U. S. Food and Drug Administration
Center for Food Safety and Applied Nutrition
March 2002

Initiation and Conduct of All 'Major' Risk Assessments within a Risk Analysis Framework

Table of Contents

Part IV: Conclusions, Recommendations, and Next Steps

Conclusions

The CFSAN Risk Analysis Working Group concluded that risk analysis is a powerful tool that should be used to enhance the scientific basis of regulatory decisions. It should be conducted within CFSAN through the efforts of risk assessment, risk management, and risk communication teams. Risk assessment should be conducted in an iterative manner that allows a refinement of the risk assessment question(s), key assumptions, and data used in the model. The exchange of information (communication) within and between the risk analysis teams, with other agencies, and stakeholders (including industry, consumer groups, and other interested parties) should be encouraged by active participation in the process and collaborations, when appropriate.

The working group considered processes and procedures to address the following three tasks:

• Identify boundaries and responsibilities of key participants in the risk analysis process.
  
• Develop a process for identifying and selecting risk assessments conducted within the Center.
  
• Establish procedures for the conduct of risk assessments within a risk analysis framework.

Before a risk assessment can be initiated, an idea for a risk assessment must be identified and then selected based on Center needs, resource availability, and a data feasibility evaluation. The selection process is divided into four phases--concept generation, problem identification, data feasibility determination, and disposition. The purpose of this decision-based approach is to ensure that the candidate risk assessments are systematically evaluated based on the Center's regulatory needs and feasibility (resources and data availability. Details of the identification and selection process were provided in Part II of this document. The conduct of the risk assessment includes four steps--planning, performing, reviewing, and issuing. The activities associated with these steps were described in Part III of this document. A summary of the overall process for initiating and conducting these risk assessments is provided in Figure IV-1.

However, having proposed a formalized procedure for the conduct of risk assessments is only the beginning. Once a process/procedure is agreed to, it must be clearly communicated to Center staff and other stakeholders. Next, the process must be followed. To the extent that it is followed we can ask ourselves the question--"did it work?"
More specifically, questions to be addressed include:

• Did the process address the issues and concerns identified by the CFSAN Risk Analysis Working Group?

• Were there places where the proposed process did not work or where modifications were made?

• How could the process be modified or improved to facilitate and improve future risk assessments?

Answering these questions may or may not require the services of a neutral facilitator. But, at a minimum, these questions should be systematically explored.

Figure IV-1. Summary: Process for initiating and conducting risk assessments

Recommendations and Next Steps

The working group recommended the following actions to support and promote the use of a risk analysis framework for 'major' risk assessments. Next steps for the first two of the six recommendations are described below.

Recommendation 1. Adopt a decision-based approach to identify and select 'major' risk assessments conducted by CFSAN.

The working group recommended an identification and selection process that is conducted in four phases: concept generation, problem identification, data feasibility determination, and disposition. This approach was described in detail in Part II of this document. To test and implement this proposed approach, the working group suggests the following next steps.

• A mechanism should be developed to request and receive ideas for risk assessments from the general public, industry, consumer groups, other Agencies, and other interested parties.

• The proposed identification and selection process should first be tested with a microbial risk assessment and later implemented for all 'major' risk assessments including chemical.

• After testing this process with a microbial risk assessment, a debriefing meeting should be held. The purpose of the debriefing is to determine whether the proposed identification and selection process was in fact followed and, if so, whether it facilitated and improved the overall decision-making process. The CFSAN Risk Analysis Working Group should conduct the debriefing with the coordinating staff and CFSAN's leadership team. The leadership team should decide whether a neutral facilitator should lead the debriefing.

• Following the debriefing, a final procedure should be described as a standard operating procedure (SOP) and used by the Center for identification and selection of all 'major' risk assessments.

• After the SOP is final, it must be clearly communicated to Center staff, other agencies, and stakeholders.

The working group recommended that CFSAN should conduct risk assessment within a risk analysis framework. Specific actions were grouped as four steps--planning, performing, reviewing and issuing. The activities associated with each of these steps are described in detail in Part III of this document. To test and implement this proposed process, the working group suggests the following next steps.

• After testing this process with a 'major' risk assessment, a debriefing meeting should be held. The purpose of the debriefing is to determine whether the proposed four step process for conducting risk assessments was in fact followed and, if so, whether it facilitated and improved the overall decision-making process. The CFSAN Risk Analysis Working Group should conduct the debriefing with the leadership team. The leadership team should decide whether a neutral facilitator should lead the debriefing.

• Following the debriefing, a final procedure should be described as a standard operating procedure (SOP) and used by the Center for conducting all 'major' risk assessments. The SOP might include checklists or forms, if appropriate.

• After the SOP is final, it must be clearly communicated to Center staff, other agencies, and stakeholders.

Recommendation 3. Develop criteria to evaluate the quality of data used for risk assessments and specify what information is needed to scientifically evaluate the usefulness of a study or data set used for risk assessment.

Recommendation 4. Develop guidelines to evaluate risk assessments and supporting data developed by stakeholders and submitted to the Center.

Recommendation 5. Formalize a peer review process that will encourage critical review and evaluation of CFSAN's risk assessments by government and non-government experts in a manner that improves the science and acceptance of complex risk assessments.

Recommendation 6. Build capacity to conduct complex risk assessments by providing training opportunities for current staff, hiring new staff or using contractors (as needed), and acquiring additional resources such as computers, software, and dedicated workspace.

The recommendations in this document are based on our experience in conducting risk assessments within a risk analysis framework. We believe that this document represents a huge leap forward for CFSAN and its efforts to formalize the use of risk analysis in a regulatory environment. As additional experience and knowledge are gained, the processes described here should be amended, as needed.