FDA BIOTERRORISM REGULATIONS UPDATE

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FDA BIOTERRORISM REGULATIONS UPDATE

• November 9, 2004
• STEVEN GILLENWATER
• Supervisor
• San Francisco District

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FDA BIOTERRORISM REGULATIONS UPDATE

• Overview of Regulations
• Registration
• Prior Notice
• Administrative Detention
• Recordkeeping

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Bioterrorism Act of 2002

• Prompted by events of 9/11/2001
• Title III Protecting the Safety and Security of
  the Food and Drug Supply
• FDA required to promulgate regulations
• http//www.fda.gov/oc/bioterrorism/PL107-188.html
  title3

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BT Regulations

• Sec 303 Administrative Detention
• Sec 305 Registration
• Sec 306 Records Maintenance
• Sec 307 Prior Notice

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Administrative Detention

• Authorizes administrative detention of food
  (domestic or import) presenting threat of serious
  illness or death

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Administrative Detention

• Proposed regulation published
• Comment period opened closed
• Final regulation published June 4, 2004
• http//www.cfsan.fda.gov/lrd/fr040604.html

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Records Maintenance

• Proposed Regulation Published
• http//www.fda.gov/OHRMS/DOCKETS/98fr/03-11460.ht
  ml
• Comment period opened and closed
• Final regulation is expected to be published soon

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Food Facility Registration

• Proposed regulation published
• Comment period opened and closed
• Interim Final Rule (IFR) published October 2003
• Regulation became effective 12/12/03

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Food Facility Registration

• Emphasis is on education until August 2004
• Enforcement is expected to begin in earnest in
  August 2004
• The comment period for the IFR was reopened until
  5/14/04
• http//www.cfsan.fda.gov/furls/ffregfr.html

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Registered Facilities

• FDA estimated 420,000 facilities worldwide need
  to register
• As of October 29, 2004 (approximately)
• Domestic (U.S.) registrations 124,000
• Foreign registrations 104,000
• Total 228,000
• For registration by country, see
• http//www.fda.gov/oc/bioterrorism/bioact.html

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Prior Notice

• Proposed Regulation published
• Public comment period opened and closed
• Interim Final Rule became effective 12/12/03
• http//www.cfsan.fda.gov/pn/pnfr.html

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Prior Notice

• Emphasis on education and enforcement discretion
  tier
• FDA Prior Notice Center (PNC) currently on line
  24/7 reviewing prior notice submissions
• Vigorous enforcement of requirements in November
  2004
• http//www.cfsan.fda.gov/pn/cpgpn3.html

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Prior Notice

• When PNC review complete, examination at border
  and/or entry forwarded to the district for 801(a)
  admissibility review

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Consequences

• Bioterrorism Act Prohibited act to import or
  offer for import food without providing prior
  notice
• FDA can bring a civil or criminal action in
  federal court
• FDA can seek to debar persons under section 306
  of the Bioterrorism Act

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Consequences

• No or inaccurate prior notice food is subject
  to refusal and must notify FDA of hold location
• Untimely - food is subject to refusal unless FDA
  already has reviewed

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Consequences

• If refused - food must be held at the port of
  entry unless
• Food is immediately exported from the port of
  arrival with CBP concurrence and under CBP
  supervision
• Directed to another location by CBP or FDA

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Prior Notice Submissions By Source
ACS - Green PNSI- Blue mini-ABI - White
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Prior Notice (PN) Submissions Completeness - ACS
Submissions with Complete PN Data - Green No PN
Data - Blue Incomplete PN Data - White
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Food Security Guidance Documents

• Food Producers, Processors, and Transporters
• Importers and Filers
• Retail Food Stores and Food Service
  Establishments
• Cosmetic Processors and Transporters
• Dairy Farms, Bulk Milk Transporters, Bulk Milk
  Transfer Stations and Fluid Milk Processors
• http//www.cfsan.fda.gov/dms/guidance.htmlsec

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Outreach Materials and Tutorials are
Available on FDAs Website