Domestic and Imported Cheese and Cheese Products

Issued November 19, 1998 CHAPTER 03 - FOODBORNE BIOLOGICAL HAZARDS DOMESTIC AND IMPORTED CHEESE AND CHEESE PRODUCTS (FY 99/00/01) Industry Code Use appropriate product code 03037 Inspections, Investigations, and ALL Sample Collections Filth Analysis Microbiological and Phosphatase Analyses Upon Receipt (LAB) 9/30

03037B 03037D -

FIELD REPORTING REQUIREMENTS NOTE: MICROBIOLOGICAL AND FILTH WORK FOR ALL CHEESE AND CHEESE PRODUCTS ARE COVERED UNDER THIS COMPLIANCE PROGRAM. MISUSE OF CHEMICALS BY THE FIRM AND COVERAGE OF ALL FOOD AND COLOR ADDITIVES IN CHEESE AND CHEESE PRODUCTS ARE COVERED UNDER THE DOMESTIC FOOD SAFETY (7303.803) AND IMPORTED FOODS - FOOD AND COLOR ADDITIVES (7309.006) COMPLIANCE PROGRAMS. NUTRITION LABELING (NLEA) AND NUTRIENT CONTENT OPERATIONS FOR CHEESE AND CHEESE PRODUCTS ARE COVERED UNDER THE DOMESTIC FOOD LABELING ENFORCEMENT (7321.005) AND IMPORT FOOD LABELING ENFORCEMENT (7321.007) COMPLIANCE PROGRAMS. REPORT ALL OPERATIONS EXPENDED FOR MONITORING (AUDIT SAMPLES) THE CERTIFICATE AGREEMENT WITH FRANCE (IMPORT ALERT 12-03) AND CURRENT DETENTIONS WITHOUT PHYSICAL EXAMINATION OF OTHER CHEESES FROM COUNTRIES OTHER THAN FRANCE AGAINST THIS PROGRAM. Hardcopy Reporting Send the following hardcopy on an as completed basis to: FDA/CFSAN/Division of Enforcement and Programs Imports Branch, HFS-606 Attention: Cheese Monitor - R. Gary 200 - C Street, S.W., Room 5413 Washington, D.C. 20204 Laboratory Attachment A, Analytical Reporting Form - Microbiological and Phosphatase Attachment B, Analytical Reporting Form - Filth

PART I - BACKGROUND

During the past few years, cheese and cheese products have been demonstrated to contain pathogenic microorganisms and to have caused human illness. Some cheeses (primarily soft cheeses) have been linked to foodborne outbreaks and illnesses caused by Salmonella, Listeria monocytogenes, and Escherichia coli contamination. Consumption of Feta and Mexican-style soft cheese, as reported by CDC, has been linked to a high rate of perinatal listeriosis. Also, a number of deaths have been associated with the consumption of these products. Due to continuing microbiological problems associated with cheese and cheese products, this Compliance Program covers domestic and imported cheese and cheese products for microbiological as well as phosphatase and filth analysis. In FY 97, cheese imported from El Salvador was found to contain excessive levels of Staphylococcus aureus. The levels were high enough to present the risk of a potential health hazard. As a result, two import alerts were implemented to address the problem with El Salvadorian cheese and cheese from countries other than El Salvador. Therefore, this program includes coverage for Staphylococcus aureus. PART II - IMPLEMENTATION OBJECTIVE To conduct inspections of domestic cheese firms. To examine samples of imported and domestic cheese for microbiological contamination, phosphatase and filth. To take appropriate action on imported lots and domestically produced cheese when violations are encountered.

Program Management Instructions A. Import Alerts and Bulletins Resources and operations expended for current Import Alerts/Bulletins covering cheese for filth, microbiological and/or phosphatase contamination must be reported against this Compliance Program. B. Examples of "Soft" Cheese For this Compliance Program "soft cheese" refers to soft, semi-soft, or soft-ripened cheese. Soft (fresh) Alemtejo Alpin Anari Asadero Asiago Bakers Banbury Bondon Cambridge **Cottage** Cream Damen Farmers Ferme Semi-Soft Bellelay Blue Brick Camosun Chantelle Edam Fontina Fynbo Gammelost Gorgonzola Gouda Havarti Herve Limburger Soft-Ripened Barberey Bel Paese Bella Alpina Bella Milano Brie Butter Camembert Coulommiers Crescenza Kloster Konigskrase Milano Monthery Old Heidlburg

Feta Formagelle Gournay Livarot Maigre Mignot Mont d'Or Mozzarella Neufchatel Queso Blanco Queso de Hoja Queso del Pais Queso de Puna Queso Fresco Provatura Ricotta Scamorze Villiers

Maribo Molbo Monterey Muenster Oka Pont L=Eveque Port du Salut **Provolone** Roquefort Saint Paulin Stilton Tilsit Trappist

Reblochon Robbiole Robbiolini Rollot Romadur Scholoss Trouville Vacherin Vittoria Vendome

