GeneWatch UK says EFSA proposal fails to consider uncertainties and the precautionary principle

GeneWatch UK has submitted a response to the European Food Safety Authority’s (EFSA's) consultation on its "Draft scientific opinion on new developments in biotechnology applied to animals: an assessment of the adequacy and sufficiency of current EFSA guidance for animal risk assessment".

The "new developments in biotechnology" in question are the genetic engineering technologies of synthetic biology (SynBio) and new genomic techniques (NGTs), such as CRISPR-Cas and other types of gene editing.

Somewhat predictably, EFSA found "no new potential hazards, and thus, no new risks to humans, animals, or the environment are anticipated" from the use of these techniques in animals, beyond those posed by conventional breeding and older gene technologies such as random mutagenesis.

GeneWatch UK says it is "concerned that the draft guidance attempts to significantly weaken the regulatory oversight of genetically modified (GM) animals in the EU, and thus fails to protect human and animal health, the environment, and animal welfare".

In its response, GeneWatch UK criticises EFSA's attempt to equate the new GM techniques with conventional breeding as incorrect, as "the equivalence of unintended effects due to so-called NGTs with conventional breeding has not been established" and "NGT animals require additional techniques (such as cloning) to be used, which cause adverse effects which are not equivalent to conventional breeding".

Genewatch UK points out that EFSA proposes restricting risk assessment to potential harms that can be identified in advance, whereas there is huge potential for harms that are unanticipated: "Repeated claims that certain aspects of the current guidance should 'only' be applied in certain (limited) cases should be deleted. This is because uncertainties and unexpected effects need to be assessed. This is particularly important because of the wide range of unexpected effects that can occur." Such unexpected – but highly likely – effects include the emergence of new pathogens or pests that evolve to overcome genetically engineered "resistance" in animals.

In its response, GeneWatch UK writes: "Numerous claims that parts of the existing [EFSA] guidance do not apply to certain techniques (including so-called New Genomic Techniques, NGTs, such as genome editing), or to certain traits, should be deleted: this undermines the legal requirements that are supposed to be being implemented, including international obligations under the Cartagena Protocol on Biosafety, and fails to take sufficient account of uncertainties, the precautionary principle, and unintended and unexpected effects."

GMWatch comments on EFSA's draft opinion

In our view, EFSA increasingly appears to be delivering its opinions to pander to political/commercial demands to minimise and downplay the profound differences between conventional breeding and genetic engineering technologies. The end goal seems to be to create a false, but politically convenient, pretence that genetically engineered living organisms are equivalent to naturally occurring and conventionally bred organisms and that they pose no greater risks.

However, this pretence is not in accord with the scientific and technical reality of GMOs, which is that they can pose unexpected risks that can be different from those from conventional breeding and natural reproduction. On top of the risks to the health and welfare of animals that are genetically engineered, cloning is often used to increase their numbers. Cloned animals can suffer from low survival rates, birth defects, and other serious diseases. EFSA itself has previously concluded that "the health and welfare of a significant proportion of clones… have been found to be adversely affected, often severely and with a fatal outcome". How and why EFSA ignored its own advice when it comes to new GM techniques and synbio is a mystery.