Attachment_14.pdf

FOOD AND DRUG ADMINISTRATION

PROGRAM 7303.037 COMPLIANCE PROGRAM GUIDANCE

MANUAL

CHAPTER 03 - FOODBORNE BIOLOGICAL HAZARDS

SUBJECT: IMPLEMENTATION

DATE

DOMESTIC AND IMPORTED CHEESE AND CHEESE

PRODUCTS

Upon Receipt

COMPLETION DATE

CONTINUING

DATA REPORTING

PRODUCT CODES PRODUCT/ASSIGNMENT CODES

INDUSTRY CODE: 12

1. REPORT INSPECTIONS UNDER

THE FOLLOWING PACS:

03037 Inspections, Investigations, and Sample Collections

USE APPROPRIATE PRODUCT

CODES

03037B Filth Analysis

03037D Microbiological and Phosphatase Analyses

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), NUTRIENT CONTENT OPERATIONS, STANDARDS AND

IDENTIFICATION FOR CHEESE AND CHEESE PRODUCTS ARE COVERED UNDER THE

DOMESTIC AND IMPORT FOOD LABELING ENFORCEMENT (7321.005) COMPLIANCE

PROGRAM.

REPORT ALL OPERATIONS EXPENDED FOR MONITORING THE CERTIFICATE

AGREEMENT WITH FRANCE (AUDIT SAMPLES; IMPORT ALERT 12-03, Detention Without Physical Examination of Imported Soft Cheese and Soft Ripened Cheese from France) AND CURRENT http://cms.fda.gov/vts/imports_publish/private/importalert_7.html

DETENTIONS WITHOUT PHYSICAL EXAMINATION OF OTHER CHEESES FROM ALL

COUNTRIES AGAINST THIS PROGRAM (PAC: 03037).

PART I - BACKGROUND

Cheese and cheese products may contain pathogenic microorganisms and thereby cause human illness. Some cheeses (primarily soft cheeses) have been linked to foodborne outbreaks and illnesses caused by Salmonella, Listeria monocytogenes, pathogenic Escherichia coli and enterotoxigenic Staphylococcus aureus contamination.

The presence of these pathogens is often times associated with poor GMPs, and/or an inadequate or total lack of a pasteurization process. For this reason, any cheese or cheese product 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 21 CFR Part 133, is prohibited from introduction into interstate commerce as cited in 21 CFR Section 1240.61(a). The presence of alkaline phosphatase in levels exceeding the limits set forth in the standard identities for cheeses found in 21 CFR 133, is another indicator of inadequate pasteurization.

Due to continuing microbiological concerns associated with cheese and cheese products, this Compliance Program covers the sampling of domestic and imported cheese and cheese products for undesirable microorganisms as well as alkaline phosphatase and filth analysis.

PART II - IMPLEMENTATION

OBJECTIVE

• To conduct inspections of cheese manufacturers in the U.S. and cheese manufacturers in countries that export cheese to the United States.

• To collect and test samples of imported and domestic cheese for microbiological contamination, alkaline phosphatase and filth.

• To take appropriate action on imported lots and domestically produced cheese when violations are encountered and appropriate regulatory action(s) against the responsible firms.

Program Management Instructions

A. Import Alerts and Bulletins

Resources and operations expended for current Import Alerts/Bulletins to collect and test samples of cheese for microbiological contamination, alkaline phosphatase analysis and filth must be reported against this Compliance Program.

B. Examples of Five Cheese Categories

Below are five tables with examples of cheese varieties appropriate to each category. These tables are listed in order of the associated public health risk, with Soft Cheese varieties posing the greatest risk. Under this Compliance Program, priority should be given to Soft Cheese and Soft-ripened Cheese varieties, followed by Semi Soft Cheeses.

1. Examples of "Soft (fresh)" Cheese

Alemtejo Cottage Maigre Queso Fresco Alpin Cream Mignot Provatura Anari Damen Mont d'Or Ricotta Asadero Farmers Mozzarella Scamorze Asiago Ferme Neufchatel Villiers Bakers Feta Queso Blanco Void Banbury Formagelle Queso de Hoja Bondon Gournay Queso del Pais Cambridge Livarot Queso de Puna

2. Examples of “Soft-ripened” Cheese

Barberey Coulommiers Monthery Scholoss Bel Paese Crescenza Old Heidlburg Trouville

Bella Alpina Gorgonzola Reblochon Vacherin Bella Milano Gouda Robbiole Vittoria Brie Kloster Robbiolini Vendome Butter Konigskrase Rollot Camembert Milano Romadur

3. Examples of “Semi-Soft” Cheese

Bellelay Gammelost Oka Trappist Blue Havarti Pont LEveque Brick Herve Port du Salut Camosun Limburger Provolone Chantelle Maribo Roquefort Edam Molbo Saint Paulin Fontina Monterey Stilton Fynbo Muenster Tilsit

4. Examples of “Hard” Cheese

Abertam Emiliano Kefalotyi Roll Appenzeller Emmentaler Kjarsgaard Romanello Battelmatt English Dairy Laguiole Romano Bitto Esrum Lapland Saloio Bra Fiore Sardo Lorraine Sassenage Cantel Fontina Mecklenburg

Skim Swiss

Cheddar Gex Montasio Tibet Cheshire Gislev Mont Cenis Tignard Christalinna Gloucester Patagras Toscanello Colby Gruyere Piora Uri Coon Karut Queso de Prensa Vize Derby Kasseri Radener

5. Examples of “Extra Hard” Cheeses

Bagos Grana Trentino Parmesan Sbrinz Bitto Lodigiano Parmesello Schabzieger Creusois Lombardo Peneteleu Spalen Grana Mizen Romano Vasterbottenost Grana Parmegiano Reggiano Saanen Walliskase Padano

PART III - INSPECTIONAL

B. INSPECTIONAL

• Establishment inspections for domestic and imported cheese and cheese product manufacturers are to be conducted according to the following priority order:

1. Soft Cheese and Soft Ripened Cheese

2. Semi-Soft Cheese

3. Hard Cheese

4. Extra Hard Cheese

5. Cheese Products

Refer to ORA Workplan for the number of inspections to be conducted by Districts.

