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Bioterrorism & Food Bioterrorism & Food SecuritySecurity

Dr. Ferhan OzadaliDr. Ferhan Ozadali

Gerber Product Co.Gerber Product Co.

Ferhan.Ozadali@ch.novartis.comFerhan.Ozadali@ch.novartis.com

Food Supply MayNOT be Secure!

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

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FDA’s New Rules and FDA’s New Rules and the Food Industry the Food Industry

PerspectivePerspective

Dr. Ferhan OzadaliDr. Ferhan Ozadali

Gerber Products CompanyGerber Products Company

Seminar on Complying with FDA’s Final Recordkeeping and Other Bioterrorism Rules

February 16, 2005Columbus, Ohio

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DisclaimerDisclaimer

“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 The Public Health Security and Bioterrorism and Bioterrorism

Preparedness and Preparedness and Response Act of 2002Response Act of 2002

(The Act)(The Act)

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What it means to us?What it means to us?

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New Rules for a New New Rules for a New WorldWorld

Bioterrorism Legislation Bioterrorism Legislation

Significantly Expands FDA Significantly Expands FDA Food-Related AuthoritiesFood-Related Authorities

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The Bioterrorism ActThe Bioterrorism Act

Purpose:Purpose: To improve the ability of the To improve the ability of the

United States to prevent, United States to prevent, prepare for, and respond to prepare for, and respond to bioterrorism and bioterrorism and other other public health emergencies.public health emergencies.

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An expansion of FDA An expansion of FDA authority:authority:

• Facility Registration Facility Registration • Prior Notice of Imports Prior Notice of Imports • Records Maintenance Records Maintenance

and Inspectionand Inspection• Administrative DetentionAdministrative Detention

Food Security Provisions of the Act

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Bioterrorism ActBioterrorism Act

– May 21, 2002 – May 21, 2002 – Compromise billCompromise bill• House (425-1); Senate House (425-1); Senate (98-0)(98-0)

– June 12, 2002 – President June 12, 2002 – President signedsigned

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Title III – Protecting Title III – Protecting Safety and Safety and

Security of Food Security of Food and Drug Supplyand Drug Supply

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Immediately Effective ProvisionsImmediately Effective Provisions:: Administrative Detention Administrative Detention

AuthorityAuthority Permissive Debarment AuthorityPermissive Debarment Authority Records Inspection AuthorityRecords Inspection Authority Prohibition against Port Prohibition against Port

ShoppingShopping Marking of articles refused US Marking of articles refused US

admission admission Notice to States regarding Notice to States regarding

imported foodimported food

Highlights of Food Provisions Title IIIHighlights of Food Provisions Title III

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Self-Implementing Provisions:Self-Implementing Provisions:

Registration of food facilitiesRegistration of food facilities Interim Final Rule: Oct 10, 2003Interim Final Rule: Oct 10, 2003

Effective Date: Dec 12, 2003Effective Date: Dec 12, 2003

Prior notice of imported food Prior notice of imported food

shipmentsshipments Interim Final Rule: Oct 10, 2003Interim Final Rule: Oct 10, 2003

Effective Date: Dec 12, 2003Effective Date: Dec 12, 2003

Highlights of Food ProvisionsHighlights of Food Provisions

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• Administrative DetentionAdministrative Detention– Final Rule: June 4, 2004Final Rule: June 4, 2004– Effective Date: July 6, 2004Effective Date: July 6, 2004

– Establishment and Establishment and Maintenance of Records (One Maintenance of Records (One forward, One Back)forward, One Back)– Final Rule: Dec 9, 2004Final Rule: Dec 9, 2004– Effective Date: Feb 7, 2005 (Phased Effective Date: Feb 7, 2005 (Phased

compliancecompliance

Highlights of Food ProvisionsHighlights of Food Provisions

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General ViewsGeneral Views ““New Rules for a New World” – New Rules for a New World” –

Recognize we are faced with new Recognize we are faced with new challengeschallenges

Industry’s compliance with the rules Industry’s compliance with the rules will mean adapting systems and new will mean adapting systems and new proceduresprocedures

FDA worked hard to ensure workability FDA worked hard to ensure workability and efficiency of the initial and efficiency of the initial concept/bill/law/rulesconcept/bill/law/rules

Industry appreciates FDA’s response to Industry appreciates FDA’s response to industry input for improving industry input for improving effectiveness and efficiencyeffectiveness and efficiency

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General ViewsGeneral Views

Industry appreciates the need for Industry appreciates the need for registration and advanced info of registration and advanced info of imports imports — the principles of efficient — the principles of efficient risk managementrisk management

But we can’t have commerce stop - But we can’t have commerce stop - we need to ensure the requirements we need to ensure the requirements allow business to advanceallow business to advance

Industry appreciates the use of Industry appreciates the use of enforcement discretionenforcement discretion during early during early implementationimplementation

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Industry’s ViewIndustry’s View

REGISTRATIONREGISTRATION

Positive ChangesPositive Changes

Emergency contact informationEmergency contact information More workableMore workable

Registration information changesRegistration information changes More reasonable time for updating More reasonable time for updating

mandatory informationmandatory information

Trade namesTrade names Clarified does not mean brand namesClarified does not mean brand names

