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Regulatory aspects associated with genome editing applications in agriculture in Argentina - Martin Lema
OECD CONFERENCE ON GENOME
EDITING: APPLICATIONS IN
AGRICULTURE – IMPLICATIONS
FOR HEALTH, ENVIRONMENT AND
Paris, June 2018
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.
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.
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
Positive economic and production impacts.
Positive effect on sustainability of agriculture.
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.
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.”
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
“minding the gap”.
GMO and NBT
years Species Consultations
“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.
- no safety issue: Identity Preservation (IP) vs. segregation.
- IP seeking reward for specialty product and bearing its costs.
- IP for does / does not contain.
- [“GMO”] & “non-GMO” labelling.
- Labelling of modified properties.
vis-à-vis third countries…
Same overall criteria
Similar criteria for certain
Similar interpretation in
regards to a few cases.
Compatible with preliminary
official scientific advice
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
Anticipating the interplay of Gene Editing
regulation and socioeconomic impacts
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.
Merci beaucoup for your time and interest!!
• Director of Biotechnology, Ministry of Agroindustry, email@example.com
• Chair of the National Advisory Commission on Agricultural Biotechnology CONABIA
• Adjunct Professor at the National University of Quilmes, firstname.lastname@example.org
• 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.