Void C. Examples of "Hard" Cheese Abertam Kjarsgaard Appenzeller Battelmatt Bitto Bra Cantel Cheddar Cheshire Christalinna Colby Coon Derby Emiliano Emmentaler English Dairy Esrum Fiore Sardo Fontina Gex Gislev Gloucester Laguiole Lapland Lorraine Mecklenburg Skim Montasio Mont Cenis Patagras Piora Queso de Prensa Radener Roll Romanello Romano Saloio Sassenage Swiss Tibet Tignard Toscanello Uri

Karut Kasseri Kefalotyi

Vize

PART III - INSPECTIONAL A. INSPECTIONAL Establishment inspections for domestic cheese and cheese product manufacturers are to be conducted according to the following priority order: Soft Cheese Hard Cheese Cheese Products Refer to ORA Workplan for the number of inspections to be conducted by Districts. Cover the product(s) that will provide a complete description of a firm=s condition and overall compliance status. Care should be taken during the inspection to fully identify sources of filth and possible routes of contamination of the product. Also, because of the nature of the adulteration, in-line bacteriological sampling may be indicated. For further guidance on conducting inspections involving microbial contamination, refer to the IOM, January 1998, Sections 536.2 and 427.7 respectively, for inspectional guidance and sampling instructions for products susceptible to pathogenic and nonpathogenic organisms. For further inspectional guidance on cheese plants, refer to the Guide to Inspections of Dairy Product Manufacturers, April 1995, pp. 12-16. Cover railcars or trucks which are off-loading or being loaded to insure food products are shipped in compliance. When the condition of a transport vehicle may lead to food contamination, attempt to dissuade the shipper from using it. If unsuccessful, notify the destination District so they may follow-up. See PART V - Regulatory/ Administrative Follow-Up for more information. B. SAMPLE COLLECTION C. General Information CRefer to ORA Workplan for District sampling obligations. CDuring scheduled inspections, collect samples when either of the following criteria have been met: the firm has a previous history of microbiological contamination (e.g., follow up to illness or injury complaint, recalled/seized product, previous inspectional history, etc.), or sampling is conducted Afor cause@ (e.g., inspectional observations warrant collection of samples for microbiological analyses) D. Sampling Priorities - Domestic and Import When possible, samples are to be collected in the following priority order: Soft Cheese Hard Cheese Cheese Products NOTE: This excludes cheese subject to detention without physical examination in accordance with current Import Alerts. E. Sample Size - Domestic and Import For the purpose of this compliance program only, the number of samples are to be collected as follows: Samples are to be collected in solid, shredded, grated, curds or extruded forms.

Imports For cheese wheels, loaves, or bricks ranging in weight from 2. 27 kg (5 lbs.) or greater, collect a sample consisting of two (2) intact units from the same lot. For retail units ranging in weight from 454 g (1 lb. ) to less than 2. 27 kg (5 lbs.), collect a sample consisting of ten (10) intact units (subsamples)from the same lot. For retail units weighing less than 454 g (1 lb. ), collect enough units to represent one (1) sample (i.e., ten (10) subsamples). For example, if the product is only available in 227 g (8 oz.) units, collect twenty (20) intact units from the same lot. Therefore, two (2) units each will equal one (1) subsample. NOTE: Larger retail packages should not be broken or cut to obtain a 454 g (l lb. ) subsample. Collect the intact retail unit as the subsample, even if it is larger than 454 g (1 lb. ) Do not collect cheese portions that were cut from larger loaves, bricks or wheels and rewrapped at the retail level. IMPORT SHIPMENTS SAMPLED MUST BE HELD PENDING ANALYSES, IN ACCORDANCE WITH 21 CFR 1.90. Domestic For retail units ranging in weight from 454 g (1 lb. ) to less than 2. 27 kg (5 lbs.), collect a sample consisting of ten (10) intact units (subsamples)from the same lot. For retail units weighing less than 454 g (1 lb. ), collect enough units to represent one (1) sample (i.e., ten (10) subsamples). For example, if the product is only available in 227 g (8 oz.) units, collect twenty (o) intact units from the same lot. Therefore, two (2) units each will equal one (1) subsample. NOTE: Larger retail packages should not be broken or cut to obtain a 454 g (l lb. ) subsample. Collect the intact retail unit as the subsample, even if it is larger than 454 g (1 lb. ) Do not collect cheese portions that were cut from larger loaves, bricks or wheels and rewrapped at the retail level.

For cheese wheels, loaves, or bricks ranging in weight from 2. 27 kg (5 lbs.) or greater, collect a sample consisting of two (2) intact units from the same lot. A separate 702(b) portion will not be necessary for collection under this program per exemption under 21 CFR 2. 10(b)(3). F. Sample Shipment Ship samples to District's servicing microbiological laboratory. Refer to IOM, January 1998, Section 452. 6, for sample handling of refrigerated samples. G. Reporting Report collections of cheese and cheese products for microbiological contamination, phosphatase and filth ONLY against this Compliance Program. Refer to title page for appropriate PACs. DO NOT REPORT COLLECTIONS FOR MISUSE OF CHEMICALS BY THE FIRM, FOOD/COLOR ADDITIVES OR NUTRITION LABELING (NLEA)/NUTRIENT CONTENT AGAINST THIS PAC. Report all operations expended for monitoring (audit samples) the certificate agreement with France (Import Alert 12-03) and current detentions without physical examination (automatic detentions) of other cheeses from countries other than France against this Compliance Program (PAC 03037). Products subject to the certificate agreement with France are to be audit sampled at the District's discretion. When audit samples are collected, these

samples are to be coded as SAMPLE TYPE "C" when reported into the Program Oriented Data System (PODS).

