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Office of Surveillance and Compliance Center for Veterinary Medicine

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Presentation on theme: "Office of Surveillance and Compliance Center for Veterinary Medicine"— Presentation transcript:

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 To submit a question about FSMA, visit and go to Contact Us Registered participants will receive an evaluation survey in two days.

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


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