IRAC Work Group Descriptions
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PDFNutritional Risk Assessment
Lead: Michael McElvaine
Members: Mary Brandt, Clark Carrington, Nancy Crane, Rita Deng, Sherri Dennis, Alison Edwards, Vasilios Frankos, Kathleen Koehler, Wesley Long, Michael McElvaine, Marianne Miliotis Donna Robie, Etta Saltos, Jan Stanton, Christine Taylor
Description: Over the past 20+ years the tools of risk analysis, Originally developed from systems engineering and later toxicology issues have been applied to health effects of biological stressors such as bacteria, viruses, chemical and drug contaminants, ecological systems, and more. There has been much recent discussion among scientists in the human health fields to look at the application of the risk analysis paradigm on issues of nutrition in humans and health endpoints caused by either excesses or deficiencies of certain nutrients.
Nutritional risk assessment may provide several unique issues:
- Nutrition provides a novel area of analysis because health effects can be either positive or negative and indeed can run the gamut from negative to positive to negative depending on the total exposure (dose). The concept of hormesis may be pertinent to nutritional examples. For example, "Selenium is a trace mineral needed in small amounts for good health, but exposure to much higher levels can result in neurological effects and brittle hair and deformed nails." (ToxFAQs* for Selenium, http://www.atsdr.cdc.gov/tfacts92.html.
- Nutritional issues may also result in risk-risk trade off such as fish consumption for intake of healthy fatty acids for nerve development when these fish may have concentrated contaminants such as dioxin and methylmercury which could have detrimental effects if exposure is high.
Another issue might be pesticides on fresh fruit and vegetables. There may be a possibility of pesticides harming a developing child by blocking the absorption of food nutrients necessary for normal growth.
- A third novel area may be the interaction of nutrients with potential toxins. An example would be the increased absorption of lead from the intestines of children who are on a calcium deficient diet. This interaction between lead and calcium may also come into play when a new mother begins lactating. If there is lead in her bones, it may be mobilized along with the calcium necessary for milk production and lead to higher than expected levels of lead exposure to the nursing infant.
Other aspects of nutritional risk that can also be considered include:
Malnutrition; Overnutrition; Nutrition imbalance; Effect of low Carbohydrate diet; Effect of decreasing folates in the diet.Potential activities of this work group would be a review of current literature on the different types/aspects/issues of nutrition and risk assessment, identify and contact researchers who have been working in the area to invite their input, develop a white paper on the state of the art at the present, bring in speakers to quarterly IRAC meetings, or plan a symposium with a goal of producing a substantial document or proceedings.
Data Gaps Analysis
Lead: Andy Hwang
Members: Sherri Dennis, John Hicks, Janell Kause, Lynda Kelley, Mark Tamplin
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.
Data Utility
Lead: Brandolyn Thran
Members: Sharon Edelson Mammel, Heather Hicks Quesenberry, Andy Hwang, Wes Long, Michael McElvaine, Marianne Miliotis, Margaret Venuto
Description: There is much interest and support for the topic of adequately designing future sampling plans and the appropriateness and applicability of data that has been collected by other researchers. These topics are of interest because sampling plan design impacts the utility of data for risk assessments.
To ensure sampling programs have a sound scientific foundation two essential things must be present, appropriate analytical methods that have been validated for their intended use, and a statistically valid sample size. In the absence of these two components, the degree of confidence regarding the data generated by the sampling program may be in jeopardy. The limitation of resources (time, money and people) impact and influence the development of any sampling program.
The Data Utility work group has organized a symposium that acted as a retrospective analysis of data collection strategies from a “lessons learned” perspective. The lessons highlighted from the initial symposium are shaping the future efforts of the workgroup as it focuses on the data utility characteristics of representativeness, relevancy, robustness, validity and defensibility.
Data and Information Quality Guidelines
Lead: Carl Schroeder
Members: Mary Bartholomew, Sherri Dennis, Kara Morgan, Brandolyn Thran
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. The workgroup is in the process of summarizing feedback from a “Best Practices” survey circulated among RAC members in 2004. The results of the survey will be presented in a briefing paper in 2005.
Dose-Response Work Group on mechanistic dose–response data
Lead: Neal Golden
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 2005 will emphasize mechanistic data: relative measures of host susceptibility; pathogen variability measured from in vitro and 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., and Cryptosporidium. 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 mechanistic approaches.
Peer Review
Co-Leads: Janell Kause, Mary Bartholomew
Members: David Goldblatt, Barry Hooberman, 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. In part, the reasonableness of public health regulations is influenced by the quality of the science used to inform risk management decisions. The Information Quality Act (IQA), sometimes referred to as the Data Quality Act, was enacted in December 2000 as Section 515 of the Treasury and General Government Appropriations Act for Fiscal Year 2001 (P.L. 106-554). The act required the Office of Management and Budget (OMB) to issue guidance to federal agencies designed to ensure the "quality, objectivity, utility, and integrity" of information disseminated to the public. To assure scientific information released to the public meets these criteria, OMB released a final bulletin to federal agencies on the conducting peer reviews of these types of information. This Bulletin establishes minimum standards for when peer review is required for scientific information and the types of peer review that should be considered by agencies in different circumstances. The conduct of peer review of risk assessments varies among food safety regulatory agencies as evidenced by presentations provided as the RAC peer review workgroup co-hosted symposium on peer review in September 2003. This workgroup is evaluating the various approaches federal agencies have taken to conduct a peer review of food safety risk assessment based on the criteria provided in the Information Quality Act. From this evaluation, a concept paper is being developed.
Risk-Risk
Lead: David Carlson
Members: Abdel Kadry, Stephen Schaub, Angelo Turturro, Mark Walderhaug
Description: The project will address cross-Agency issues relevant to risk-risk comparisons and tradeoffs, especially the balancing of chemical and microbial risk. Currently, the workgroup is identifying and supporting presentations at RAC meetings on the topic of risk-risk assessments to: (1) learn about important risk-risk issues that member agencies have previously dealt with, and, (2) determine how the risk-risk workgroup can help their agencies and whether there are specific needs or questions the agencies have regarding risk-risk issues.
The goal of the workgroup is to create a white paper to help guide IRAC member agencies faced with risk management decisions that include risk tradeoffs and 'risk-risk' scenarios. Possible factors to consider include:
- What are the experiences of different Agencies with Risk-Risk comparisons, including microbial vs. non-microbial?
- Are there some common issues that can be identified in these comparisons?
- What sources of information and references are especially useful and germane to Risk-Risk comparisons?
- What different expertise is needed to make an appropriate analysis, and who should be involved?
- How should the results be presented to the public?