• Include inspection of 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 possible routes of microbial contamination of the product and sources of filth. Also, because of the nature of bacterial contamination, in-line bacteriological sampling may be indicated.

For further guidance on conducting inspections involving microbial contamination, and sampling instructions for products susceptible to pathogenic and non-pathogenic organisms, refer to the IOM, Chapters 5 & 4 respectively. For further inspectional guidance on cheese plants, refer to the Guide to Inspections of Dairy Product Manufacturers, http://www.fda.gov/ICECI/Inspections/InspectionGuides/ucm074974.htm

• Observe and evaluate railcars, trucks and other vehicles used to off-load or load to insure food products are shipped under sanitary conditions. Refer to the Guidance for Industry Sanitary Transportation Of Food, http://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInfor mation/ucm208199.htm

• Document if product time and temperature abuse is suspected.

B. SAMPLE COLLECTION

1. General Information

Refer to ORA Workplan and CFSAN Sample Collection Operations Planning Effort (SCOPE) for District sampling obligations. During scheduled inspections, collect samples when either of the following criteria has been met:

• the firm has a previous history of unmitigated microbiological contamination in the environment and/or in finished product (e.g., follow up to illness or http://www.fda.gov/ICECI/Inspections/IOM/default.htm http://www.fda.gov/ICECI/Inspections/InspectionGuides/ucm074974.htm http://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/ucm208199.htm http://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/ucm208199.htm injury complaint, recalled/seized product, previous inspectional history, etc.), or

• sampling is conducted for cause (e.g., inspectional observations warrant collection of samples for microbiological analyses.)

Please Note- Unless filth analysis is indicated in the collection report, all samples collected under this compliance program will generally be analyzed for general micro and alkaline phosphatase only.

2. Sampling Priorities - Domestic and Import - When possible, samples are to be collected in the following priority order:

a. Soft Cheese and Soft-ripened Cheese

b. Semi-Soft Cheese

c. Hard Cheese

d. Extra Hard Cheese

e. Cheese Products

NOTE: This excludes cheese subject to detention without physical examination in accordance with current Import Alerts. FDA typically does not sample products subject to DWPE.

3. Sample Size - Domestic and Import

For the purpose of this compliance program only, sample sizes to be collected are as follows: (Samples are to be collected in solid, shredded, grated, curds or extruded forms).Samples should be labeled according to IOM 4.5.2.

a. Imports

• For solid cheese (wheels, loaves, or bricks) weighing from 4.54 kg (10 lbs.) or greater, collect a sample consisting of one (1) intact unit from the lot.

• For solid cheese (wheels, loaves, or bricks) ranging in weight from

2.27 kg (5 lbs.) to less than 4.54 kg (10 lbs.), collect a sample consisting of two (2) intact units from the same lot.

• For retail units (solid, shredded, grated, curds or extruded forms) 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.

weighing less than 454 g (1 lb.), collect a sample containing of ten

(10) subsamples with each subsample at least 454 g (1 lb.). 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 to one (1) subsample. Minimum total size for each sub sample should be 454g (1 lb.). Total sample size will be ten (10) pounds or slightly more.

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.

• SAMPLED IMPORTED PRODUCTS MUST BE HELD PENDING

THE ANALYSIS RESULTS IN ACCORDANCE WITH 21 CFR

1.90.

b. Domestic

• For cheese wheels, loaves, or bricks weighing 4.54 kg (10 lbs.) or greater, collect a sample consisting of one (1) intact unit from the lot.

• For cheese wheels, loaves, or bricks ranging in weight from 2.27 kg (5 lbs.) to less than 4.54 kg (10 lbs.), collect a sample consisting of two (2) intact units from the same lot.

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.

weighing less than 454 g (1 lb.), collect a sample containing of ten

(10) subsamples with each subsample at least 454 g (1 lb.). 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 to one (1) subsample. Minimum total size for each sub sample should be 454g (1 lb.). Total sample size will be ten (10) pounds or slightly more.

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.

• A separate 702(b) portion will not be necessary for samples collected to test for microbial analysis under this program per exemption 21 CFR 2.10(b)(3).

• Samples collected for other reasons may require a separate 702(b) portion.

4. Sample Shipment

• Ship samples to District's servicing microbiological laboratory.

• Refer to IOM, Sections 4.5.3, for sample handling and 4.5.3.6 for specific information related to the handling of refrigerated samples.

5. Reporting

• Report collections of cheese and cheese products for microbiological contamination, alkaline phosphatase and filth ONLY against this Compliance Program. Refer to title page for appropriate PACs.

• NOTE: IF FILTH ANALYSIS IS DESIRED BY THE COLLECTING

DISTRICT, INDICATE THAT REQUEST IN THE COLLECTION

REPORT. IF FILTH ANALYSIS IS NOT SPECIFICALLY

REQUESTED IN THE COLLECTION REPORT, THE

LABORATORY WILL ANALYZE FOR GENERAL MICRO AND

ALKALINE PHOSPHATASE ONLY.

