U. S. Food and Drug Administration
Center for Food Safety and Applied Nutrition
Retail Food Safety Branch
DRAFT: February 6, 1998
DRAFT: April 24, 2001
DRAFT: June 28, 2001

This document has been superceded by a more recent version. Below is an earlier version.

Criteria	YES	NO
Investigation Procedures
1. Written operating procedures exist for conducting investigations of foodborne illness.	1
2. Memoranda of Understanding:* Is cooperation with another department or agency required in order to fully conduct an illness investigation and report findings? If 2.a. is yes, then a written MOU exists.
	2a
	2b
3. The operating procedure and/or MOU clearly identify the roles, duties and responsibilities of each party.	3
4. Database or log of all complaints alleging food-related illness or injury is maintained.	4
5. Follow-up on each complaint alleging food-related illness or injury is conducted within 24 hours.	5
6. Investigation findings are recorded in the log or database.	6
7. Any investigation involving a particular establishment can be accessed or retrieved by the establishment's name or by looking in the establishment's inspection file.	7
Reporting
8. During illness or injury investigations, procedures used and information collected are similar to those found in the International Association for Food Protection Procedures to Investigate A Foodborne Illness, Fifth Edition.	8
9. In each report of investigation of illness or injury, possible contributing factors to the illness or injury are identified.	9
10. A copy of the final report is shared with the state epidemiologist and CDC.	10
Laboratory Support
11. A written document exists that describes the laboratory support available, and includes support for illness or injury investigations and follow-up sampling and surveillance activities related to a foodborne illness investigations for the food program.	11
12. Memoranda of Understanding:* Is cooperation with another department or agency required in order to obtain laboratory support? If 11.a. is yes, then a written MOU exists.
	12a
	12b
13. The written document and/or MOU describe the types of pathogens, chemical agents, and other food adulterants that can be identified by the laboratory.	13
14. The laboratory support available includes the ability to conduct environmental sample analysis, food sample analysis and clinical sample analysis.	14
Trace-back Procedures
15. A written procedure exists for the trace-back of food implicated in an illness or outbreak.	15
16. The trace-back procedure provides for the coordinated involvement of all the appropriate agencies.	16
17. The trace-back procedure identifies a coordinator to guide investigations when they involve more than one agency.	17
18. Trace-back reports are shared with all agencies involved and with CDC.	18
Recalls
19. Recalls of a product are initiated, if appropriate, based on the conclusions of an illness injury investigation.	19
20. Written procedures equivalent to 21 CFR, Part 7, exist and are used when the jurisdiction has the responsibility to request or monitor a product recall.	20
21. Written policies and procedures exist for verifying the effectiveness of recall actions by firms (effectiveness checks) when requested by another agency.	21
Media Management
22. A written policy or procedure exists that defines criteria for when information is provided to the public regarding a Foodborne Illness outbreak.	22
23. A media person for the agency is identified.	23
Trend Analysis
24. An annual review of the complaint database or log is conducted to identify trends and possible contributing factors to the illness outbreaks. (if yes, supply the date of the last review in the 'yes' column)	24
25. The trend analysis included all seven of the areas required in Standard No. 5.	25
	Yes	No
TOTALS

Credit for all 25 items is required to meet Standard No. 5 (See note below for further explanation).

* NOTE: If the answer to question 2.a. is "yes," then the answer to 2.b. must be "yes" also in order to gain credit for compliance with this item in the Standard. If the answer to question 12.a. is "yes," then the answer to 12.b. must be "yes" also in order to gain credit for compliance with this item in the Standard. If authority over foodborne illness investigations (question 2.) or laboratory support (question 12.) resides within the department/agency conducting the self-assessment and no memoranda of understanding is required to fully perform these functions, then a "yes" answer is not required for compliance credit. Example: If the answers to questions 2.a and 12.a. are both "no," then credit for the remaining 23 items only is required to meet Standard No. 5.

Last updated by dav/ear/cjm 2006-NOV-14