FDA's Domestic and Imported Cheese Compliance Program Results
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Food Protection Trends, Vol. 31, No. 4, Pages 216–226 Copyright© 2011, International Association for Food Protection 6200 Aurora Ave., Suite 200W, Des Moines, IA 50322-2864 FDA’s Domestic and Imported Cheese Compliance Program Results: January 1, 2004—December 31, 2006 DENNIS J. D’AmICO* and CatHERINE W. DONNELLY Dept. of Nutrition and Food Sciences, 109 Carrigan Drive, 361 Joseph Carrigan Wing, University of Vermont, Burlington, VT 05405, USA INTRODUCTION ABSTRACT Current regulations governing the Between January 1, 2004, and December 31, 2006, the U.S. use of raw, heat-treated and pasteurized Food and Drug Administration tested a total of 17,324 cheese milk for cheesemaking were promulgated samples as part of the Domestic and Imported Cheese and in 1949. One of two options could be selected by cheesemakers to assure the Cheese Products Compliance Program. Of 2,181 cheese samples safety of cheese: pasteurize milk intended examined for the presence of Listeria monocytogenes, 2.4% were for cheesemaking, or hold the cheese at positive. Approximately half of the positive samples (52%) were a temperature not less than 35°F (1.67 traced to imported Mexican-style soft cheese or soft-ripened °C) for a minimum of 60 days (9, 10). cheeses, primarily from France and Italy. A total of 3,520 cheese Research has shown that numerous samples were analyzed for the presence of Salmonella, with 1.3% pathogenic organisms including Salmo- testing positive; in general, the majority of samples came from soft nella spp., Escherichia coli O157:H7 and or soft-ripened cheeses produced in Mexico or Central America. Listeria monocytogenes can survive well The FDA also examined 3,360 cheese samples for the presence of beyond the mandatory 60-day holding period in various cheese varieties (5, 14, enterohemorrhagic Escherichia coli, of which only 3 (0.09%) tested 34, 36, 37, 38, 40). Of particular con- positive, including samples of imported Mexican-style soft cheese cern to the U.S. Food and Drug Admin- and imported soft-ripened cheeses. Staphylococcus aureus was the istration (FDA) was a report by Reitsma most commonly detected pathogen of concern, being present in and Henning (34) detailing the survival 6.9% of the 3,449 cheeses samples tested. In summary, these data of E. coli O157:H7 in aged Cheddar suggest that increased U.S. regulatory focus should be given to cheese. In a referral to the National Mexican-style soft cheeses, particularly those produced in Mexico/ Advisory Committee on Microbiological Central America. These data also help inform risk assessments that Criteria for Foods in April of 1997, the evaluate the microbiological safety of cheese. FDA asked if a revision of current policy was necessary, noting that the current aging requirement may be insufficient to provide an adequate level of public health protection. In response to the A peer-reviewed article detection of pathogenic microorganisms *Author for correspondence: Phone: +1 802.656.8300; Fax: +1 802.656.0001 in cheese and cheese products as well as E-mail: [email protected] 216 FOOD PROTECTION TRENDS | APRIL 2011 foodborne outbreaks and illnesses caused cal/chemical findings. (5) Data from in- High moisture Jack; Mexican-style soft; by L. monocytogenes (1, 22, 23, 25, 27), spections of cheese firms, including the Monterey; Muenster; Non-standard- Salmonella (2, 6, 16, 18, 24, 32, 33), inspection forms utilized, a summary of ized natural, smoked cheese; Parme- E. coli (13, 19) and Staphylococcus aureus violations encountered, and regulatory san; Standardized pasteurized, blended (3, 28, 36, 39, 42, 43), the FDA issued action taken as a result of violations. cheese; Standardized pasteurized process the Domestic and Imported Cheese and Cheese; Pizza cheese; Provolone; Reg- giano; Ricotta; Romano; Roquefort; Cheese Products Food Compliance Pro- Sample collection gram in November of 1998 (8). The ob- Semisoft; Semisoft, part skim; Sheep; jectives of this program were to authorize Samples were collected in accordance Standardized, spiced, part skim; Stilton; the FDA to conduct inspections of do- with the procedures detailed in the com- Standardized stirred curd; Swiss, Em- mestic cheese firms; to examine samples pliance program (8). During scheduled mentaler; Syrian; Standardized washed of imported and domestic cheese for inspections, samples are collected when curd; Cottage (Not < 4% Milkfat); Dry microbiological contamination, presence the firm had a history of microbiological curd Cottage cheese (< 0.5% Milkfat); of phosphatase, and filth; and to take contamination (such as follow up to ill- Pasteurized cheese spread; Pasteurized appropriate regulatory action when vio- ness or injury complaint, recalled/seized process cheese spread; Pasteurized pro- lations are encountered (8). Under this product, previous inspectional history). cess cheese foods; Pasteurized process initiative, direct reference seizure or de- Sampling is also conducted “for cause” cheese spread with fruits, vegetables or tention of cheese based on the presence of (for