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 |
|
Codes and Abbreviations
(Table of Contents)
CFSAN Regulatory Codes
|
CFSAN Program Priority Codes: FY2000
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Abbreviations
CFSAN Regulatory Codes:
- PRODUCE, GENERAL:
- Analyzing produce samples for pathogenic microorganisms more effectively / cost-efficiently
- Guidance for industry on "good agricultural practices" and "good manufacturing practices" to help assure the safety
of fresh / fresh-cut produce
- Identify / evaluate the strategies/technologies to prevent, reduce, or effectively eliminate pathogenic microorganisms
on produce.
- (Baseline Information). Incidence/prevalence of foodborne pathogens on fruits / vegetables associated with outbreaks
of illness (e.g., berries, cantaloupes, lettuce).
- Infiltration into plant tissues.
- Rapid techniques to reliably determine the level of viable Cryptosporidium parvum oocysts on produce.
- Role of hand sorting in cross contamination.
- SPROUTS:
- Guidance on safe sprout production.
- Evaluate the plausibility / safety of proposed approaches for the prevention, reduction, or effective elimination of
pathogenic bacteria on seeds or sprouts.
- Assess sprout contamination with foodborne pathogens.
- JUICE:
- Simple, non-thermal treatments for reduction / elimination of pathogens in fruit and vegetable juices amenable for use
by small processors.
- 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.
- 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).
- GRAINS AND RELATED PRODUCTS
- Acquisition of data to assess risks posed by dietary exposures to specific mycotoxins.
- FOODS OF ANIMAL ORIGIN
- DAIRY PRODUCTS:
- 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.
- Evaluate concerns about Mycobacterium paratuberculosis in pasteurized milk or pasteurized milk-derived
products.
- EGGS:
- Analytical methods / sampling procedures for more reliable / cost-effective detection of Salmonella enteritidis
in eggs [low frequency/level contamination].
- 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.
- SEAFOOD: Molluscan Shellfish:
- 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).
- 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).
- Determine means to identify when there is an unacceptable risk of tdh+ V.
parahaemolyticus outbreaks from the consumption of raw molluscan shellfish.
- Effect of temperatures (air/water) on the seasonal incidence / prevalence of total V. parahaemolyticus /
tdh+ V. parahaemolyticus in molluscan shellfish and their growing waters.
- Find effect of salinity on the seasonal incidence / prevalence of total V. parahaemolyticus /
tdh+ V. parahaemolyticus in molluscan shellfish and their growing waters.
- 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.
- 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.
- Handling techniques or processing treatments (e.g., heat shock, irradiation, other) to reduce / eliminate
V. parahaemolyticus and V. vulnificus from raw molluscan shellfish.
- SEAFOOD: Viral Contamination:
- 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).
- SEAFOOD: Fin Fish and Crustaceans:
- Means for preventing scombrotoxin intoxications.
- Scombrotoxin/Biogenic Amines/Decomposition
- Determine correlation, if any, between sensory attributes used to identify decomposition and formation of cadaverine
and putrescine? Histamine?
- 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?
- Devise analytical methods to reliably/objectively determine decomposition. What part of the fish is the best indicator
that decomposition has occurred?
- 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.
- Food safety implications of different forms of product packaging.
- Approaches for measuring/ reducing the risks associated with the consumption of raw fin fish and crustaceans
- Determine the likelihood that aquiculture products are a source of pathogenic bacteria that are resistant to multiple
antimicrobials.
- Handling and Preparation of Raw Fin Fish and Crustaceans
- Means to reduce levels of Listeria monocytogenes on cold smoked salmon.
- Cooking practices in the homes/food service establishments - sufficiency to inactivate pathogenic bacteria, viruses,
or parasites present in fin fish.
- SPECIAL NUTRITIONALS
- 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.
- 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.
- 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.
- 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.
- ESTIMATING THE RISK AND IMPACT OF FOODBORNE DISEASE
- 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?
- Alternative means for deducing dose-response relationships for foodborne pathogens - to human volunteer feeding
studies - to use of animals.
- Determine segments (e.g., neonates, the elderly) of the general population to be considered at increased risk for
foodborne disease. Variation among disease agents.
- 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.
- 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?
- 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.