PART IV - ANALYTICAL A. MICROBIOLOGICAL AND PHOSPHATASE ANALYSIS 1. Analyzing Laboratories All field laboratories as specified in the current servicing laboratories chart under Appendix III of the ORA Field Workplan. 2. Analyses to be Performed Each sample must be analyzed for the following six (6) attributes: a. Listeria monocytogenes b. Salmonella c. Escherichia coli and Enterotoxigenic E. coli (ETEC) NOTE: ETEC WILL ONLY BE PERFORMED IF E. COLI IS PRESENT AT 104 (10,000) OR ABOVE PER GRAM. d. Enterohemorrhagic E. coli (O157: H7) e. Staphylococcus aureus NOTE: STAPHYLOCOCCAL ENTEROTOXIN TESTING WILL ONLY BE PERFORMED IF PRODUCT ABUSE IS SUSPECTED, OR IF VIABLE STAPHYLOCOCCAL SPP. COLONIES, MPN RESULTS OR DIRECT PLATE COUNTS INDICATES A LEVEL OF 1 x 104. f. Phosphatase 3. Sample Preparation For the purpose of this compliance program only, samples are to be prepared as follows: a. Import or Domestic Cheese - 2. 27 kg (5 lbs.) or greater NOTE: IT IS VERY IMPORTANT TO REMOVE PORTIONS FOR MICROBIOLOGICAL ANALYSES FIRST BEFORE PERFORMING PHOSPHATASE ANALYSES. SPECIAL PRECAUTIONS MUST BE TAKEN TO AVOID CONTAMINATING THE PORTIONS FOR MICROBIOLOGICAL ANALYSES AS WELL AS THE PORTION FOR PHOSPHATASE ANALYSES WITH MICROBIAL PHOSPHATASE THAT MAY BE PRESENT ON THE SURFACE. REMAINING PORTIONS ARE TO BE USED FOR FILTH ANALYSIS WHEN NECESSARY. Since the product will be analyzed for multiple pathogens under this program, compositing and individual subsample analysis on the same sample will be necessary. 1. Listeria and Salmonella Two (2) composites per sample will be analyzed. Obtain each composite aseptically, divide the cheese unit in half; take a plug of the cheese, which includes both surfaces from each half of the cheese unit; For Listeria analysis, remove 125 g from each of the halves in order to obtain a 250-gram composite. Remove 25 g from the

composite for analysis. For Salmonella analysis, remove 187.5 g from each of the halves in order to obtain a 375-gram composite. To obtain the second composite for each analysis, repeat this process on the other individual unit of cheese. NOTE: When compositing shredded, grated and extruded forms of cheese, remove the amount required for each composite from the packages aseptically in order to obtain the required composite amounts for Listeria and Salmonella analysis. To obtain the second composite for analysis, repeat this process on the other packages. 2. E. coli,ETEC,EHEC,and S.aureus Once the portions have been removed for the Listeria and Salmonella composites, analyze each individual subsample for these pathogens. b. Import or Domestic Cheese - retail units 454 g (1 oz.) Since the product will be analyzed for multiple pathogens under this program, compositing and individual subsample analysis on the same sample will be necessary. 1. Listeria Make two (2) composites from the ten (10) subsamples. Prepare each composite by removing 50 g from each of five (5) subsamples. Each composite will contain a total of 250 g. Remove 25 g from each composite for analysis. 2. Salmonella Make (2) composites from the ten (10) subsamples. Prepare each composite by removing 75 g from each of five (5) subsamples. Each composite will contain a total of 375 g. NOTE: When compositing shredded, grated and extruded forms of cheese, remove the amount required for each composite from the packages aseptically in order to obtain the required composite amounts for Listeria and Salmonella analysis. To obtain the second composite for analysis, repeat this process on the other packages. 3. E. coli,ETEC,EHEC,and S.aureus Once the portions have been removed for the Listeria and Salmonella composites, analyze each individual subsample for these pathogens. 4. Sample Preparation for Phosphatase Analysis a. Import or Domestic Cheese - subsamples 2. 27 kg (5 lbs.) or greater Refer to BAM 8th Ed. ,1995, Chapter 27, Screening Method for Phosphatase (Residual) in Cheese, Section C, Sampling of Cheeses, for sample preparation. Remove a 15 g plug of cheese from freshly exposed surface at or near center of cheese. NOTE: SPECIAL PRECAUTIONS MUST BE TAKEN TO AVOID CONTAMINATING SAMPLE WITH MICROBIAL PHOSPHATASES THAT MAY BE PRESENT ON THE

