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OECD CONFERENCE ON GENOME
EDITING: APPLICATIONS IN
AGRICULTURE – IMPLICATIONS
FOR HEALTH, ENVIRONMENT AND
REGULATION
Paris...
Session 3: Regulatory aspects
Session 3 will address the regulatory questions associated with
genome editing applications ...
Abstract
Argentina is a world leader in regards to regulation and adoption of
GM crops. As a consequence, the regulatory a...
ARGENTINA and GM crops
One of the “six founder” countries (1996).
Third largest grower (23 M ha).
1st world exporter of so...
Regulatory Framework for GMOs
Since 1991 (creation of CONABIA).
Member CODEX and WTO (SPS, IPPC).
Signatory to the Cartage...
Applicability to GECs
Resolution no. 173/2015 on NBTs (incl. GETs):
Cartagena Protocol definitions: “()…organism
that poss...
Regulatory classification criteria
Use of r-DNA leads to presumption of GMO.
Sorting out process Line by Line.
Base inform...
Regulatory
Classification:
Roadmap
Regulatory
Classification:
GMO and NBT
Caseload
Literature cases
Real cases
Preliminary
statistics
over 3
years Species Consultations
“GMO” vs “Conventional” GECs scenarios
Risk analysis: “minding the gap” solution.
Low Level or Adventitious Presence:
- GM...
vis-à-vis third countries…
Same overall criteria
Coincident decisions
Similar criteria for certain
techniques.
Similar int...
Economic studies comparing GM vs non-GM GECs
handled under different regulatory scenarios. Useful
for weighting the impact...
Blueprint for economic studies:
Compare timespan and cost of the R&D and regulatory stages of
transgenic vs gene edited cr...
Merci beaucoup for your time and interest!!
Martin Lema:
• Director of Biotechnology, Ministry of Agroindustry, mlema@magy...
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Regulatory aspects associated with genome editing applications in agriculture in Argentina - Martin Lema

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This presentation addresses the regulatory questions associated with genome editing applications in agriculture in Argentina, with a view to discussing approaches to address them.

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Regulatory aspects associated with genome editing applications in agriculture in Argentina - Martin Lema

