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The Food and Drug Administration (FDA) made available research funds in fiscal year 2000 to support research in the areas of produce safety, egg safety, development of extraction procedures of foodborne viruses from foods to enhance detection, evaluation of surrogate microorganisms for use in HACCP validation, and food service, transportation, and consumer practices.
Seven new grants totaling over $1 million were funded.
Project Title: Development of Methods for Virus Extraction from Foods
Organization: Florida Department of Health
Principal Investigator: Lillian Marcus Stark
Research Grant #: FD-U-00-1942-01 Duration-3 years
2000 Award Amount: $200,000
Foodborne viral illness is a major public health concern, and FDA is mandated under the Food Safety initiative to reduce foodborne illness to the greatest extent possible. Norwalk-like viruses (NLVs), based on number of cases. Although advances have been made in detecting viruses in foods, currently there are no standardized methods suitable for routine monitoring and outbreak investigation. This project proposes to develop simple, reliable methods for extraction and detection of viruses from a variety of food products.
Project Title: Development of Viral Extraction Processing and Detection Methods for Food Commodities
Organization: The University of North Carolina at Chapel Hill
Principal Investigator: Mark Sobsey
Research Grant #: FD-U-00-1957-01 Duration-3 years
2000 Award Amount: $200,000
The general objective of this project is to develop and standardize an integrated framework of extraction, processing and molecular detection of NLVS and HAV suitable for routine monitoring and outbreak investigation in a variety of food commodities, including intact and minimally processed fruits and vegetables, shellfish, and other complex food items.
Project Title: Effect of Inoculation on Efficacy of Chlorine Dioxide Gas and Chlorinated Water to Decontaminate
Produce
Organization: Purdue Research Foundation
Principal Investigator: Richard H. Linton
Research Grant #: FD-U-00-1952-01 Duration-3 years
2000 Award Amount: $110,000
It is a challenge to compare or interpret the efficacy data of antimicrobials determined using different inoculation procedures. An ideal inoculation protocol needs to be standardized to safely determine the efficacy of antimicrobial and ensure the safety of produce. The long-term goal of this proposed research is to improve produce safety by developing and applying novel non-thermal food processing technologies. Results from the proposed research will help improve and ensure the safety of fresh and MPR fruits and vegetables by using new sanitation technologies. Furthermore, it will enhance our understanding of the potential benefits and feasibility of using CIO2 gas a new disinfectant for food industry.
Project Title: Foodborne Protozoa: Inoculation and Inactivation Methods
Organization: University of Georgia Research Foundation, Inc.
Principal Investigator: Ynes R. Ortega
Research Grant #: FD-U-00-1948-01 Duration-2 years
2000 Award Amount: $103,000
The objective of this proposal is to determine the effects of inoculation such as dipping, spraying and spotting to analyze the recovery of Cryptosporidium parvum and Cyclospora cayetanensis each individually from produce. Optimal time between inoculation and recovery will be evaluated. The project will also determine the efficacy of inactivation against parasites (Cryptosporidium parvum and Cyclospora cayetanensis) in experimentally inoculated basil, strawberries, raspberries and tomatoes by home cooking practices such as microwave, boiling and steam and consumer practices such as storage of food in refrigeration at different times and temperatures.
Project Title: Home Refrigeration Knowledge and Practice of Consumers
Organization: Tennessee State University
Principal Investigator: Sandra L. Godwin
Research Grant #: FD-U-00-1950-01 Duration-3 years
2000 Award Amount: $185,000
The goals are to obtain information to support the science behind the U.S. Public Health Service Code, which provides guidance to the retail and food service industry, as well as information to support guidance to the consumer. Little is known about the actual refrigeration practices of American consumers, although proper cooling of foods is known to help prevent food borne illness. Thus, the overall goal of this project will be to determine the food refrigeration knowledge and practices of consumers in six states.
Project Title: Effect of Previously S. Enteritidis Contaminated Environment . . . A Prospective Study
Organization: California Department of Food Agriculture, Animal Health and Food Safety Services
Principal Investigator: David Mario Castellan
Research Grant #: FD-U-00-1963-01 Duration-3 years
2000 Award Amount: $40,657
The goals are to ensure egg safety by developing improved sampling and detection methods for detection of low-levels of and enumeration of Salmonella Enteritidis (S. Enteritidis) in eggs. A longitudinal study is proposed which addresses the need to develop better on-farm indicators for predicting whether eggs are contaminated with S. Enteritidis.
Project Title: Surrogates for Evaluating Efficacy of Thermal Processes
Organization: National Food Processors Association
Principal Investigator: David Ernest Gombas
Research Grant #: FD-U-00-1964-01 Duration-2 years
2000 Award Amount: $70,000
The National Food Processors Association has established process recommendations for pasteurization of juices, and thermal processing of hot dog batter, chicken meat and surimi-based imitation crab. This study will be conducted (1) to identify potential surrogate organisms for evaluating adequacy of the recommended health processes and (2) to evaluate the utility of their use for validating the processes in inoculated pack studies.
