1. Food Safety Culture 301 Animal Food Sector Perspective FDA FSMA Readiness Training 23 June 2016

2. Office of Surveillance and Compliance Center for Veterinary Medicine
Welcome
Jenny Murphy
Office of Surveillance and Compliance
Center for Veterinary Medicine

3. Agenda Jenny Murphy, CVM Michele Evans, Diamond Pet Food
Introduction, Q&A and Wrap Up
Michele Evans, Diamond Pet Food
Industry Perspective
FDA Perspective – PC Rule Requirements

4. Objectives / Overview
Define the FSMA Preventive Controls for Animal Food (PCAF) regulation and the rationale for the regulation
Identify the differences between  human food and animal food facilities
Discuss Food Safety Culture and Risk in an animal food environment
Describe how food safety risk plays a role in food safety culture development and identify the correct steps in building the food safety plan
Identify key participants in strong food safety culture and their roles (Company, Customers, Suppliers, Regulators)

5. Michele Evans Diamond Pet Food, PFI Member Presenting on behalf of:
Industry Perspective
Michele Evans
Diamond Pet Food, PFI Member
Presenting on behalf of:

6. Topline objective of FSMA Animal Food and Pet Food Rule - clarify the regulation and the rationale for the regulation

7. Differences Between Animal Food, Pet Food and Human Food Facilities

8. Animal Food vs. Pet Food vs. Human Food
Number of employees
Bulk vs. packaged
Number of ingredients
Complexity of production
Complexity of finished product

9. What is Food Safety Culture?
Food Safety Culture involves commitment, respect, trust and ownership
Respect for employees and their judgment
Trust to have target animals’ & company’s interests at heart
Ownership by employees of their decisions
What employees do when no one is watching...

10. Commitment to Food Safety
Comprehensive effort
Management, employees
Suppliers, customers
Regulators
More than words – what does this entail?
Money (budgets)
Time (including down time)
Resources (people)
Communication/Education
Data (collection and evaluation)

11. Commitment

12. What is Food Safety Culture?
Food Safety Culture is driven by/based on risk
So what is risk?
Merriam-Webster:
A situation involving exposure to danger
Codex:
Function of the probability of an adverse health effect and severity of that effect, consequential to a hazard(s) in food.

13. What is Risk? Real risk Perceived risk Insurance company models
33,000 car crash deaths
443,000 smoking
36,500 drug overdose
3500 drown
75 lighting strikes
20 shark attacks
Perceived risk
Insurance company models
# of tickets
# of wrecks
Age
Gender
marital status

14. How to Assess Risk?
Models
Data
Significant Emotional Event

15. CDC Yearly Estimates of Foodborne Illness
Emerging Infectious Diseases, Vol. 19 No.3 March 2013

16. CDC Yearly Estimates of Foodborne Deaths
Emerging Infectious Diseases, Vol. 19 No.3 March 2013

17. Risks for Different Food Categories
Animal food (feed)
Nutritional, chemical, physical and biological  
Pet food
Nutritional, chemical, physical and biological
 Human food
Biological, chemical (allergen), physical and radiological

18. Risks Associated with Animal Food
Risks to humans
Pathogens, product handling
Risks to animals
Nutritional deficiencies, toxicities
Any illness could indicate a problem/error that requires attention

19. Food Safety Culture Development
Driven by risk regardless (human or animal)
Different risks will dictate different approaches that shape food safety culture
There is no one food safety culture model for animal food
Risks and food safety culture are both present and different throughout our sector
FDA approach to Salmonella – risk-based
Compliance Policy Guide
Testing for Salmonella in animal feed (species-specific serotypes) and pet food (all serotypes)

20. Food Safety Culture Development
A strong food safety culture makes economic / business sense
Recall devastation to a business
Post recall success due to culture (Diamond example)
True cost/benefit analysis
Temporary lost productivity to address a potential food safety issue versus a product recall
Rewards for productivity carry immediate and certain consequences; quality-related actions carry future and uncertain consequences
How to change this?

21. Food Safety Culture and Operations
Employees at all levels should feel responsible for product safety and empowered to make the decisions and/or changes to ensure it.
A strong food safety culture values product safety above short-term productivity.
Quick, informed decision making that addresses potential food safety issues should be encouraged and rewarded.
Employee performance should evaluate contributions to safety as well as productivity.

22. Culture Change Company - internal Customers Suppliers/vendors
Regulatory Agencies
No Really…HOW???

23. Culture Change - Reality
Company
Don’t be a hypocrite!
Communicate
Toyota Example
Customers
Communicate efforts
Discuss ramifications (cut orders, delays)

24. Culture Change - Reality
Suppliers/vendors
Communicate efforts
New expectations

25. Culture Change - Reality
Regulatory Agencies
Communicate (visits, meetings)
Adversarial to Amicable
Industry paradigm shift
Industry Segment
Trade organization
Industry collaboration

26. FSC Differences Animal Feed & Pet Food
As a Company:
Different Risks:
Pet Food – human heath and animal health
Animal Food – animal heath
Size and Nature of operations
Thermal processed vs. minimal processed
Employee #’s

27. FSC Differences Animal Feed & Pet Food
Ingredient Suppliers/Vendors
Number of ingredients
Farmers vs. Ingredient Manufacturers
Bulk vs. non bulk
Customers
Farms vs. Consumers
Local Feed Distributors vs. Commercial Chains (Tractor Supply vs. Walmart)
Livestock vs. People and Pets
Regulators
Past routine visits with previous experience vs no experience unsure expectations and fear
Opportunities for Education.

28. Important Qualities for Inspectors
Animal Feed and Pet Food
Patience
Teaching opportunity
Educate facilities on objectives of reg
Reassurance that FDA is there to help
Diffuse the fear factor
Collaboration
Partnership

29. Thank you! Michele Evans MEvans@diamondpet.com
Richard Sellers, AFIA:
David Fairfield, NGFA:
Peter Tabor, PFI:

30. Office of Surveillance and Compliance Center for Veterinary Medicine
FDA Perspective
Jenny Murphy
Office of Surveillance and Compliance
Center for Veterinary Medicine

31. Q & A – Use the Adobe Connect pod
Questions & Answers
Jenny Murphy, CVM
Q & A – Use the Adobe Connect pod
to type your questions

32. FSMA Rule Readiness Training Resources
FDA Employees:
State Employees:

33. Feedback
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34. THANK YOU FOR ATTENDING FSMA TRAINING Food Safety Culture 301 Animal Food Sector Perspective FDA FSMA Readiness Training