Transparency and sustainability of the EU risk assessment process

Transcription

1 Transparency and sustainability of the EU risk assessment process 6 March 2018 EuropaBio position Strengthening of trust requires a holistic approach - Transparency and sustainability of the EU risk assessment, including its efficiency, consistency and robustness, are equally important to build public trust. - The sustainability of the EU risk assessment process necessitates a mechanism to attract the best expertise and to guarantee continuity and in-depth understanding of the risk assessment principles. It also requires more participation of the Member States in EFSA s activities and a clear separation between risk assessment and risk management. - The current system provides for high standards and adequate checks to ensure quality and reproducibility of the data submitted by applicant companies. - In addition to consistent risk management, effective communication is essential. We support transparency of the EU safety assessment - Effective transparency is achievable through a mechanism for disclosure of information, which ensures the protection of legitimate private and public interests, including innovation and competitiveness. - The timing and modalities of information disclosure should not interfere with the efficiency of the process for product authorisationstransparency should apply to all stakeholders involved in the risk assessment process. - Transparent procedures should include stakeholder consultations during the development of EFSA guidance documents and pre-submission activities for obtaining scientific advice from EFSA. Communication needs to be enhanced - A step change in communication is needed, addressing the broad public. - Improved communication should highlight the integrity and quality of EFSA s scientific opinions in a manner that is understandable for the general audience. Major strengths of the current system, like adherence to EU and international guidelines for conduct of scientific studies, independence of the EFSA review and quality systems under independent control, need to be explained to EU citizens. - We encourage the European Commission and other EU institutions to combat the spread and sources of misinformation that severely undermine science-based risk assessment and the credibility of EFSA.

2 1. Strengthening of trust requires a holistic approach We welcome that the European Commission and EFSA are seeking ways to strengthen the trust in the EU risk assessment model in the food and feed chain. This requires a holistic approach, which aims at ensuring both the sustainability and transparency of the risk assessment and consistent decision-making by risk managers along with improved risk communications by the European Commission, EFSA and the EU Member States. Sustainability of the system implies an efficient process - Efficiency generates trust in the system: Lengthy risk assessment processes cast doubts over the quality and the scientific excellence of the regulatory decision-making. Similarly, innovation suffers from lengthy authorisation procedures which do not provide additional value to the scientific debate. - Attracting dedicated experts: The EFSA s procedures on selection of scientific experts should ensure the enrolment of the best professionals in the risk assessment process. The same level of scrutiny should apply to candidates for the membership in EFSA Scientific Panels from industry and other stakeholder groups. A politicised selection of experts should be avoided. - Longer terms of office of the experts in the Scientific Panels than the current three years would improve the continuity of the risk assessment and avoid unnecessary delays. - Risk assessment training: The scientific experts of EFSA, both staff and Panel members, should be provided with comprehensive training in risk assessment in accordance with the internationally agreed principles. The scientific work of EFSA should be driven by risk assessment principles and not by academic curiosity. Better representation of Member States and stakeholders - Member States on board: The disconnect between some Member States risk assessment experts and their representatives at the policy level is an impediment to the trust and functioning of the overall authorisation process. Therefore, we support the representation of Member States on the EFSA Management Board. Robustness of the system through checks and balances - High standards and adequate checks to ensure quality and reproducibility of data: The current system is very robust ensuring the highest level of data integrity. There are three complementary mechanisms in place in the food safety area (including GMOs) safeguarding the quality and integrity of the data provided by company applicants: 1) Mandatory compliance with EU legislation and internationally agreed guidelines; 2) Mandatory formal quality assurance processes, such as Good Laboratory Practice (GLP) 1 and ISO; 1 The application of GLP is required for all regulated products within EFSA s remit. Directive 2004/9/EC requires that the OECD Guides for Compliance Monitoring Procedures for GLP, as well as the OECD Guidance for the Conduct of Test Facility Inspections and Study Audits, be followed during laboratory inspections and study audits. The Directive also lays down the obligation of EU countries to designate the authorities responsible for GLP inspections in their territory.