• Record any suspected product abuse in the collection report, such as

GMP issues, consumer illness, and/or lack of storage controls. This information will drive the laboratory to include additional pathogens in their microbiological analysis of the sample.

• The following Program Area Flags (PAFs) should be used to identify attributes to be analyzed for the sample collected:

o Microbiological and Alkaline Phosphatase- PAF: MIC o Filth- PAF: FIL http://www.fda.gov/ICECI/Inspections/IOM/default.htm

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 seven (7) attributes:

a. Listeria monocytogenes

b. Salmonella

c. Escherichia coli

NOTE: Non-toxigenic generic E. coli is not a human pathogen.

d. Enterohemorrhagic E. coli (O157:H7) (EHEC) and Shiga toxin-producing E. coli (Non-O157:H7) (STEC)

e. Staphylococcus aureus

NOTE: STAPHYLOCOCCAL ENTEROTOXIN TESTING WILL ONLY

BE PERFORMED IF IT IS NOTED IN THE COLLECTION REPORT

THAT PRODUCT ABUSE IS SUSPECTED, OR IF VIABLE

STAPHYLOCOCCAL SPP. COLONIES, MPN RESULTS OR DIRECT

PLATE COUNTS INDICATES A LEVEL AT OR ABOVE 1 x 104/g.

f. Alkaline Phosphatase

g. Filth*

*NOTE: FILTH WILL BE PERFORMED ONLY UPON REQUEST

3. Sample Preparation for Microbilogical Analysis (Table 1)

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

ALKALINE 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.

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 (250 g total), and blend or stomach them in 250 mL of BLEB without supplements (basal BLEB); 50 g of this composite blend (equivalent to 25g food plus 25 ml basal BLEB) is combined with 200 ml of basal BLEB.

The composite is then inoculated as described by BAM chapter 10.

For Salmonella analysis, if sampling from a single wheel of cheese, remove 187.5 g from each of the halves in order to obtain a 375g 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.

If a wheel of cheese weighs more than 10 lb., obtain one wheel per lot and prepare two composites from the wheel. If a wheel weighs between 5 and 10 lb., obtain two wheels and prepare one composite per wheel.

To obtain the second composite for analysis, repeat this process on the other packages.

http://www.fda.gov/Food/FoodScienceResearch/LaboratoryMethods/ucm2006949.htm

E. coli, EHEC and STEC:

Aseptically, take 10 core subsamples from the wheel and analyze individually for EHEC O157:H7 and STEC. Analyze only 5 of those 10 core subsamples for generic E. coli (refer to Part V, Regulatory/Administrative Follow-Up).

S. aureus:

Aseptically, take 10 core subsamples of 50 g and analyze for S.

aureus.

b. Import or Domestic Cheese - retail units 454 g (1 lb.)

Since the product will be analyzed for multiple pathogens under this program, compositing and individual subsample analysis on the same sample will be necessary.

Listeria

Make two (2) composites from the ten (10) subsamples. To prepare a composite, remove 50 g from each of five (5) subsamples, and blend or stomach them in 250 mL of BLEB without supplements (basal BLEB); 50 g of this composite blend (equivalent to 25g food plus 25 ml basal BLEB) is combined with 200 ml of basal BLEB. The composite is then inoculated as described by BAM chapter 10.

Salmonella

Make two (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.

E. coli, EHEC and STEC

Analyze 10 subsamples individually for EHEC O157:H7 and STEC.

Analyze 5 of those subsamples for generic E. coli.

http://www.fda.gov/Food/FoodScienceResearch/LaboratoryMethods/ucm2006949.htm

S. aureus

Analyze 10 subsamples, take 50 g each and test individually for S.

aureus.

4. Sample Preparation for Phosphatase Analysis

a. Import or Domestic Cheese - subsamples 2.27 kg (5 lbs.) or greater

From the outer round edge of the cheese, remove the rind or the surface from the test sample with a clean knife. Ensure that the test sample is not contaminated with surface microflora during its preparation. The test portions to be analyzed are sampled by taking a portion of 1 cm thick, taken at 0.5 cm below the rind of the round side.

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.

From the outer round edge of the cheese, remove the rind or the surface from the test sample with a clean knife. Ensure that the test sample is not contaminated with surface microflora during its preparation. The test portions to be analyzed are sampled by taking a portion of 1 cm thick, taken at 0.5 cm below the rind of the round side

NOTE: SPECIAL PRECAUTIONS MUST BE TAKEN TO AVOID

CONTAMINATING SAMPLE WITH MICROBIAL PHOSPHATASES

THAT MAY BE PRESENT ON THE SURFACE OF THE CHEESE.

Table 1: Sample Preparation

Cheese weight

Salmonella Listeria E. coli, and

EHEC/STEC

S. aureus

>10 lb • obtain one wheel per lot

• prepare two composites from the wheel

• divide the wheel in half

• take a plug of 187.5g cheese, which includes both surfaces from each of halves in order to obtain a 375 g composite

• repeat this process to obtain the second composite

• obtain one wheel per lot

• prepare two composites from the wheel

• divide the wheel in half

• take 5 plugs of 50g cheese each, blend in 250 mL of BLEB without selective agents in order to obtain a composite

• repeat this process to obtain the second composite

• obtain one wheel per lot

• take 10 plugs of 25 g each and test individually for

EHEC/STEC

• take 5 plugs of 50 g each and test for generic E. coli.

