Posts Tagged Risk
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.
Our paper on the innovation principle, with Kathleen Garnett and Leonie Reins is just out in Law, Innovation and Technology. We discuss how industry has been pushing for the principle to be added as a regulatory driver. Not as a trojan horse: industry knocks politely but firmly at the EU door, it is then simply let in by the European Commission. We discuss the ramifications of such principle and the wider consequences for EU policy making.
(Handbook of) EU Environmental Law (with Dr Reins), 1st ed. 2017, Chapter 2.
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.
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.
The CJEU held yesterday in Case C-296/16P Dextro Energy (text of judgment available in French and German only at the time of posting), an appeal against the General Court’s ruling in T-100/15. The General Court had declined to annul the European Commission Regulation which refused to authorise certain health claims made on foods, other than those referring to the reduction of disease risk and to children’s development and health. Dextro Energy had wanted to include health claims such as ‘glucose supports normal physical activity’ and ‘glucose contributes to normal muscle function’. The EC had refused: citing (in Regulation 1215/8)
‘Pursuant to Articles 6(1) and 13(1) of Regulation … No 1924/2006 health claims need to be based on generally accepted scientific evidence. Authorisation may also legitimately be withheld if health claims do not comply with other general and specific requirements of Regulation … No 1924/2006, even in the case of a favourable scientific assessment by [EFSA]. Health claims inconsistent with generally accepted nutrition and health principles should not be made. [EFSA] concluded that a cause and effect relationship has been established between the consumption of glucose and contribution to energy-yielding metabolism. However, the use of such a health claim would convey a conflicting and confusing message to consumers, because it would encourage consumption of sugars for which, on the basis of generally accepted scientific advance, national and international authorities inform the consumer that their intake should be reduced. Therefore, such a health claim does not comply with point (a) of the second paragraph of Article 3 of Regulation … No 1924/2006 which foresees that the use of claims should not be ambiguous or misleading. Furthermore, even if the concerned health claim was to be authorised only under specific conditions of use and/or accompanied by additional statements or warnings, it would not be sufficient to alleviate the confusion of the consumer, and consequently the claim should not be authorised.’
The General Court performed its standard review in the face of a wide discretionary room for manoeuvre for the EC, and decided the EC had not exceeded its authority in holding as it did – even in the face of more lenient EFSA recommendations. The Court of Justice has now entirely sided with the General Court. The Judgment is a good reminder of aforementioned standard test (no de novo or merits review; annulment in the event of manifest transgression of power or error in judgment only), and readers best refer to reading the judgment itself.
One consideration however, I should like to highlight: Dextro Energy had suggested the health claims needed to be assessed in light of the target group (determined in the product’s advertising), which, it was suggested, were physically active people for whom consumption of the glucose tablets in question is not harmless. The Court rejected this approach: the population as a whole, for whom the product is available, are the group which the EC justifiably seeks to protect. The manufacturer’s professed target group is not the relevant group to consider (do bear in mind that this is a product which is widely available and not restricted in any way at points of sale):
At 76-77: si les allégations de santé en cause étaient autorisées, elles s’adresseraient à la population en général, pouvant ainsi encourager la consommation de sucres par les personnes autres que les hommes et les femmes bien entraînés. Dans ces conditions, le Tribunal n’a pas commis d’erreur de droit lorsqu’il a rejeté, au point 57 de l’arrêt attaqué, l’argument de Dextro Energy, selon lequel c’était le groupe cible qui importait aux fins de l’appréciation des allégations de santé en cause.
There is as yet no EU harmonisation on amino acids, in so far as they have a nutritional or physiological effect and are added to foods or used in the manufacture of foods. A range of EU foodlaws therefore do not apply to national action vis-a-vis amino acids, in particular Regulation 1925/2006 – the food supplements Regulation. In the absence of specific EU law rules regarding prohibition or restriction of the use of other substances or ingredients containing those ‘other substances’, relevant national rules may apply ‘without prejudice to the provisions of the Treaty’.
In C-282/15 Queisser Pharma v Germany, moreover there were no transboundary elements: Articles 34-36 TFEU therefore do not in principle apply.
No doubt food law experts may tell us whether these findings are in any way unusual, however my impression is that the Court of Justice in this judgment stretches the impact of the ‘general principles of EU food law’ as included in Regulation 178/2002. Indeed the Court refers in particular to Article 1(2)’s statement that the Regulation lays down the general principles governing food and feed in general, and food and feed safety in particular, at EU and national level (my emphasis). Article 7 of the Regulation is of particular relevance here. That Article gives a definition of the precautionary principle, and consequential constraints on how far Member States may go in banning foodstuffs, as noted in the absence of EU standards and even if there is no cross-border impact.
Article 7 Precautionary principle
1. In specific circumstances where, following an assessment of available information, the possibility of harmful effects on health is identified but scientific uncertainty persists, provisional risk management measures necessary to ensure the high level of health protection chosen in the Community may be adopted, pending further scientific information for a more comprehensive risk assessment.
2. Measures adopted on the basis of paragraph 1 shall be proportionate and no more restrictive of trade than is required to achieve the high level of health protection chosen in the Community, regard being had to technical and economic feasibility and other factors regarded as legitimate in the matter under consideration. The measures shall be reviewed within a reasonable period of time, depending on the nature of the risk to life or health identified and the type of scientific information needed to clarify the scientific uncertainty and to conduct a more comprehensive risk assessment.
Germany on this point is probably found wanting (‘probably’, because final judgment on the extent of German risk assessment is left to the national court) – reference is best made to the judgment for the Court’s reasoning. It is clear to me that the way in which the Regulation defines precaution, curtails the Member States considerably. Further ammunition against the often heard, and wrong, accusation that the EU is trigger happy to ban substances and processes in the face of uncertainty.