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Domestic and Imported Cheese and Cheese

ProductsIssued November 19, 1998

CHAPTER 03 - FOODBORNE BIOLOGICAL HAZARDS

DOMESTIC AND IMPORTED CHEESE AND Upon Receipt

CHEESE PRODUCTS (FY 99/00/01)

(LAB) 9/30

Industry Code 03037 - Inspections,

Use appropriate product code Investigations,

and ALL Sample

Collections

03037B - Filth Analysis

03037D - Microbiological

and Phosphatase

Analyses

FIELD REPORTING REQUIREMENTS

NOTE: MICROBIOLOGICAL AND FILTH WORK FOR ALL CHEESE AND CHEESE PRODUCTS ARECOVERED 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 ANDCOLOR 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 CERTIFICATEAGREEMENT WITH FRANCE (IMPORT ALERT 12-03) AND CURRENT DETENTIONS WITHOUT

PHYSICAL EXAMINATION OF OTHER CHEESES FROM COUNTRIES OTHER THAN FRANCE AGAINSTTHIS PROGRAM.

Hardcopy Reporting

Send the following hardcopy on an as completed basis to:

FDA/CFSAN/Division of Enforcement and ProgramsImports Branch, HFS-606

Attention: Cheese Monitor - R. Gary200 - C Street, S.W., Room 5413

Washington, D.C. 20204

LaboratoryAttachment A, Analytical Reporting Form - Microbiological and Phosphatase

Attachment B, Analytical Reporting Form - Filth

PART I - BACKGROUND

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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 softcheeses) 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 numberof 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 formicrobiological 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 healthhazard. 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 programincludes 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 thisCompliance Program.

B. Examples of "Soft" Cheese

For this Compliance Program "soft cheese" refers to soft, semi-soft, or soft-ripened cheese.

Soft (fresh) Semi-Soft Soft-Ripened

Alemtejo Bellelay Barberey

Alpin Blue Bel Paese

Anari Brick Bella Alpina

Asadero Camosun Bella Milano

Asiago Chantelle Brie

Bakers Edam Butter

Banbury Fontina CamembertBondon Fynbo Coulommiers

Cambridge Gammelost Crescenza

**Cottage** Gorgonzola Kloster

Cream Gouda Konigskrase

Damen Havarti Milano

Farmers Herve Monthery

Ferme Limburger Old Heidlburg

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Feta Maribo Reblochon

Formagelle Molbo Robbiole

Gournay Monterey Robbiolini

Livarot Muenster Rollot

Maigre Oka Romadur

Mignot Pont L=Eveque ScholossMont d'Or Port du Salut Trouville

Mozzarella **Provolone** Vacherin

Neufchatel Roquefort Vittoria

Queso Blanco Saint Paulin Vendome

Queso de Hoja Stilton

Queso del Pais Tilsit

Queso de Puna Trappist

Queso Fresco

Provatura

Ricotta

Scamorze

Villiers

Void

C. Examples of "Hard" Cheese

Abertam Kjarsgaard

Appenzeller Laguiole

Battelmatt Lapland

Bitto Lorraine

Bra Mecklenburg Skim

Cantel Montasio

Cheddar Mont Cenis

Cheshire Patagras

Christalinna Piora

Colby Queso de Prensa

Coon Radener

Derby Roll

Emiliano Romanello

Emmentaler RomanoEnglish Dairy Saloio

Esrum Sassenage

Fiore Sardo Swiss

Fontina Tibet

Gex Tignard

Gislev Toscanello

Gloucester Uri

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Karut Vize

Kasseri

Kefalotyi

PART III - INSPECTIONALA. INSPECTIONAL

Establishment inspections for domestic cheese and cheese productmanufacturers 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 conductedby 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 filthand 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 microbialcontamination, refer to the IOM, January 1998, Sections 536.2 and427.7 respectively, for inspectional guidance and sampling

instructions for products susceptible to pathogenic and non-pathogenic 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 foodproducts are shipped in compliance. When the condition of a transport

vehicle may lead to food contamination, attempt to dissuade the shipperfrom using it. If unsuccessful, notify the destination District so they may

follow-up. See PART V - Regulatory/ Administrative Follow-Up for moreinformation.

B. SAMPLE COLLECTIONC. 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, previousinspectional 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 samplesare to be collected as follows: Samples are to be collected in solid, shredded,

grated, curds or extruded forms.

