Attachment_21.pdf

DFI FIELD BULLETIN #32

FOODS

Subject: Internal Testing Programs and Environmental Sampling.

Effective Date: 2/10/2009

Target Audience: CSOs and State investigators conducting inspections at food processing establishments, Field Managers

Purpose: ORA analysis of our investigation operations, informed recently by investigations at firms associated with foodborne disease outbreaks, has identified two areas for enhanced focus during routine inspections or targeted investigations: 1) Firm’s internal testing program for incoming/in-process/finished product for pathogens or other contaminants; 2) Enhanced environmental sampling by FDA.

Action Item:

During routine food inspections, investigators should determine if the firm has an internal sampling and testing program. In many cases firms will use outside testing laboratories.

Ask the firm if they test product and/or ingredients, and if so, determine the results and ask that the firm provide the relevant records for your review. Note: Food firms are not required to conduct internal testing and/or provide records to you (exception involves situations that invoke Section 414 of the FD&C Act). The firm’s response to this request would be voluntary. Your review of the records and discussion with management would dictate further investigation approaches and can be used to determine whether there are potential sources of contamination, whether the firm took appropriate corrective actions when positive samples were reported, and/or whether controls and checks are in place to provide a greater assurance of product safety.

CP 7303.803 “Domestic Food Safety”, does not currently provide for the routine collection of surveillance samples other than “for cause”. Such “for cause” conditions need not be severe to warrant enhanced environmental sampling. Investigators should consider collecting environmental (Refer to DFI Field Bulletin #30) and/or product samples for standard microbial analysis when conditions are observed that are conducive to the presence of pathogenic bacteria such as moisture or pooled water, evidence of cross contamination, improper cleaning and sanitization practices, a history of positive product samples, recent construction, cracks in floors around processing areas, and evidence of roof leaks above food handling areas.

http://inside.fda.gov/PolicyProcedures/GuidanceRegulations/FieldInvestigations/UCM010365.html