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Industry’s ViewIndustry’s View

REGISTRATIONREGISTRATIONPositive ChangesPositive Changes Allows multi-facility registrationAllows multi-facility registration

Clarified who can be US Agent - a Clarified who can be US Agent - a “person” (i.e. individual, partnership, “person” (i.e. individual, partnership, corporation) and not a specific corporation) and not a specific individualindividual

Transportation vehicles used for Transportation vehicles used for transit/ packaging transit/ packaging manufacturers/homes excludedmanufacturers/homes excluded

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Industry’s Remaining ConcernsIndustry’s Remaining Concerns

Interpretation of Interpretation of acceptable 24/7 acceptable 24/7 emergency contactemergency contact

Rapid resolution of Rapid resolution of technical problems with technical problems with registration systemregistration system

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Industry’s ViewIndustry’s ViewPRIOR NOTICEPRIOR NOTICE

Positive ChangesPositive Changes

Better integration with Customs and Better integration with Customs and Border Protection requirements and Border Protection requirements and proceduresprocedures

Time frames for filing based on mode of Time frames for filing based on mode of transporttransport

Flexibility to accommodate unanticipated Flexibility to accommodate unanticipated scheduling changes scheduling changes

Clarification/modification of numerous Clarification/modification of numerous data elementsdata elements

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Industry’s ViewIndustry’s ViewPRIOR NOTICEPRIOR NOTICE

Positive ChangesPositive Changes

A four month transition period A four month transition period of enforcement (Phasing in of enforcement (Phasing in Period)Period) Doesn’t mean a “reprieve” Doesn’t mean a “reprieve” Education phase—Global Education phase—Global

educationeducation

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Industry’s Remaining ConcernsIndustry’s Remaining Concerns

Importing R & D samples – Importing R & D samples – working working through implementationthrough implementation

Finalizing harmonization with Customs Finalizing harmonization with Customs and Border Protection – including and Border Protection – including facilitated entry for approved facilitated entry for approved manufacturers and transportersmanufacturers and transporters

Consistent adoption of requirements by Consistent adoption of requirements by industry, service providers, and industry, service providers, and customerscustomers

Protecting proprietary information with Protecting proprietary information with customers, service providers, and customers, service providers, and governmentgovernment

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Industry’s View Industry’s View Establishment, Maintenance andEstablishment, Maintenance and

Availability of Records - Availability of Records - (Records Rule)(Records Rule)Positive Changes Positive Changes More reasonable time frame for respondingMore reasonable time frame for responding

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

Clarify use/adapt existing records if Clarify use/adapt existing records if information requirements metinformation requirements met

Allow records off-site if response can be metAllow records off-site if response can be met

Remove lot tracking for in-store Remove lot tracking for in-store delivery/transportdelivery/transport

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Industry’s Remaining ConcernsIndustry’s Remaining Concerns

FDA protection of confidential information- FDA protection of confidential information- reference existing rules/procedures – urge reference existing rules/procedures – urge rulemakingrulemaking

Urge elaboration on conditions for meeting Urge elaboration on conditions for meeting “reasonable belief a food is adulterated “reasonable belief a food is adulterated andand presents a threat of serious adverse health presents a threat of serious adverse health consequences or death” – now case by caseconsequences or death” – now case by case

Doesn’t fully recognize industry’s current Doesn’t fully recognize industry’s current performance and capabilities in an “emergency” performance and capabilities in an “emergency” situationsituation

Potential to impose greater burden than Potential to impose greater burden than estimated on industry for limited benefitestimated on industry for limited benefit

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Industry’s ViewIndustry’s View

Administrative DetentionAdministrative Detention

Positive Features Positive Features High level decision making at FDAHigh level decision making at FDA

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

Process for “rapid” resolution Process for “rapid” resolution

Invoking administrative detention will be Invoking administrative detention will be the exception – not the rule the exception – not the rule

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Industry’s Remaining ConcernsIndustry’s Remaining Concerns Interpretation/application of “credible evidence Interpretation/application of “credible evidence

or information that the food presents a threat of or information that the food presents a threat of serious adverse health consequences or death to serious adverse health consequences or death to humans or animals”humans or animals”

Availability/access to information for the Availability/access to information for the

detention orderdetention order

Applies to all food--interstate and intrastateApplies to all food--interstate and intrastate

Timeframes remain a problem for perishable Timeframes remain a problem for perishable foods foods

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

Detention order as a public process – managing Detention order as a public process – managing adverse impactadverse impact

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ConclusionsConclusions

Successfully implementing the Successfully implementing the Bioterrorism Act Rules will be a Bioterrorism Act Rules will be a challenge for industry and FDAchallenge for industry and FDA

More than simply compliance, meeting More than simply compliance, meeting the rules and being prepared, the rules and being prepared, demonstrates industry commitment to demonstrates industry commitment to providing safeguardsproviding safeguards

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

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AcknowledgementAcknowledgement

Food Products Association Food Products Association (FPA) – Formerly, NFPA(FPA) – Formerly, NFPA

Gerber ProductsGerber Products OSUOSU

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Questions / CommentsQuestions / Comments