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NIAA Meeting - Animal Health
Emergency Management
Committee
Barb Masters
OFW Law
April 16, 2013
Emergency Preparedness and
Response
• Food Defense
• Foodborne Outbreaks and Regulatory
Actions
• Product Recalls
Impact
Emergency Preparedness and
Response
• Emergency/Response can protect animal
health or public health
Within USDA – APHIS has primary role for
oversight in protecting animal health
FSIS has primary role for oversight in protecting
public heath
 Work together in areas of emergency management
(e.g., BSE, AI, etc.)
Food Defense
• Having measures in place to reduce the
chances of someone intentionally
contaminating the food supply in order
to kill or hurt people, disrupt our
economy, or ruin your business.
Food Defense
• An attack on the food supply might be carried out by
an extremist group, but it could be carried out by a
disgruntled employee or result from something
happening in a local area.
• While an individual facility might not be directly at
risk, there is a high likelihood that if an attack where
to occur even at one establishment it would likely
impact the entire industry, including international
trade.
Food Defense Plan
• Inside and outside security,
• Slaughter and processing,
• Security,
• Storage security,
• Shipping and receiving security,
• Water and ice security, and
• Mail-handling
securityhttp://www.fsis.usda.gov/PDF/Securityguide.pdf
Food Defense Tools
• FSIS has a “Risk Mitigation Risk Tool”
“Look up” tool on website – This tool identifies
some possible countermeasures that companies
could implement, as part of a food defense plan,
to better protect their business, employees, and
customers.
Food Defense Tools
• Transportation Guidelines
http://www.fsis.usda.gov/PDF/Transportation_Security
• Disposal Guidelines
http://www.fsis.usda.gov/PDF/Disposal_Decontaminat
• FDA tools
http://www.fda.gov/Food/FoodDefense/ToolsEducatio
Model Food Defense Plans
• Official establishments are not required to
have food defense plans
• In the event unintentionally contaminated product is
shipped from the establishment, swift removal of the
adulterated materials from commerce would be
essential to protect the public health.
One mechanism for doing this would be a recall.
 By having an integrated recall-food defense plan, a firm
can implement either one, or both, of these measures at a
moment’s notice, as needed.
Response to Findings
• Most of the food safety practices already in
place apply equally to intentional
contamination.
 If specific, credible threats are received, then
USDA, in cooperation with other homeland
security agencies, would keep the public informed
of measures to take.
Foodborne Outbreaks and
Regulatory Actions
Foodborne Outbreaks and
Regulatory Actions
• FSIS works with the public health community
(CDC and states) when there are outbreaks
that may involve FSIS regulated products
identify the source of production and the
distribution, of the suspect meat, poultry, or
processed egg product
Identify contributing factors to the outbreak
Recommend actions or policies to prevent future
occurrences
Foodborne Outbreaks and
Regulatory Actions
• FSIS looks at all the evidence and may
Take samples
Conduct an in-depth investigation at the plant
Issue a public health alert
Recommend the plant conduct a product recall
Take enforcement action at the establishment
Foodborne Outbreaks and
Regulatory Actions
• FSIS conducts pathogen testing in RTE products and
STEC testing in raw ground beef (and ground beef
components)
Any finding and the products are considered
adulterated
• When FSIS conducts pathogen testing in these
commodities, establishments are expected to hold
the associated products pending test results
• FSIS also conducts process control testing
Salmonella performance standard testing
Salmonella (raw)
• FSIS conducts on-going performance standard
testing for Salmonella
• However, if at any point FSIS determines there
is specific product in commerce making
people sick… They WILL ask for a voluntary
recall of that specific production of product.
Salmonella (raw)
• With Salmonella, if multiple production days
implicated, (i.e., on-going outbreak) FSIS
beginning to look at pre-harvest as the source
Unclear as to the break point if a recall is
determined necessary
Unclear what steps a grower could take to “break”
the source of “contamination”
 Model for animal disease outbreaks and recall
Product Recalls
Product Recalls
• A recall is a firm’s action to remove product
from commerce (e.g., by manufacturers,
• distributors, or importers) to protect the
public from consuming adulterated or
misbranded products.
Intentional contamination
Response to an outbreak
Shipment of adulterated product
Product Recalls
• FSIS has procedures for requesting
establishment to conduct recall
These procedures would be followed in the event
an establishment has shipped adulterated
product, including intentional contamination
FSIS post product labels and information to assist
consumers in returning recalled product
 One could expect heightened media surrounding an
intentionally contaminated product
Product Recalls
• Can lead to national/international news
stories (depending on the nature and size of
the recall)
• Cameras and media may appear at the facility
• Product labels appearing in the press and on
the major news outlets
Impact of Recalls
• Settlement Reached in hemolytic-uremic syndrome (HUS)
Case Linked to Multistate Outbreak of E. coli O157:H7
Infections from November-December 2006
• This outbreak was clearly linked to XXX lettuce served in YYY
restaurants in the northeastern United States. As of
December 14, 2006, Thursday, 71 persons with illness
associated with the YYY restaurant outbreak have been
reported to CDC from 5 states….
