African seed industry was also adopted. AFSTA will continue to actively support the harmonization of seed legislation in the various sub-regions.
Training and building capacity of its members remains as one of the main objectives of AFSTA. It is planned to organize one-day courses on Material Transfer Agreements and Coexistence of GM and non-GM seeds, respectively, on 17 and 18 October 2005 in Nairobi, Kenya.
The next AFSTA Annual Congress 2006 will be held from 28-31 March 2006 at the Imperial Resort Beach Hotel in Entebbe, Uganda. Justin Rakotoarisaona, AFSTA, P.O Box 2428-00202 KNH, Nairobi, Kenya; Fax: + 254-2-727-861; E-mail:insight@kenyaweb.com; http://www.afsta.org
ISF World Seed Congress 2005
Chile hosted the annual World Seed Congress from 30 May to 1 June 2005. A total of 1071 persons attended the congress representing members of the seed industry in 55 countries, including a sizeable number from Latin America. International organizations such as FAO, ISTA, OECD and UPOV, and regional seed associations such as AFSTA, APSA, ESA and FELAS were represented and participated in the debates.
The topics of the various crop sections and technical committees included the Chilean seed industry, trends in GM crops in Chile and other Southern American countries, essential derivation, traceability, seed health testing and pathogen coding including industry wide position papers.
During the congress three position papers were adopted:
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Plant Genetic Resources for Food and Agriculture: Use and Conservation |
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Genetically Modified Crops and Plant Breeding |
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Essential Derivation from a Not-yet Protected Variety and Dependency |
For the implementation of the concept of essential derivation, the General Assembly adopted a Regulation for the Arbitration of Disputes concerning Essential Derivation (RED), which in the case of a dispute between two parties concerning an essentially derived variety provides a basis for a balanced procedure tailored to the specific (technical) aspects of the case. This was a breakthrough as the subject has been under consideration for several years. This document along with the position papers can be found on the ISF website.
In his opening speech Selwyn Manning, President of ISF highlighted the major issues facing the industry worldwide. The challenges themselves, viz; protection of intellectual property, adventitious presence of GM material in non-GM seeds, phytosanitary restrictions as a barrier to trade and harmonization of seed treatment regulations, he said, were not especially new. In fact, they had been discussed many times before but in presenting them again he asked for a renewed appreciation of their importance. In speaking of the evolution of the seed industry Bernard Le Buanec, Secretary General emphasized the need for it to be structured at the national, regional and international levels.
The next annual World Seed Congress will be held in Copenhagen, Denmark on 29-31 May 2006. Radha Ranganathan, ISF, Chemin du Reposoir 7, 1260 Nyon, Switzerland Fax: +41-22-3654421; E-mail: r.ranganathan@worldseed.org; Website: http://www.worldseed.org
Azerbaijan Accedes to UPOV Convention
According to press releases issued in November 2004, Azerbaijan becomes the 58th member of the International Union for the Protection of New Varieties of Plants. This brings the number of countries which are members of UPOV to five in CWANA region. Jordan, Kyrgyzstan, Tunisia and Uzbekistan have already acceded to the UPOV Convention. The purpose of the UPOV Convention is to encourage the development of new varieties of plants by granting breeders an intellectual property right on the basis of a set of clearly defined principles. To be eligible for protection, varieties need to satisfy certain conditions, such as being distinct from existing, commonly known varieties and sufficiently uniform and stable. New varieties of plants are one of the important tools to enhance food production in a sustainable way, to increase income in the agricultural sector and to contribute to overall economic development.
Harmonization of Phytosanitary Regulations in Asia
According to the International Plant Protection Convention (IPPC), every country has a sovereign right to protect its environment and food security and take appropriate measures. The purpose of the treaty is to secure a common and effective action to prevent the spread and introduction of pests in plants and to promote appropriate measures for their control. Seed is a potential carrier of pests and a risk for introducing them into new areas or countries. A quarantine pest (QP) is a pest of potential national economic importance to the country endangered thereby and not yet present there, or present but not widely distributed and being actively controlled. The SPS agreement of WTO encourages member countries to use international standards or even higher standards based on appropriate pest risk analysis (PRA). However, this should be based on scientific principles and enforced in a transparent manner. These standards should not be misused for protectionist purposes and should not result in unnecessary barrier to international trade.
The SPS agreement encourages developing international phytosanitary standards on scientific grounds and member countries are encouraged to harmonize them at regional level. Thus, the Asia and Pacific Seed Association (APSA) took an initiative to harmonize phytosanitary regulations in Asia within the framework of IPPC and SPS agreement. Initially five countries, which are major agricultural economies of Asia were included, namely; India, Indonesia, Thailand, the Philippines, and Vietnam. In view of their importance in international seed trade, 10 agricultural and horticultural crops were selected such as maize, rice, sunflower, cabbage, cauliflower, cucumber, eggplant, hot pepper, tomato and watermelon.
The plant quarantine authorities of the five countries, APSA and Iowa State University participated in this task. A survey was conducted in the five countries to analyze the constraints to be addressed in the harmonization process. In all, eight major constraints were listed related to administrative and technical issues.
Administrative and technical constraints
The administrative constraints include delays in issuing import permits, high fees, inadequate storage facilities at ports, and lack of clear and transparent information of procedures. The technical constraints include unnecessarily regulated pests, regulations limiting imports/ exports, lack of clear information on pest lists and undue sampling at entry ports. A systematic discussion on Quarantine Pests (QP) was made by scientists and the executives of the Plant Quarantine Authorities of the participating countries in six consecutive workshops held in Thailand (17-18 February and 6-10 October 2003); Indonesia (26 April -1 May 2004); in the Philippines (14-18 June 2004); Vietnam (18-20 August 2004); and Thailand (16-20 November 2004).
