The 34th National Customs Brokers

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• The 34th National Customs Brokers Forwarders
  Association of America Annual Conference
• April 9, 2008
• Import Safety A New Focus
• Presentation by
• CDR Domenic J. Veneziano,
• Director, Division of Import Operations

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Overview of Presentation

• How we got here
• What is FDA doing in FY-08 as a result 
• Update on ORA Transformation
• Questions

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How we got here

• Changes and Challenges
• Consumer behavior
• High risk population
• Global food supply
• Bioterrorism
• Need to update regulatory approach

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Import Examples of how we got here

• Kinder Surprise Candy Eggs Containing an Internal
  Small Toy
• September 07, 2007, importation of chocolate
  Kinder Surprise eggs were imbedded with a
  non-nutritive plastic toy that presents a
  chocking hazard. (Import Alert 34-02)
• Farm-raised Seafood from China Containing New
  Animal Drugs or Unsafe Food Additives June 28,
  2007, farm-raised catfish, basa, shrimp, dace
  (related to carp), and eel from China found to
  contain unapproved drug residues, such as
  malachite green, nitrofurans, fluoroquinolones,
  and gentian violet. (Import Alert 16-131)
• Dentifrice Products Containing Diethylene Glycol
  June 08, 2007, dentifrice products such as
  toothpaste and tooth powders were found to
  contain diethylene glycol (DEG). DEG is a toxic
  substance commonly found in antifreeze that is a
  low-cost substitute for glycerin and sorbitol and
  that has been identified in certain toothpastes
  from China. (Import Alert 66-74)

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How we got here

• Vegetable Proteins for China Containing Melamine
  or Melamine Analogs On April 24, 2007,
  vegetable protein products from China used in or
  for human or animal food were found to contain
  the presence of melamine and/or melamine analogs.
  This resulted in the death of many cats and dogs.
  (Import Alert 99-29)
• Bottled Water from Armenia Containing Arsenic
  March 27, 2007, bottled water from Armenia was
  found to contain the presence of arsenic, a toxic
  substance and known human carcinogen. (Import
  Alert 29-02)
• Green and Black Olives with Elevated pH Levels
  March 2, 2007, fermented green and thermally
  processed black olives were found to have
  elevated pH level and processing conditions
  conducive to the growth of Clostridium botulinum.
  (Import Alert 21-01)
• Human Growth Hormone Lacking Approved Drug
  Applications January 23, 2007, shipments of HGH
  finished drug products and certain APIs are being
  obtained from unapproved sources or without the
  supervision of a physicians. This can lead to
  serious long-term side effects. (Import Alert
  66-71)

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How we got here

• General Accounting Office
• Congressional Oversight Committees
• The Media

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What is FDA doing FY-08 as a result

• Food Protection Plan (FPP)
• Import Safety Action Plan (ISAP)
• Food and Drug Amendments Act (FDAAA)
• ORA Revitalization

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ISAP and the FPP

• Time for a New Approach
• Reactive

Proactive
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The Food Protection Plan
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Import Safety Action Plan

• The Import Safety Action Plan follows the
  organizing principles identified in the Strategic
  Framework
• Prevention
• Intervention
• Response
• Six building blocks
• Advance a Common Vision
• Increase Accountability, Enforcement, and
  Deterrence
• Focus on Risk over the Life-Cycle of an Imported
  Product
• Build Interoperable Systems
• Foster a Culture of Collaboration
• Promote Innovative Technologies and New Science

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ISAP and FPP Themes

• Prevention
• China
• Build in Safety Upfront
• FDA Beyond Our Borders
• Risk-Based Approaches
• Intervention
• Import Review IT Systems
• Field Capacity
• Tools
• Response
• States
• Track and Trace
• Risk Communication

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Food and Drug AdministrationAmendments Act
(FDAAA)
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Selected Medical products Provisions

• Sec 222 224 require medical device
  establishments to register and list
  electronically before they engage in any activity
  and must do so, on a yearly basis.
• Sec 228 requires 3rd party inspection program
• Sec 901 involves civil money penalties for
  false/misleading drug ads
• Sec 902 concerns new prohibited act and civil
  money penalties concerning Risk Evaluation and
  Mitigation strategies and post-market commitments
• Sec 912 - Prohibits the introduction or delivery
  for introduction into interstate commerce any
  food which had been added certain drugs or
  biologics.
• Sec 913 - Involves enhancing capabilities
  involving Rx products and securing the drug
  supply chain, this includes enforcement
  activities.

