Regulation of GM Animals in Argentina. Yanina Petracca, Ph.D.

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1 Regulation of GM Animals in Argentina Yanina Petracca, Ph.D.

2 REGULATORY FRAMEWORK IN ARGENTINA» Enforced since 1991 at the Federal Level & within the scope of the Ministry of Agriculture, Livestock & Fisheries.» Regulation of activities involving GMOs of AG use.» The main goal of the regulation is to ensure that GMOs are safe for the agro ecosystem and for human and animal consumption & that they are beneficial to our farmers (domestic & int l impacts).» Activities with GMOs are regulated and demand prior written authorization by the Secretary of Agriculture, Livestock and Fisheries.

3 TYPES OF AUTHORIZATIONS Confined release: All types of GMOs. Commercial release (deregulation): Only GM crops (no GM animals or GM microorganisms yet!). Authorizations are granted upon fulfilment of specific regulatory requirements by the applicants.

4 AUTHORIZATIONS FOR THE CONFINED RELEASE OF GMA Under Resolution 57/03 Argentina currently regulates the confined release of GMA of agricultural interest (for experimental purposes). Tests in Lab animal facilities. Confined Field trials. Activities may begin only after proper authorization is granted.

5 AUTHORIZATIONS FOR THE CONFINED RELEASE OF GMA Applicants must fill & submit a Form and attest to the truth of the information submitted. Applicants must inform: Applicant and/or Legal representative ID. Characteristics of the non GMA & potential receiving environment. The genetic modification & genetic engineering techniques applied. Genotypic and phenotypic changes in the GMA (intendedunintended) comparing with the non modified recipient. Activities conducted, biosafety conditions & risk mitigation in the trial.

6 WHICH ARE THE AGENCIES THAT ENFORCE THE GMA REGULATORY FRAMEWORK? A number of agencies take part in the risk assessment & oversight of the activities involving GMA. Ministry of Agriculture, Livestock & Fishieries RA process Secretary of Agriculture, Livestock & Fisheries Directorate of Biotechnology National Advisory Commission on Agricultural Biotechnology (CONABIA) National Service of Agrifood Health and Quality (SENASA). Descentralized agency Enviro RA» The DB & CONABIA assess the applications focusing on confinement conditions.» RA follows a case by case & a scienced based approach.» CONABIA submits a report advising the Secretariat about the advisability of granting (or denying) the application.» Based on this report, the Secretariat grants (or not) the authorization.

7 WHICH ARE THE AGENCIES THAT ENFORCE THE GMA REGULATORY FRAMEWORK? A number of agencies take part in the risk assessment & oversight of the activities involving GMA. Ministry of Agriculture, Livestock & Fishieries Secretary of Agriculture, Livestock & Fisheries Directorate of Biotechnology National Advisory Commission on Agricultural Biotechnology (CONABIA) National Service of Agrifood Health and Quality (SENASA). Descentralized agency Inspections Enviro RM Upon authorization» SENASA verifies the fulfillment of the biosafety conditions by periodic inspections.» SENASA has competence on animal health & welfare, import requirements for animals and quarantine conditions.» During the trial, applicants must submit periodic reports to the DB & CONABIA on the activities done and/or on events that could have an impact on biosafety.

8 CASE OF STUDIES IN ARGENTINA Since 2005, we have received 15 applications for conducting confined trials with GMA. Biopharming Functional Foods Production of recombinant proteins in the milk of GM cattle: human Growth Hormone. bovine Growth Hormone. human Insulin. GM cattle that express: llama Nanoantibodies against Rotavirus in the milk (gastrointestinal infections). human lysozime and lactoferrin in the milk (antifungal, antibacterial and antiviral functions).

9 NEW CHALLENGES TO EXISTING REGULATIONS There have been huge advances in the animal biotechnology field since 2003, when our current regulation on GMA was enforced. For confined releases: At present, we are revising our regulations taking into account previous experience + new technologies. e.g: New Forms with a format easier to fill and more focused on confinement & other biosafety conditions. For commercial releases (deregulation): We will work on new regulations in anticipation of such applications in the near future. Risk assessment should be focused on the environmental, feed &food and economic impacts and would be carried out by different agencies.

10 NEW CHALLENGES TO EXISTING REGULATIONS There have been huge advances in the animal biotechnology field since 2003, when our current regulation on GMA was enforced. For confined releases: At present, we are revising our regulations taking into account previous experience + new technologies. e.g: New Forms with a format easier to fill and more focused on confinement & other biosafety conditions. For commercial releases (deregulation): We will work on new regulations in anticipation of such applications in the near future. Risk assessment should be focused on the environmental, feed &food and economic impacts and would be carried out by different agencies.

11 NEW CHALLENGES TO EXISTING REGULATIONS» The organisms generated by the use of the gene editing techniques represent a new challenge to most of the existing regulatory frameworks.» 2015: In Argentina, a new regulation was enforced to address new breeding techniques plants products. Resolution Nº 173/15 sets out the steps to follow to determine in which cases a crop obtained by new breeding plant techniques (NBPT), does NOT fall under GMO rules and regulations.

12 NEW CHALLENGES TO EXISTING REGULATIONS NBTP: Applicant s previous consultation CONABIA Is there a new combination of genetic material?» Applicants shall requests CONABIA to establish whether the crop obtained by new breeding techniques, bears a new combination of genetic material (GMO definition). What is a new combination of genetic material? NO Non GM The crop is not covered by regulation of GMPO YES GM Under Regulation

13 NEW CHALLENGES TO EXISTING REGULATIONS NBTP: Applicant s previous consultation CONABIA Is there a new combination of genetic material? DEFINITION: A genetic change shall be regarded as a new combination of genetic material when the assessment establishes that one or more genes or DNA sequences that are a part of a defined genetic construct have been inserted jointly & stably into the plant genome. NO Non GM The crop is not covered by regulation of GMPO YES GM Under Regulation

14 NEW CHALLENGES TO EXISTING REGULATIONS NBTP: Applicant s previous consultation CONABIA Is there a new combination of genetic material?» For the assessment, applicants must submit to CONABIA data on: The breeding methodology used to obtain the crop. The new trait or characteristic introduced. The genetic changes present in the final product. NO Non GM The crop is not covered by regulation of GMPO YES GM Under Regulation

15 NEW CHALLENGES TO EXISTING REGULATIONS NBTP: Applicant s previous consultation CONABIA Is there a new combination of genetic material?» CONABIA will determine if the final product has a new combination of genetic material. X If not, the Applicant will be informed that the NBT product is not covered by the regulations of GM plants. Otherwise, the NBT product will have to go through a regulatory process. NO Non GM The crop is not covered by regulation of GMPO YES GM Under Regulation

16 NEW CHALLENGES TO EXISTING REGULATIONS It is possible that, in the near future, we will debate within CONABIA new criteria on how to address animal products obtained by use of gene editing techniques. The abovementioned presentation represents my expert opinion on the matters therein and those not necessarily represent the ones of the Argentine Government.

17 THANK YOU VERY MUCH FOR YOUR ATTENTION!