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

Three Year Research Plan
National Food Safety Initiative
Produce and Imported Foods Safety Initiative
2000-2002 Update
May 2001

Appendix A
Risk Assessments and Related Activities

(Table of Contents)


Project Title: Risk Assessment on the Public Health Impact of Vibrio parahaemolyticus in Raw Molluscan Shellfish

Start Date: January 1999
Completion Date: January 2001 (Draft document for public comment)

Statement of Research Problem:

Vibrio parahaemolyticus is a marine bacterium that occurs naturally in filter-feeding molluscan shellfish, like oysters. Food poisoning can occur from the consumption of raw shellfish containing pathogenic strains of V. parahaemolyticus. Outbreaks in 1997 and 1998 renewed concern for this pathogen and prompted FDA to evaluate the effectiveness of current criteria for closing and reopening harvest areas and FDA's guidance that no more than 10,000 V. parahaemolyticus per gram should be present in shellfish.

The risk assessment provides analyses and models that consider the levels of V. parahaemolyticus in oysters at harvest and consumption, environmental factors affecting V. parahaemolyticus levels in oysters, dose response and patient susceptibility relationships, and the influence of post-harvest practices on the growth of this pathogen. Models are used to predict the likelihood that illness will result from consuming oysters containing this pathogen.

A draft risk assessment was released for public comment in January 2001. Following the public comment period, a final assessment is planned.

Statement of Project Objective(s):

The purpose of the assessment is to systematically examine available scientific data and information concerning the public health impact of consuming raw oysters containing pathogenic V. parahaemolyticus. The model simulates the processes from oyster harvest to consumption and can be used to predict the number of expected cases of V. parahaemolyticus food poisoning.

Anticipated Impact on FDA Regulatory Program:

This assessment is meant to be a tool to assist food safety regulatory agencies and others to identify the scientific knowledge and information that is needed to further reduce foodborne disease from V. parahaemolyticus. It can be used to evaluate the effectiveness of potential intervention measures for reducing or controlling V. parahaemolyticus levels, the current criteria for opening and closing harvest waters, and FDA's guidance of 10,000 total V. parahaemolyticus cells per gram of food.

Administrative Liaison: Sherri B. Dennis: 202-260-3984


Project Title: Risk Assessment on the Public Health Impact of Foodborne Listeria monocytogenes

Start Date: January 1999
Completion Date: January 2001 (draft document for public comment)

Statement of Research Problem:

Listeriosis a rare but life threatening disease that is caused by foodborne Listeria monocytogenes. It is estimated that foods contaminated with L. monocytogenes cause approximately 2,500 cases of illness, including approximately 500 fatalities, in the United States each year. In May 2000 President Clinton called on the federal food safety regulatory agencies to consider control of listeriosis a priority initiative and to achieve a 50% reduction in listeriosis by 2005.

The risk assessment provides analyses and models that (1) estimate the potential level of exposure of three age-based population groups of consumers to L. monocytogenes contaminated foods and (2) relate exposure to public health consequences. Models are used to predict the likelihood that serious illness or death will result from consuming foods contaminated with this pathogen.

A draft risk assessment was released for public comment in January 2001. Following the public comment period, a final assessment is planned.

Statement of Project Objective(s):

The purpose of the assessment is to systematically examine available scientific data and information in order to estimate the relative risks of serious illness and death that may be associated with consumption of ready-to-eat foods that may be contaminated with L. monocytogenes.

Anticipated Impact on FDA Regulatory Program:

This assessment is meant to be a tool to assist food safety regulatory agencies and others to manage risk associated with L. monocytogenes. Furthemore it serves to identify gaps in scientific knowledge and information about L. monocytogenese that need to be satisfied to further help efforts to reduce foodborne listeriosis.

Administrative Liaison: Sherri B. Dennis: 202-260-3984


Project Title: Food Safety Risk Analysis Clearinghouse

CFSAN Regulatory Codes: X
CFSAN Program Priority Codes: 1.14B
Start Date: 06/00/1997         Completion Date: ongoing

Statement of Research Problem: The Risk Analysis Clearinghouse is currently found on the worldwide web at www.foodriskclearinghouse.umd.edu. The Clearinghouse is under development because of a need for data, information, models, and tools for use in food safety risk assessment, risk management, and risk communication. The Clearinghouse was initially described in the May 1997 Report to the President as a technical resource for risk analysts from industry, academe, and government. The Clearinghouse staff is working with Risk Assessment Consortium (RAC) member agencies, academia, and trade and professional organizations to create a topical web-based resource. While the focus remains on risk assessment, the scope has been broadened to include risk management and risk communication.

Statement of Project Objective(s):

Anticipated Impact on FDA Regulatory Program:
The clearinghouse supports regulatory programs across all federal food safety agencies that utilize risk analysis as a tool for determining research priorities, developing and evaluating policy, and promoting international harmonization.