Litigation and settlement (extremely costly)
Impact of Recalls
“Blaming The Victim" Strategy Remains In Food Industry's Playbook
 New York Times story titled "Increasingly, Food Companies Cannot
Guarantee Safety" by Michael Moss:
• Mr. Moss looks at the aftermath of the pot pie salmonella outbreak
of 2007 that sickened at least 15,000 Americans. The New York
Times reports this:
• "So ZZZ — which sold more than 100 million pot pies last year
under its popular WWW label — decided to make the consumer
responsible for the kill step. The “food safety” instructions and four-
step diagram on the 69-cent pies offer this guidance: “Internal
temperature needs to reach 165° F as measured by a food
thermometer in several spots.”
Bad Press – Tarnish the brand….
Impact of Recalls
Costs
 Improvements to facility (but timeline becomes someone else’s)
 Public perception of the brand
 Negative publicity last years
•Personnel
 Under a microscope
 Pressure to implement changes
 Often personnel changes implemented during a crises
•Corporation
 Can use the information as a “lesson learned”
 Must support the team at the affected facility (often at the expense to other
facilities
 May be asked to testify to the issues at the facility
Better to prevent than react to a situation.
• CASE STUDY
Impact of Recalls - Beyond the Plant
Public Perception – Beyond “The Plant”
• Polls have shown consumer confidence in food
safety declining (22.5% consumers confident in their
food supply) [2007]
Recalls of pet food involving illness and deaths of pets
 Melamine issues
 Recalls with national attention: peanuts, pistachios, peanut butter,
peppers, beef, canned food, tomatoes, lettuce
When the public loses confidence…
The Tipping Point
• Impacted those we love
Our pets (they can not make decisions for them
selves - we fed them the contaminant)
• It was an intentional contamination
• It was imported
Strategies to Address Food Safety
Concerns
• Legislation
 2008 (10 food safety bills introduced in Congress)
Food Safety Modernization Act
• Regulation
Preventive Controls
 Includes Mandatory Recall and Food Defense
Produce Safety
Hold and Test (FSIS)
• Enforcement
Things do improve….
• 2009
Questions

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Dr. Barb Masters - Emergency Preparedness and Response

  • 1. NIAA Meeting - Animal Health Emergency Management Committee Barb Masters OFW Law April 16, 2013
  • 2. Emergency Preparedness and Response • Food Defense • Foodborne Outbreaks and Regulatory Actions • Product Recalls Impact
  • 3. Emergency Preparedness and Response • Emergency/Response can protect animal health or public health Within USDA – APHIS has primary role for oversight in protecting animal health FSIS has primary role for oversight in protecting public heath  Work together in areas of emergency management (e.g., BSE, AI, etc.)
  • 4. Food Defense • Having measures in place to reduce the chances of someone intentionally contaminating the food supply in order to kill or hurt people, disrupt our economy, or ruin your business.
  • 5. Food Defense • An attack on the food supply might be carried out by an extremist group, but it could be carried out by a disgruntled employee or result from something happening in a local area. • While an individual facility might not be directly at risk, there is a high likelihood that if an attack where to occur even at one establishment it would likely impact the entire industry, including international trade.
  • 6. Food Defense Plan • Inside and outside security, • Slaughter and processing, • Security, • Storage security, • Shipping and receiving security, • Water and ice security, and • Mail-handling securityhttp://www.fsis.usda.gov/PDF/Securityguide.pdf
  • 7.
  • 8. Food Defense Tools • FSIS has a “Risk Mitigation Risk Tool” “Look up” tool on website – This tool identifies some possible countermeasures that companies could implement, as part of a food defense plan, to better protect their business, employees, and customers.
  • 9. Food Defense Tools • Transportation Guidelines http://www.fsis.usda.gov/PDF/Transportation_Security • Disposal Guidelines http://www.fsis.usda.gov/PDF/Disposal_Decontaminat • FDA tools http://www.fda.gov/Food/FoodDefense/ToolsEducatio
  • 10. Model Food Defense Plans • Official establishments are not required to have food defense plans • In the event unintentionally contaminated product is shipped from the establishment, swift removal of the adulterated materials from commerce would be essential to protect the public health. One mechanism for doing this would be a recall.  By having an integrated recall-food defense plan, a firm can implement either one, or both, of these measures at a moment’s notice, as needed.
