New genomic techniques

The Commission’s pro­posed Reg­u­la­tion on plants obtained with New Genom­ic Tech­niques (NGT) aims to accel­er­ate mar­ket access for the lat­est gen­er­a­tion of GM plants and avoid con­sumer rejec­tion of GM food. The pro­pos­al expos­es con­sumers and the envi­ron­ment to unknown risks, jeop­ar­dis­es both organ­ic and con­ven­tion­al GMO-free agri­cul­tur­al pro­duc­tion and would lead to a surge of patent­ed GM seeds. With­out labelling of final prod­ucts, con­sumers would be left in the dark.

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What are New Genom­ic Tech­niques (NGTs)?
New Genom­ic Tech­niques (NGTs) are genet­ic mod­i­fi­ca­tion tech­niques that have been devel­oped since the adop­tion of EU GMO Direc­tive 2001/18/EC. Some are based on the trans­fer of genes from relat­ed species (cis­ge­n­e­sis). Oth­ers are so-called gene edit­ing tech­niques such as CRISPR/Cas. They have in com­mon that, in prin­ci­ple, the final organ­ism con­tains no for­eign DNA (i.e. genet­ic mate­r­i­al from a species that is not
sex­u­al­ly com­pat­i­ble).

Are NGT plants genet­i­cal­ly mod­i­fied organ­isms (GMOs)?
Organ­isms pro­duced with New Genom­ic Tech­niques are GMOs and sub­ject to the rules of the EU’s GMO leg­is­la­tion, accord­ing to the Euro­pean Court of Jus­tice. The Commission’s pro­pos­al acknowl­edges that in its Arti­cle 3. The EU’s GMO leg­is­la­tion aims to pro­tect human and ani­mal health and the envi­ron­ment, and to sup­port the EU inter­nal mar­ket.

What has the Euro­pean Com­mis­sion pro­posed?
On 5 July 2023, the Com­mis­sion pre­sent­ed a pro­pos­al estab­lish­ing two cat­e­gories of GM plants obtained through NGTs.

  • Cat­e­go­ry 1 NGT plants have no more than 20 genet­ic mod­i­fi­ca­tions. The Euro­pean Com­mis­sion con­sid­ers these GM plants to be “equiv­a­lent” to con­ven­tion­al­ly bred plants. It wants to remove exist­ing require­ments for GMOs, includ­ing autho­ri­sa­tion based on an indi­vid­ual risk assess­ment, detec­tion meth­ods, trace­abil­i­ty, mon­i­tor­ing and con­sumer labelling. Seeds and oth­er plant repro­duc­tive mate­r­i­al (e.g. tubers, cut­tings) would be labelled as “cat 1 NGT” and list­ed in a pub­lic data­base.
  • Cat­e­go­ry 2 NGT plants are all oth­er NGT plants. For these GM plants, most GMO require­ments would be main­tained, although some (e.g. the sub­mis­sion of a detec­tion test) could also be dropped. EU coun­tries would no longer be allowed to ban the cul­ti­va­tion of NGT2 plants in their ter­ri­to­ries. How­ev­er, they would be required to adopt mea­sures to avoid the unin­tend­ed pres­ence of these GM plants in organ­ic and con­ven­tion­al crops.

Like any oth­er GMOs, NGT1 and NGT2 plants would be banned in organ­ic pro­duc­tion.

Why should these GM plants not be reg­u­lat­ed like oth­er GMOs?
Com­pa­nies like Corte­va, Bay­er and oth­ers have long argued that GMOs that do not con­tain for­eign DNA are not GMOs. They also claim that new GM tech­niques are a faster route – com­pared to ordi­nary breed­ing – to plants that with­stand droughts, resist dis­eases and achieve high­er yields.

The Euro­pean Com­mis­sion has adopt­ed this line of argu­ment although it recog­nis­es that, tech­ni­cal­ly and legal­ly, NGT organ­isms are GMOs. The Com­mis­sion wants to speed up the com­mer­cial­i­sa­tion of such organ­isms and cir­cum­vent con­sumer rejec­tion of GM food.

