Posts Tagged GMO

Now you see me, now you don’t. The CJEU on the precautionary principle in Fidenato.

Hang on a minute. Were not the EU and its Member States supposed to be precaution obsessed? Don’t the EU and its Member States alike adopt bans on all things GMO for no other reason than that they simply do not want them? How then can the CJEU hold in C-111/16 Fidenato that Member States do not have the option of adopting, in accordance with Article 54 of Regulation 178/2002, the EU’s general food safety law, interim emergency measures solely on the basis of the precautionary principle?

The reason lies in pre-emption, aka exhaustion, and in the balance between EU and national risk management which EU law strikes in the specific field of GM cultivation. Of note is that in the meantime most biotech companies have given up on cultivation of GM varieties in the EU.

As extremely well summarised by Bobek AG in his Opinion in the case, the formulation of the relevant EU legislation is such as to provide that post EU authorisation (here: of genetically modified maize MON 810) Member States may only take emergency measures where the continued cultivation of the approved products is ‘likely to constitute a serious risk’. While the precautionary principle may play its role fully at the level of the EU’s risk management preceding authorisation, and indeed post such authorisation, too, Member States are given less leeway in their national emergency measures. In prescribing these rules, the EU safeguards the harmonised approach to the GM varieties at issue.

(Mr Fidenato nb is something of a cause celebre among the GM community). Please note, again, that the case concerns the growing (‘cultivation’) of GM crops. Not the import, export or use of products containing GM.

Finally it is important to point out that the Court does not equate precaution with the absence of science. It is the degree of scientific certainty here which is relevant, not the absence ‘v’ presence thereof.

Geert.

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Not on my soil! The Council of the EU compromise on national vetoes to GMO cultivation.

The Council has published its first-reading position on a draft directive granting member states more flexibility to decide whether or not they wish to cultivate genetically modified organisms(GMOs) on their territory – I had flagged it here before I had an opportunity chance to look at the text. My initial reaction is confirmed however.

Under the text, the possibility would be provided for a Member State to request the Commission to present to the notifier/applicant its demand to adjust the geographical scope of its notification/application to the effect that all or part of the territory of that Member State be excluded from cultivation. The Commission shall facilitate the procedure by presenting the request of the Member State to the notifier/applicant without delay and the notifier/applicant should respond to that request within an established time-limit. In the event of refusal, the Member State may block cultivation on its territory for reasons other than the scientific assessment which will have been carried out by the relevant authorities. (And note that the EC may after refusal also proceed to adjusting geographically the request for authorisation for scientific reasons).

The list of ‘compelling reasons’ which may lead a Member State to refuse cultivation, is non-exhaustively listed as

(a) environmental policy objectives distinct from the elements assessed according to the Directive and to Regulation 1829/2003;  (since those environmental objectives will have been considered in the scientific assessment);

(b) town and country planning;

(c) land use;

(d) socio-economic impacts;

(e) cross-contamination with other products;

(f) agricultural policy objectives; and

(g) public policy.

Those grounds may be invoked individually or in combination, with the exception of the public policy exception (which awkwardly needs to be coupled with one of the other grounds). An authorisation procedure will apply (with no need to apply the transparency Directive, 98/34, concurrently).

An important point to note is that the Directive only applies to growing (‘cultivation’) of GMOs in situ: not to the import, marketing etc. of GMO containing products, food, feed etc. I would not be surprised that in practice this will mean a continuation of industry practice to leave the EU altogether for growing GMOs, focusing its efforts instead on securing authorisation to market. (This regime does not feature the much wider leeway for non-science driven objections).

Today is the Saint’s Day of Saint Ignatius Loyola, founder of the Jesuits. A suitable day to ponder a proposal heavy with risk analysis, regulatory theory,  and trade law implications.

Geert.

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Beggars can’t be choosers: has the EU’s GMO compromise outsourced moral reservation?

The compromise (official minutes of the Meeting concerned reveal very little detail; more is available here) between the EU Member States on the market authorisation for GMOs has been condemned by opponents and proponents of the technology alike. Market authorisation for GMOs has a long and troublesome history in the EU, with most recently the spat over Pioneer 1507.

I would love to get my hands on any kind of legal formulation for the apparent deal which as been struck. As is common knowledge, some Member States object categorically to GMOs on a mix of scientific (precautionary), moral, sustainability grounds. The EU have for some time been trying to find a way to accommodate moral objections in particular. (Where there are serious indications of scientific uncertainty vis-a-vis a particular application, these are picked up by EFSA and authorisation will be refused for the EU as a whole: this is not problematic per se – lest of course per the US arguments at the WTO in EC Biotech, one does not accept that there is scientific uncertainty). The suggested way out is now, apparently, for the Member States concerned to request the applicant companies, via the European Commission, to exclude their territory from the application.

This raises all sorts of questions. (Including exam questions). It near-effectively outsources regulatory autonomy to the applicant companies. The suggested regime reminds me of the Voluntary Export Restraints which were popular(ish) in the 1980s – and highly controversial under GATT. Under the WTO, they are all but blacklisted. Especially after SEAL pups I believe it would be much better for the EU regime itself to allow opt-out, even of individual Member States, on moral or ethical grounds (again, the scientific debate is different) and to take any WTO fight into open field.

Should anyone out there have the actual text which is being tabled (in the UK English sense of the word) – and the liberty to share it, I would love to hear from you. (Postscript 31 July 2014: see later post with link to text).

Geert.

 

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