FDA

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• FDA
• National Infrastructure Protection Program (NIPP)
• Sector Specific Plan (SSP)
• NASDA Annual Meeting
• David Acheson, M.D.
• DirectorOffice of Food Safety, Defense and
  OutreachCenter for Food Safety and Applied
  NutritionFood and Drug Administration

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General Approach to Food Defense

• A deliberate attack on the food supply is likely
  to be detected locally.
• Preparedness
• Awareness
• Prevention
• Build Capacity
• Response
• Recovery

3
Integration of NIPP/SSP/SPPA/NADB

• What is the NIPP
• National Infrastructure Protection Plan
• What is the SSP
• Sector Specific Plan
• What is the SPPA
• Strategic Partnership Program on Agroterrorism
• What is the NADB
• National Asset Data Base
• How do they all fit together?
• How can the states best be involved in this?

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Integration of NIPP/SSP/SPPA/NADB

• Overall goal is to protect the national critical
  infrastructures
• Food is one of the 17 critical infrastructures
• What are the critical assets?
• What are the vulnerabilities of those assets?
• What type of plan is needed to protect them?
• Involvement at the federal, state and local level

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Integration of NIPP/SSP/SPPA/NADB
Assets (NADB)
Vulnerabilities (SPPA)
FDA USDA
SSP
One of 17
NIPP
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NIPP - HSPD 7

• Homeland Security Presidential Directives (HSPD)
  7 - Critical Infrastructure Identification,
  Prioritization, and Protection
• Established national policy to identify and
  prioritize U.S. critical infrastructures and key
  resources and to protect them from terrorist
  attacks
• Designated food and agriculture sector a critical
  infrastructure

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NIPP- HSPD 7

• USDA and HHS share responsibility for the
  security of the food sector along with our state
  counterparts, including
• collaborating with key persons and entities
• conducting or facilitating vulnerability
  assessments
• encouraging risk management strategies and
• identifying, prioritizing, assessing,
  remediating, and protecting internal critical
  infrastructure and key resources

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NIPP and SSPs

• 17 sectors in the US were identified as critical
  infrastructures/key resources Food and
  Agriculture is one
• Purpose is to provide a consistent, unifying
  structure for integrating critical infrastructure
  protection efforts into a national program

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NIPP and SSPs

• 5 main goals of the NIPP
• Protect critical infrastructures
• Long term reduction of vulnerabilities in a
  comprehensive and integrated manner
• Maximize efficient use of resources for
  protection
• Build partnerships among stakeholders to
  implement protection
• Track and improve national protection

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2004 FDA Food SSP Structure 8 sections

• Foreword
• Sector Background
• Sector Profile
• FDA CFSAN and CVM activities
• Overview of the size and scope of the food
  industry
• Review of Regulatory Authorities
• Relationships between Federal, State, Industry
  partners and the National Food Safety Laboratory
  System
• Identifying Sector Assets
• FDA Inspectional Assets
• Process for Identifying Sector Assets
• Defining Asset Data Parameters
• Challenges and Initiatives
• Implementation of the BT 2002 Rules
• Milestones
• Publication of the BT 2002 Rules and stand up of
  the Prior Notice Center

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2004 FDA Food SSP Structure 8 sections

• Assessing Vulnerabilities and Prioritizing Agents
• Process for Assessing Vulnerabilities and Asset
  Prioritizing
• Challenges and Initiatives
• Classified SECRET issues
• Undergoing CARVER Shock training and
  partnerships with selected commodity groups
• Milestones
• Developing Protective Programs
• Ten point plan for ensuring safety and security
  of the food supply
• Challenges
• Initiatives
• Food Security Awareness training
• Implementation of Bioterrorism Act of 2002
• Guidance documents

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2004 FDA Food SSP Structure 8 sections

• Measuring Progress
• Three types of metrics for the program
• Descriptive
• Necessary to understand sector resources and
  activity but do not reflect critical
  infrastructure performance
• Process
• Measure whether specific activities are performed
  as planned, track the progression of a task and
  report on the output of a process
• Outcome
• Track progress toward a strategic goal, in terms
  of results rather than a level of activity

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2004 FDA Food SSP Structure 8 sections

• Planning for Research and Development
• Four main areas for planning
• Prevention Technologies
• Agent Characteristics
• New Methods
• Dose Response Relationships
• Current Research and Development Initiatives
• Development of prevention and mitigation
  technologies and strategies
• Elucidation of agent characteristics
• Development of the means for continuously
  assessing foods for contamination

