1. Food Security and Bioterrorism “Protecting the Food Supply”

2. Food Security Traditional Definition: Traditional Definition: Access by all people at all times to enough nutritious food for an active, healthy life Access by all people at all times to enough nutritious food for an active, healthy life New term that includes “more sinister” hazards to foods New term that includes “more sinister” hazards to foods Poisoning, tampering Poisoning, tampering Considers all aspects of food production Considers all aspects of food production Farm to table protection of food supply from terrorism Farm to table protection of food supply from terrorism Current food safety practices can serve as defense against intentional product terror Current food safety practices can serve as defense against intentional product terror

3. Food Protection Practices HACCP HACCP GMPs GMPs Traceability and record keeping Traceability and record keeping Lot and batch labeling Lot and batch labeling Inspection of imported foods Inspection of imported foods Packaging Packaging Manufacturing Plant security Manufacturing Plant security

4. Homeland Security Tom Ridge Tom Ridge NAS panel of experts NAS panel of experts Expected to produce report on remedies and research needed to keep nation safe Expected to produce report on remedies and research needed to keep nation safe Threats to food supply Threats to food supply

5. Legislative Proposals Additional resources and power to prevent contaminate foods from entering US Additional resources and power to prevent contaminate foods from entering US Only 1% of imported food is currently inspected Only 1% of imported food is currently inspected New power to order product recalls New power to order product recalls Mandatory HACCP Mandatory HACCP FDA published guidance documents 4 mos after 9/11 to: FDA published guidance documents 4 mos after 9/11 to: Producers and Processors Producers and Processors Transporters and Distributors Transporters and Distributors

7. Food Security Impossible to eliminate threat to 100% certainty Impossible to eliminate threat to 100% certainty Concepts behind food security are preventive Concepts behind food security are preventive Make tampering more difficult Make tampering more difficult Lot and batch numbering most important in limiting casualties in event of terrorism Lot and batch numbering most important in limiting casualties in event of terrorism

8. FDA Guidance Divide food producing into segments Divide food producing into segments Management Management Physical facilities Physical facilities Employees Employees Computers Computers Raw materials and packaging Raw materials and packaging Operations Operations Finished product Finished product

9. Example: Raw Materials and Packaging Using only “licensed” sources for all ingredients Using only “licensed” sources for all ingredients Compressed gas Compressed gas Labeling Labeling Suppliers and transporter practices Suppliers and transporter practices Authentication of labeling Authentication of labeling Inspection and testing of incoming materials Inspection and testing of incoming materials Locked and sealed vehicles, containers and railcars Locked and sealed vehicles, containers and railcars

10. Raw Materials and Packaging Quarantine and release procedures Quarantine and release procedures Segregation under inspection Segregation under inspection Reconciling amounts ordered with amounts received Reconciling amounts ordered with amounts received Supervising off-loading procedures Supervising off-loading procedures Traceability of packaging and labels and ingredients, etc. Traceability of packaging and labels and ingredients, etc. Investigating discrepancies Investigating discrepancies

11. Raw Materials and Packaging Destroying used labels to prevent reuse Destroying used labels to prevent reuse Pre-hiring screening Pre-hiring screening Restricted Access Restricted Access Identification Identification Personal items Personal items Training in food security Training in food security Unusual behavior Unusual behavior

12. Industry Response to Terrorist Event: Strategy for triaging the event Strategy for triaging the event Plan for emergency evacuation, including preventing security breaches during evacuation Plan for emergency evacuation, including preventing security breaches during evacuation Identifying management that employees should alert about potential security problems Identifying management that employees should alert about potential security problems Identifying 24-hour contact information for local, state, and federal police/fire/rescue/government agencies Identifying 24-hour contact information for local, state, and federal police/fire/rescue/government agencies Identifying a media spokesperson Identifying a media spokesperson Having generic press statements and background information Having generic press statements and background information FDA Guidance Document

