July 18, 2005 - ASM Comments on FY 2006 CFSAN Program Priorities

Division of Dockets Management
5630 Fishers Lane
Room 1061
Rockville, MD 20852
[Docket No. 1998N–0359 (formerly Docket No. 98N-0359)]

American Society for Microbiology (ASM) is responding to the Food and Drug Administration (FDA) notice requesting comments concerning the establishment of program priorities in the Center for Food Safety and Applied Nutrition (CFSAN) for fiscal year 2006 (FY 2006) in the Federal Register, Vol. 70, No. 97 on May 20, 2005, Docket No. 1998N–0359. The following comments were developed by the Committee on Agriculture and Food Microbiology and the Committee on Public Health, of the ASM Public and Scientific Affairs Board.

ASM is the largest single life science society with more than 42,000 members, including scientists in academic, industrial, clinical, and government institutions, working in areas related to basic and applied research, the prevention and treatment of infectious diseases, laboratory and diagnostic medicine, the environment, and water and food safety. The ASM applauds FDA efforts to reduce the incidence of foodborne illnesses, and to protect the safety of the food supply.

The ASM encourages CFSAN to develop a framework based on risk assessment that would enable better prioritization of risk within food defense and security, nutrition and dietary supplement safety, food/color additives and cosmetic safety, and food safety among cross-cutting areas. This framework could be used to assist the agency in ranking priorities and guiding appropriate risk management interventions. ASM believes this approach would ensure that resources are efficiently directed to have the most beneficial effect for consumers and health.

The ASM has identified the following major food safety program and research needs, within Sections IV and V of the FY 2006 workplan, Ensuring Food Safety: Crosscutting Areas and Priority Ongoing Activities, in rank order:

  1. New and novel approaches to study routes of contamination by microbial pathogens, especially Salmonella spp. onto produce, shell eggs, and aquacultured shrimp. 
  2. Develop improved methods for the detection of pathogens, particularly viruses in aquacultured shellfish. 
  3. Develop contamination prevention approaches and technologies for produce, shell eggs, finfish and shellfish. 
  4. Determine the mechanisms of virulence for Listeria monocytogenes, Enterobacter sakazakii, and Vibrio parahaemolyticus, and determine how the distribution of virulence potential relates to the prevalence and survival of the species in foods and food production and processing environments. 
  5. Establish a mechanistic dose-response curve for listeriosis for healthy and susceptible human subpopulations. 
  6. Research to support development of cGMPs, to include the destruction of foodborne pathogens on food processing equipment and in processing facilities. 
  7. Research to support the scientific basis for cooperative programs, including the FDA Food Code, Pasteurized Milk Ordinance and Shellfish Sanitation Program. This includes validation of new cooking, holding and cleaning requirements. 
  8. Further development and expansion of molecular "fingerprint" databases for foodborne pathogens to facilitate forensic and epidemiological investigations and to facilitate the development of rapid detection and identification methods based on molecular targets. 
  9. FDA food safety research programs have lost critical mass in the area of bacterial toxins, particularly toxins of Bacillus cereus, Staphylococcus aureus and Clostridium perfringens
  10. Methods to verify the destruction of TSE prions in foods and on food, equipment, and facilities. 
  11. Validate the safety and effectiveness of new food packaging technologies, i.e., ensure that low oxygen packaging does not increase the risk of Clostridium botulinum intoxication. 
  12. Determine analytical sampling plans yielding a high level of confidence for produce, shell eggs, fish and shell fish, dairy products, grains, and infant formula.

CFSAN plays an important role in reducing the incidence of foodborne illnesses and protecting the safety and security of the food supply. It is our understanding that there is a reduction in CFSAN’s capacity to conduct food safety research. Food safety priorities, such as research on Cryptosporidium parvum, Salmonella Enteritidis, Campylobacter, Salmonella spp., and Listeria monocytogenes, are not receiving adequate funding. Food safety research is essential for ensuring a safe and secure food supply for consumers and health. Food defense research, which focuses on new methods for non-traditional agents; threat agent characteristics in foods; threat agent dose response in humans; and agent prevention strategies, is important, but funding for this research should not come at the expense of food safety research.

We are pleased to have the opportunity to provide comments on CFSAN’s program priorities for FY 2006, and hope that these recommendations are of assistance to the FDA.

Sincerely,

Ruth Berkelman, M.D., Chair, Public and Scientific Affairs Board
Michael Doyle, Ph.D., Chair, Committee on Agriculture and Food Microbiology

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