Stewardship and Integrated Pest Management for generic / off patent GM crops

Transcription

1 Stewardship and Integrated Pest Management for generic / off patent GM crops Georges FREYSSINET 1

2 Stewardship and Integrated Pest Management for generic GM crops Generic Off Patent GM crops Stewardship Integrated Pest Management Conclusions and Prospects 2

3 Stewardship and Integrated Pest Management for generic GM crops Generic Off Patent GM crops Stewardship Integrated Pest Management Conclusions and Prospects 3

4 Generic / of patent GM crops Definition GM events which are out of patent protection or without patent protection in the targeted countries for cultivation and importation Does not cover GM events which are produced with transgenes and technologies which are out of patent protection or have no patent protection Some parameters are similar to the situation in Pharma and Crop Protection, but others are different. The main difference being the fact that there is a need to access the event (cannot be made again as of today), while in Pharma and Crop Protection the active molecule (small molecule or protein) can be resynthesized Current status Soybean tolerant to Glyphosate (soybean event = Round Up Ready 1) Maize resistant to insects (MON 810) Two different types of commercialised seed: a non-hybrid (soybean) and an hybrid crop (maize) Already covered Legal access to the event (Philippe Dumont) Regulatory (permits or deregulation status) in the targeted countries (cultivation and importation) (Patrick Rudelsheim) are in place or in the process to be 4

5 Stewardship and Integrated Pest Management for generic GM crops Generic Off Patent GM crops Stewardship Integrated Pest Management Conclusions and Prospects 5

6 Stewardship for Generic GM crops Definition Product Stewardship is the responsible management of a product from its inception through to its ultimate use and discontinuation Which actions / steps should be covered From Excellence Through Stewardship a program, supported by the biotechnology industry, to promote the adoption of stewardship programs and quality management systems across the full biotechnology plant product life cycle Plant Development Seed Production Seed Marketing and Distribution Crop Production Crop Utilisation Gene Discovery Product Discontinuation 6

7 Stewardship for Generic GM crops Seed Production The situation is different in soybean and maize o For soybean, the farmer can produce his own seed (has to buy them at least once) o For maize, the farmer needs to buy the hybrid seed every year Two cases to be considered o Seed are produced by a seed company or another organisation (public) o Seed are produced by the farmers Regulatory should be followed carefully in the first case, may be more difficult / risky in the second case 7

8 Stewardship for Generic GM crops Seed Production Seed are produced by a seed company or an organisation o Need to follow normal seed production practices o Special care should be taken to avoid contamination between the non-gm and the GM seed productions. The best is to have two seed production facilities (GM and non-gm) o In addition to the genetic purity of the seed, a certain level of purity for the trait (glyphosate tolerance or insect resistance) should be defined / guarantied, generally 95 to 98% Need to design a specific tool to detect the event and the trait (genotypic or phenotypic: presence of the gene, the protein, the trait) Alternatively, the tool originally developed by the Originator/Developer and validated independently could be used if permitted by the Originator/Developer o Traceability is very critical o Quality control should be present at all stages o Avoid escape 8

9 Stewardship for Generic GM crops Seed Production Seed are produced by the farmers (farm saved seed) for their own use o Farmers need to be trained by the extension / technical services of the country o Critical point: avoid mixing GM and non-gm material o For herbicide tolerance, quality is easy to obtain, will be more difficult for other traits when available 9

10 Stewardship for Generic GM crops Seed Marketing and Distribution In countries were the product is already available this is not as critical as it was for the first launch of the trait, farmers and other stakeholders should be well aware and informed of the characteristics of the product and the conditions to use it (the case in North and South America) In countries were the product was not available before, the first launching of such a product should be well prepared and managed by the organisation (seed company or other organisation) which is developing this GM product. In such a case, cooperation with the Originator/Developer of the event is probably wise (if both parties whish to do so). Very unlikely it will be a farmer 10

11 Stewardship for Generic GM crops Seed Marketing and Distribution Need to start as early as possible to define, at least, in which countries the seed will be sold (cultivation countries) and in which countries the harvest (grain or main derivative products) will be used (importing countries). This will determine the regulatory requirements Main parameters to cover (in addition to the market analysis) o Define the marketing strategy, will depend on the practices in use in the country of seed sale (direct sale, distributors ) o Need to inform the farmers of the specificities of the GM product, do not oversell the trait o Need to train the farmers on the specificities for the use of the product o Can be done directly by the company / institute who develops the cultivar or can be done through the distributors or extension services Follow carefully the distribution process to make sure that the needed information are passing through, from the seed distribution to the collect of the harvest 11

