2004 Annual CFS Meeting

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U.S. Food and Drug Administration
Food Protection Plan
David W. K. Acheson, M.D., F.R.C.P. Associate
Commissioner for Foods
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Outline

• Changes that need to be addressed
• Food Protection Plan
• Major elements
• Legislative proposals
• Other activities
• Import Safety Action Plan
• China MOA
• Importance of partnering with States

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Changes and Challenges Trends in Consumption
Demographics

• Consumer demand for items 24/7, year round
• Convenience foods are increasing in popularity
• Spending on foodservice equals half of U.S. food
  spending
• Consumers are eating more fresh produce
• 20 - 25 of the population is high risk
• In 1980 - 15 over age 60
• In 2025 - 25 will be over age 60
• 4 of the population is immune-compromise

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Changes and Challenges Global Food Supply

16.3 MILLION IMPORT LINES

9.1 MILLION FOOD LINES

Estimated
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Changes and Challenges New Foodborne Pathogens
Since 1977

• Campylobacter jejuni
• Cryptosporidium parvum
• Shiga toxin-producing E. coli
• Noroviruses
• Vibrio cholerae O139
• Vibrio parahaemolyticus

• Campylobacter fetus
• Cyclospora cayetanesis
• Listeria monocytogenes
• Salmonella Enteritidis
• Vibrio vulnificus
• Yersinia enterocolitica
• Enterobacter sakazakii
• Salmonella Typhimurium DT104

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Changes and Challenges Bioterrorism

• Intelligence indicates terrorists have discussed
  components of the food sector
• Manuals for intentional contamination of food are
  widely available
• Food and Agriculture are critical assets and
  concern exists for exploitation of soft targets,
  such as the food supply
• Use of biological or chemical weapons against our
  food supply could cause mass casualties
• Even an ineffective attack could cause
  significant economic and psychological damage

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Changes and Challenges Communication

• Outdated FDA data handling capacity.
• Growing imports
• Need for integrated systems
• Information to protect consumers difficult to
  deliver.
• Consumer level
• Retail level

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Time for a New Approach
Reactive
Proactive
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Food Protection Plan

• In May 2007, the Secretary of HHS and the
  Commissioner of Food and Drugs charged FDA with
  developing a comprehensive, integrated Food
  Protection Plan
• Food for people and animals
• Domestic and imported
• Food safety and food defense

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The Food Protection Plan
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Food Protection Cross-Cutting Themes

• Focus on risks over a Products life cycle
• Target resources to achieve maximum risk
  reduction
• Gather the science
• Rank products based on risk
• Focus prevention and intervention
• Integration of food safety and food defense
• Use science and modern technology systems

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Food Protection Plan

• Three core elements
• Prevention
• Intervention
• Response
• Under each element
• Key steps
• FDA actions
• Legislative proposals
• Approach
• 38 FDA Administrative Actions
• 10 Legislative Proposals

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PreventionAgency Actions

• Promote Increased Corporate Responsibility
• Solicit stakeholder input on Food Protection Plan
• Issue guidance on developing food protection
  plans and other preventive measures for industry
• Meet with trading partners to discuss domestic
  efforts on prevention and approaches to improving
  prevention abroad
• Identify Food Vulnerabilities and Assess Risk
• Use available tools to evaluate and prioritize
  risk from food and feed agents
• Work with CDC to attribute pathogens and
  illnesses to specific foods
• Expand Understanding and Use of Effective
  Mitigation Measures
• Research plan on mitigation approaches (source,
  spread, prevention) for high-risk foods
• Research and develop new detection methods

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PreventionLegislative Proposals

• Preventive Controls Against Intentional
  Contamination by Terrorists or Criminals at
  Points of High Vulnerability
• Focus in areas of greatest risk
• Preventive Controls for High-Risk Foods
• Foods associated with repeated instances of
  serious illness or death
• Registration Renewal Every Two Years and
  Modification of Registration Categories
• Expand available food categories to reflect
  current food types

