Industry Perspective of
the FDA Rule for
Salmonella enteritidis
(SE) Monitoring
Eric Gingerich, DVM
Diamond V
March 28, 20...
Industry Perspective of FDA Egg
Safety Rule
 Egg Safety Rule
 Response of industry
 FDA implementation of rule
FDA Egg Safety Rule
Components
 Written SE plan
 Designated person responsible for plan
 Plan contents:
 Negative pull...
FDA Egg Safety Rule of 2009
 Federal Register Final Rule (July 9, 2009,
74 FR 33030): Prevention of Salmonella
Enteritidi...
Egg Recall of 2010
SE Human Prevalence – US
0
0.5
1
1.5
2
2.5
3
3.5
4
2004 2005 2006 2007 2008 2009 2010
Casesper100,000
US
Dr. Jean Guard, U...
SE Human Prevalence – US vs. EU
0
5
10
15
20
25
30
35
Casesper100,000
2004 2005 2006 2007 2008 2009 2010
US
EU
Dr. Jean Gu...
Response of Industry
 Increased efforts to reduce chance of positive
results
 Vaccination
 Pest control
 Intestinal he...
Cost of a Positive Manure Test
 Cost of testing
 Total of 4000 eggs in 20-egg pools divided in 4
submissions every 2 wee...
Cost of an Egg Positive
 An egg positive requires a clean set of 4000 eggs over
an 8 week period to return to shell egg m...
Vaccination During Grow
 SE bacterin
 Usually 1x at 13 to 15 weeks
 Live ST vaccines
 3 applications – 2, 6, and 12
we...
Live ST Vaccination During Lay
 Could be used to boost immunity
during production
 Shown effective prior to molt
 Holt,...
Vaccine Efficacy
PEQAP Data 2006-2008
Vaccine Efficacy
PEQAP Data 2006-2008
Rodent Control
 Rodent control found
to be highly
correlated to SE
infection in layers
 Rodent index
formulated in PA
 ...
Rodent Control
Rodent Index
No. of mice
caught
Rodent Index Description
0 to 10 1 Low
11-25 2 Moderate
26 + 3 High
An inde...
Rodent Control
 Integrated approach required
 Seclusion of rodents from house
 Plugging all entry holes
 Reduction of ...
Fly Control
 Flies can carry SE from manure to hens
 Requires integrated approach
 Reduce breeding area and proper cond...
Intestinal Health Improvement
 Water sanitation
 Reduces inflammation in intestine
 Feed additives
 Have an effect on ...
Feed Contamination
 Concern after findings at Wright County
 Most testing ingredients prior to receipt in feed mill
to a...
Refrigeration Issues
 Storage of eggs at
45F by 36 hours
after laying is
required
 Operations that farm
pack must upgrad...
FDA Inspections
 High risk farms inspected first
 Second tier underway at present
 To begin inspections on farms with 3...
FDA Inspections
 Written SE prevention plan
 Documentation that pullets were raised under “SE-monitored”
conditions
 Re...
FDA Inspections
 Keys to passing inspections – “Say What You Do and
Do What You Say”
 Have valid programs covering the k...
FDA Inspections – Reasons for
Failure
 Records
 No record that chicks are from NPIP sources
 No record of times when ac...
FDA Inspections – Reasons for
Failure
 Pest Control
 Failure to control rodents
 Failure to follow the frequency of mon...
FDA Inspections – Reasons for
Failure
 Egg Storage
 Failure to maintain eggs at 45F or below
 Testing
 Failure to test...
Salmonella heidelberg (SH)
 Salmonella heidelberg found in pullet samples
at Wright County traceback investigation
 FDA ...
Summary
 The battle to control SE is going to continue
 SE positivity is expensive
 Implementation of the plan by small...
Questions??
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Dr. Eric Gingerich - Industry Perspective of the FDA Rule for Salmonella enteritidis Monitoring

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Industry Perspective of the FDA Rule for Salmonella enteritidis (SE) Monitoring - Dr. Eric Gingerich, Poultry Technical Services Specialist, Diamond V, from the 2012 Annual Conference of the National Institute for Animal Agriculture, March 26 - 29, Denver, CO, USA.

