Food Protection Trends - February 2009 - (Page 74)

unpalatable finished products that would not be commercially viable. Thus, the guidelines stress that it is up to manufacturers to fully consider all the variables mentioned in the document and then assure that validation testing adequately addresses those variables most meaningful to achieving the required lethality for their products. regulatory agency may help manufacturers to anticipate the amount and type of data needed to demonstrate that the selected parameters provide adequate lethality for appropriate pathogens. Importance of sanitary operating conditions The guidelines emphasize that failure to control sanitary conditions within NRTE manufacturing establishments can adversely affect the adequacy of otherwise properly validated cooking instructions. Instructions validated to inactivate a specified number of organisms will be inadequate if sanitary conditions within the processing facility allow contamination with pathogens or growth of pathogens to numbers greater than those considered during validation testing. Thus, it is important to assure that the target lethality selected for validation testing takes into consideration the sanitary conditions in the plant. Then, on an ongoing basis, manufacturers must assure that proper attention is paid to sanitation, including verification that sanitary conditions are being maintained. Lethality requirements Before beginning a validation study, it will be necessary to determine the target lethality value for the specific NRTE product. The guidelines review the various sources of lethality information upon which validation testing can be based, including regulatory guidance, published scientific papers, and product-specific microbiological inactivation studies. Safe harbor times and temperatures are available for certain products in regulations and/or in regulatory guidance documents such as FDA’s Model Food Code (15) and FSIS’ Appendix A: Compliance guidelines for meeting lethality performance standards for certain meat and poultry products (11). Many studies published in peer-reviewed scientific journals provide times and temperatures for cooking products to eliminate target pathogens or provide data on the heat resistance of pathogens expressed as D- and z-values. Summary information on such time-temperature recommendations or on heating values that can be used to determine time-temperature combinations adequate to destroy specific pathogens of concern may be obtained from the scientific literature (3, 4). When literature values do not adequately address product parameters, it may be necessary to develop information on the heat resistance of specific pathogens in specific food products. The target lethality may be different for NRTE products containing NRTE meat or poultry components versus those containing RTE meat or poultry components along with some other uncooked ingredients. In some cases, a lower target lethality may be justified for a product containing RTE meat or poultry because of the types and numbers of pathogens to be inactivated. Lower target lethalities may also be supportable for manufacturers that elect to implement incoming ingredient controls and/or environmental and in-process microbiological control programs. Under these circumstances, firms must continually document adherence to these specified conditions and must be prepared to demonstrate their scientific adequacy if questioned by regulatory agencies. Validation strategies There are at least two strategies for conducting cooking instruction validation studies. The simplest way to determine that the cooking instructions provide adequate lethality is to identify a target time/temperature combination that has been scientifically determined to be adequate to eliminate the appropriate level of the pathogen of concern (see lethality requirements) and to confirm that the test product reaches the target time/temperature after it has been cooked following the directions on the label. If the target time/ temperature associated with the required lethality for the product is attained, then the instructions are validated. Alternatively, microbiological inactivation studies may be a desirable or necessary cooking instruction validation strategy. The purpose of these studies is to determine whether pathogen(s) of concern intentionally introduced into the product to be tested are inactivated when the product is cooked according to the instructions. Microbial inactivation studies may be most appropriate for those products with a higher risk of microbial contamination (for example, products containing NRTE meat or poultry) or in cases where validation testing of product temperatures alone has shown that the target temperature has not been achieved consistently or has demonstrated wide variability. Additional recommendations on inactivation studies are included in the guidelines (5), as are references to other sources of information (10) pertinent to validation studies. Justification for the log reduction targeted for microbiological inactivation should be provided. In the absence of regulatory guidelines, a 5-log reduction of the pathogen of concern (often Salmonella) has generally been acceptable for most products. Nevertheless, under some circumstances more modest reductions may be scientifically justified as adequate for public health protection. The guidelines suggest that consultation with the relevant Number of samples to test The Task Force determined that while it would be convenient to set a minimum number of samples that should be tested in a validation study, there is simply too much variation in the range of products and their heating characteristics to permit this. Rather, the guidelines stress that the number of samples to be tested should be sufficient to provide reasonable assurance that the cooking instructions, if followed, will result in a safe product. This number will depend on the food and the method of heating, with fewer replicates needed for methods that provide more uniform heating. The number of samples tested must be sufficient to capture the variability in product heating and determine which factors are most responsible for this variability. More samples are recommended for products with greater variability in key parameters (for example, a product with non-uniform sized pieces of NRTE meat). In addition, the guidelines recommend that multiple (e.g., three separate) lots of product be tested to account for variability among lots. Factors affecting the validation test A variety of product factors can affect the validity of cooking instructions, and all factors pertinent to the cooking method should be accounted for in the 74 FOOD PROTECTION TRENDS | FEBRUARY 2009

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

Food Protection Trends - February 2009 Contents Sustaining Members Perspectives from Your President Commentary from the Executive Director Assuring the Safety of Not-Ready-to-Eat (NRTE) Products: Industry Guidelines for Validation of Consumer Cooking Instructions Cooking Food Safely with Microwave Ovens: Challenges for the Food Industry Special Interest Series: Newly Developed Workshop Series on “Molecular Methods in Food Microbiology” 2009–2010 Secretary Election Abstracts – IAFP’s Fourth European Symposium on Food Safety Audiovisual Library Audiovisual Library Order Form New Members What’s Happening in Food Safety Industry Products IAFP 2009: Networking Opportunities IAFP 2009: General Information IAFP 2009: Registration Form Coming Events Advertising Index Journal of Food Protection Table of Contents Booklet Order Form Membership Application

Food Protection Trends - February 2009

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