• obtain one wheel per lot

• take 10 plugs of 50 g each and test individually for S. aureus

5 1b to <10 1b

• obtain two wheels per lot

• prepare one composite per wheel

• take 2 plugs of 187.5g cheese, which includes both surfaces from the wheel in order to obtain a 375 g composite

• repeat this process on the other wheel to obtain the second composite

• obtain two wheels per lot

• prepare one composite per wheel

• take 5 plugs of 50g cheese each, blend in 250 mL of BLEB without selective agents in order to obtain a composite

• repeat this process to obtain the second composite

• obtain two wheels per lot

• take 5 plugs of 25 g from each wheel and test individually for

EHEC/STEC

• take 5 plugs of 50 g each (2/3 split from 2 wheels) and test for generic E. coli.

• obtain two wheels per lot

• take 5 plugs of 50 g from each wheel and test

Cheese weight

Salmonella Listeria E. coli, and

EHEC/STEC

S. aureus

< 5 1b • make 2 composites from the 10 subsamples

• Prepare each composite by removing 75 g from each of 5 subsamples in order to obtain a 375 g composite

• make 2 composites from the 10 subsamples

• From each of the 5 subsample, take 50g cheese, blend in 250 mL of BLEB without selective agents in order to obtain a composite

• repeat this process to obtain the second composite

• obtain 10 subsamples, take 25 g and test individually for

EHEC/STEC

• take 50 g from 5 subsamples and test for generic E.

coli.

• obtain 10 subsamples, take 50 g and test

Methodology

a. Listeria monocytogenes

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: Avoid skin contact or aerosol formation and inhalation.

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: Refer to BAM online. Rapids test kit methods validated as AOAC OMA methods can be used. If L.

monocytogenes is detected in the sample, enumeration of the level of contamination in the food is required and representative isolated cultures should be sent to DEN for phage typing.

For phage typing, send a copy of the collection report and analyst worksheet for each sample. Place accompanying records inside the http://www.fda.gov/Food/FoodScienceResearch/LaboratoryMethods/ucm071400.htm shipping container, but not in the culture container. Ship according to Federal Standards for etiological agents to:

Sample Custodian Food and Drug Administration 6th Avenue & Kipling Street Denver Federal Center Building 20 Denver, Colorado 80225-0087

b. Salmonella

Examine (2) composites.

Isolation and identification: Refer to BAM online, chapter 5 (May 2014 Version).

Either the VIDAS Salmonella SLM (AOAC OMA method 2004.03 or 996.08) or VIDAS Salmonella SLM Easy (AOAC 2011.03) may be used in this assignment.

Add 187.5 g cheese to a sterile blender jar containing 1687.5 mL lactose broth and blend for 2 min at 10,000 – 12,000 rpm. Repeat with a second 187.5 g cheese portion. Combine the contents of the 2 blender jars into a single 4 L flask (or any other appropriate container). The combined contents of the 2 blender jars shall constitute a single 375 g composite. Repeat procedure with two

187.5 g cheese portions to form the second 375 g cheese composite.

Allow flasks to stand for 60 ± 5 min at room temperature. Mix well and determine the pH with test paper. Adjust pH, if necessary, to 6.8 ± 0.2 with sterile 1 N NaOH or 1N HCl.

Test according to VIDAS SLM and Easy SLM assays

• For the VIDAS Salmonella SLM and Easy SLM assays incubate flasks without shaking for 18-24 h at 34-36º C.

• For the VIDAS SLM Assay for Salmonella transfer 0.1 ml lactose broth to 10 ml RV medium and transfer another 1.0 ml of pre-enrichment broth to 10 ml TT broth and incubate in a circulating, thermostatically controlled water bath for 18-24 h at 41-42°C. Subculture 1.0 ml aliquots from the incubated TT and http://www.fda.gov/Food/FoodScienceResearch/LaboratoryMethods/ucm070149.htm

RV broths to separate tubes containing 10 ml portions of M-broth (post enrichment) and incubate at 41-42°C for 6-8 h.

Continue as described in the kits instructions (AOAC Official Method of Analysis 2004.03 or 996.08).

• For the VIDAS® Easy Method (OMA First Action Method

2011.03), transfer 0.1 ml preenrichment broth to 10 ml SX2 broth and incubate in a circulating, thermostatically controlled water bath for 16-22 h at 42±1°C. Continue as described in the kits instruction.

• Presumptive positive samples must be confirmed culturally by streaking selective enrichments to selective agars as described in the BAM, May 2014 Version, Chapter 5, section D-3 and section D-4 (http://www.fda.gov/Food/FoodScienceResearch/LaboratoryM ethods/ucm070149.htm). Continue as described in the BAM.

Speciation

Submit cultures on brain heart infusion (BHI) agar slants and provide hardcopy information as directed in BAM, Chapter 5, section E.11.

(http://www.fda.gov/Food/FoodScienceResearch/LaboratoryMethods/uc m070149.htm) and send to:

Isolates from NRL, WEAC, SRL and ARL will be serotyped in ARL:

Arkansas Regional Laboratory 3900 NCTR Road Building 26 Jefferson, AR 72079 Attention: Gwendolyn Anderson Phone: 870-543-4621

Isolates from SAN, PRL-NW, PRL-SW and DEN will be serotyped in

DEN:

Denver District Laboratory 6th Avenue & Kipling Street DFC Building 20 Denver, CO 80225-0087 Attention: Shauna Madson Phone: 303-236-9631

c. E.coli (non-toxigenic generic E.coli)

• Examine only five (5) subsamples individually. Do Not conduct testing on each individual 10 (ten) subsamples allocated for Listeria monocytogenes and Salmonella or pathogenic E.coli (EHEC and STEC)

• Isolation, identification, and enumeration: Refer to BAM, Online, Chapter 4, Section I.

