regulatory+guidance+/+experiences+for+new+plant+breeding+...
TRANSCRIPT
Agus%na Whelan Biotechnology Directorate
Ministry of Agriculture, Livestock and Fisheries of Argen%na
“Regulatory Guidance / Experiences For New Plant Breeding Molecular Biology Technologies in Argen?na”.
Regulatory Agencies
SENASA
INASE
CONABIA Biotechnology Directorate
SENASA CTAUOGM
Directorate of Agricultural Markets
CONABIA Biotechnology Directorate
CONABIA: Na%onal Advisory Commission on Agricultural Biotechnology (Environmental) SENASA: Na%onal Service of Agri-‐ food Health and Quality (Food and Feed) CTAUOGM: Technical Advisory Commitee on GMO use INASE: Na%onal Seed Ins%tute
Field trials Commercial Release
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Regulatory System in Argen?na
» Commercial Approval granted by the Secretariat of Agriculture, Livestock and Fisheries (SAGyP)
» Follows a case-‐by-‐case approach, based on scien%fic data
» Risk assessment focuses on environment, feed & food and economic impacts and is driven by 3 independent commissions (DB/CONABIA/Inase, SENASA/CTAUOGM and DMA)
Approval Process Ministry of Agriculture, Livestock and Fisheries
(MAGyP)
Secretary of Agriculture, Livestock and Fisheries (SAGyP)
INASE SENASA
(DESCENTRALIZED AGENCIES)
Directorate of
Agricultural Markets (DMA)
Directorate of
Biotechnology (DB)
CONABIA
CTAUOGM
Regulatory Framework
Resolu?on 763/11: Under this resolu%on Argen%na currently regulates the ac%vi%es with GMPO
Resolu?on 701/11: This resolu%on is complementary to Resolu%on 763/11 and has the general guidelines applicable to the ac%vi%es involving GMPO
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Defini?ons Gene?cally Modified Plant Organism (GMPO): plant organism that has a combina(on of gene(c material obtained through the applica%on of modern biotechnology.
Event: the combined and stable inser%on into the plant genome of ONE or more genes or DNA sequences that are part of a defined gene%c construct.
* The first defini%ons is in the Cartagena Protocol, but the second, event, is not. Argen%na made this defini%on
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Defini?ons
Combina?on of gene?c material: a new DNA sequence that has been introduced into the plant genome and encodes for a new protein or some func%onal element.
* Currently CONABIA is working on the defini%on of combina%on of gene%c material. There is no formal conclusion yet.
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Technique Preliminary Conclusion
Cisgenesis The final product has a new combina%on of
gene%c material into the plant genome
It is considered GMPO according to the regula%ons in
force
Intragenesis
Floral dip
SDN*-‐3
Synthe%c biology
SDN* (Site – directed nucleases): Set of techniques that can be used to introduce the same change to the plant genome. For example, TALEN, Zinc Finger, Meganucleases. (Maria Lusser and Howard V. Davies) 7
Technique Preliminary Conclusion Gracing
Case: Orange tree
As the tree will be grown in the field
It is a GMPO, according to the regula%ons in force
• If the applicant wanted to make a new product with a rootstock with commercial authoriza%on and a non-‐GM scion, the resul%ng product will not be regulated.
• Food safety assessment would be obligatory even though the fruit (orange) corresponds to the non-‐GM part of the gracing.
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Technique Preliminary Conclusion SDN-‐1 • The modifica%on into the plant genome is site
specific. As a result there is no new combina%on of gene%c material.
• The applicant must show evidence of the removal of the transgene (used temporarily) from the final product.
If the evidence shows that there is not a transgene in the final product, these NPBT products will not be considered as GMPO.
SDN-‐2
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Technique Preliminary Conclusion Reverse Breeding
• In the resul%ng product there is no new combina%on of gene%c material.
• The applicant must show evidence of the removal of the transgene (used temporarily) from the final product.
If the evidence shows that there is not a trangene in the final product, these NPBT products will not be considered as GMPO.
RNA-‐ dependent DNA methyla%on
Technique Preliminary Conclusion
Oligonucleo%de Directed Mutagenesis
There are different types of oligonucle%des that can be used:
• Single stranded DNA oligonucleo%des • Chimeric oligonucleo%des • Triple helix-‐forming oligonucleo%des (TFOs) • RNA oiligonucleo%des
The resul%ng product may (or may not) have a new combina%on of gene%c material and depending on the extent and nature of the modifica%on, the NPBT product could be covered by the GMPO regula%ons in force.
Technique Preliminary Conclusion
Agroinfiltra%on • Research use • Transient expression of trangenes • There is not an inser%on of gene%c material into the plant genome.
Risk assessment should focus on the microorganism carrying the construct of interest.
Agroinocula%on
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The current draW regula?on
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• The resolu%on drac is not limited to the techniques described before.
• It is open to evaluate any other techniques that may come up.
• Sets out the steps to follow when the applicant uses these techniques
* Currently CONABIA is working on this issue. This is preliminary informa%on
The applicant should submit:
• Background informa%on about the process when obtaining the NPBT product.
• Evidence of the introduced gene%c transforma%ons.
• Evidence of the removal of transgenes used temporarily for obtaining the product (if necessary)
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CONABIA will determine:
• If the gene%c modifica%on into the plant genome does not have enough en%ty to be considered a new combina%on of gene%c material.
• If the informa%on submiied does confirm that a transgene used temporarily has been removed from the crop to be commercialized.
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If the assump?ons above are fulfilled; the applicant will be informed that the NPBT product is not covered by the regula?on of GMPOS.
NPBT proposes evalua?on guideline
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1.NPBT: Applicant previous consulta?on
CONABIA
2. Is there a new combina?on of
gene?c material?
Res. 763/11
NO
3. Does the NPBT use a transgene
temporarily?
NO
4. Is the final product free
of transgenes?
NO YES
YES
YES
GM
Non GM
The applicant will be informed that the crop is not covered by regula?on of
GMPO
Acknowledgements
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