2. 1 Bioterrorism & Food Security Dr. Ferhan Ozadali Gerber Product Co. Ferhan.Ozadali@ch.novartis.com

3. Food Supply May NOT be Secure! What can you do to protect your company and family?

4. 3 FDA’s New Rules and the Food Industry Perspective Dr. Ferhan Ozadali Gerber Products Company Seminar on Complying with FDA’s Final Recordkeeping and Other Bioterrorism Rules February 16, 2005 Columbus, Ohio

5. 4 Disclaimer “Opinions presented here are not necessarily one individual company’s views of the rules. Opinions have been captured from my conversations with the industry professionals and the members of the trade organizations….” Ferhan Ozadali

6. 5 FDA’s Bioterrorism Regulations: An Industry View

7. 6 The Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (The Act) (The Act)

8. 7 What it means to us?

9. 8

10. 9 New Rules for a New World Bioterrorism Legislation Significantly Expands FDA Food-Related Authorities

11. 10 The Bioterrorism Act Purpose: To improve the ability of the United States to prevent, prepare for, and respond to bioterrorism and other public health emergencies. To improve the ability of the United States to prevent, prepare for, and respond to bioterrorism and other public health emergencies.

12. 11 An expansion of FDA authority: An expansion of FDA authority: Facility Registration Facility Registration Prior Notice of Imports Prior Notice of Imports Records Maintenance and Inspection Records Maintenance and Inspection Administrative Detention Administrative Detention Food Security Provisions of the Act

13. 12 Bioterrorism Act – May 21, 2002 – Compromise bill House (425-1); Senate (98-0) House (425-1); Senate (98-0) – June 12, 2002 – President signed

14. 13 Title III – Protecting Safety and Security of Food and Drug Supply

15. 14 Immediately Effective Provisions: Immediately Effective Provisions: Administrative Detention Authority Administrative Detention Authority Permissive Debarment Authority Permissive Debarment Authority Records Inspection Authority Records Inspection Authority Prohibition against Port Shopping Prohibition against Port Shopping Marking of articles refused US admission Marking of articles refused US admission Notice to States regarding imported food Notice to States regarding imported food Highlights of Food Provisions Title III

16. 15 Self-Implementing Provisions: Registration of food facilities Registration of food facilities Interim Final Rule: Oct 10, 2003 Interim Final Rule: Oct 10, 2003 Effective Date: Dec 12, 2003 Effective Date: Dec 12, 2003 Prior notice of imported food shipments Prior notice of imported food shipments Interim Final Rule: Oct 10, 2003 Interim Final Rule: Oct 10, 2003 Effective Date: Dec 12, 2003 Effective Date: Dec 12, 2003 Highlights of Food Provisions

17. 16 Administrative Detention Administrative Detention – Final Rule: June 4, 2004 – Effective Date: July 6, 2004 – Establishment and Maintenance of Records (One forward, One Back) – Final Rule: Dec 9, 2004 – Effective Date: Feb 7, 2005 (Phased compliance Highlights of Food Provisions

18. 17 General Views “New Rules for a New World” – Recognize we are faced with new challenges “New Rules for a New World” – Recognize we are faced with new challenges Industry’s compliance with the rules will mean adapting systems and new procedures Industry’s compliance with the rules will mean adapting systems and new procedures FDA worked hard to ensure workability and efficiency of the initial concept/bill/law/rules FDA worked hard to ensure workability and efficiency of the initial concept/bill/law/rules Industry appreciates FDA’s response to industry input for improving effectiveness and efficiency Industry appreciates FDA’s response to industry input for improving effectiveness and efficiency

19. 18 General Views Industry appreciates the need for registration and advanced info of imports — the principles of efficient risk management Industry appreciates the need for registration and advanced info of imports — the principles of efficient risk management But we can’t have commerce stop - we need to ensure the requirements allow business to advance But we can’t have commerce stop - we need to ensure the requirements allow business to advance Industry appreciates the use of enforcement discretion during early implementation Industry appreciates the use of enforcement discretion during early implementation

20. 19 Industry’s View REGISTRATION Positive Changes Emergency contact information Emergency contact information More workable More workable Registration information changes Registration information changes More reasonable time for updating mandatory information More reasonable time for updating mandatory information Trade names Trade names Clarified does not mean brand names Clarified does not mean brand names

21. 20 Industry’s View REGISTRATION Positive Changes Allows multi-facility registration Allows multi-facility registration Clarified who can be US Agent - a “person” (i.e. individual, partnership, corporation) and not a specific individual Clarified who can be US Agent - a “person” (i.e. individual, partnership, corporation) and not a specific individual Transportation vehicles used for transit/ packaging manufacturers/homes excluded Transportation vehicles used for transit/ packaging manufacturers/homes excluded

