Biotech Industry’s New Hope ‘Gene Editing’ Dealt a Serious Double Blow

Posted on Feb 20 2020 - 9:50pm by Sustainable Pulse

The U.S. Food and Drug Administration (FDA) and a French court have dealt separate blows to the Biotech industry and their attempt to slide new gene editing techniques through the back door and in to the foods we eat.

The Conseil d’Etat, France’s top administrative court, recently ruled that organisms obtained via new plant breeding techniques (NPBTs), namely gene editing and in-vitro mutagenesis, should be subject to GMO regulation, EURACTIV reported.

The court ordered the government to update regulation to include such crops within six months, which includes identifying the agricultural plant varieties which have been obtained by these techniques and subjecting them to the assessments applicable to GMOs.

The court also said that authorities should carry out an assessment to evaluate potential risks related to herbicide-resistant crops and define growing conditions intended to limit the use of herbicides.

In a statement on the Conseil d’Etat’s website, they say that, in accordance with the precautionary principle, the prime minister “cannot refuse to take preventive measures for the use of plant varieties that have been made tolerant to herbicides.”

The French government will now study how to implement the court’s ruling in line with EU legislation, the French Agriculture and Environment Ministries said in a joint statement.

Meanwhile in the U.S., the FDA released an expert statement, in which they outline the need to be careful regarding the use of gene-editing in animals.

Steven M. Solomon, Director of the FDA’s Center for Veterinary Medicine, made this strongly worded statement outlining the possible “unintended consequences” of gene-editing;

“Today, the journal Nature Biotechnology published the FDA-authored analysis ‘Template plasmid integration in germline genome-edited cattle,’ which describes how a bioinformatics method developed by FDA scientists was able to detect previously unreported, unintended alterations in genome-edited bulls. The analysis emphasizes the FDA’s expertise and critical role in risk-based evaluation of intentional genomic alterations.

“Our analysis demonstrated that genome editing in animals can have unintended consequences, and in this case, it caused foreign DNA to be integrated into the animals’ genomes. While the existence of an unintended alteration does not necessarily mean that the genome edit is unsafe to animals or consumers, it does show that both scientists and regulators need to be alert to the potential for such unintended alterations to take place.

“A companion piece, ‘Genome editing in animals: Why FDA regulation matters,’ also published today explains the value of the agency’s oversight of intentional genomic alterations in animals to protect animal and human health, even when the intended modification seeks to replicate a naturally occurring mutation. The commentary further describes the FDA’s intent to support innovative scientific approaches, while balancing the agency’s role to protect public health through a risk-based approach.”

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