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NIPP - Next Steps

• FDA and USDA SSPs currently undergoing review and
  comment period
• Comments coordinated through the Food and
  Agriculture Sector NIPP Joint Working Group
  (ASTHO, NASDA, NACCHO).
• Current due date for comments is November 1,
  2005.
• FDA and USDA SSPs Version 2 due to DHS
  tentatively February 2006

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SPPA Initiative

• Overall goal is to undertake or validate
  vulnerability assessments

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SPPA Initiative

• A joint effort of the FBI, DHS, USDA, and FDA to
  help secure the U.S. food supply
• Announced July 26, 2005
• Collaborate with private industry and the states
• Use CARVER Shock assessment tool

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SPPA Initiative Program Objectives

• Validate or identify sector-wide vulnerabilities
  by conducting critical infrastructure/key
  resources assessments
• Identify indicators and warnings that could
  signify planning for an attack.
• Develop mitigation strategies to reduce the
  threat/prevent an attack.

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SPPA Initiative Program Objectives (contd)

• Validate assessments conducted by the United
  States Government (USG) for food and agriculture
  sectors.
• Gather information to enhance existing tools that
  federal, state and industry can employ.

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SPPA Initiative Program Objectives (contd)

• Provide the federal, state and industry with
  comprehensive reports including warnings and
  indicators, key vulnerabilities, and potential
  mitigation strategies.
• Provide sub-sector reports that combines
  assessment results to determine national critical
  infrastructure vulnerability points to support
  the National Infrastructure Protection Plan
  (NIPP) and national preparedness goals.

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SPPA Initiative Program Objectives (contd)

• Establish and/or strengthen relationships between
  Federal, State, and local law enforcement and the
  food and agriculture industry along with the
  critical food/agriculture sites visited.

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SPPA Initiative Implementation

• Site visits will be conducted at multiple food
  and agriculture and production facilities.
• Every Food and Agriculture Sector sub-sector will
  be studied (i.e. production, processing, retail,
  warehousing, and transportation) in order to
  assess the farm-to-table continuum.
• All of the visits will be conducted on a
  volunteer basis.

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SPPA Initiative Implementation (contd)

• The first assessment is in October, 2005.
• Two sites visits will be conducted each month -
  approximately one FDA and one USDA facility.
• Teams comprised of knowledgeable personnel from
  the FDA/USDA, FBI, DHS, local and state
  officials, and industry.

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SPPA Initiative Implementation

• Each industry sub-sector will apply the CARVER
  assessment tool, and adapt, if necessary, to its
  unique production, processing, retrial,
  warehousing, and transportation system.
• CARVER Shock templates
• Lessons learned

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SPPA Initiative Results

• Reports will be generated
• That detail identified vulnerabilities,
• possible mitigation strategies,
• Warnings and indicators for each site.
• The reports will be distributed to all site
  participants.
• Sector-wide vulnerabilities and lessons learned
  will be identified
• Communicated to stakeholders

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SPPA Initiative Results (contd)

• Assessment templates for each 'system' by
  sub-sector that can be exported to other sites to
  identify vulnerabilities that incorporate
  existing tools.
• Sector-specific investigative templates and field
  guides for the food and agriculture/intelligence
  sector.

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SPPA Initiative Results (contd)

• Increase awareness within industry and government
  regarding resources requirements and
  capabilities current threats and recognition of
  attack indicators.
• Identify and validate RD initiatives related to
  the food and agriculture sector. Ensure that
  industry concerns and issues are carried forward
  to further RD efforts.

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SPPA Initiative Web Site

• Further information is available on our website
  as well as response forms for volunteering.
• www.cfsan.fda.gov/dms/agroterr.html
• Information related to protection of information
  (confidentiality disclosure forms) will also be
  posted here

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National Asset Data Base

• What are the top critical assets in the food
  industry?
• Systems approach vs Site approach
• Fluid milk vs dairy X
• Fresh produce vs farm Y
• Goal to use the NADB to direct assessments and
  resources

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National Asset Data BaseWhat are the criteria?

• Greatest impact on Public Health or Livestock
  Health
• Greatest consumer impact if out of production or
  compromised - including consumer confidence
• Economic impact on the state
• Largest number of industry customers affected if
  out of production or compromised
• Largest size (/year or volume/year) of food,
  animal, plant operation
• Other

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Farm-to-Table understanding of assets,
vulnerabilities and a plan to protect them
Assets (NADB)
Vulnerabilities (SPPA)
FDA USDA
SSP
One of 17
NIPP
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Summary

• The interconnection of various initiatives with a
  common goal
• Need to clearly define the role of stakeholders
• What do states need from FDA to help protect the
  food supply from deliberate attack?

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Questions?