• Alternatively, the use of a flurogenic substrate method for enumerating for E. coli in cheese has also been cleared by ORS (DFS) per Notification No: 2009-10-29. Microbiology Operations – Cheese Program – Use of ColiComplete Procedure and Confirmation Steps for E. coli Identification.

• The following also pertains to cheese analysis. Notification No:

2009-11-13. Microbiology Operations – Cheese Program – E. coli, MPN Analysis.

d. Enterohemorrhagic E.coli (O157: H7) and Shiga toxin-producing E. Coli (Non-O157:H7) STEC

• Examine each of the 10 subsamples individually.

• "Screening Methods for Enterohemorrhagic E. coli (EHEC) and STEC", refer to BAM, Online, Chapter 4A, Sec. K.

e. Staphylococcus aureus

• Examine each of the 10 subsample individually.

• Methods for identification, enumeration, coagulase, ancillary tests, and Most Probable Number -- Bacteriological Analytical Manual, Online: Chapter 12, Staphylococcus aureus (http://www.fda.gov/Food/FoodScienceResearch/LaboratoryMethods /ucm071429.htm) and Appendix 2, Most Probable Number from Serial Dilutions, (http://www.fda.gov/Food/FoodScienceResearch/LaboratoryMethods /ucm109656.htm).

• Enterotoxin testing is recommended when: direct plate counts indicate a level of greater than or equal to 104 cfu/g; MPN results of greater than or equal to 104 MPN/g; or if product time and temperature abuse is suspected.

http://www.fda.gov/Food/FoodScienceResearch/LaboratoryMethods/ucm064948.htm http://www.fda.gov/Food/FoodScienceResearch/LaboratoryMethods/ucm070080.htm http://www.fda.gov/Food/FoodScienceResearch/LaboratoryMethods/ucm071429.htm http://www.fda.gov/Food/FoodScienceResearch/LaboratoryMethods/ucm071429.htm http://www.fda.gov/Food/FoodScienceResearch/LaboratoryMethods/ucm109656.htm http://www.fda.gov/Food/FoodScienceResearch/LaboratoryMethods/ucm109656.htm

Staphylococcal Enterotoxin Determination

• Methods for staphylococcal enterotoxin testing -- Bacteriological Analytical Manual, Online: Chapter 13A, Staphylococcal enterotoxins (http://www.fda.gov/Food/FoodScienceResearch/LaboratoryMethods /ucm073674.htm). There is zero tolerance for staphylococcal enterotoxin presence in foods. Detection of any level of staphylococcal enterotoxin is justification that the food is unfit for consumption.

NOTE: Some species of Staphylococcus produce an enterotoxin that is extremely heat stable and not destroyed during food processing procedures or pasteurization temperatures. Therefore, it’s possible to have staphylococcal enterotoxin presence without viable Staphylococcus aureus.

If the product is suspected to have caused staphylococcal food poisoning and undergone retort procedures, see references 11 and 12 in the BAM for alternative detection methods for staphylococcal enterotoxin.

f. Alkaline 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 1240.61(a).

Products to be Analyzed

• Soft/semi-soft/soft-ripened cheese samples MUST be analyzed for alkaline phosphatase and for all the other attributes specified under A. 2. "Analyses to be performed".

• Soft cheeses containing herbs MUST be analyzed for alkaline 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 alkaline 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.

http://www.fda.gov/Food/FoodScienceResearch/LaboratoryMethods/ucm073674.htm

• Other cheeses that are labeled as either pasteurized or made from dairy ingredients that have all been pasteurized MUST be analyzed for alkaline phosphatase and for all the other attributes specified under A. 2. "Analyses to be performed".

Screen Analysis

To determine the amount of alkaline phosphatase in a cheese sample, refer to BAM, online 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 BAM, Chapter 27 for the maximum phenol equivalent values allowed in different types of cheese and the 21 CFR Part 133 reference.

A sample is violative for alkaline phosphatase:

• if the cheese is listed in ATTACHMENT B, and the phenol equivalent value per gram is greater than the value listed for the cheese in ATTACHMENT B; or,

• if the cheese is NOT listed in ATTACHMENT B, and the phenol equivalent value per gram is greater than 12 mg.

Check Analysis

Check analyses MUST be performed on ALL violative samples.

Method: AOAC,18th Ed., 33.7.27 AOAC Official Method 946.

03, Phosphatase (Residual) in Cheese.

NOTE: This method is equivalent to AOAC Method 16. 275-16.

277 (13th Ed., 1980), cited in 21 CFR 133.5(c).

If a district laboratory chooses to use the AOAC method for the screening method then the check analysis is for a different analyst to run the AOAC method.

http://www.fda.gov/Food/FoodScienceResearch/LaboratoryMethods/ucm073603.htm http://www.fda.gov/Food/FoodScienceResearch/LaboratoryMethods/ucm073603.htm

B. FILTH ANALYSIS

If filth analysis is not specifically requested in the collection report, the laboratory should not perform filth analysis.

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 alkaline 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 18th Ed. Official Method 994. 05 (see 16.3. 04), Light Filth in Cheeses page 12.

If not applicable, then use:

AOAC, 18 Ed., Chapter 16, Extraneous Materials: Isolation, AOAC Official Method 960.49 (see 16. 3. 03), Filth in Dairy Products, pages 11-12.

C. ANALYTICAL REPORTING

Report all microbiological, alkaline phosphatase and filth analyses against this Compliance Program. Refer to the 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 alkaline Phosphatase

• ORA/ORS will notify CFSAN and ORA/OFFO/FFPOB of the results of the speciation at ORA HQ FOOD FEED PROGRAM REPORTING.

• Laboratories will enter data into FACTS.

