IRAC Annual Plan (FY2004)

1. Continue from FY03:
   1. Presentations (Basic RAC activities)

   An attempt will be made to continue to have at least one presentation per RAC quarterly meeting.

   1. Presentations by agency representatives on current and completed risk assessments
   2. Update on CDC projects that impact risk assessments to be determined; and/or a presentation by a representative of The Agency for Toxic Substances and Disease Registry (ATSDR) (CDC)
   3. Presentations by invited guests
   4. Additional presentations:

Sampling plan design impacts the utility of data for risk assessments. RAC initial emphasis will be on having presentations to help us understand the scope and impact of the problem. These could be held as an all-day meeting. Possible presentations include:

1. ARS million hot dog sampling study for Listeria monocytogenes
2. The Japanese frozen sample study
3. Problems associated with creating sampling plans to support surveillance and regulatory activities. Examples include:
   1. Detection of peanut allergens in a variety of foods.
   2. Detection of histamine in shrimp and tuna
   3. Detection of Salmonella in/on fresh whole cantaloupe.

The following presentations will be carried over into FY04:

1. Presentation on CFSAN's risk management framework
2. Presentation on the completed Vibrio and Listeria risk assessments and risk management plans
   1. Work Group projects (Enhanced RAC activities)

1. Dose-Response Work Group on mechanistic dose–response data 

   Lead: Peg Coleman

   Members: Steve Anderson, Dennis Kopecko, Robert Hall, Lynda Kelley, Marianne Miliotis, Richard Raybourne, Steve Schaub, Angelo Turturro

   Description: Continue compilation of data on variability among the three elements of the disease triangle (host, pathogen, and environment, with interactions) to extend current dose-response models in a more mechanistic rather than empirical perspective. Scope of the work group in FY 2004 will emphasize mechanistic data: relative measures of host susceptibility; pathogen variability measured from in vitroand animal and human clinical studies; rates of pathogen excretion and attachment; rates of host cell sloughing, repair, and lesion formation; efficacy of host physiological and immune defenses; and biomarkers for activation of immune defenses. The work group may engage researchers through NIH, CSREES, and other means to examine a broad range of food and water-borne pathogens, potentially including Listeria monocytogenes, Campylobacter jejuni/coli, EHECs, Salmonella spp., Cryptosporidium, and viral hazards. In addition to a focus on data and models, the expansion in membership and frequency of work group meetings will provide more opportunities to address more specifically the data gaps for dose-response modeling that offer potential clarification using mechanisitic approaches. A starting point for the work group is a manuscript submitted to Risk Analysis (Buchanan et al, 2003) from a workshop on mechanistic modeling in microbial dose-response assessment. [FSIS, Charter Goals 1 and 2, enhanced]

   Deliverables: for this project continuing in FY04 include:

• Presentations at work group meetings (targets Campylobacter, Listeria, Salmonella).
• Presentations at quarterly RAC meetings (targets tissue and organ culture; human clinical trials; extrapolating from in vitro and animal clinical studies). 
• A manuscript highlighting case studies developed by the work group relating to some of the more controversial issues in the field (e.g., extrapolations from in vitro and animal clinical studies; variability between normal and susceptible hosts).

2. Data Gaps Analysis

   Lead: Mark Tamplin

   Members: Sherri Dennis, John Hicks, Lynda Kelley

   Description: The primary objectives of this work group were to identify data gaps in current (and potentially in-progress) microbial risk assessments, to consolidate data gaps into one document, and to communicate the data gaps via the Clearinghouse website.

   Deliverables: A document describing data gaps to be archived on the RAC website. 

   The work of this group is a work-in-progress and will continue into FY04

2. Proposed New Projects 
   1. Data and Information Quality Guidelines

      Lead: Carl Schroeder

      Members: Mary Bartholomew; Sherri Dennis; Uday Dessai 

      Description:
      Data quality is essential to risk assessment. Guidelines for determining which data to include in risk assessments are needed to improve risk assessment methodology. Furthermore, development of a uniform system of weight of evidence included in risk assessments would likely help in developing predictions that more accurately reflect the real world.

      Deliverables:

      1. A summary of OMB guidelines for data quality
      2. Collection of website links for agencies that have data quality guidelines, with the possibility that these links may be posted on the JIFSAN Clearinghouse web site
      3. Summary of data needs for the Clearinghouse web site
      4. Development of a RAC document based on member agencies’ data quality guidelines 
   2. Peer Review

Co-Leads: Janell Kause, Mary Bartholomew

Members: Barry Hooberman, Mike Kasnia, Jacqueline McQueen, Marianne Miliotis, Stephen Schaub

Description:
Over the past twenty years, there has been a growing interest in the use of analytic tools such as risk assessment and cost-benefit analysis to improve the scientific basis and transparency for decision-making within the regulatory process. These tools, required under various executive orders since the 1980s (Executive Order 12291 and Executive Order 12866) have been put forth by the Executive branch to ensure regulatory agencies develop reasonable regulations that improve public health and weigh the costs to the industry. Legislature for the use and conduct of risk assessments, cost-benefit analysis, and peer review has been put forth. In 1999, Senator Carl Levin reintroduced the Regulatory Improvement Act of 1999 to the Senate (S 981). While this bill has not been enacted, it provides guidance for the conduct of peer reviews of regulatory risk assessments. The process for conducting peer reviews of regulatory risk assessments has been well laid out in the EPA Science Policy Council handbook on peer review (December 2000). These documents and others are likely to provide a starting point for the development of a concept paper on peer review for food safety microbial risk assessments used to inform regulatory decision-making under current OMB guidelines. These guidelines are essential for determining the adequacy of a peer review process for regulatory risk assessment. Without such guidance, a risk assessment may not be targeted enough to provide adequate scientific supports for the estimation of benefits in a cost-benefit analysis. Consequently, regulations based on such a cost-benefit analysis could be deemed arbitrary and capricious by a judge. 

This workgroup will co-host a public meeting to gather information on all aspects of regulatory peer review from academia, industry, consumers and government. This information, along with published literature and regulatory and judicial reports, will be used by the interagency Risk Assessment Consortium Peer Review Workgroup to develop a concept paper on recommended guidelines for conducting peer review that can be used by federal agencies.

Deliverables:

• Co-host a public meeting on regulatory peer review with JIFSAN and SRA (Sept. 30, 2003).
• Develop a discussion paper on “Recommended guidelines for conducting Regulatory Peer Review”.

3. Risk-Risk

The Policy Council suggested that an additional work group be formed to develop a framework for a chemical vs. microbial risk-risk assessment. EPA has much experience with balancing chemical intervention with microbial risk, e.g., study on drinking water in New Orleans – huge document has been published. Another example would be presence of histamine in tuna fish.

Lead: To be determined

Members: Stephen Schaub, Angelo Turturro, Mark Walderhaug, Margaret Venuto

Description and Deliverables: Currently being developed.