  1. 1. OECD CONFERENCE ON GENOME EDITING: APPLICATIONS IN AGRICULTURE – IMPLICATIONS FOR HEALTH, ENVIRONMENT AND REGULATION Paris, June 2018 Country-Report: Argentina
  2. 2. Session 3: Regulatory aspects Session 3 will address the regulatory questions associated with genome editing applications in agriculture, with a view to discussing approaches to address them. A short introduction will suggest key issues to be considered regarding the regulatory oversight of genome edited products. The following series of presentations will consider policy frameworks in specific countries. They will address the regulatory approaches to genome editing, including legal definitions of genetic modification/engineering in relation to genome editing and risk assessment considerations, taking into account the safety of plant breeding practices and existing regulations of agricultural products. For example, how regulatory frameworks may address different types of risks and enforceability of regulations (identification, monitoring, traceability, labelling). Other topics might arise if relevant to national frameworks such as sustainability considerations, socioeconomics and innovation.
  3. 3. Abstract Argentina is a world leader in regards to regulation and adoption of GM crops. As a consequence, the regulatory aspects of gene editing applied to agriculture were considered proactively, and a simple but solid pioneering regulatory criteria has been developed. At present, the Argentine regulatory system is fully able to establish if a gene-edited crop should be classified (and handled) either as a GM crop or a conventional new variety. To this end, the concept of “novel combination of genetic material” derived from the Cartagena Protocol is of decisive importance. After some pilot cases that have been handled under the new regulation, now applicants appreciate the ease, speed and predictability of this regulation. Moreover, it has been considered by other countries in the course of developing their own regulations, thus acting also as a harmonization factor for the safe and effective insertion of these technologies in the global market.
  4. 4. ARGENTINA and GM crops One of the “six founder” countries (1996). Third largest grower (23 M ha). 1st world exporter of soya oil and meal, 3rd of soy grains and 2nd of corn grain. Adoption of GM soya, corn and cotton over 90%. Positive economic and production impacts. Positive effect on sustainability of agriculture.
  5. 5. Regulatory Framework for GMOs Since 1991 (creation of CONABIA). Member CODEX and WTO (SPS, IPPC). Signatory to the Cartagena Protocol. FAO Center of Reference in GMO Biosafety. 49 commercial approvals in 6 crop species. over 2000 FTs of GM crops, animals and MO. Complex traits, molecular pharming, etc.
  6. 6. Applicability to GECs Resolution no. 173/2015 on NBTs (incl. GETs): Cartagena Protocol definitions: “()…organism that possesses a novel combination of genetic material obtained through …in vitro rDNA (techniques) and direct injection of nucleic acid into cells.”
  7. 7. Regulatory classification criteria Use of r-DNA leads to presumption of GMO. Sorting out process Line by Line. Base information: NBT applied, overall breeding process, genetic changes, trait, bred-out of helper transgenes. Option for putative assessment at design stage. “minding the gap”.
  8. 8. Regulatory Classification: Roadmap
  9. 9. Regulatory Classification: GMO and NBT Caseload Literature cases Real cases
  10. 10. Preliminary statistics over 3 years Species Consultations
  11. 11. “GMO” vs “Conventional” GECs scenarios Risk analysis: “minding the gap” solution. Low Level or Adventitious Presence: - GMO GEC: Monitoring, detectability: Intrinsic difficulty? - Mutant GEC new variety: Seed purity standards. Coexistence: - no safety issue: Identity Preservation (IP) vs. segregation. - IP seeking reward for specialty product and bearing its costs. - IP for does / does not contain. Food Labelling: - [“GMO”] & “non-GMO” labelling. - Labelling of modified properties.
  12. 12. vis-à-vis third countries… Same overall criteria Coincident decisions Similar criteria for certain techniques. Similar interpretation in regards to a few cases. Compatible with preliminary official scientific advice
  13. 13. Economic studies comparing GM vs non-GM GECs handled under different regulatory scenarios. Useful for weighting the impact of policymaking options on agroindustrial innovation and productivity. Construction of Gene Editing as a socio-technical artifact: dynamics of social alliances, sociotechnical resistance, and interpretative flexibility. Useful for anticipating the societal response to different policymaking options. Anticipating the interplay of Gene Editing regulation and socioeconomic impacts
  14. 14. Blueprint for economic studies: Compare timespan and cost of the R&D and regulatory stages of transgenic vs gene edited crops vs other breeding techniques; and also compare the combined potential of products from each technological option to increase productivity. Analyze if differences found may foster innovation (particularly by public institutions and SMEs that opt to use gene editing for crop improvement); and if differences could finally translate into an increased availability of technologies for growers (e.g. by reducing technology cost or access waiting times, and/or through a wider list of technology suppliers or a wider diversification of genetic improvements). For countries where GM crops have encountered more sociotechnical resistance and consequently R&D has been virtually halted, these studies may be enlightening about how promising and realistic are the possibilities of reopening opportunity for biotech innovation in the seed sector from public research institutions to SMEs seed companies to the farmer.
  15. 15. Merci beaucoup for your time and interest!! Martin Lema: • Director of Biotechnology, Ministry of Agroindustry, mlema@magyp.gob.ar • Chair of the National Advisory Commission on Agricultural Biotechnology CONABIA • Adjunct Professor at the National University of Quilmes, mlema@unq.edu.ar REFERENCES: • Whelan, Lema (2015). Regulatory framework for gene editing and other new breeding techniques in Argentina. GM Crops Food 6(4):253-65. • Petracca, Van Eenennaam, Lema (2016) Gene Editing: Do not forget about Animal Agriculture. J Adv Res Biotech 1(1):2. • Whelan, Lema (2017) A research program for the socioeconomic impacts of gene editing regulation. GM crops & food 8(1), 74-83. • Duensing, Sprink, Parrott, Fedorova, Lema, Wolt, Bartsch (2018). Novel features and considerations for ERA and regulation of crops produced by genome editing. Frontiers in Bioengineering and Biotechnology 6, 79. • Whelan, Lema (2018). Regulation of Genome Editing in Plant Biotechnology: Country Report – Argentina. In: Dederer H-G & Hamburger D (eds) Regulation of Genome Editing in Plant Biotechnology: A comparative analysis of the regulatory framework for genome-edited plants in selected countries. Springer, Heidelberg, New York, Dordrecht, London.

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