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1 Pathogens in Pet Food: A Problem as Old as Pet Food Itself Siobhan DeLancey, RVT, MPH Senior Advisor for Strategic Initiatives FDA Center for Veterinary Medicine COSDA 2018 September 30,

2 2

3 At its most basic: Animal food must be safe, wholesome, sanitary and properly labeled. 3

4 Animal food must be safe, wholesome, sanitary and properly labeled. Safe for the animal and safe for the people exposed to it. This is great for people food. It doesn t work as well for pet food. Why not? 4

5 Animal food must be safe, wholesome, sanitary and properly labeled. Safe for the animal and safe for the people exposed to it. 5

6 Some History: Pig Ears and Other Treats Salmonella Infantis cases human illness in Canada, many children Rollover Brand pig ear dog treats FDA implemented IA to DWPE imported pet treats prior to entry Currently 83 firms/21 countries on IA Kasel Associates 2013 Random sample collected by Colorado found Salmonella + Major house brands for Target, Petco, Costco, Sam s Club, etc. Pig ears, jerky treats, bully sticks, bones, etc. Follow-up inspection: all finished treats and 48/87 environmental + for 10 different Salmonella serovars Numerous GMP violations First use of FDA mandatory recall authority Kasel subsequently recalled all products made between 4/20 9/19/2012 6

7 More History: Extruded Food, aka Kibble Salmonella Schwartzengrund patients, 48% children Outbreak strain found in enrobing room, where flavoring was sprayed on kibble post-processing Also isolated from canine fecal samples 105 dry dog food brands recalled Plant permanently closed Salmonella Infantis 2012 Retail sample collected by MDARD 53 cases/21 states and Canada (retrospective) Subsequent inspection found outbreak strain in finished product 16 brands recalled Had been shipped to 40 states and 26 countries 7

8 Do pets get sick? They definitely do, but reporting may be reduced because: Most pets not insured/care is fee for service structure Owners with financial constraints may euthanize Owners questioned about dietary misadventure, less about what they are feeding Patients treated symptomatically, not tested Fragmented veterinary health care system No central reporting system to track/record pet illnesses no CDC for pets 8

9 How did we bring industry into compliance? Regulatory and enforcement actions Import Alerts Recalls Untitled/warning letters GMP/PCAF Inspections Educational activities Industry meetings Regulatory meetings Discussion of potential interventions: heat treatment, irradiation, others? ULTIMATE GOAL: SAFE PET FOOD 9

10 10

11 Pathogens in Pet Food A Problem as Old as Pet Food Itself This is just the latest example. 11

12 Current Challenges Raw/unprocessed/lightly processed pet foods Not intended to be cooked 22 recalls in 2018 mostly as the result of state sampling L. mono, E. coli, Salmonella findings 2 reported human illnesses At least 2 pet deaths conclusively linked Numerous pet illnesses Outreach challenges Perception that b/c people don t eat product, safe handling techniques for human food are also appropriate Perception that these pathogens don t sicken animals 12

13 How do we bring this industry into compliance? Educational activities Challenge industry to make a safe product Industry/regulatory meetings: Is there a cohesive industry group for these products? Discussion of potential interventions No validated methods for addressing pathogens that seem to appeal to these manufacturers No apparent data sharing between firms Regulatory and enforcement actions Import Alerts GMP/PCAF Inspections Untitled/warning letters Recalls, not market withdrawals (DTC sales) Public notification this is important for consumers ULTIMATE GOAL: SAFE PET FOOD 13

14 Plans for multifaceted stakeholder outreach Industry/Retailers: Dear Industry Letter Remind of obligation to market product safe to pets and others Encourage industry collaboration and data sharing Require appropriate public notification of recalls/violative products Advise of potential for compliance/enforcement actions Veterinarians/Technicians/Breeders Learn from advocates why they recommend these products Educate about other pathways of exposure Encourage reporting of pet illness cases to FDA Consumers Online resources (FDA, CDC, States?) Educate on exposures and risks to human/animal health Encourage discussion with medical professionals Provide ready access to firm s recall, compliance history Human Health Care Providers Increase awareness Advise at-risk patients Consider in patient historytaking Work collaboratively with veterinarians to identify illness, potential for linkage 14

15 Let s talk about your role Challenges? Concerns? Ideas? Partnerships? 15

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