More presentations at: http://www.trufflemedia.com/agmedia/conference/2012-decreasing-resources-increasing-regulation-advance-animal-agriculture

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Dr. Eric Gingerich - Industry Perspective of the FDA Rule for Salmonella enteritidis Monitoring

  1. 1. Industry Perspective of the FDA Rule for Salmonella enteritidis (SE) Monitoring Eric Gingerich, DVM Diamond V March 28, 2012 – NIAA Annual Conference, Denver CO
  2. 2. Industry Perspective of FDA Egg Safety Rule  Egg Safety Rule  Response of industry  FDA implementation of rule
  3. 3. FDA Egg Safety Rule Components  Written SE plan  Designated person responsible for plan  Plan contents:  Negative pullet procurement  Rodent monitoring and plan for control  Fly monitoring and plan for control  Testing plan – pullets, layers (40-45 weeks and post molt)  Refrigeration of eggs at 45F within 1 ½ days  Biosecurity plan  Plan for C&D of positive houses  Plan for holding eggs if manure positive until egg tests done  Plan for diversion of eggs if egg positive  Records for all above
  4. 4. FDA Egg Safety Rule of 2009  Federal Register Final Rule (July 9, 2009, 74 FR 33030): Prevention of Salmonella Enteritidis in Shell Eggs During Production, Storage, and Transportation  Implementation began July 9, 2010 for all farms over 50,000 layers  Implementation begins July 9, 2012 for farms of 3000 to 49,999 layers
  5. 5. Egg Recall of 2010
  6. 6. SE Human Prevalence – US 0 0.5 1 1.5 2 2.5 3 3.5 4 2004 2005 2006 2007 2008 2009 2010 Casesper100,000 US Dr. Jean Guard, USDA-ARS: US – Foodnet data; EU – EFSA data
  7. 7. SE Human Prevalence – US vs. EU 0 5 10 15 20 25 30 35 Casesper100,000 2004 2005 2006 2007 2008 2009 2010 US EU Dr. Jean Guard, USDA-ARS: US – Foodnet data; EU – EFSA data
  8. 8. Response of Industry  Increased efforts to reduce chance of positive results  Vaccination  Pest control  Intestinal health improvement  Feed related contamination  Refrigeration
  9. 9. Cost of a Positive Manure Test  Cost of testing  Total of 4000 eggs in 20-egg pools divided in 4 submissions every 2 weeks  200 pools x $10 to $50 per pool = $2000 to $10,000  Withholding eggs  To avoid recall, eggs are packed in cases and held until egg test results are received  Depending on test used, 27 hours to 10 days
  10. 10. Cost of an Egg Positive  An egg positive requires a clean set of 4000 eggs over an 8 week period to return to shell egg market  Difference between shell market and breaking market (07 Feb 2011)  Shell = $1.17 – 0.40 = $0.77  Breaker = $0.48 – 0.05 discount = $0.43  $0.77 – 0.43 = $0.34  8 weeks production about 3.9 dozen  3.9 dozen x $0.34 = $1.33 per hen
  11. 11. Vaccination During Grow  SE bacterin  Usually 1x at 13 to 15 weeks  Live ST vaccines  3 applications – 2, 6, and 12 weeks  Bacterin + live vaccine  Live vaccine - 2 and 6 weeks  Bacterin – 13 to 15 weeks  Vaccine Costs  0.5 cents for live  8.0 cents to add bacterin (5 for handling, 2.5 for vaccine)
  12. 12. Live ST Vaccination During Lay  Could be used to boost immunity during production  Shown effective prior to molt  Holt, et. al., Avian Diseases 47:656-661. 2003.  Live vaccines not human pathogens  Mass applied, no handling required
  13. 13. Vaccine Efficacy PEQAP Data 2006-2008
  14. 14. Vaccine Efficacy PEQAP Data 2006-2008
  15. 15. Rodent Control  Rodent control found to be highly correlated to SE infection in layers  Rodent index formulated in PA  Twelve live traps (Tin-Cats) placed in layer house  Mice counted after 7 days
  16. 16. Rodent Control Rodent Index No. of mice caught Rodent Index Description 0 to 10 1 Low 11-25 2 Moderate 26 + 3 High An index of 1 or less is acceptable
  17. 17. Rodent Control  Integrated approach required  Seclusion of rodents from house  Plugging all entry holes  Reduction of harborage areas  No trash or tall grass outside  No manure buildup on cross beams  Reduced manure levels in high rise houses  Baiting  Rotation programs using effective baiting techniques