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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 unitsfrom 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 unitsto 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 willequal 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 cheeseportions 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 unitsto 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 willequal 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 unitsfrom 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 microbiologicalcontamination, 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 ORNUTRITION 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 withoutphysical 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 auditsampled at the District's discretion. When audit samples are collected, these

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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 ANALYSIS1. Analyzing Laboratories All field laboratories as specified in the current servicinglaboratories 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 monocytogenesb. 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 VIABLESTAPHYLOCOCCAL SPP. COLONIES, MPN RESULTS OR DIRECT PLATE

COUNTS INDICATES A LEVEL OF 1 x 104.

f. Phosphatase3. 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 PHOSPHATASEANALYSES.

SPECIAL PRECAUTIONS MUST BE TAKEN TO AVOID CONTAMINATING THE

PORTIONS FOR MICROBIOLOGICAL ANALYSES AS WELL AS THE PORTIONFOR 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 samplewill 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 fromeach half of the cheese unit;

For Listeria analysis, remove 125 g from each of the halves inorder to obtain a 250-gram composite. Remove 25 g from the

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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 thepackages 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 thisprogram, compositing and individual subsample analysis on the same sample

will be necessary.

1. Listeria

Make two (2) composites from the ten (10) subsamples. Prepare eachcomposite 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. Eachcomposite will contain a total of 375 g.

NOTE: When compositing shredded, grated and extruded forms ofcheese, remove the amount required for each composite from the

packages aseptically in order to obtain the required compositeamounts for Listeria and Salmonella analysis.

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

3. E. coli,ETEC,EHEC,and S.aureus Once the portions have been removedfor 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 centerof cheese.

NOTE: SPECIAL PRECAUTIONS MUST BE TAKEN TO AVOID CONTAMINATINGSAMPLE WITH MICROBIAL PHOSPHATASES THAT MAY BE PRESENT ON THE

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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, forsample 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 THESURFACE OF THE CHEESE.

For samples of shredded, grated or extruded forms of cheese, remove 15 g

from the unit aseptically for analysis.

5. Methodologya. Listeria monocytogenes

1. Examine (2) composites.

Safety Precautions: Media preparation for L. monocytogenes directs

the use of cycloheximide which is an extremelytoxic 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

extremesafetyprecautions 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 ascycloheximide 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 ofListeria Rapid Methods for FoodMicrobiology@ dated July 9, 1998, may be used according to

the instructions and restrictions explained in the memo. If thelaboratory 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 toDEN 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, butnot in the culture container. Ship according to Federal Standards for

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etiological agents to:

McHarrell Thomas

Food and Drug AdministrationP.O. Box 25087

Denver Federal CenterBuilding 20

Denver, Colorado 80225-0087

Contact McHarrell Thomas, Supervisory Microbiologist at (303) 236-3067 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 tothe 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-MW400240 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 Tellurite-

Cefixime-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.

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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/ unpasteurizedmilk, 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 in21 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 underA. 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 beanalyzed for phosphatase, but MUST be analyzed for all the

other attributes specified under A. 2. "Analyses to bePerformed. "

NOTE: A naturally aged cheese is one made from unpasteurized milkwhich 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 madefrom dairy ingredients that have all been pasteurized MUST be

analyzed for phosphatase and for all the other attributesspecified 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 thesecheeses to determine the phenol equivalent value.

Refer to Table 1 of the method for the maximum phenol equivalentvalues 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 cheesein 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.

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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 servicinglaboratories chart under Appendix III of the ORA field workplan.

2. Sample Preparation Instructions for Filth Analysisa. 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. Forsamples 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 (8oz.) 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 Method960.49 (see 16. 3. 03), Filth in Dairy Products (Supplement March 1995), pages 11-

12.

C. ANALYTICAL REPORTING

NOTE: Report all microbiological, phosphatase and filth analyses against this ComplianceProgram 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 Phosphatasea. CMIN will notify the Home District of the results of the speciation.

b. Record all analytical findings, including the level of microorganism found (ifappropriate) 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

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address.

2. Filtha. 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 maylead 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 recommendationto 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 inCPG 545. 300 with regard to action against the carrier.

Listeria and Salmonella

Direct reference seizure or detention of cheese and cheese products based on the presenceof 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, allpositive 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-upactivity, if requested.

Obtain information on the follow-up activities the State plans to initiate on the remainingproduct 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 shouldbe 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 regulatorycontact 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 arefound:

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/DOEPregulatory 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,

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collection report, labeling, etc. ).