12 Stewardship for Generic GM crops Crop Production Done by the farmers using good agronomic practices Careful traceability should be in place: where, when, how, Farmers should follow the recommendations from the organisation which has developed the product Crop utilization The collector should be aware of the material he is collecting and follow any restrictions put in place by the seed producing entity such as: o Segregation from non-gm grain (this is not recommended) o Limit on exportations (viable only if exportations are limited to a few countries with very specific non-gm material, which will then be segregated) The best situation will be to have no limitation on the use of the harvest Do not want the grain and derived products in markets in which regulatory authorisations have not been obtained or are not valid anymore 12

13 Stewardship for Generic GM crops Product Discontinuation At a certain time, there may be a need to remove the product from the market o The trait is of no use anymore - development of insects resistant to the trait for instance o The product has lost authorisation in some major countries (no renewal) The organisation which has developed the product should take care of this situation and manage the discontinuation o Inform all stakeholders that the product will be discontinued (need to anticipate) o Destroy or ask for the destruction of all available seed Not an easy task will take time Will be difficult / impossible for non-hybrid crops 13

14 Stewardship for Generic GM crops Incident Response Management Due to the complexity of the complete process and of the scrutiny by different stakeholders, it is wise to put in place, as early as possible, an Incident Response System It is an ETS requirement and should be a part of the more general Quality Management System which is probably appropriate to put in place inside the organisation when developing such products Incident can occur at all stages of the development of the product, the response will depend on the type of incident, the stage of development. A few examples: o The trait is not functioning o There is an unintended, unauthorised release of plant material in the environment o Seed quality failure o A regulatory authorisation is not obtained on time 14

15 Stewardship for Generic GM crops Incident Response Management The system could cover the following o Define roles and accountabilities, a team and a team leader o Define an escalation process, escalation will depend on the nature and impact of the incident (internal external / level of the project) o Establish a communication network to disseminate information (internal and external) o Define stakeholder map to know who should be involved depending on the type of incident o Define documentation requirements o Establish ongoing training program 15

16 Stewardship and Integrated Pest Management for generic GM crops Generic Off Patent GM crops Stewardship Integrated Pest Management Conclusions and Prospects 16

17 Integrated Pest Management What is Integrated Pest Management? A holistic approach to sustainable agriculture Focused on managing pests [e.g., weeds (HRM), insects (IRM), viruses (VRM) ] Using a combination of sound agronomic best management practices (i.e., cultural, biological, and chemical methods) To minimize pest damage and maximize the availability and longevity of tools needed for pest management Applicable to chemical products and now biotech products used in agriculture Should be defined early in the process Need to inform the corresponding stakeholders (farmers), education and training Can be voluntary or imposed by the Regulators 17

18 Integrated Pest Management Herbicide Resistance Management (HRM) Main goal: to avoid the development of weeds resistant to the herbicide used on the herbicide tolerant crop Limit repetitive treatments with the same molecule on the same field Use the recommended dose and treatment regime Control resistant weeds as they appear using another chemical Not easy when mainly one technology is used on several crops (tolerance to glyphosate) The availability of several technologies (tolerance to different herbicides in one given crop or in different cultivars of the same crop should help) 18

19 Integrated Pest Management Insect Resistance Management (IRM) Perform a risk assessment o Determine the spectrum of activity (insect affected and not affected, based on the crop) o Check the activity against insects known to be resistant to similar products o Check the level of activity, should kill the insects at the heterozygous stage Identify appropriate measures. In this case, the main recommendation (compulsory) is to have a refuge of generally 20% of plants which are not resistant. Need for a supply of similar seed not carrying the trait Need for extensive monitoring, mainly the appearance of resistant insects Follow carefully the establishment and maintenance of refuges Very often, it is a regulatory requirement, will probably increase with the development of GM crops Training of stakeholders is critical, generally the crop is not resistant to all insects attacking it (need for some insecticide treatment) 19

20 Stewardship and Integrated Pest Management for generic GM crops Generic Off Patent GM crops Stewardship Integrated Pest Management Conclusions and Prospects 20

21 Conclusions and Prospects Conclusions Generic / Off patent GM crops are becoming a reality It is very likely that the number of these GM crops will increase Care should be taken by all stakeholders involved in the development of such crops to make certain there is no incident (adventitious presence, failure in regulatory ) If an organisation is interested to develop and commercialise such products, it is probably wise to adhere to the standards of ETS and to become a member of ETS Prospects / Recommendations Will be difficult to stop farmers from using them Development of agreements such as DUCA and GEMMA should help, to be developed in other countries? Need extensive discussion with the regulatory bodies to adapt the regulatory process for the generic / off patent products Analyse what processes have developed in the Pharma and Crop Protection domains, will probably go in the same directions, but it will take time Will need a leader company or organisation willing to develop such crops 21

22 T H A N K Limagrain Limagrain Y O U Ouest France Le Figaro 22