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Issue Number: Council III 030

Title

Designating certain cheeses non-time/temperature control for safety foods

Issue you would like the Conference to consider

Many natural cheeses have pH and water activity (aw) that result in their being classified as time/temperature control for safety (TCS) foods when evaluated using Table B in the definition of "time/temperature control for safety food' in Subpart 1-201.10 (B) of the 2013 FDA Food Code. Retailers would like to store and display these cheeses under non-refrigerated conditions to enhance the cheese flavor and aroma, but are not allowed to do so. The Food Code allows a product assessment to conclusively determine TCS status for any food product. Product assessment studies were done at the University of Wisconsin-Madison using 67 cheeses inoculated with Staphylococcus aureus, Salmonella spp., Listeria monocytogenes, and Escherichia coli O157:H7 and stored for up to 15 days at 25°C (77°F). The results of these studies, along with the results of earlier published studies, support the designation of cheeses with specific pH and % salt-in-moisture phase (% SMP) values as non-TCS foods.

A peer-reviewed published survey of the scientific literature (presented at the 2008 CFP Biennial Meeting) suggested that certain types of cheese are non-TCS foods. Many of these recommended cheeses, because they do not support growth of Listeria monocytogenes, are already exempted from date-marking requirements (see Table in Annex 3 under Section 3-501.18, based on the FDA/USDA/CDC Listeria monocytogenes Risk Assessment). A series of targeted product assessments, done at the University of Wisconsin-Madison according to laboratory methods specified by the FDA (http://www.fda.gov/Food/FoodScienceResearch/SafePracticesforFoodProcesses/ucm094141.htm), tested cheeses of many types, including those exempted from date-marking, for their ability to support room-temperature growth of L. monocytogenes and other relevant pathogenic bacteria (Staphylococcus aureus, Salmonella spp., and Escherichia coli O157:H7). The results of the product assessments, along with those of relevant product assessments published previously, are described in a paper which has been submitted to the Journal of Food Protection for peer review (Non-TCS Cheeses, Supporting Document #1). The product assessment results indicate that cheeses with certain pH and % SMP levels do not support growth of any of the tested pathogens under non-refrigerated conditions. Separate lots of the same cheese type, e.g. Provolone, with different pH and % SMP, may vary in their ability to support pathogen growth. For this reason, we propose that the exemption of certain natural cheeses from being classified as TCS status should be based on pH and %SMP, not cheese type designation. Critical combination of pH and %SMP for preventing pathogen growth are listed in Non-TCS Cheeses, Supporting Document #2.

Public Health Significance

Extensive laboratory research at the University of Wisconsin-Madison (Non-TCS Cheeses, Supporting Document #1) has shown that natural cheeses with certain pH and % salt-in-moisture phase (% SMP) values will not support the growth of relevant food-borne pathogenic bacteria (Listeria monocytogenes, Staphylococcus aureus, Salmonella spp., and Escherichia coli O157:H7) during storage at 25°C (77°F) for up to 15 days. These storage conditions were intentionally longer and warmer than typical room-temperature storage of cheese in order to be sure that pathogen growth would not occur under slightly abusive temperature conditions. Previous studies (cited in Non-TCS Cheeses, Supporting Document #1) used storage temperatures ranging from 20 to 30°C (68 - 86°F) and yielded results that were consistent with the UW-Madison findings. Data analysis has determined critical combinations of cheese pH and %SMP for preventing pathogen growth under non-refrigerated conditions. Natural cheeses with pH and %SMP at least as restrictive as these critical combinations can be stored under non-refrigerated conditions without increasing the risk of foodborne illness. These critical combinations are listed in Non-TCS Cheeses, Supporting Document #2.

Recommended Solution: The Conference recommends...

That a letter be sent to FDA requesting the 2013 Food Code be amended to add 3(f) under the definition of "Time/temperature control for safety food" in subpart 1-201.10 (B) as follows (new language is underlined):

3 (f) Natural cheeses made from pasteurized cow's milk, that are not ripened with mold, that are not surface-ripened with bacteria, that are not Swiss, emmentaler and related cheeses produced using propionic acid-producing bacterial cultures, and that have pH and % salt- in-moisture phase (SMP) levels meeting one of the following requirements:

pH not greater than 4.60 and % SMP not less than 0.24

pH not greater than 4.70 and % SMP not less than 0.91

pH not greater than 4.80 and % SMP not less than 1.58

pH not greater than 4.90 and % SMP not less than 2.24

pH not greater than 5.00 and % SMP not less than 2.91

pH not greater than 5.10 and % SMP not less than 3.58

pH not greater than 5.20 and % SMP not less than 4.25

pH not greater than 5.30 and % SMP not less than 4.92

pH not greater than 5.40 and % SMP not less than 5.59

pH not greater than 5.50 and % SMP not less than 6.26

pH not greater than 5.60 and % SMP not less than 6.93

Attachments

Submitter Information

Name Jacqueline Owens
Organization Wisconsin Department of Agriculture, Trade, and Consumer Protection
Address P.O. Box 8911
Madison, WI 53708
Telephone 608-224-4734
Fax 608-224-4710
Email Jacqueline.Owens@wisconsin.gov
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