Will crucial animal toxicity studies be exempted from disclosure?
Following the groundbreaking ruling from the European Court of Justice in favour of a group of NGOs who want greater access to confidential industry studies on pesticides, concerns have arisen among NGOs regarding a possible loophole for industry written into the ruling.
The court’s press release (item 2 below) about the ruling says that the requirement to release data relating to chemical and pesticide emissions to the environment “does not include information relating to purely hypothetical emissions, such as, for example, data from tests to study the effects of the use of a dose of a product which is significantly above the maximum dose for which the marketing authorisation was granted and which is used in practice."
In a worst case scenario, this could provide industry with a loophole that will enable them to exclude from disclosure the most important data of all – the animal toxicity studies on pesticides and other chemicals, since they almost exclusively use unrealistically high doses. Realistic doses that people and animals are routinely exposed to are not tested in these industry studies.
However, the tests involving these unrealistically high doses underlie vital regulatory decisions – for example, permitted residues in foods, acceptable daily intake (chronic reference dose in the US), and pesticide applicator exposures. So an argument could conceivably be made that these data do not relate only to purely hypothetical emissions, but also to real emissions.
And part of the rationale for carrying out such high dose studies is that they are a surrogate for testing lower, more realistic doses over a more long-term (lifelong) period, as it is difficult to study these with the relatively small numbers of animals that industry uses and in the relatively short timescales that industry favours.
Further legal cases are needed to clarify the implications of this part of the ruling.
One reassuring sign about the ruling as a whole is that we have heard from a knowledgeable source in the EU that the industry is seriously worried by it.
Why are animal feeding studies important?
Disclosure of industry animal feeding studies is crucial to understanding whether pesticides have been approved by regulators fraudulently, in spite of industry data showing toxicity.
For example, major controversies have arisen about the findings of industry animal feeding studies on glyphosate. The European Food Safety Authority (EFSA) claimed that glyphosate was not carcinogenic, based on industry animal feeding studies that are kept secret under commercial confidentiality agreements.
The World Health Organisation’s cancer agency IARC, in contrast, decided that glyphosate was carcinogenic, based only on publicly available studies.
The blog Health & Environment was prompted to ask: “If the secret data which EFSA could access but IARC could not is so compelling, why keep it confidential?”
It remains to be seen if the new ruling will enable the public and independent scientists to see such data and challenge the regulators’ conclusions.
1. ECJ ruling on document access rattles chemical, pesticide industries – Politico
2. Judgments in Cases C-673/13 P Commission v Stichting Greenpeace Nederland and PAN Europe and C-442/14 Bayer CropScience and Stichting De Bijenstichting v College voor de toelating van gewasbeschermingsmiddelen en biociden – European Court of Justice press release
1. ECJ ruling on document access rattles chemical, pesticide industries
By Simon Marks and Giulia Paravicini
Politico, 23 Nov 2016
A decision by the European Court of Justice on Wednesday in favor of disclosing confidential safety tests by large pesticide companies has sent shockwaves through the wider chemical industry.
The court’s decision dealt with two cases in which non-governmental organizations had been denied access to documents about pesticides on the grounds that the information was commercially sensitive.
Some lawyers argued that Wednesday’s rulings on what documents can be accessed set an important precedent and could radically shift the balance of power away from big business when authorities decide whether or not to release sensitive information such as confidential safety studies for pesticides and other industrial chemicals.
“The impact to any industry that can possibly pollute is that any study or test result has to be made available to the public if these tests are relevant to the actual toxicity, hazard, danger or risk the substance can have when used in real conditions,” said Vito Buonsante, a legal expert in health and environmental issues for ClientEarth, which seeks to protect the environment through litigation.
Buonsante explained that because the ECJ ruling deemed all safety tests and documents as potentially disclosable as long as they are related to actual or foreseeable “emissions,” the commercial interests of large businesses have been severely diminished. Crucially, pesticides can be viewed as a form of “emission.”
“Usually there is always a balance between commercial interests and that of the public interest. In this case, when you can prove that the information is about an emission, this balancing does not happen anymore. You prove it’s about an emission and the document goes out,” he said.
The Court ruling dealt with two related cases in which the European Commission and a court in the Netherlands declined access to documents to three NGOs on the grounds that the information was confidential.
One case dealt with an access to documents request from the Pesticide Action Network Europe and Greenpeace to the European Commission for internal studies linked to the safety of the controversial weedkiller glyphosate. The second case concerned a request from the Dutch bee preservation group Stichting de Bijenstichting for confidential information on the authorization process of a neonicotinoid pesticide called imidacloprid, which is produced by Bayer CropScience. Both cases must now go back to the original court of decision for a final decision.
