The minimum EFSA can do to restore public trust

Complete transparency of the decision-making process and public access is the minimum EFSA can do to restore public trust

EFSA's Transparency Initiative, Position of : APSODA, Cancer Prevention and Education Society, ClientEarth, Corporate Europe Observatory, Earth Open Source, European Environmental Bureau, Firab, Friends of the Earth Europe, GMWatch, GIET, Inf'OGM, PAN Europe, TestBiotech

Political context

European legislation makes it mandatory for a large range of food-related products (including food additives, pesticides, GMOs...) to be authorised prior to their marketing. This authorisation is considered on the basis of an application, transferred by the European Commission to the European Food Safety Authority (EFSA) for a scientific opinion before EU authorities take a final decision. This application contains different information, depending on the product, but typically provides results of experimental analysis led by the applicant on this product to test its safety (for instance compositional analysis, toxicity analysis, feed analysis, allergenicity, impacts on non-target organisms...). Applicants in general tend to consider these dossiers as commercially sensitive, and most have so far refused to disclose them unless legally forced to.

Having the applicant performing and reporting the tests on which its product will be assessed is casting doubt on the validity of the entire decision-making process: in such a context, and in the light of EFSA's institutional and financial limitations, full transparency and public scrutiny is the only real additional defence mechanism available to EFSA against potential capture by industry. This means providing access not only to the entire content of the applicant's dossier but also to the interests of the public decision-makers involved (EFSA experts and staff)1. Such a transparency would allow the scientific community to play its role of generating knowledge through counter-expertise and new experiments as detailed below.

Legal aspects

Such transparency is not only politically indispensable but legally required. International (Aarhus convention) and European legislation (regulation 1049/2001, regulations 178/2002 and 1367/2006, regulation 503/2013) make it mandatory for the administration to grant citizens complete access to documents and information it retains, with clearly delineated and limited exceptions. Such exceptions are to be interpreted in a restrictive manner, taking into account the public interest served by disclosure. Particularly, the exemptions relating to (inter alia) proceedings of public authorities, commercial and industrial information (including intellectual property), personal data and voluntarily supplied information but also information relating to inspections, investigations and audits may under no circumstances be applied to information that relates to emissions into the environment. Individual confidentiality considerations to protect the privacy of officials must be balanced against the public's right to know these persons' interests in their performance of public duties. Finally, World Trade Organisation regulations stipulate that regulations should be science-based according to the Agreement on the Application of Sanitary and Phytosanitary Measures, as illustrated by the conclusion in 2006 of the case brought to WTO against European moratorium on GMOs, which has strong transparency implications.

Scientific methodology

The basic consideration for a scientific experiment is indeed the reproduction of its results by other scientists having followed the same protocol and used the same research materials. Accordingly, scientific papers published in peer-reviewed journals ensure that the following information is published: protocols followed and materials used, names of the laboratories that conducted the experiments, and the complete data obtained. Freedom of dissemination (sourcing, quotation, partial reproduction in other publications...) of those results is also guaranteed. If EFSA's decisions are to be science-based, they have to comply with these methodological requirements, enabling other scientists to reproduce experiments performed by applicants in order to confirm or challenge their results, and experts of national committees to re-analyse the applicant's results. But EFSA is not a peer-review journal and having this key public administration adopt a genuinely scientific approach would have very concrete consequences.

We submit that these should include the following:

• Complete, unrestricted and proactive online publication of applicants' files when these reach EFSA; the data contained must be accessible to everyone without justification or identification, and must be re-publishable.
• Applications should not only include the raw data but also the detailed protocols and research material² used (whether biological or technical, such as the name of the software used by the applicant and all information needed for the exhaustive comprehension of the operation, use of the software and the obtained results: design of experiments and the materials used are indeed critical for making sense of the raw data), the names of the laboratories that led the experiments, and funding sources for this experiment;
• The available data (including raw data) should be published in a usable, editable format (e.g. spreadsheet) in order for the re-analysis work to be possible;
• Declarations of interests of EFSA's main experts and employees should be proactively published and kept online for five years after their employment at EFSA has expired.

We consider that proactive transparency on information and elements having led to a product's authorisation are necessary conditions to any market authorisation of this product. While relieving EFSA from the excessive workload imposed by the present reactive transparency regime, proactive transparency can also enable EFSA to fight regulatory capture and improve this administration's reputation with the public and among scientists.

Signatories

Association pour la suppression des OGM dans l'alimentation (APSODA), Cancer Prevention and Education Society, ClientEarth, Corporate Europe Observatory (CEO), Earth Open Source, European Environmental Bureau (EEB), Fondazione Italiana per la Ricerca in Agricoltura Biologica e Biodinamica (Firab), Friends of the Earth Europe (FoEE), GMWatch, Groupement International d'Etudes Transdiciplinaires (GIET), Inf'OGM, Pesticide Action Network Europe (PAN Europe), TestBiotech

• 1. See for instance the approach followed by French food safety agency, http://www.anses.fr/fr/liste-membres.
• 2. In the case of GMOs, transparency and replicability demands that industry make freely available to all researchers the necessary research materials – the GMO and the closest non-GM isogenic comparator, for research purposes. Without access to these materials, no independent research can be carried out.