• LMS data entry for Salmonella - Use Form Code "MIC" and Flag Code

"MIC"

• The analyzing laboratory should inform the collecting District when the lab cannot rule out (CRO) a pathogen finding and as soon as there is confirmation of a pathogen finding or non-finding in a sample collected under this compliance program.

2. Filth

• Record all filth findings on Attachment A. Also, when completing

Attachment A, be sure to indicate the method used on the form. This form should be shared with the home district and ORA/ OFFO/FFPOB

@ ORA HQ FOOD FEED PROGRAM REPORTING.

3. Sharing information with State Counterpart:

The Districts, ORA/Office of Partnerships (ORA/OP), and ORA/ORS will coordinate State involvement including sharing of FDA analytical results, which may be performed under contract, cooperative agreement, partnership agreement, or other collaborative efforts.

Table 2: Sample Analysis

Sample Analysis for Salmonella

BAM online, Chapter 5 (May 2014 Version):

http://www.fda.gov/Food/FoodScienceResearch/LaboratoryMethod s/ucm070149.htm.

Sample Preparation

• Add 187.5 g cheese to a sterile blender jar containing 1687.5 mL lactose broth and blend for 2 min at 10,000 – 12,000 rpm, or 187.5g of cheese should be blended with a sufficient volume of lactose broth to adequately blend the cheese and then bringing the total volume up to 1875mls.

• Repeat with a second 187.5 g cheese portion.

• Combine the contents of the 2 blender jars into a single 4 L flask (or any other appropriate container). The combined contents of the 2 blender jars shall constitute a single 375 g composite.

• Repeat procedure with two 187.5 g cheese portions to form the second 375 g cheese composite.

• Allow flasks to stand for 60 ± 5 min at room temperature. Mix well and determine the pH with test paper. Adjust pH, if necessary, to 6 8 ± 0.2 with sterile 1 N NaOH or 1N HCl.

Preenrichment • Incubate flasks without shaking for 22-26 h at 35±2º C.

Or if VIDAS Salmonella SLM and Easy SLM assays will be used, incubate flasks as instructed by the kit manufacturer.

Selective enrichment

• Follow the BAM online, Chapter 5 (May 2014 Version):

http://www.fda.gov/Food/FoodScienceResearch/LaboratoryMethods/ucm0 70149.htm.

Or if VIDAS Salmonella SLM and Easy SLM assays will be used, selectively enrich as instructed by the kit manufacturer.

Isolation and Identification

Follow the BAM online, Chapter 5 (May 2014 Version):

http://www.fda.gov/Food/FoodScienceResearch/LaboratoryMethods/ucm070 149.htm.

Culture submission

Follow the BAM online, Chapter 5 (May 2014 Version):

http://www.fda.gov/Food/FoodScienceResearch/LaboratoryMethods/ucm070 149.htm.

Sample Analysis for Listeria

BAM online (Chapter 10) http://www.fda.gov/Food/FoodScienceResearch/LaboratoryMethods/u cm071400.htm

Sample Preparation

From the prepared composite mix, 50 g is added to 200 mL of BLEB without selective agents

Incubate for 4 h at 30°C. Add the selective agents and continue incubating for a total time of 48 h at 30° C.

VIDAS Listeria AOAC 999.06 or 2004.06 Follow BAM online (Chapter 10) http://www.fda.gov/Food/FoodScienceResearch/LaboratoryMethods/ucm071 400.htm

Follow BAM online (Chapter 10) http://www.fda.gov/Food/FoodScienceResearch/LaboratoryMethods/ucm071 400.htm

Sample Analysis for E.coli and EHEC

E. coli – use the MPN method described in Chapter 4. Online

BAM

http://www.fda.gov/Food/FoodScienceResearch/LaboratoryMetho ds/ucm064948.htm The fluorogenic method using ColiComplete is also permitted for cheese testing as per DFS Notification No: 2009-10-29.

EHEC/STEC – Use method described in Chapter 4A. Online

BAM

http://www.fda.gov/Food/FoodScienceResearch/LaboratoryMetho ds/ucm070080.htm

Sample Preparation E. coli – Blend 50 g sample in 450 ml Butterfield’s phosphate buffered water. Do 10 fold serial dilutions and inoculate LST tubes. Follow http://www.fda.gov/Food/FoodScienceResearch/LaboratoryMethods/ucm070149.htm http://www.fda.gov/Food/FoodScienceResearch/LaboratoryMethods/ucm070149.htm http://www.fda.gov/Food/FoodScienceResearch/LaboratoryMethods/ucm070149.htm http://www.fda.gov/Food/FoodScienceResearch/LaboratoryMethods/ucm070149.htm http://www.fda.gov/Food/FoodScienceResearch/LaboratoryMethods/ucm070149.htm http://www.fda.gov/Food/FoodScienceResearch/LaboratoryMethods/ucm070149.htm http://www.fda.gov/Food/FoodScienceResearch/LaboratoryMethods/ucm064948.htm http://www.fda.gov/Food/FoodScienceResearch/LaboratoryMethods/ucm064948.htm

MPN procedure as described in Chapt. 4, Sec. I.C. of the BAM procedure.

EHEC/STEC – Blend or stomach 25 g of sample in 225 ml mBPWp.

Preenrichment/ selective enrichment

EHEC/STEC – follow procedure described in Chap. 4A Sec. N.2.

Screening enrichment sample

EHEC/STEC – use the rt-PCR method described in Chap. 4A, Sec. K. of the BAM procedure.

Isolation and identification

EHEC/STEC – used method described in BAM Chap. 4A, Sec. P for O157:H7 and Sec. R. for STEC.

