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Questions and Answers on Ensuring the Independence of the Federal Institute for Risk Assessment (BfR)
FAQ of BfR 30 May 2012
The independence of experts is a fundamental prerequisite for independent risk assessment. For this reason, the separation of scientific risk assessment and subsequent risk management has asserted itself in Europe over the last 10 years. The Federal Institute for Risk Assessment (BfR) is an independent scientific institution within the portfolio of the Federal Ministry of Food, Agriculture and Consumer Protection (BMELV). It conducts its own research on the basis of its own establishment act and advises the Federal Government and Federal Laender on questions of food, chemical and product safety. The BfR is independent in its scientific evaluations, research and communication.
The overall concept of the BfR has the explicit intention of interacting with all stakeholders (NGOs, consumer associations, trade and industry, politics, science, media). The involvement of various stakeholders is of great significance, especially when scientific positions are represented and justified. It is of decisive importance that no funding may be obtained from industry for reasons of independence.
Rules intended to ensure the independence of the Federal Institute for Risk Assessment have been summarised below.
- How does BfR conduct its risk assessments?
- How is the independence of BfR personnel ensured?
- Can BfR personnel be faced with a conflict of interests due to parallel secondary employment?
- Which rules apply to the selection of assessors?
- What rules apply to the work of the commissions?
- How are possible conflicts of interest between members of BfR commissions documented?
The risk assessments are made by BfR personnel. External experts merely advise the BfR, they do not make any official decisions. The work results and recommendations of the BfR serve all interested parties as an important decision-making aid for taking the necessary measures. The statements made by BfR are based on internationally recognised principles and are justified in a way that outsiders can also understand. Existing knowledge is always taken sufficiently into account and presented in a clear and straightforward manner. Relevant scientific opposite views are also mentioned.
Transparency is necessary on all levels of risk assessment. From the objective and area of application of the statement through the source, type and evidence of the basic data, the methods used along with the assumptions, uncertainty and variability to the result and conclusions, the assessments have to be clear, understandable and reproducible.
The BfR has published a guideline for health assessments in the field of consumer protection (BfR 2010: Guidance document for Health Assessments). The BfR guideline is the template for the assessment of possible health risks from foods, chemical substances and consumer products and the guidance document for the BfR within the scope of its quality management system.
The criteria stipulated in the legal regulations of the federal parliament are authoritative for BfR personnel. By signing an employment contract or being awarded civil servant status, every BfR employee is obliged to comply with the obligations contained therein. All of the civil servants and salaried public service employees at BfR must comply with the legal provisions of the civil service. These include official regulations on impartiality, effectiveness, specialised knowledge and corruption protection as prescribed by German law and the implementing provisions of the Federal Ministry of the Interior (see German Civil Service Act, Art. 10 Administrative Procedures Act, and other regulations).
All spare-time work undertaken by BfR employees is fundamentally subject to official authorisation in line with the relevant legal provisions. Possible conflicts of interest are checked in advance within this framework. This means that BfR personnel cannot be faced with an unlawful conflict of interest due to parallel secondary employment. For the reasons of independence given above, BfR employees may not work for industry in their spare time, for example. With these rules and procedures, the Federal Government ensures objective consultancy through its departmental research institutions.
Members of the BfR commissions and scientific advisory board are selected in line with objective and transparent criteria purely on the basis of their scientific excellence, competence and specialised skills and knowledge. The concept of the BfR commissions recognises scientific excellence as the decisive criterion rather than membership or non-membership in certain social groups. The honorary positions are awarded in accordance with a public tendering process in which every expert in the world is at liberty to apply on the basis of his or her professional self-assessment. The process is openly structured and deliberately does not only address specialists from universities and research institutions but also representatives of consumer protection and environmental conservation organisations, industry and public authorities, in order to cover the scientific consultancy needs of the BfR in sufficient width and depth. The process is structured as follows: to begin with, all of the experts interested in getting involved in a BfR commission are requested to submit their applications in a public call. Thereafter, an appointment panel set up especially for this purpose selects suitable experts from the group of applicants. The appointment panel comprises members of the BfR Scientific Research Council, the chair persons of the Senate Commissions on Food Safety and on Substances and Resources in Agriculture of the German Research Foundation (DFG) and a member of the Governing Board of the Senate of Federal Research Agencies.
The BfR commissions all work in accordance with a binding agenda. The commissions advise the BfR in open scientific matters and are expressly encouraged to critically reflect the state of each art and technology in the current assessment work of the BfR, while also marking out future work areas of risk assessment. Due to their restricted mandate, however, the commissions do not reach any official decisions by themselves. The members of the commissions come from universities and other research institutions, federal and state authorities, commercial and consumer associations, private laboratories and industry.
Any possible conflicts of interest among the members of the commissions must be recorded in writing. To this end, the experts sign a corresponding declaration which is published on the BfR website. In addition to this, oral inquiries about possible conflicts of interest concerning the topics dealt with in the commission are made at the beginning of each meeting in order to check the suitability of each member to participate in the consultations and decision-making process. A note to this effect is made in the summary minutes which can also be viewed at the BfR website. Because BfR employees are deliberately debarred from voting in the commissions, the consulting work of the commissions is completely separate from the official assessment processes.