SURFACE OF THE CHEESE. For samples of shredded, grated or extruded forms of cheese, remove 15 g from the unit aseptically for analysis. b. Import or Domestic Cheese - retail units 454 g (1 lb. ) Randomly select two (2) subsamples. Refer to BAM 8th Ed. ,1995, Chapter 27, Screening Method for Phosphatase (Residual) in Cheese, Section C, Sampling of Cheeses, for sample preparation. Remove a 15 g plug of cheese from freshly exposed surface at or near center of cheese. NOTE: SPECIAL PRECAUTIONS MUST BE TAKEN TO AVOID CONTAMINATING SAMPLE WITH MICROBIAL PHOSPHATASES THAT MAY BE PRESENT ON THE SURFACE OF THE CHEESE. For samples of shredded, grated or extruded forms of cheese, remove 15 g from the unit aseptically for analysis. 5. Methodology a. Listeria monocytogenes 1. Examine (2) composites. Safety Precautions: Media preparation for L. monocytogenes directs the use of cycloheximide which is an extremely toxic chemical. Likewise, the L. monocytogenes method requires the use of acriflavin HCl which is a powerful mutagen (use caution). Since the L. monocytogenes method gives the option of using a naphthol, DO NOT use a - Naphthylamine. All analysts should take extreme safety precautions when handling this chemical; i.e., weigh in a containment hood free of drafts; wear gloves and face mask. Those laboratories with pesticide capabilities should take additional precautions against possible contamination as cycloheximide is a fungicide. Isolation and identification -- BAM 8th Ed. ,1995, Chapter 10 and 11. Additionally, Rapid Test Kits as identified in the memo, A Guidance for the Use of Listeria Rapid Methods for Food Microbiology@ dated July 9, 1998, may be used according to the instructions and restrictions explained in the memo. If the laboratory does not have a copy of the memo, they should request a copy from the Division of Field Science, HFC-140. Gene Probe -- If the sample is found to be positive for L. monocytogenes and growth was observed at 24 hrs, then enumerate using the gene probe method, BAM, 8th Ed. , 1995, Chapter 24. Phage Typing -- If the sample is found to be positive for L. monocytogenes, then send representative isolated cultures to DEN for phage typing.

Isolated cultures should be prepared on trypticase soy agar slants with 0.6% yeast extract in screw capped test tubes. Identify each culture with a sample number, subsample number and serotype. Send a copy of the collection report and analyst worksheet for each sample. Place accompanying records inside the shipping container, but not in the culture container. Ship according to Federal Standards for

etiological agents to: McHarrell Thomas Food and Drug Administration P.O. Box 25087 Denver Federal Center Building 20 Denver, Colorado 80225-0087 Contact McHarrell Thomas, Supervisory Microbiologist at (303) 2363067 or Moises O=Neill, Microbiologist at (303) 236-9605, with shipping information. b. Salmonella 1. Examine (2) composites. 2. Isolation and identification -- BAM, 8th Ed. , 1995, Chapter 5. Additionally, Rapid Test Kits as identified in the memo, AGuidance for the Use of Rapid Methods for Food Microbiology@ dated April 24, 1998, may be used according to the instructions and restrictions explained in the memo. If the laboratory does not have a copy of the memo, they should request a copy from the Division of Field Science, HFC-140. 3. Speciation -- Submit cultures on brain heart infusion (BHI) agar slants and provide hardcopy information as directed in BAM, 8th Ed. , 1995, Chapter 5, section E.11. and send to: Food and Drug Administration ATTN: Al Schwab, HFR-MW400 240 Hennepin Avenue Minneapolis, MN 55401 c. E.coli/Enterotoxigenic E. coli (ETEC) 1. Examine each subsample individually. 2. Isolation, identification, and enumeration -- BAM, 8th Ed. , 1995, Chapter 4. 3. LT/ST Toxin Test -- BAM, 8th Ed. , 1995, Chapter 24. NOTE: Do not analyze for ETEC unless E. coli is > 10,000 per gram. d. Enterohemorrhagic E.coli (0157: H7) 1. CExamine each subsample individually. 2. "Isolation Methods for Enterohemorrhagic E. coli (EHEC)", BAM, 8th Ed. ,1995, Chapter 4, page 4. 20, C. AIsolation with TelluriteCefixime-Sorbitol MacConkey (TC SMAC) Agar.@ e. Staphylococcus aureus 1. Examine each subsample individually. 2. Direct microscope examination -- BAM, 8th Ed. , 1995, Chapter 2, Microscopic Examination of Foods. NOTE: Do not quanitate. Do smear to get general idea of number of cocci present, only. 3. Identification, enumeration, coagulase, ancillary tests, and viable count (MPN) -- BAM, 8th Ed. , 1995, Chapter 12. NOTE: Do not perform enterotoxin testing unless viable Staphylococcal spp. colonies, MPN results of direct plate counts indicate a level of 1 x 104 or product abuse is suspected.

