title: Determining the microbiological criteria for lot rejection from the performance objective or food safety objective.
abstract: The Microbiological Criteria (MC) is a set of parameters used to determine whether a specific lot of food is acceptable or not. These parameters are the microbial test protocol and its sensitivity, the confidence level that an unacceptable lot will be detected, the number of samples to be taken and the number of positive samples that are allowed before rejecting the lot. Determining the microbiological criteria begins with knowledge of the distribution of contamination from samples within a lot, particularly within a lot that is just at the unacceptable level of the microbial hazard. The just unacceptable lot can be defined by the Food Safety Objective (FSO) or Performance Objectives (PO), the small fraction of samples that can exceed these values and the standard deviation of the samples from the lot. With this information, a microbial test protocol is chosen to have a sensitivity level that would detect between approximately 15% and 45% of the samples. A confidence level for the MC and the number of positive samples that would be acceptable (c value which is usually zero) are also chosen. With this information the number of samples (n) required can be calculated. A critical factor in setting the microbiological criteria is the sensitivity of the microbiological test (m value). The sample size (weight) and sampling procedure can affect the standard deviation of the samples, particularly foods with non-homogeneous distribution and low numbers of microorganisms. Sampling, sample preparation and analytical procedures that reduce the variation between the samples will affect the choice of m value and maximum lot mean that meets the MC.
authors.affiliation: Center for Food Safety and Applied Nutrition, Food and Drug Administration, College Park, MD 20740, USA. richard.whiting@fda.hhs.gov
authors.forename: R C
authors.initials: RC
authors.lastname: Whiting
authors.forename: A
authors.initials: A
authors.lastname: Rainosek
authors.forename: R L
authors.initials: RL
authors.lastname: Buchanan
authors.forename: M
authors.initials: M
authors.lastname: Miliotis
authors.forename: D
authors.initials: D
authors.lastname: Labarre
authors.forename: W
authors.initials: W
authors.lastname: Long
authors.forename: A
authors.initials: A
authors.lastname: Ruple
authors.forename: S
authors.initials: S
authors.lastname: Schaub
mesh_terms: D015169:Colony Count, Microbial / Q000379:methods* / Q000592:standards*; D003257:Consumer Product Safety; D005506:Food Contamination / Q000032:analysis*; D019649:Food Industry / Q000592:standards*; D005516:Food Microbiology; D006801:Humans; D011786:Quality Control; D018570:Risk Assessment; D012680:Sensitivity and Specificity