On new GMOs no rule is necessary for environmental and health protection. So ruled the Advocate General at the EU Court of Justice that organisms obtained by mutagenesis are exempt from the risk assessment, authorization and consumer information requirements of “conventional” GMOs obtained by transgenesis.
New GMOs at EU Court of Justice
The Advocate General delivered his opinion on 18.1.18 on the reference for a preliminary ruling raised by the French Council of State to the EU Court of Justice. As part of the lawsuit filed by the Confédération paysanne and 8 other agricultural associations against the government in Paris. (1)
Farmers from beyond the Alps
had in fact challenged the national provision exempting so-called new GMOs
from the rules established in Europe for the deliberate release into the environment and market as well as the use of genetically modified organisms.
The GMO Directive introduced at the time a system of rules, (2) under which the release of genetically modified organisms into the environment is conditioned on the issuance of a permit by the European Commission. Following appropriate risk assessment – for the environment and biodiversity – by Efsa. (3)
Additional authorization is provided for the use of GMOs and their derivatives in the production of food or feed. After verifying their ‘harmlessness’ to human and animal health. These substances and related goods are also subject to precise traceability, food and feed labeling, and monitoring requirements. (4)
From GMOs to new GMOs, no rules
Back in 2001, the European directive had offered a definition of GMOs that was sufficiently broad compared to the knowledge at the time. And yet-like any technical regulation of areas where research is continually evolving-insufficient to cover any subsequent development in synthetic biology. (5)
A ‘genetically modified organism (GMO) is defined as an organism, other than a human being, whose genetic material has been altered in a way that does not occur naturally by mating and/or natural genetic recombination ‘ (dir. 2001/18/EC, Art. 2.1.2).
Mutagenesis benefited from an exemption from the application of the regime provided for GMOs, (6) because at the time of the directive it involved traditional or ‘random’ techniques (e.g., exposure to ionizing radiation), applied in vivo to the whole plant, and their use was considered ‘safe.’
Mutagenesis, in theory, differs from transgenesis in that it does not involve the insertion of foreign DNA into a living organism. Even if it involves altering the DNA of a living species.
However, genetic engineering has advanced
to the point where, in recent years, mutagenesis can be used to create seeds resistant to
pesticides
. According to the classic script of the Big 6 who control 75 percent of the global market for agrotoxics and seeds. (7)
French farmers have denounced the risks of significant damage — to human and animal health, the environment biodiversity — that may result from the uncontrolled release of the ‘new GMOs’. That is, those made by mutagenesis. And they called for the rules for GMOs to apply to them as well, starting with risk assessments and approvals.
Accumulation of carcinogenic molecules and endocrine disruptors in plants intended for food or feed, unwanted or off-target mutations on other parts of the genome. These are the risks to be assessed first, the plaintiffs explain.
New GMOs, no rule for attorney general
The EU Court of Justice has therefore been asked to consider whether the long-standing exemption-at the time granted to traditional mutagenesis-can be extended to current techniques as well. Which produce genetic mutation effects fully equivalent to those of GMOs subject to the appropriate regime. (8)
The precautionary principle should inform the drafting but also the interpretation of any discipline that may affect-even potentially- the health of humans, animals, and the environment.
‘The Union’s environmental policy aims for a high level of protection, taking into account the diversity of situations in different regions of the Union. It is based on the principles of precaution and preventive action, the principle of correcting, as a priority at the source, damage caused to the environment, and the principle of ‘polluter pays‘ (Treaty on the Functioning of the European Union, TFEU, Article 191.2)
In contrast, the conclusions of Advocate General Michal Bobek deny the need to update the protection of our society’s fundamental values and goods. Instead of looking at the substance of the issue, the Czech togee (blind?) relies on matters of mere form to make a political decision in favor of the unchecked Franken-seed and agrotoxin business. With the greater shame of gratuitous mockery – ‘Beauty is in the eye of the beholder‘ (9) – towards the precautionary principle and those who confide in it.
And thus, no distinction is made between traditional and evolved mutagenesis, (10) nor ‘dowe see any reason (…) to update legislation (in this case reinforced by the precautionary principle) that might affect the validity of the exemption for mutagenesis.’
Member states, however ‘could actually go beyond the GMO directive and decide to subject organisms obtained by mutagenesis to the obligations of the directive or to purely national standards.’ (11) Yet another hypocrisy, as if national measures could stem transnational flows of seeds, commodities and foods not identified as GMOs (despite being equivalent).
The Court is not bound to follow the Advocate General’s conclusions, although this happens in almost all cases. The European Parliament will then have to take urgent action to limit the damage that could manifest itself before long.
For further insights
and reflections on the general topic, please refer to thefree ebook ‘GMOs, the Big Scam‘
. The author of which thus comments on the position expressed by the Czech togato, in a word, Shame!
Dario Dongo
Notes
(1) Case C-528/16, Confédération paysanne and others vs.
Premier ministre et ministre de l’Agriculture, de l’Agroalimentaire et de la Forêt
(France). Conclusions 18.1.18 by Advocate General Michal Bobek at http://curia.europa.eu/juris/document/document.jsf?text=&docid=198532&pageIndex=0&doclang=IT&mode=req&dir=&occ=first&part=1&cid=779292
(2) See dir. 2001/18/EC, on the deliberate release of genetically modified organisms into the environment, as amended. Testo consolidato su http://eur-lex.europa.eu/legal-content/IT/TXT/HTML/?uri=CELEX:02001L0018-20150402&qid=1517605080215&from=EN
(3) Efsa, European Food Safety Authority. The criteria for the environmental risk assessment of GMOs are given in dir. 2001/18/EC, Annex II
(4) See reg. CE 1829, 1830/00
(5) Dir. 2001/18/EC lists genetic modification techniques and those considered not to have ‘the effect of genetic modification‘ (Annex I A, Parts 1 and 2). Such lists, however, tend toward rapid obsolescence, compared with the continuous advancement of science
(6) Directive cited above, Article 3.1 and All. I B
(7) As extensively demonstrated in the free ebook ‘GMO the Big Scam,’ the
business
of seeds is functional to that of pesticides whose value is triple. Designing seeds that resist their own pesticides allows for increased sales of those pesticides, which, however-not an insignificant side effect-poison populations and the environment (see glyphosate, paraquat and dicamba)
(8) The techniques now in use, moreover, are extraordinarily cheaper than traditional ones. See
Nature
, at https://www.nature.com/news/crispr-the-disruptor-1.17673
(9) Cf. Conclusions cited in Note 1, item 47
(10) While traditional mutagenesis involves random mutations, site-specific mutagenesis methods-thanks to new genetic engineering techniques such as oligonucleotide directed mutagenesis (ODM) and mutagenesis by site-directed nuclease (SDN1)-cause precise mutations in genes. With what effects in the long and very long term, generations to come will find out
(11) Member states that expressed views in the judgment, moreover, were largely in favor of unconditional extension of mutagenesis (so Greece, England, Sweden). Some others (Austria, France, the Netherlands), on the other hand, have felt that case-by-case assessments should be made on the basis of risk analysis. The Italian government, coincidentally absent
Dario Dongo, lawyer and journalist, PhD in international food law, founder of WIISE (FARE - GIFT - Food Times) and Égalité.