f. Staphylococcal Enterotoxin Determination Refer to the guidance provided in the memorandum dated August 1, 1997, *Revised Guidance for Staphylococcal Enterotoxin Testing in Foods.* Subsamples are not to be composited for analysis; each subsample is to be tested individually. g. Phosphatase NOTE: Any cheese sample that has been made from raw/ unpasteurized milk, without proper curing or use of a process that is an acceptable alternative to pasteurization as outlined in the applicable regulation in 21 CFR Part 133, is prohibited from introduction into interstate commerce as cited in 21 CFR Section 1240.61(a). 1. Products to be Analyzed Soft/semi-soft/soft-ripened cheese samples MUST be analyzed for phosphatase and for all the other attributes specified under A. 2. "Analyses to be Performed." Soft cheeses containing herbs MUST be analyzed for phosphatase and for all the other attributes specified under A. 2. "Analyses to be Performed." Naturally aged (cured) cheese samples should NOT be analyzed for phosphatase, but MUST be analyzed for all the other attributes specified under A. 2. "Analyses to be Performed. " NOTE: A naturally aged cheese is one made from unpasteurized milk which has been cured at a temperature of not less than 35 degrees F for not less than 60 days. Other cheeses that are labeled as either pasteurized or made from dairy ingredients that have all been pasteurized MUST be analyzed for phosphatase and for all the other attributes specified under A. 2. "Analyses to be Performed. " 2. Screen Analysis To determine the amount of phosphatase in a cheese sample, refer to BAM, 8th Ed. , 1995, Chapter 27, "Screening Method for Phosphatase (Residual) in Cheese" NOTE: Do NOT perform this screening method on any *soft* cheeses containing herbs. Instead perform the method, referenced under 3) Check Analysis below, directly on these cheeses to determine the phenol equivalent value. Refer to Table 1 of the method for the maximum phenol equivalent values allowed in different types of cheese and the 21 CFR Part 133 reference. A sample is violative for phosphatase: if the cheese is listed in Table 1, and the phenol equivalent value per gram is greater than the value listed for the cheese in Table 1; or, if the cheese is NOT listed in Table 1, and the phenol equivalent value per gram is greater than 12 mg. 3. Check Analysis Check analyses MUST be performed on ALL violative samples.

Method: AOAC,16th Ed. , 33. 7.27 AOAC Official Method 946. 03, Phosphatase (Residual) in Cheese, Final Action NOTE: This method is equivalent to AOAC Method 16. 275-16. 277 (13th Ed. , 1980), cited in 21 CFR 133. 5(c). B. FILTH ANALYSIS Filth analysis can be performed at the District's discretion. 1. Analyzing Laboratories All field laboratories as specified in the current servicing laboratories chart under Appendix III of the ORA field workplan. 2. Sample Preparation Instructions for Filth Analysis a. Import or Domestic Cheese - subsamples 2. 27 kg (5 lbs.) or greater Remove six (6) - 227 g (8 oz.) subsamples from the unit of cheese. For samples of shredded, grated or extruded forms of cheese, remove the same amount. NOTE: Each subsample should be examined individually and not composited. b. Import or Domestic Cheese - consumer size units, 227 g (8 oz.) Randomly select six (6) subsamples from the remaining portions of the ten (10) subsamples used for micro and phosphatase analysis. Remove 227 g (8 oz.) from each of the six (6) subsamples for analysis. For samples of shredded, grated or extruded forms of cheese, remove the same amount. NOTE: Each subsample should be examined individually and not composited. 3. Analytical Guidance Filth, Mold and Foreign Objects: Microscopic and Macroscopic Methodology: AOAC, 16th Ed. , Chapter 16, Extraneous Materials: Isolation, AOAC Official Method 994. 05 (see 16. 3. 04), Light Filth in Cheeses (Supplement March 1995), page 12. If not applicable, then use: AOAC, 16 Ed., Chapter 16, Extraneous Materials: Isolation, AOAC Official Method 960.49 (see 16. 3. 03), Filth in Dairy Products (Supplement March 1995), pages 1112. C. ANALYTICAL REPORTING NOTE: Report all microbiological, phosphatase and filth analyses against this Compliance Program only(refer to title page for appropriate PACs). DO NOT REPORT ANALYSES FOR CHEMICAL MISUSE, FOOD/COLOR ADDITIVES, OR NUTRITION LABELING (NLEA)/NUTRIENT CONTENT AGAINST THIS PAC. 1. Microbiological and Phosphatase a. CMIN will notify the Home District of the results of the speciation. b. Record all analytical findings, including the level of microorganism found (if appropriate) on Attachment A, Analytical Reporting Form. c. Laboratories will send Attachment A on an as completed basis to HFS-606, Attn: Cheese Monitor. Refer to page 1 of this Compliance Program for mailing address. d. Laboratories will enter data into MICRO-IS using established Q-Sets. e. LMS data entry for Salmonella - Use Form Code "MIC" and Flag Code "MIC" f. DEN will submit a copy of the analytical worksheets for samples analyzed for L. monocytogenes phage typing on an as completed basis to HFS-606, ATTN: Cheese Monitor. Refer to page 1 of this Compliance Program for mailing

