Argentina

[last updated: 06 May 2021]

Argentina was the first country to consider and provide clarification on whether the application of NBTs should be regulated as GMOs. The country’s regulatory framework is based on its membership of a number of international groups and committees (incl. FAO/WHO/CODEX ^[1], WTO/SPS ^[2], FAO/IPPC ^[3]), as well as its effort to ratify the CPB ^[4].

After a three-year country-internal debate concerning the applicability of the GMO regulation to products obtained through the application of NBTs, Argentina issued a regulation (resolution 173/2015) that aimed to establish case-by-case procedures to determine if a crop obtained by breeding techniques involving modern biotechnology does not fall under GMO regulations (Whelan & Lema, 2019); the Figure below illustrates the underlying decision-making process, whose approach is based on the following components (Friedrichs, et al., 2019; Whelan & Lema, 2015):

All NBTs involve recombinant DNA techniques, which leads to the presumption of GMOs.
If the NBT in question does not involve a new combination of genetic material (e.g. does not use a transgene / uses a transgene, which is removed in the final product), a non-GM regulatory classification is applied.
If the NBT in question involves a new combination of genetic material (e.g. uses a transgene, which remains in the final product), the regulatory classification stipulates that the final product falls under GM classification.

The line-by-line process described above can be (and has been) applied to both real products and hypothetical products; it asks basic information on the overall breeding process, genetic changes, traits, bred-out of helper transgenes, etc..

In a detailed description of the regulation, Whelan and Lema (2019) explain that

[…]

To such end, applicants shall submit each product (NBTs-derived crop) to establish whether the result of the breeding process is a new combination of genetic material or not. A genetic change shall be always regarded as a new combination of genetic material when a stable and joint insertion of one or more genes or DNA sequences that are a part of a defined genetic construct have been introduced permanently into the plant genome.

Also, if appropriate, it must be established if there exists enough scientific evidence to support the absence of the transgenes that may have been used transiently during the crop breeding process.

[…]

In case the crop is not required to be regulated as a GMO but its features and/or novelty lead to a significant risk hypothesis, this must be also reported by the regulatory commission and such report is channeled to the appropriate regulator of varieties obtained by “conventional” breeding for consideration.

(Whelan & Lema, 2019)

In 2019, Lema reported that several crops obtained by NBTs had been presented for determination of their regulatory status in Argentina; the reviewing regulatory authorities found that for SDN1-type NBTs, ‘the final product would not be a GMO, regardless of the nuclease being originated from a recombinant DNA introduced in the plant cell (which is lost later along the breeding process) or by introduction of the protein previously expressed in an heterogeneous system.’ (Lema, 2019).

[1] Website: Food and Agriculture Organisation of the United Nations (FAO) and World Health Organisation (WHO) CODEX ALIMENTARIUS – International Food Standards (accessed: 10^th March 2023)

[2] Website: World Trade Organisation (WTO) Sanitary and Phytosanitary Measures (accessed: 10^th March 2023)

[3] Website: FAO International Plant Protection Convention (IPPC) (accessed: 10^th March 2023)

[4] According to Argentina’s Country Profile at the Biosafety Clearing House for the CPB, Argentina signed the CPB in May 2000, but has not yet ratified it.

[last updated: 06 May 2021]