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IRAC History
INTRODUCTION
The Interagency Risk Assessment Consortium (IRAC) was established in response to the Presidential Executive Order 13100 (dated August 25, 1998) and subsequent planning and implementation documents of the President’s Food Safety Council, to provide a forum for enhanced communication and coordination among federal agencies that develop and utilize food safety risk assessments. Since its creation, the IRAC has steadily gained recognition as an essential part of effective food safety interagency coordination. IRAC serves as a resource for each of its individual member agencies, in addition to identifying, cataloging, and providing access to extensive amounts of information on food safety risk assessment. The IRAC meets on a quarterly basis and provides a summary report from these meetings for members.
The IRAC seeks technical and policy representatives from all federal agencies with risk analysis responsibilities related to food safety and human health research. The IRAC’s technical representatives serve as scientific delegates to their agency. The IRAC Policy Council provides general direction to the IRAC, including approval of annual program plans and final work products. The IRAC Policy Council is composed of an appointed senior policy official from each individual member agency.
The goals of IRAC include identifying gaps in data and necessary research for food safety risk assessments, improving the quality of research related to risk assessment by encouraging multi-disciplinary efforts and by reducing unnecessary redundancy and repetition in the research processes. In addition to these goals, others include identifying and cataloguing risk assessment reports, methods, models, and data sets, and providing this information to the Joint Institute for Food Safety and Applied Nutrition (JIFSAN) Food Safety Risk Analysis Clearinghouse as well as providing advice and functioning as a technical resource for member agencies. The IRAC also seeks expertise and advice from risk assessment professionals and scientists from the public and private sectors, the academic community, and consumers.
The IRAC’s commitment to food safety risk assessment is vital to improving public health and economic development. The IRAC and its member agencies are working to protect public safety by developing new risk assessment tools and methodologies. Close ties to stakeholders in academia, consumer groups and industry allow the IRAC to better serve as a federal risk assessment group and provide the federal government with an opportunity to apply the knowledge that is garnered through these collaborations. This entities existence greatly improves the quality of life for many individuals, and is an important and integral part of this nation’s infrastructure.
ACTIVITIES SINCE 1998
Over the last thirteen years, IRAC has made a considerable contribution to the risk assessment field including technical workshops, international meetings, joint public meetings with JIFSAN, symposiums and working group projects (Table 1). These accomplishments have allowed for networks to be developed between individuals in different fields of risk assessment including food safety, water safety, and nutrition. In addition to the networking benefits, there have also been publications in peer reviewed journals.
Following is a brief overview of the results of the various working groups that have been established by IRAC.
Data Gaps Analysis – FY 2004-2005
A list of data gaps for selected microbial risk assessments was developed and posted on the IRAC website in FY 2004 and was updated in FY 2005.
Table 1. Chronological list of the Interagency Risk Assessment Consortium’s accomplishments since 1998
|
Fiscal Year |
Accomplishments |
|
1998 |
Technical workshop, "Relating Numbers of Foodborne Pathogens to Human Illness". The workshop focused on epidemiological correlations, human clinical studies, animal dose-response studies, mechanistic studies of pathogenesis and correlations of host resistance and susceptibility with biomarkers. |
|
1999 |
JIFSAN hosted an open meeting to present information on on-going risk assessments and models for accessing and collecting data. This information was utilized in the further development of the Risk Assessment Clearinghouse. |
|
2000 |
Facilitated discussion with the scientific community and the public on dose-response modeling of foodborne pathogens. IRAC also looked at the use of human and non-human models of infection and disease to predict human dose-response relationships. |
|
2001 |
IRAC and JIFSAN held a joint public meeting to discuss and gain public and professional input on data quality issues as they relate to the Food Safety Risk Analysis Clearinghouse. |
|
2002 |
IRAC hosted the First International Conference on Microbial Risk Assessment. In addition to building both domestic and international networks, the conference covered a range of topics such as risk assessment frameworks, dose-response models, dynamic exposure assessment models, evaluation of intervention strategies, the interface between risk managers and risk assessors, and communicating the results of risk assessments. |
|
2003 |
Conducted a symposium entitled “Peer Review of Risk Assessments and Related Activities”. This involved the sharing of information, thoughts, and opinions on all aspects of regulatory peer review among private industry, the academic community, consumers and government. The information was used by the IRAC Peer Review Workgroup to develop a concept paper on recommended procedures for conducting peer review for federal agency use. |
|
2004 |
Symposium entitled “Data Collection and Utilization in Risk Assessment and Management Decisions”. The objectives of the symposium were to describe how researchers have designed data collection strategies and how risk assessors and risk managers have utilized available data to support decision making. |
|
2005 |
IRAC hosted two workshops – “Nutritional Risk Assessment: Bridging Perspectives, Sharing Methodologies” and “Food and Waterborne Pathogen Risk Ranking Models: From Theory to Practice”. The nutritional risk assessment workshop discussed the use of risk assessment tools to establish nutritional recommendations to prevent disease and maintain health. The Pathogen Risk Ranking workshop provided a forum for researchers, managers, consumers, and assessors interested in risk ranking models and techniques to share ideas and experiences, gain hands on experience, and identify data gaps. |
|
2006 |
Workgroups on microbiological criteria and Nutritional Risk Assessments were established. |
|
2007 |
The workgroups on Nutritional Risk Assessment continued and the Data Utility and Produce Safety workgroup was added. |
|
2008 |
The workgroups on Data Utility and Produce Safety were continued. |
|
2009 |
IRAC in collaboration with the Society for Risk Analysis-and JIFSAN hosted a symposium entitled “New Tools, Methods and Approaches for Risk Assessment”. This symposium brought together experts to discuss hot topics in risk assessment, including novel approaches to dose-response modeling and application of proteomics and genomics to food safety risk assessments. |
|
2010 |
IRAC hosted a workshop on defining susceptible populations in food safety risk assessment and a workshop on risk based inspection. |
Dose-Response -- FY 2004-2005
The working group advanced the understanding of mechanistic dose-response using a vast range of water and food-borne pathogens as examples. The dose response working group also held two meetings to discuss mechanistic considerations of Campylobacter pathogenesis and data from human vaccine trials for campylobacteriosis. In addition, a member of the working group presented concepts of using tissue culture data for dose-response modeling during one of the IRAC’s quarterly meetings.
