Legal expert explains why the European Court of Justice ruling that gene-edited plants are GMOs is not anti-science

Stefan Jansson, a plant science professor and lobbyist for de-regulation of new gene-edited GMOs, claims to have planted a CRISPR gene-edited cabbage in his garden and eaten it.

Jansson was disappointed when the European Court of Justice (ECJ) ruled in 2018 that gene-edited plants are GMOs and fall under the EU's GMO Directive, which requires safety checks and labelling. Gene editing is referred to in the case as a new form of mutagenesis. Jansson asked about his cabbage, which was now officially a GMO, "Do I have to remove it?"

The ECJ's ruling has been derided by the agbiotech lobby and scientists whose careers focus on plant genetic engineering as anti-science and absurd. But this interpretation fails to appreciate how EU law works, writes legal expert Kathleen Garnett, a PhD candidate at Wageningen School of Social Sciences (WASS), Department of Law and Governance, in a new peer-reviewed article (abstract below).

Garnett points out, "The purpose of EU environmental legislation is first and foremost ‘to protect human health and the environment’, not to incentivize science. That said, EU environmental legislation is not anti‐science. Quite the opposite. Transparent, objective, science‐based justification lies at the heart of the EU’s precautionary principle."

Garnett explains that the EU's GMO Directive defines a GMO as "an organism, with the exception of human beings, in which the genetic material has been altered in a way that does not occur naturally by mating and/or natural recombination". Thus it is likely that the ECJ ruling will also apply to other new GM techniques that will emerge in the coming years.

Garnett writes that the law differentiates between new techniques of mutagenesis brought about by gene editing and random mutagenesis using chemicals or radiation. Random mutagenesis has been used in plant breeding since the 1960s. Thus the legislators who wrote the EU's GMO regulations deemed it to have a long safety record and it was exempted from the GMO legislation.

But, Garnett writes, no one could claim that CRISPR Cas‐9 seeds are an organism created through natural mating and/or natural recombination. Nor can anyone suggest that these seeds have a long safety record.

Thus it seems logical that CRISPR'd organisms are classed as GMOs and must be risk assessed for safety.

Court ruling means regulation, not a ban

In conclusion, Garnett writes, "Professor Jansson need not fear that the findings in Confédération will in any way impinge upon his professional academic study of altering the genetic material of seeds through mutagenic technique. Scientists such as Professor Jansson are, however, required to do so in a regulated, controlled environment, and not by planting such novel seeds in their back garden. Nor does the ruling end all scientific endeavour in new plant breeding techniques. The risk assessment obligations set out in the Directive are not about gut‐feeling but about objective, transparent and open science."

She adds that the ECJ ruling does not prevent the commercial cultivation of these plants on EU soil: "In practice, however, very few GMO varieties are grown in the EU, as industry seemingly finds the obligations set out in Directive 2001/18 too stringent to invest the time, effort and money required. Even in cases where industry has had varieties go through the whole process, some of them have been subject to national moratoriums in application of ‘safeguard measures’."

Thus, while the ruling does not stop academic researchers from pursuing their academic enquiry, Garnett writes, it does make it harder for industry to market and commercialize novel gene-edited plants throughout the EU.

Jansson's CRISPR'd cabbage

What about the cabbage grown in Jansson’s back garden? In answer to his question "Is my cabbage a GMO?", writes Garnett, "The answer is yes as a matter of EU law. Like any other novel mutagenic plants in the EU, the CRISPR Cas‐9 cabbage will now be subject to notification to the national competent authority, using a standard authorization procedure. Environmental risk assessment must be carried out, any risks must be managed and any further growing must be subject to regular inspections from national competent authorities."

As for keeping the CRISPR seed supplier anonymous, as Jansson has done, Garnett points out that this "clearly will no longer be possible".
---
Hold your pipettes: The European Court of Justice's findings in Confédération Paysanne & Others stirs GMOtions
Kathleen Garnett
Reciel, 17 June 2019
https://onlinelibrary.wiley.com/doi/full/10.1111/reel.12291 (open access)

Abstract

In July 2018, the Court of Justice of the European Union (CJEU) gave its final ruling on the much anticipated Confédération Paysanne & Others case on the regulation of mutagenic plants in the European Union (EU). Advocate General Bobek had opined that mutagenic techniques for the development of novel plant varieties should be exempted from the stringent provisions set out in the EU genetically modified organisms (GMO) Directive. It came as somewhat of a surprise, therefore, when the Court of Justice, in its final ruling, took a diametrically opposite point of view to that of the Advocate General, and concluded that novel mutagenic techniques must be subject to the provisions set out in the EU's various regulations relating to GMOs. The scientific community are now calling for the European Commission to consider new legislation to take account of novel plant breeding techniques. This case note sets out how the CJEU reached its conclusions, explains why the GMO Directive is not anti‐science and considers the important role that defining ‘natural’ within a legal context will play in the forthcoming debate on science, innovation and novel plant breeding techniques.