Posts Tagged Risk management
Ghostbusters and the Marshmallow Man. The European Commission covert consultation and study on the innovation principle.
I have reported before on the innovation principle, the industry efforts behind it and the European Commission response to same. I have linked our initial paper as well as media and other reports in an earlier posting. The most comprehensive overview of the genesis of the principle is included here.
One of the comments I made in that earlier post is that Commissioner Moedas has emphasised verbatim that the innovation principle is not binding EU law: ‘“I think we have some misunderstanding here … The Horizon Europe proposal does not in any way establish the innovation principle or incorporate it into EU law. It is referred to in the recitals but it is not something that is [in] the proposal,” he said.
At the end of the original Ghostbusters movie, a giant Marshmallow Man appears as a result of the main ghost’s conjuring up himself as the physical manifestation of the first thought popping up into the mind of the lead characters’ mind (further info here). The road to turning the imagination of the innovation principle into reality is currently equally continuing with no less than a Commission-ordered Consultation Report, from the Centre for European Policy Studies, on the evaluation of the innovation principle: see the Directorate-General’s invitation letter and the questionnaire.
Both documents reached me via a little Berlaymont bird. I have anonymised individuals mentioned in the documents and I have also changed the order of questions in the questionnaire just in case individual copies were drafted to facilitate the coveted ‘confidentiality’ – contents of the questionnaire have stayed the same. The questionnaire is meant for ‘selected stakeholders’ who are instructed not to ‘share, quote or cite it’.
The principle even if it does exist certainly does not do so in EU law – as confirmed by the Commissioner. Yet it is his DG which has instructed CEPS to carry out the study, confidentially: not exactly a driving principle of the Better Regulation Agenda to which the documents purport to answer.
The invite states that ‘the overall aim of this evaluation is to describe the status quo and prepare recommendations for future action in accordance with the better regulation guidelines. These recommendations will serve to apply the Innovation Principle in a way which helps the achievement of EU policy objectives and is consistent with identified stakeholder needs.’
The text pays lip service to the general interest which ‘innovation’ is meant to serve, yet also repeatedly emphasises that existing regulatory hurdles to ‘innovation’ ought to be classified and potentially removed; that the EC may take the necessary steps to initiate this; and nowhere does it question the very existence of the principle.
It is noteworthy in this respect that Horizon Europe, Europe’s next flagship research and development program, refers drastically less to responsibly research and innovation -RRI than did its predecessor. Parliament did not halt references to the innovation principle in its recitals.
I would like to emphasise again that with my co-authors of the paper, I am not an unshakable opponent of the introduction of an innovation principle. Provided the discussion on it is done in the appropriate institutions and at the very least in the public domain. A confidential survey confirms the reactionary character which this principle so far represents on the EU scene.
French Court annuls market authorisation of Roundup. Contrary to public perception, it neither used nor needed the precautionary principle to do so.
In March 2017, France’s ANSES, the relevant food, environment, and occupational health and safety agency, approved Monsanto’s Roundup Pro 360. That authorisation has now been annulled by the Courts at Lyon – around the same time the story broke of extensive unquestioned copy /pasting by regulators of industry dossiers.
At the beginning of its reasoning the court cites France’s environment charter, to which its Constitution refers. The Charter guarantees everyone in its first Article the right to live in a balanced environment and one with respect for human health. Article 5 entails the precautionary principle, with reference (of course) to scientific assessment and proportionality.
Yet this intro is made for dramatic effect only. The judgment is in fact nothing but a straightforward application of risk assessment requirements on the basis of prevention, not precaution, and a simple observation of infringement of EU law.
At 3 (p.7) the court points out the consequences of the relevant EU authorisation regime. Active ingredients such as glyphosate are authorised (or not; and potentially with conditions) by the EU. Applications in wich these substances are used, by the Member States.
France’s Centre International de Recherche sur le Cancer (CIRC) had classified glyphosate as ‘probably carcinogenic’. Its report on same is referred to by the court as a ‘handbook’, based on peer reviewed studies, the data of which are objectively verifiable as well as replicable. In the other corner, one study referred to by Monsanto (at 7). Relevant EFSA studies only look at the active ingredient and it is these studies upon which ANSES’ decision was based. These studies do not assess the active ingredients’ actual use in preparations such as Roundup Pro 360 which is 41.5% glyphosate. Consequently ANSES quite straightforwardly violates Regulation 1107/2009, particularly its Article 36(6), which prescribes that interaction between the active substance, safeners, synergists and co-formulants shall be taken into account in the evaluation of plant protection products.
The judgment is convincing and straightforward. The road to it was all but easy.
EU environmental law (with Leonie Reins), Edward Elgar, soft cover edition 2018, p.28 ff.
A short update on the Court of Justice’s ruling in C-151/17 Swedish Match, in which yesterday it upheld the legality of Directive 2014/40’s ban on ‘snus’ and generally on tobacco products for oral consumption. (Sweden is exempt: Article 15(1) of the 1994 Act of Accession).
The Court reaffirms the bite of the precautionary principle; emphasises the ‘gateway effect’ of snus for the young, including intern alia because consumption of snus can be done very discreetly and hence enforcement of an age ban (a suggested alternative) not effective; and the importance of giving precedence to public health over economic profit.
