Risk assessment at the BfRshort forGerman Federal Institute for Risk Assessment: independent and transparent

The risk assessments are carried out by BfRshort forGerman Federal Institute for Risk Assessment employees. External experts provide the BfRshort forGerman Federal Institute for Risk Assessment with advice, when necessary, but they do not make risk assessment decisions. The work results and recommendations made by the BfRshort forGerman Federal Institute for Risk Assessment are used by all interested parties as an important source of information and decision-making tool. Statements made by the BfRshort forGerman Federal Institute for Risk Assessment follow internationally recognised scientific principles and are presented in a manner that is also transparent for outsiders. To prepare these statements the BfRshort forGerman Federal Institute for Risk Assessment conducts its own research and evaluates existing scientific studies. It also takes into account previously unpublished reports and data, for example, from authorisation procedures. Relevant opposing scientific views are stated.

Transparency is required at all levels of risk assessment. An opinion must be clear, understandable and reproducible from start to finish, beginning with the its objectives and scope and continuing on with the source, nature and evidence of its underlying data. The same qualities must also hold for the methods and assumption used in the opinion, the uncertainty and variability contained in the opinion and, finally, with the opinion's result and conclusion. For this reason, the BfRshort forGerman Federal Institute for Risk Assessment has been advocating for transparency in risk assessment procedures and for the disclosure of industry studies in numerous forums around the world for many years.

The individual steps of risk assessment are described in detail in our “Guidelines for health risk assessments in consumer protection” (External Link:BfR 2020: Guidelines for health risk assessments). The BfRshort forGerman Federal Institute for Risk Assessment guidelines set out how the assessment of possible health risks from food, feed, chemical substances and consumer products is to be performed. The guidelines serve as a reference for the BfRshort forGerman Federal Institute for Risk Assessment and are, therefore, part of its quality management system.

All BfRshort forGerman Federal Institute for Risk Assessment employees must comply with federal legislation in their work and decisions. Each employee expressly undertakes to do so by signing their employment contract or receiving the status of civil servant. The legal norms of the public service apply to them, for example, with regard to objectivity, effectiveness, expertise as well as impartiality, incorruptibility and corruption prevention. The relevant regulations are the result of laws and implementing provisions from the Federal Ministry of the Interior (see e.g. the Federal Civil Servants Act, Section 10 Administrative Procedures Act and other regulations). 

As set out in the relevant legal provisions, BfRshort forGerman Federal Institute for Risk Assessment employees are generally required to declare secondary employment or to obtain permission for secondary employment, depending on the type of employment contract they have with the BfRshort forGerman Federal Institute for Risk Assessment (employee covered by a collective wage agreement or civil servant). The BfRshort forGerman Federal Institute for Risk Assessment checks any planned secondary employment for conflicts of interest. If there are indications that a BfRshort forGerman Federal Institute for Risk Assessment employee’s secondary employment might impair their legally intended independence, then the secondary employment is strictly prohibited by the BfRshort forGerman Federal Institute for Risk Assessment. In this way, BfRshort forGerman Federal Institute for Risk Assessment employees cannot have an inadmissible conflict of interest due to a parallel activity in industry. Through these rules and procedures, the legislator ensures that the federal government receives objective advice from its scientific institutions.

Generally, it is one of the tasks of BfRshort forGerman Federal Institute for Risk Assessment employees to communicate with stakeholders as part of their duties. To this end, they are involved in working groups and bodies of foundations or institutions as well as in interest groups in industry or consumer protection associations. This is then part of their main job. BfRshort forGerman Federal Institute for Risk Assessment employees perform their duties impartially and independently in accordance with their legal or collective agreement obligations. They are expressly obliged to do so when they are hired or appointed and are regularly made aware of this.

Employees are obliged to report secondary employment. The secondary employment of a BfRshort forGerman Federal Institute for Risk Assessment employee is to be prohibited as soon as this employment could have an impact on the professional interests of the employee.

Furthermore, employees are generally obliged to maintain secrecy about matters that they have become aware of as part of their work in public service, even after the termination of their civil servant or employment contract.

The participation of BfRshort forGerman Federal Institute for Risk Assessment staff in conferences and other scientific events is part of the BfR’s scientific work. Any participation on behalf of the BfRshort forGerman Federal Institute for Risk Assessment must be approved by BfRshort forGerman Federal Institute for Risk Assessment management. As part of the approval procedure, an assessment is made as to whether participation in the event in question would create a conflict of interest with regard to the Institute’s tasks and independence. Scientific events may also be organised by stakeholders with whom the BfRshort forGerman Federal Institute for Risk Assessment communicates regularly. A list of these stakeholders can be found in External Link:BfR background information no. 033/2014 “BfR Risk Communication in Practice” on the BfRshort forGerman Federal Institute for Risk Assessment website.

Members of BfRshort forGerman Federal Institute for Risk Assessment committees and of the Scientific Advisory Board are selected using objective and transparent criteria. They are chosen solely on the basis of their scientific excellence, competence and expertise. 

The concept of the BfRshort forGerman Federal Institute for Risk Assessment committees intends for scientific excellence to be the decisive criterion, not the affiliation or non-affiliation with certain social groups. Volunteer positions are awarded following a public tender procedure in which every expert around the world is free to apply on the basis of their professional self-assessment. The procedure is open and explicitly addresses not only experts from universities and research institutions, but also representatives from consumer and environmental protection organisations, industry and authorities, in order to cover the BfR’s scientific advisory needs in terms of technical breadth and depth. The procedure is as follows: first, all experts interested in participating in a BfRshort forGerman Federal Institute for Risk Assessmentcommittee are asked in a public invitation to apply.  The specially established Appointment Board then selects suitable experts from among the applicant pool. The Appointment Board is composed of the members of the BfR’s Scientific Advisory Board, one representative each from the Federal Ministry of Food and Agriculture (BMELshort forGerman Federal Ministry of Food and Agriculture) and the Federal Ministry for the Environment, Nature Conservation, Nuclear Safety and Consumer Protection (BMUV), a representative from the “Senate Commissions on Food Safety” and a representative from one of the BMEL’s departmental research institutions.

The BfRshort forGerman Federal Institute for Risk Assessment committees all work according to External Link:binding rules of procedure. The committees advise the BfRshort forGerman Federal Institute for Risk Assessment on open scientific specialist issues and are asked specifically to adopt a critical approach, to bring the current state of science and technology to bear on the latest assessment work of the BfRshort forGerman Federal Institute for Risk Assessment and also to identify future fields of activity for risk assessment. The advice resulting from the committees’ work is addressed to the BfRshort forGerman Federal Institute for Risk Assessment and is only intended to be understood as a recommendation. The BfRshort forGerman Federal Institute for Risk Assessment takes note of these opinions and makes decisions independent of the committees. Committee members come from universities and other research institutions, federal and state authorities, business and consumer associations, private laboratories and industry.

In addition, members are prompted verbally at the beginning of each meeting to state any conflicts of interest in relation to the topics discussed within the committee. If a conflict of interest is identified, the committee member in question is excluded from the deliberations on the relevant topics. This is noted in the minutes of the meeting. All BfRshort forGerman Federal Institute for Risk Assessment committee meeting minutes can be viewed on the BfRshort forGerman Federal Institute for Risk Assessment website. BfRshort forGerman Federal Institute for Risk Assessment employees explicitly have no voting rights in the committees, so that the committees’ advisory work is completely separated from the official assessment processes.