MEMORANDUM OF UNDERSTANDING BETWEEN THE UNITED STATES FOOD AND DRUG ADMINISTRATION AND THE GERMAN FEDERAL INSTITUTE FOR RISK ASSESSMENT CONCERNING THE SHARING OF INFORMATION AND FACILITATION OF COLLABORATIVE RESEARCH PROJECTS

The United States Food and Drug Administration (“U.S. FDA”) and the German Federal Institute for Risk Assessment (Bundesinstitut für Risikobewertung, hereinafter “BfR”), collectively referred to as the “Participants”;

Recognizing the importance of timely and effective communication and scientific collaboration;

Wishing to develop effective collaboration with respect to human food safety as it concerns the development and sharing of mutual research strategies and priorities; the research, development, and validation of microbiological and chemical detection methodologies; and the evaluation of novel and innovative technologies;

Wishing to establish a strong network of risk assessors between the Participants and to advance scientific analysis used to develop food safety measures;

Wishing to facilitate collaboration on research projects; and

Wishing to facilitate the sharing of food safety data and information and build on the scientific and technical expertise of each Participant;

HAVE COME TO THE FOLLOWING UNDERSTANDINGS:

1. PURPOSE

   The purpose of this Memorandum of Understanding (MOU) is to establish a network of food safety risk assessors, facilitate the sharing of technical information and data and facilitate collaborative research projects related to food safety between the Participants.

2. ACTIVITIES

   • (a) The Participants intend to:
     • (i) Share information related to food safety, including, but not limited to:
       • (A) method development and research;
       • (B) food safety and risk assessments;
       • (C) research and method needs;
       • (D) research data and results;
       • (E) genomic sequence data;
       • (F) chemical and microbiological risk profiles; and
       • (G) method validation data.
     • (ii) Engage in collaborative activities including, but not limited to:
       • (A) Food safety and risk assessment;
       • (B) Each inviting the other Participant to its meetings on technical or policy matters of mutual interest; and
       • (C) Organization and sponsoring of conferences or workshops hosted by the Participants on subjects of common interest.
   • (b) The Participants may co-author publications resulting from the analysis, interpretation, or consolidation of information shared. If one Participant wishes to publish a co-authored document, that Participant intends to share a draft with the other Participant for input prior to publication.

3. RESOURCES

   This MOU represents the broad outline of the Participant’s intent to enter into specific arrangements for collaborative research efforts and sharing of technical information and data in areas of mutual interest to the Participants. Each Participant intends to fund its own activities under this MOU with the understanding that all activities carried out pursuant to the MOU are subject to priorities of the Participants and the availability of personnel, resources, and funds.

4. INFORMATION SHARING AND CONFIDENTIALITY

   • (a) Each Participant intends to share and use information under this MOU in accordance with its domestic law.
   • (b) The Participants intend that any sharing of non-public information be done under the terms of separate signed confidentiality commitment and in accordance with any other legal requirements of the Participants.

5. REPRESENTATIVES

   • (a) The BfR designates the following as its representatives for this MOU: For administrative and scientific purposes: President, Bundesinstitut für Risikobewertung (German Federal Institute for Risk Assessment, BfR, Germany).
   • (b) The U.S. FDA designates the following as its representatives for this MOU: For administrative scientific purposes: Deputy Commissioner for Food Policy and Response, United States Food and Drug Administration.
   • (c) The Participants intend to promptly give written notice to the other Participant of any change in their representatives.

6. NON-BINDING

   The Participants intend for all activities carried out pursuant to this MOU to be conducted in accordance with applicable laws and regulations. This MOU does not create any binding obligations under international or other law.

7. DURATION AND PROCESS

   The activities under this MOU may commence upon signature by both Participants and are expected to continue for a period of five (5) years. The MOU may be modified by mutual written decision of the Participants and may be discontinued by either Participant at any time. A discontinuing Participant is expected to give thirty (30) days advanced written notice to the other of its intent to discontinue participation in this MOU.