3 3) Independent review process carried out by EFSA, including applicant studies and available peer-reviewed literature An appeal system, similar to those used by national authorities, European Medicines Agency (EMA) and the European Chemicals Agency (ECHA), would be desirable as an additional layer of checks and balances. The possibility to refer an EFSA scientific opinion to an appeal body should be made available to ensure the robustness of the scientific assessment. Extensive experience with complementary studies - Many complementary GMO studies already exist: Over the past 25 years, the EU has spent well over 300 million on over 50 complementary studies on GMOs alone 2, consistently confirming the world-wide scientific consensus that all safety assessed GM crops are at least as safe as conventionally bred crops. Most recently, the Commission allocated more than 15 million in the combined GRACE/G-TwYST/GMO90+ studies. Yet, public perception has not improved. - EFSA already re-conducts certain studies provided by applicants in the GMO area through procurement projects, such as bioinformatic studies and statistical analyses. - Additional complementary studies are unlikely to increase public trust in the risk assessment. If conducted, they would have to follow the same regulatory requirements and quality principles (i.e. GLP and in some cases ISO, internationally agreed testing guidelines), to ensure reliable and reproducible results. These studies would also have to be conducted on the basis of qualifiable and justifiable criteria. - Associated Costs: The responsibility for commissioning and financing studies in the context of submitting a product application for risk assessment a practice accepted worldwide - goes hand in hand with the applicant s liability for putting a safe product on the market. If complementary studies were to be conducted, the associated costs would logically have to be paid by the EU budget. - Communication is essential to build trust. Please read more in section 3. 2 EU Commission-sponsored Research on Safety of Genetically Modified Organisms ( ): The use of more precise technology and the greater regulatory scrutiny probably makes GMOs even safer than conventional plants and foods. "A decade of EU-funded GMO research ( ). 50 EU projects, more than 400 independent research groups, European research grants of some EUR 300 million; Biotechnology, and in particular GMOs, are not per se more risky than conventional plant breeding technologies.

4 2. We support transparency of the EU safety assessment EuropaBio supports effective transparency. In order to strengthen trust, transparency must be embraced by all players and across all processes. Transparency on regulatory data - Significant steps have already been undertaken on transparency in the GMO area. Nonconfidential information, including studies, can already be disclosed to any citizen of the EU upon request by e-tools. 3 The type of information protected by confidentiality is very limited. - Experience has shown that disclosure of information, on its own, is unlikely to improve the public understanding of science and the trust in the risk assessment process. There have been cases where disclosed information facilitated criminal actions, such as the vandalisation of GM field trials. Appropriate disclosure mechanism to limit the risk of misuse - Effective transparency is achievable through a robust and enforceable mechanism for access to regulatory data, which does not allow for the unfair commercial use of the disclosed data and supports innovation and competitiveness. Misuse of regulatory data threatens innovation, investments and jobs in the EU and beyond. - The timing and modalities of information disclosure should not interfere with the risk assessment process. We support the following general principles on transparency - predictability and legal certainty, fairness, proportionality and coherence. 4 Precise terms and conditions for granting access to non-confidential information should be set out to minimise the risk of misuse. This can best be achieved by well-managed and controlled disclosure (requestor identification needed), whereby the information would be virtually downloaded in the IT system, but not physically transferred to the requestor s computer. Access to nonconfidential information, including to regulatory studies, should be granted after the the authorisation process has been completed. Disclosure preceding the scientific opinion of EFSA would be inconsistent with the EU legislation on public access 5 and the EU case law and would put the EFSA Panel experts under pressure, thus affecting their independence and the quality and efficiency of their work. Even studies re-conducted by EFSA in the GMO area, such as bioinformatic studies and statistical analyses, are disclosed only once the EFSA opinion has been adopted and published. Transparency on EFSA processes - Pre-submission activities for obtaining scientific advice from EFSA regarding the specific characteristics of the product, including its mode of action, as well as the completeness of the safety data are an efficient tool to ensure compliance and efficiency, as evidenced in 3 Regulation (EC) No 1049/2001 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 30 May 2001 regarding public access to European Parliament, Council and Commission documents 4 Letter Principles for Balanced Transparency of Risk Assessment Data Made Available to EFSA of 15 November 2016 sent to EFSA and signed by 17 European associations. 5 Article 4(3) of Regulation (EC) No 1049/2001

