FDA Guidance 213 Managing expectations Peter Davies BVSc, PhD College of Veterinary Medicine University of Minnesota, USA
FDA Guidance 213Managing expectations
Peter Davies BVSc, PhDCollege of Veterinary MedicineUniversity of Minnesota, USA
FDA Guidances 209/213
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Vets Producers
Feed Industry
Expectations
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Professional industry critics Government entities – FDA,
CDC Not an act of congress
Legislators Pressures to legislate further
Scientists General consumers
Acting in the name of public health and/or better ‘stewardship’
Changes motivated by perceived concerns of AMU in animals generating AMR in bacteria infection people
Link between availability and abuse Greater oversight = less abuse? Less use = less abuse?
Defining appropriate use Treatment >> Control >Prevention>Production
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What does success look like? Does compliance = success?
Non-compliance does = failure! Does less AMU = success?
Measurement Public Health Benefits/Risks
Residues Resistant foodborne pathogens Other resistant organisms Lower incidence of resistant infections
or treatment failures
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Expectations for banning of AGP in Denmark and EU
Reduction of antibiotic use in food animals Minimal impact on production Reduction of antibiotic resistance
Animal isolates Human isolates
Reduced risk to human health Zoonotic and foodborne pathogens Commensal organisms and animal pathogens
Aggregate antimicrobial use in Danish swine industry
• Lowest use was in 1999 before weaned pig ban• Replacement of AGP with therapeutic use
Avoparcin ban and ban on vet sales
AGP banF N
Antimicrobial use in pigs in Holland (MARAN)
• Use peaked in 2008 after 2006 ban• Increased enteric disease in weaned pigs• Marked reduction later due to government
mandate
DANMAP 2004Antimicrobial resistance in Salmonella
DANMAP 2012Antimicrobial resistance in Salmonella
AMR in Salmonella in pigs DANMAP 1998/2012
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What about MRSA?(Methicillin resistant S. aureus)
Emergence of ‘livestock associated’ MRSA since 2004 Many countries
Hot subject in current discussions Use of growth promotants often blamed
Despite complete absence of evidence
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Growth promotants as the culprit?
MRSA cases in Denmark (all types)
Ban of AGP In finishers
Ban of AGP in nurseries
MRSA ST398 detected
DANMAP 2010
Residue violations in market hogs
Unheralded success! 1978: violative residues (USDA)
5.6% for antibiotics 9.7% for sulfonamides
2011: Sulfonamides No violative sulfonamide residues in 204 tests
2008-2011: Antibiotics No violative antibiotic residues in 1,199 market
hogs 2011: 1 in 11,509 ‘inspector generated’ tests
(FAST)
Expectations for food safety
Major route for resistance transfer to public Salmonella Campylobacter Listeria, Yersinia, E. coli, ….
Major impetus for restrictions on AMU Salmonella in particular (DT104 and other MDR) Denmark and EU CDC in the 1990’s
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Multidrug Resistance Among Salmonella Isolates NARMS, 1997-2010
• Decrease in MDR Salmonella isolates in humans• No marked change in pigs or other animals
Do we have any useful public health measure? Residues already close to zero Reducing prevalence of MDR Salmonella already No reliable measure re human illness Focus likely to be on AMU
Industry benchmarking Understanding purpose of use Defining meaningful metric
Professional industry critics can never be satisfied
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