- EMERGENCE OF NEW MICROBIAL CONCERNS
- Common virulence characteristics likely to be transferred among foodborne microorganisms for use as molecular targets
to develop detection reagents/ methods for emerging pathogens.
- Estimate dose-response relations for a newly emerged foodborne pathogen based on the integration of its virulence
characteristics.
- 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
1.1a Foodborne outbreaks associated with imported food
1.1b Increase surveillance of imported food products at the border
1.1c Education/Outreach assistance to foreign countries on GAP/GMP
1.1d Evaluate food regulatory systems in foreign countries
1.1e Conduct 75-100 foreign inspections of food establishments
1.2 Hazard Analysis and Critical Control Points (HACCP)
1.2a Seafood HACCP
1.2b Juice HACCP
1.2c HACCP at Retail
1.3 Produce Initiative
1.3a Good Agricultural Practices
1.3b Sprouts
1.4 Additional Prevention Efforts
1.4a Citrus Juices
1.4b Apple Cider
1.4c Fresh Cut Produce
1.4d Prevention Measures for Eggs
1.4e Food Code
1.4f MOU with FSIS
1.4g Vibrio vulnificus
1.5 Surveillance and Outbreak Response
1.5a Outbreak Response
1.5b Foodborne Outbreak Response Coordinating Group (FORCG)
1.5c Listeria
1.5d Salmonella enteritidis
1.6 Research
1.6a Food Safety Initiative Research and Risk Assessment
1.6b Extramural Research
1.6c Consultation with USDA
1.6d Joint Institute for Food Safety Research
1.7 Risk Assessment
1.7a Listeria
1.7b Vibrio parahaemolyticus
1.7c Methylmecury
1.8 Education
1.8a Shell Eggs
1.8b Fight BAC
1.8c Food Safety Education Month
"B" List
1.9B Update on frequently asked seafood HACCP questions
1.10B HACCP template code of practice for fish products
1.11B Foster farm egg quality assurance programs
1.12B Technology Transfer
1.13B Risk Assessment Consortium (finalize charter and initiate implementation)
1.14B Risk Assessment Consortium Clearinghouse
1.15B Information Network
Part II - Strategic Program Areas
2.1 Premarket Review of Food Ingredients
2.1a Expedited Review
2.1b Food and Color Additives
2.1c GRAS Determinations
2.1d Indirect Food Additives
2.1e Irradiation Labeling
2.1f Food Quality Protection Act
"B" List (Premarket Review of Food Ingredients)
2.2B Food Additives - investigate additional procedures that impact on the antimicrobial action against
human pathogens in foods
2.3B Identify efficiencies/streamlining mechanisms for the food additive review process
2.4B Develop a strategy regarding the use of bromates in baking products
2.5B Complete an evaluation of the safety issues concerning Cochineal extract and carmine color
additives
2.6B Complete revision of two chapters of the new edition of the "Redbook."
2.7B FR Notice addressing labeling requirements for Olestra-containing products.
2.8B Develop guidance for the industry (enzymes, proteins, fibers & lipids)
2.9 Nutrition, Health Claims and Labeling
2.9a Trans Fatty Acids
2.9b Meet Premarket Review Statutory Timeframes (Infant formula)
2.9c Nutrient Content/Health Claims (120-days)
2.9d Nutrient Content/Health Claims (190-days)
2.9e Infant Formula
2.9f Citizen Petition (98P-0968)
2.9g Food Regulatory Report
"B" List (Nutrition, Health Claims and Labeling)
2.10B Nutrient Content/Health Claim notifications Based on an AuthoritativeStatement
2.11B Amend Regulations on Nutrient content claims and Health claims to Provide Additional Flexibility
2.12B Establish a Pilot Enforcement Program directed at Consumer Deception on Food Labeling
2.13B Initiate Public Forum on Scientific and Regulatory Framework for Structure/Function Claims
2.14 Dietary Supplements
2.14a Ephedra
2.14b New Dietary Ingredients
2.14c Nutrient Content/Health Claims
2.14d Overall Strategy
2.14e Stakeholder Outreach
2.14f Citizen Petition 98P-0509
"B" List (Dietary Supplements)
2.15B Elevate the Priority of Field Assignments on Dietary Supplements
