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. 2017 Mar 30;5(1):24–28. doi: 10.14252/foodsafetyfscj.2016033s

Table 5. Criteria and outcomes of release assessment, exposure assessment and consequence assessment.

Relevant parameters Classification of concern Outcome of Concern
Release Assessment
1) Are there any concerns about emergence of the hazard (eg, mechanisms of acquired resistance, genetic information)?
2) Are there any concerns about susceptibility distribution of bacteria including the hazard?
3) Are there any concerns about other factors (eg, pharmacokinetics, usage, amount applied)?
Statements for the concern are classified as follows on each item 1)~3):
The concern is “Great”, “Moderate” or “Little”.
Two or more items assessed as “Great”. “High”: The hazard* is selected with high probability.
Only one item assessed as “Great”, or two or more items assessed as “Moderate”. “Medium”: The hazard is selected with certain extents of probability.
One item assessed as “Moderate” and no item assessed as “Great”. “Low”: The hazard is selected with reduced extents of probability.
Three items assessed as “Little”. “Negligible”: The hazard is unlikely to be selected.
Exposure Assessment
1) Are there any concerns about biological properties of bacteria including the hazard (eg, survival, proliferation)?
2) Are there any concerns about food contaminations with bacteria including the hazard?
3) Are there any concerns about other factors (eg, meat processing process, marketing channels)?
Statements for the concern are classified as follows on each item 1)~3):
The concern is “Great”, “Moderate” or “Little”.
Two or more items assessed as “Great”. “High”: Human exposure to the hazard is highly probable.
Only one item assessed as “Great”, or two or more items assessed as “Moderate”. “Medium”: Human exposure to the hazard is of certain probability.
One item assessed as “Moderate” and no item assessed as “Great”. “Low”: Human exposure to the hazard is of reduced probability.
Three items assessed as “Little”. “Negligible”: Human exposure to the hazard is unlikely.
Consequence Assessment
1) (a) Is the antimicrobial ranked as “I: Critically important as human antimicrobials”?
(b) Is the antimicrobial a primary one for the human infectious disease caused by bacteria including the hazard?
For item 1), statement for the concern is classified as follows:
The concern is “Great” if both (a) and (b) suffice, “Moderate” if either (a) or (b) suffices, or “Little” if neither (a) nor (b) suffices.
2) Are there any concerns about the severity and incidences of human diseases caused by the hazard?
3) Are there any concerns about other factors (eg, availability of alternative drugs, status of antimicrobial resistance in hospitals)?
Statements for the concern are classified as follows on each item 1)~3):
The concern is “Great”, “Moderate” or “Little”.
Two or more items assessed as “Great”. “High”: Reduction or loss of clinical effectiveness to diseases caused by the hazard is highly probable.
HHS Vulnerability Disclosure