U.S. Food Drug Administration
Center for Food Safety Applied Nutrition

Food Compliance Program

Domestic and Imported Cheese and Cheese Products
Issued 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 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

 



 

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


 

Program Management Instructions
 
 

    

  1. 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.

  2. 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

Camembert

    

    
Bondon

Fynbo

Coulommiers

    

    
Cambridge

Gammelost

Crescenza

    

    
**Cottage**

Gorgonzola

Kloster

    

    
Cream

Gouda

Konigskrase

    

    
Damen

Havarti

Milano

    

    
Farmers

Herve

Monthery

    

    
Ferme

Limburger

Old Heidlburg

    

    
Feta

Maribo

Reblochon

    

    
Formagelle

Molbo

Robbiole

    

    
Gournay

Monterey

Robbiolini

    

    
Livarot

Muenster

Rollot

    

    
Maigre

Oka

Romadur

    

    
Mignot

Pont L=Eveque

Scholoss

    

    
Mont 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

 

 

    

    

  3. 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

Romano

    

    
English Dairy

Saloio

    

    
Esrum

Sassenage

    

    
Fiore Sardo

Swiss

    

    
Fontina

Tibet

    

    
Gex

Tignard

    

    
Gislev

Toscanello

    

    
Gloucester

Uri

    

    
Karut

Vize

    

    
Kasseri

 

    

    
Kefalotyi

 

    

    
 

    PART III - INSPECTIONAL
    

      

    1. INSPECTIONAL

        

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

          

        1. Soft Cheese

        2. Hard Cheese

        3. 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
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 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.
      

    2. SAMPLE COLLECTION

        

      1. General Information
CRefer to ORA Workplan for District sampling obligations.
CDuring scheduled inspections, collect samples when either of the
following criteria have been met:

          

        1. 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

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

        

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

          

        1. Soft Cheese

        2. Hard Cheese

        3. Cheese Products
 
        

        NOTE: This excludes cheese subject to detention without
physical examination in accordance with current Import Alerts.
 

      3. 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.

          

        1. 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.

          

        2. 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).
          

        

      4. Sample Shipment

        • Ship samples to District's servicing microbiological laboratory.

        • Refer to IOM, January 1998, Section 452. 6, for sample handling of
refrigerated samples.
        

      5. 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


    

  1. 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:

        

      1. Listeria monocytogenes

      2. Salmonella

      3. 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.

      4. Enterohemorrhagic E. coli (O157: H7)

      5. 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.

      6. Phosphatase

      

    3. Sample Preparation

      For the purpose of this compliance program only, samples are
to be prepared as follows:

        

      1. 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.

        

      2. 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

        

      1. 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.

      2. 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. 

    6. Methodology

        

      1. 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).

          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)  236-3067
or Moises O=Neill, Microbiologist at (303)  236-9605, with shipping
information.

        

      2. Salmonella

          

        • Examine (2)  composites.

        • 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.

        • 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
          

          

        

      3. E.coli/Enterotoxigenic E. coli (ETEC)

          

        • Examine each subsample individually.

        • Isolation, identification, and enumeration -- BAM, 8th Ed.  , 1995, Chapter 4.

        • LT/ST Toxin Test -- BAM, 8th Ed.  , 1995, Chapter 24.
 

          NOTE: Do not analyze for ETEC unless E.
coli is > 10,000 per gram.
 

        

      4. Enterohemorrhagic E.coli (0157: H7)

        • CExamine each subsample individually.

        • "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.@
        
 

      5. Staphylococcus aureus

          

        • Examine each subsample individually.

        • 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.

        • 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.

        

      6. 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.
 

      7. 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).

        

      

    
 

  2. 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

        

      1. 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.

      2. 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 11-12.

    

  3. 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

        

      • CMIN will notify the Home District of the results of the speciation.

      • Record all analytical findings, including the level of microorganism
found (if appropriate) on Attachment A, Analytical Reporting Form.

      • 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.

      • Laboratories will enter data into MICRO-IS using established Q-Sets.

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

      • 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

        

      • Record all filth findings on Attachment B.   Also, when completing
Attachment B, be sure to indicate the method used on the form.

      • 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

 

 

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


    

  1. 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

  2. REFERENCES
 


  3. PROGRAM CONTACTS

 

  4. SPECIFIC METHOD CONTACTS




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 Date
FY 1999April 1, 2000
FY 2000April 1, 2001
FY 2001April 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. monocyto-
genes, 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

SUB # 1

SUB # 2

SUB # 3

SUB #4

SUB # 5 




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 - 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

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)

 

 

 

 

 

 




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

CFR
Reference




brick 

20

133.  108(a)(2) 




cheddar 

12

133.  113(a)(2) 




colby

12

133.  118(c)(2) 




cook cheese, koch kaese

12

133.  127(a)(2) 




washed curd and soaked curd


12

133.  136(a)(2) 




edam

12

133.  138(a)(2) 




granular and stirred curd


12

133.  144(a)(2) 




gruyere

12

133.  149(a)(2) 




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.




 


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