CFSAN Regulatory Codes:

1. PRODUCE, GENERAL:
1. Analyzing produce samples for pathogenic microorganisms more effectively / cost-efficiently
2. Guidance for industry on "good agricultural practices" and "good manufacturing practices" to help assure the safety of fresh / fresh-cut produce
3. Identify / evaluate the strategies/technologies to prevent, reduce, or effectively eliminate pathogenic microorganisms on produce.
4. (Baseline Information). Incidence/prevalence of foodborne pathogens on fruits / vegetables associated with outbreaks of illness (e.g., berries, cantaloupes, lettuce).
5. Infiltration into plant tissues.
6. Rapid techniques to reliably determine the level of viable Cryptosporidium parvum oocysts on produce.
7. Role of hand sorting in cross contamination.
2. SPROUTS:
1. Guidance on safe sprout production.
2. Evaluate the plausibility / safety of proposed approaches for the prevention, reduction, or effective elimination of pathogenic bacteria on seeds or sprouts.
3. Assess sprout contamination with foodborne pathogens.
3. JUICE:
1. Simple, non-thermal treatments for reduction / elimination of pathogens in fruit and vegetable juices amenable for use by small processors.
2. Surrogates. Study nonpathogenic microorganisms (e.g., Lactobacillus fermentans, Enterobacter aerogenes) with similar behavior to pathogens [e.g., Salmonella Hartford or E. coli 0157:H7] for validating the effectiveness of antimicrobial treatments / processes on the reduction of pathogens during commercial juice production. Fill gaps in the safety data with the most promising surrogate organisms.
3. Reduction achieved through antimicrobial treatments (e.g., pulsed light, ultraviolet light, pulsed electric fields, ozone, etc.). Relevant treatment parameters (e.g., temperature, pH, radiation dose, field strength, concentrations, etc) needed to achieve specified reductions (e.g., 1 log, 3 logs).
4. GRAINS AND RELATED PRODUCTS
1. Acquisition of data to assess risks posed by dietary exposures to specific mycotoxins.
5. FOODS OF ANIMAL ORIGIN
1. DAIRY PRODUCTS:
1. Evaluate adequacy of 60-day aging period for raw milk cheese to eliminate non-spore forming pathogenic bacteria, [E. coli O157:H7, L. monocytogenes]. Alternative procedures to minimize the risk of foodborne illness resulting from pathogens.
2. Evaluate concerns about Mycobacterium paratuberculosis in pasteurized milk or pasteurized milk-derived products.
2. EGGS:
1. Analytical methods / sampling procedures for more reliable / cost-effective detection of Salmonella enteritidis in eggs [low frequency/level contamination].
2. Devise /test for effective means to reduce the levels of S. enteritidis and other salmonellae in intact shell eggs while maintaining the raw characteristics of the food. Define parameters that influence the effectiveness of the process both in relation to food safety/ food quality.
6. SEAFOOD: Molluscan Shellfish:
1. Determine levels in raw molluscan shellfish at retail of tdh⁺ Vibrio parahaemolyticus strains (V. parahaemolyticus strains with the gene that encodes for thermolabile direct hemolysin).
2. Determine the infectious dose (or probability of infection) for tdh⁺ V. parahaemolyticus. Relationship of serotypes/strains to infectivity /virulence. Infectivity of tdh⁺ V. parahaemolyticus - variation among subpopulations, (e.g., those at increased risk).
3. Determine means to identify when there is an unacceptable risk of tdh⁺ V. parahaemolyticus outbreaks from the consumption of raw molluscan shellfish.
4. Effect of temperatures (air/water) on the seasonal incidence / prevalence of total V. parahaemolyticus / tdh⁺ V. parahaemolyticus in molluscan shellfish and their growing waters.
5. Find effect of salinity on the seasonal incidence / prevalence of total V. parahaemolyticus / tdh⁺ V. parahaemolyticus in molluscan shellfish and their growing waters.
6. Determine feasibility for environmental parameters such as salinity, temperature, or nutrient profiles to predict when elevated levels of V. parahaemolyticus, particularly tdh⁺ V. parahaemolyticus in raw molluscan shellfish occur.
7. Investigate parameters to determine objectively when growing waters can be reopened to harvesting after closure due to excess levels of V. parahaemolyticus or tdh⁺ V. parahaemolyticus.
8. Handling techniques or processing treatments (e.g., heat shock, irradiation, other) to reduce / eliminate V. parahaemolyticus and V. vulnificus from raw molluscan shellfish.
7. SEAFOOD: Viral Contamination:
1. Define microbiological, chemical, or physical attributes (e.g., coliphage levels, water temperature or salinity) that can be predictive for an increased risk of contamination of molluscan shellfish with viruses of public health concern (e.g., Norwalk viruses, hepatitis type A).
8. SEAFOOD: Fin Fish and Crustaceans:
1. Means for preventing scombrotoxin intoxications.
2. Scombrotoxin/Biogenic Amines/Decomposition
3. Determine correlation, if any, between sensory attributes used to identify decomposition and formation of cadaverine and putrescine? Histamine?
