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U.S. Food and Drug Administration

Notice: Archived Document

The content in this document is provided on the FDA’s website for reference purposes only. It was current when produced, but is no longer maintained and may be outdated.


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Effects of the use of antimicrobial drugs in food producing animals on pathogen shedding:Summary ofCritical points

Dr. David G. White

Center for Veterinary Medicine

VMAC Meeting-Pathogen Load

January 23,2002


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Relevant factors related to drug use and pathogen load on potential human health impacts

  • Mid 1970’s, 21 CFR 558.15 “studies”

    • sub-therapeutic uses

      • shedding and resistance components

  • 1998, Guidance for industry #78

    • all uses of all classes of antimicrobial new animal drugs

      • rate and extent of development of resistance

      • changes in pathogen load

  • 2000, CVM meeting on pre-approval studies in antimicrobial resistance and pathogen load

    • pre-approval studies to evaluate potential microbial effects associated with antimicrobial drug use in food-producing animals(http://www.fda.gov/cvm/antimicrobial/oldmeet.htm)

  • j


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Relevant factors related to drug use and pathogen load on potential human health impacts

  • A consideration of the potential microbiological effects of antimicrobial new animal drugs has been identified as a significant component of the animal drug safety evaluation process

  • The lessons learned from the “558.15 studies” along with 20 years of advancement in scientific knowledge, are important factors for helping to develop appropriate methodologies for evaluating the relevant microbiological effects associated with the use of antimicrobial drugs in food-producing animals


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VMAC pathogen load presentations potential human health impactsJanuary, 23, 2002

  • Dr. Stephen Sundlof, CVM, Regulatory history

  • Dr. Jeffrey Gilbert, CVM: History of 21 CFR 558.15 “studies”

  • Dr. Tom Shryock, Elanco: Conduct of shedding studies

  • Dr. Jeff Gray, USDA: Design considerations

  • Dr. Mike Goodman, Exponent: Literature review

  • Dr. Scott McEwen, Univ. of Guelph: Epidemiological evidence

  • Dr. Richard Isaacson, Univ. of Minnesota: Pathogen shedding

  • Dr. Barbara Masters, USDA: PR/HAACP

  • Dr. Mark Robinson, CVM: Human food safety evaluation


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21 CFR 558.15 “Studies” potential human health impactsregulatory perspective

  • Dr. Jeff Gilbert presented a brief history regarding submitted sponsor pre-approval studies to support microbiological safety of antimicrobial drugs

    • study design and examined parameters

    • integrity measurements

    • study results

    • identified problems

    • based on policy and regulation of the time


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21 CFR 558.15 “Studies” potential human health impactssponsor perspective

  • Dr. Tom Shryock presented industry experience with studies

    • study design and interpretation

    • study results

    • identified problems and limitations

    • relevance


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Pathogen load potential human health impactsstudy design considerations

  • Dr. Jeff Gray presented information regarding pathogen load study designs

    • organism

    • study design

    • measuring effects

    • confounding factors


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Exponent literature review potential human health impacts

  • CVM contracted with Exponent to conduct a review of published literature on the effect of using antimicrobials in food-producing animals on pathogen load

  • Dr. Mike Goodman presented summary of Exponent report

    • located athttp://www.fda.gov/cvm/antimicrobial/PathRpt.pdf

    • 33 literature databases were searched

      • challenge or observational studies

      • limited data


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Epidemiological evidence of pathogen load effects potential human health impacts

  • Dr. Scott McEwen presented an overview of relevant epidemiological information related to food animal studies

    • human studies

    • companion animal studies

    • food animal studies

    • study results


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Pathogen shedding issues potential human health impacts

  • Dr. Richard Isaacson presented information relevant to shedding of pathogens in food animals

    • study design

    • bacterial detection

    • culture methods

    • confounding factors

    • take home points


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PR/HAACP potential human health impacts

  • Dr. Barbara Masters presented information with regards to USDA/FSIS PR/HAACP

    • history

    • regulatory requirements

    • implementation

    • performance criteria

    • performance standards


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Human food safety evaluation potential human health impacts

  • Dr. Mark Robinson presented information describing evaluation of sponsor generated data

    • relevance to public health

    • identify and mitigate potential adverse human health effects

    • “safety” of drug product


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CVM - Pathogen load potential human health impacts

  • CVM recognizes that scientific information in this area is limited and acknowledges the concerns raised at the February 2000 public meeting

  • CVM contracted with Exponent to conduct a literature review on the subject to gather additional information

  • Today’s VMAC represents our ongoing efforts to look at the issue of pathogen load and to develop appropriate policy in this area

    • CVM is seeking recommendations from the VMAC on the issue of evaluating potential antimicrobial drug effects on pathogen load in food-producing animals as part of the new animal drug application process


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Open public session (am) potential human health impacts

Presentation of questions to VMAC

Committee deliberations

Meeting summary

Special thanks:

William Flynn

Patrick McDermott

Charles Eastin

Karen Lampe

Jeff Gilbert

Aleta Sindelar

Mark Robinson

Bert Mitchell

VMAC pathogen load January, 24, 2002


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