address. 2. Filth a. Record all filth findings on Attachment B. Also, when completing Attachment B, be sure to indicate the method used on the form. b. Laboratories will send Attachment B on an as completed basis to HFS-606, Attn: Cheese Monitor. Refer to page 1 of this Compliance Program for mailing address. PART V - REGULATORY/ADMINISTRATIVE FOLLOW-UP When an investigation leads to the conclusion that the condition of a transport vehicle may lead to food contamination, attempt to dissuade the shipper from using the vehicle. If unsuccessful, notify the destination District so they may follow-up. Send a recommendation to CFSAN/Division of Enforcement and Programs, Case Processing Branch, HFS-607, for issuance of a "Warning Letter" to the shipper. If an investigator suspects that a carrier, through the conditions on its transport vehicles, may have been responsible for the contamination of food, follow the guidance provided in CPG 545. 300 with regard to action against the carrier. Listeria and Salmonella<</u>/p> Direct reference seizure or detention of cheese and cheese products based on the presence of Listeria monocytogenes or Salmonella is authorized (see CPG Sec. 527.300, Pathogens in Dairy Products, August 1996 Edition). If no INTERSTATE documentation can be associated with intrastate cheese samples, all positive findings of L. monocytogenes or Salmonella are to be referred to State authorities for follow-up activities. Provide assistance to the state for sanctioning their follow-up activity, if requested. Obtain information on the follow-up activities the State plans to initiate on the remaining product at the retail store and/or processing plant (if applicable). Send this information to the address identified on page 1 of this program. Recommendations for detention without physical examination of imported products should be referred to the Division of Import Operations and Policy, Operations and Policy Branch (HFC-172) . E. coli, Enterotoxigenic E. coli (ETEC), Enterohemorrhagic E. coli (0157: H7)(EHEC)and Staphylococcus aureus For products in domestic or domestic/import status, notify the CFSAN/ DOEP regulatory contact listed in PART V, under section C. PROGRAM CONTACTS, for further guidance if the following levels for E. coli, ETEC, Enterohemorrhagic E. coli or Staphylococcus aureus are found: E. coli - 1 X 104 or greater organisms per gram; perform inspection to document insanitary conditions ETEC - 1 x 103 per gram, LT or ST positive. EHEC - presence of organism. S. aureus - positive for Staphylococcal enterotoxin or when viable count (MPN) is 1 x 104 or greater per gram and toxin test is negative. For imported products, refer to the appropriate Compliance Policy Guides and Import Alerts for further guidance. In the absence of a CPG or Import Alert, notify the CFSAN/DOEP regulatory contact listed in PART V, under section C. PROGRAM CONTACTS, for further guidance if the levels stated above are found. Recommendations for detention must be accompanied by all analytical worksheets (original and check, when required)and other appropriate documentation (entry paperwork,

collection report, labeling, etc. ). Recommendations for detention without physical examination of imported products should be referred to the Division of Import Operations and Policy, (HFS-170). Phosphatase Districts should submit recommendations for regulatory action based on phosphatase findings to CFSAN using the following criteria: For standardized cheeses with phenol equivalent value cited in 21 CFR Part 133: a cheese sample with a phenol equivalent value per gram greater than the value listed in Attachment C. The table lists the type of cheese, the maximum phenol equivalent value allowed per gram of cheese, and the appropriate 21 CFR reference.

For standardized cheeses without a phenol equivalent value cited in 21 CFR Part 133 and nonstandardized cheeses: a cheese sample made from PASTEURIZED milk with a phenol equivalent value per gram greater than 12 mg, or a cheese sample made from UNPASTEURIZED milk and cured (aged) properly with a phenol equivalent value per gram greater than 12 mg. ANY cheese sample made from either RAW or UNPASTEURIZED milk without proper curing or use of a process that is an acceptable alternative to pasteurization as outlined in 21 CFR Part 133. 21 CFR Section 1240.61(a) prohibits such cheeses from introduction into interstate commerce.

NOTE: BEFORE RECOMMENDING REGULATORY ACTION, CHECK ANALYSES MUST BE PERFORMED ON ALL VIOLATIVE SAMPLES USING THE AOAC 16TH EDITION METHOD 943. 03 (33. 7.27), APHOSPHATASE (RESIDUAL) IN CHEESE (FINAL ACTION)@. THIS METHOD IS EQUIVALENT TO THE AOAC 13TH EDITION METHOD, APHENOL EQUIVALENT VALUE@, SECTIONS 16. 275-16. 277, AS CITED IN 21 CFR PART 133, SECTION 133. 5(c). PART VI - REFERENCES, ATTACHMENTS AND PROGRAM CONTACTS A. ATTACHMENTS Attachment A, pp.1,2,3-Analytical Reporting Form - Microbiological Analyses Attachment A, page 4-Analytical Reporting Form - Phosphatase Analyses Attachment B -Analytical Reporting Form - Filth Analyses Attachment C -List of Standardized Cheeses with Phenol Levels from 21 CFR Part 133 B. REFERENCES Guide to Inspections of Dairy Product Manufacturers, April 1995 (Copies may be obtained from the ORO Division of Emergency and Investigational Operations, Investigations Branch, HFC-132, (301) 443-3340.) *Revised Guidance for Staphylococcal Enterotoxin Testing in Foods* - Memorandum dated August 1, 1997. (Copies may be obtained from Rosemary Gary, Division of Enforcement and Programs, Imports Branch, HFS-606, (202) 205-4606. ) AGuidance for the Use of Rapid Methods for Food Microbiology@ dated April 24, 1998. (Copies may be obtained from the Division of Field Science, HFC-140.)

