Biotech Updates

EMBRAPA Tackles Brazil's Regulatory Framework for Genome Editing

June 16, 2021

Biosafety laws must reflect and acknowledge technological innovations to maintain food quality and safety while permitting diversification in the production chain. This is one of the key points in the EMBRAPA publication on Regulatory Framework of Genome Editing in Brazil and Worldwide.

Regulation of products derived from genome editing techniques has been a subject of discussions globally. One of the main focuses in the discussions is whether the products that used site-directed nucleases should be classified and regulated as GM products. Since SDN-1 and SDN-2 systems simulate the pattern of genetic variability induction that happens in nature, detection in genome-edited products is impossible. Thus, the paper highlights that genome-edited products generated through such systems must not be subjected to risk analysis applied to GM products.

Brazil, being one of the first countries to have legislation that regulates genome editing techniques, understands the importance of harmonizing the biosafety laws of food exporting and importing countries. Harmonization of regulatory rules also facilitates legal confidence for developers in each country, avoiding individual national/regional rules for products resulting from conventional random mutagenesis or the use of SDN systems. Harmonization of regulations also ensures that two indistinguishable products are not regulated in two different ways.

Download the publication from EMBRAPA.

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