13. Role of the Consumer: Examination of packaging Examination of packaging Examination using sensory tools Examination using sensory tools This is about all the consumer can do because tampering usually sophisticated This is about all the consumer can do because tampering usually sophisticated No obvious evidence of tampering No obvious evidence of tampering Consumer must rely primarily upon vigilance of food producers and handlers Consumer must rely primarily upon vigilance of food producers and handlers

14. Legal Implications: Regulatory Liability Regulatory Liability Failure of manufacturer to follow FDA recommended practices Failure of manufacturer to follow FDA recommended practices Civil Liability Civil Liability Private actions against food manufacturers by consumers injured by bio-terrorism Private actions against food manufacturers by consumers injured by bio-terrorism Reasonability (What is reasonable after 9/11) Reasonability (What is reasonable after 9/11) Foreseeability Foreseeability Does manufacturer have a new duty to consumers after 9/11? Does manufacturer have a new duty to consumers after 9/11?

15. U.S. Food and Drug Administration 5600 Fishers Lane Rockville, MD 20857 24-hour Emergency Number: 301-443-1240

16. FDA Actions: It will hire 210 additional import inspectors to monitor food as it enters the United States It will hire 210 additional import inspectors to monitor food as it enters the United States Add 100 inspectors to survey points that are critical for product safety in the domestic food production and distribution system Add 100 inspectors to survey points that are critical for product safety in the domestic food production and distribution system Add 100 technical analysts to multiply the number of food samples tested for possible contamination. Add 100 technical analysts to multiply the number of food samples tested for possible contamination.

17. USDA Actions: Enhanced security for USDA facilities Enhanced security for USDA facilities Design and construction of a satellite facility at the USDA laboratory in Ames, Iowa for research activities Design and construction of a satellite facility at the USDA laboratory in Ames, Iowa for research activities Technical assistance to State, local, Federal, and private sector entities to improve biosecurity Technical assistance to State, local, Federal, and private sector entities to improve biosecurity Education and training to strengthen response mechanisms to potential food supply threats, improve data collection and dissemination Education and training to strengthen response mechanisms to potential food supply threats, improve data collection and dissemination

18. EPA Actions: EPA is responsible for ensuring that the American public is protected from unreasonable health risks posed by eating foods that have been treated with pesticides EPA is responsible for ensuring that the American public is protected from unreasonable health risks posed by eating foods that have been treated with pesticides Pesticide review and evaluation Pesticide review and evaluation Development of “safer” pesticides Development of “safer” pesticides Exchange of expertise with Codex and others Exchange of expertise with Codex and others Also for Quality of the water supply Also for Quality of the water supply

19. FEDERAL ANTI-TAMPERING ACT § 1365. Tampering with consumer products: § 1365. Tampering with consumer products: (a) Whoever, with reckless disregard for the risk that another person will be placed in danger of death or bodily injury and under circumstances manifesting extreme indifference to such risk, tampers with any consumer product that affects interstate or foreign commerce, or the labeling of, or container for, any such product, or attempts to do so, shall (a) Whoever, with reckless disregard for the risk that another person will be placed in danger of death or bodily injury and under circumstances manifesting extreme indifference to such risk, tampers with any consumer product that affects interstate or foreign commerce, or the labeling of, or container for, any such product, or attempts to do so, shall (1) in the case of an attempt, be fined under this title or imprisoned not more than ten years, or both; (2) if death of an individual results, be fined under this title or imprisoned for any term of years or for life, or both; (3) if serious bodily injury to any individual results, be fined under this title or imprisoned not more than twenty years, or both; (4) in any other case, be fined under this title or imprisoned not more than ten years, or both (4) in any other case, be fined under this title or imprisoned not more than ten years, or both

20. Summary Food Security has a new definition Food Security has a new definition Impossible to ensure 100% safe food supply Impossible to ensure 100% safe food supply FDA has issued guidance documents to food industry FDA has issued guidance documents to food industry FDA, USDA and EPA all involved and taking measures to increase security FDA, USDA and EPA all involved and taking measures to increase security Consumers must also be diligent Consumers must also be diligent