Sample Analysis for S. aureus

S. aureus –Use the MPN method for routine surveillance of products in which small numbers of S. aureus are expected and direct plate count method when more than 100 S. aureus cells/g may be expected, as described in the Chapter 12, Staphylococcus aureus. Online BAM.

http://www.fda.gov/Food/FoodScienceResearch/LaboratoryMethods/uc m071429.htm and Appendix 2, Most Probable Number from Serial Dilutions. Online BAM.

http://www.fda.gov/Food/FoodScienceResearch/LaboratoryMethods/uc m109656.htm

Sample Preparation S. aureus – Blend 50 g sample in 450 ml Butterfield’s phosphate buffered water. Follow MPN procedure as described in Chapter 12, Staphylococcus aureus. Online BAM.Chapter 12, Staphylococcus aureus. Online BAM.

Preenrichment/ selective enrichment

S. aureus – Inoculate 3 tubes of TSB containing 10% NaCl and 1% sodium pyruvate with 1 ml portions of decimal dilutions of each sample.

Follow procedure described in Chapter 12, Staphylococcus aureus.

Online BAM.

Screening enrichment sample

S. aureus – follow procedure described in Chapter 12, Staphylococcus aureus. Online BAM.

Isolation and identification

S. aureus – use the identification methods described in Chapter 12, Staphylococcus aureus. Online BAM.

Additional testing Enterotoxin testing is recommended when: direct plate counts indicate a level of greater than or equal to 104 CFU/g; MPN results of greater than or equal to 104 MPN/g; or if product time and temperature abuse is suspected.

Methods for staphylococcal enterotoxin testing

Staphylococcal Enterotoxin testing - use the detection methods as described in Chapter 13A, Staphylococcal enterotoxins. Online BAM.

(http://www.fda.gov/Food/FoodScienceResearch/LaboratoryMethods/uc m073674.htm). There is zero tolerance for staphylococcal enterotoxin presence in foods. Detection of any level of staphylococcal enterotoxin is justification that the food is unfit for consumption http://www.fda.gov/Food/FoodScienceResearch/LaboratoryMethods/ucm064948.htm http://www.fda.gov/Food/FoodScienceResearch/LaboratoryMethods/ucm064948.htm http://www.fda.gov/Food/FoodScienceResearch/LaboratoryMethods/ucm070080.htm http://www.fda.gov/Food/FoodScienceResearch/LaboratoryMethods/ucm070080.htm http://www.fda.gov/Food/FoodScienceResearch/LaboratoryMethods/ucm070080.htm http://www.fda.gov/Food/FoodScienceResearch/LaboratoryMethods/ucm070080.htm http://www.fda.gov/Food/FoodScienceResearch/LaboratoryMethods/ucm070080.htm http://www.fda.gov/Food/FoodScienceResearch/LaboratoryMethods/ucm071429.htm http://www.fda.gov/Food/FoodScienceResearch/LaboratoryMethods/ucm071429.htm http://www.fda.gov/Food/FoodScienceResearch/LaboratoryMethods/ucm109656.htm http://www.fda.gov/Food/FoodScienceResearch/LaboratoryMethods/ucm109656.htm http://www.fda.gov/Food/FoodScienceResearch/LaboratoryMethods/ucm071429.htm http://www.fda.gov/Food/FoodScienceResearch/LaboratoryMethods/ucm071429.htm http://www.fda.gov/Food/FoodScienceResearch/LaboratoryMethods/ucm071429.htm http://www.fda.gov/Food/FoodScienceResearch/LaboratoryMethods/ucm071429.htm http://www.fda.gov/Food/FoodScienceResearch/LaboratoryMethods/ucm071429.htm http://www.fda.gov/Food/FoodScienceResearch/LaboratoryMethods/ucm071429.htm http://www.fda.gov/Food/FoodScienceResearch/LaboratoryMethods/ucm071429.htm http://www.fda.gov/Food/FoodScienceResearch/LaboratoryMethods/ucm071429.htm http://www.fda.gov/Food/FoodScienceResearch/LaboratoryMethods/ucm073674.htm

PART V - REGULATORY/ADMINISTRATIVE FOLLOW-UP

Districts should use the following table to aid in determining appropriate regulatory response to microbiological contamination, filth or phosphatase results. The overarching compliance goal is to remove adulterated product from the market, and prevent future entry of adulterated product into the market.

Regulatory activities that should be considered in both domestic and import cases include:

• The recommendation of a follow up comprehensive GMP inspection to determine potential source(s) of contamination;

• When pathogens are detected, further sampling efforts should consider testing of raw materials (incoming raw milk if pathogenic E. coli was detected in cheese), finished product cheese and/or swabbing of the processing environment (of domestic manufacturers) to verify adequacy of sanitation;

• A review of PFGE and whole genome sequencing data to investigate related food, environment and clinical isolates;

• Working with the firm to obtain prompt voluntary corrective actions to address violative findings; and

• A determination as to whether controls and checks are in place to provide assurance of product safety.

