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Bioterrorism & Food Security. Dr. Ferhan Ozadali Gerber Product Co. [email protected] Food Supply May NOT be Secure!. What can you do to protect your company and family?. FDA’s New Rules and the Food Industry Perspective. Dr. Ferhan Ozadali Gerber Products Company.

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Bioterrorism & Food Security

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Bioterrorism & Food Security

Dr. Ferhan Ozadali

Gerber Product Co.

[email protected]

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Food Supply May

NOT be Secure!

  • What can you do to protect your company and family?

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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

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“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

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FDA’s Bioterrorism Regulations:

An Industry View

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The Public Health Security and Bioterrorism Preparedness and Response Act of 2002

(The Act)

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What it means to us?

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New Rules for a New World

Bioterrorism Legislation Significantly Expands FDA Food-Related Authorities

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The Bioterrorism Act


  • To improve the ability of the United States to prevent, prepare for, and respond to bioterrorism and other public health emergencies.

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Food Security Provisions of the Act

An expansion of FDA authority:

  • Facility Registration

  • Prior Notice of Imports

  • Records Maintenance and Inspection

  • Administrative Detention

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Bioterrorism Act

  • May 21, 2002 – Compromise bill

    • House (425-1); Senate (98-0)

  • June 12, 2002 – President signed

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Title III – Protecting Safety and Security of Food and Drug Supply

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Highlights of Food Provisions Title III

Immediately Effective Provisions:

  • Administrative Detention Authority

  • Permissive Debarment Authority

  • Records Inspection Authority

  • Prohibition against Port Shopping

  • Marking of articles refused US admission

  • Notice to States regarding imported food

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Highlights of Food Provisions

Self-Implementing Provisions:

  • Registration of food facilities

    • Interim Final Rule: Oct 10, 2003

    • Effective Date: Dec 12, 2003

  • Prior notice of imported food shipments

    • Interim Final Rule: Oct 10, 2003

    • Effective Date: Dec 12, 2003

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Highlights of Food Provisions

  • 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

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General Views

  • “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

  • 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

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General Views

  • 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

  • Industry appreciates the use of enforcement discretion during early implementation

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Industry’s View


Positive Changes

  • Emergency contact information

    • More workable

  • Registration information changes

    • More reasonable time for updating mandatory information

  • Trade names

    • Clarified does not mean brand names

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Industry’s View


Positive Changes

  • Allows multi-facility registration

  • 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

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Industry’s Remaining Concerns

  • Interpretation of acceptable 24/7 emergency contact

  • Rapid resolution of technical problems with registration system

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Industry’s View


Positive Changes

  • Better integration with Customs and Border Protection requirements and procedures

  • Time frames for filing based on mode of transport

  • Flexibility to accommodate unanticipated scheduling changes

  • Clarification/modification of numerous data elements

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Industry’s View


Positive Changes

  • A four month transition period of enforcement (Phasing in Period)

    • Doesn’t mean a “reprieve”

    • Education phase—Global education

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Industry’s Remaining Concerns

  • Importing R & D samples – working through implementation

  • 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

  • Protecting proprietary information with customers, service providers, and government

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Establishment, Maintenance and

Availability of Records - (Records Rule)

Positive Changes

More reasonable time frame for responding

Process for invoking – high level FDA decision-making (in guidance)

Clarify use/adapt existing records if information requirements met

Allow records off-site if response can be met

Remove lot tracking for in-store delivery/transport

Industry’s View

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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

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

Industry’s Remaining Concerns

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Administrative Detention

Positive Features

High level decision making at FDA

Described as addition to current approach with states - not a replacement

Process for “rapid” resolution

Invoking administrative detention will be the exception – not the rule

Industry’s View

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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

Applies to all food--interstate and intrastate

Timeframes remain a problem for perishable foods

Resolving “False Positives” - loss of product due to “errors”

Detention order as a public process – managing adverse impact

Industry’s Remaining Concerns

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  • 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

  • Compliance and achieving the purpose of the rules will require creativity and changes to how we do business

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  • Food Products Association (FPA) – Formerly, NFPA

  • Gerber Products

  • OSU

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Questions / Comments

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