Current Food Safety and Food Defense Policy Development in the United States

1
Current Food Safety and Food Defense Policy
Development in the United States FDA/CFSAN
Perspective

• Morris Potter
• Office of Science
• Center for Food Safety and Applied Nutrition

2
Food Research Program

• At FDA
• Center for Food Safety and Applied Nutrition
• Center for Veterinary Medicine
• National Center for Toxicological Research
• Office of Regulatory Affairs
• At USDA
• Agriculture Research Service
• CSREES
• Economic Research Service

3
Food Research at FDA

• Intramural
• Extramural
• Targeted cooperative research grants with an
  applied focus
• Annual budget of 1,500,00 - 2,000,000
• Projects of 2 or 3 year duration
• 200,000 per year maximum for each project
• Joint centers of excellence with universities

4
Bioterrorism Preparedness and Response Act of 2002

• Sec. 302 Focus on food imports
• Develop analytical and sampling methods
• Sec. 303 Administrative detention
• Sec. 305 Registration of food firms
• Sec. 306 Records requirement for product tracing
• Sec. 307 Prior Notice

5
Food Defense Research Agenda

• New Laboratory and Field Methods
• Development of rapid, reliable methods to detect,
  identify, and enumerate unconventional agents in
  foods
• Agent Characteristics
• Ability of unconventional agents to survive and
  grow in foods, and to cause disease through
  foodborne exposure
• Intervention Technologies
• Prevention
• Inactivation and decontamination
• Dose Response/Threat Assessments
• Ability of foodborne threat agents to cause mass
  casualties

6
Methods development and validation

• Deployable, rapid field tests
• Laboratory-based screening tests
• Laboratory-based confirmatory tests
• Methods Validation
• Sampling Techniques

7
Knowledge of Unconventional Foodborne Hazards

• Behavior in foods and food systems
• Stability
• Survival/growth
• Impact of processing
• Oral pathogenicity/toxicity
• Infectious dose
• Pathogenicity

8
Intervention Tools

• Prevention
• Identify product- and process-specific
  vulnerabilities
• Operational risk management advice to industry
• Response
• Field laboratory facilities and training
• Product tracing
• Inactivation and decontamination

9
Chemical Select Agent Methods
Unknown hazard
Non-Laboratory Rapid Screening (ELISA, lateral
flow, paper)
Laboratory Based Rapid Screening/Confirmation (GC/
MS, LC/MS, Infra-red)
10
FDA BSE Interim Final Rulefor Food and Cosmetics

• Animals not inspected and passed
• Non-ambulatory disabled cattle
• Mechanically separated beef
• SRMs from cattle 30 months and older
• Tonsils and small intestine from all cattle

11
Chronic Wasting Disease

• Animal feed issues
• Food safety issues
• Research
• Interspecies transmission
• Environmental exposures
• Risk assessment

12
Other Areas of FDA Food Safety Policy Development

• Trans Fat
• E. sakazakii in infant formula
• Produce safety
• Process-generated mutagens

13
Other Areas of FDA Food Safety Policy Development

• Trans Fat
• E. sakazakii in infant formula
• Produce safety
• Process-generated mutagens

14
U. S. Food Drug Administration

• Limited internal research resources
• Primarily directed toward food defense
• Prion diseases
• Enterobacter sakazakii
• Produce safety
• Dependent on ARS for research needs
• Developing field and laboratory food methods that
  need validation