*Guidance for the Use of Listeria Rapid Methods for Food Microbiology* dated July 9, 1998. (Copies may be obtained from the Division of Field Science, HFC-140.)

C. PROGRAM CONTACTS General Program Matters - Rosemary Gary, CFSAN/OFP/Division of Enforcement and Programs/Imports Branch, HFS-606, (202) 205-4606, FAX (202) 260-0208 Regulatory Contact Domestic and Domestic/Imports - Donald Greaves, CFSAN/OFP/Division of Enforcement and Programs/Case Processing Branch, HFS-607, (202) 205-5235 Imports - Rosemary Gary, CFSAN/OFP/Division of Enforcement and Programs/Import Branch, HFS-606, (202) 205-4606, FAX (202) 260-0208 Inspectional Inquiries - Barbara Marcelletti, Division of Emergency and Investigational Operations, Investigations Branch, HFC-132, (301) 827-5635 Import Alert and Import Procedures Inquiries - Doug Randes, Division of Import Operations and Policy, HFS-170, (301) 443-6553. Analytical Inquiries - Division of Field Science, HFC-141, (301) 443-3320. Microbiology -Marsha Hayden, (301) 443-3007 Filth -Larry D=Hoostelaere, (301) 443-3320 D. SPECIFIC METHOD CONTACTS E. coli - William L. Payne, CFSAN/Division of Molecular Biological Research & Evaluation/Molecular Biology Branch, HFS-237, (202) 205-6341 Enterohemorrhagic E. coli (EHEC) - Peter Feng, CFSAN/Division of Microbiological Studies/Microbiology Methods Development Branch, HFS-516, (202) 205-4518 Salmonella - Wallace Andrews, Jr., CFSAN/Division of Microbiological Studies/Microbiology Methods Development Branch, HFS-516, (202) 205-4462 Listeria - Anthony Hitchins, CFSAN/Division of Microbiological Studies/Microbiology Methods Development Branch, HFS-516, (202) 205-4650 Listeria Gene Probe - Thomas Cebula, CFSAN/Division of Molecular Biological Research & Evaluation/Molecular Biology Branch, HFS-237, (202) 205-4817 Phosphatase - George C. Ziobro, CFSAN/Division of Natural Products/Microanalytical Branch, HFS-315, (202) 205-4994

Filth - John S. Gecan, CFSAN/Division of Natural Products/ Microanalytical Branch, HFS-315, (202) 205-4911 PART VII - CENTER RESPONSIBILITY

The Director, Office of Plant and Dairy Foods and Beverages (OPDFB), HFS-300 will evaluate the effectiveness of the program and provide further guidance to the Director, Division of Enforcement and Programs, HFS-605, as appropriate by the dates indicated below: EvaluationDue FY 1999 April FY 2000 April FY 2001 April Date 1, 2000 1, 2001 1, 2002

DOMESTIC AND IMPORTED CHEESE ANALYTICAL REPORTING FORM - MICROBIOLOGICAL ANALYSES FY: _______ SAMPLE NUMBER: ____________________ TYPE OF CHEESE: ____________________ (e.g. , hard, soft, semi-soft, soft- ripened) COLLECTING DISTRICT: ______________ ANALYZING DISTRICT: _______________ NAME OF CHEESE: ___________________ (e.g. , colby, swiss, feta, brie, etc. ) COUNTRY OF ORIGIN: ________________ ************************************************************************ ANALYSIS COMPOSITE 1 COMPOSITE 2 ************************************************************************ LISTERIA (circle one) POS NEG POS NEG SPECIES: SEROTYPE: If positive growth at 1: 10 24 hrs. for L. monocytogenes, give gene probe 1: 100 results: RAPID TEST KIT USED ************************************************************************ SALMONELLA (circle one) POS NEG POS NEG GROUP: SPECIES, IF KNOWN: RAPID TEST KIT USED DOMESTIC AND IMPORTED CHEESE ANALYTICAL REPORTING FORM - MICROBIOLOGICAL ANALYSES (CONTINUED) FY: _______ SAMPLE NUMBER: ____________________ TYPE OF CHEESE: __________________ (e.g. , hard, soft, semi-soft, soft-ripened) COLLECTING DISTRICT: ______________ ANALYZING DISTRICT: _______________ NAME OF CHEESE: _________________ e.g. , colby, swiss, feta, brie, etc. ) COUNTRY OF ORIGIN: ________________ MICROORGANISM E. COLI (+/-)and MPN/G SUB # 1 SUB # 2 SUB # 3 SUB #4 SUB # 5

