1 Bioterrorism & Food Security Dr. Ferhan Ozadali Gerber Product Co. [email protected].
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Transcript of 1 Bioterrorism & Food Security Dr. Ferhan Ozadali Gerber Product Co. [email protected].
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Bioterrorism & Food Bioterrorism & Food SecuritySecurity
Dr. Ferhan OzadaliDr. Ferhan Ozadali
Gerber Product Co.Gerber Product Co.
[email protected]@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