Title: FDA
1- 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
2General Approach to Food Defense
- A deliberate attack on the food supply is likely
to be detected locally. - Preparedness
- Awareness
- Prevention
- Build Capacity
- Response
- Recovery
3Integration 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?
4Integration 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
5Integration of NIPP/SSP/SPPA/NADB
Assets (NADB)
Vulnerabilities (SPPA)
FDA USDA
SSP
One of 17
NIPP
6NIPP - 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
7NIPP- 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
8NIPP 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
9NIPP 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
102004 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
112004 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
122004 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
132004 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
14NIPP - 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
15SPPA Initiative
- Overall goal is to undertake or validate
vulnerability assessments
16SPPA 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
17SPPA 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.
18SPPA 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.
19SPPA 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.
20SPPA 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.
21SPPA 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.
22SPPA 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.
23SPPA 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
24SPPA 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
25SPPA 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.
26SPPA 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.
27SPPA 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
28National 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
29National 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
30Farm-to-Table understanding of assets,
vulnerabilities and a plan to protect them
Assets (NADB)
Vulnerabilities (SPPA)
FDA USDA
SSP
One of 17
NIPP
31Summary
- 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?
32Questions?