example; inspectional observations meats; Queso Crema; Soft-ripened from L. monocytogenes was also authorized. that warrant sample collection for mi- Cow’s milk; Soft-ripened from a mixture On June 14, 2004, the Cheese of crobiological analyses). Collection prior- of animal milk; Soft-ripened from Goat’s Choice Coalition (CCC) requested, ity specifies the sampling of soft cheese, milk, Soft-ripened from Sheep’s milk; under the Freedom of Information followed by hard cheese and cheese pro- Soft, Semi-soft from Cow’s milk. Act, all test results obtained under ducts. For this Compliance Program, FDA’s “Domestic and Imported Cheese “soft cheese” refers to fresh soft (for ex- Sample preparation, isolation and Cheese Products Compliance ample, Asiago, Feta, Ricotta, Queso and identification Program” for the period 1998 to June Fresco), semi-soft (for example, Gorgon- Samples were processed in accor- 2004. On August 7, 2007, the CCC zola, Limburger, Stilton, Gouda), and dance with the procedures detailed in the agreed, at FDA’s urging, to amend the soft-ripened (for example, Brie, Cam- compliance program (8). Briefly, since time period to include only January 1, embert and Vacherin) cheese varieties. the products were analyzed for multiple 2004–December 31, 2006. The FDA Hard cheese includes varieties such as pathogens under this program, both provided data in response to the CCC Cheddar, Romano, and Swiss, among compositing and individual subsample request on February 6, 2008. This man- others. Each sample was analyzed for analysis on the same sample were neces- uscript provides an analysis of those data the presence of L. monocytogenes, Salmo- sary. Two (2) composites per sample were and the implications for the safety of nella, E. coli, Enterohemorrhagic E. coli analyzed separately for L. monocytogenes domestic and imported cheeses analyzed (defined as serotype O157:H7) (EHEC), and Salmonella. After the portions were within the FDA program. and S. aureus. Samples were analyzed removed for L. monocytogenes and Sal- for the presence of Enterotoxigenic monella composites, each individual sub- MATERIALS AND METHODS E. coli (ETEC) when E. coli was present sample was analyzed for E. coli, ETEC at ≥ 104 (10,000) CFU/g. Staphylococcal (if necessary), EHEC and S. aureus. Iso- Data acquisition enterotoxin testing was conducted when lation and identification followed the product abuse was suspected or if viable Under the Freedom of Informa- procedures outlined in the FDA Bacte- staphylococcal colonies, MPN results or tion Act, the CCC specifically requested riological Analytical Manual (11). the following information: (1) The total direct plate counts indicated a level of number of cheese samples analyzed un- 104 (10,000) CFU/g or above. Cheese RESULTS AND DISCUSSION der this directive, with data broken down varieties sampled in the reports provided with respect to the number of domestic by the FDA included Standardized, Not During the period January 1, 2004, firms inspected and the number of do- Elsewhere Mentioned (NEC); Cheese to December 31, 2006, the FDA tested mestic and imported cheese samples ana- and cheese products NEC; Standard- a total of 17,324 domestic and imported lyzed. (2) Data on the specific analyses ized cheese food, Cold pack (Hickory cheese samples. Our analysis of results that FDA had conducted on the cheeses, smoked, for example); Non-standardized obtained by FDA focused on the inci- and results of all analyses. (3) In particu- products NEC; Standardized cheese dence of the primary pathogens of con- lar, microbiological data, with a break- products NEC; Asiago, fresh, medium, cern, which included E. coli O157:H7, down of data by cheese category, includ- soft and old; Blue; Brick; Cheddar; Col- Salmonella, L. monocytogenes and S. aur- ing all microbiological results (negative by; Cook, Koch; Cream cheese; Cream eus. and positive). (4) Data on appropriate cheese with other foods; Edam; Goat; During the aforementioned period, regulatory action (seizure, detention, Gorganzola; Gouda; Gruyere; Hard the FDA examined 3,360 cheese samples recall) taken as a result of microbiologi- cheese; Hard grating cheese; Havarti, for the presence of E. coli O157:H7. As APRIL 2011 | FOOD PROTECTION TRENDS 217 TABLE 1. Incidence of enterohemorrhagic Escherichia coli (E. coli O157:H7) in cheese ana- lyzed under the Domestic and Imported Cheese Compliance Program between January 1, 2004 and December 31, 2006 Year Category No. positive/ Cheese type Country of origin No. tested (%) 2004 Domestic 0/478 (0) 2004 Imported 2/1070 (0.2) Mexican-style soft Mexico Soft-ripened Honduras 2005 Domestic 0/317 (0) 2005 Imported 1/699 (0.1) Mexican-style soft Mexico 2006 Domestic 0/210 (0) 2006 Imported 0/586 (0) Total 3/3360 (0.09) shown in Table 1, only 3 (0.09%) of these curred in Wisconsin in 1998, when vats contaminated cheese in the U.S. prompt- tested positive: 2 samples of Mexican- used to make raw milk Cheddar cheese ed by intensive FDA surveillance. Based style soft cheese imported from Mexico were inadvertently used to make fresh on the results of multiple surveys, Nor- (one in 2004 and one in 2005), and one cheese curds (13).