Food Protection Trends - August 2009 - 501

method. examples of these elements are described in table 3. Corrective actions to be taken when a positive is found should also be outlined (see examples in table 4). – Sampling devices noted in the program should be appropriate for the types of samples collected and validated as necessary. For example, if sponges are used, they must not contain preservatives, and validation of Salmonella recovery is recommended. – Sampling sites should be delineated into zones to facilitate program development, provide focus to critical sampling areas, and help direct appropriate corrective actions. For example, four zones may be established: • Zone 1 for PCSs in the Primary Salmonella Control area; Zone 2 for non-PCSs adjacent to or within close proximity to pCSs in the primary Salmonella Control area; Zone 3 for non-PCSs more distant from pCSs in the primary Salmonella Control area and process areas outside the primary Salmonella Control area; and Zone 4 for areas outside the process area (e.g., employee entrance, locker room, warehouse, loading dock). • • listing is by no means inclusive of all potential sites. – Using only preset sample sites is not recommended, since it significantly limits the scope of sampling and will likely miss emerging areas of concern. however, some sites may be sampled on a continuing basis to assess trends. Sampling data should be reviewed on a routine basis. the sampling program should be dynamic and responsive to the data generated. – A rotation schedule should be developed to allow all areas of the plant to be sampled on a periodic basis, e.g., weekly monitoring with rotation of sites between different areas of the plant, with all sites sampled within a specified time period (e.g., monthly or quarterly). however, this should not be set up in a manner that excludes the sampling of an area of concern identified in a “non-scheduled” area. the sampling plan should be flexible and allow for additional samples to be collected where appropriate. ❏ increase environmental monitoring (frequency and/or number of samples), as well as other control measures, in response to plant events such as during and after construction, and after equipment installation and major repairs are completed. an example of intensified control and monitoring is shown in table 6. ❏ develop a policy on whether and when to test PCSs and/or finished product and a program for this testing. – Testing of PCS, if included in the program, should be done only after a policy has been established with regard to the impact of a pCS-positive on finished product and the actions to be taken. routine testing of pCSs is not particularly meaningful in verification because, given an effective Salmonella control program, contamination, if any, is likely to be sporadic, and sampling is unlikely to find positives on pCS. • PCS testing may be done as part of corrective actions for an environmental positive, e.g., in sampling for investigational purposes following positive Salmonella findings in areas that may pose a risk for pCS contamination on the line (see table 4). pCS testing may also be valuable under other circumstances, such as hygienic qualification of a piece of equipment prior to use in production, e.g., for new equipment or newlyacquired equipment that has been used in another facility. – Manufacturers should decide whether or not to conduct finished product testing based on an evaluation of risk. Customer requirements (i.e., Certificates of analysis) may also dictate the need for finished product testing. • Whenever finished product testing is performed, the tested lot should be isolated, placed on hold, and released into commerce only if the product tests negative for Salmonella. • If a product sample tests positive for Salmonella, the tested lot is considered adulterated and should not be released into commerce. As noted previously, retesting should not be conducted for the purpose of negating the initial test results (31, 48). Resampling almost always increases the chance of accepting a contaminated lot. The lower the prevalence level of Salmonella in the product, the more difficult it will be to confirm, and it is virtually impossible to confirm very low prevalence by resampling (31). • Retesting for investigational purposes only (i.e., to try to determine the level or incidence of contamination in the sample) may be appropriate. • The lot associated with a positive sample may be reworked using a validated inactivation step. in addition to product disposition, other corrective actions may be taken as appropriate (see below). • – Routine environmental monitoring should target testing non-pCSs under normal operating conditions. Samples taken post-sanitation provide sanitation verification only and would not meet the true intent of environmental sampling. a “seek and destroy” philosophy should be adopted in environmental monitoring. this means that the monitoring program is designed to aggressively search for Salmonella, particularly in environmental sites where Salmonella might be expected to be present, might concentrate, or might grow and spread. table 5 provides examples of potential Salmonella-positive sites, based on food industry experience; the AUGUST 2009 | FOOD PROTECTION TRENDS 501

Food Protection Trends - August 2009

Table of Contents for the Digital Edition of Food Protection Trends - August 2009