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Selected Food/Feed Provisions

• Sec. 1002 is about Surveillance and early warning
  system to detect pet food adulteration/outbreaks
• Sec. 1003 is about recall communications,
  including a searchable database on recalled food.
  
• Sec. 1004 is about enhancing cooperation with the
  States in regulating food.
• Sec. 1005 is about the creation of a new
  "reportable food registry" for food for which
  there is a reasonable probability of serious
  adverse health consequences or death in humans or
  animals.
• Sec. 1006 is about enhancing "as necessary" our
  seafood inspection regime and requires a report
  to Congress that, among other things describes
  our seafood and aquaculture inspection programs.
• Sec. 1009 is an ANNUAL report to Congress
  concerning data on imported foods. We need to
  provide data on the volume of imported food by
  country and type of food number of inspectors
  and inspections of imported food and data on
  inspection findings and follow up, including
  enforcement actions taken.

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ORA Transformation Update
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ORA Revitalization

• In the Summer of 2007 ORA began the process of
  revitalizing its operations and exploring new
  strategies in response to its dynamic environment
  and new challenges. It examined its operations,
  which include but not limited to
• Inspections both domestically and foreign
• Reviewing information about and examining
  products offered for import
• Collecting of samples of products
• Conducting laboratory analyses of samples
• Engaging in enforcement actions to ensure
  compliance
• Promoting compliance through education and
  training
• Investigating allegations of criminal activity
• Conducting consumer complaint and other special
  investigations
• Efforts related to product recalls, including
  recall effectiveness checks
• Collaboration with other federal, state, local
  and foreign regulatory authorities

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ORA Revitalization

• Using the following strategic framework
• Ensure continuity of mission and leadership
• Foster regulatory compliance throughout the
  life-cycle of imported and domestic products
• Enhance tools and scientific resources
• Embed scientific risk based assessments and
  approaches
• Encourage collaboration and leveraging to
  maximize regulatory impact
• We condense many ideas and proposals into 28
  business cases that articulate the goals of the
  proposals, their rationale, and detailed action
  steps and milestones.
• The 28 business cases was aligned with the ISAP,
  FPP, and the FDAAA, as well as those that would
  be key to enabling ORA operations in the future
  and therefore would be instrumental to the
  success of the revitalization effort.
• As a result of this evaluation 13 Business cases
  were identified for the first stage of
  implementation. These are

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ORA Revitalization

• Proposal 1 ORA Deploys its resources
  efficiently and effectively using a science
  risk-base approach (BC 1.3)
• Proposal 2 ORA Deploys its highly skilled
  foreign inspection workforce (BC 1.3)
• Proposal 3 Strengthen the Scientific Support of
  ORA Laboratories (BC 2.1)
• Proposal 4 Enhance ORAs Risk Management
  Capability and Capacity (BC 3.3)
• Proposal 5 Acceptance of Inspection,
  investigation and surveillance information from
  other sources (BC 4.1)

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ORA Revitalization

• Proposal 6 Obtain additional information from
  untapped sources to make risk based regulatory
  decisions (BC 4.3)
• Proposal 7 FDA Foreign Presence (BC 5.1)
• Proposal 8 Private laboratories - (BC 5.2)
• Proposal 9 Information Technology / OASIS (BC
  5.4)
• Proposal 10 Adequate Resources of Mission
  Support Components (BC 6.3)
• Proposal 11 Highly Skilled workforce (BC 7.1)
• Proposal 12 Modernize ORAs regulatory software
  applications (BC 3.1)
• Proposal 13 Quality Management Systems
  Implementation BC 9.1)

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Import initiatives that are on-going

• Industry Outreach
• Legislative Changes
• Good Importer Practices
• Private Laboratory Guidance
• Use of and sharing data
• Center Views
• Business Process Initiative (CMS)

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Import initiatives that are on-going

• PREDICT
• FDAs Import Trade Communication (FITC) allow
  brokers to get status updates and provide
  document submission
• ACE/ITDS
• SEDS
• Import Alert/Bulletin Database
• Secure Supply Chain
• Certification
• OASIS upgrades Historical data, Inspections,
  examinations, cross district reviews

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• Thank you
• Questions?