photo of orange juice U.S. Food and Drug Administration - August 2001

Food Safety Progress Report

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photo of fish on ice

Fiscal Year 2000

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Research and Risk Assessment

(Table of Contents)

Solidifying the Science Base

In FY 2000, food production technologies continued to advance rapidly, adding to the Center for Food Safety and Applied Nutrition's (CFSAN) challenges as a guardian of the public health responsible for ensuring a safe food supply. And in that fiscal year, CFSAN continued its longstanding practice of collaborating with the external scientific community to complement the core of expertise within the agency. As a primary CFSAN strategy, leveraging has brought a wide range of scientific thinking to bear on public health issues.

In FY 2000, FDA worked in cooperation with many partners _ in such federal and state collaborations as the Joint Institute for Food Safety Research (JIFSR) and the Risk Assessment Consortium (RAC), and in partnership with these research institutions:

  • Joint Institute for Food Safety and Applied Nutrition (JIFSAN). In FY 2000, the JIFSAN partnership between FDA and the University of Maryland continued its involvement in areas of risk assessment and education. For example, in that year, a database on temperatures of stored and cooked foods, based on a survey by Audits International, became the first significant risk data posted to JIFSAN's Food Safety Risk Analysis Clearinghouse, a resource for those interested in food safety risk assessment, management and communication. "This type of project fit in perfectly with our role of providing a science base for sound health policy by filling in gaps in needed knowledge," explains JIFSAN Director David Lineback, Ph.D. JIFSAN was also a key player in international "good agricultural practices" training programs undertaken in FY 2000.

  • National Center for Food Safety and Technology (NCFST). This joint effort of the Illinois Institute of Technology, FDA and the food industry continued its groundbreaking work in FY2000 developing alternative technologies to enhance the safety of food products, such as sprouts or juice, that have the potential for causing foodborne illness. For example, in FY 2000 NCFST initiated or continued work on projects related to the following issues: the effectiveness of microwave energy for pasteurization of in-shell eggs; tests of spent irrigation water to prevent the release of sprouts contaminated with pathogens; the efficacy of thermal and nonthermal technologies for elimination of pathogens in fresh fruit juices and other foods; the potential allergenicity of new food proteins in genetically modified foods; molecular subtyping of Listeria monocytogenes and Vibrio parahaemolyticus; and survival of food pathogens during the 60-day aging period of hard cheeses made from unpasteurized milk.

    "The center's research projects bring together participants from industry, FDA, and academia," explains NCFST Director Charles Sizer, Ph.D., adding that "the collaboration works because, when it comes to food safety, we're all on the same page."

  • Other Cooperative Efforts. In FY 2000, FDA continued to seek involvement with the scientific community, through such mechanisms as CFSAN's "post-doc" program, extramural grants and cooperative agreements with outside experts. "These kinds of collaborations fill the scientific gaps when FDA doesn't have expert personnel or specialized equipment needed in a targeted research area," explains Arthur Miller, Ph.D., CFSAN's Lead Scientist for Microbiology. "The programs allow us to tap talent from various scientific institutions and, with their input, to develop guidance and policies much faster than we otherwise could."

Bolstered by additional food safety funding, and often in collaboration with the partners previously described, FDA made important strides in FY 2000 toward better scientific data, methods, and models. The following were among the significant accomplishments in that fiscal year:

photomicrograph of Cyclospora

  • developed an improved polymerase chain reaction (PCR) method for detecting Cyclospora. The method, which has been used by FDA and CDC, provided the first isolation of this pathogen from a food product associated with human illness.

  • demonstrated that surface heating of apples is not an effective method of improving the safety of apple juice. An accompanying thermal penetration model was developed that showed there is minimal penetration of heat below the surface. Therefore, while heating eliminated microorganisms, including E. coli 0157:H7, from the apples' surface, it was not effective in destroying microorganisms that had migrated into the apples.

  • demonstrated that temperature plays a critical role in inactivation of common types of Clostridium botulinum spores during high pressure processing (HPP). No direct relationship was observed between the thermal resistance of C. botulinum spores at atmospheric pressures and the thermal resistance at elevated pressures.

  • demonstrated that pulsed electric field (PEF) energy and heat work together in the destruction of Listeria monocytogenes.

  • developed an improved procedure for the quantification of the natural toxin patulin in
    fruit juices and demonstrated that patulin levels in apples are a reasonable indicator for dropped or moldy apples.

  • successfully applied a reverse transcription polymerase chain reaction (RT-PCR) method to the detection of Hepatitis A virus in shellfish, water and cilantro.

  • in conjunction with the U.S. Department of Agriculture (USDA), funded a pilot project with eight federal, state and local laboratories to develop standards for E. coli 0157:H7 sampling and testing (to be completed in FY 2001).

  • developed a multiplex PCR method to characterize new and unusual strains of pathogenic E. coli. The method simultaneously characterizes five genetic features and allows FDA to recognize a much broader range of enterohemorrhagic E. coli than is possible with other, 0157:H7-specific methods.

  • developed a draft risk assessment that examined the risk of foodborne listeriosis from eating certain ready-to-eat foods, to the point where release of the document could be planned for January 2001. "The information from the risk assessment will guide future policy on Listeria monocytogenes, helping to direct resources where the greatest impact on public health can be achieved," says CFSAN's Microbial Risk Assessment Coordinator, Sherri Dennis, Ph.D.

    photo of 3 scientists in a lab

  • developed a draft risk assessment on the public health risks associated with raw oysters containing pathogenic Vibrio parahaemolyticus. Launched in response to widespread outbreaks in 1997 and 1998, the project addressed questions such as: how often Vibrio parahaemolyticus occurs in water and in shellfish, the relationship of the level of the bacteria ingested to the severity of illness, the differences in response to the bacteria for consumers with various health conditions, and the influence of post-harvest handling on the numbers of Vibrio parahaemolyticus pathogens in oysters. Like the Listeria monocytogenes risk assessment, the project will provide a scientific framework for developing health-improving food safety guidance and policy.

  • improved the analytical method for detection of Vibrio parahaemolyticus and transferred this technology to FDA and state regulatory laboratories.

  • developed improved tests aimed at detecting and avoiding the development of antibiotic-resistant bacteria in the human food chain. With FDA's Center for Veterinary Medicine (CVM) and National Center for Toxicological Research (NCTR) taking lead roles, the agency's recent antibiotic resistance-related research has included a showing that the "agar dilution test" may be uniquely reliable for quantifying antimicrobial susceptibility in Campylobacter; the undertaking of studies to determine the epidemiology of antimicrobial resistance in Salmonella and shigatoxin-producing E. coli (such as E coli 0157:H7) organisms as they move longitudinally from feed into animals; and an application of risk assessment methodology to antibiotic resistance to
    better predict the extent of public health risk.

  • requested that the American Gastroenterologist Association survey its members regarding the incidence of gastroenterological parasitic infections in the United States resulting from consumption of raw fish. (Survey will be completed in FY 2001.)

CFSAN updated its food safety "Three-Year Research Plan," which keeps FDA's food safety research on track with regulatory objectives. "Our research plan is not carved in stone," explains John Newland, Ph.D., CFSAN's Microbial Research Coordinator. "At a given time, the three-year plan provides a snapshot of where the agency projects it will be in terms of research accomplishments."

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