The following Table lists the sample results and possible regulatory responses with FD&C Charges:

Sample Result FD&C Act Charge Possible Response1

Salmonella

Listeria monocytogenes

Enterohemorrhagic E. coli (O157:H7) and Shiga toxin-producing E. coli (Non- O157:H7)2

DOMESTIC

402(a)(1)

• Voluntary recall

• Administrative Detention

• Seizure

• Injunction

• Mandatory recall

• Suspension of Registration

• Environmental sampling at manufacturing site (if Salmonella or L.

monocytogenes is detected)

• Sampling of raw milk (if pathogenic E.

coli is detected)

1 See CPG Sec. 527.300, Dairy Products- Microbial Contamination and Alkaline Phosphatase Activity (currently being updated).

http://www.fda.gov/downloads/iceci/compliancemanuals/compliancepolicyguidancemanual/ucm238480.pdf

2 Samples that are only positive for stx1 and/or stx2 are indicative that non-O157 STEC may be present. There are ~ 300 serotypes of STEC and not all appear to cause severe illness in humans, therefore, these isolates require further testing. Follow the procedure described in BAM Chap. 4A, Sec. R. for isolation of non-O157 STEC. Send the STEC isolate to Peter Feng, CFSAN, for additional testing to determine if is a STEC strain of health concern.

http://www.fda.gov/downloads/iceci/compliancemanuals/compliancepolicyguidancemanual/ucm238480.pdf

Staphylococcal enterotoxin charge

Bacillus cereus enterotoxin

IMPORT

402(a)(1)/ 801(a)(3)

• Detention/Refusal

• Addition of firm/product to Import Alert

12-10

• Consider increased import sampling

• Consider inspection of foreign firm

(Direct reference for import actions based on Salmonella and Listeria monocytogenes) Staphylococcus enterotoxin, or Bacillus cereus enterotoxin) http://inside.fda.gov:9003/PolicyProcedures/ Compliance/DirectReference/default.htm

Non-toxigenic (generic) E.

coli3 - Levels exceeding 10 MPN/g but less than 100 MPN/g in three or more subsamples of the five examined; or levels at or above 100 MPN/g in one or more subsamples of the five examined

S. aureus - Greater than or equal to 104 colony forming units per gram (cfu/g) B. cereus - Greater than or equal to 104 colony forming units per gram (cfu/g)

DOMESTIC

402(a)(4)

• Warning Letter

• Regulatory Meeting

• Seizure of adulterated lot

402(a)(4)/ 801(a)(3)

• Detention/Refusal

• Addition of firm/product to Import Alert

12-10

• Consider increased import sampling

• Consider inspection of foreign firm

Alkaline Phosphatase DOMESTIC 402(a)(4)

• Determine if there is evidence that bovine milk is inadequately pasteurized or unpasteurized

• Warning Letter

IMPORT

402(a)(4)/ 801(a)(3)

• Consider Detention/refusal

• Consider inspection of foreign firm

Filth DOMESTIC 402(a)(3)

• Warning Letter

• Seizure of adulterated lot

3 Discuss any excessive generic E. coli findings with the Center.

http://inside.fda.gov:9003/PolicyProcedures/Compliance/DirectReference/default.htm http://inside.fda.gov:9003/PolicyProcedures/Compliance/DirectReference/default.htm

402(a)(3)/ 801(a)(3)

• Detention/refusal

• Consider inspection of foreign firm

Consider referral to the State when:

There is no interstate, AND There is no evidence of widespread contamination.

Follow up with the state should include discussion of activities the State plans to initiate on the remaining product at the retail level and/or processing plant (if applicable).

Consider a voluntary recall when:

Implicated product is on the market.

Consider a mandatory recall when:

Implicated product is on the market, AND The party in control of the product refuses to recall voluntarily, AND The party in control of the product is a facility as defined in 21 CFR 1.227(2)(i), AND There is clear evidence of serious adverse health consequences or death to humans or animals.

Consider administrative detention when:

A seizure is contemplated, AND The Agency needs to quickly gain control of the food while the seizure case is built.

Consider a seizure when:

The product is in domestic commerce, AND The amount of product meets the seizure monetary threshold in the RPM and, The firm refuses to voluntarily destroy or recondition the product.

Consider detention when:

The implicated product is in import status.

Consider DWPE when:

The conditions of Import Alert 12-10, Detention Without Physical Examination of Cheese Due to Microbiological Contamination have been met.

Domestic products:

• 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, Foods, Rail Car Sanitation – Adulteration, with regard to action against the carrier (.

• When finished product samples are positive for presence of Listeria or Salmonella, districts may consider direct reference seizure of the cheese and cheese products as authorized (see CPG Sec. 527.300, Dairy Products- Microbial Contamination and Alkaline Phosphatase Activity.

http://cms.fda.gov/vts/imports_publish/private/importalert_9.html http://www.fda.gov/iceci/compliancemanuals/compliancepolicyguidancemanual/ucm074513.htm http://www.fda.gov/downloads/ICECI/ComplianceManuals/CompliancePolicyGuidanceManual/UCM238465.pdf

• If no INTERSTATE documentation can be associated with violative intrastate cheese samples, contact State authorities to coordinate appropriate follow-up activities. Provide assistance to the State for sanctioning their follow-up activity, if requested.

Import Products:

• Recommendations for detention without physical examination of imported products should be referred to the Division of Import Operations, Import Operations and Maintenance Branch through CMS.

• Districts may consider detention of cheese and cheese products when samples are positive for presence of human pathogens and enterotoxins as authorized (see CPG Sec.

527.300, Dairy Products- Microbial Contamination and Alkaline Phosphatase Activity.

• For imported products that are in domestic or domestic/import status, notify the

CFSAN/ DE regulatory contact listed in PART VI, under section C. PROGRAM CONTACTS, for further guidance if the levels for E. coli, Enterohemorrhagic E. coli, STEC or Staphylococcus aureus are found at or above the levels mentioned in the above Table.

• 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/DE regulatory contact listed in PART VI, 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, Import Operations and Maintenance Branch through CMS.

Alkaline phosphatase samples for both domestic and imported products:

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. A cheese sample with a phenol equivalent value per gram greater than the value listed in Attachment B.