National Advisory Committee on Microbiological Criteria for Foods

1
Parameters for Determining Inoculated
Pack/Challenge Study Protocols
Donald Zink, Ph.D. Senior Science Advisor
2
Inoculated Pack/Challenge Study Protocols
Significant Edits to the Document

• Addition of an Abstract
• Statistical considerations
• The Use and Limitations portion of the document
  was modified to note the need to balance
  statistical validity with practicality.
• The document was modified in several places to
  note the need to consult with an experienced
  statistician.
• The document also notes that sampling schemes for
  food microbiology experiments are often dictated
  by common practice, not solely on statistical
  design.

3
Inoculated Pack/Challenge Study Protocols
Significant Edits to the Document

• 3. Appendix B Considerations for Selecting a
  Laboratory
• The questions are not listed in order of
  importance.
• A negative response to one or more of these
  questions does not necessarily disqualify a
  laboratory from consideration.
• The most important considerations are associated
  with qualifications of personnel in designing,
  conducting and evaluating challenge studies.