EFSA: Existing guidelines insufficient for risk assessment of Gene Drives

Berlin, 13. Novem­ber 2020 - The Euro­pean Food Safe­ty Agency (EFSA) has pub­lished an assess­ment on whether the cur­rent­ly exist­ing Euro­pean guide­lines for the risk assess­ment of genet­i­cal­ly mod­i­fied insects are suf­fi­cient for the risk assess­ment of genet­i­cal­ly mod­i­fied Gene Dri­ve insects.

Mareike Imken, Gene Dri­ve advi­sor at Save Our Seeds, com­ments:

EFSAs assess­ment, that exist­ing guide­lines for genet­i­cal­ly engi­neered insects are insuf­fi­cient in order to con­duct envi­ron­men­tal risk assess­ment for Gene Dri­ve Organ­isms, con­firms our analy­sis: Due to their nov­el char­ac­ter­is­tics it will be extreme­ly chal­leng­ing – if not impos­si­ble – to mod­el, pre­dict and mon­i­tor the behav­iour of these genet­i­cal­ly engi­neered organ­isms.

Imken con­tin­ues:

“How­ev­er, EFSA does not acknowl­edge a key chal­lenge for the risk assess­ment and mon­i­tor­ing of genet­i­cal­ly engi­neered Gene Dri­ve Organ­isms – so called next-gen­er­a­tion-effects – due to their choice of com­para­tors which lack the key char­ac­ter­is­tic of uncon­trol­lable cross-gen­er­a­tion genet­ic engi­neer­ing.

Next gen­er­a­tion effects would encom­pass unin­tend­ed changes to the bio­log­i­cal char­ac­ter­is­tics in the off­spring of Gene Dri­ve Organ­isms, that will like­ly hap­pen due to the repeat­ed and uncon­trol­lable process of genet­ic engi­neer­ing that Gene Dri­ves set in motion in nature. When the repeat­ed process of genet­ic engi­neer­ing can­not be con­trolled in space and time – as is the case with genet­i­cal­ly engi­neered Gene Dri­ve Organ­isms – its effects can­not be pre­dict­ed by risk assess­ment.

The like­ly impos­si­bil­i­ty to mod­el and pre­dict next-gen­er­a­tion-effects, as already observed with the off­spring of genet­i­cal­ly engi­neered plants, calls for the estab­lish­ment of cut-off-cri­te­ria for risk assess­ment. They would apply when predici­tions can­not be made due to uncer­tain­ty and lim­its of knowl­edge. In this case risk assess­ment would have to be inter­rupt­ed and autho­riza­tion could not be grant­ed.

Apart from that we should not for­get that deci­sion-mak­ing about this tech­nol­o­gy needs to be informed by more than risk assess­ment: There is an urgent need for a broad­er polit­i­cal debate and process­es for par­tic­i­pa­to­ry, inclu­sive and demo­c­ra­t­ic soci­etal delib­er­a­tion around the desir­abil­i­ty, costs and ben­e­fits of this tech­nol­o­gy in com­par­i­son to alter­na­tive solu­tions as well as its com­pat­i­bil­i­ty with soci­etal val­ues and ethics as a base for polit­i­cal deci­sion-mak­ing around gene dri­ve tech­nol­o­gy.“

Con­tact: Mareike Imken, , 0151–53112969