Spokespeople for Bayer and the Commission said they needed more time to analyze the decisions due to their complexities.
One of those complexities centers on what exactly the ECJ has deemed as appropriate for public release. While the Court stated that public authorities should consider the requested documents as “information related to actual emissions,” it also concluded that “the concept of information on emissions into the environment does not include information relating to purely hypothetical emissions.” In other words, only documents containing data on the actual exposure to human beings can be released, leaving some potential wiggle room for authorities to deny some access.
The Commission observed, however, that the Court’s rulings clarified the scope of the rules on access to documents containing information on the environment “in an important way.”
Still, legal experts said broadening the definition of what information is deemed an emission could set a dangerous precedent for many chemical businesses.
“There is a very serious concern about the dangerous broadening of the definition of what constitutes an emission into the environment,” said Peter Bogaert, managing partner at the law firm Covington & Burling.
In a sign of just how significant the rulings could be, the European Chemical Industry Council, which represents the wider chemical industry, said the rulings set a “potentially dangerous precedent for the protection of confidential business information submitted by companies for EU substance and product registrations and approvals.”
Businesses producing chemicals and pesticides say confidentiality and the protection of business secrets linked to production is a vital driver for increased investment in the market.
“As an industry, we are not opposed to access to data. I cannot be clearer on this,” said Graeme Taylor, director of public affairs for the European Crop Protection Association, the EU’s pesticide lobby. But, he added, “in order to continue to invest in bringing important innovations to the market we have to be able to protect confidential business information like any other sector.”
Hans Muilerman, chemicals officer for PAN Europe, which requested the documents on glyphosate, said the ECJ’s decision potentially opened the door for documents containing information about the production process for glyphosate. This information could include toxicity data on the different “runs,” or samples the likes of Monsanto uses when conducting safety tests, he said.
Muilerman noted that pesticide companies currently test different samples of their products on animals, some of which are more toxic than others depending on where and how they are manufactured.
“It’s possible that one ‘run’ is tested and other ‘runs’ that are more toxic are being used in our fields,” he said. “Releasing the documentation could show us this information.”
Brandon Mitchener, a spokesperson for Monsanto, said the company does not selectively choose the best data to provide to regulators.
“The tests are done by us, or for us, in certified labs according to standardized testing protocols specified by law,” he said.
2. Judgments in Cases C-673/13 P Commission v Stichting Greenpeace Nederland and PAN Europe and C-442/14 Bayer CropScience and Stichting De Bijenstichting v College voor de toelating van gewasbeschermingsmiddelen en biociden
Court of Justice of the European Union, 23 Nov 2016
When a person requests access to environmental documents, the concept of ‘information on emissions into the environment’ covers, inter alia, information concerning the nature and effects of the release of a pesticide into air, water or soil, or onto plants The confidentiality of commercial and industrial information may not be invoked to preclude the disclosure of such information.
The Court of Justice has heard two cases which, although different in terms of the facts, address, in essence, the right of access to environmental documents.
In Case C-673/13 P, the associations Stichting Greenpeace Nederland and Pesticide Action Network Europe (PAN Europe) submitted a request to the Commission, on the basis of an EU regulation, for access to a number of documents relating to the initial marketing authorisation for glyphosate, one of the most widely used herbicides in the world for agricultural weeding and the maintenance of urban and industrial areas. The Commission granted access to those documents, with the exception of part of the draft assessment report prepared by Germany. The Commission justified its refusal stating that the document in question contained confidential information on the intellectual property rights of the applicants for the glyphosate authorisation, that is to say, inter alia, the detailed chemical composition of that substance, its manufacturing process, and the impurities and composition of the finished products.
The two associations brought an action before the General Court of the European Union for annulment of the Commission’s decision. The General Court upheld that action by judgment of 8 October 2013. The General Court considered that certain parts of the document at issue contained information relating to emissions into the environment. Consequently, the Commission was not entitled to invoke the confidentiality of commercial and industrial information and should have granted the associations access to those parts. The Commission was not satisfied with the judgment and asked the Court of Justice to set it aside.
In Case C-442/14, Bijenstichting, a Dutch bee-protection association, submitted a request to the Netherlands authority responsible for authorising the marketing of plant protection products and biocidal products (the College voor de toelating van gewasbeschermingsmiddelen en biociden, CTB) for disclosure of 84 documents concerning marketing authorisations issued by that authority for certain plant protection products and biocides. Bayer, a company holding a large number of these authorisations, objected to that disclosure, on the ground that it would infringe copyright and adversely affect the confidentiality of commercial or industrial information. In 2013 the CTB authorised the disclosure of 35 of the 84 documents requested, on the ground that they contained information on emissions into the environment,4 even though such disclosure could have an adverse effect on the confidentiality of commercial or industrial information. Under an EU directive,5 commercial and industrial confidentiality may not be invoked to preclude the disclosure of such information.
