Familiarity. in the context of Risk Assessment of Transgenic Crops in the Americas. São Paulo, Brazil. September 20th, 2018

Transcription

1 Familiarity in the context of Risk Assessment of Transgenic Crops in the Americas São Paulo, Brazil September 20th, 2018

2 ILSI Brazil ILSI Argentina Deise M. F. Capalbo Embrapa Environment Biotec Task Force at ILSI Date

3 Familiarity 2018 This workshop builds on previous international and regional meetings aimed at sharing the state of the science and its application to the practice of the Risk Assessment of transgenic crops.

4 June 26-28, 2013 Familiarity 2018 It was held in Buenos Aires, Argentina. Brought together GM food safety assessors from the main exporting and importing countries from Asia and the Americas who: shared their evaluation approaches identified similarities discussed areas for future work

5 General recommendations Familiarity 2018 GM Crops and Food 6:69-79,2015 Need to agree on the science and what would constitute an effective safety testing strategy -Agreement needs to be based on what we know now, not on what has been historically done. Come up with a process whereby some countries get together and reach an agreement on the safety of certain transgenic proteins/crops Develop criteria to help discriminate solid, relevant evidence from irrelevant/poor quality evidence to support decision making Develop platforms to have better access to information or decision from other regulatory agencies. Communication, Communication, Communication! Regional or sub-regional approaches should be developed.

6 Historic Data transportability Brasilia June 2013 Oct 2013 Comparativa approaches Buenos Aires

7 October 14-15,2013 Familiarity 2018 ILSI Brazil workshop food safety and ERA new plants (sugar cane, eucaliptus, microorganisms, sorghum, mosquitoes) new techniques data transportability

8 Historic Data transportability Brasilia June 2013 Oct 2013 Sept 2015 Comparative approaches Comparative approaches Buenos Aires Sao Paulo

9 September 16-17, 2015 Familiarity 2018 ILSI Brazil regional workshop on compared safety assessment approaches

10 Main take home recommendations Revisit the purpose of compositional studies Familiarity 2018 Although in the normative, animal studies with whole food, not strictly required /not submitted accepted Guide for interpretation of Codex principles for FF safety assessment, recommended evaluation process based on problem formulation, case studies (in Spanish/portuguese) Develop training modules on Codex, OECD documents, available resources, etc. For current and new regulators and committee members Discuss /revisit/re interpret comparators (Codex definition) Meetings on NBTs: criteria for regulatory treatment, and required experimental evidence - regional scope Need to have harmonized standards for regulatory field trials

11 Historic Data transportability Mutual recognition Brasilia Indaiatuba June 2013 Oct 2013 Sept 2015 Sept 2016 Comparative approaches Comparative approaches Buenos Aires Sao Paulo

12 September 27-28, 2016 Familiarity 2018 ILSI Brazil workshop applications of precision breeding (NBTs) regulatory assimetry principles of Prob Formulat on human and animal health mutual recognition in safety assessment of food containing GMs

13 September 27-28, 2016 Familiarity 2018

14 Historic Data transportability Mutual recognition Brasilia Indaiatuba June 2013 Oct 2013 Sept 2015 Sept 2016 March 2018 Comparative approaches Comparative approaches Conceptual tools Buenos Aires Sao Paulo Brasilia

15 Familiarity 2018 March 8, 2018 ILSI Brazil in cooperation with ILSI Argentina Workshop Conceptual tools for risk assessment of GMOs transportability comparators stacks

16 Consejo Agropecuario del Sur (CAS) Ministers of Agriculture (Argentina,Brazil, Chile, Paraguay, Uruguay) 34th meeting August 2017 (São Paulo) Considering Declare The use of new technologies for agricultural production should be carried out in a safe way to guarantee the future of food production and the global sustainable supply The asynchrony in the process for GM approval (exporting / importing countries) is causing a negative impact on the food production system The asynchrony in this process constitutes a barrier in international trade that should be minimized It is necessary to promote cooperation in the construction of joint capacities through the training of experts in new technologies the strengthening of their regulatory frameworks. The countries of the region must work together to: intensify the exchange of information in the approval of GM reduce the asynchrony in the approval of these organisms in the region. The CAS countries will jointly seek to promote the approval of events of regional interest in third markets

17 This CAS declaration is a recent example of initiatives to exchange information in the region. Initiatives that require familiarity with the systems and criteria used by each country and apply conceptual tools such as transportability among others.

18 Familiarity in the context of Risk Assessment of Transgenic Crops in the Americas São Paulo, Brazil September 20th, 2018

19 Date