2.16 Chemical and Other Contaminants
2.16a Patulin
2.16b Pesticide Monitoring Improvements Act (PMIA)
2.16c Total Diet Study Workshop
2.16d Fumonisin
"B" List (Chemical and Other Contaminants)
2.17B Compliance Policy Guide for Filth in Food
2.18B Compliance Policy Guide for Hard Sharp Objects in Food
2.19B Guidance Document - Lead Containing Decoration on Glassware
2.20B Compliance Policy Guide for Sampling and Analyzing Fresh and Frozen Raw Shrimp
2.21B Compliance Policy Guide, Pesticide Residues in Food and the Food Quality Protection Act of 1996
2.22B Elemental Analysis Manual
2.23 Cosmetics
2.23a Alpha Hydroxy Acids
2.23b Diethanolamine
2.23c Voluntary Reporting
2.23d Program Restoration
Part III - Crosscutting Areas
3.1 Science Base
3.1a Joint institute for Food Safety and Applied Nutrition (JIFSAN)
3.1b National Center for food Safety and Technology (Moffett Center)
3.1c Review Non-FSI Research/ Consolidated Mgmt. System for FSI and non-FSI Research
3.1d Peer Review
3.1e Scientific Expertise across CFSAN Regulatory Programs
3.2 Federal-State-Local
3.2a Integrated Food Safety System
3.2b Food Code
"B" List (Federal-State-Local)
3.3B Milk Safety
3.4B Shellfish
3.5B Retail
3.6 International
3.6a Develop Affirmative Agenda
3.6b Equivalence Criteria
3.6c Equivalence Determinations
3.7 Human Resources
3.7a Communication
3.7b Training
3.7c Quality Environment
3.7d Future Skill Needs
Abbreviations for CFSAN Organizational Units:
OCAC-Office of Cosmetics and Colors
DSAT-Division of Science and Applied Technology
DPEP-Division of Programs and Enforcement Policy
OPA-Office of Premarket Approval
DPP-Division of Product Policy
DHEE-Division of Health Effects Evaluation
DPC-Division of Petition Control
DPMU-Division of Product Manufacture and Use
OPDFB-Office of Plant and Dairy Foods and Beverages
DPIC-Division of Pesticides and Industrial Chemicals
DFPP-Division of Food Processing and Packaging
DNP-Division of Natural Products
DPPS-Division of Plant Product Safety
DDES-Division of Dairy and Egg Safety
Division of Risk Assessment
DMS-Division of Microbiological Studies
ONPLDS-Office of Nutritional Products, Labeling and Dietary Supplements
DSLR-Division of Standards and Labeling Regulations
DNSP-Division of Nutrition Science Policy
DCE-Division of Compliance and Enforcement
OS-Office of Seafood
DSAT-Division of Science and Applied Technology
DPEP-Division of Programs and Enforcement Policy
OARSA-Office of Applied Research and Safety Assessment
DMB-Division of Molecular Biology
DVA-Division of Virulence Assessment
DTNPS-Division of Toxicology and Nutritional Product Studies
DIVBT-Division of In-Vitro and Biochemical Toxicology
OSAS-Office of Scientific Analysis and Support
DM-Division of Mathematics
DGSS - Division of General Scientific Support
DMS- Divison of Market Studies
OFP-Office of Field Programs
DEP-Division ofEnforcement and Programs
DHP-Division of HACCP Programs
DCP-Division of Cooperative Programs
OSCI-Office of Science
QAS-Quality Assurance Staff
CSC-CFSAN Staff College
MRRACS-Microbial Research and Risk Assessment Coordination Staff
JLS-JIFSAN Liaison Staff
CFACS-CFSAN Food Advisory Committee Staff
Other Abbreviations:
BAM - Bacteriological Analytical Manual
EHEC - Enterohemorrhagic Escherichia coli [notably E. coli O157:H7]
ELISA - Enzyme linked Immunosorbant Assay
ESR - Electron spin resonance
GMP - Good Manufacturing Practices / GAP - Good Agricultural Practices
HACCP - Hazard Analysis and Critical Control Points
ISSC - Interstate Shelfish Sanitation Conference
NAMRI - Naval Medical Research Institute
NCTR - National Center for Toxicological Research
NMR - Nuclear magnetic resonance
NSSP - National Shellfish Sanitation Program
PCR - Polymerase Chain Reaction
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Hypertext updated by bap/dav 2001-OCT-04