Bijenstichting and Bayer both appealed against the CTB’s decision before the Netherlands courts. Those courts referred a number of questions to the Court of Justice for a preliminary ruling regarding, inter alia, whether the information requested by Bijenstichting falls within the concept of ‘information on emissions into the environment’ within the meaning of the directive, with the result that it should be disclosed without Bayer being entitled to object on the ground that such disclosure could adversely affect the confidentiality of commercial or industrial information.
In two judgments delivered today, the Court clarifies what must be understood by ‘emissions into the environment’ and ‘information on [or which relates to] emissions into the environment’ 6 within the meaning of the regulation applicable in Case C-673/13 P and the directive applicable in Case C-442/14.
In both judgments, the Court finds, first, that the concept of ‘emissions into the environment’ includes the release into the environment of products or substances, such as plant protection products or biocides or active substances contained in those products, to the extent that that release is actual or foreseeable under normal or realistic conditions of use of the product or substance.
Therefore, in particular, that concept is indistinguishable from the concepts of ‘release’ and ‘discharge’ and cannot be restricted to emissions emanating from industrial installations (such as factories and power stations) but also covers emissions resulting from the spraying of a product, such as a plant protection product or biocide, into the air or its use on plants, in water or on soil. Such limitations would be at odds with the objective of the regulation and directive of disclosing environmental information as widely as possible.
The Court also confirms that the regulation and directive cover not only information relating to actual emissions, that is to say emissions which are actually released into the environment when a plant protection product or biocide is used on plants or in soil, but also information on foreseeable emissions from that product into the environment. However, the Court states that the concept of information on emissions into the environment does not include information relating to purely hypothetical emissions, such as, for example, data from tests to study the effects of the use of a dose of a product which is significantly above the maximum dose for which the marketing authorisation was granted and which is used in practice.
Furthermore, the Court states that the concept of ‘information on emissions into the environment’ must be interpreted as covering not only information on emissions as such (that is to say information relating to the nature, composition, quantity, date and place of those emissions) but also information enabling the public to check whether the assessment of actual or foreseeable emissions, on the basis of which the competent authority authorised the product or substance in question, is correct, as well as the data relating to the medium or long-term effects of those emissions on the environment. In particular, that concept covers information relating to the residues in the environment after the product in question has been used and studies on the measurement of the substance’s drift during that use, whether those data come from studies performed entirely or in part in the field, from laboratory studies or translocation studies.
In Case C-673/13 P, the Court nonetheless sets aside the judgment of the General Court, in so far as that court considered that it is sufficient that information relates ‘in a sufficiently direct manner’ to emissions into the environment in order for it to fall within the scope of the regulation. The Court points out that that regulation concerns information which ‘relates to emissions into the environment’, that is to say information which concerns or is relevant to such emissions and not information containing any link at all, direct or indirect, to emissions into the environment. The Court of Justice therefore refers the case back to the General Court so that it may determine whether the information at issue does in fact relate to emissions into the environment and, if necessary, rule on the parties’ arguments which were not examined in its judgment.
1. Regulation (EC) No 1367/2006 of the European Parliament and of the Council of 6 September 2006 on the application of the provisions of the Aarhus Convention on Access to Information, Public Participation in Decision-making and Access to Justice in Environmental Matters to Community institutions and bodies (OJ 2006 L 264, p. 13).
2. Case (T-545/11).Stichting Greenpeace Nederland and PAN Europe v Commission.
3. This concerns those parts of the document containing: (1) information on the identity and quantity of the impurities in glyphosate, (2) data concerning the impurities present in the various batches (including the minimum, median and maximum quantities of each impurity) and (3) information on the composition of the plant protection products developed by the various operators concerned.
4. Those documents included, inter alia, laboratory studies concerning the effects of the active substance imidacloprid on bees and studies performed partly in the field measuring the residues of plant protection products and biocides and their active ingredients present after use of those products in the air or soil, in seeds, leaves, pollen or nectar of the treated plant, as well as in honey and on bees.
5. Directive 2003/4/EC of the European Parliament and of the Council of 28 January 2003 on public access to environmental information and repealing Council Directive 90/313/EEC (OJ 2003 L 41, p. 26).
6. The terms ‘relates to’ in Regulation No 1367/2006 and ‘on’ in Directive 2003/4 are equivalent.