Data Information and Quality -- FY 2004-2005
A draft document was developed that compiled publicly available procedures for how various government agencies ensure the quality of risk assessments. Information and links to OMB and other federal agency Data Quality Guidelines were made available. A questionnaire was developed to be sent to the IRAC member agencies to garner supplemental information pertaining to risk assessment specific data quality issues. The results of the survey served as the basis for a discussion paper prepared in fiscal year 2005.
Data Utility – FY 2004-2008
A symposium on sampling plans entitled “Data Collection and Utilization in Risk Assessments and Management Decisions” was held on September 14, 2004. A symposium entitled, “The Status of Data Utility in Decision Making: A Multi-disciplinary Review” was presented at the annual meeting for Society for Risk Analysis (SRA) in December, 2005. The symposium investigated data utility issues associated with four health risk assessment disciplines which included human and ecological chemical risk assessment, as well as, food and water microbial risk assessment in order to increase awareness between disciplines and stimulate dialogue to facilitate future improvements regarding data utility in health risk assessments. A discussion paper was developed based on the symposium and was submitted to Risk Analysis. This working group sponsored a symposium at the SRA Annual Meeting in December, 2008 entitled “Practicing the Science and the Art: Real World Case Studies in Sample Collection for Chemical and Microbial Risk Assessment”. The paper based on the 2005 workshop and 2006 SRA symposium were published in the December issue of Human and Ecological Risk Assessment.
International Microbial Risk Assessment Conference -- FY 2004
The Proceedings from the First International Conference on Microbial Risk Assessment was published as a supplement in the September 2004 issue of the Journal of Food Protection. The thirteen manuscripts included in this supplement represented many of the widespread topic areas presented during this conference.
Microbiological Criteria
This working group was created to aid the CODEX effort by developing principles for relating microbiological criteria to public health goals and the stringency of food and water control programs. A paper entitled “Determination of Microbiological Criteria” was drafted and sent for review to the agencies represented by the working group. A paper on “Determining the microbiological criteria for lot rejection from the performance objective or food safety objective” was developed by the work group and published in the International Journal of Food Microbiology.
Nutritional Risk Assessment – FY 2004-2007
A workshop entitled “Nutritional Risk Assessment: Bridging Perspectives, Sharing Methodologies, Identifying Data Challenges” was held in Washington, DC. The workshop served as a forum for experts on various disciplines to discuss the use of risk assessment tools to inform dietary and nutritional recommendations. It addressed the use of risk assessment to evaluate standards for adequate nutrient intake and to explore the relationship of diet and nutrition to chronic disease risk.. The workgroup provided the background information to develop a workshop on “Nutritional Risk Assessment: Bridging Perspectives, Sharing Methodologies, and Identifying Data Challenges.”
Produce Safety – FY 2007-2008
A work group was formed, composed of representatives from USDA/ARS/BARC, USDA/FSIS, FDA/CFSAN, and FDA/NCTR. A conceptual model was developed for a farm to table risk assessment for green leafy vegetables and E. coli O157:H7. The model served as a framework to identify and prioritize research needs for conducting a quantitative risk assessment. IRAC co-sponsored a workshop on “Research Needs Prioritization for Conducting a Quantitative Risk Assessment of E. coli O157:H7 in Leafy Greens” jointly with the JIFSAN at the Holiday Inn in College Park, MD. The purpose of this workshop was to identify and prioritize research data gaps for conducting a quantitative risk assessment on E.coli O157:H7 foodborne illness from the consumption of leafy green vegetables. The workshop brought together more than 70 experts in a variety of scientific disciplines and practical applications from academia, industry, and government. A model based on the analytical hierarchy process was pilot tested.
Risk Based Inspection- FY 2009-2010
A workshop was held in 2009 on “Risk Based Inspection” with presentations from scientists from APHIS, FSIS, FDA and DOD. Agencies are looking at risk based approaches to identify and try to prevent or mitigate risks. All agencies have limited resources and need to focus them where they are most needed. Lessons learned included a need to improve data quality; a need for both risk based and random sampling plans and a need for training/ education in using risk based techniques.
Susceptible Populations and Food Safety Workshop – FY 2009-2010
The IRAC hosted a workshop in 2010 entitled “Susceptible Populations and Food Safety Workshop”. University and federal government scientists provided oral presentations, and break-out groups addressed the definition of susceptibility, population health statistics, consumer exposure, and the issues in defining susceptible populations for chemical and microbial hazards. The results from this meeting have been posted on the IRAC website and are being prepared for publishing in a peer reviewed journal.
MEMBER AGENCIES OF IRAC
- Center for Food Safety and Applied Nutrition, FDA, HHS
- US Army Public Health Command, DOD
- National Center for Toxicological Research, FDA, HHS
- Office of Water, EPA
To find more information on the Interagency Risk Assessment Consortium and its working groups, please visit the IRAC website at www.foodrisk.org/irac.