Quarantine pest and pest risk analysis
Pest Risk Analysis is the process of evaluating biological or otherwise scientific and economic evidence to determine whether a pest should be regulated. Three major parameters to decide the QP are as follows:
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Whether or not the pest is reported to be already present in the country. This is based on scientific publications |
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Whether or not the pest is transmitted through the seed |
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What is the economic importance of the pest? |
In view of the above, CABI Crop Protection Compendium 2003 was used for deciding the quarantine pests of designated crops in participating counties. The participating countries submitted original list of QP in the first workshop and this is summarized in Table 1.
It is important to note that the total number of QP for the designated crops in participating countries was 241. Based on scientific analysis and discussions, the QP lists of the participating countries were reviewed and unnecessary pests were deleted (Table 2). From a total of 241 pests in the participating countries 182 pests were deleted whereas 59 pests were retained as QPs.
The QP list was, thus, drastically pruned and this made the task of authorities easier in monitoring only 59 pests as against 251 monitored in the past.
Time frame for phytosanitary procedures
The participating countries decided the maximum time for completion of issuing seed import permit, seed export clearance, issue of phytosanitary certificate for export as shown in Table 3.
| Table 1. Original list of QP in five countries | ||||||
| Crop |
Countriesa
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Total (crop)
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1
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2
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3
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4
|
5
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| Maize |
12
|
15
|
14
|
8
|
2
|
51
|
| Rice |
4
|
12
|
8
|
2
|
2
|
28
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| Sunflower |
1
|
4
|
2
|
6
|
1
|
14
|
| Cabbage/ Cauliflower |
4
|
5
|
3
|
2
|
0
|
14
|
| Cucumber |
6
|
7
|
3
|
6
|
2
|
24
|
| Eggplant |
3
|
7
|
4
|
11
|
2
|
27
|
| Hot pepper |
4
|
6
|
0
|
3
|
0
|
13
|
| Tomato |
9
|
17
|
11
|
11
|
5
|
53
|
| Watermelon |
4
|
3
|
3
|
4
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3
|
17
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| Total (country) |
47
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76
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48
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53
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17
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241
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| Note: a1 = India; 2 = Indonesia; 3 = Philippines; 4 = Thailand; and 5 = Vietnam | ||||||
The Plant Quarantine Authorities also accepted to make a provision for appeals and also decided the time frame for taking decision on this matter. Furthermore, seed export/import manual was developed for each participating country and it will be made available to anyone interested in seed export/import. This will undoubtedly not only increase transparency and awareness of phytosanitary procedures, but eventually help in promoting trade in participating countries. The five countries are committed to implement the recommendations of workshops on Harmonization of Phytosanitary Regulations in Asia, latest by 30 July 2005.
| Table 2. List of quarantine pests of 10 crops | |||||||
| Crop |
Original pest list
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Deleted unnecessary pests
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Final pest list
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| Maize |
51
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42
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9
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| Rice |
28
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24
|
4
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| Sunflower |
14
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11
|
3
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| Cabbage/Cauliflower |
14
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9
|
5
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| Cucumber |
24
|
18
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6
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| Eggplant |
27
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18
|
9
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| Hot pepper |
13
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9
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4
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| Tomato |
53
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41
|
12
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| Watermelon |
17
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10
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7
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| Total |
241
|
182
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59
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In another development a series of workshops are being planned for 2005 for the harmonization of the phytosanitary rules of seven other Asian countries, namely: Bangladesh, Cambodia, Laos, Malaysia, Myanmar, Pakistan and Sri Lanka.
| Table 3. Agreed time line for phytosanitary procedures (number of working days) | |||||
| Procedures |
Timeline of each countrya
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1
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2
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3
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4
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5
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| Seed import permit |
3
|
10
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5
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25
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10
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| Seed import clearance |
10
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14
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12
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14
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10
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| Seed export |
10
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14
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12
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15
|
10
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| Appeals |
10
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10
|
10
|
10
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10
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| Note: a1 = India; 2 = Indonesia; 3 = Philippines; 4 = Thailand; and 5 = Vietnam | |||||
J. Sindhu, APSA, P.O. Box 1030, Kasetsart Post Office, Bangkok 10903, Thailand; Fax: +66-02-940-5467; E-mail: director@apsaseed.com
ISTA Announces Proficiency Test on GMO Testing
The International Seed Testing Association (ISTA) announces the 5th ISTA Proficiency Test on GMO Testing to all laboratories which participated in a previous round or are interested in the fifth round. The aim of the proficiency test is to check the ability of individual laboratories to detect the presence or absence of GM seeds and to quantify their presence in samples of conventional seed of soya bean (Glycine max).
The results of the proficiency test rounds are intended for use by the laboratories for their internal performance assessment. At present the performance, based on voluntary participation, will bear no consequences for the participating laboratories. However, once GMO testing is included in the ISTA Accreditation Program and become part of laboratory's intended scope of accreditation, the results from voluntary proficiency tests may be taken into account. This will speed up the accreditation process for laboratories that have performed satisfactorily. Laboratories interested in participating should contact the ISTA Secretariat as soon as possible.
For details visit the announcement posted on the ISTA Web. For more information contact: Bettina Kahlert, Head of Technical Committee, ISTA, Zürichstrasse 50, P.O. Box 308, 8303 Bassersdorf, Switzerland; Fax: +41-1-8386001; E-mail: ista.office@ista.ch; Website: http://www.seedtest.org.