Project Priority Changes During FY2000: Priorities remained the same, but scope was broadened to include risk management and risk communication.

Project Associated Personnel

Administrative Liaison(s): Wes Long: 202/205-4024

Research Personnel:
Name Office/Division FTE [00, 01, 02] Component
W. Long OCD/SASS 0.1 0.2 0.2 1
M. Walderhaug OSRS/DMS 0.5 0.0 0.0 1
D. Lowther OCAC/DSAT 0.5 0.0 0.0 1
Detailees   0.0 1.0 1.0 1
  Total FTE: 1.1 1.2 1.2  

Collaborators: Joint Institute for Food Safety and Applied Nutrition

Virginia - Maryland Regional College of Veterinary Medicine
National Food Processors Association
Risk Assessment Consortium

Component 1: Food Safety Risk Analysis Clearinghouse

Component 1 FY 2000 Deliverables:
  1. The Food Safety Risk Analysis Clearinghouse is now an online resource found at www.foodriskclearinghouse.umd.edu. Priorities for the Clearinghouse and a draft strategic plan have been developed. Support from the UM Computer Sciences Human-Computer Interaction Laboratory have resulted in modifications to the site to improve accessibility. An ongoing user survey continues to provide input in this area.
  2. A public meeting was held in conjunction with a closed workshop. The public meeting reviewed ongoing microbiological risk assessment data needs and examined existing models for data sharing. The closed workshop provided input into the Clearinghouse framework and Clearinghouse priorities. One of the important outcomes of this workshop was the recommendation to change the name of the Clearinghouse to the Risk Analysis Clearinghouse in recognition of the inter-relationship between risk assessment, risk management, and risk communication. The name change reflects the broadened scope and conforms with accepted international nomenclature. In addition, the workshop recommended that the top four priorities be to establish links, develop data quality criteria, focus initially on food net pathogens, and work on gaining access to data.
  3. An Internet communities workshop was also held that brought together major Internet food safety resources to foster dialogue, linkage and collaboration among the different sites.
  4. Success in the development of data sources include cooperation with the National Food Processors Association to become the repository for data from an ongoing study, funded by an USDA grant, of the prevalence and quantitation of Listeria monocytogenes in ready-to-eat foods. Data from a post retail handling survey have been provided and are being converted to a web-based resource. Data are to be obtained the grain industry on the occurrence of deoxynivalenol (DON, vomitoxin) in wheat and wheat food products. Linkage to an allergen database maintained by the Central Science Laboratory, Ministry of Agriculture, Fisheries, and Food, UK, is underway.
  5. An expanded risk management subweb has been developed, offering extensive risk management links primarily in the field of economics, along with other original resources, including a discussion paper on economic decision criteria.
Component 1 FY 2000 Progress:
All deliverables as above
Technical Barriers to Meeting Component 1 Objectives or Deliverables: none listed
FY 2001 Deliverables:
  1. Continued promotion of Clearinghouse among industry, academia, and governments by presentations at national and international meetings for the purposes of soliciting data and raising awareness of the resource.
  2. Development of HTML, hyperlinked, completed risk assessments for L. monocytogenes and V. parahaemolyticus. These web documents will facilitate transparency in microbiological risk assessments by providing full disclosure of the data, modeling tools, and methodology used in these assessments. It is expected that a new standard for transparency will emerge from these efforts and demand for similarly presented assessments will rise. We predict that data submissions will increase when affected industries become aware of the impact of the data limitations. Critical dialogue on modeling techniques, model validation, and methodologies will be initiated, with the Clearinghouse as a focal point for these activities.
  3. Conduct a workshop on data quality and study design that will provide basic points to consider. These points to consider will serve to advise both submitters and users of data posted on the Clearinghouse. Further workshops or more specific points to consider for particular data issues (e.g. epidemiological study design) may follow. The points to consider will not be considered official federal guidance, but will be available for use by federal agencies if the development of such guidance becomes a priority in the future.
  4. Develop web-based risk communication resources for risk communicators, risk assessors, and risk managers.
  5. Develop web-based introductory tutorials on risk analysis topics.
  6. Expand efforts to identify links to national and international risk analysis resources.
  7. Post a bulletin board where interested individuals from around the world can discuss relevant food safety issues. This resource will improve communication among the rapidly expanding food safety risk analysis community.
FY 2002 Deliverables:
  1. Posting data from industry and other sources. We anticipate that we will begin to receive data from additional outside sources in 2002. (Data should begin to be received in 2001)
  2. Apply, refine, and promote data quality measures developed in FY2001.
  3. Broaden efforts beyond microbiological risk analysis.
  4. Continue to develop online tutorials and learning aids.
  5. Initiate efforts with developing world to develop resources targeted to them.
  6. Development of knowledge-based tools.

FY 2000 Publications Associated with the Project: none listed


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Hypertext updated by bap/dav 2001-OCT-04