Year 2000 New Funding Subtotal: $908,675
Project Title: Establish a Correlative Dose-Response Model for Human Cryptosporidiosis
Organization: Tufts University, School of Veterinary Medicine
Principal Investigator: Saul Tzipori
Research Grant #: FD-R-001621 Duration-3 years
2000 Award Amount: Done
The goal of this proposal is to provide data to confirm strain variation effects on illness severity of volunteers challenged with different Cryptosporidium parvum strains, and to investigate whether these same differences are observed in animal models, using the gamma interferon knockout (GO) mouse model. Three strains previously used to challenge volunteers will be tested in the GO mouse model. In addition, two more strains will be tested both in volunteers and in the mice. Volunteer studies will be performed at the University of Texas medical Center, and the animal work at Tufts University.
Project Title: Development of a Risk Assessment Dose-Response Model for Food borne
Listeria monocytogenes
Organization: University of Georgia
Principal Investigator: Mary Alice Smith
Research Grant #: FD-U-001622-01 Duration-3 years
2000 Award Amount: $156,326
The goal of this proposal is to develop a dose-response model of L. monocytogenes using pregnant rhesus monkey as surrogates for immunocompromised subpopulations. One of the objectives of the study is the development of an hepatocyte model to screen for relative virulence of different strains of this pathogen.
Project Title: Dose-Response to Vibrio Species
Organization: University of Maryland
Principal Investigator: J. Glenn Morris, Jr.
Research Grant #: FD-R-001625-01 Duration-3 years
2000 Award Amount: Done
The goal of this proposal is to determine the dose of V. cholerae non O1 needed to colonize and/or cause illness in volunteers when ingested in raw oysters. Previously uncontaminated oysters will be infected with non O1 V. cholerae at the Columbus Center. Human dose-response to Vibrios will be correlated with data from animal models; doses of non-O1 V. cholerae needed to cause colonization/illness in rabbits and mice after oral inoculation will be established and compared with V. parahaemolyticus and V. vulnificus in animals. Impact of host and strain differences on dose-response relationships will be assessed.
Project Title: Disinfection of Alfalfa Seeds and Sprouts
Organization: University of Georgia
Principal Investigator: Larry R. Beuchat
Research Grant #: FD-U-001626-01 Duration-3 years
2000 Award Amount: Done
The overall objective of this study is to determine the effectiveness of several food-grade chemicals and natural antimicrobials in killing E. coli O157:H7 and Salmonella spp. The specific goal is to develop efficacy data that can be used to formulate recommendations for application of one or more treatments to alfalfa seeds and/or sprouts for the purpose of minimizing the risk of illness.
Project Title: Inactivation of Pathogens on Produce by GRAS Chemicals
Organization: University of Georgia
Principal Investigator: Michael P. Doyle
Research Grant #: FD-U-001631-01 Duration-3 years
2000 Award Amount: $57,807
The overall objective of this project is to develop practical, cost effective methods for reducing or inactivating pathogenic microorganisms on fresh fruits and vegetables, to reduce or eliminate E. coli O157:H7, L. monocytogenes, and Salmonella spp. on apples, oranges, lettuce and sprouts. Treatments include different concentrations of lactic acid, sodium benzoate, lactic acid plus glycerol monolaurate. Each treatment will be evaluated at different temperatures and times.
Project Title: A Non-Thermal Method to Enhance Safety of Fresh Produce
Organization: University of Georgia
Principal Investigator: Yen-Con Hung
Research Grant #: FD-U-001638-01 Duration-3 years
2000 Award Amount: $85,888
The overall objective of this project is to develop intervention methods and technologies other than cooking that can be used by consumers in the home and by operators of food service facilities. The study will focus on "High Oxidation Potential" (HOP) water to wash fruits and vegetables.
Project Title: Natural Variation in Escherichia coli O157:H7
Organization: University of Wisconsin
Principal Investigator: Frederick Blattner
Research Grant #: FD-U-001627-01 Duration-3 years
2000 Award Amount: Done
Sequence information of Escherichia coli O157:H7 will provide unique insights into the evolution, survival, and growth of this pathogen with respect to its virulence factors. Proposed research should initiate a pathway to the eventual development of rapid and sensitive methods for detection, identification, and enumeration of this important pathogen.
Project Title: Consumer Handling and Washing of Fresh Fruits and Vegetables
Organization: UCLA
Principal Investigator: Linda Jones Harris
Research Grant #: FD-U-001629-01 Duration-3 years
2000 Award Amount:
The objectives of this proposal include:
a) identification of consumer handling practices
b) evaluation of the effectiveness of washing methods commonly used by consumers
c) evaluation of the effectiveness of modified washing procedures that incorporate antimicrobial agents (e.g., chlorine,
organic acids, etc.; Salmonella, L. monocytogenes, and E. coli O157:H7 will be the test pathogens)
d) evaluation of consumer understanding and likelihood of following recommended washing procedures.