  • 11. Response to Findings • Most of the food safety practices already in place apply equally to intentional contamination.  If specific, credible threats are received, then USDA, in cooperation with other homeland security agencies, would keep the public informed of measures to take.
  • 13. Foodborne Outbreaks and Regulatory Actions • FSIS works with the public health community (CDC and states) when there are outbreaks that may involve FSIS regulated products identify the source of production and the distribution, of the suspect meat, poultry, or processed egg product Identify contributing factors to the outbreak Recommend actions or policies to prevent future occurrences
  • 14. Foodborne Outbreaks and Regulatory Actions • FSIS looks at all the evidence and may Take samples Conduct an in-depth investigation at the plant Issue a public health alert Recommend the plant conduct a product recall Take enforcement action at the establishment
  • 15. Foodborne Outbreaks and Regulatory Actions • FSIS conducts pathogen testing in RTE products and STEC testing in raw ground beef (and ground beef components) Any finding and the products are considered adulterated • When FSIS conducts pathogen testing in these commodities, establishments are expected to hold the associated products pending test results • FSIS also conducts process control testing Salmonella performance standard testing
  • 16. Salmonella (raw) • FSIS conducts on-going performance standard testing for Salmonella • However, if at any point FSIS determines there is specific product in commerce making people sick… They WILL ask for a voluntary recall of that specific production of product.
  • 17. Salmonella (raw) • With Salmonella, if multiple production days implicated, (i.e., on-going outbreak) FSIS beginning to look at pre-harvest as the source Unclear as to the break point if a recall is determined necessary Unclear what steps a grower could take to “break” the source of “contamination”  Model for animal disease outbreaks and recall
  • 19. Product Recalls • A recall is a firm’s action to remove product from commerce (e.g., by manufacturers, • distributors, or importers) to protect the public from consuming adulterated or misbranded products. Intentional contamination Response to an outbreak Shipment of adulterated product
  • 20. Product Recalls • FSIS has procedures for requesting establishment to conduct recall These procedures would be followed in the event an establishment has shipped adulterated product, including intentional contamination FSIS post product labels and information to assist consumers in returning recalled product  One could expect heightened media surrounding an intentionally contaminated product
  • 21. Product Recalls • Can lead to national/international news stories (depending on the nature and size of the recall) • Cameras and media may appear at the facility • Product labels appearing in the press and on the major news outlets
  • 22. Impact of Recalls • Settlement Reached in hemolytic-uremic syndrome (HUS) Case Linked to Multistate Outbreak of E. coli O157:H7 Infections from November-December 2006 • This outbreak was clearly linked to XXX lettuce served in YYY restaurants in the northeastern United States. As of December 14, 2006, Thursday, 71 persons with illness associated with the YYY restaurant outbreak have been reported to CDC from 5 states…. Litigation and settlement (extremely costly)
  • 23. Impact of Recalls “Blaming The Victim" Strategy Remains In Food Industry's Playbook  New York Times story titled "Increasingly, Food Companies Cannot Guarantee Safety" by Michael Moss: • Mr. Moss looks at the aftermath of the pot pie salmonella outbreak of 2007 that sickened at least 15,000 Americans. The New York Times reports this: • "So ZZZ — which sold more than 100 million pot pies last year under its popular WWW label — decided to make the consumer responsible for the kill step. The “food safety” instructions and four- step diagram on the 69-cent pies offer this guidance: “Internal temperature needs to reach 165° F as measured by a food thermometer in several spots.” Bad Press – Tarnish the brand….
  • 24. Impact of Recalls Costs  Improvements to facility (but timeline becomes someone else’s)  Public perception of the brand  Negative publicity last years •Personnel  Under a microscope  Pressure to implement changes  Often personnel changes implemented during a crises •Corporation  Can use the information as a “lesson learned”  Must support the team at the affected facility (often at the expense to other facilities  May be asked to testify to the issues at the facility Better to prevent than react to a situation.
  • 25. • CASE STUDY Impact of Recalls - Beyond the Plant
  • 26. Public Perception – Beyond “The Plant” • Polls have shown consumer confidence in food safety declining (22.5% consumers confident in their food supply) [2007] Recalls of pet food involving illness and deaths of pets  Melamine issues  Recalls with national attention: peanuts, pistachios, peanut butter, peppers, beef, canned food, tomatoes, lettuce When the public loses confidence…
  • 27. The Tipping Point • Impacted those we love Our pets (they can not make decisions for them selves - we fed them the contaminant) • It was an intentional contamination • It was imported
  • 28. Strategies to Address Food Safety Concerns • Legislation  2008 (10 food safety bills introduced in Congress) Food Safety Modernization Act • Regulation Preventive Controls  Includes Mandatory Recall and Food Defense Produce Safety Hold and Test (FSIS) • Enforcement