ETEC (ND/+/-)and Level found EHEC 0157: H7 (INDOLE SCREEN) (+ / - ) EHEC 0157: H7 (TEST KIT) (+ / - ) EHEC 0157: H7 (GENE PROBE) LEVEL/GM S. AUREUS (LEVEL/G) STAPH ENTEROTOXIN (+/-) If positive, list absorbance level:

DOMESTIC AND IMPORTED CHEESE ANALYTICAL REPORTING FORM - MICROBIOLOGICAL ANALYSES (CONTINUED) FY: _______ SAMPLE NUMBER: ____________________ TYPE OF CHEESE: __________________ (e.g. , hard, soft, semi-soft, soft-ripened) COLLECTING DISTRICT: ______________ ANALYZING DISTRICT: _______________ NAME OF CHEESE: _________________ (e.g. , colby, swiss, feta, brie, etc. ) COUNTRY OF ORIGIN: ________________ MICROORGANISM SUB # 6 SUB # 7 SUB # 8 SUB # 9 SUB # 10

E. COLI (+/-)and MPN/G ETEC (ND/+/-)and Level found EHEC 0157: H7 (INDOLE SCREEN) (+ / - ) EHEC 0157: H7 (TEST KIT) (+ / - ) EHEC 0157: H7 (GENE PROBE) LEVEL/GM S. AUREUS (LEVEL/G) STAPH ENTEROTOXIN (+/-) If positive, list absorbance level:

DOMESTIC AND IMPORTED CHEESE ANALYTICAL REPORTING FORM - PHOSPHATASE ANALYSES FY: ________ SAMPLE NUMBER: ____________________ TYPE OF CHEESE: ____________________ (e.g. , hard, soft, semi-soft, soft- ripened) COLLECTING DISTRICT: ______________ ANALYZING DISTRICT: _______________ NAME OF CHEESE: ___________________

(e.g. , cheddar, swiss, feta, brie, etc. ) COUNTRY OF ORIGIN: ________________ ************************************************************************ **** ANALYSIS SUBSAMPLE 1SUBSAMPLE 2 ************************************************************************ **** PHOSPHATASE METHOD USED: mg phenol equivalents/g CHEESE FILTH REPORTING FORM FY: ________ SAMPLE NUMBER: __________ METHOD NO. SUBSAMPLE WT. COLLECTING DISTRICT: _________________ ANALYZING DISTRICT: _________________ COUNTRY OF ORIGIN: ___________________ PRODUCT NAME: **_____________________________________ MANUFACTURER/DISTRIBUTOR: _________________________________________________________________________ Filth Findings Subsample Number 1 1. W/E Stored Product Insects* 2. W/E Filth Insects* 3. W/E Other Insects* 4. Insect Fragments - Stored Product* 5. Insect Fragments - Filth* 6. Insect Fragments - Other* 7. Fly Setae 8. Other Insect Filth (describe) 9. Mites* 10. Other Arthropods 11. Rat/Mouse Hairs (include size) 2 3 4 5 6

12. Cat/Dog Hairs (include size) 13. Other Striated Hairs (include size) 14. Human Hairs (include size) 15. Other Non-Striated Hairs (ID & size) 16. Feather Fragments (size) 17. Other (Describe) 18. Other (Describe) 19. Other (Describe) 20. Other (Describe)

Submit to: U.S. Food and Drug Administration, Attn: Rosemary Gary, HFS-606, 200 "C" Street, S.W., Washington, D.C. 20204; Phone: 202-205-4606; FAX: 202-260-0208 * IDENTIFY WHEN POSSIBLE. ** INCLUDE COPY OF INGREDIENT STATEMENT, WHEN AVAILABLE. List of Standardized Cheeses with Phenol Levels from 21 CFR Part 133 Cheese Fg phenol/ g cheese 20 12 12 12 12 12 12 12 CFR Reference

brick cheddar colby cook cheese, koch kaese washed curd and soaked curd edam granular and stirred curd gruyere

133. 108(a)(2) 133. 113(a)(2) 133. 118(c)(2) 133. 127(a)(2) 133. 136(a)(2) 133. 138(a)(2) 133. 144(a)(2) 133. 149(a)(2)

hard limburger monterey & monterey jack mozzarella & scamorza low moisture mozzarella & scamorza muenster & munster pasteurized process pasteurized process cheese food pasteurized neufchatel cheese spread with other foods pasteurized process cheese spread provolone samsoe semisoft semisoft part-skim spiced swiss & emmentaler

12 16 12 12 12 12 12 12 12 12 12 12 20 20 12 12

133. 150(c)(2) 133. 152(a)(2) 133. 153(a)(2) 133. 155(a)(2) 133. 156(a)(2) 133. 160(a)(2) 133. 169(a)(2) 133. 173(a)(2) 133. 178(a)(2) 133. 179(a)(2) 133. 181(a)(2) 133. 185(a)(2) 133. 187(c)(2) 133. 188(c)(2) 133. 190(a)(2) 133. 195(a)(2)

NOTE: The phenol equivalent value per gram of cheese was obtained by multiplying the value listed in the 21 CFR reference by 4.