Year 2000 Renewal Funding Subtotal: $300,021
Year 2000 Funding Total: $1,208,696
Start Date: June 1998
Stop Date: August 2000
Statement of Research Problem:
Several outbreaks of Escherichia coli O157:H7 and other pathogens in the 1990's were associated with the consumption of fresh apple cider and unpasteurized natural apple juice. In laboratory studies, this organism was shown to be more resistant to acid than expected and survived in acidic products like apple cider, particularly when products were refrigerated. Concerns about controlling this pathogen and others (Salmonella, Cryptoporidium) in unpasteurized juices along with the small business character of the cider industry, which prevented the industry from performing its own research lead to this project.
Statement of Project Objectives:
The purpose of this project was to investigate, in the environment of a small juice processing plant, the efficacy of proposed interventions to reduce pathogens that might be in cider and determination of potential routes of contamination that might lead to pathogens in the product. This project started with testing of the microbial load of the apples used to make cider and the resulting juice. Inoculation procedures were developed to test the effectiveness of proposed control measures.
Anticipated Impact on Food Safety and FDA Regulatory Program:
Some aspects of this research was used in support of developing comprehensive regulation on juice safety, issued on January 18, 2001. Research also has been used to help validate use of UV as an intervention that is capable of providing a 5-log reduction at least in cider. Research also has revealed some problems inherent in nature of these rather primitive plants that may render them refractory to removal of contaminants. Also notable were several cases in which expectations based on laboratory research were contradicted by studies performed in the pilot plant.
Progress:
The work on microflora and patulin in cider and microflora on apples has established that use of fresh tree-picked apples will provide a product with less overall contamination and with no detectable patulin. Culling was shown to be effective in eliminating patulin from ciders produced from stored apples. Surface cleaning and disinfecting measures were shown to be inadequate to eliminate potential pathogens from apples or resulted in ciders with counts that did not reflect sufficient removal or killing of bacteria.
Administrative Liaison: Robert I. Merker (OPA/DPP)
Other Personnel: Susanne Keller (OPDFB/DFPP), Arthur Miller (OSCI), Elisa Elliot (OFP/DHACCP), Lauren Jackson (OPDFB/DFPP), Stuart Chirtel (OSAS/DM), Cathy Melvin (FDA ORA), Hsu Ling Tan (UC Davis), Kirk Taylor (El Dorado County Dept. of Agriculture), David Bolster (formerly El Dorado County Dept. of Agriculture).
Collaborators: Edgar Murakami (OPDFB), Tong Fu (OPDFB), Gerald Sapers (USDA), Linda Harris (UC Davis), Randy Worobo (Cornell Univ.), Mary Wang (California. Dept of Health Services), Ray Nelson (FDA ORA, retired), Bill Snodgrass (El Dorado County Dept. Agriculture), Sharon Shoemaker (UC Davis).
Start Date: October 1998
Stop Date: September 2000
Statement of Problem:
Investigation of outbreaks can provide information for use in risk assessment dose-response models. Dose-response is the term that refers to relationship which exists between the number of pathogenic organisms ingested and a characteristic infection outcome, e.g., illness, disability, death, etc., for a given population. However, typical outbreak investigations do not collect quantitative data needed for risk assessments.
Activity Performed:
Local health departments that investigate foodborne outbreaks do not have guidelines for the collection of epidemiological and microbiological data that can be used for the evaluation of pathogen-host dose-response, a key step in quantitative microbial risk assessments. This project, which was funded through a cooperative agreement with the National Center for Food Safety and Technology and the Chicago Department of Health, developed a protocol for obtaining quantitative information through intensive investigation of outbreaks of foodborne illness. The guidance that they developed included the following critical elements: (1) quantification of the amount of food ingested by the at risk population; (2) quantification of the probability and severity of adverse health outcomes; (3) accounting for the effects of a variety of host factors on the amount and severity of the resulting foodborne illness, such as age, immune status and concurrent medications; (4) quantification of pathogen concentration in the implicated food(s); and, (5) providing a description of the pathogen's growth and disease relevant characteristics in the suspect food(s). They also developed a detailed questionnaire to be used for outbreak interviews and analytical methods for the enumeration of pathogens in suspect food samples.
Study Objective:
The goal of this effort was to collect the relevant data needed to model the consumed dose of pathogen and to establish the number of organisms associated with adverse health outcomes. Laboratory procedures were to be defined for the enumeration of the foodborne pathogen(s) identified in specific outbreaks. The laboratory quantification data and the information from the intensive investigation would then be used to support the refinement or development of future risk assessments.
Achieved Results:
The protocol developed for intensive outbreak investigations was used to facilitate the accumulation of vitally important dose-response information for use in risk assessments of pathogens associated with incidents of foodborne illness. The data collection protocol was implemented in the investigation of a foodborne illness outbreak of Salmonella Enteriditis (SE). Although SE was not recovered from any of the available food specimens, valuable experience in the acquisition of dose response data through the intensive investigation of foodborne outbreaks was obtained by implementing the protocol and developing the accompanying questionnaire.
The questionnaire has been posted on the JIFSAN website at: http://www.foodriskclearinghouse.umd.edu. An article focusing on the Chicago Department of Health's experience has been submitted for publication in a peer-reviewed journal.
Administrative Liaison: Eileen Parish (FSI)
Hypertext updated by bap/dav 2001-OCT-04