Are any of these GM plants already on the mar­ket?
Even though coun­tries like the US, Brazil, Japan and oth­ers have more lenient reg­u­la­tions, only a hand­ful of prod­ucts are com­mer­cialised out­side the EU. A her­bi­cide-tol­er­ant oilseed rape from Cibus and a soy­bean with a sup­pos­ed­ly health­i­er oil com­po­si­tion from Calyxt have failed in the mar­ket­place. Niche prod­ucts, such as a toma­to claimed to low­er blood pres­sure (Sanat­e­ch, Japan) and a sal­ad with a longer shelf life (Green­Venus, US), have been intro­duced in some coun­tries.

What are the main prob­lems with the pro­posed leg­is­la­tion?
Farm­ers’ organ­i­sa­tions, inde­pen­dent sci­en­tists, envi­ron­men­tal groups and the organ­ic sec­tor have warned that the dereg­u­la­tion of the lat­est gen­er­a­tion of GM plants would lead to major prob­lems:

Poten­tial risks – NGT1 plants could pose risks to nature and human health. This view is shared by GMO experts in nation­al author­i­ties such as ANSES in France, BfN in Ger­many and UBA in Aus­tria who have ques­tioned the sci­en­tif­ic basis of the pro­pos­al.

Lack of choice for busi­ness­es and con­sumers – Although farm­ers would know whether they grow NGT1 plants, they would not be able to detect out­cross­ing or oth­er adven­ti­tious pres­ence in fol­low­ing gen­er­a­tions. Food pro­duc­ers, retail­ers and con­sumers would not be able to choose. This would make it hard­er for them to avoid GM food. Sur­veys have shown that most peo­ple in the EU want GM food to be labelled as such, and con­sumer asso­ci­a­tions have called for appro­pri­ate labelling.

Increase in patent­ed seeds – Genet­ic mod­i­fi­ca­tion tech­niques and their result­ing traits are patent­ed, while con­ven­tion­al­ly bred plant vari­eties are pro­tect­ed under seed vari­ety laws (UPOV). Patents pre­vent the use repro­duc­tive mate­r­i­al for fur­ther breed­ing unless licenced by the patent hold­er. With the intro­duc­tion of NGT plants, the num­ber of patent­ed seeds and traits would increase, threat­en­ing small- and medi­um-sized breed­ers and farm­ers as well as the organ­ic and GMO-free sec­tors.

Ben­e­fi­cial plant traits, such as increased resis­tance to heat, water stress or pathogens, have been achieved through clas­si­cal breed­ing and selec­tion. How­ev­er, NGT patents could jeop­ar­dise access to these traits and make them the sub­ject of legal dis­putes.

What is the Parliament’s posi­tion?
The Euro­pean Par­lia­ment has vot­ed to intro­duce

  • Manda­to­ry labelling and trace­abil­i­ty of NGT1 plants and prod­ucts con­tain­ing or con­sist­ing of NGT1 plants. MEPs have called for a label indi­cat­ing the words “New Genom­ic Tech­niques” and doc­u­ment-based trace­abil­i­ty, so that oper­a­tors and con­sumers can “exer­cise their free­dom of choice in an effec­tive man­ner”. (AMs 264 and 265)
  • A ban on patents on “NGT plants, plant mate­r­i­al, parts there­of, genet­ic infor­ma­tion and process fea­tures they con­tain”. The aim was to avoid legal uncer­tain­ties, increased costs and new depen­den­cies for farm­ers and breed­ers. (AMs 23, 33)
  • Eval­u­a­tion and mon­i­tor­ing of envi­ron­men­tal impacts. Only in a recital, not in the arti­cles, the Par­lia­ment said: “NGT plants with the poten­tial to per­sist, repro­duce or spread in the envi­ron­ment, with­in or beyond fields, should be eval­u­at­ed with the high­est lev­el of scruti­ny in respect of such plants’ impact on nature and the envi­ron­ment.” (AM 8) In anoth­er recital, MEPs called for “a mon­i­tor­ing plan for envi­ron­men­tal effects” (AM 260).

These changes address some, but not all, of the prob­lems with this pro­pos­al. Any final text nego­ti­at­ed in the tri­logue that does not include them should be reject­ed.

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