4. Relationship of decomposition in non-scombroid species of fish (e.g., salmon) and other seafood to illness symptoms similar to scombroid poisoning. Do microbial toxins other than biogenic amines play a role in outbreaks of scombrotoxicity?
5. Devise analytical methods to reliably/objectively determine decomposition. What part of the fish is the best indicator that decomposition has occurred?
6. Develop reliable field method to rapidly detect if fish, especially tuna, have been treated with CO. [CO treatment of scombroid fish may mask visual/other sensory signs of decomposition common as indicators of possible scombrotoxin formation.
7. Food safety implications of different forms of product packaging.
8. Approaches for measuring/ reducing the risks associated with the consumption of raw fin fish and crustaceans
9. Determine the likelihood that aquiculture products are a source of pathogenic bacteria that are resistant to multiple antimicrobials.
10. Handling and Preparation of Raw Fin Fish and Crustaceans
11. Means to reduce levels of Listeria monocytogenes on cold smoked salmon.
12. Cooking practices in the homes/food service establishments - sufficiency to inactivate pathogenic bacteria, viruses, or parasites present in fin fish.
9. SPECIAL NUTRITIONALS
1. Find the food safety significance of non-spore forming gram-negative bacteria (e.g., Enterobacter sakazaki) found sporadically at low levels in powdered infant formulas. Devise more effective/ cost-effective sampling methods for detecting low levels of these microorganisms in powdered infant formulas.
2. Find microbial food safety significance of low levels of B. cereus/ other spore forming microorganisms in infant formulas. Determine potential for heat stable enterotoxins, e.g., that produced by B. cereus, to be carried into finished powdered infant formulas if present in the ingredients.
3. Data to assess the risk posed by potential contaminants (TSE infective agents and microbial pathogens) in glandular products of animal origin and meat byproducts used as dietary supplements.
4. Risk that microorganisms used as probiotic (e.g., Lactobacillus spp., blue-green algae) dietary supplements could cause infections in individuals with severely compromised immune systems.
10. ESTIMATING THE RISK AND IMPACT OF FOODBORNE DISEASE
1. How can the findings from epidemiological investigations of outbreaks of foodborne illness be used to draw the most accurate estimates of both background risk and cost of foodborne disease and "attributable risks and costs," i.e., the risk and cost of disease from a particular microorganism as a result of eating a particular food?
2. Alternative means for deducing dose-response relationships for foodborne pathogens - to human volunteer feeding studies - to use of animals.
3. Determine segments (e.g., neonates, the elderly) of the general population to be considered at increased risk for foodborne disease. Variation among disease agents.
4. Alternative approaches to the validation of new chemical/ microbiological methods to be more cost effective/timely than existing collaborative study protocols, while still maintaining an equivalent level of assurance. Relative costs.
5. Develop more effective and cost-efficient manner to acquire exposure data on foodborne pathogens that occur only sporadically and at low levels. Develop means to assess current ability of industry to control the presence of foodborne pathogens in various foods. How can improvements in microbial food safety be assessed objectively and cost-effectively?
6. Are there quantitative data available on the extent of transfer of pathogenic bacteria from the hands of food workers to food items? Influence by food type, frequency of hand washing, and other parameters on rate of transfer. Differences in transfer rates when a food worker is the source of contamination versus when they are the means for cross contamination between raw and ready-to-eat foods.
11. EMERGENCE OF NEW MICROBIAL CONCERNS
1. Common virulence characteristics likely to be transferred among foodborne microorganisms for use as molecular targets to develop detection reagents/ methods for emerging pathogens.
2. Estimate dose-response relations for a newly emerged foodborne pathogen based on the integration of its virulence characteristics.
3. Impact of food production, processing, and marketing operations on the frequency of genetic and physiological changes that would foster the emergence or re-emergence of pathogens with increased potential to cause disease.

CFSAN Program Priorities Codes: FY2000

Part I - Program Priorities
Food Safety Initiative

1.1 Imports

1.2 Hazard Analysis and Critical Control Points (HACCP)

1.3 Produce Initiative

1.4 Additional Prevention Efforts

1.5 Surveillance and Outbreak Response

1.6 Research

1.7 Risk Assessment

1.8 Education

"B" List

Part II - Strategic Program Areas

"B" List (Premarket Review of Food Ingredients)

2.9 Nutrition, Health Claims and Labeling

"B" List (Nutrition, Health Claims and Labeling)

2.17B  Compliance Policy Guide for Filth in Food

3.1    Science Base

Abbreviations for CFSAN Organizational Units:

Other Abbreviations:

Table of Contents

Hypertext updated by bap/dav 2001-OCT-04