It also, yet again, shows that measures like these do not fall out of thin air because, as proponents of the precautionary principle would suggest, anti-innovation zealots dream up restrictive measures to kill enterprise. Rather, following extensive scientific advice, the ban is a sensible and proportionate measure to take.
EU Environmental Law, with Dr Leonie Reins, 2017, Chapter 2, Heading IV.
Update 10 January 2019 the final report is out here. Social scientists will be particularly interested in Chapter 3 and Chapter 4, where the report takes a holistic view of risk management.
There are many scientific and legal /regulatory angles to the pollution caused by micro and nanoplastics (MNPs). I was pleased to have been invited to be part of a scoping exercise with the European Commissions Group of Chief Scientific Advisors, following which that Group issued its initial statement early July.
MNPs is an issue where the EU undoubtedly can recognise its regulatory leadership – at the same time appreciating that the challenge is of a truly global nature (many of the worst plastics pollution issues are located in river deltas way outside EU borders). At the scientific level, studies particularly in the marine environment show cause for great concern – but not necessarily easy fixes.
I accepted therefore to be part of the SAPEA Consortium (Science Advice for Policy by European Academies) Working Group on MNPs, which will oversee in first instance the collation of the state of the art: from a regulatory as well as a scientific point of view – and subject to tight deadlines.
Autumn should be interesting.
A short post on manufactured nanomaterials and data. (Readers will be aware that although the blog focuses mostly on litigation, I dabble in regulatory research and practice, too. And that nanotechnology regulation has been a consistent interest of mine).
Thank you Lynn Bergeson and Carla Hutton for flagging the study by EUON on data collection and reporting methodology for manufactured nanomaterials. EUON, the European Union’s Observatory for Nanomaterials, is hosted by ECHA – the EU’s Chemicals Agency. The study’s purpose is made clear on p.15 (only) of the report: the overall context is for the regulators to have an overview of the heterogeneous market for nanomaterials. In order to do so, the study measures the reliability etc of existing reports and studies on the nanomaterials market. It concludes that a Delphi study of the existing research would be required.
For those of you with an interest in information flows and the transparency of data, the implications are clear: part of the exercise of regulating new technologies is to know what is out there; and manufacturers’ data clearly are not making it into the public domain in a transparent and coherent manner. Consider alongside this report, for instance the proposed US EPA rule on transparency in regulator science.
WTO examiners: at ease! Canadian Supreme Court holds in R. v. Comeau (New Brunswick restrictions on alcohol trade).
Fellow faculty about to examine students on the Law of the World Trade Organisation, have their exam sorted (especially if it is an oral exam). In 2018 SCC 15 R v Comeau the Canadian Supreme Court held last week. At issue is New Brunswick’s restrictive regime on the import and sale of alcoholic beverages. Greg Tereposky and Daniel Hohnstein have background to the case.
Despite the Province’s regime having clear trade impact, the SC held that it was not illegal under Canada’s internal free trade rules – with occasional reference to GATT and WTO. For comparative and exam purposes, the interesting angle is clear: has the Supreme Court adopted the kind of aims and effects test which the WTO is no fan of?
Copy of the judgment. 15 mins prep. And Bob’s your (oral exam) uncle.
(Handbook of) The law of the World Trade Organisation, forthcoming at OUP with Demeester, Coppens, Wouters and Van Calster.
Repeat after me: the precautionary principle does not imply reversal of the burden of proof. Neither does it mean ‘when in doubt, opt-out’.
Allow me a succinct grumble about the precautionary principle. A recent Guardian item on trade talks post-Brexit refers ia to proponents of Brexit wanting to use future trade talks eg with the US, to ditch the precautionary principle. It states the proponents’ strategy ‘also advocates tearing up the EU’s “precautionary principle”, under which traders have to prove something is safe before it is sold, rather than waiting for it to be proved unsafe’.
Reversing the burden of proof (also known as the ‘no data no market rule’) is not a necessary prerequisite of the precautionary principle. If it were, public authorities’ task in regulating health, safety and the environment would look very different than it does today, as would the regulation of new technologies such as nano or synthetic biology (indeed even AI). Only in specific sectors, has the burden of proof been reversed. This includes, in the EU, REACH – the flagship Regulation on chemicals. In others, it was discussed (e.g. in the reform of the EU’s cosmetics Directive into a Regulation), but eventually dismissed.
Neither does the EU’s approach to the precautionary principle imply ‘when in doubt, opt out’, or ‘when in doubt, don’t do it’. One need only refer to the recent decision to extend the licence for glyphosate to show that the EU does not ban what is not proven safe (the least one can say about glyphosate is that its health and environmental safety is not clearly established). I blame Cass Sunstein’s Laws of Fear, superbly reviewed (critically) by Liz Fisher in the 2006 Modern Law Review for misrepresenting the principle – such that even its proponents often misunderstand its true meaning.
Precaution is not an alternative to science. It is a consequence of science.
EU environmental law (with Leonie Reins), Edward Elgar, soft cover edition 2018, p.28 ff.