5 EMA and ECHA. This would enhance the quality of applications and facilitate efficiency through better use of resources. - Fit-for-purpose guidance: The development of guidance documents by EFSA should be assisted by early involvement of interested stakeholders from the scientific community, including Member States and applicants. Focus groups can enhance the robustness of guidance documents by prioritising fitness-for-purpose over number 6. - Stability of the regulatory requirements is also needed. Frequent changes of guidance 7 reduce the efficiency and robustness of the risk assessment, and absorb significant resources. 8 - EFSA internal processes should be established for each sector and transparently communicated. Need for appropriate and transparent risk management - A clear separation between risk assessment and risk management is crucial. Political interference with risk assessmentundermines trust. The risk assessor should deliver an independent opinion based exclusively on scientific knowledge which facilitates the decisionmaking process of risk managers. - Transparency is also important for the risk management phase. We support the idea to publish the voting behaviour of Member States 9. Voting of risk managers against the scientific evidence from the EU s own risk assessment body has been significantly undermining trust in the risk assessment, innovation and food safety. Equally, risk managers should refrain from undermining EFSA s reputation when the scientific evidence does not support political preferences. 6 There is a positive precedent for a focus group approach within EFSA, with the objective of establishing the scientific need and rationale for amending or introducing regulatory requirements: the supplementary guidelines on allergenicity assessments of genetically modified organisms. 7 In the past 10 years, EFSA has introduced 29 guidance documents in the area of GMO risk assessment alone, without necessarily enhancing the scientific robustness of EFSA s risk assessment opinions. 8 ECHA has paused the adoption of new guidance documents in order to allow the applicants to adapt and to allow all stakeholders to assess the effects of adopting new guidance on the robustness of risk assessments. 9 This was proposed in the Commission s comitology proposal COM(2017) 85 final, on which EuropaBio has published a position paper.

6 3. Communication needs to be enhanced A step change in risk communication is needed and expected to address the broad public. Improved communication should highlight the integrity and quality of EFSA s scientific opinions in an understandable manner. Step Change needed - The Commission, EFSA and the Member States should roll out an ambitious risk communications strategy, engaging the broad public. Risk communication should be clear, tailored to address public perceptions, and involve all stakeholders from the outset to ensure maximum dissemination and leadership at national and EU levels. Quality, comprehensibility, lucidity and relevance of information that can be easily understood by citizens is more important than quantity. Need to communicate on robustness and scientific consensus - The strength and robustness of the current system should be communicated to increase both understanding and trust in the risk assessment process as well as decision-making processes. Relevant information should be provided in an understandable manner to the consumer and should be tailored to consumer questions (e.g., salmonella in baby formula). - Risk communication should take into account both the innovation principle and the precautionary principle, whilst avoiding abuse of the precautionary principle, which has been repeatedly criticised by the European Court of Justice, the WTO and other bodies. This means recognising that innovation provides benefits and that the absence of innovation includes risks. - The Commission and other public institutions are encouraged to combat the spread and sources of misinformation and conspiracy theories, especially insofar as they receive funding from taxpayers. Holistic efforts must address concretely the sources of unscientific information, their business models and funding sources. If misinformation is allowed to flourish and expand, science-based risk assessment and the credibility of EFSA and national risk assessment authorities will continue to be undermined.