Draft Voluntary National
Retail Food Regulatory Program Standards

Appendix E - Supplement to Standard No. 5 - Foodborne Illness and Food Defense Preparedness and Response

Criteria	YES	NO
1. Investigation Procedures
a. The program has written operating procedures for responding to and/or conducting investigations of foodborne illness and injury that clearly identify the roles, duties and responsibilities of program staff and how the program interacts with other relevant departments and agencies.  (The procedures may be contained in a single source document or in multiple documents.)	a.
b. The program maintains contact lists for individuals, departments, and agencies that may be involved in the investigation of foodborne illness, injury or contamination of food.	b.
c. The program maintains a written operating procedure or a memorandum of Understanding (MOU) with the appropriate epidemiological investigation program/department to conduct foodborne illness investigations and to report findings.  The operating procedure or MOU clearly identifies the roles, duties, and responsibilities of each party.	c.
d. The program maintains logs or databases for all complaint or referral reports from other sources alleging food-related illness, injury or intentional food contamination.  The final disposition for each complaint is recorded in the log or database and is files in or linked to the establishment record for retrieval purposes.	d.
e. Program procedures describe the disposition, action or follow-up and reporting requirement for each type of complaint or referral report. .	e.
f. Program procedures require disposition, action or follow-up on each complaint or referral report alleging food-related illness or injury within 24 hours.	f.
g. The program has established procedures and guidance for collecting information on the suspect foods’ preparation, storage or handling during on-site illness, injury, or outbreak investigations.	g.
h. Program procedures provide guidance for immediate notification of appropriate law enforcement agencies if at any time intentional food contamination is suspected.	h.
i. Program procedures provide guidance for the notification of appropriate state and/or federal agencies when a complaint involves a product that originated outside the agency’s jurisdiction or has been shipped interstate.	i.
2. Reporting Procedures
a. Possible contributing factors to the illness, injury or intentional food contamination are identified in each on-site investigation report.	a.
b. The program shares final reports of investigations with the state epidemiologist and reports of confirmed outbreaks with CDC.	b.
3. Laboratory Support Documentation
a. The program has a letter of understanding, written procedures, contract or MOU acknowledging that a laboratory(s) is willing and able to provide analytical support to the jurisdiction’s food program.  The documentation describes the type of biological, chemical, radiological contaminants or other food adulterants that can be identified by the laboratory.  The laboratory support available includes the ability to conduct environmental sample analysis, food sample analysis and clinical sample analysis.	a.
b. The program maintains a list of alternative laboratory contacts from which assistance could be sought in the event that a food-related emergency exceeds the capability of the primary support lab(s) listed in paragraph 3.a.  This list should also identify potential sources of laboratory support such as FDA, USDA, CDC, or environmental laboratories for specific analysis that cannot be performed by the jurisdiction’s primary laboratory(s).	b.
4. Trace-back Procedures
a. Program management has an established procedure to address the trace-back of foods implicated in an illness, outbreak or intentional food contamination.  The track-back procedure provides for the coordinated involvement of all appropriate agencies and identifies a coordinator to guide the investigation.  Trace-back reports are shared with all agencies involved and with CDC.	a.
5. Recalls
a. Program management has an established procedure to address the recall of foods implicated in an illness, outbreak or intentional food contamination.	a.
b. When the jurisdiction has the responsibility to request or monitor a product recall, written procedures equivalent to 21 CFP, Part 7 are followed.	b.
c. Written policies and procedures exist for verifying the effectiveness of recall actions by firms (effectiveness checks) when requested by another agency.	c.
6. Media Management
a. The program has a written policy and procedure that defines a protocol for providing information to the public regarding a foodborne illness outbreak or food safety emergency.  The policy/procedure should address coordination and cooperation with other agencies involved in the investigation.  A media person is designated in the protocol.	a.
7. Trend Analysis
a. At least once per year, the program conducts a review of the data in the complaint log or database and the illness and injury investigations to identify trends and possible contributing factors that are most likely to cause illness or injury.  These periodic reviews of multiple complaints and contributing factors may suggest a need for further investigations and may suggest steps for illness prevention.	a.
b. The review is conducted with prevention in mind and focuses on, but is not limited to, the following: i. Multiple complaints on the same establishment; ii .Multiple complaints on the same establishment type; iii. Multiple complaints implicating the same food; iv. Multiple complaints associated with similar food preparation processes; v. Number of laboratory-confirmed, food-related outbreaks; vi. Number of non-laboratory-confirmed but epidemiologically linked, food-related outbreaks; vii. Number of complaints involving real and alleged threats of intentional food contamination; and viii. Multiple complaints involving the same agent and any complaints involving unusual agents.	b.
c. In the event that there have been no illness or injury outbreak investigations conducted during the twelve months prior to the trend analysis,  program management will plan and conduct a mock  foodborne illness investigation to test program readiness.  The mock investigation should simulate response to an actual illness outbreak and include on-site inspection, sample collection and analysis.  A mock investigation must be completed at least once per year when no illness outbreak investigations occur.	c.

A 'yes' affirmation to each statement is required to meet Standard 5. If an appendix item contains multiple questions, then all questions must be answered in the affirmative in order to meet that element of the Standard.

The source documents, such as the various policies and procedures, that support this summary record must be maintained in good order by the regulatory authority and must be made available upon request for purposes of a verification audit.

I affirm that the information represented on this record is true and correct. This jurisdiction meets all the requirements for Standard No. 5, ________Yes _______NO

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Signature of Self-Assessor	Date
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Printed Name of Self-assessor and Title
_________________________________________________________
Name and Address of Jurisdiction