Recommendations for detention without physical examination of imported products shouldbe referred to the Division of Import Operations and Policy, (HFS-170).

Phosphatase

Districts should submit recommendations for regulatory action based on phosphatasefindings 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 phenolequivalent 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 pergram 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 asoutlined in 21 CFR Part 133. 21 CFR Section 1240.61(a) prohibits such cheeses fromintroduction into interstate commerce.

NOTE: BEFORE RECOMMENDING REGULATORY ACTION, CHECK ANALYSES MUST BEPERFORMED ON ALL VIOLATIVE SAMPLES USING THE AOAC 16TH EDITION METHOD

943. 03 (33. 7.27), APHOSPHATASE (RESIDUAL) IN CHEESE (FINAL ACTION)@. THISMETHOD 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 ofEnforcement 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.)

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*Guidance for the Use ofListeria Rapid Methods for Food Microbiology* dated July9, 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 ofEnforcement and Programs/Case Processing Branch, HFS-607, (202) 205-5235

Imports - Rosemary Gary, CFSAN/OFP/Division of Enforcement andPrograms/Import Branch, HFS-606, (202) 205-4606, FAX (202) 260-0208

Inspectional Inquiries - Barbara Marcelletti, Division of Emergency andInvestigational Operations, Investigations Branch, HFC-132, (301) 827-5635

Import Alert and Import Procedures Inquiries - Doug Randes, Division of ImportOperations 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 MicrobiologicalStudies/Microbiology Methods Development Branch, HFS-516, (202) 205-4518

Salmonella - Wallace Andrews, Jr., CFSAN/Division of MicrobiologicalStudies/Microbiology Methods Development Branch, HFS-516, (202) 205-4462

Listeria - Anthony Hitchins, CFSAN/Division of Microbiological Studies/MicrobiologyMethods Development Branch, HFS-516, (202) 205-4650

Listeria Gene Probe - Thomas Cebula, CFSAN/Division of Molecular BiologicalResearch & Evaluation/Molecular Biology Branch, HFS-237, (202) 205-4817

Phosphatase - George C. Ziobro, CFSAN/Division of Natural Products/MicroanalyticalBranch, HFS-315, (202) 205-4994

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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 theeffectiveness 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 DateFY 1999 April 1, 2000FY 2000 April 1, 2001FY 2001 April 1, 2002DOMESTIC AND IMPORTED CHEESEANALYTICAL REPORTING FORM - MICROBIOLOGICAL ANALYSESFY: _______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 NEGSPECIES:SEROTYPE:If positive growth at 1: 1024 hrs. for L. monocyto-genes, give gene probe 1: 100results:RAPID TEST KIT USED

************************************************************************

SALMONELLA(circle one) POS NEG POS NEGGROUP:SPECIES, IF KNOWN:RAPID TEST KIT USED

DOMESTIC AND IMPORTED CHEESEANALYTICAL 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 # 1 SUB # 2 SUB # 3 SUB #4 SUB # 5

E. COLI (+/-)and MPN/G

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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 CHEESEANALYTICAL 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 CHEESEANALYTICAL REPORTING FORM - PHOSPHATASE ANALYSESFY: ________SAMPLE NUMBER: ____________________ TYPE OF CHEESE: ____________________(e.g. , hard, soft, semi-soft, soft- ripened)COLLECTING DISTRICT: ______________ANALYZING DISTRICT: _______________ NAME OF CHEESE:___________________

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(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 2 3 4 5 6

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)

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hard 12 133. 150(c)(2)

limburger 16 133. 152(a)(2)

monterey & monterey jack 12 133. 153(a)(2)

mozzarella & scamorza 12 133. 155(a)(2)

low moisture mozzarella & scamorza 12 133. 156(a)(2)

muenster & munster 12 133. 160(a)(2)

pasteurized process 12 133. 169(a)(2)

pasteurized process cheese food 12 133. 173(a)(2)

pasteurized neufchatel cheese spread with other foods 12 133. 178(a)(2)

pasteurized process cheese spread 12 133. 179(a)(2)

provolone 12 133. 181(a)(2)

samsoe 12 133. 185(a)(2)

semisoft 20 133. 187(c)(2)

semisoft part-skim 20 133. 188(c)(2)

spiced 12 133. 190(a)(2)

swiss & emmentaler 12 133. 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.