  18. 18. Fly Control  Flies can carry SE from manure to hens  Requires integrated approach  Reduce breeding area and proper conditions  Dry manure  Reduced amount of manure  Predator insects  Fungus treatment  Insecticides
  19. 19. Intestinal Health Improvement  Water sanitation  Reduces inflammation in intestine  Feed additives  Have an effect on microflora and immune cells of intestinal tract  Probiotics  Prebiotics  Fermentation products  Used continuously or during periods of stress
  20. 20. Feed Contamination  Concern after findings at Wright County  Most testing ingredients prior to receipt in feed mill to avoid recalls of product  Meat and bone meal from plants complying to the APPI Salmonella Education Reduction Program  Anti-Salmonella treatments being used for some high risk ingredients  Formaldehyde  Organic acids  Feed mills being certified by AFIA program – Safe Feed/Safe Food
  21. 21. Refrigeration Issues  Storage of eggs at 45F by 36 hours after laying is required  Operations that farm pack must upgrade refrigeration or not store eggs over 1 ½ days  Need good records of temperatures
  22. 22. FDA Inspections  High risk farms inspected first  Second tier underway at present  To begin inspections on farms with 3000 to 50,000 layers 3rd or 4th quarter of 2012
  23. 23. FDA Inspections  Written SE prevention plan  Documentation that pullets were raised under “SE-monitored” conditions  Records documenting compliance with the SE prevention measures  Biosecurity measures.  Rodent and other pest control measures.  Cleaning and disinfection procedures performed at depopulation.  Refrigeration requirements.  Environmental and egg sampling procedures  Results of SE testing  Diversion of eggs  Eggs at a particular farm being given a treatment  Records of review and of modifications of the SE prevention plan and corrective actions taken.
  24. 24. FDA Inspections  Keys to passing inspections – “Say What You Do and Do What You Say”  Have valid programs covering the key components of the FDA Egg Safety Plan  Pullets are negative  Biosecurity  Pest control  Cleaning and disinfection  Refrigeration  Testing of manure or eggs  Have records to show that you are doing what is in your plan
  25. 25. FDA Inspections – Reasons for Failure  Records  No record that chicks are from NPIP sources  No record of times when activities were performed  No rodent control records  No record of compliance of biosecurity plan  No site specific SE plan
  26. 26. FDA Inspections – Reasons for Failure  Pest Control  Failure to control rodents  Failure to follow the frequency of monitoring stated in the company plan  Failure to prevent stray animals entering houses  Failure to remove debris and vegetation around houses  Failure to provide fly monitoring records with name and location of fly tapes or cards
  27. 27. FDA Inspections – Reasons for Failure  Egg Storage  Failure to maintain eggs at 45F or below  Testing  Failure to test pullets at 14 to 16 weeks of age  Failure to test eggs after a manure positive test  Shipping eggs from egg positive flock  Biosecurity  Failure to maintain practices to prevent cross- contamination when workers move between houses
  28. 28. Salmonella heidelberg (SH)  Salmonella heidelberg found in pullet samples at Wright County traceback investigation  FDA does not have a program to address SH  FDA will act as if SE is found if finding SH in records of testing by a producer  Do not report SH on lab tests  FDA is not actively looking for SH during inspections if samples are taken
  29. 29. Summary  The battle to control SE is going to continue  SE positivity is expensive  Implementation of the plan by smaller producers will be a challenge  The FDA Egg Safety Plan is resulting in increased actions against SE in all states as intended
  30. 30. Questions??

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