22. 21 Industry’s Remaining Concerns Interpretation of acceptable 24/7 emergency contact Interpretation of acceptable 24/7 emergency contact Rapid resolution of technical problems with registration system Rapid resolution of technical problems with registration system

23. 22 Industry’s View PRIOR NOTICE Positive Changes Better integration with Customs and Border Protection requirements and procedures Better integration with Customs and Border Protection requirements and procedures Time frames for filing based on mode of transport Time frames for filing based on mode of transport Flexibility to accommodate unanticipated scheduling changes Flexibility to accommodate unanticipated scheduling changes Clarification/modification of numerous data elements Clarification/modification of numerous data elements

24. 23 Industry’s View PRIOR NOTICE Positive Changes A four month transition period of enforcement (Phasing in Period) A four month transition period of enforcement (Phasing in Period) Doesn’t mean a “reprieve” Doesn’t mean a “reprieve” Education phase—Global education Education phase—Global education

25. 24 Industry’s Remaining Concerns Importing R & D samples – working through implementation Importing R & D samples – working through implementation Finalizing harmonization with Customs and Border Protection – including facilitated entry for approved manufacturers and transporters Finalizing harmonization with Customs and Border Protection – including facilitated entry for approved manufacturers and transporters Consistent adoption of requirements by industry, service providers, and customers Consistent adoption of requirements by industry, service providers, and customers Protecting proprietary information with customers, service providers, and government Protecting proprietary information with customers, service providers, and government

26. 25 Industry’s View Establishment, Maintenance and Availability of Records - (Records Rule) Positive Changes More reasonable time frame for responding More reasonable time frame for responding Process for invoking – high level FDA decision-making (in guidance) Process for invoking – high level FDA decision-making (in guidance) Clarify use/adapt existing records if information requirements met Clarify use/adapt existing records if information requirements met Allow records off-site if response can be met Allow records off-site if response can be met Remove lot tracking for in-store delivery/transport Remove lot tracking for in-store delivery/transport

27. 26 Industry’s Remaining Concerns FDA protection of confidential information- reference existing rules/procedures – urge rulemaking FDA protection of confidential information- reference existing rules/procedures – urge rulemaking Urge elaboration on conditions for meeting “reasonable belief a food is adulterated and presents a threat of serious adverse health consequences or death” – now case by case Urge elaboration on conditions for meeting “reasonable belief a food is adulterated and presents a threat of serious adverse health consequences or death” – now case by case Doesn’t fully recognize industry’s current performance and capabilities in an “emergency” situation Doesn’t fully recognize industry’s current performance and capabilities in an “emergency” situation Potential to impose greater burden than estimated on industry for limited benefit Potential to impose greater burden than estimated on industry for limited benefit

28. 27 Industry’s View Administrative Detention Positive Features High level decision making at FDA High level decision making at FDA Described as addition to current approach with states - not a replacement Described as addition to current approach with states - not a replacement Process for “rapid” resolution Process for “rapid” resolution Invoking administrative detention will be the exception – not the rule Invoking administrative detention will be the exception – not the rule

29. 28 Industry’s Remaining Concerns Interpretation/application of “credible evidence or information that the food presents a threat of serious adverse health consequences or death to humans or animals” Interpretation/application of “credible evidence or information that the food presents a threat of serious adverse health consequences or death to humans or animals” Availability/access to information for the detention order Availability/access to information for the detention order Applies to all food--interstate and intrastate Applies to all food--interstate and intrastate Timeframes remain a problem for perishable foods Timeframes remain a problem for perishable foods Resolving “False Positives” - loss of product due to “errors” Resolving “False Positives” - loss of product due to “errors” Detention order as a public process – managing adverse impact Detention order as a public process – managing adverse impact

30. 29Conclusions Successfully implementing the Bioterrorism Act Rules will be a challenge for industry and FDA Successfully implementing the Bioterrorism Act Rules will be a challenge for industry and FDA More than simply compliance, meeting the rules and being prepared, demonstrates industry commitment to providing safeguards More than simply compliance, meeting the rules and being prepared, demonstrates industry commitment to providing safeguards Compliance and achieving the purpose of the rules will require creativity and changes to how we do business Compliance and achieving the purpose of the rules will require creativity and changes to how we do business

31. 30 Acknowledgement Food Products Association (FPA) – Formerly, NFPA Food Products Association (FPA) – Formerly, NFPA Gerber Products Gerber Products OSU OSU

32. 31 Questions / Comments