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InterventionAgency Actions

• Increase Risk-Based Inspections and Sampling
• Increase food and feed safety inspections and
  sampling
• Identify and implement methods and tools for
  quick and accurate contaminant detection
• Collaborate with foreign authorities to reduce
  risk of imported food
• Enhance targeting of imports for inspection based
  on risk
• Conduct additional foreign food and feed
  inspections
• Improve the Detection of Food System Signals
  that Indicate Contamination
• Improve adverse event and consumer complaint
  reporting systems
• Establish a Reportable Food Registry (FDAAA)
• Develop a database for veterinarians that
  captures data on food safety incidents (FDAAA)

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InterventionLegislative Proposals

• Accredit Third Parties for Food Inspections
• FDA accreditation program, including audit and
  training
• Certification could be considered for import
  review and domestic inspection priorities
• Electronic Import Certificates for Designated
  High Risk Products
• FDA determines products of concern and criteria
  for certification
• Shipments without proper certification are
  refused entry
• Refusal of Admission if Inspection Access Is
  Denied
• Currently, FDA cannot refuse admission if foreign
  inspections are denied or delayed
• Provides a level playing field for domestic
  foreign manufacturers

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ResponseAgency Actions

• Improve Immediate Response
• Enhance capabilities of FDAs Emergency
  Operations Network Incident Management System
• With stakeholders, develop an action plan for
  more effective traceback (process/technologies)
  of contaminated food and feed
• Enhance IT networking for real-time lab
  communication
• Improve Risk Communication to the Public,
  Industry, and Other Stakeholders
• Update Food Protection Risk Communication Plan
  with strategies to effectively communicate with
  consumers
• In a food emergency, implement Food Protection
  Risk Communication Plan to get appropriate
  information to consumers, retailers, industry,
  healthcare community, public health officials,
  and other stakeholders

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ResponseLegislative Proposals

• Mandatory Recall of Food Products
• Reasonable belief the food is adulterated and
  presents a risk of serious illness or death
• Used only when firm refuses or delays a voluntary
  recall
• Enhanced Access to Food Records during
  Emergencies
• Current access requires reasonable belief that a
  food is adulterated AND presents a risk of
  serious illness or death
• Would allow access when specific adulterant has
  not been identified
• Expand access to records for related foods, such
  as food produced on the same production line

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The Import Safety Plan Import Safety Action Plan
(ISAP)

• Executive Order 13439 July 2007
• Involvement of 12 Federal Departments and
  Agencies - Led by HHS Secretary Leavitt
• Strategic Framework September 2007
• Risk-Based, Life Cycle Approach
• Organizing Principles
• Prevention (with Verification)
• Intervention
• Response
• Action Plan November 2007
• 14 Broad Recommendations
• 50 Specific Action Steps
• Short and Long Term

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FDA Amendments Act

• Title X Food Safety
• Built into FPP
• Section 1002 Ensuring the Safety of Pet Food
• Section 1003 Ensuring Efficient and Effective
  Communications During a Recall
• Section 1004 State and Federal Cooperation
• Section 1005 Reportable Food Registry
• Section 1006 Enhance Aquaculture and Seafood
  Inspection (traceability system study)

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U.S. and ChinaMemorandum of Agreement
(MOA)Agreement on the Safety of Food and Feed

• Signed December 11, 2007
• Key points
• New registration and certification requirements
• Greater information sharing
• Increased access to production facilities
• Implementing and establishing key benchmarks
• Implementation of agreement will begin with
  designated covered products
• LACF/AF
• pet food/treats of animal or plant origin
• ingredients for food and feed (e.g., wheat
  gluten)
• all aquaculture farming products except molluscan
  shellfish

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Public Health Impact of the Food Protection Plan
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Next Steps

• Develop an implementation plan
• Initiate 2008 deliverables
• Meet with stakeholders
• Work with Congress on legislative proposals
• Degree of progress is resource dependent
• Integrate with China MOA and Import Safety Action
  Plan
• Recognize that this is a long term activity

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Partnering with States

• Addressing some key issues at FDA
• How to share the BT registration database
• How to use secure electronic communication during
  recalls
• Making good use of state data
• Input from states regarding the FPP
• Direct call to state associations
• 50 State meeting

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Summary

• Changes in the food supply necessitate a new
  approach to food protection
• Food Protection Plan is integrated with greater
  emphasis on Prevention, plus effective
  Intervention and rapid Response
• Coordination of various food-related activities
  within FDA
• Partnerships are critical to overall success

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Questions?